cyrilzakka/clinical-trials huggingface dataset:
Unified Protocol for Children: A Randomized Controlled Trial for the Portuguese Population

The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children (UP-C) is a transdiagnostic and emotion-focused cognitive-behavioral group intervention for children aged 6-12 years old with emotion disorders (i.e., anxious and/or mood disorders) and their parents.

UP-C consists of 15 weekly group sessions and unifies cognitive-behavioral, contextual (e.g., mindfulness) and parental training techniques, for parents and children, aimed at reducing the intensity and frequency of strong and aversive emotional experiences in children and their clinical symptomatology.

The present study aims to assess the feasibility, acceptability and efficacy of the UP-C in the Portuguese population in reducing children's anxiety/depression symptoms. It also aims to investigate which mechanisms explain the therapeutic change.

Participants will be recruited at child mental health services and schools from Central Portugal and also through online dissemination of the study.

A randomized controlled trial (RCT) will be conducted in a sample of children aged 6-13 years old with emotional disorders and their parents in order to answer the critical question of whether the UP-C is more efficacious in reducing children's symptomatology than a psychoeducational group intervention (active control group).

Once the eligibility criteria are met (assessed by the project researchers) parents and children will be randomly assigned to one of two study conditions:

1. experimental group (i.e., children and parents who benefit from the UP-C program).
2. control group (i.e., children who benefit from a psychoeducational intervention program, named "ABC of Emotions").

Parents and children from both groups will complete several psychometrically robust and developmentally appropriate measures at baseline (T0), mid-treatment (only at week 7 of the UP-C; T1), post treatment (T2) and at 3 months follow-up (T3).


Eligibility Criteria:
Inclusion Criteria:

* Children aged 6-13
* Primary diagnosis of an anxiety and/or depression disorder
* Speaking, reading and understanding Portuguese

Exclusion Criteria:

* Diagnosis of a psychotic disorder, bipolar disorder or intellectual disability;
* Severe current suicidal/homicidal ideation;
* The child is not on a stable dose of a psychotropic or other type of medication for at least 1 month prior to T0 assessment.
Muscle MRI in Becker Muscular Dystrophy and in Limb-girdle Muscular Dystrophy Type 2I

The purpose of this study is to investigate the paradoxical muscle enlargement in the calves and tongue seen in patients affected by Becker muscular dystrophy and Limb-girdle muscular dystrophy type 2I.

The enlarged calves' muscle quality will be assessed primarily on the basis of the muscle structure on MRI and based on a calculation of muscle strength per cross-sectional area.The findings will be compared with results from non-affected controls.

Additionally we want to describe the tongue muscle appearance on T1-weighted MRI.

The purpose of this study is to investigate the paradoxical muscle enlargement seen in patients affected by Becker muscular dystrophy and Limb-girdle muscular dystrophy type 2I.

Becker and limb-girdle muscular dystrophies are both hereditary muscular disorders. Both diseases appear clinically with shrinkage and muscle weakness of the muscles around the shoulder girdle and pelvis, while muscle hypertrophy of the calves and tongue is seen.

The quality of the enlarged calves has to the investigators knowledge not previously been described, and their hypothesis is that the normal correlation between muscle strength and muscle cross-section is absent in the calf muscles. Thus the investigators hypothesis suggests that there is no actual hypertrophy of the calf muscles, but rather a pseudohypertrofy with reduced force per cross-sectional area. With a picture of increased fat infiltration and disorganized muscle fibers.

The enlarged calves' muscle quality will be assessed primarily on the basis of the muscle structure on MRI (assessed on both T1 imaging, 3-point Dixon scans, and diffusion tension imaging), and based on a calculation of muscle strength per cross-sectional area. Isokinetic muscle dynamometry (Biodex-4) will be used to measure muscle strength. The findings will be compared with results from non-affected controls.

Additionally the investigators want to describe the tongue muscle appearance on T1-weighted MRI.

