cyrilzakka/clinical-trials huggingface dataset:
Comparison of Geriatric Screening Methods in Newly Diagnosed Multiple Myeloma Patients

The purpose of this study is to compare clinical judgment and comprehensive geriatric assessment as screening tools for optimization of treatment for newly diagnosed elderly multiple myeloma patients.

Given the growing elderly multiple myeloma population, the increase in therapeutic possibilities and the importance of geriatric screening, this study wants:

* to compare clinical judgment with standardized geriatric screening approaches (G8, CGA and IMWG score) in newly diagnosed elderly myeloma patients and to evaluate their influence on the detection of geriatric problems and on the choice of the anti-myeloma treatment
* to evaluate how geriatric scoring and the subsequent treatment choice influences the therapeutic efficacy and toxicities

Geriatric scoring will be performed in 3 different ways:

* by clinical judgment performed by the treating physician
* by validated scoring systems independently performed by a trained nurse/ health care worker. Initial scoring will be done by the G8 score. If an abnormal G8 score is present (\<= 14), CGA will be performed.
* based on the CGA parameters, the Palumbo/IMWG geriatric score will be calculated

Results obtained by physician-based assessment and by geriatric assessment will be compared before treatment initiation. If, and to what extent the knowledge of the GA influences the therapeutic decision of the treating physician will be registered. In addition, we will register which geriatric problems diagnosed by the CGA assessment were already known or unknown by the treating physician. After three months of treatment and at the time of disease progression, geriatric assessment will be repeated in order to judge the evolution (disappearance, improvement, worsening) of the scored parameters, or the emergence of new geriatric symptoms.

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed multiple myeloma
* age =\> 70 years
* no previous anti-myeloma treatment except for local radiotherapy or short course (max 4 days) of high-dose dexamethasone
* signed informed consent
* patients included in an interventional therapeutic trial are eligible

Exclusion Criteria:

* previous systemic anti-myeloma treatment
* severe mental or cognitive disorder precluding geriatric assessment
* patient refusal to sign informed consent
Massage Therapy in Premature Neonates

The goal of this clinical trial is to learn about the effects of Neonatal Touch and Massage Therapy on premature babies.

The main questions it aims to answer are:

* Do babies who receive Neonatal Touch and Massage Therapy get discharged sooner from the NICU
* Does Neonatal Touch and Massage Therapy have a beneficial effect on weight gain, pain and stress responses, and neurodevelopmental outcomes.

Participants assigned to the treatment group will receive Neonatal Touch and Massage Therapy while admitted to the NICU. Researchers will compare their outcomes to a control group, receiving standard NICU care, to see if there are any differences in the length of hospital stay, weight gain, pain scores, neurodevelopmental outcomes, and incidence of other common conditions associated with prematurity.

The purpose of this study is to determine the effects of Neonatal Touch and Massage Therapy on premature infants in the NICU. Babies enrolled in this study will be randomly assigned to receive Neonatal Touch and Massage or standard NICU care. Babies in the therapy group will be given Neonatal Touch or Massage therapy by certified providers 3 days per week for 5 to 15 minutes. Therapy will be done for a minimum of 4 weeks. The investigators will assess pain and stress responses before and after treatment. The investigators will also review participant's medical records to collect information about weight gain, length of hospitalization, and general health status. After a participant is discharged home, information will be collected about participant's developmental assessments at regularly scheduled NICU follow-up clinic appointments. There are no significant risks with this therapy. Potential benefits of therapy include increased weight gain, shorter hospitalization, decreased pain and stress, and improved developmental outcomes. Information gained from this study could also help future babies.

Eligibility Criteria:
Inclusion Criteria:

* Infants born or admitted to University of Maryland NICU in the first 14 days of life
* Gestational age greater than 23 6/7 weeks and less than 32 weeks at birth
* Deemed medically stable by the medical care team

Exclusion Criteria:

* Life limiting conditions, including genetic syndromes
* Cyanotic heart disease
* Requiring major surgery or critically ill at time of intervention
* Osteopenia of prematurity with an existing fracture
Beneficial Effects of Korean Traditional Diets in Subjects With Hypertension and Type 2 Diabetes

This trial is being conducted to look for following changes when Korean traditional diets is taken in subjects with hypertension and type 2 diabetes:

To evaluate the improvement of the controlling fasting blood glucose and glycated hemoglobin.

