cyrilzakka/clinical-trials huggingface dataset:
Impact of Stem Cell Donation on Unrelated and Related Donors' Health.

Haematopoietic stem cell donation represents a unique chance for curing patients affected with onchohaematologic and inherited diseases.If a related donor is unavailable a unrelated donor must be used. For both categories an accurate physical and laboratory examination is mandatory to establish the eligibility to bone marrow or peripheral blood stem cell collection since side effects related to donation may occur. To ensure high standards of safety and satisfaction of unrelated stem cells donors dedicated guidelines are available. On the other hand, there is no unambiguous guidance on the management of the related donor and published data on donation and long term follow-up are scarce.

The study, for the retrospective part, aims to report the experience in family and registry donor management at Transfusion Service from 2016 to 2022 (enrollment, stem cell donation, 30-day follow-up) and, for the prospective part, to continue monitoring on donors who will be enrolled in the next five years (2023 to 2028).

Eligibility Criteria:
Inclusion Criteria:

* Family donors ≥18 years referred by the Hematology and Oncohematology Transplant Center Pediatric of the Foundation of Centro Donatori -SIMT, following the national and international guidelines after medical evaluation
* Volunteer donors from IBMDR registry ≥18 years, following the national and international guidelines after medical evaluation

Exclusion Criteria:

* Donors 18 \< years
Brain Oxygenation During Prehospital Anesthesia: an Observational Study

Brain oxygenation of adult patients undergoing prehospital emergency anesthesia is monitored using noninvasive near-infrared spectroscopy. Patients are afterwards interviewed to define neurological outcome to measure quality of life. The purpose of this study is to reveal the risk factors of prehospital anesthesia related cerebral desaturation events (CDE) and to define the association between CDE and survival, neurological outcome or quality of life.


Eligibility Criteria:
Inclusion Criteria:

* sedation or anesthesia provided to facilitate endotracheal intubation, performed by Helicopter Emergency Medical Services (HEMS) team regardless of the reason

Exclusion Criteria:

* Ongoing cardiopulmonary resuscitation at the time of intubation
* Physical barrier for near-infrared spectroscopy measuring (e.g. forehead laceration)
* HEMS unit does not escort patient to the hospital (exception: in case of death on scene after inclusion, patient is included)
* Workload too high to ensure standard level of clinical care during the study
* For interviews: no competence in Finnish, Swedish or English
The Relationship Between Internet-use Behavior and Mental Health in Youth

Introduction: WHO defines youth as 15-24 years age group. At this stage, the brain is still under development, with high impulsiveness, being fond of stimulation and yearning for peer life. Compared with traditional interpersonal interaction, modern youths use the Internet as a main interpersonal interaction platform and conduct lots of leisure activities on the Internet. Poor cognitive emotion regulation strategies and personal traits may extend to new types of mental health issues; and are associated with depression, anxiety, suicidal/self-injurious behaviors, and cyberbullying.

Objectives: (1) To investigate whether emotion regulation strategies while facing stressful events are highly related to with cyberbullying, social media, and internet gaming disorder. (2) To investigate the relation between cyberbullying and depression, anxiety, suicide/self-injury among Taiwanese youths. (3) To investigate the probability of cyberbullying, social media addiction, and internet gaming disorder occurring at the same time.

Method: This cross-sectional study recruits cases of youths from 15 to 24 years old and collects data through questionnaires survey. In addition to collection of basic data, Internet using habits, and medical history, self-rated questionnaires include Suicide/Self-Injury Ideation Questionnaire, The Beck Depression Inventory 2nd Edition, Multidimensional Anxiety Scale for Children-Taiwan version, Cognitive Emotion Regulation Questionnaire, Cyberbullying Questionnaire, and Internet Gaming Disorder Scale-Short Form.


Eligibility Criteria:
Inclusion Criteria:

Control group

* Able to understand the content of all questionnaires
* Healthy youths aged 15-20 years old and adults aged 20-24 years old

Experimental group

* Able to understand the content of all questionnaires
* Youths aged 15-20 years old and adults aged 20-24 years old
* Diagnosed with major depressive disorder, anxiety disorder, post traumatic stress disorder, or Adjustment disorder according to DSM-V

Exclusion Criteria:

* Illiterate or unable to understand the content of the questionnaires
* Diagnosed with organic brain injury, schizophrenia, or bipolar disorder according to DSM-V
18F-FLT PET/CT in Measuring Cell Proliferation in Patients With Brain Tumors

This pilot clinical trial studies fluorine F 18 fluorothymidine (FLT) positron emission tomography (PET)/computed tomography (CT) in measuring cell proliferation in patients with brain tumors. Comparing results of diagnostic procedures done before, during, and after treatment may help doctors measure tumor growth and plan the best treatment.

