cyrilzakka/clinical-trials huggingface dataset:
Determination of Protein Requirement in Elderly Female Subjects 65-75 Yrs Old

Minimal data are available on protein requirements throughout the lifespan. Currently available recommendations are based on nitrogen balance data. The limitations of the nitrogen balance method have been well described. Importantly, nitrogen balanced underestimates requirements.

The current DRI requirement for healthy adult males is based on the reanalysis of the nitrogen balance date from Young and Scrimshaw. This data was reanalyzed statistically by Rand et al. and he concluded that the protein requirement of healthy adults was 0.65 and 0.83 (mean and RDA) g/kg/day of good quality protein. Using IAAO, the investigators group estimated the protein requirement of young men (mean age 27 years) to be 0.93 and 1.2 g/kg/day (mean and RDA).

Currently there are no studies on protein requirement in the elderly. In a recent nutrition survey conducted by NHANES, the authors concluded that adults between the ages of 51 - 70 years old consumed an average on 1.0 g/kg/day (ideal body weight) of protein which represents about 15 % of calories. Depending on the calculations used for ideal body weight some older adults could be getting higher or lower than requirement. There is no scientifically derived protein estimate for older adults. Therefore there is a need to measurer protein requirement in that population.

The goal of this study therefore is to measure the protein requirement of female elderly subjects between the ages of 65 - 70 years using the IAAO technique.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy elderly females between the ages of 65 to 75 and \>75 years
2. Willingness to participate in the study
3. Females without a chronic disease or acute illness that could affect protein and AA metabolism eg, diabetes, cancer, liver or kidney disease, HIV, acute cold or flu, hypo or hyperthyroidism, rheumatoid arthritis treated with anti-inflammatory medications.
4. Females with hypertension if well controlled by medications

Exclusion Criteria:

1. Presence of disease known to affect protein and AA requirement and synthesis like diabetes, cancer, liver o kidney disease, HIV, acute cold or flu, hypo or hyperthyroidism, rheumatoid arthritis treated with anti-inflammatory medications.
2. On medications known to affect protein and amino acid metabolism like e.g. steroids.
3. Significant weight loss during the past month.
A Multiple Ascending Dose Study of 9MW3011 in Patients With Non-transfusion-dependent β-thalassemia

This is a phase Ib, randomized, double-blind, placebo-controlled, multiple ascending dose study . The objectives of the study are to evaluate the safety , tolerability, pharmacokinetics(PK), pharmacodynamics(PD), and immunogenicity of 9MW3011 in patients with non-transfusion-dependent β- thalassemia .

A total of 40 subjects diagnosed with non-transfusion-dependent β-thalassemia will be enrolled in this study and assigned into four dosage cohorts. In each cohort, subjects will be randomized in a 4:1 ratio to receive 9MW3011 or placebo via intravenous infusion.

Eligibility Criteria:
Key Inclusion Criteria:

1. Male and female subjects aged 18 to 65 years (inclusive)
2. Subject must have a documented genetic diagnosis of β-thalassemia or hemoglobin E/ β-thalassemia
3. Subjects must meet the criteria for non-transfusion-dependent thalassemia
4. Subjects must have a baseline hemoglobin level between 70-100 g/L(inclusive), based on 2 consecutive measurements taken at least 1 week apart within 4 weeks before randomization
5. Subjects must have evidence of iron overload during screening
6. Subject must have performance status: Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1
7. Subjects must fully understand the study procedures and methods, voluntarily participate in the trial, and sign an informed consent form

Key Exclusion Criteria:

1. Subjects diagnosed with alpha-thalassemia
2. Subjects diagnosed with HbS/beta-thalassemia or transfusion-dependent beta-thalassemia
3. Subjects exhibit severe iron overload at the time of screening
4. In addition to thalassemia, subjects have any other forms of anemia and hematological disorders that the investigator assesses may compromise safety or influence study outcomes
5. Combined with any significant systemic diseases or psychiatric disorders
6. Subjects have New York Heart Association (NYHA) Class III-IV heart failure and other cardiovascular diseases within 6 months prior to screening or currently present
7. During the screening or baseline period, subjects exhibiting a QTcF interval of ≥450ms for males and ≥470ms for females on a 12-lead electrocardiogram (ECG), or presenting an abnormal 12-lead ECG with clinical significance
8. Uncontrolled hypertension before screening
9. A history of malignant neoplasm occurring within the last five years
10. Severe infection requiring hospitalization or intravenous antimicrobial therapy, or uncontrolled systemic bacterial, fungal, or viral active infection
11. Subject have received concomitant treatment that was not permitted by the protocol
12. Subjects whose hematological parameters did not meet the inclusion criteria during screening
13. Subjects with a history of substance abuse, as well as those who yield positive results on substance abuse screening
14. Subjects who are unable to undergo MRI scans
15. Pregnant or lactating women
16. Subjects presenting any other factors deemed unsuitable for participation assessed by the investigator
A Study of MK-1084 With Midazolam and Digoxin in Healthy Participants (MK-1084-009)

The goal of the study is to see what happens to levels of midazolam and digoxin in a person's body over time (a pharmacokinetic or PK study). Researchers will compare what happens to midazolam and digoxin in the body when it is given with and without another medicine called MK-1084. Researchers are testing if digoxin and midazolam levels in the body are different when digoxin and midazolam are given with or without MK-1084.


Eligibility Criteria:
Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

* Is medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vitals signs, and electrocardiograms (ECGs)
* Has a body mass index (BMI) ≥18 and ≤32 kg/m\^2, inclusive

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

* Has a medical history that may confound the results of the study or poses an additional risk to the participant in the study
* Has a history or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds
DLBS1033 Treatment in Diabetic With Peripheral Arterial Disease

This is a prospective, randomized, double-blind, double-dummy, and controlled study of DLBS1033 for the improvement of ankle-brachial index in diabetic patients with peripheral arterial disease (PAD). It is hypothesized that the addition of DLBS1033 on top of aspirin treatment will augment significantly the resting ABI in diabetes patient with PAD in comparison with that of aspirin alone.

Subjects in this study will be screened consecutively and eligible subjects will be randomized to receive aspirin tablet 80 mg once daily and either the investigational drug (DLBS1033 tablet 490 mg three times daily) or its placebo, for 12 weeks.

Diabetic subjects who have been being under therapy with aspirin can directly start with study treatment. For those who are currently not under therapy with aspirin, there will be a run-in period during which they will receive (or be switched to) aspirin treatment, for two weeks. After then, they will receive study medication.

Clinical and laboratory examinations to evaluate the investigational drug's efficacy and safety will be performed at baseline and at the interval of six weeks over the twelve week-course of therapy.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent before any trial related activities.
* Male or female subjects of 40 - 65 years of age.
* Diagnosis of diabetes mellitus defined as HbA1c level of ≥ 6.5% (for newly diagnosed diabetes) or based on medical history.
* Presence of peripheral arterial disease with resting ankle-brachial index (ABI) of 0.41-0.90 inclusive

Exclusion Criteria:

* Females of childbearing potential: pregnancy, breast-feeding, and the intention of becoming pregnant.
* Recent stroke attack, myocardial infarction/unstable angina/acute coronary syndrome, coronary artery bypass surgery (CABG) or percutaneous transluminal coronary angioplasty (PTCA)/stent within 3 (three) months prior to screening.
* Impaired liver function: serum ALT \> 2.5 times upper limit of normal.
* Impaired renal function: serum creatinine ≥ 1.5 times upper limit of normal.
* Concomitant use of other antithrombosis drugs or any antiplatelets other than the study medication.
* Subjects with concurrent herbal (alternative) medicines or food supplements
* Subjects with any other disease state, including chronic or acute systemic infections, uncontrolled illnesses or other chronic diseases, which judged by the investigator, could interfere with trial participation or trial evaluation.
* Subjects with high risk of bleeding:
* Subjects with prior experience with DLBS1033 or other oral lumbrokinase products.
* Subjects with known or suspected allergy to any of study medications used in the study, including other lumbrokinase products.
* Subjects with known or suspected allergy or resistant to aspirin.
Probiotic Supplementation to Improve the GUT Microbiota of Very Low Birth Weight Preterm, a Pilot Study

