cyrilzakka/clinical-trials huggingface dataset:
PUMA (Paediatric Osseous Marrow Assessment)

This is a pilot cancer imaging study investigating change in the apparent diffusion coefficient (ADC) at a single time point post-transplantation in patients. The treatment is bone marrow transplant as per standard patient care, without change for trial purposes.

Its main aim is to evaluate the engraftment of bone marrow after transplantation performing functional Magnetic Resonance Imaging (MRI) of the lumbar spine and pelvis at baseline and after 2-3 weeks after the transplantation (according to the appearances of raised white blood cells).This will enhance the understanding of bone marrow features on imaging at engraftment and improve the management of children/young adults who suffer acute leukaemia.

Following allogenic haemopoietic stem cell transplantation, changes in bone marrow apparent diffusion coefficient (ADC) are measurable at the point of engraftment and in conjunction with peripheral blood counts may provide a future biomarker of successful clinical outcome.

This is a single-center pilot study. The investigators intend to image 12 inpatients, aged 5-24 years old who are scheduled for haemopoietic stem cell transplantation.

Patients will have two MRI scans requiring them to lie in the scanner for approximately 15 minutes. Patients unable to tolerate lying flat for this length of time or to tolerate the scan for any reason will be withdrawn from the study. If required a play specialist can be organised to help the young patients feel more at ease in the MRI department. MRI does not involve radiation exposure and when performed within national safety guidelines do not pose a significant risk. Patients with contraindications to MRI such as pacemakers, certain metal implants and claustrophobia will not be recruited. Every effort will be made to book scan appointments to coincide with clinic visits.

Scans will be reported as per clinical procedures and data will be made available to the referring consultants immediately via the radiology picture archiving and communications system (PACS).

Eligibility Criteria:
Inclusion Criteria:

1. All patients with relapsed or high risk acute lymphoblastic or myeloblastic leukaemia planned for haemopoietic stem cell transplantation
2. Cooperative paediatric individuals and young adults (5-24-years-old) not requiring general anaesthesia or sedation for the purpose of MRI
3. Able to lie flat throughout the scan

Exclusion Criteria:

1. Non cooperative patients
2. Ferromagnetic implants, contraindicating MRI
3. Claustrophobia
4. Unable to lie flat throughout the scan
5. Uncertain histological diagnosis
6. Musculoskeletal disorders
7. Metabolic disorders
8. Lack of signed parental consent and patient's verbal approval
Validity and Reliability of the Egyptian-Arabic Version of ABILHAND-Kids

HYPOTHESES It is hypothesized that the Egyptian-Arabic ABILHAND-Kids 21-item will be psychometrically appropriate to be used with Egyptian children with cerebral palsy.

BACKGROUND Upper extremity functional impairment is a common problem in children with cerebral palsy. This has a significant impact on the children's manual ability which leads to activity limitation and participation restriction. The ABILHAND-Kids is a parent-reported outcome measure that quantifies the manual ability of children with CP. ABILHAND-Kids measures a child's ability to manage 21 daily activities that require the use of the upper limbs. The ABILHAND-Kids demonstrated very good measurement properties and is currently available in English, French, Dutch, Sweden, and Polish. It was also translated and adapted into the classic Arabic language in Saudi Arabia; in their study removal of two items resulted in a 19-item, valid, and reliable unidimensional scale meeting the requirement of the Rasch model without establishing measurement invariance between cultures. A linguistic adaptation is not sufficient to prove cross-cultural validity as item difficulties may vary across countries due to translation errors or cultural differences.

Eligibility Criteria:
Inclusion Criteria:

- Parents of 100 children with CP will be recruited.

Exclusion Criteria:

* mental retardation
Music for Sleep-onset Insomnia

The study is a randomized controlled trial evaluating the effect of bedtime music as an early intervention for sleep-onset insomnia in adults. The investigators use a randomized controlled trial design with two parallel groups. All participants receive sleep hygiene advice as standard treatment and participants in the intervention group are additionally asked to listen to a sleep playlist daily at bedtime. Subjective and objective sleep measures are evaluated before and after the 4 weeks intervention period. In addition, follow-up measures of subjective outcomes are assessed 4 weeks after the end of the intervention period.