PRIMARY OBJECTIVES:

I. Using FLT PET/CT as a measure of cellular proliferation, assess tissue proliferation in disease sites of brain tumor patients before therapy (surgery, chemotherapy or radiotherapy or any combination of these).

II. Determine level of change in cellular proliferation compared with baseline (scan 1) in brain tumors at mid-therapy (scan 2), after completion of therapy (scan 3) and in the clinical follow-up period (scan 4), when possible.

III. Correlate levels of cellular proliferation measured by FLT PET/CT at baseline and treatment-induced changes in brain tumor proliferation with clinical response status (clinical categories are complete remission, lesser degrees of response/stable disease, and no response).

SECONDARY OBJECTIVES:

I. Assess spatial heterogeneity of FLT uptake to identify local differences in brain tumor disease burden.

OUTLINE:

Patients undergo 18F-FLT PET/CT at baseline (pre-therapy), mid-therapy, completion of therapy, and 1 year after completion of therapy or time of suspected recurrence.

After completion of study, patients are followed for up to 7 years.

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis or suspected diagnoses of brain tumor (primary, recurrent, or metastatic) by standard clinical diagnosis such as pathology or imaging
* Planned for treatment with radiation, chemotherapy and surgical resection or any of these treatment strategies combined

Exclusion Criteria:

* Inability to provide informed consent
* Pregnancy
* Inability to lie still for the imaging study
* Weight over 350 lbs.
Social Deprivation Features in Intensive Care Unit Patients

Socioeconomic inequalities are increasingly recognised as an important public health issue, and it is now well established that patients with socioeconomic deprivation (SED) features demonstrate higher mortality and morbidity. The epidemiology and impact of SED on the specific population of ICU patients has been insufficiently investigated.

In this prospective multicenter study of patients admitted to 9 ICUs of the Paris area, the investigators aim to explore the epidemiology of SED features, and its impact on mortality and length of stay.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Admission to one of the participating intensive care units

Exclusion Criteria:

* None
STEP TEENS Weight Maintenance: A Research Study on How Well Semaglutide Helps Teenagers With Excess Body Weight to Lose Weight and Maintain Weight Loss

The study is testing how well semaglutide can help adolescents with excess body weight to lose weight and to maintain weight loss. All participants in the study will receive semaglutide as a weekly injection. The study medicine is injected with a thin needle in the stomach, thighs or upper arms. All participants will get semaglutide treatment for a minimum of 3 years.


Eligibility Criteria:
Inclusion criteria:

* Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study:

  1. The parent(s) or legally acceptable representative (LAR) of the participant must sign and date the Informed Consent Form, according to local requirements
  2. The participant must sign and date the Child Assent Form or provide oral assent, according to local requirements
* Age 12 to less than 15 years at the time of signing the informed consent
* BMI greater than or equal to 95th percentile at screening
* Body weight greater than 60 kg at screening

Exclusion criteria:

* Prepubertal status (Tanner stage 1)
* Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening
* Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. However, the following are allowed:

  1. Liposuction and/or abdominoplasty, if performed more than 1 year prior to screening
  2. Adjustable gastric banding, if the band has been removed more than 1 year prior to screening
  3. Intragastric balloon, if the balloon has been removed more than 1 year prior to screening
  4. Duodenal-jejunal bypass liner (e.g., Endobarrier), if the sleeve has been removed more than 1 year prior to screening
* Endocrine, hypothalamic, or syndromic obesity
* History of type 1 or type 2 diabetes mellitus
Blood Glucose Variability and Insulin Action During Menstrual Cycle in Females With Type 1 Diabetes

This research study is designed to look at differences in responsiveness to the subcutaneous injection of a standardized dose of rapid-acting insulin analog and blood glucose variability during different phases of the menstrual cycle in females with type 1 diabetes (T1D).

Type 1 Diabetes (T1D) is a chronic disease that leads to disability and premature death if not well treated. While females and males are equally affected by T1D, diabetes places additional burdens of care on females. Characteristically, females with T1D have worse glycemic control, a higher incidence of diabetic ketoacidosis, and a greater risk of cardiovascular complications as compared to their male peers. It has been hypothesized that variations in responsiveness to pre-meal bolus doses of insulin during menstrual cycling is an important underlying cause for increased management problems in females with T1D, but the hypothesis has not been adequately tested. Consequently, insulin treatment of females during the different cycles of menstruation remains a guessing game that often results in major swings in blood glucose from high to low levels. The unfavorable impact of this gap in knowledge extends to the efficiency and accuracy of artificial pancreas closed-loop (CL) system insulin delivery algorithms designed based on insulin action parameters. The proposed study addresses this unmet need in diabetes management for females both in open-loop (OL) and CL therapies.

