cyrilzakka/clinical-trials huggingface dataset:
The TElemonitoring in the Management of Heart Failure (TEMA-HF) 1 Long-term Follow-up Study

TEMA-HF 1 Long-Term Follow-up study is a follow-up study of TEMA-HF 1. It assessed the long-term impact of a 6-months telemonitoring program in chronic heart failure patients.

The telemonitoring (TM) group patients received a 6-months TM program, followed by standard heart failure care until the long-term follow-up evaluation.

The usual care (UC) patients received ususal care during the first six months, followed by standard heart failure care until the long-term follow-up evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Chronic heart failure patients
* Treated for heart failure according to current guidelines
* ≥ 18 years of age
* Able to provide informed consent

Exclusion Criteria:

* Reversible forms of acute heart failure (myocarditis)
* Presence of severe aortic stenosis
* Previous residency in a nursing home
* Inclusion in a cardiac rehabilitation program on discharge
* Chronic kidney disease stage ≥ 4
* Planned dialysis in the next six months
* Life expectancy \< 1 year due to non-heart failure related reasons
* Severe chronic obstructive pulmonary disease, GOLD ≥ III
* Cognitive and/or mental problems interfering with the performance of daily measurements and data transmission
Effect of Celliant Materials on Pain and Blood Oxygenation in Subjects With Chronic Elbow and Wrist Pain

The purpose of this research is to determine whether a new type of fabric, Celliant, can reduce elbow and wrist pain associated with chronic medical conditions such as carpel tunnel syndrome, arthritis or tennis elbow and whether it can increase blood flow and oxygenation levels in the arms and hands after wearing the material.

A new type of fabric, Celliant, is made from polymer yarns containing optically active particles (1-1.2 micron diameter titanium dioxide, quarts and aluminum oxide particles) with modify absorption, reflection and transmission of light in the visible and near infrared portion of the spectrum. It is believed that the Celliant particles increase skin illumination such taht cytochrome pigments and other enzymes are activated, leading to increased blood flow and oxygenation of the skin and neighboring soft tissues. In addition, numerous anecdotal reports from patients with chronic foot and arm pain indicate that wearing Celliant garments for even a few days leads to dramatic improvement in many different painful conditions. This is a single center, stratified, randomized, prospective, double-blind study. Questionnaires that subjects will be asked complete are 1) Visual Analog Scale, 2) Brief Pain Inventory, 3) McGill Short Form Pain Survey and 4) SF-36 Quality of Life Inventory.

Eligibility Criteria:
Inclusion Criteria:

* Chronic pain for a minimum of 6 months
* A score of equal to or greater than 3 on question III of McGill Short Form Pain Questionnaire

Exclusion Criteria:

* Open wounds on the involved limb
* Threatened limb loss from ischemia
* Changes in pain or inflammatory medication within the last 30 days
* Psychiatric or other conditions that would affect compliance
* Inability to comply with use of the study articles or to fill out questionnaires
Neonatal Spinal Muscular Atrophy (SMA) Screening

Parents or legal guardian of neonates who signed agreement will receive SMA screening test if their neonates are affected with SMA. The dried blood spots of routine newborn screening samples will be used to test if neonates have lost 2 copies of SMN1 gene. If neonates have positive SMA screening test, further confirmation with multiplex ligation-dependent probe amplification (MLPA) test and prospective motor function monitoring including physical and neurological examinations will be proved to make SMA confirmation. For any confirmed SMA patient, genetic counseling and standard of care will be proved.


Eligibility Criteria:
Inclusion Criteria:

1. Neonates born in Taiwan who receive regular newborn screening suggested by Ministry of Heath and Welfare.
2. Parents or legal guardian agree to perform SMA newborn screening.

Exclusion Criteria:

Parents or legal guardian do not agree to perform SMA newborn screening.
Clinical Scenarios for Long-term Monitoring of Epileptic Seizures With a Wearable Biopotential Technology

Clinically validate a biopotential and motion recording wearable device (Byteflies Sensor Dot) for detection of epileptic seizures in the epilepsy monitoring unit (EMU) and at home.

