cyrilzakka/clinical-trials huggingface dataset:
Proteins From Duckweed Trial

This study aims to study the digestibility of isolated duckweed protein. The digestibility of the isolated duckweed protein will be compared to an isolated benchmark protein whey.

Objective: The primary objective is to investigate the digestibility of isolated duckweed protein and the isolated benchmark protein whey.

Study design: The study is a cross-over, double blind, controlled trial in which study participants will visit the research facility on two occasions under fasting conditions. Subjects will receive two protein sources in randomized order with a washout period of one week. Blood will be collected via a catheter before and up-to 3 hours after protein consumption.

Study population: We aim to include 12 healthy volunteers aged 18-50 years. Intervention: Study participants will receive 20 grams of isolated duckweed protein and the isolated benchmark protein whey.

Main study parameters/endpoints: The main study parameter is blood amino acids measured before and after consumption of 20 g protein.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 18 and 25 kg/m2
* Having veins suitable for blood sampling via a catheter (judged by study nurse/ medical doctor)

Exclusion Criteria:

* Any metabolic, gastrointestinal, inflammatory or chronic disease (such as diabetes, anaemia, hepatitis, cardiovascular disease)
* History of gastro-intestinal surgery or having (serious) gastro-intestinal complaints
* History of liver dysfunction (cirrhosis, hepatitis) or liver surgery
* Kidney dysfunction (self-reported)
* Use of medication that may influence the study results, such as gastric acid inhibitors, laxatives, stomach protectors and drugs that can affect intestinal motility
* Anaemia (Hb values \<7.5 for women and \<8.5 for men)
* Reported slimming, medically prescribed, vegan/vegetarian or other extreme diets or the use of protein supplements
* Not willing to give up blood donation during the study
* Current smokers
* Alcohol intake ≥4 glasses of alcoholic beverages per day
* Pregnant, lactating or wishing to become pregnant in the period of the study (self-reported)
* Abuse of illicit drugs
* Food allergies for products that we use in the study
* Participation in another clinical trial at the same time
* Being an employee of the department Consumer Science \& Health group of Wageningen Food \& Biobased Research
Suitability of DCE-MRI for Detection of Vascular Changes After VBT

This is a pilot study of DCE MR imaging to detect vascular changes in the vagina during and after radiotherapy n patients receiving adjuvant brachytherapyfor cervical or endometrial cancer.


Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years of age.
* Must have histologically confirmed carcinoma of the cervix, carcinoma or carcinosarcoma of the uterus.
* Subjects are receiving intracavitary brachytherapy.
* ECOG performance status of 0-2.
* Creatinine clearance 30.

Exclusion Criteria:

* Subjects with an inability to tolerate MR imaging (i.e. claustrphobia)
* Study subjects who have contraindication to MRI scanning such as but not limited to subjects with pacemakers, metal fragments in the eye or certain metallic implants.
* Patients who do not speak or read English.
Pharmacokinetics/Pharmacodynamics (PK/PD) Equivalence Study of MSB11456

This study aims to compare the PK/PD of a single injection of investigational Medicinal Product (IMP) MSB11456, US licensed Actemra and EU approved RoActemra in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects, 18 to 55 years of age, with a body mass index (BMI) between 18 and 29.9 kilogram per meter square (kg/m\^2).
* Subjects who are on adequate contraception as defined in the protocol and are willing and able to comply with the scheduled study visits, Investigational medicinal product (IMP) administration, safety laboratory tests, and all other study procedures.
* Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

* Subjects with history and/or current presence of clinically significant atopic allergy (for example, asthma including childhood asthma, urticaria, angio-edema, eczematous dermatitis).
* Subjects with hypersensitivity or allergic reactions, including known or suspected clinically relevant drug hypersensitivity to any components of the IMP formulations, comparable drugs, or to latex.
* Subjects who have active or latent tuberculosis as indicated by a positive QuantiFERON®-Tuberculosis (TB) Gold test or a history of tuberculosis, lifetime history of invasive systemic fungal infections (for example, histoplasmosis) or other opportunistic infections, including recurrent or chronic local fungal infections, frequent (more than 3 per year requiring treatment) chronic or recurrent infections, having previously been treated with tocilizumab or taken a recombinant monoclonal antibody.
* Subjects who have received a live vaccine within 12 weeks before enrolling in this study or planning for any such vaccination during the study or within 4 months after IMP administration.
* Other protocol defined exclusion criteria could apply.
Targeted Lifestyle Change Group Prenatal Care

To conduct a randomized trial to determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal and neonatal outcomes in women at high risk for developing gestational diabetes mellitus (GDM).

