cyrilzakka/clinical-trials huggingface dataset:
The CareWell-programme for Community-dwelling Frail Elderly Persons.

The purpose of this study is to investigate the effect of the CareWell-programme on overall functioning of community-dwelling frail elderly persons. Furthermore, the total costs and the cost-effectiveness of the CareWell-programme, in comparison with regular medical care, will be studied.


Eligibility Criteria:
Inclusion Criteria:

* Frail community dwelling elderly patients aged 70 years or above. Frailty is determined with a two-phase screening instrument.

Exclusion Criteria:

* Non-frail elders
* Patients in palliative or end-of-life stages of disease
* Patients residing in long-term care facilities (care homes and nursing homes)
* Patients already enrolled in specific dementia-related case-management programmes who lack other health-related problems
* Patients not speaking or understanding the Dutch language
HEADS: UP Online Psychological Self-management Intervention: Feasibility 2

To test feasibility of online version of HEADS: UP

Study aim(s): to conduct feasibility testing of online HEADS: UP, a tailored adaptation of an existing psychological intervention (MBSR) to help people affected by stroke self-manage symptoms of anxiety and depression.

Objectives: 1) Assess feasibility and acceptability of delivering the HEADS: UP intervention online and identify any additional adaptations to the HEADS: UP manual and supporting materials. 2) Assess feasibility and acceptability of online research processes, including recruitment, screening, and obtaining informed consent, and data collection processes.

Research question: What elements of intervention design, delivery, and study processes require to be optimised ahead of a 3-arm RCT?

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years
* Have had ≥1 stroke at least 3 months previously
* Interested in learning skills to help cope with self-reported anxiety and/or depression
* Able to speak and understand conversational English
* Score ≥ 4 on either sub-scale Hospital Anxiety and Depression Scale (HADS)
* Desirable: Able to identify a family member/peer who would: like to take part, can speak and understand conversational English; not participating in another trial.

Potential participants who do not identify someone else to take part with them will not be excluded.

Exclusion Criteria:

* Prior MBSR attendance in the last three years (as this may confound results)
* Current participant in another trial
* Cannot follow a 2-stage command
Monitoring the Response of Port Wine Stain Birthmarks to Laser Therapy With Wide-field Functional Imaging Technologies

The researcher develop non-invasive imaging modalities for assessment of port wine stain during laser therapy treatment of Port Wine Stain. The imaging modalities will be used to guide immediate retreatment of regions of persistent perfusion during the procedure.

The researcher can use imaging system operates by projecting low-power near-infrared structured light patterns on to the tissue of interest in a non-contact, reflection geometry and then capturing the reflectance with a camera.The system can image the depth-resolved optical properties of in-vivo tissues, allowing rapid, non-invasive visualization of sub-surface structures of Port Wine Stain.

Eligibility Criteria:
Inclusion Criteria:

* All minors, birth to 18 years of age or older with Port Wine Stain birthmark
* Ability to understand and carry out subject instructions
* Sign photograph release form

Exclusion Criteria:

* Inability to understand and/or carry out instructions
* Pregnant women
* Do not sign photograph release form
Dental Device for Treatment of Sleep Apnea

This study is being done to see if treatment of obstructive sleep apnea (OSA) with a mandibular advancement device (MAD) shows an increase in the quality of life. Many patients prefer to call them mandibular advancers, jaw advancers, jaw advancement splints, jaw advancement devices, anti-snoring mouthpieces, or oral appliances for the treatment of snoring and mild to moderate obstructive sleep apnea. The investigators will also see how helpful the mandibular advancement device is on insulin resistance.

Patients with obstructive sleep apnea (OSA) will be included in this prospective controlled trial. OSA patients who are unable to tolerate CPAP or refuse CPAP(Continuous positive airway pressure) (and who are deemed appropriate by their attending physician for dental device treatment of OSA will be randomized to a control group (no MAD treatment) or to active MAD therapy.

Epidemiologic studies suggest that OSA is associated with insulin resistance independent of other known risk factors such as obesity. The cyclic intermittent hypoxia in OSA is the primary stimulus that leads to insulin resistance, a primary risk factor for the development of type 2 diabetes. There is an association between the level of hypoxic stress in OSA and insulin resistance.

