cyrilzakka/clinical-trials huggingface dataset:
Lifestyle Intervention for Toddlers Pilot Study

Study aims to pilot a family-centred tailored nutrition intervention at child welfare clinics, targeting the previously observed dietary defaults of Finnish children.

Eating habits can predict diet-related health problems and obesity. The defaults observed previously in the diet of Finnish children include low consumption of vegetables, fruits and vegetable oil-based fats, high consumption of sucrose, poor quality of drinks and low frequency of family meals. Child welfare clinic is the place to promote healthy lifestyles because most Finnish families visit there at regular intervals.

Eligibility Criteria:
Inclusion Criteria:

* all families at their child's standard 6-month child welfare clinic visit

Exclusion Criteria:

* families with twins
* families who do not speak Finnish
Evaluation of Diagnostic Accuracy of CEUS for HCC Diagnosis

This study aims to compare the diagnostic accuracy of Contrast-enhanced ultrasound (CEUS) for diagnosing hepatocellular carcinoma (HCC) with that of gadoxetic acid-enhanced liver magnetic resonance imaging (MRI) using non-invasive diagnostic criteria (American Association for the Study of Liver Disease (AASLD or Liver Imaging Reporting and Data System (LI-RADS) v2018 and Korean Liver Cancer Study Group- National Cancer Center Korea (KLCSG-NCC) v2018).


Eligibility Criteria:
Inclusion Criteria:

* High risk group of developing HCC
* hepatic nodule equal to or larger than 1cm on ultrasound or computed tomography (CT)
* newly detected nodule (equal to or larger than 1cm, at least 2cm distance from radiofrequency ablation (RFA) site or resection margin) in patients with history of hepatic resection or RFA for HCC AND in remission more than a year
* scheduled for gadoxetic acid-enhanced liver MRI
* signed informed consent

Exclusion Criteria:

* hypersensitivity for ultrasound contrast media
* pregnancy
* history of recent treatment for HCC in a year
* standard of reference is not available
* severe cardiopulmonary disease (right to left shunt, severe pulmonary hypertension, uncontrolled hypertension, etc)
A Study in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With BPS804

The purpose of this study is to select a suitable dose of BPS804 by measuring the strength/quality of bone using a special type of CT scanner. Participants will be treated for 12 months and followed up for a further 12 months.

This study was previously posted by Mereo Biopharma and was transferred to Ultragenyx in February 2021.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a clinical diagnosis of OI Type I, III or IV with a confirmed defect in the COL1A1/COL1A2 genes, as confirmed by genetic testing
* One or more fractures in the past 5 years
* Capable of giving signed consent

Exclusion Criteria:

* History of skeletal malignancies or other bone diseases (other than OI)
* History of neural foraminal stenosis (except if due to scoliosis)
* History of myocardial infarction, angina pectoris, ischaemic stroke or transient ischaemic attack
* History of endocrine or thyroid/parathyroid conditions that could affect bone metabolism
* Treatment with bisphosphonates within 3 months of randomisation
* Treatment with teraparatide, denosumab or other anabolic/anti-reabsorptive medications within 6 months of randomisation
Robot-assisted Hand Rehabilitation for Children With Cerebral Palsy: a Pilot Study

Objective: To investigate the effects of robot-assisted hand rehabilitation with a Gloreha device on hand function and the participation of ADL for children with cerebral palsy(CP).

Materials and Methods: Five children with CP aged 6 to 18 years were recruited and received 12times of robot-assisted hand rehabilitation for 6 weeks of treatment (Sixty minutes a time, twice a week). The performance was assessed by a assessor for three times (pre-test, post-test, follow up at one month). The outcome measures Fugl-Meyer Assessment-Upper Limb section(FMA-UE),Box and block test(BBT), Maximal voluntary contraction(MVC) of extensor digitorum communis(EDC), Flexor digitorum(FD), Grasp strength, \& ABILHAND-Kids for ADL ability. Collected data will be analyzed with ANOVA test by SPSS version 20.0, and alpha level was set at .05. Our hypothesis are robot-assisted hand rehabilitation with a Gloreha device has positive effects on hand function and the participation of ADL for children with CP.