To assess the controlling blood pressure and heart rate.

To evaluate the influence on cardiovascular risk factor, Triglyceride, cholesterol, High Density Lipoprotein-cholesterol and Low-Density Lipoprotein-cholesterol.

To evaluate the influence on Gamma-Glutamyl Transpeptidase.

To evaluate the influence on Cardiovascular risk factor.

To evaluate the influence on valsava score, breathing score and upright score.

The investigators aimed to investigate the efficacy of Korean traditional diets in controlling fasting blood glucose fluctuation, blood pressure, and cardiovascular risk factors in hypertensive and type 2 diabetic patients who were taking medications prescribed for respective diseases in a 12-week.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who are men and women volunteers 19\~80years
* Subject who have hypertension and type 2diabetes.
* Subject who have taking oral medications :

(hypoglycemic, blood pressure and lipid modifying drugs).

* Subject must provide written informed consent to participate in the study.

Exclusion Criteria:

* Subject with a history or evidence of clinically significant gastrointestinal,anorectal, hepatic, renal, neurological, pulmonary, endocrine, blood tumor,psychiatric.
* Hypertension(DBP\>116mmHg or SBP\>200 mmHg) having the history of cardiovascular events or taking medications known to affect lipoprotein metabolism.
* Having Type 1 diabetes mellitus or uncontrolled Type 2 diabetes mellitus (HbA1c \>9.0%).
* Subjects with the history of cancer.
* Subjects who have a gastrointestinal (GI) disease (Crohn's disease, etc.) that would increase the influence with absorbance medication or a GI surgery excluding appendectomy and hernia surgery.
* Having digestive, or central nervous system disorders.
* Subject is hematologic, or neuroretinopathy.
* Subject with uterine fibroids at ultrasonography.
* Having severe or malignant retinopathy.
* Having the impairment of renal and liver function, dysproteinemia, nephritic syndrome, or other renal disease.
* Having coagulopathy
* Having human immunodeficiency virus.
* Having the history of mental instability and of drug and alcohol.
* Having the history of reactions to our experimental products.
* Participating in other clinical trials within the past 2 months.
* Having laboratory tests, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study.
* Having the history of alcohol or substance abuse.
* Subject is pregnant, planning to become pregnant, or breast-feeding.
Hyperglucagonaemia in Patients With Type 2 Diabetes - Role of Glucagon Clearance

The study aims to evaluate the elimination and degradation of glucagon in patients with type 2 diabetes compared to matched healthy subjects.

In the present project the investigators wish to identify whether the elimination and degradation of glucagon differ between healthy control subjects and patients with type 2 diabetes. Furthermore, the investigators wish to examine whether obesity is an independent factor for altered glucagon metabolism. Thus, by examining glucagon elimination in obese subjects with and without type 2 diabetes and in lean subjects with and without type 2 diabetes the investigators will be able to describe the metabolic clearance rate (MCR) of glucagon in a broad spectrum of individuals with different levels of insulin resistance and beta cell dysfunction.

Eligibility Criteria:
Inclusion Criteria:

Patients with type 2 diabetes

* Caucasians above 35 years of age with diet or/and metformin-treated type 2 diabetes of at least 3 month duration (diagnosed according to World Health Organization (WHO) criteria
* BMI either below 27 or above 33 kg/m\^2
* Normal haemoglobin
* Informed consent

Subjects with NGT

* Caucasians above 35 years of age
* BMI either below 27 or above 33 kg/m\^2
* Normal HbA1c (according to WHO criteria)
* Normal haemoglobin
* Informed consent

Exclusion Criteria:

Patients with type 2 diabetes

* Inflammatory bowel disease
* Operation within the last 3 months
* Severe kidney disease (eGFR \< 60 ml/min)
* Severe liver disease (serum alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) \>2×normal values)
* Pregnancy and/or breastfeeding
* Age above 80 years
* Any condition that the investigators feel would interfere with trial participation