Eligibility Criteria:
Inclusion Criteria:

1. Age 12-35
2. diagnosis of T1D\>1year;
3. BMI%\<85th;
4. HbA1c \<9%.
5. Subjects ages 21-35y on combination oral contraceptive pills (OCP) could be included.

Exclusion Criteria:

1. irregular periods,
2. pregnant, breastfeeding,
3. subjects\>20y on progesterone only pills or injections,
4. Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol,
5. mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, including blood glucose monitoring requirements including the documentation of blood glucose data and insulin dosing,and/or inability to return for follow-up visits, and unlikely to complete the study.
6. Subjects on OCP will be excluded in the 12-20y group to capture the physiologic variability in insulin action during pubertal progress.
Therapeutic Approaches for Subjects With Scapula Dyskinesis

The investigators will test whether conscious control with manual guides and video or EMG biofeedback will enhance 3-D kinematics of scapula in shoulder dysfunction subjects with different type of scapula dyskinesis. The investigators will also examine how correction of scapular orientation may affect the activation of associated muscles during various dynamic movements in these subjects.


Eligibility Criteria:
Inclusion criteria:

* At least three positive of five tests, including Neer's test, Hawkin's test, Empty can test, tenderness in tendon of rotator cuff and resisted external test.
* Each patient will need a prescription of the physician or orthopedic surgeon for diagnosing impingement symptoms

Exclusion criteria:

- Shoulder pain onset due to trauma, a history of shoulder fractures or dislocation, cervical radiculopathy, degenerative joint disease of the shoulder, surgical interventions on the shoulder, or inflammatory arthropathy
Safety, Tolerability, and Efficacy of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome

This is a Phase 2b, randomized, double-blind, placebo-controlled, dose-optimization study to evaluate the efficacy, safety, and tolerability of NBI-98854 titrated to the subject's optimal dose administered once daily (qd) for a total of 12 weeks of treatment in pediatric subjects with TS.


Eligibility Criteria:
Inclusion Criteria:

1. Have a clinical diagnosis of Tourette Syndrome (TS)
2. Have at least moderate tic severity
3. Have TS symptoms that impair school, occupational, and/or social function
4. If using maintenance medication(s) for TS or TS spectrum diagnoses (e.g. obsessive-compulsive disorder \[OCD\], Attention-Deficit Hyperactivity Disorder \[ADHD\]), be on stable doses
5. Be in good general health
6. Adolescent subjects (12 to 17 years of age) must have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids and a negative alcohol screen
7. Subjects of childbearing potential who do not practice total abstinence must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment and follow-up periods of the study

Exclusion Criteria:

1. Have an active, clinically significant unstable medical condition within 1 month prior to screening
2. Have a known history of long QT syndrome or cardiac arrhythmia
3. Have a known history of neuroleptic malignant syndrome
4. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed)
5. Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors
6. Have a blood loss ≥250 mL or donated blood within 30 days prior to screening
7. Have a known history of substance dependence, substance (drug) or alcohol abuse
8. Have a significant risk of suicidal or violent behavior
9. Have initiated Comprehensive Behavioral Intervention for Tics (CBIT) during the screening period or at baseline or plan to initiate CBIT during the study
10. Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study
Functional Rehabilitation of Upper Limb Apraxia in Patients Poststroke

The purpose of this study is to analyze the effects of a mixed intervention of occupational therapy (rehabilitative and compensatory approach) at home to upper limb apraxia in mild and moderate patients post stroke in comparison to a control group with a traditional health educative protocol.

Apraxia is a neurological disorder characterized by a loss of ability to execute and carry out skilled movements and gestures despite intact motor and sensory systems, coordination and comprehension.

Upper limb apraxia comprises a wide spectrum of higher motor disorders caused by acquired brain disease, affecting the performance of skilled movements carried out by the upper limbs.

Few data are available on the effectiveness of interventions in this disorder and no exists studies that implement a mixed intervention (rehabilitative and compensatory ) of Occupational Therapy in these patients at home.

Eligibility Criteria:
Inclusion Criteria:

* Mild-moderate stroke after two month of the cerebrovascular attack.
* Upper limb apraxia lasting at least 2 months.
* Less than 9 points in validated Apraxia Screen of TULIA (AST) following Vanbellingen et al., 2010.
* Voluntary participation.
* The neurologist, the occupational therapist and the patient judge the intervention to be necessary.