Subjects with refractory epilepsy who are admitted to the Epilepsy Monitoring Unit (EMU) for clinically-indicated long-term video-EEG assessment will be simultaneously monitored with Sensor Dots to record electroencephalographic (EEG), electrocardiographic (ECG), electromyographic (EMG), and motion signals.

A subset of subjects will continue using Sensor Dot devices at home (Home Phase) after completing the EMU Phase.

The data recorded by Sensor Dots will be used to: 1) annotate epileptic seizures, which will be compared to the annotations made as part of routine EMU monitoring and seizure diaries kept at home, and 2) to develop seizure detection algorithms. The data collected as part of this study will not be used to influence clinical decision making.

Eligibility Criteria:
Inclusion Criteria:

* Subjects (4+ years old) with refractory epilepsy who are admitted to the hospital for clinically-indicated long-term video-EEG assessment or presurgical evaluation, and a high likelihood of experiencing seizures during the EMU Phase
* For subjects continuing into the Home Phase: successful recording of their habitual seizures with Sensor Dot during the EMU Phase
* For subjects continuing into the Home Phase: the ability to keep an e-diary

Exclusion Criteria:

* Known allergies to any of the biopotential electrodes or adhesives used as part of the study protocol
* Having an implanted device, such as (but not limited to) a pacemaker, cardioverter defibrillator (ICD), and/or neural stimulation device because Sensor Dot contains magnets that could interfere with the operation of these devices
* Women who are pregnant
Effectiveness of Early Parental Sensitivity Intervention for Preterm Infant Mothers

In Taiwan, according to the birth notification statistics of the Ministry of Health and Welfare. 164,496 newborns were born in 2020, with preterm births accounting for about 11.58%.Most preterm infants need to be hospitalized for highly specialized care, resulting in the separation of preterm infants from their parents after birth, which may have a negative impact on the healthy attachment development between parents and preterm infants. Moreover, due to the vulnerability of preterm infants, parents often lack the confidence to take care of them.

The study was a quantitative study of a randomized controlled trial, designed by experimental research method. Using GPower 3.1.2 to estimate the number of samples, and the statistical method chosen was Repeated measures ANOVA, the sample size was 80.

The subjects were divided into two groups, The control group received general routine nursing guidance, while the experimental group received general routine nursing guidance and early parental sensitivity intervention program. Using the NICU VR Tour and Premature Infant Behavioral Clues Teaching Materials as educational tools for early parental sensitivity intervention program. The outcome used the Maternal Attachment Inventory, Maternal Confidence Questionnaire and Parental Stressor Scale: Infant Hospitalization as evaluated tools.

Eligibility Criteria:
Inclusion Criteria:

1. Preterm infants:

   1. Preterm infants less than 37 weeks gestation and hospitalized in the NICU
   2. The birth weight is classified as VLBW and LBW, and the birth weight is between 1,000-2,499gm
2. Preterm infant mothers:

   1. Children have not been hospitalized in the NICU in the past
   2. At least 20 years old
   3. They can speak Chinese, Taiwanese fluently and need to be literate

Exclusion Criteria:

1. Preterm infants :

   1. Combined congenital diseases and chromosomal abnormalities
   2. Immediate surgery, first aid and unstable vital signs are necessary after birth
   3. The birth weight is classified as ELBW, and the birth weight is less than 1,000gm
2. Preterm infant mothers:

   1. Hospitalized in the intensive care unit
Interprofessional Community-Based Diabetes Intervention for Older Adults

This study will examine the feasibility and acceptability of a 6-month interprofessional community-based health promotion program, and explore its effects on older adults' self-management of Type 2 Diabetes (T2DM). Recently enrolled clients of Diabetes Care Guelph (DCG), who are age 65+ and have at least two other chronic conditions, will be eligible to participate. Participants must be English speaking, community-dwelling, independent in activities of daily living, and mentally competent to give informed consent. The 6-month intervention will consist of: in-home visits by a Registered Nurse and Registered Dietitian from DCG; participation in a monthly Diabetes Wellness Day group program offered through the Guelph Wellington Seniors Association (GWSA) together with DCG; peer support from trained volunteers at the Diabetes Wellness Day group program; care coordination by the DCG Registered Nurse to help participants access necessary supports and services; and monthly team conferences between care providers at DCG and the GWSA to develop a client-centred plan of care. To evaluate the program, participants will complete interviewer-administered questionnaires before and after the intervention, and care providers and peer volunteers will take part in group interviews.