Hand function is the most important for ADL and learning ability. Many cerebral palsy(CP) suffered problems with the gross motor dysfunction and hand function disability. An inability to use the upper extremity in daily life can lead to loss of independence with ADLs and of important occupations (eg, school). Robotic therapy can deliver larger amounts of upper extremity movement practice for these individuals. Although the Robotic therapy appears to provide some benefit for upper extremity motor abilities and participation but is of uncertain utility for cerebral palsy(CP).

Objective: To investigate the effects of robot-assisted hand rehabilitation with a Gloreha device on hand function and the participation of ADL for children with cerebral palsy(CP).

Five children with CP aged 6 to 18 years were recruited and received 12times of robot-assisted hand rehabilitation for 6 weeks of treatment (Sixty minutes a time, twice a week). The performance was assessed by a assessor for three times (pre-test, post-test, follow up at one month). The outcome measures Fugl-Meyer Assessment-Upper Limb section(FMA-UE),Box and block test(BBT), Maximal voluntary contraction(MVC) of extensor digitorum communis(EDC), Flexor digitorum(FD), grasp strength, \& ABILHAND-Kids for ADL ability. Collected data will be analyzed with ANOVA test by SPSS version 20.0, and alpha level was set at .05. Our hypothesis are robot-assisted hand rehabilitation with a Gloreha device has positive effects on hand function and the participation of ADL for children with CP.

Eligibility Criteria:
Inclusion Criteria:

* Children with cerebral palsy(CP) or stroke
* Age younger than 18 and older than 6 years old
* Could follow 2 step order instruction
* No Botulinum injection during the recent 6 month and the experiment period
* Chronicity \> 1 years and stable medicine condition
* Could sit steady after the position

Exclusion Criteria:

* Individuals with other medical symptoms that can affect movement
* Individuals with visual or auditory impairment who couldn't see or hear the feedback from the device clearly
Prospective Double-blinded Randomized Controlled Trial of 12-weeks High Dose Rabeprazole (Pariet) in the Treatment of Reflux Laryngitis in Chinese Patients

The purpose of this study is to evaluate the efficacy of rabeprazole (pariet) versus placebo in treating reflux laryngitis in Chinese patients. Patients who attend the voice clinic of Department of ENT, Queen Mary hospital with suspected reflux laryngitis will be recruited. A questionnaire will be administered by the research assistant of the Department of Medicine and ENT, Queen Mary hospital. A 12-week course of PPI versus placebo trial will be commenced and patients' symptoms and signs will be documented at 6-week and 12-week time. The study will finish after a 12-week course of rabeprazole.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory patients with age between 18-80 years old
* Patients with newly presented laryngitis.

Exclusion Criteria:

* They were under 18 or over 80 years of age
* Has significant concomitant medical disease
* Pregnancy or lactating women
* Chronic cough attributable to known chronic pulmonary or tracheobronchial disease
* Previous glottal surgery, radiotherapy or malignancy
* Acid suppressive therapy within 4 wk prior to recruitment
* Pharyngo-laryngeal infection in the previous 3 months
* Tracheal intubation in previous 12 months
* Immunosuppression and use of inhaled corticosteroid
Evaluation of Diagnostic Accuracy of [68Ga]Ga-PSMA-11 PET/CT in Primary Staging of Intermediate and High Risk Prostatic Cancer in Men Newly Diagnosed

This is a diagnostic accuracy prospective, single-centre, open-label, single group assignment interventional study.

Its aim is to evaluate the diagnostic accuracy of \[68Ga\]Ga-PSMA-11 PET/CT in detection of primary tumour and extra prostatic disease (lymph node, soft tissues spread or bone metastases) in men newly diagnosed with Prostate Cancer at Intermediate and High Risk, according to 2019 Prostate Cancer EAU Guidelines Risk Group Stratification (see Study Population paragraph).

The investigators are interested in the possible future role of \[68Ga\]Ga-labelled PSMA PET/CT as integration to conventional imaging mpMRI (with or without CT of the lower abdomen and Bone scan) in the detection of primary tumor and extra-prostatic disease (lymph node and soft tissues spread or bone metastases).

This is a diagnostic accuracy prospective, single-centre, open-label, single group assignment interventional study.