Eligibility Criteria:
Inclusion Criteria:

* Sleep-onset insomnia for 3-18 months

Exclusion Criteria:

1. use of medications (benzodiazepines, z-drugs, antidepressive and anti-psychotic drugs)
2. alcohol or substance abuse
3. pregnant or breastfeeding women
4. other sleep disorders (e.g. sleep apnea, restless leg syndrome, etc.)
5. current psychiatric disorder or a history of psychotic disorders
6. somatic disorders interfering with sleep (e.g. critical illness, pain disorders, neuro-degenerative disorders)
7. shift work.
Prevention of Permanent Obesity in Children

In the county of Oppland, Norway, questionnaires addressing physical and mental health and socioeconomic status is issued to all (1960) families who meet for the pre-school assessment at the public health clinics in 2007. Particularly growth, physical activity and diet is addressed.

Families who have children with a BMI \>18.9, which corresponds to BMI\>30, and living in selected municipalities in the county are invited to participate in a 5 year intervention program in order to avoid future overweight conditions in children. Similarly overweight children from the rest of the county serve as controls.

Background: Intervention programs to limit or reduce weight in severely obese adults and adolescents are rarely successful. In the present study intervention is aimed at moderately overweight children of 6 years.

Families in 7 municipalities who have children with BMI \>18.9 are invited to a group-based family oriented program involving pediatricians, physiotherapists, dieticians, psychologists and nurses with special training. The families are invited to meet in groups times the first year, two times the second and one time the third year. According to personal interest the families are also invited to meet with the nurse between each of the the above gatherings.

The children are examined by a pediatrician before entry and after 1, 2, 3 and 5 years with specific focus on height and weight. No blood studies are routinely done.

BMI development will be related to BMIs in the family, mother's weight increase in pregnancy, socioeconomic background, general health, psychological factors scored through the Strengths And Difficulties Questionnaire, and compliance with the program. Furthermore, the results are compared to similarly overweight children from the counties who are not invited to participate in the intervention program. The results are obtained through the routine health follow-up programs in school.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 18.9
* Age 5-7 years
* Residing in Oppland county

Exclusion criteria:

* chronic disease
The Forteo Alendronate Comparator Trial

The main purpose of this study is to evaluate the effects of teriparatide with those of alendronate on spine bone mineral density (BMD) and other osteoporosis factors in postmenopausal women with osteoporosis.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women with osteoporosis.
* Ambulatory, 5 years or more past menopause.
* BMD T score between -2.5 and -4.0 at the lumbar spine or femoral neck.
* Normal or clinically insignificant abnormal laboratory values, including serum calcium, parathyroid hormone (PTH) 1-84, 25-hydroxyvitamin D, and alkaline phosphatase.

Exclusion Criteria:

* Prior treatment with PTH or a PTH analogue.
* Treatment with bisphosphonates within 12 months, anabolic corticosteroids or calcitriol or vitamin D analogues or agonists within 6 months, estrogens or selective estrogen receptor modulators within 3 months, or calcitonin within 2 months; therapeutic doses of fluoride; systemic corticosteroid use within 1 month or for more than 30 days in the prior year; use of anticoagulants within 1 month.
* History of diseases other than postmenopausal osteoporosis that affect bone metabolism.
* History of an increased risk of osteosarcoma (ie, patients with Paget disease of bone, previous skeletal exposure to external beam radiotherapy, or previous malignant neoplasm involving the skeleton).
* Malignant neoplasms within 5 years; carcinoma in situ of the uterine cervix within 1 year.
* Nephrolithiasis or urolithiasis within 2 years, or impaired renal function.
* Abnormal uncorrected thyroid function.
* Liver disease or clinical jaundice.
* Alcohol or other drug abuse.
* Poor medical or psychiatric risk for treatment.
Effects of a Comprehensive Intervention on Blood Pressure Control in a Primary Care Setting

The implementation of lifestyle modifications, home blood pressure (BP) measurement, and optimization of antihypertensive drug therapy have been shown to improve BP control in tightly controlled research settings. The investigators objective is to determine the effect of these interventions in a primary care setting, with the family practitioners and nurses serving as the interventionists. The investigaotrs hypothesis is that a comprehensive intervention performed in a primary care setting would lead to better blood pressure control.