Eligibility Criteria:
Inclusion Criteria:

* Danish patients genetically verified with either becker muscular dystrophy or limb-girdle muscular dystrophy type 2I
* calves enlargement

Exclusion Criteria:

* Patients who have metal implants in the body, for instance surgical clips, cochlear implants, pacemaker etc.
* pregnant or breast-feeding patients
* patients who are claustrophobic
* atrophic calves
Four or Six Weeks of Immobilization in the Conservative Treatment of Distal Radius Fractures in Elderly Population?

The purpose of this study is to compare if there are differences in wrist function and pain after a distal radius fracture treated conservatively with immobilization for 4 or 6 weeks in elderly patients after six months of follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 65 years with a low energy distal radius fracture
* Intra or extraarticular distal radius fracture (A2, A3, C1, C2)
* Acceptable primary reduction (dorsal inclination \<10º, radial shortening \<3mm, articular gap \<2mm)

Exclusion criteria:

* History of ipsilateral fracture
* Bilateral fracture
* Open fracture
* Other concomitant fracture (except ulnar styloid fracture)
* Fracture AO B
* Previous surgeries in this area
* Dementia
Hip Protector for Prevention of Hip Fracture

This study aims to evaluate the efficacy of the investigators PSU hip protector for prevention of fracture in elderly.The eligible patients include those with previous diagnosed as unilateral hip fracture. They will be randomized into 2 groups;psu hip protector and no protector. The patients will be instructed to wear the protector fulltime.The inceidence of hip fracture will be compared between both group at the end of 1 year.


Eligibility Criteria:
Inclusion Criteria:

* Patients with previous diagnosed as unilateral hip fracture

Exclusion Criteria:

* Poor communicative ability
* Cannot independently ambulate
* Local skin problem at trocahnteric area
An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Cancer Participants With Inadequately Controlled Pain by Non-Narcotic Analgesics

The purpose of this study is to evaluate the efficacy and safety of Transdermal Therapeutic System (TTS)-fentanyl D-Trans (transdermal patch containing a drug that is put on the skin so the drug will enter the body through the skin) treatment in cancer participants of Korea with inadequately controlled pain by non-narcotic analgesics (drug used to control pain) and participant's satisfaction.

This is an open-label (all people know the identity of the intervention), single-arm, multicenter (conducted in more than one hospital or medical school team work on a medical research study), prospective (study following participants forward in time) study conducted to assess the efficacy and safety of TTS-fentanyl D-trans in cancer participants of Korea with inadequately controlled pain by non-narcotic analgesics and for participant's satisfaction. The participants will receive the initial dose of TTS-fentanyl D-trans patch releasing 12 micrograms per hour (12 mcg/hr) of fentanyl and will be increased by 12 mcg/hr or 25 mcg/hr, every 3 days depending on the participant's pain control. Efficacy will primarily be evaluated by participant's satisfaction with pain treatment. Participant's safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Participants who complains of cancer pain
* Participants who have taken non-opioid analgesics for the past one month for cancer pain relief purpose, but still have average 4 or higher pain level on the Visual Analogue Scale (VAS) for the last 24 hours
* Participants with an estimated life expectancy of at least 2 months
* Participants who are able to communicate with the investigator
* Participants who can avoid getting pregnant appropriately if there is a possibility of pregnancy during this study period

Exclusion Criteria:

* Participants participating in another clinical trial
* Participants with a history of oversensitive reaction to a narcotic analgesic or with an existing history of drug abuse
* Participants who have active skin disease, avoiding application of the transdermal system
* Participants with a history of CO2 (carbon di-oxide) retention (i.e. chronic obstructive pulmonary disease)
* Participants undergoing chemotherapy/radiotherapy right now or is going to get chemotherapy/radiotherapy within the study period
Effects of Sustained Natural Apophyseal Glides Combined With Kinesiotaping in Patients With Chronic Mechanical Neck Pain: A Randomised Controlled Trial

This study is a randomized controlled trial and its purpose is to determine the combined effects of sustained natural apophyseal glides and kinesiotaping on pain, range of motion and neck disability in patients with chronic mechanical neck pain.