Subjects with NGT

* Diabetes
* Prediabetes (impaired FPG or HbA1c above 42 mmol/mol)
* First-degree relatives with diabetes
* Inflammatory bowel disease
* Intestinal resection
* Severe kidney disease (eGFR \< 60 ml/min)
* Liver disease (ALA T and/or serum ASA T \>2×normal values)
* Pregnancy and/or breastfeeding
* Age above 80 years Any condition that the investigators feel would interfere with trial participation
Effects of Aripiprazole in Overweight Patients Treated With Olanzapine for Schizophrenia or Schizoaffective Disorder

The primary purpose of this study is to compare the affects of aripiprazole and olanzapine on weight change.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients diagnosed with schizophrenia or schizoaffective disorder who are currently taking olanzapine.
Dose Escalation Study of TAK-117 (MLN1117) in Subjects With Advanced Cancer

The purpose of this study is to determine the maximum tolerated dose (MTD) and/or optimal biologic dose(OBD), safety and tolerability, dose-limiting toxicity (DLT) of TAK-117 when administered orally in subjects with advanced solid malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Subjects have had their PIK3CA gene mutation status assessed prior to enrolling into the study
* Subjects must have documented disease progression prior to enrolling into the study
* locally advanced or metastatic solid tumors with the exception of primary brain tumor, and have failed or are not eligible for standard of care therapy.
* Age greater than or equal to (\>=) 18 years, including males and females;
* Eastern cooperative oncology group (ECOG) performance status (PS) 0-1;
* Adequate organ function;
* Male subjects must be surgically sterile or must agree to use physician-approved contraception during the study and for 30 days following the last study drug administration;
* Ability to swallow oral medications;
* Ability to understand and willingness to sign informed consent prior to initiation of any study procedures;
* For women of child-bearing potential, negative serum pregnancy test within 14 days prior to the first study drug administration and use of physician-approved method of birth control from 30 days prior to the first study drug administration to 30 days following the last study drug administration

Exclusion Criteria:

* Diagnosis of primary brain tumor; untreated brain metastasis or history of leptomeningeal disease or spinal cord compression;
* Received prior cancer or other investigational therapy within 2 weeks prior to the first administration of study drug;
* Have received a systemic corticosteroid within one week prior to the first administration of study drug;
* Clinically significant cardiac disease;
* Myocardial infarction or unstable angina within 6 months prior to the first administration of study drug;
* Malabsorption ;
* Poorly controlled diabetes mellitus;
* Pregnancy (positive serum or urine pregnancy test) or breast feeding;
* Untreated brain metastasis or history of leptomeningeal disease or spinal cord compression;
* Failed to recover from the reversible effects of prior anticancer therapies;
* Have received a selective phosphoinositide-3-kinase alpha isoform (PI3K-alpha) inhibitor
* Other clinically significant co-morbidities, such as uncontrolled pulmonary disease, active central nervous system (CNS) disease, active infection, or any other condition that could compromise the subject's participation in the study
* Known human immunodeficiency virus (HIV) infection
* Have a secondary malignancy within the last 3 years prior to first dose of study drug, excluding treated non-melanoma skin cancer, carcinoma in situ, or locally-treated prostate cancer
Taste And Smell TEsting in End Stage Renal Disease

Malnutrition is an important complication of advanced kidney disease and impairment in smell and taste may affect nutritional status. This study will examine the association between impairment in smell and taste and nutritional and functional markers among patients with end stage renal disease, as well as risk factors for smell and taste impairment.

People with advanced chronic kidney disease (CKD) are at risk for malnutrition, which is associated with significantly increased mortality. Impairments in olfaction and taste are under-recognized and under-addressed symptoms that affect this population. Olfaction and taste influence appetite and nutritional status and represent a unique target for study and intervention. Small cross-sectional studies have shown a higher prevalence of olfactory (up to 56%) and taste disturbances (up to 35%) among patients with CKD compared with the general population, but little is known about longitudinal change in olfaction and taste in this population. Additionally, there is a lack of understanding about why these sensory disturbances more commonly occur in people with CKD, although there is speculation that uremia may contribute.