The primary objective of this study is to evaluate the diagnostic accuracy of \[68Ga\]Ga-PSMA-11 PET/CT in detection of primary tumor and extraprostatic disease (lymph node, soft tissues spread or bone metastases) in men newly diagnosed with prostate cancer at intermediate or high-risk.

The secondary objective of this study is to compare the diagnostic accuracy of \[68Ga\]Ga-PSMA-11 PET/CT to the diagnostic accuracy of conventional imaging mpMRI (with or without CT of the lower abdomen and Bone scan) in the prostatic bed and extra prostatic disease in men newly diagnosed with prostate cancer at intermediate or high-risk.

To evaluate association between \[68Ga\]Ga-PSMA-11 PET/CT uptake value (SUVmax and SUVmean) and aggressiveness of prostate tumor (e.g. PSA serum level and Gleason Score).

Eligibility Criteria:
Inclusion Criteria:

I. Patients with histo-pathological confirmation of PCa with intermediate or high-risk disease according to 2019 Prostate Cancer EAU Guidelines Risk Group Stratification (see Study Population paragraph)

II. Patients with conventional imaging mpMRI (with or without CT of the lower abdomen and Bone scan) performed as baseline in primary PCa staging according to 2019 Prostate Cancer EAU Guidelines

III. Age \>18 years/old

IV. Ability to provide written informed consent

Exclusion Criteria:

I. Contra-indication for PET/CT scan: Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam

II. Impaired renal function

III. Impaired liver function: AST or ALT \> 2.5 x ULN

IV. Patients unable to understand the purpose of the study

V. Medical history of allergic reactions or hypersensitivity to \[68Ga\] Ga-PSMA-11 as well as to any excipient or component of the experimental medicinal product

VI. Having partecipated in clinical trial in which the experimental intervention was administered within 30 days (or 5 half-life) from administration the endovenous solution of \[68Ga\]Ga-PSMA-11
Sociological Study of the Life Courses of Young TRANSgender Patients

The number of people consulting for a request related to trans identity is increasing sharply. The study monocentric qualitative study of discursive material aims to describe the diversity of practices and discourses mobilized by the people concerned and their relatives in the wake of work already carried out in the human sciences. Conducting non-directive interviews (life stories) with transgender patients consulting the Reproductive Medicine Department and their volunteer relatives.The ceiling is 20 interviews and 80 hours of observation.

The number of people consulting for a request related to trans identity is increasing sharply. The study aims to describe the diversity of practices and discourses mobilized by the people concerned and their relatives in the wake of work already carried out in the human sciences.

The care pathway is a central determinant of transgender experiences and differentiated care pathways indicate differentiated relationships to medicalisation and gender, which translate into practices. For the moment, transgender people who do not wish to preserve their fertility or who are not hormonally treated are over-represented in the sample. It is extremely important to gain access to the population that turns to the Reproductive Medicine Service.

The consultation is a place where knowledge (medical, activist, etc.) circulates and meets, which can then be re-appropriated or negotiated by transgender people. While interviews alone are not enough to describe this re-appropriation and negotiation, it is possible to do so through observations of consultations.

Conducting non-directive interviews (life stories) with transgender patients consulting the Reproductive Medicine Department and their volunteer relatives.

The ceiling is 20 interviews and 80 hours of observation.

Patients are given a 'flyer' at the time of their consultation on which the interviewer's contact details are given. They are free to contact the interviewer to find out when and where an interview might take place (outside hospital).

The ceiling is 20 interviews and 80 hours of observation. Discussions during the interview are recorded using a voice recording device, then transcribed in full in Word and anonymised. Discussions during consultations were recorded using notes, then formatted in Word and anonymised.