Eligibility Criteria:
Inclusion Criteria:

* Age 65+
* Referred to Diabetes Care Guelph within the past 12 months
* At least two chronic conditions in addition to Type 2 Diabetes Mellitus
* English speaking
* Community-dwelling, in the city of Guelph
* Independent in activities of daily living
* Mentally competent to provide informed consent
Glyceryl-Trinitrate-Induced Headache in Patients With Familial Hemiplegic Migraine Type 1 and 2

The aim of the present study is to explore functional consequences of migraine gene mutations on their responses to GTN infusion.

Glyceryl trinitrate (GTN) induces migraine attacks indistinguishable from spontaneous attacks in approximately 80% of migraine sufferers. After systemic administration GTN is transformed to nitric oxide (NO). Treatment of spontaneous migraine attacks with an inhibitor of NO is effective in 60% of patients. These data show that NO is involved in both initiation and maintenance of migraine attack.

The consequence of migraine gene mutations on relevant migraine pathways has never been tested. The aim of the present study is to explore functional consequences of migraine gene mutations on their responses to GTN infusion. The project will improve our understanding of the neurobiology of migraine and stimulate development of new treatment targets.

Eligibility Criteria:
Inclusion Criteria:

Patients: Diagnosis of familial hemiplegic migraine (IHS-classification criteria) caused by mutations in the CACNA1A gene and the ATP1A2 gene.

Controls: healthy volunteers

Exclusion Criteria:

Controls: No primary headache in their own history

Patients and controls:

* A history of cerebrovascular disease and other CNS- disease
* A history of serious somatic and mental disease
* A history suggesting ischaemic heart disease
* A history of hypo- or hypertension
* Daily intake of medication apart from oral contraceptives
* Abuse of alcohol or medicine (opioid analgesics).
* Pregnant or breastfeeding women.

On the study day:

* No intake of a simple analgesic in the previous 48 hours
* No headache in the previous 48 hours
Ultrasound-enhanced Uptake of Chemotherapy in Patients With Inoperable Pancreatic Ductal Adenocarcinoma

Patients with inoperable pancreatic cancer have extremely poor prognosis with five year survival below 8% in Norway. Life-prolonging chemotherapy has very limited effect, but is the only therapeutic option for these patients. This tumor is characterized by poor uptake and chemoresistance. Toxic effects on healthy tissue restrict doses applied and maintenance of treatment intensity. This severely limits clinical outcome. Increasing the local uptake of chemotherapy has potential benefits for patients in connection to side effects, survival and possible cure. Treatment with Focused Ultrasound (FUS) combined with microbubbles (MBs) is proved promising to improve treatment response in animal and clinical trials. Ultrasound can induce biological effects deep inside the body without surgical intervention. This opens for local delivery of drugs at desired sites. FUS in combination with regular contrast MBs has been reported to influence the delivery of drugs to tumors.

In this trial FUS and MB will be applied to locally advanced pancreatic cancers shortly after the administration of conventional chemotherapy. Primary aim of the trial is to investigate whether the effect of the cytostatic drug, measured in tumor volume, can be increased.


Eligibility Criteria:
Inclusion Criteria:

* Radiologically verified stage III or IV PDAC or medically inoperable stage IIB T3 PDAC
* eligible for 1st line treatment with FOLFIRINOX, Gemcitabine -nab Paclitaxel, or Gemcitabine monotherapy.
* ECOG 0 - 1

Exclusion Criteria:

* Known contraindications for SonoVue
* Hematological bleeding status before experimental treatment:
* Hb \< 8g/dL, trc \< 80 x10 superscr 9/l, APTT˃ 45s, INR ˃ 1,5
* Pregnancy
Angiogenesis With Positron Emission Tomography (PET) Tracer Uptake

Purpose: L-\[3-18F\]-α-methyltyrosine (18F-FMT) is an amino-acid tracer for PET. We have conducted a clinicopathologic study to elucidate the correlation of angiogenesis with 18F-FMT and 18F-FDG uptake in the patients with non-small cell lung cancer (NSCLC).