Eligibility Criteria:
Inclusion Criteria:

* Aged 35-74 years
* Untreated office blood pressure of ≥ 160/100 mmHg or on active antihypertensive treatment.

Exclusion Criteria:

* Severe psychiatric or neurologic illnesses
* Heart failure (ejection fraction \< 40% or previous hospitalization for heart failure)
* Hemodynamically significant valvular disease
* Unstable coronary heart disease
* Chronic kidney disease (proteinuria \> 1 g/l or a serum creatinine concentration \> 160 mmol/l)
A Study of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) for the Treatment of Chronic Renal Anemia in Participants With Diabetic Nephropathy

This single arm, open label study will assess the efficacy, safety and tolerability of methoxy polyethylene glycol-epoetin beta for the treatment of chronic renal anemia in participants with chronic kidney disease (CKD) secondary to diabetes. Participants who are not on dialysis and not currently treated with erythropoiesis stimulating agents (ESAs) will receive methoxy polyethylene glycol-epoetin beta subcutaneously every 4 weeks (Q4W). The starting dose of 1.2 microgram/kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta will be adjusted according to hemoglobin levels. Anticipated time on study treatment is 28 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Diabetic nephropathy
* Chronic renal anemia with stage III-IV CKD
* Not on dialysis and not expected to require dialysis within the next 6 months
* Not receiving any ESA in the 2 months prior to study
* Adequate iron status

Exclusion Criteria:

* Transfusion of red blood cells during the previous 2 months
* Known or clinical suspicion of pure red cell aplasia
* Hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
* Haemoglobinopathy
* Significant acute or chronic bleeding
A Phase I/II Study of the Pan-immunotherapy in Patients With Local Advanced/Metastatic BTC

Biliary tract cancer (BTC) is a rare heterogeneous collection of malignancies arising within the biliary tract, characterized by innate chemoresistance and abysmal prognosis. PD-1 blockade has been developed to a new class of cancer immunotherapy that could restore an adequate immunosurveillance against the neoplasm and enhance T-cell-mediated anticancer immune responses. Manganese has been confirmed to activate antigen-presenting cells and function as mucosal immunoadjuvants in pre-clinical studies. This open-label, phase I/II study is designed to assess the safety and efficacy of Manganese primed combined therapy of anti-PD-1 antibody and gemcitabine/cisplatin chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years old.
2. Life expectancy of at least 3 months.
3. Subjects must have Histopathological/cytological diagnosis of unresectable or recurrent /metastatic biliary tract carcinoma (intra-hepatic, extrahepatic or gall bladder).
4. Eastern Cooperative Oncology Group performance status 0-2.
5. Subjects must have at least one measurable lesion ≥ 1 cm as defined by response criteria.
6. Subjects may have received prior radiotherapy, chemotherapy, or other local ablative therapies, which completed ≥ 4 weeks prior to registration AND patient has recovered to \<= grade 1 toxicity.
7. Subjects with Anti-PD-1 antibody treatment history are eligible which must be resistance.
8. Adequate organ function.
9. Participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug.