This study aims to determine the combined effects of sustained natural apophyseal glides and kinesiotaping in chronic mechanical neck pain patients of age range 18-40. Outcome variables are pain, range of motion and functional disability of neck which will be determined by using the following respective data collection tools:

1. Numeric pain rating scale
2. Inclinometer
3. Neck Disability Index

Participants of interest will be approached and explained about the research. They will be randomly allocated in to two groups. Informed written consent will be taken. The intervention protocol will be comprised of six sessions over a 2-week period (3 sessions per week on alternate days). Outcome measures will be assessed at baseline and after 2 weeks. Data will be analyzed and interpreted using SPSS.

Eligibility Criteria:
Inclusion Criteria:

* Mechanical Neck Pain
* Age range: 18-40 years
* Both males and females
* Having pain from at least last 3 months (chronic)
* Pain score greater than 3 on NPRS
* Pain and limitation on neck moverment

Exclusion criteria :

* Recent surgery of spine, Temporomandibular joint or shoulder in the previous 12 months.
* Open wound around neck.
* History of traumatic injuries or fractures in the cervical spine.
* History of neurological and cardiac pathologies.
* History of some serious pathologies (e.g., malignancy, inflammatory disorder etc.).
* History of cervical or shoulder neurological movement disorder.
* Cervical spondylolisthesis, cervical radiculopathy, and spinal stenosis.
* Vascular syndromes such as basilar insufficiency.
* Diagnosed psychiatric disorders such as anxiety and depression.
* Interventions including medications, exercise or physical therapy in the last 3 months.
* Any other condition that contraindicates kinesiotaping such as skin sensitivity.
Effect of Fruit Smoothie Supplementation on Psychological Distress Among People Receiving Opioid Agonist Therapy

Background: People with substance use disorders generally have poor diets including limited intake of fruit and vegetables. Evidence shows substantial health benefits from increasing fruit and vegetable consumption on a variety of indicators and possibly also psychological distress. A pilot study has indicated that supplementation with fruit smoothie could be promising also among people receiving opioid agonist therapy (OAT) for opioid dependence. FruktBAR will compare the efficacy of fruit smoothie supplementation within the OAT clinics compared to standard treatment.

Study design: FruktBAR is a multicentre, randomised controlled trial. The trial will recruit approximately 230 patients receiving OAT in Bergen and Stavanger, Norway.

Intervention: The intervention involves daily supplementation with 250 ml fruit smoothie. The main endpoints are 16 weeks after intervention initiation. Participants will be included and followed up during and after intervention.

Study population: The target group will be patients with opioid dependence receiving OAT from involved outpatient clinics in Bergen and Stavanger.

Expected outcome: This study will inform on the relative advantages or disadvantages of a fruit supplementation in addition to the current medically and psychologically oriented treatment of people receiving opioid agonist therapy. If the supplementation is found to be safe and efficacious, it can be considered for further scale-up.

See below each section

Eligibility Criteria:
Inclusion Criteria:

* Receiving OAT from an included outpatient clinic with outpatient follow-up on weekly basis
* Having fruit and vegetable intake below 3 portions per day (assessed at screening)
* Confirming interest in participating in diet intervention (criteria specified)
* Giving informed consent

Exclusion Criteria:

* Allergies or prior anaphylactic reactions involving fruits or vegetables
* Poorly regulated diabetes type 1 or 2 (HbA1c \>60 mmol/mol)
A Study to Compare the Conversion to Prograf® (Tacrolimus) to the Continuation of Cyclosporine in Patients at Risk for Chronic Renal Allograft Failure

A study to compare the conversion to Prograf® (tacrolimus) to the continuation of cyclosporine in patients at risk for chronic renal allograft failure

A two arm study (1 Active, 1 Active control) to compare the incidence, progression and severity of chronic renal allograft failure in at-risk patients who are converted from cyclosporine-based to tacrolimus-based immunosuppression to patients who remain on cyclosporine-based therapy

Eligibility Criteria:
Inclusion Criteria:

* Patient has been on cyclosporine-based immunosuppression regimen since the transplant
* Patient has at least one pre-defined risk factor for chronic allograft failure

Exclusion Criteria:

* Patient is dialysis dependent
* Patient is recipient of a solid organ transplant other than the kidney
HAIC Plus Lenvatinib and Toripalimab for Advanced HCC

The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus lenvatinib and toripalimab in patients with advanced hepatocellular carcinoma (HCC)

Hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin was effective and safe for hepatocellular carcinoma. Lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma, and programmed cell death protein-1 (PD-1) antibody was effective and tolerable in patients with advanced hepatocellular carcinoma. No study has evaluated HAIC plus lenvatinib and toripalimab. Thus, the investigators carried out this prospective, single-arm study to find out it.

Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
* Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.
* Barcelona clinic liver cancer-stage C
* Eastern Cooperative Oncology Group performance status of 0 to 2
* With no previous treatment
* No Cirrhosis or cirrhotic status of Child-Pugh class A only
* Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
* The following laboratory parameters:

Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3

• Ability to understand the protocol and to agree to and sign a written informed consent document

Exclusion Criteria:

* Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
* Known history of HIV
* History of organ allograft
* Known or suspected allergy to the investigational agents or any agent given in association with this trial.
* Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
* Evidence of bleeding diathesis.
* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
* Known central nervous system tumors including metastatic brain disease
Mindfulness Training for Stress Management

This study will assess the short and long term effects of a group-based mindfulness programme (Mindfulness-Based Stress Reduction, MBSR) on first year medical and psychology students at the Universities of Oslo and Tromso.

The primary outcome variables are mental distress, student stress and subsequent work stress, subjective wellbeing, empathy, mindfulness and spirituality. The investigators will also study explanatory moderator and mediator variables.

The study will be a two-centre randomized controlled study involving 288 medical and psychology students from the University of Oslo and from the University of Tromso. The sample size calculation is based on a reduction in mental distress and perceived medical/psychology school stress of 20% in the intervention group. The control group will not receive an intervention. After the initial seven week course (taking place in 2009 and 2010) the intervention group will receive a follow-up session of 1.5 hours twice a year throughout their study course of 5-6 years. The follow-up period will last until 1 year after graduation in the Oslo cohort and until 3 years after graduation in the Tromso cohort.


Eligibility Criteria:
Inclusion Criteria:

* All students in term 3 of their medical and psychology study at the University of Oslo in the autumn of 2009, and spring of 2010.
* All students in term 3 of their medical and psychology study at the University of Tromso in the autumn of 2010, and autumn of 2011.
Study of Intralesional Injection of M4N in Patients With Refractory Malignant Tumors of the Head and Neck

The purpose of this study will be to determine the safety and tolerability of intratumoral M4N. Patients suffering from cancer of the head and neck that is recurrent after primary treatment with surgery, radiation therapy, and/or chemotherapy may be eligible. The design is a Phase 1 dose escalation study of M4N administered intratumorally once weekly, initially for three weeks. Dose will be escalated on the starting schedule to a target of 20 mg/cm3 tumor volume and then, new patient cohorts will have their schedule extended to weekly M4N for 4 weeks. Dose escalation will continue, assuming tolerability, so that cohorts will be treated for 6 weeks, and finally, 8 weeks.

Study data collected will include pre-study demographics and measurements, treatment compliance, efficacy determined by tumor measurements, M4N levels in blood for pharmacokinetics, serum and biochemical determinations, hematology determinations, and patient vital signs.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients ≥ 18 years of age.
* Patients with documented histologic evidence of head and neck cancer with clinically measurable disease. Head and neck cancer could have been recurrent after primary treatment with surgery, radiation therapy and/or chemotherapy.
* Measurable tumor by direct inspection, photography, or by imaging (CT scan or MRI).
* Life expectancy of at least 3 months in the Investigators' opinion.
* Negative pregnancy test if in women of childbearing potential within 1 week of starting therapy.
* Patients had provided written informed consent to participate in study.
* ECOG Performance Status of 0, 1, or 2.
* Absolute neutrophil ≥ 1500/uL, hemoglobin ≥ 8 gm%, platelets ≥ 50,000/uL,
* ALT/AST ≤ 3 x ULN (upper limit of the normal range), bilirubin ≤ 1.5 x ULN and creatinine ≤ 1.5 x ULN, PT and PTT within normal limits.