Eligibility Criteria:
Inclusion Criteria:

* transgender

Exclusion Criteria:

* Refusal by the patient.
* Refusal by the patient's legal guardian.
* Person under guardianship
Quality of Life in Schizophrenic Patients

This is a non-interventional study evaluating quality of life in schizophrenic patients treated with atypical antipsychotics, in the ambulatory setting. This is a 9-month, observational, multicentric prospective study.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Schizophrenia treated with atypical antipsychotics (ambulatory patients).
Tuvusertib (M1774) Human Mass Balance and Absolute Bioavailability Study (DDRIVER Solid Tumors 303)

This is a single sequence 2-period open label study in participants with advanced solid tumors. The purpose of Period 1 of this study is to assess the mass balance to determine drug-related entities present in circulation and excreta and provide a comprehensive understanding of biotransformation pathways and clearance mechanisms in participants with advanced solid tumors. The purpose of Period 1a is to assess the extent of ABA of tuvusertib and the mass balance, PK, metabolism, and elimination of 14C-tuvusertib after iv dosing in participants with advanced solid tumors. After either Period 1 or Period 1a; participants may enter an optional extension phase (Period 2) where participants will receive tuvusertib until disease progression or other criteria for study intervention discontinuation are met.


Eligibility Criteria:
Inclusion Criteria:

* Are histologically proven advanced solid tumors that are considered appropriate for treatment in Period 2 of this study, for which no effective standard therapy exists, or standard therapy has failed or cannot be tolerated
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) less than or equal to 1 (\<=) 1
* Have evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at Screening
* Are capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Uncontrolled or poorly controlled arterial hypertension, symptomatic congestive heart failure (New York Heart Association Classification more than equal to (\>=) Class III), uncontrolled cardiac arrhythmia, calculated Corrected QT interval (QTc) average using the QT Interval Corrected Using Fridericia's Formula (QTcF) more than (\>) 480 msec; unstable angina pectoris, myocardial infarction, or a coronary revascularization procedure, cerebral vascular accident, transient ischemic attack, or any other significant vascular disease within 180 days of study intervention start
* Presence of toxicities due to prior anticancer therapies (e.g. radiotherapy, chemotherapy, immunotherapies, Et cetera (etc.)) that do not recover to (\<=) Grade 1 with the exception of toxicities that do not pose a safety risk to the participant in the judgment of the Investigator (e.g. ongoing Grade 2 alopecia)
* Treatment with live or live attenuated vaccine within 30 days of dosing (non-replicating vector vaccines are permitted)
* Participation in a study involving administration of 14C-labeled compound(s) within last 6 months prior to start of study intervention
* Other protocol defined exclusion criteria could apply
Evaluation of the Relationship Between Zinc Vitamin D and b12 Levels in the Covid-19 Positive Pregnant Women

Zinc d vitamin and b12 serum levels in covid-19 positive pregnants will be compared in terms of patients' responses to computed tomography and treatment.

Serum zinc, vitamin d vitamin b12 levels of 45 patients will be measured and evaluated together with the information of the patients.

Eligibility Criteria:
Inclusion Criteria:

* covid-19 positive pregnant women
* under 18 or more than 45 years old

Exclusion Criteria:

* vitamin D , Vitamin B12 or Zinc supplement use
* Multivitamine use
* have taken vitamin supplements in the past 3 months
* use of medicines for vitamin deficiency
* having metabolic disease covid-19 negative pregnant women
Development of a Web-Based Interactive Patient Decision Aid for the Treatment of Acute Low Back Pain and Depression

Shared decision making (SDM) has been advocated as an appropriate approach for physician patient communication. Positive effects of SDM are e.g higher patient satisfaction, greater treatment adherence, lower decisional conflict and better clinical outcomes. The Section of Clinical Epidemiology and Health Services Research at the University Medical Center in Freiburg (Germany) is developing and evaluating a web-based interactive decision aid ("patient dialogue") to support shared decision making in cooperation with the Techniker Krankenkasse, a large German health insurance company. Both development and evaluation are conducted along the International Patient Decision Aid Standards (IPDAS).

The decision aid contains information on acute low back pain and depression and addresses insurance members who are facing a treatment decision in one of the indications. It aims at the development of patient competencies for participating in decision making, the support of constructive health behavior and patients' acceptance of evidence based treatment options.

In an RCT the decision aid will be compared to a regular patient information on a sample of N=500 patients in each group. Data collection will take place at three points of time: before and after use of the decision aid as well as 3 months later.