Method: Thirty-seven NSCLC patients were enrolled in this study, and a pair of PET study with 18F-FMT and 18F-FDG was performed. Uptake of PET tracers was evaluated with standardized uptake value. VEGF, CD31, CD34, LAT1 and Ki-67 labeling index of the resected tumors were analyzed by immunohistochemical staining, and correlated with the clinicopathologic variables and the uptake of PET tracers.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent a thoracotomy within 4 weeks after 18F-FMT PET and 18F-FDG PET study
* Histology is non-small cell lung cancer

Exclusion Criteria:

* Patient who received neoadjuvant chemotherapy or radiotherapy before surgery
* Patients who have insulin-dependent diabetes
Improving Happiness in Flanders

This study aims to assess the effects of two different types of interventions aimed at increasing happiness in the Flemish general population as compared to individuals that receive no intervention.

This randomized trial has two aims:

1. First, it investigates the efficacy of two different happiness interventions in increasing feelings of happiness in the Flemish general population using a wait-list controlled design.
2. Second, this study aims to identify predictors of response in both interventions ("what works for whom?")

Methods

Design and procedure

* Participants will be contacted through social media and directed to a website that is specifically designed for this study.
* All participants who register for the study first will electronically sign an informed consent and will be asked to complete a brief battery of questionnaires online (base line measures) before randomization.
* Participants then are assigned randomly using a block-randomized design to one of the three conditions using a computerized algorithm:

  1. a condition in which daily small and concrete happiness tips are sent to participants during one month via email (n=400)
  2. a condition in which weekly more in-depth happiness tips with a (doing and experiencing) task are given during one month via email (n=400)
  3. a wait-list condition (1 month); these participants will be subsequently (after the end of the 4-week intervention) randomized to condition (a) or (b) (n=400) using a block-randomized design.
* All participants will be assessed weekly during the intervention (see below) and followed-up 6 months after the end of the study.

Measures

Participants will complete a detailed demographic questionnaire.

Primary outcome measures:

* Subjective Happiness Scale (SHS; Lyubomirsky \& Lepper, 1999)
* Steen Happiness Inventory (SHI; Seligman, Steen, Park, \& Peterson, 2005)

Secondary outcome measures

* Positive and Negative Affect Scales (PANAS; Watson, Clark, \& Tellegen, 1988)
* Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, \& Williams, 2001)
* Warwick Edinburgh Mental Well-Being Scale (WEMWBS; Tennant et al., 2007)
* Brief Symptom Inventory (Korte KlachtenLijst; KKL; Lange, \& Appelo, 2007)

Predictors of outcome

* Meaning in Life Questionnaire (MLQ; Steger, Frazier, Oishi, \& Kaler, 2006)
* Depressive Experiences Questionnaire (DEQ; Blatt, D'Afflitti, \& Quinlan, 1976)
* Experiences in Close Relationships-Revised (ECR-R, Fraley, Waller, \& Brennan, 2000)
* Kentucky Inventory of Mindfulness (KIMS; Baer, Smith, \& Allen, 2004)
* Toronto Alexithymia Scale (TAS; Bagby, Parker, \& Taylor, 1994)

Data analyses

Repeated measures Anova and multilevel modeling will be used to assess differences between the three conditions in primary and secondary outcomes at the end of the intervention and at follow-up. Regression analyses and growth curve modeling will be used to examine the effects of the predictors on primary and secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Sufficient fluency in Flemish
* at least 18 years of age

Exclusion Criteria:

* no fluency in Flemish
* living outside of Flanders
Novel Psychosocial Influences on Smoking Cessation

Our overall research goal is to determine how these novel psychosocial factors impact cessation. This pilot study will answer how dual use of other tobacco products, direct to consumer marketing, and the new phenomenon of butting-out and relighting influences cessation, and how understanding impulsivity and task persistence could lead to new and improved behavioral interventions for tobacco dependence. Answers to these pilot questions will lead to the publication of several manuscripts and provide important feasibility data to design large, well-powered clinical trials, population-level epidemiological studies, and contribute to furthering the field of tobacco treatment.