Long term, the investigator aims to test the central hypothesis that those in TLC will have better maternal and neonatal outcomes than those in TC. The objective is to conduct a randomized trial to determine the effect of TLC group prenatal care on birthweight and neonatal body composition, maternal healthy lifestyle and diabetes-related outcomes, delivery and neonatal outcomes, and psychosocial stress and depression.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* ≤16 weeks gestation
* Two or more of the following GDM risk factors:
* BMI ≥ 25
* Physical inactivity
* First degree relative with diabetes
* High risk race or ethnicity (African American, Latino, Native American, Asian American, Pacific Islander)
* Prior infant weighing ≥ 4,000 g
* Prior GDM
* Hypertension (140/90 mm Hg or receiving treatment)
* High-density lipoprotein cholesterol level \<35 mg/dL or triglycerides \> 250 mg/dL
* Polycystic ovarian syndrome
* A1c ≥ 5.7%
* Impaired glucose tolerance
* Impaired fasting glucose on previous testing
* History of cardiovascular disease
* Ability to attend group prenatal visits at specified days and times
* Willingness to be randomized
* Ability to give informed consent

Exclusion Criteria:

* Type 2 diabetes (eligible for Diabetes Group Care)
* Positive glucose challenge test during early pregnancy
* Multiple gestation (require extra care)
* Major fetal anomaly (require extra care)
* Serious medical co-morbidity necessitating more care than can be safely provided in group setting, as deemed by medical provider (require extra care)
* Serious psychiatric illness, including schizophrenia, necessitating more care than can be safely provided in group setting, as deemed by medical provider (require extra care)
Health Benefits of Expressive Writing: Study One

This study is a randomized controlled trial (RCT) with the aim of determining the cultural sensitivity, feasibility, and effectiveness of an expressive writing intervention for Chinese breast cancer survivors.

The study examines the potential health benefits (i.e., physical health, psychological health, and quality of life) of this expressive writing intervention for Chinese-speaking breast cancer survivors. The study also explores the mechanism through which expressive writing confers health benefits and investigates who will benefit most from the expressive writing intervention. Chinese-speaking breast cancer survivors who have completed primary treatment will be randomly assigned to a control writing condition, a self-regulation condition, or an emotional disclosure writing condition. Health outcomes are assessed at baseline, and 1, 3, and 6 months follow-ups. Mixed qualitative-quantitative mixed methods are used to explore the effect of the intervention on health outcomes and explore the mechanisms that explain the benefits of this intervention.

Eligibility Criteria:
Inclusion Criteria:

* 1) having a breast cancer diagnosis
* 2) completing primary medical treatment within four years
* 3) being comfortable writing and speaking Chinese (i.e. Mandarin or Cantonese)
Comparative Effects of Fish Oil Supplementation and a Montelukast on EIB and Airway Inflammation in Asthma

Combining fish oil supplementation and Montelukast \[a commonly used cyst LT1 receptor antagonist to treat exercise-induced bronchoconstriction (EIB)\] will provide a greater antiinflammatory effect against developing EIB that either agent alone

The aim of this study is to extend previous published findings that fish oil supplementation represents a beneficial treatment on exercise-induced bronchoconstriction (EIB). An important question is how dietary fish oil supplementation fits in with the available armamentarium \[e.g., leukotriene (LT) modifiers\] to decrease the expression of LTs, and whether fish oil supplementation may be additive, or used in its own right to block the EIB response. For example, it is possible that a combination of fish oil supplementation and a cyst LT1 receptor antagonist (LTRA) may provide a greater antiinflammatory effect against developing EIB that either agent alone.