Exclusion Criteria:

1. Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
2. Serious uncontrolled medical disorders or active infections, pulmonary infection especially.
3. Prior organ allograft.
4. Women who are pregnant or breastfeeding.
5. Women with a positive pregnancy test on enrollment or prior to investigational product administration.
6. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
Community Clinic Test of Youth Anxiety Treatment

Structured, manualized treatments have been developed for numerous mental health problems and disorders among children and adolescents, and a number of these have shown strong beneficial effects in clinical trials. Such findings have led to proposals that the empirically supported treatments be used to improve outcomes of conventional clinic treatment, which some research suggests may not be very effective. But can these lab-tested treatments actually work in service-oriented clinics with referred youth? Available evidence cannot tell us, because the therapists, conditions, and clientele in the laboratory efficacy tests tend to differ so markedly from those of clinical practice. To assess the clinical potential of efficacy-tested treatments, we need effectiveness research that tests these treatments in the crucible of clinical practice. To help begin this process, the proposed research focuses on a specific treatment program for a specific cluster of disorders: Kendall's (1994) cognitive-behavioral "Coping Cat" program for child and adolescent anxiety disorders. The program has shown unusually positive effects across a series of clinical trials in the U.S. and Australia, but it has never been tested in real-world clinical conditions. The proposed study will test the effectiveness of the treatment with clinic-referred youth, treated in community clinics, with the treatment carried out by clinic staff therapists. Some 128 youth, aged 9-14, referred for anxiety and diagnosed with anxiety disorders, will be randomly assigned to receive either the usual treatment in the clinic, or the Kendall program, carried out by clinic staff who have been trained to proficiency. Therapists for the two treatment conditions will also be chosen randomly, from a pool of volunteers. Outcome assessment at immediate post-treatment, 1-year, and 2-year follow-ups, will test effects across many outcomes. It is hypothesized that outcomes for youths treated using the cognitive-behavioral treatment will be superior to those treated using usual care.


Eligibility Criteria:
Inclusion Criteria:

* Primary DSM-IV anxiety or depressive disorder

Exclusion Criteria:

* Pervasive developmental disorder
* Psychotic disorder
* Mental retardation
Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery

Recombinant factor VIII for the prevention of bleeding in women/girls with haemophilia A undergoing major surgery

Female patients with mild to moderate haemophilia A will often need FVIII concentrates to provide haemostatic cover during major surgery. This prospective, open-label, non-controlled, single-arm, multinational, multicentre study aims to evaluate the overall perioperative haemostatic efficacy of Nuwiq in women/girls over 12 with haemophilia A undergoing major surgery requiring FVIII treatment

Eligibility Criteria:
Inclusion Criteria:

1. Women/girls with haemophilia A (FVIII:C ≥1-\<40%) according to medical history
2. At least 12 years of age
3. Scheduled to undergo major elective surgery requiring FVIII treatment
4. Freely given written informed consent of the patient, or parent/legal representative where applicable, obtained in accordance with local regulations

Exclusion Criteria:

1. Coagulation disorder other than haemophilia A
2. Present or past FVIII inhibitor (≥0.6 Bethesda units \[BU\]/mL)
3. Severe liver or kidney disease (alanine aminotransferase \[ALT\] and/or aspartate aminotransferase \[AST\] levels \>5 times the upper limit of normal; or creatinine \>120 μmol/L)
4. Known hypersensitivity to Nuwiq's active substance or its excipients (sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, poloxamer 188)
5. Pregnancy
6. Already had surgery in this study
7. Current participation in another interventional clinical trial
8. Treatment with any investigational medicinal product (IMP) within 30 days prior to screening visit
Oral Bioavailability of Solid Formulation of GLPG1837 With and Without Food

The purpose of the study is to evaluate the amount of GLPG1837 and metabolite present in the blood (relative bioavailability) after a single oral administration of 500 mg GLPG1837 given as an oral suspension under fasted conditions as well as a tablet formulation under fasted and fed conditions, in male healthy subjects.

Also, the safety and tolerability of a single oral dose of 500 mg GLPG1837 given as an oral suspension under fasted conditions as well as a tablet formulation under fasted and fed conditions, will be assessed.