This pilot trial is designed to investigate the benefits of the use of probiotics in GUT microbiota development and/or immunological biomarkers and how this can be related with the clinical status of very low birth weight preterms during their first weeks of life at the neonatal intensive care unit(NICU).

This pilot trial is designed to investigate the benefits of the use of mixtures of probiotics isolated from human milk in GUT microbiota development and/or immunological biomarkers. Furthermore, the relationship between evaluated parameters and the clinical status of very low birth weight preterms during their first weeks of life at the NICU will be analysed.

Eligibility Criteria:
Inclusion Criteria:

* preterm infants with birth weight less than one thousand and three hundred grammes
* preterm infants with gestational age less than 29 weeks

Exclusion Criteria:

* mayor malformations
* chromosomopathies
* congenital infections
* non parental consent
Retinal Vessel Analysis (rGA) at the Patient Bed in the Context of Non-traumatic Subarachnoid Haemorrhage

A subarachnoid hemorrhage occurs in about 10 out of 100,000 people each year. This bleeding leads to irritation and constriction of blood vessels in the brain (vasospasm) in two out of three people affected within four to 21 days and thus to reduced blood flow. This can lead to a stroke and serious damage. In order to be able to diagnose and treat a constriction of the blood vessels at an early stage, there are various examination methods which, however, have various disadvantages such as radiation exposure of the patient, low sensitivity or high effort. Therefore, the prediction and timely therapy of vascular constrictions is currently only successful in a few cases before the reduced blood flow has already led to irreversible damage.

The aim of this study is to investigate whether the so-called retinal vascular analysis can be used in addition to previous standard examinations for the early detection of diseases of the cerebral blood circulation. This method has few side effects and has been successfully used for 50 years to examine the blood circulation in the eye.


Eligibility Criteria:
Inclusion Criteria:

* Female or male patient, age ≥ 18 years
* Inpatient stay in the clinic
* Written informed consent for participation in the study prior to beginning of treatment
* Written consent for further evaluation of the images and for the scientific publication of the study results
* Non-traumatic subarachnoid haemorrhage confirmed by computer tomography or magnetic resonance tomography or cerebrospinal fluid puncture (collection of nerve water from the lower part of the lumbar spine

Exclusion Criteria:

* Female or male patient \< 18 years
* Pregnancy, Lactation
* Lack of written consent to participate in the study and to further evaluate the image material collected
* Known allergy to MS eye drops (active substance: phenylephrine/tropicamide
* Narrow chamber angle, narrow angle glaucoma, Terson syndrome (if it makes retinal vascular imaging impossible
* Persons in a dependency or employment relationship with the investigator
* Persons who are accommodated in a facility by judicial or administrative order
* Receipt and intake of a study drug within the last 30 days
* Supine position in bed
Metformin and Congenital Nephrogenic Diabetes Insipidus

The purpose of this study is to determine whether metformin can increase urine concentration (osmolality) and decrease the amount of urine in patients with congenital nephrogenic diabetes insipidus (NDI).

Nephrogenic diabetes insipidus (NDI) is a genetic disease. Patients with this disease make large amounts of urine because their kidneys don't hold on to water. The large amount of urine means that patients need to urinate very frequently. They are also at increased risk for dehydration if they don't drink enough. The large amount of urine can sometimes damage their bladders and kidneys. There are some medicines that may help these patients urinate less, but they are not very effective. There is evidence in animal studies that a medication called metformin may help patients with NDI urinate less.