Eligibility Criteria:
Inclusion Criteria:

* Demonstrate a fall in post-exercise FEV1 of \> 10% after dry air exercise challenge for the diagnosis of EIB and
* \> 12% increase in FEV1 from the baseline value after the administration of a β2-agonist. However, if the bronchodilator response is \< 12% increase in FEV1 from the baseline value then asthmatic subjects with EIB must further demonstrate
* A \< 16.0 mg.ml-1 concentration of methacholine causing a 20% decrease in FEV1 (PC20)

Exclusion Criteria:

* Subjects will be excluded if they are pregnant
* Have a history of hyperlipidemia, hypertension, diabetes, bleeding disorders, delayed clotting time
* Taking aspirin medication and have a resting FEV1 less than 65% predicted.
* A complete blood count and urinary pregnancy tests will be conducted at the beginning of the study and subjects with a hematocrit \< 35 will be excluded from participation in the study.
* In addition, subjects will also be excluded if they have a history of taking n-3 PUFA supplements or supplements with antioxidants above the levels recommended for Adequate Intake, or regularly consume more than one fish meal per week.
Rod Shape Changing After Scoliosis Correction Surgery

The change of the fixation-rod after posterior srew-rod fixation segmentdesis is not widely known. The recent development of the 3D scanning technics and the opportunities of the EOS 2D/3D system made us possible to have the exact rod shape immediately after implantation, and at each control examination. These progressions made us available to follow up the shape changing of the fixation-rod, hereby the changing of the correction.

The adolescent idiopathic scoliosis can affect the 0,5-2% of the European population. One of the widely accepted treatment of severe scoliosis (Cobb angle is over 40-50°, or more than 10° progression observed a year) is posterior correction segmentdesis with screw and rod instrumentation. As a scoliosis treatment center, about 90-110 scoliosis correction surgeries are performed in our department, using conventional preoperative planning, coronal and sagittal translation technique from posterolateral approach.

An EOS 2D/3D system is available in our department making possible the scanning of the patient with upright biplanar ultra-low dose x-rays technique. The SterEOS software makes us possible to reconstruct the surface of the spine, pelvis and lower limb. The biplanar modality of the images makes possible to 3D reconstruct any simple shape using CAD (computer-aided design) softwares.

The recent updates in the 3D scanning technology also made us possible to perform intraoperative scannings without harming the sterility.

The aim of the study to define the change of the fixation-rod's shape after scoliosis correction surgery.

Main hypothesis: there is significant change in the rod shape after implantation

Secondary hypothesis 1: during the implant of the rod, it will loose from the prebent correction depending of the severity and rigidity of the curve.

Secondary hypothesis 2: in the early stage of the rehabilitation, after the mobilization the shape of the rod (and the spinal parameters) can change Secondary hypothesis 3: after the 3. month postoperatively the shape of rod does not change anymore

Eligibility Criteria:
Inclusion Criteria:

* routine patient care of University of Pécs Medical School Department of Orthopaedics
* diagnosed idiopathic adolescent scoliosis
* scoliosis induced surgical indication (Cobb-degree\>45)

Exclusion Criteria:

* early onset or adult degenerative scoliosis
* scoliosis with known origin
* the angle of the curve does not reach the criteria of surgical indication (Cobb-degree\<45)
* former spine surgery
Prodromal ImPACT Intervention for Children at Elevated Likelihood of ASD

This randomised-controlled trial will assess the effect of an early intervention on the social-communicative abilities and brain activity of infants with elevated likelihood of Autism Spectrum Disorder (ASD). The children´s social-communicative abilities and the related brain activity will be evaluated at three time points: before the start of the intervention (pre-intervention), immediately after its conclusion (post-intervention) and 6 months after its conclusion (follow-up).

Previous research has shown that parent-implemented interventions are effective in improving the social skills of children with autism spectrum disorder (ASD).Considering that several differences in social and non-social skills start to emerge before a diagnosis can be made, this project aims to investigate the effects of an adapted prodromal version of an evidence-based parent-mediated intervention (Project ImPACT) in children with an elevated likelihood to develop ASD (namely siblings and children who were born preterm). The effect of the intervention will be evaluated at both behavioural and neural levels. The intervention is suitable for infants and consists of 12 session with the child and his/her parents, of maximum 2 hours each, one session per week, delivered by therapists of the home guidance and home guidance centers in Flanders. Children between 9 and 18 months old and their parents will participate in the study. They will be randomly assigned to the ImPACT intervention group or a no-intervention group (monitoring only). The families will be invited to come to the Faculty of Psychology and Pedagogical Sciences at three time points: before the start of the intervention, immediately after the end of the intervention (which is expected to last 12 weeks) and 24 weeks after the end of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Elevated likelihood of ASD: the child must be a preterm (less than 30 weeks of gestation) or a sibling/half-sibling of a child with diagnosed ASD.
* Parents are Dutch, English on French speakers.