Twelve subjects will receive GLPG1837 on 3 occasions as single dose administrations: as an oral suspension fasted, as an oral tablet, fed and fasted. Treatment administrations will be separated by a wash-out period of at least 6 days.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male, age 18-50 years
* BMI between 18-30 kg/m2

Exclusion Criteria:

* Any condition that might interfere with the procedures or tests in this study
* Drug or alcohol abuse
* Smoking
Aortic Valve Replacement Above the Aortic Annulus (SA-AVR) With the Carpentier-Edwards Magna-Ease Bioprosthesis

Surgical valve replacement is commonly performed in patients with severe aortic valve disease. In small aortic annulus, implantation of bioprosthetic valves can be associated with limited functional capacity. To avoid this condition, we changed our surgical technique to implant a larger bioprosthesis. Briefly, the prosthesis is sutured to the aortic annulus along the left and right coronary sinuses, and in a supraannular position along the noncoronary sinus, therefore allowing us to insert a prosthetic valve with a one-size larger diameter than the native aortic annulus.

Surgical aortic valve replacement (AVR) is recommended for severe aortic valve disease. Bioprosthesis remains the substitute of choice for elderly patients. However, it may be associated with patient-prosthesis mismatch particularly for patients with small aortic annulus. Moreover, "valve-in-valve" transcatheter aortic valve replacement (TAVR) has become a suitable therapeutic option for bioprosthesis structural degeneration, especially in patients with high surgical risk. It is therefore of great importance to implant the widest bioprosthesis as possible at the first AVR. The investigators report a surgical technique allowing the implantation of a larger bioprosthesis in patients with small aortic annulus: the supra-annular aortic valve replacement (SA-AVR) above the aortic annulus. The investigators analyzed the postoperative outcomes of the SA-AVR technique using the Perimount Magna Ease (Carpentier-Edwards, Irvine, California) bioprosthesis.

Eligibility Criteria:
Inclusion Criteria:

* patients older than 18 years who underwent a suprannular implantation of the Carpentier Edwards Magna Ease bioprosthetic valve between January 2010 and December 2017 in our institution, whatever the aetiology of the aortic valve disease.

Exclusion Criteria:

* patients younger than 18 years, patients who received a different bioprosthesis valve in the aortic position, patients who were lost of follow-up.
tDCS for Chronic Low Back Pain

The goal of this study is to investigate the role of central neural pathways in mediating chronic pain. The aim of the study is to test the effect of stimulating brain regions that are part of a network underlying central pain processing using a non-invasive brain stimulation technique, transcranial Direct Current Stimulation (tDCS). Prior studies have used tDCS to target both sensory related cortical areas and those important for higher-order representations of pain. This study will target brain regions important for the behavioral response to the chronic sensation of pain. The hypothesis is that stimulation of these brain regions can modulate not only the affective component of pain, but ultimately also improve functioning and quality of life. This hypothesis will be tested by treating study participants eighteen and older with chronic low back pain (CLBP) of greater than six months using tDCS. To be part of this study, participants must meet all the inclusion and exclusion criteria.


Eligibility Criteria:
Inclusion Criteria:

* Chronic Low Back Pain ≥ 6 months duration in the lumbar region, present more than half the days of the month, and on average be at a moderate level of severity in the last month
* At least one trial of physician recommended medication (e.g. acetaminophen, NSAIDS, skeletal muscle relaxants)
* Pre-existing opioid and non-opioid pain medication must be non-existent or stable (medications have not changed for one month)
* Be able to understand, read and write English
* If female and of childbearing age, agree to use acceptable birth control during the study treatment period (oral contraceptives, history of tubal ligation, history of a hysterectomy, or a reliable barrier method)

Exclusion Criteria:

* Lifetime Diagnostic and Statistical Manual (DSM) IV diagnosis of bipolar disorder, schizophrenia, or other chronic psychotic condition
* Current DSM-IV diagnosis of substance dependence for alcohol, sedative/hypnotic drugs, stimulants, cocaine
* Current cancer, infection, or inflammatory arthritis
* Broken skin or other lesions in the area of the electrodes
* Uncontrolled medical problems, such as diabetes mellitus, hypertension, pulmonary or airway disease, heart failure, coronary artery disease, or any other condition that poses a risk for the subject during participation
* Presence of metal in the cranial cavity
* Holes in the skull made by trauma or surgery
* Pacemakers, medication pumps, and other implanted electronic hardware
* Pregnancy