cyrilzakka/clinical-trials huggingface dataset:
Holding a Foster Child's Mind in Mind

The aim of this study is to examine the effects of Mentalization Based Therapy (MBT) for foster families in Denmark on child mental health and well-being, parental stress, mental health, and reflective function, parental mind-mindedness and the parent-child relationship.

Children placed in foster care are psychologically and physically vulnerable and show more social, developmental, and behavioral problems than children living with their family of origin. Many foster parents struggle to care for these children, some of whom have experienced serious adversity at a young age. The study examines the effects of Mentalization Based Therapy (MBT) in a cluster-randomized controlled trial with 175 foster families with children aged 4-17 years in 10 Danish municipalities.

Eligibility Criteria:
Inclusion Criteria:

* Any kind of foster family (including professional and kinship care) with at least one full-time foster child aged 4-17 years.
* Elevated child symptoms as measured by X scales and
* An expressed need for support from either the foster parents or the foster child.

Exclusion Criteria:

* Foster families in which there are no reported difficulties and concerns regarding the child or the placement.
* Foster families in which the child was placed with the family within the last X months
Survey on Belgian Patients Suffering From Irregular Heartbeat and Starting Treatment With a Drug to Prevent Blood Clots in Blood Vessels and the Heart. This Study is Also Called BELANCOS.

In this study researchers want to learn more about the patient's and treating doctor's concerns about possible bleedings during treatment with drugs preventing blood clots in blood vessels and the heart - so called blood thinner. The study also wants to find out more about the patient's knowledge on the importance, risks and benefits of treatment with this drug group.

Patients with irregular heartbeat not caused by valvular heart disease who will start treatment with a blood thinner will be asked by their treating cardiologist to complete a questionnaire related to their knowledge and fear of possible bleedings or stroke (blockage or rupture of a blood vessel to the brain) due to the intake of a blood thinner. The treating doctor will complete a similar questionnaire. The study plans to involve 15 cardiologists and 300 patients in Belgium.


Eligibility Criteria:
Inclusion criteria:

* Male or female adult patients diagnosed with NVAF.
* NOAC treatment-naive patients who will start a NOAC treatment.

Exclusion criteria:

* Previous stroke or thrombosis
* Previous severe bleeding
Study to Assess Adverse Events and the Movement of Oral Venetoclax Tablet Through the Body of Female Participants Aged 18-75 Years With Impaired Renal Function

Renal insufficiency is common in participants with blood cancers. The main objective of this study is to evaluate adverse events and movement of oral venetoclax tablets through the body of female participants with severe normal renal function and those with end stage renal disease (ESRD) requiring hemodialysis.

Venetoclax is an investigational drug being developed for the treatment of various hematologic malignancies. Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group receives a different treatment. Approximately 12 female participants between 18 and 75 years, with Body Mass Index (BMI) between 18 to 42 kg/m2 will be enrolled in approximately 4 sites across the world.

Participants with normal renal function will receive single dose of oral venetoclax tablet. Participants with ESRD will receive oral venetoclax tablets just prior to hemodialysis (Period 1 Day 1) and between dialysis days (Period 2 Day 1), doses in the two periods will be separated by at least 7 days.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood and urine tests, checking for side effects.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 18.0 and 42.0 kg/m2.
* Postmenopausal or permanently surgically sterile (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).
* Women of childbearing potential, practicing at least 2 protocol specified methods of birth control that are effective from at least 30 days before starting study drug through at least 30 days after the last dose of any study drug.
* Group 1 only: Must be in general good health based upon the results of a medical history, physical examination, and 12-lead electrocardiogram (ECG) with normal Glomerular Filtration Rate (GFR) at Screening.
* Group 2 only: Stable condition and acceptable for study participation based upon the results of a medical history, physical examination, laboratory profile, and ECG. Participant with end stage renal disease (ESRD) requiring dialysis on hemodialysis must have been receiving hemodialysis for at least 1 month.