Eligibility Criteria:
Inclusion Criteria:

* Males with a documented mutation in the vasopressin type 2 receptor (V2R)
* Willing to provide consent and/or assent as appropriate
* Capable of providing urine samples as dictated by the protocol

Exclusion Criteria:

* Urinary incontinence
* Subjects who have heart disease, liver disease, diabetes, cancer, or other significant disease other than Nephrogenic Diabetes Insipidus (NDI)
* Subjects with significant renal dysfunction (defined as a calculated glomerular filtration rate (GFR) \<80 ml/min/1.73 m\^2)
* Subjects with acquired NDI
Sirolimus Based Immunosuppression for Patients Undergoing Kidney Transplantation in the Eurotransplant Senior Program

The Eurotransplant Senior Program (ESP) started in 1999 with local allocation of kidneys from deceased donors elder than 65 years to recipients elder than 65 years. The requirements for immunosuppression in this group of patients are high due to the large amount of comorbidities.

This prospective randomized trial compared the standard immunosuppressive protocol based on cyclosporine A (CyA) used at our center within the ESP, to a calcineurin inhibitor-free protocol based on sirolimus (SRL).

The aim of this study is to investigate the effect of a CNI-free therapy on the function of elderly kidneys 6 months post transplantation, measured by GFR.


Eligibility Criteria:
Inclusion Criteria:

* Recipients of the Eurotransplant Senior Program
* negative cytotoxic crossmatch
* signed informed consent

Exclusion Criteria:

* High sensitized recipients (PRA \> 40%)
* Non heart Beating Donor
* Hyperlipidemia
* Leucocytopenia (\< 3000/mm3)
* Thrombocytopenia (\< 75000/mm3)
Minding the Baby Home Visiting: Program Evaluation

This is an efficacy study of an intensive home visitation intervention, "Minding the Baby" (MTB). This reflective parenting program (aimed at enhancing maternal reflective capacities), is focused on first-time young mothers and infants living in an urban community. The study, grounded in attachment and human ecology theories integrates advanced practice nursing and mental health care by pairing master's level nurse practitioners and social workers with at-risk young families. Aims of the study are: 1) to determine the efficacy of the MTB intervention in young mothers and infants with respect to a) maternal outcome variables including the quality of the mother-infant relationship, maternal reflective capacities, maternal mastery/self-efficacy, parental competence, and maternal health and life course outcomes (educational success, employment, delaying subsequent child-bearing); and b) infant outcome variables including early attachment, infant health, and developmental outcomes; 2) to monitor fidelity and dose of the program with young mothers; 3) to describe the evolution of reflective capacities in adolescent mothers (contrasting intervention group with control group) through descriptive qualitative analyses of transcribed Pregnancy Interviews and Parent Development Interviews at the last trimester of pregnancy and at 24 months; 4) to conduct cost-effectiveness analyses of the program. The longitudinal two-group study (subjects nested within randomly assigned groups), will include multi-method (self report, interview and direct observation and coding of behaviors) approaches with a cohort of first-time multi-ethnic mothers between the ages of 14-25 (and their infants). MTB home visits occur weekly for intervention families (n=69) beginning in mid pregnancy and continuing through the first year, and then bi-weekly through the second year. Mothers and infants (n=69) in the control group will receive standard prenatal, postpartum and pediatric primary care in one of two community health centers (as will the intervention group) and also receive monthly educational materials about child health and development mailed to their homes. Maternal and infant outcome variables will be followed over time (pregnancy, 4, 12, and 24 months) as well as compared between the 2 groups. Cost analyses and analysis of the dose and sample characteristics linked to efficacy, will allow us to plan for translation of the model into clinical care and community sustainability.


Eligibility Criteria:
Inclusion Criteria:

* Having a first child
* Speak English
* Obtains primary care from community health centers

Exclusion Criteria:

* No psychoses or terminal illnesses
Serotonin Role on Brain Circuits Involved in Food Avoidance in Anorexia Nervosa

Serotoninergic activity in brain structures involved in food control and avoidance, such as the basal ganglia, is poorly understood in Anorexia Nervosa.