Eligibility Criteria:
Inclusion Criteria:

* smokers 18 years of age or older

Exclusion Criteria:

* non-English speaking participants
Efficacy of Vitamin D Supplementation in Multiple Sclerosis (EVIDIMS)

Examination of efficacy, safety and tolerability of vitamin D3 in the treatment of Multiple Sclerosis (MS).


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Age between 18 and 65 at randomization
* Relapsing-remitting MS according to the revised McDonald-Criteria (2005)
* EDSS ≤ 6,0
* Stable immunomodulatory treatment for at least 3 months
* Sufficient birth control (Pearl-Index \<1) and negative pregnancy test at screening/randomization

Exclusion Criteria:

* Any other MS-course than RRMS
* Treatment with high dose vitamin D within 6 months prior to randomization
* Patients who have received over the last three months prior to randomization, an immunomodulatory therapy with the exception of IFN-β1b (Betaferon ®)
* Any condition that could interfere with MRI or other study related investigation
* Intolerability to Gd-DTPA
* Hypersensitivity to the drug Colecalciferol
* Patients with sarcoidosis
* Presence or history of nephrolithiasis
* Pseudohypoparathyroidism
* Clinically relevant dysfunction of liver, bone narrow or kidney defined by the following laboratory values:

  * HB \<8.5 g / dl
  * WBC \<2.5 / nl
  * platelet count \<100/nl
  * Creatinine clearance by Cockcroft-Gault formula: Cl \<110ml/min (male) and Cl \<95ml/min (female)
  * AST / ALT\> 3.5 times higher than the upper reference value
  * bilirubin\> 2.0 mg / dl
  * hypercalcaemia\> 2.7 mmol / l
  * calcium / creatinine ratio in urine\> 1
* Treatment with hydrochlorothiazide, digitoxin, digoxin, phenytoin, barbiturates
* Pregnancy or lactation period
* Participation in any clinical study within 3 months before or at any time during study
* Any medical, psychiatric or other condition that could interfere with the patient's ability to understand and give the informed consent, to comply with the protocol or to finish the study any ruling commitment or placement in an institution
Hypopituitarism Following Traumatic Brain Injury or Spontaneous Subarachnoidal Haemorrhages

The purpose of this study is to assess the prevalence and predictors of pituitary dysfunction, as well as secondary out-come in patients with traumatic brain injury or spontaneous subarachnoidal haemorrhages.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of traumatic brain injury (TBI) or subarachnoidal haemorrhages (SAH)

Exclusion Criteria:

* Alcohol or drug abuse
* Prior TBI or SAH
* Chronic use of glucocorticoids
* Pregnancy or breast feeding
* Diagnosis of psychiatric diseases or malignant neoplasms
Serum Vascular Endothelial Growth Factor in Infants With Intravitreal Ranibizumab

To determine the serum concentrations of ranibizumab and vascular endothelial growth factor (VEGF) in infants with retinopathy of prematurity (ROP) who received intravitreal ranibizumab

Infants with ROP are studied. They received 0.25 mg or 0.5 mg of intravitreal ranibizumab to either 1 eye (unilateral cases) or both eyes (bilateral cases) with vascularly active ROP. Serum samples are collected 1 day before and 1 day, 3 days, 1 week after intravitreal ranibizumab. The serum concentrations of ranibizumab and VEGF are measured by enzyme-linked immunosorbent assay, and the changes of the serum VEGF levels are determined.

Eligibility Criteria:
Inclusion Criteria:

* Infants with vascularly active ROP
* intravitreal ranibizumab

Exclusion Criteria:

* already accepted laser therapy