Exclusion Criteria:

* The child must not have a diagnosis of other neurological or developmental disorders.
Pilot Study for the Evaluation of Food Choices in Patients With Inflammatory Bowel Diseases (MICI2021)

This project is a pilot study exploring the effects of dietary choices and quantitative digestion of gluten ingested by individuals with IBD compared to a control population. The aim of the study is to evaluate for the first time in an Italian population of subjects with IBD the presence of a diet based on GFD (gluten free diet).

Subjects with IBD will be recruited among the patients referred to the IBD clinic of the Policlinico of Milan. These patients are subject to annual check-ups during which, where possible, they will be asked to sign an informed consent. These patients are subjected during the visits of normal clinical follow-up to:

* Questionnaire on eating habits for the patient with IBD versus control patients;
* Modified Food Habits Frequency Questionnaire (FFQ), validated for the celiac population. The questionnaire assesses the extent, frequencies of consumption and quantity of gluten-containing foods in a year; this, in order to estimate the average introduction of gluten through the diet versus control patients;
* Anthropometric and plicometric analysis;
* Validated clinical activity questionnaires for RCU (ulcerative rectocolitis) and CD (Chron disease) (Mayo Score and Harvey-Bradshaw Index).

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 years
* Gender: women and men
* Patients who have been diagnosed with IBD for at least 12 months
* patients who have signed an informed consent

Exclusion Criteria:

* Pregnancy status
* Patients not suffering from the two main forms of IBD, i.e. CD or RCU (unclassified IBD colitis, collagenous colitis, lymphocytic colitis will be excluded).
Randomized Controlled Trial of Vitamin D3 Supplementation for Viral Upper Respiratory Tract Infections (URI) Prevention

Background: Vitamin D has been shown to be an important immune system regulator. Vitamin D insufficiency during the winter may cause increased susceptibility to infections, particularly viral upper respiratory tract infections (URIs).

Objective: To determine whether vitamin D supplementation during the winter season prevents or decreases URI symptoms in adults.

Methods: A randomized, double-blind, placebo-controlled trial was conducted in 162 adults. Participants were randomized to receive vitamin D3 50 mcg (2000 IU) daily or matching placebo for 12 weeks from December 2006 to March 2007. A biweekly questionnaire was used to record the incidence and severity of URI symptoms


Eligibility Criteria:
Inclusion Criteria:

* ambulatory adult age 18-80 and stable medical condition with no change in medications for 6 months prior to study entry.

Exclusion Criteria:

* morbid obesity (body mass index \> 35 kg/m2)
* current tobacco use
* history of hypercalcemia, nephrolithiasis or sarcoidosis
* pregnancy
* recent hospitalization
* current liver or kidney disorders, malignancy and malabsorption
* use of immunosuppressants or medications that interfere with vitamin D metabolism such as phenytoin and carbamazepine.
Muscle Protein Metabolism in Obesity

Obesity is associated with reduced adenosine triphosphate (ATP) turnover in skeletal muscle, a condition that can impair muscle metabolism. The proposed research will discover mechanisms responsible for decreased content in mitochondrial proteins as well as in protein β-F1-ATPase, which is directly responsible for ATP assembly, in the muscle of obese individuals. This research will further examine the effectiveness of interventions, such as increased plasma amino acid availability and exercise, to increase the rate of production of mitochondrial proteins as well as that of β-F1-ATPase in the muscle of obese individuals. The findings will help to develop appropriate interventions to improve muscle ATP turnover and metabolism in obese people.