A simultaneous positron emission tomography (PET)- functional magnetic resonance imaging (fMRI) approach and testing of food preferences and choices will provide further insight into the link between potential abnormalities in serotoninergic transmission and the specific food restriction disorder for Anorexia Nervosa. These Data can pave the way for new therapeutic avenues.

Eligibility Criteria:
Common Criteria for inclusion :

* Signature of written consent
* Subject affiliated or entitled to a social security scheme

Inclusion Criteria: Patients with restrictive anorexia nervosa (30 subjects).

* Anorexia nervosa common features : fear of weight gain, dysmorphophobia, BMI \< 17.5 kg/ m², amenorrhea
* Absence of food compulsions and purges
* Subgroup 1 (15 subjects) : STAI Y2 anxiety score \> 61
* Subgroup 2 (15 subjects) : STAI Y2 anxiety score \< 51

Inclusion criteria - Female control subjects (15 subjects)

* BMI between 18.5 and 25 kg/ m²
* Absence of a psychological profile of eating disorder or other psychiatric disorders.

Exclusion Criteria:

* Subjects with an oral contraception and breastfeeding woman
* Subject with heart failure
* Subject treated during the last three months with neuroleptics, and antiparkinsonian drugs, monoamine oxidase (MAO)-A or monoamine oxidase (MOA)-B inhibitors, tricyclic antidepressants, 5HT reuptake inhibitors, thymo regulators (lithium), antiepileptic dugs, codeine derivatives, morphinics, tramadol-containing products (Topalgic, ...),dopaminergic drugs.
* Subjects with suspected pregnancy; Test β human chorionic gonadotropin (HCG) positive prior to examination.
* Subjects for whom MRI is contraindicated (pacemaker, intracerebral clips, prosthesis made of ferromagnetic material or claustrophobia).
* Subjects unable to sign written consent for participation in the study.
* Subject deprived of liberty by a judicial or administrative decision
Effects of Dry Needling on Spasticity, Functions, Balance and Independence Level in Patients With Stroke

The aim of this study is to investigate the effects of dry needling method in addition to neurodevelopmental therapy on spasticity, upper and lower extremity functions, balance and independence level in patients with stroke who have spasticity.

The aim of this study is to investigate the effects of dry needling method in addition to neurodevelopmental therapy on spasticity, upper and lower extremity functions, balance and independence level in patients with stroke who have spasticity. In this study, goniometric measurement, Modified Ashworth Scale, Nine Hole Peg Test, 10 Meter Walking Test, Fullerton Advanced Balance Scale and Functional Independence Scale will be used for outcome measurement. The participants will be randomised into two groups; Group 1 will receive NDT and Group 2 will receive both NDT and dry needling therapy. Both groups will be given 45 minutes of NDT, 3 sessions per week in 4 weeks period (total of 12 sessions). Group 2 will also receive dry needling therapy 3 sessions per week in 4 weeks period (total of 12 sessions). Dry needling will be applied on M. Gastrocnemius, M.Quadriceps, M.Flexor Carpi Radialis and M.Biceps Brachii muscles. The application time on each muscle will be 60 seconds (sec). Fast in and fast out technique will be used for dry needling therapy. All patients will be measured before treatment (T1) and after treatment (T3). An inter-measurement will be performed after the treatment session (T2) in addition to T1 and T3 measurements in the Group 2, to evaluate the acute effects of dry needling therapy. No additional treatment will be applied to the Group 1. All assessments will be performed by the same physiotherapist.

Eligibility Criteria:
Inclusion Criteria:

* First time stroke,
* Patients who has spasticity due to stroke,
* At least 6 months after stroke,
* Individuals between the ages of 18-75 will be included in the study.

Exclusion Criteria:

* Any contraindication for dry needling (eg, anticoagulants, infections, bleeding, etc.),
* Having diabetes,
* Having cardiovascular diseases,
* Having any other neurological problems,
* Application of Botox within 6 months prior to the study,
* Individuals included in another treatment program will not be included in the study.