Exclusion Criteria:

- Participants on a strict vegetarian or vegan diet.
The Effect of Ketone Esters on Forearm Glucose Metabolism

Ketones are naturally produced by our body and can affect our blood sugar levels. Ketones could be important tool for treating disease or recovering from exercise. The purpose of this research is to determine if a ketone drink can increase sugar uptake in our muscles. This research will provide new knowledge about the regulation of blood sugar.

Impaired skeletal muscle glucose uptake following a meal ("insulin resistance"), is a primary risk factor for developing type 2 diabetes. We and others have consistently shown that ingesting exogenous ketones can reduce blood glucose concentration. Mechanistically, this must arise through reduced glucose release (i.e. from liver), and/or increased uptake (i.e. into skeletal muscle). Our current MRC-funded work is focussing on ketone-liver interactions in patients with type 2 diabetes. Here we aim to investigate how KE influence skeletal muscle glucose metabolism.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-40

Exclusion Criteria:

* Any diagnosed metabolic health condition
* Pregnant
* Smoker
* Diagnosed Cardiovascular disease
* Use of medications deemed by research team to affect study outcomes
* Recent history of musculoskeletal injury
* Aged \>40 or \<18
* Allergy to ingredients in the supplement, including ketones, lactose or milk protein
Initiating ACP in General Practice. A Phase II Study

End-of-life care often fails in providing optimal patient-centred care and quality of life. Patients frequently suffer from inadequate control of pain, from a lack of communication about their illness and options for treatment, and from poor psychosocial and spiritual support. Advance care planning (ACP) can tackle these problems by providing patients with an opportunity to formulate their wishes and plan their future care, should they become incapable of participating in medical treatment decisions. Previous studies show that ACP improves concordance between patient's preferences and end-of-life care received and quality of care at the end-of-life. However, ACP is yet to be embedded in routine clinical practice and public consciousness. General practitioners (GPs) are in an ideal position to discuss ACP with their patients. By introducing ACP during a routine office visit, GPs can facilitate a structured discussion of the patient's wishes for end-of-life care. However, no ACP models have been systematically developed and tested in general practice. We developed a complex intervention to improve the initiation of ACP in general practice following the steps of an international guidance for development and evaluation of complex interventions. Before performing a full-scale intervention trial to study the effectiveness of this intervention on quality of care and quality of life, this model needs to be validated and tested in a pilot trial.

Aim

1) to conduct the Phase II trial with GPs who will facilitate a structured ACP session with patients with a serious or life-threatening illness versus usual care and 2) to evaluate and validate the ACP intervention in terms of feasibility, acceptance to GPs and patients with a serious or life-threatening illness, and preliminary proof of effectiveness

Method

The implementation and preliminary evaluation of this intervention will be done by following the steps of the Medical Research Council (MRC) framework on complex intervention designs. This framework proposes a stepwise approach going from phase 0 to phase IV.

Phase 0-I were previously conducted by the research team and comprised the development of the intervention. This project proposal comprises phase II (exploratory trial) in which the feasibility and acceptability of the intervention will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* patients with a serious or life-threatening illness
* older than 18 years
* Dutch speaking
* eligible according to the Surprise question
* able to give informed consent
* able to complete questionnaires and participate in qualitative interview

Exclusion Criteria:

* younger than 18 years
* incompetent to participate due to mental incapacity
* unable to give informed consent
* unable to complete questionnaires or participate in qualitative interviews
Food Effects on Milademetan Pharmacokinetics in Healthy Participants

The primary objectives of this trial are:

* To evaluate the effect of a high-calorie, high-fat meal on the single-dose pharmacokinetics (PK) of milademetan
* To evaluate the effect of a standard meal on the single-dose PK of milademetan

The key secondary objective is to evaluate the safety and tolerability of single-dose milademetan in all treatments.

The duration of the study for each individual participant will be approximately 8 weeks from the start of Screening (within 28 days prior to dosing of study drug on Day 1) through the final Follow-up visit or phone call. Participants will remain in the Clinical Research Unit (CRU) from Study Day -2 through Study Day 20 (a total of 22 days and 21 nights).

Participants will receive 3 single doses of study drug (at least 1 week apart) over the course of 15 days.

At the investigator's discretion, participants may be asked to return to the CRU 14 days (±2 days) after final dose of study drug for a follow-up visit.