Eligibility Criteria:
Inclusion criteria:

1. Body mass index (BMI): lean, 19-26 kg/m2; obese, 30-40 kg/m2
2. Availability of transportation
3. Ability to sign informed consent form

Exclusion criteria:

1. Medication or supplements (i.e. amino acids, protein) known to affect protein metabolism
2. Presence of acute illness
3. History of liver disease
4. Uncontrolled metabolic disease
5. ECG documented abnormalities, atrial fibrillation, history of syncope, limiting or unstable angina, or congestive heart failure
6. Chronically elevated blood pressure (systolic, \>140 mmHg; diastolic, \>100 mmHg)
7. Cardiac pacemaker or other medical device implanted in the body
8. Low hemoglobin or hematocrit
9. Current participation in a weight-loss regimen, including extreme dietary practices
10. Smoking
11. Use of anabolic steroids or corticosteroids (within 3 months)
Handwriting Interventions for People With Parkinson's

Background: Problems with handwriting are frustrating and debilitating and affect the majority of people with Parkinson's. Manifest as micrographia it is a distinctive feature of the condition characterised by small handwriting and/or a progressive reduction in size through a sentence\[2\] coupled with a reduction in writing speed and legibility.

In Parkinson's impaired automaticity is thought to contribute to handwriting deficits and attention has been shown to improve both 'consistent' (small handwriting) and 'progressive' (progressive reduction in letter size through a sentence) aspects of the symptom. Moreover, recent interventional studies indicate handwriting may be improved through practice. This study is investigating a novel handwriting practice stimulus to improve symptoms of micrograpthia

Question: Is a diverging line cued handwriting intervention potentially more effective at improving symptoms of mircograpthia than a parallel line cued handwriting intervention in people with Parkinson's?

Specifically, an assessor blind randomised controlled exploratory trial will:

1. Estatimate the effect of the intervention on measures of: Handwriting amplitude (consistent and progressive reduction), hand writing performance and percieved handwriting difficulties.
2. Explore the appropriateness of these outcome measures
3. Explore the approriateness of eligibilty criteria
4. Explore intervention fidelity
5. Explore participants views of the intervention

Design: A phase II exploratory randomised controlled trial of a handwriting intervention with an active comparator control group and blinded assessments

Setting: The intervention will be carried out at home

Sample size: This study is not designed to determine efficacy. The aim to recruit a total of 50 people (25 people per group) in order to estimate the effects on outcome measures and achieve the aims of this exploratory trial.

Assessment: Participants will be asked to follow their usual Parkinson's medication regime and if they have ON and OFF periods, assessments will be carried out during ON state.

Duration and follow-up: the assessment is schedule 0Weeks (baseline), 6weeks (end intervention) and 12weeks (follow up). Assessments will be carried out by a researcher blind to trial arm allocation using all outcome measures.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Diagnosis of idiopathic Parkinson's disease
* A score of ≤3 on the Hoehn and Yahr scale
* Self-reported problem with handwriting (≥1 UPDRSII, 2.7)
* Able to communicate in Italian
* Following a stable medication regimen (no changes in the last 2 weeks and anticipated changes for the course of the study).

Exclusion Criteria:

* Severe depression or psychosis (history of),
* reduced cognition that would preclude active involvement or capacity to consent (according to stages outlined in metal capacity act (ie trigger, information, existing diagnosis, functional test))
* Orthopaedic, neurological or other condition that significantly impairs hand function,
* Pregnancy
The Effects of Lifebloom One on Physical Activity After Acquired Brain Injury

The goal of this clinical trial is to evaluate the effects of Lifebloom One in people who have suffered a stroke or a traumatic brain injury.

The main questions to be answered are:

* Does Lifebloom One allow users to spend more time standing each day?
* Does Lifebloom One allow users to improve their balance and gait?

Participants will use Lifebloom One during 8 weeks.

For each participant, gait and balance are compared either with and without Oxilio or before and after Lifebloom One intervention.


Eligibility Criteria:
Inclusion Criteria:

* Stroke or traumatic brain injury more than 2 months old
* Unable to walk without assistance
* Expected length of stay equal to or greater than 4 months

Exclusion Criteria:

* Anthropometric incompatibility with Oxilio
* Unable to walk prior to brain injury
* No functional upper limb
* Complete sensory deficit in the lower limb(s)
* Degenerative impairment (tumor, neurodegenerative disease, etc.)