This information gained from this study will address these gaps in knowledge by studying longitudinal changes in olfaction and taste and their associations with concurrent and future nutritional and functional status. Additionally this study will attempt to identify potentially modifiable risk factors associated with olfactory and taste impairment.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 or older
* End-stage renal disease requiring chronic dialysis

Exclusion Criteria:

* Known allergy to quinine
* Presence of a pacemaker or internal defibrillator
* Pregnancy or breastfeeding
Airway Epithelium Gene Expression in the Diagnosis of Lung Cancer: AEGIS CLIA

The primary objective of this study is to substantiate prediction accuracy(with a tighter 95% confidence interval compared to current diagnostic modalities), of a lung cancer biomarker for risk stratification of patients into high and low risk categories to aid in clinical evaluation of the patient.


Eligibility Criteria:
Inclusion Criteria:

1. The patient is being evaluated for the diagnosis of possible lung cancer or "rule out lung cancer" and is indicated for bronchoscopy.
2. The patient is undergoing bronchoscopy
3. ≥ 21 years of age
4. Patient meets local site's standard of care (SOC) for performing diagnostic bronchoscopy
5. The patient is a current or former cigarette smoker (defined as having smoked \>100 cigarettes in their lifetime.

Exclusion Criteria:

1. The Pulmonary physician does not recommend that bronchoscopy be performed
2. The patient is unable to be consented into the study or unable to comply with requirements of the study
3. The patient has previously been diagnosed with primary lung cancer
4. Immediately prior to bronchoscopy, the patient has been on a mechanical ventilator for ≥ 24 consecutive hours.
Investigating How CagriSema, Semaglutide and Cagrilintide Regulate Insulin Effects in the Body of People With Type 2 Diabetes

This study will look at how CagriSema, semaglutide and cagrilintide regulate insulin effects in the body of people with type 2 diabetes (T2D). CagriSema is a new investigational medicine that combines two medicines called cagrilintide and semaglutide. Doctors may not yet prescribe CagriSema. Participants will either get CagriSema, semaglutide, cagrilintide, or a ''dummy'' medicine. Which treatment the participants will get is decided by chance. Participants will get the study medicine together with the current daily diabetes medicine metformin. Participants should not take other medicines for diabetes during the study. The study will last for about 42 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Male or female.
* Aged 18-75 years (both inclusive) at the time of signing informed consent.
* Diagnosed with type 2 diabetes greater than or equal to (\>=) 180 days before screening.
* Stable daily dose(s) of metformin at effective or maximum tolerated dose, as judged by the investigator for 90 or more days before screening with or without one additional oral antidiabetic drug (OAD), except for the use of glucagon-like peptide-1 (GLP-1) receptor agonists, or sodium-glucose co-transporter-2 (SGLT-2) inhibitors in case of a high risk of cardiovascular disease (as judged by the investigator), or established cardiovascular disease, or chronic kidney disease (Glomerular Filtration Rate (eGFR) less than (\<) 60 milliliter per minute per 1.73 square meter \[ml/min/1.73 m\^2\]).
* Glycated hemoglobin (HbA1c) at screening of 6.5-9.5 percent (48-80 millimoles per mole \[mmol/mol\]) (both inclusive) if on metformin only, or 6.0- 9.0 percent (42-75 mmol/mol) (both inclusive) if on metformin in combination with one other OAD. A minimum of 65% of randomised participants must have HbA1c \>= 7.0 % at screening.
* Body Mass index (BMI) between 25.0 and 45.0 kilogram per square meter (kg/m\^2) (both inclusive) at screening.

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
* Renal impairment with estimated Glomerular Filtration Rate (eGFR) \< 45 ml/min/1.73 m\^2 at screening.
* Treatment with any medication for the indication of T2D or weight management other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed.
Study of TJ033721 (givastomig) in Subjects with Advanced or Metastatic Solid Tumors

This is an open label, multi-center, multiple dose Phase 1 study to evaluate the safety, tolerability, MTD PK, and PD of TJ033721 (givastomig) in subjects with advanced or metastatic solid tumors.