Exclusion Criteria:

* Women who were pregnant or nursing.
* Women of child bearing potential who were unwilling to use an adequate method of contraception during the course of the study.
* Treatment with prior investigational agent within 30 days of entering the study.
* Patients who are unable to comply with the study requirements.
* Patients with known sensitivity to any of the study medication components.
* Patients not consenting to photography.
* Patients with tumors that have enveloped the carotid artery or whose anatomy had been distorted such that in the Investigator's opinion present high-risk of perforation or compromise during injection.
* Prior chemotherapy, radiation therapy, or surgery for the primary carcinoma within 30 days of dosing and/or had not recovered from prior therapy toxicities.
Tadalafil Taken Daily Compared to Placebo on Improvement of Getting and Maintaining an Erection and Sexual Quality of Life

To determine if tadalafil 5 mg daily compared to placebo when given for 12 weeks improves getting and maintaining an erection in men with erectile dysfunction and if there are improvements in the sexual quality of life of the man and his female study partner


Eligibility Criteria:
Inclusion Criteria:

Male

* History of erectile dysfunction (ED) for at least 3 months duration
* Anticipate having the same female partner willing to participate throughout the study
* At least 18 years of age at Visit 1 and agree to make at least 4 sexual attempts during the early phase of the study
* Adequate partner sexual function as determined by a Female Sexual Function Index
* Willing to record responses to efficacy questionnaires, sexual quality of life questionnaires and other instruments used in the study

Exclusion Criteria:

* May not participate in the study if you have taken tadalafil previously.
* History of cardiac conditions including angina requiring treatment with nitrates, heart disease of coronary conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for specified time before starting the study.
* Have sexual partner not willing to complete the scales.
* Use of nitrates.
Mesenchymal Stem Cell for Osteonecrosis of the Femoral Head

Mesenchymal Stem Cells (MSCs) have been shown to have immunosuppressive and repairing properties. Bone marrow mononuclear cells (BMMNCs) have revascularization properties and complimentary effects to MSCs. The investigators will infuse expanded autologous MSCs and BMMNCs into patients with osteonecrosis of the femoral head. The study purpose is to examine whether this treatment will result in improvement in osteonecrosis of the femoral head.

Mesenchymal Stem Cells (MSCs) have been shown to have immunosuppressive and repairing properties. Bone marrow mononuclear cells (BMMNCs) have revascularization properties and complimentary effects to MSCs. Patients in this study will receive infusion of expanded autologous MSC and BMMNCs. The puncture of femoral artery will be conducted with digital subtraction angiography(DSA), and the tubes will be inserted into medial femoral circumflex artery,lateral femoral circumflex artery and obturatou artey. The study will evaluate the safety and effectiveness of MSC infusion in patients with osteonecrosis of the femoral head. This study will last for 5 years. Patients will undergo infusions at Day 0. Afterward, patients will be evaluated for response, and undergo X-ray examination, CT and MR scanning at a 6-month interval.

Eligibility Criteria:
Inclusion Criteria:

* Ages: 12 to 60 years old.
* Association Research Circulation Osseous(ARCO) Classification criteria for osteonecrosis of the femoral head: ARCO phase I and phase II.
* Able to give informed consent.

Exclusion Criteria:

* Pregnant women.
* Previous history of malignancy
* Active infection including hepatitis B, hepatitis C, HIV, or TB as determined by a positive skin test or clinical presentation, or under treatment for suspected TB.
* Evidence of cardiovascular disease, existing congestive cardiac failure on physical exam and/or acute coronary syndrome in the past 6 months.
* Psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible.
* Any illness that in the opinion of the investigator would jeopardize the ability of the Patient to tolerate this treatment.