The end of the study is defined as the date of final follow-up visit of the last subject undergoing the study.


Eligibility Criteria:
Healthy participants with no clinically significant medical history or physical examination findings and who also meet all protocol-defined inclusion and exclusion criteria summarized as follows:

Inclusion Criteria:

* Has negative urine test for drugs of abuse, alcohol and tobacco
* If female, is surgically sterile or postmenopausal
* If male, agrees to protocol-defined contraceptive methods
* Has adequate hematologic, hepatic, and renal function as defined by the protocol
* Is able and willing to follow all study procedures
* Has provided a signed informed consent

Exclusion Criteria:

* Is female who is pregnant or breastfeeding
* Is unable to swallow oral medication
* Is unable to follow study procedures
* Has creatinine clearance \< 90 mL/min at screening
* Is taking or has taken any medications or therapies outside of protocol-defined parameters
* Has history of or a known allergic reaction to azole antifungal agents
* Has any disease or condition that, per protocol or in the opinion of the investigator, might affect:

  1. safety and well-being of the participant or offspring
  2. safety of study staff
Comparative Study of Turmeric Extract in Patients With Arthrosis.

The aim of this study is to test if an extract of Turmeric can alleviate symptoms of osteoarthritis in volunteers with osteoarthritis of the hip and or knee.

The included volunteers, who are devided into two groups either placebo or turmeric extract, will be tested using WOMAC questionnaires focussing on pain, stiffness and daily activity. In addition different aspects of quality of life will be evaluated and the consumption of rescue medication will be recorded in patients personal diary.

The treatment period is 3 month with the posibility to continue for an additional 3 month.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers
* 40 years of age or more
* Osteoarthritis of the hip and or the knee
* Suffering from pain in the hip and or knee -

Exclusion Criteria:

* If volunteers are on a waiting list for hip or knee surgery
* If the volunteers are involved in an other clinical trial
* If the volunteers are taking other herbal remedies, which canhav influende on # Osteoarthritis.
* Abusers of alcohol and drugs
* Volunteers not easy to cope with
Efficacy of Fluoroscopic Guided Atlantoaxial Joint Injection on Head and Neck Pain and Sleep Quality in RA Patients

Efficacy of intra-articular steroid injection for inflamed atlantoaxial joint in patients with rheumatoid arthritis Inclusion criteria Patients with rheumatoid arthritis with MRI findings of atlantoaxial joint inflammation and failure of resolution after 2 weeks systemic steroid administration Exclusion criteria Coagulopathy, allergy to contrast material, pregnancy Interventional group (AS) group, received intra-articular steroid injection for atlantoaxial joint. , in addition to methotrexate and chloroquine 400 mg per day.

Efficacy of intra-articular steroid injection for inflamed atlantoaxial joint on sleep quality and head and neck pain in patients with rheumatoid arthritis Inclusion criteria Patients with rheumatoid arthritis with MRI findings of atlantoaxial joint inflammation and failure of resolution after 2 weeks systemic steroid administration Interventional group (AS) group, received intra-articular steroid injection for atlantoaxial joint. , in addition to methotrexate and chloroquine 400 mg per day.

Eligibility Criteria:
Inclusion Criteria:

* Patients with rheumatoid arthritis with MRI findings of atlantoaxial joint inflammation and failure of resolution after 2 weeks systemic steroid administration

Exclusion Criteria:

* Coagulopathy, allergy to contrast material, pregnancy
Effects of a 12-week VR Intervention on the Functional Fitness of Adults of Different Age Ranges

This study aimed to evaluate the effects of a 12-week VR fitness intervention on the functional fitness of adults of different age ranges.

Previous studies have shown age-related decreases in physical activity and functional fitness among older adults. Virtual Reality (VR) exercise programs are currently used in leisure and entertainment to improve the physical health of older adults. However, VR exercise in assessing physical health or functional fitness in older adults of different age ranges is rare. To fill this research gap, VR exercise was to assess functional fitness improvement in young and middle-aged participants.