Eligibility Criteria:
Inclusion Criteria:

Part 1 - Monotherapy

• Subjects with advanced or metastatic solid tumor in subjects whose disease has progressed despite standard therapy, or who has no further standard therapy, or who is unsuitable for available standard treatment options.

Part 2 - Combination Therapy Subjects with treatment naïve locally advanced, unresectable or metastatic gastric, GEJ, esophageal adenocarcinoma;

* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 with adequate organ function
* Have known PD-L1 status with prior testing by immunohistochemistry and a corresponding combined positive score (CPS)

For dose expansion and Part 2 Combination subjects:

• Must have CLDN18.2-positive tumor expression

Exclusion Criteria

* Prior exposure to CLDN18.2 -targeted therapy
* Prior exposure to 4-1BB agonists
* Second malignancy within the last 3 years with the exception of cutaneous squamous cell carcinoma or cutaneous basal cell carcinoma or cervical carcinoma in situ
* Known active or chronic Hepatitis B or Hepatitis C, other hepatitides
* Unstable/active ulcer or digestive tract bleeding within 6 weeks
* Active autoimmune disease requiring systemic treatment within the past 2 years
* Active interstitial lung disease (ILD) or pneumonitis or a history of ILD or pneumonitis requiring treatment
* Known active CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment;
* New York Heart Association (NYHA) Class 3 or 4 congestive heart failure, severe/unstable angina, myocardial infarction (MI), symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack (TIA), arterial embolism, percutaneous transluminal coronary angioplasty (PTCA), or coronary artery bypass grafting (CABG) in the previous 6 months
* Diagnosis of immunodeficiency such as known active HIV
* Any active infection requiring parenteral treatment

For Part 2 Combination subjects:

• Prior treatment with anti-PD-1 or PD-L1
Clinical Trial to Evaluate the Safety and Efficacy of NTCB01-1 in Patients Who Require Parenteral Nutrition

A Randomized, Open-labeled, Multi-center, Active-controlled, Parallel-group Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of NTCB01-1 versus NTCB-P in patients who require parenteral nutrition


Eligibility Criteria:
Inclusion Criteria:

* Those who are 19 years old or older at the screening visit
* Patients are expected to require PN for more than 3 days
* Patients who voluntarily signed the consent form

Exclusion Criteria:

* Patients are expected difficult to survive more than 3 days
* Patients BMI is over 30 kg/m2
* Patients having hypersensitivity to any peanut-, fish-, soy-, egg protein, or investigational drug
* Patients with difficult peripheral intravenous line
* Patients judged to be unsuitable for this trial by investigators
A Trial of Bed Versus Stirrups Delivery in Nulliparous Women for Prevention of Perineal Lacerations

The investigators hypothesize that the rate of perineal lacerations in nulliparous women will be reduced by a simple change in common obstetrical delivery practice, i.e., bed delivery versus conventional delivery in obstetrical stirrups.

This is a randomized controlled trial of bed delivery in the supine position versus conventional delivery in obstetrical stirrups. It will include nulliparous women presenting in active labor to the L\&D East (low risk) Unit at Parkland Hospital, \> 370/7 weeks gestation, with singleton fetuses in cephalic presentation. The primary outcome variable is any perineal laceration. Secondary outcomes measures include (1) 3rd or 4th degree lacerations and (2) any lacerations in subgroup comparisons between study arms.

Eligibility Criteria:
Inclusion Criteria:

* Nulliparous women presenting in active labor to Parkland L\&D East Unit
* ≥ 370/7 weeks gestation
* Singleton fetus in cephalic presentation
* ≥ 4 cm but ≤ 8 cm of cervical dilation
* No medical or obstetrical complication

Exclusion Criteria:

* Women with any obstetric or medical complication of pregnancy, such as pregnancy related hypertension, diabetes, labor induction
* Prior history of perineal trauma requiring surgical repair or known congenital perineal malformation
* Non-English or non-Spanish speaking