Exclusion Criteria:

* History of apraxia before current stroke.
* Stroke had occurred less than two months or more than twenty four month ago.
* Cognitive impairment (\< 23 in normal school population and \< 20 points with a low education or illiteracy, in Spanish validation of Mini-Mental State Examination (MMSE)).
* Severe aphasia.
* Previous brain tumour.
* History of other previous neurologic disorders.
* Mother tongue different to Spanish.
* Drugs addiction.
* Intellectual or learning disorders.
* Brain damage for traumatism or neurodegenerative process.
* A history of serious consciousness impairments
* Uncooperativeness, presence of orthopedic or other disabling disorders.
Safety Study of Radiofrequency Ablation of Locally Advanced Pancreatic Cancer

The purpose of the study is to determine the safety of radiofrequency ablation of locally advanced pancreatic cancer that can not be surgically removed with the current standard procedures. Complications after the operation will be registered. Moreover a pain score will be determined, length of hospital stay, chemotherapy, survival, progression free survival and a tumour marker.

Pancreatic cancer is the fourth leading cause of cancer related death in the Western world. At time of diagnosis, 20% of patients present with a resectable tumour, 40% with an irresectable locally advanced tumour (without metastases) and 40% with metastatic disease. The median survival of patients with irresectable locally advanced pancreatic cancer is only 6 months. Currently, there is no effective treatment for these patients. Therefore, there is an urgent need for new therapies. Radiofrequency ablation (RFA) is a technique that has been demonstrated to be effective in the treatment of several irresectable tumours. RFA produces local tumour destruction through high frequency alternating current flowing from an electrode implanted directly into the tumour and causing frictional heating. The purpose of this study is to determine the safety of RFA-pancreas in patients with non-metastasized, irresectable, locally advanced pancreatic cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with irresectable locally advanced pancreatic cancer found at laparotomy with histologic diagnosis before start of RFA
2. Patient considered eligible to undergo pancreatic surgery as assessed by the general criteria of the departments of anaesthesiology and surgery of the UMC Utrecht
3. Fully informed written consent given

Exclusion Criteria:

1. Patients younger than 18 years
2. Pregnancy
3. Patients with distant metastases
4. Portal vein thrombosis seen on CT preoperatively
Budesonide Effervescent Tablets vs. Viscous Budesonide Suspension vs. Placebo in Eosinophilic Esophagitis

The purpose of this study is to assess the efficacy of a low and high dose of a budesonide effervescent tablet and oral viscous budesonide suspension vs. placebo for the induction treatment of active eosinophilic esophagitis.


Eligibility Criteria:
Major Inclusion Criteria:

* Signed informed consent
* Male or female patients, 18 to 75 years of age
* Confirmed clinicopathological diagnosis of EoE according to established diagnostic criteria:

(A) Clinical symptoms of esophageal dysfunction (B) Peak eosinophils ≥ 15 in at least 1 high-power field (hpf)

- Active symptomatic and histological EoE at baseline

Major Exclusion Criteria:

* Clinically and endoscopically suspicion for gastroesophageal reflux disease, achalasia, or sklerodermia
* Gastroesophageal reflux disease and PPI-responsive esophageal eosinophilia
* Other clinical evident causes than EoE for esophageal eosinophilia
* Any concomitant esophageal disease and relevant gastro-intestinal disease (celiac disease, inflammatory bowel disease, oropharyngeal or esophageal bacterial, viral, or fungal infection)
* Any relevant systemic disease (e.g., AIDS, active tuberculosis)
* Abnormal hepatic function at screening visit, liver cirrhosis, or portal hypertension
* Abnormal renal function at screening
* History of cancer in the last five years (except for non-metastatic cancers, e.g., basalioma)
* History of esophageal surgery at any time or of esophageal dilation procedures within the last 8 weeks prior to screening visit
* Upper gastrointestinal bleeding within 8 weeks prior to screening visit
* Concomitant, or within the 4 weeks prior to screening visit, treatment with systemic therapies for any reason that may affect assessment of primary and secondary endpoints, i.e., systemic glucocorticoids, histamine antagonists, mast cell stabilizers, leukotriene receptor antagonists, biologics, or immunosuppressants
* Concomitant, or within the 2 weeks prior to screening visit, treatment with topical therapies for any reason that may affect assessment of primary and secondary endpoints, i.e., topical glucocorticoids or inhaled sodium cromoglycate
* Installation of dietary restrictions within 4 weeks prior to screening visit or during treatment
* Intake of grapefruit containing food or beverages during the treatment with study medication
* Known intolerance/hypersensitivity to study drug
* Existing or intended pregnancy or breast-feeding