Eligibility Criteria:
Inclusion Criteria:

* aged more 65 and less 84 years
* with no listening/vision impairments
* who did not have any history of illness based on their response to the Physical Activity Readiness Questionnaire (PAR-Q)
* interested in the virtual reality exercise

Exclusion Criteria:

* age less than 65 or more than 84 years
* disability and unable to live independently
Pencil Beam Proton Therapy for Recurrences in Anal Cancer Patients Previously Treated With Radiotherapy (DACG 5)

This protocol aims to determine toxicity and efficacy of re-irradiation for patients with recurrences from anal cancers with dose-escalated pencil beam proton therapy either pre-operative for marginally resectable recurrences or as a definitive treatment strategy (un-resectable, operation declined etc.). The over-all aim is to improve local tumor control with acceptable side effects.


Eligibility Criteria:
Inclusion Criteria:

* Recurrent anal cancer
* Bioptically verified (squamous cell carcinoma)
* Available dose plan from primary radiotherapy
* Previous RT (\>30Gy EQD2)
* Evaluated in MDT-conferences (Herlev, Aarhus)
* Age\>18 years
* PS 0-2
* Adequate organ function
* Written informed consent

Exclusion Criteria:

* Distant metastases deemed without curative intended treatment options (PET-CT)
* Unable to undergo MRI, PET-CT
* Inability to attend full course radiotherapy and follow up in the outpatient clinic.
Adverse Events in Pharmaceutical Bioequivalence Study of Two Formulations of Metformine Hydrochloride 500 mg

The objective is evaluate, in healthy volunteers, the bioavailability of two products containing metformine 500 mg to determine if they are bioequivalent and identify the occurrence of adverse events.

OBJECTIVE: To evaluate, in healthy volunteers, the bioavailability of two products containing metformine 500 mg to determine if they are bioequivalent and identify the occurrence of adverse events.

MATERIAL AND METHODS: The study was approved by research Ethics Committee and all twenty-eight volunteers signed the selected IC. An open, randomized, crossover study with two periods of confinement and an interval of seven days between them was performed. Twenty (20) blood collections were performed between 30 minutes and 36 hours after drug administration. Plasma samples were analyzed by liquid chromatography mass spectrometry (LC-MS/MS). Statistical analysis was conducted based on pharmacokinetic parameters: maximum concentration (Cmax) and area under the curve (AUC 0-te AUC 0-inf). Analysis of variance (ANOVA) model appropriate was employed for the two periods cross under the logarithmically transformed data.

Eligibility Criteria:
Inclusion Criteria:

* Within 10% of their ideal body weight
* Age between 18 and 50 years
* Healthy conditions
* Ability to understand the written informed consent

Exclusion Criteria:

* Pregnancy
* Smokers
* Alcohol and drugs
Long-term Clinical Outcomes in Patients With FFR Guided-Deferred Coronary Lesions, Assessed by IVUS Analysis

This study was a multicenter retrospective study that included intravascular ultrasound (IVUS) in patients with delayed stent insertion based on fractional flow reserve (FFR) in moderately narrowed coronary lesions. We would like to see the effect of lesion characteristics on clinical course.

From January 2007 to August 2014, patients who meet the criteria for selection and exclusion from Keimyung University Dongsan Hospital, Seoul National University Hospital, Inje University Busan Paik Hospital, and Ulsan University Hospital are included.

1. Target patient screening The database will select patients who meet the selection and exclusion criteria.
2. target patient characteristics The age, sex, smoking status, medical history (hypertension, diabetes mellitus, hyperlipidemia), diagnosis, and left ventricular blood count measured by echocardiography should be checked through a computerized medical record.
3. coronary angiography Coronary angiography images of the subjects in the blinded state are analyzed to investigate the length of lesions, reference vessel diameter, and minimal vessel diameter.
4. intravascular ultrasound In the blinded state, the vessel's vessel area, plaque area, lumen area, etc. are measured by analyzing intravascular ultrasound images of the patient using EchoPlaque (Indec Systems, Mountain View, CA).