Eligibility Criteria:
Inclusion Criteria:

* insurance members with acute low back pain or depression

Exclusion Criteria:

* insurance members without symptoms, with chronic back pain, with a bipolar disorder, relatives of people with symptoms
Analgesic Effect of Perineural Fentanyl Additive to Local Anesthetics in Femoral Nerve Block

The purpose of this study is to evaluate the analgesic efficacy of perineural fentanyl combined with local anesthetics in the post operative pain control with continuous femoral nerve block after total knee arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* patients who scheduled to receive knee arthroplasty with general anesthesia
* ASA physical status 1 or 2

Exclusion Criteria:

* allergy to drug
* refuse to the study
* ASA physical status 3 and 4
* history of drug abuse
* cognitive disfunction such as dementia
* patients who do not adequate for general anesthesia
CHOICES: Family Physicians Treat Overweight Children

CHOICES is a program to provide children and families with lifetime tools and lifestyle strategies to achieve and maintain a healthy body size. Both parents and children get active, learn about the food choices they can make, and about the roles of TV in their lives. Led by physicians and young adults, the 12 weekly 90 minute sessions provide hands on experiences that connect into the participants' daily lives. In the study, the families were divided into two groups, beginning their classes 6 months apart. Body measurements were taken at baseline and every 4 months to 16 months.

The specific aim of this pilot study was to use the group office visit model to provide an obesity treatment intervention for children 8-11 years of age in gender-specific groups and their parents in a clinic setting. The targeted lifestyle components of the intervention are less TV viewing, less sweetened beverages, smaller food portions, less fast food/better choices away from home and more general physical activity. The psychosocial component was based in Resiliency; the Choices model focused on a non-judgmental approach to empowerment in relation to personal goals and knowledge of the basics of nutrition and physical activity.

Our aim was to recruit 35-40 children (approximately equal boys and girls) ages 8-11 and their parents for a 12 weekly sessions group office visit program. Participants were randomized into 2 groups; one group starting in March 2006 and the lagged intervention control group starting in September 2006. Physical measurements and data collection were at baseline, 4, 8, 12, 16 months from randomization.

We evaluated the acceptability and feasibility of the group office visit model and effect size (body mass index (BMI) and weight-for-age Z-scores). Feasibility and acceptability included ability to recruit within clinics, attendance, completion, follow-up rates, focus groups data and interviews of those who drop out. Evaluation of effect size included the patterns of growth over 15 months from baseline in relation to expected growth patterns and intervention exposure.

Eligibility Criteria:
Inclusion Criteria:

* Children in the 3rd to 5th grades and above the 85th percentile of BMI for age.

Exclusion Criteria:

* Conditions that would preclude dietary change or physical activity.
Bone Marrow Donation

The study evaluates the knowledge, attitude and practice about bone marrow donation among medical students and medical staff.

In Europe the biggest database of bone marrow donors have Germany - more than 5.5 million people registered, in Poland is only 700 thousand people, and a total worldwide 24 million people willing to donate bone marrow.

In the study the investigators are examining how medical students and medical staff feel about the issues of bone marrow donation, especially: bone marrow shortage, methods of donation.

The investigators are planning to focus on the following specific questions:

What is the level of knowledge about bone marrow donation among participants? What are the sociodemographic, sociocultural and socioeconomic characteristics of listed as an Organ Donor and non-listed as an Organ Donor among participants? Evidence on the role of financial and other incentives in eliciting bone marrow donation.

Eligibility Criteria:
Inclusion Criteria:

* Give voluntary consent to participate in the study

Exclusion Criteria:

* not meet the above criteria
Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin for 12 Weeks (MK-2355-005)

The purpose of this study is to assess the safety and antiviral activity of IDX184 in combination with pegylated interferon and ribavirin in treatment-naïve subjects with genotype 1 chronic hepatitis C virus (HCV) infection.


Eligibility Criteria:
Inclusion Criteria:

* Males and females with documented genotype 1, chronic hepatitis C infection.
* Must agree to use double-barrier method of birth control for at least 6 months after the last dose of study drugs.
* Has not received prior antiviral treatment for HCV.
* Written informed consent by participant.

Exclusion Criteria:

* Pregnant or breastfeeding.
* Co-infected with hepatitis B virus (HBV; hepatitis B surface antigen \[HBsAg\] positive) and/or human immunodeficiency virus (HIV).