Eligibility Criteria:
Inclusion Criteria:

* Subject over 19 years old
* Patients with mild or moderate stenosis lesions on coronary angiography
* Patients with lesions with FFR values greater than 0.80
* Patients with analytical intravascular ultrasound images

Exclusion Criteria:

* Left main lesion
* History of coronary artery bypass grafting
* Patients with lower left ventricular ejection fraction (\<25%)
Comparison of Different Preoperative Fasting Times in Pediatric Patients Undergoing Elective General Anaesthesia

Rationale of this study is to provide an evidence on minimal safe clear fluid fasting duration without the risk of aspiration of gastric contents during elective pediatric procedures under general anesthesia.

Pre-operative fasting is a specific time period before a procedure in which participants will be advised not to take any liquid or solid by mouth. Nil per oral (NPO) is a universally accepted practice before elective general anesthesia in order to reduce gastric contents aspiration. In the period of chloroform anesthesia NPO was introduced because of vomiting and discomfort associated with anesthesia. Hence prevention from aspiration of gastric contents was a main focus during general anesthesia. With introduction of better anesthesia drugs recommendations were given to keep minimal fasting time before general anesthesia.

Recent guidelines suggest six, four and two hours fasting for solids/ infant formula milk, breast milk and clear fluids respectively. It is common practice to keep children NPO for 6 hours before surgery. But many times, children have to suffer excessive unnecessary fasting due to delayed surgery that lead to reduction in systolic blood pressure, induce catabolic state and behavioral effects. Moreover prolonged fasting increases insulin resistance and may increase the inflammatory response to surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Both male and female patients
2. Age between 1 to 12 years
3. Patients undergoing elective surgical procedures ( orchidopexy, lymph node biopsy, skin grafting, tongue ties and hernia repair ) under general anesthesia

Exclusion Criteria:

1.Patients with co-morbidities like acid peptic disease with history of dyspepsia and family history or self-history of diabetes mellitus.
Comparison Between Efficiency of Inferior Alveolar Nerve Block and Buccal Infiltration Techniques Using Articaine 4% 1:100000

This split mouth randomized control trial is designed as to compare the effectiveness of the buccal infiltration technique with the gold standard inferior alveolar nerve block in anesthetizing mandibular second primary molars to undergoing pulpal treatment.

patient will be videotaped during pulpal treatment of their teeth and an accessing pain will be through an objective pain scale (SEM scale), (sound-eye-motor scale).

the patient will be asked to fill in a subjective Wong Baker pain scale for the pain suffered during injecting the local anesthetic agent in both techniques.


Eligibility Criteria:
A-Inclusion Criteria:

1. first dental visit.
2. cooperative children (rating 4 or 3 based on Frankl behavior scale) aging from 6 to 8 years suffering from one or more deep carious lesions in their primary molars seeking treatment.
3. Restorable molars with stainless steel crowns.

B-Exclusion Criteria:

1. medically compromised patients. uncooperative children (rating 1 or 2 on the Frankl behavior scale)needing special line of treatment through general anesthesia.
2. signs and symptoms of irreversible pulpitis, spontaneous pain, necrosis or any signs or symptoms of any infection.
3. presence of any radiographic signs of abcess, bone loss, internal or external root resorption.
4. parents or guardians who refuse participating in the study.
A Study Evaluating if Pridopidine is Safe, Efficacious, and Tolerable in Patients With Huntington's Disease

The purpose of the study is to collect and assess long term data on the safety, tolerability, and efficacy of pridopidine in patients with Huntington's disease (HD).


Eligibility Criteria:
Inclusion Criteria:

* Pride HD completion within the last 6 months, including 2 week follow up period or patients who transitioned from the Open HART study or patients who complete future safety and efficacy clinical trials of pridopidine. In addition, patients who have already completed their defined study period under Open PRIDE HD global or local amendments and have discontinued treatment with pridopidine will be allowed to re enter the Open PRIDE HD study.
* Women of child bearing potential or male participants: Adequate contraception and birth control
* Good general health

  * other criteria apply, please contact the investigator for more information

Exclusion Criteria:

* Similar baseline criteria for ECG, vital signs, cardiovascular system, and renal function to PRIDE HD;
* Similar concomitant medication restrictions to PRIDE HD.

  * other criteria apply, please contact the investigator for more information