The overall hypothesis to be tested is that treatment of OSA with MAD will improve insulin sensitivity, increase levels of HMW (High-molecular- weight) adiponectin, and improve psychological adjustment.

Eligibility Criteria:
Inclusion Criteria:

* Apnea-hypopnea index (AHI) of at least 20 events/hr based on overnight polysomnography
* \> 18 years of age
* Unable to tolerate or refuse CPAP treatment

Exclusion Criteria:

* Known diabetes mellitus
* Body mass index (BMI) \> 45 kg/m2
* Uncontrolled hypertension
* Known congestive heart failure
* Use of illicit drugs
* Excessive alcohol consumption, defined as:

  * More than 3 glasses of wine a day
  * More than 3 beers a day
  * More than 60 mL of hard liquor a day
* Room air oxyhemoglobin saturation \< 90%
* Use of home oxygen
* Use of corticosteroids
* Unable to give voluntary consent
Single-Arm Open-Label Multicenter Study of VB-111 in Patients With Recurrent Glioblastoma Multiforme

The purpose of this study is to evaluate the safety, tolerability and efficacy of VB-111 in patients with Relapsed Glioblastoma Multiforme.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must have a histologically confirmed diagnosis of glioblastoma multiforme or gliosarcoma;
2. Measurable disease by RANO criteria;
3. Disease progression or recurrence following standard of care treatment with temozolomide and radiation;
4. An interval of at least 4 weeks between prior surgical resection and study enrollment;
5. An interval of at least 12 weeks between prior radiotherapy or at least 4 weeks from prior chemotherapy, and enrollment in this protocol;
6. Recovered to Grade 1 or less from the toxic effects of any earlier intervention;
7. Karnofsky performance status \> 60%

Exclusion Criteria:

1. Prior anti-angiogenic therapy including VEGF sequestering agents (ie bevacizumab, aflibercept, etc) or VEGFR inhibitors (cediranib, pazopanib, sunitinib, sorafenib, etc);
2. Prior stereotactic radiotherapy;
3. Active infection;
4. Evidence of CNS haemorrhage CTCAE grade 2 or above on baseline MRI;
5. Subjects who suffered from an acute cardiac event within the last 12 months;
6. Subjects with active vascular disease, either myocardial or peripheral;
7. Subjects with proliferative and/or vascular retinopathy;
8. Subjects with known active second malignancy;
Metabolic Effects of Melatonin in Patients Treated With Second Generation Antipsychotics

Schizophrenia and bipolar disorder are frequently associated with an elevated risk for obesity, metabolic syndrome, diabetes mellitus, dyslipidemia and other metabolic disturbances. Second Generation Antipsychotics (SGA) have a demonstrated efficacy in acute and long term treatment of these disorders and are considered a first option on most treatment guidelines. Unfortunately the use of SGA is associated to drug induced weight gain, disturbed glucose and lipid regulation and an increase of cardiovascular risk and mortality as well as non- adherence to treatment. There are several hypotheses attempting to explain the complex pathways that lead to antipsychotic therapeutic effects and their accompanying adverse effects. Recently, in animals receiving SGA, melatonin prevented to a large extent the body weight increase, which indicates a possible role for biological rhythms in SGA induced body weight accumulation. Melatonin is a hormone secreted by the pineal gland that follows a circadian rhythm with an increased secretion in the middle of the night. This hormone acts importantly on the suprachiasmatic nucleus and other areas in the brain and periphery. Thus melatonin is involved in a series of biological functions such as sleep regulation, blood pressure, regulation of circadian rhythms, mood, behavior, and more recently in the regulation of metabolic processes including insulin, leptin, and lipid regulation.

Given previous results in experimental animals, the purpose of the present study is to test the potential effect of melatonin in reducing or preventing some of the metabolic disturbances associated with SGA


Eligibility Criteria:
Inclusion Criteria:

1. Men and non-pregnant, non-lactating women aged between 18 and 45 years;
2. DSM-IV-TR criteria for schizophrenia or bipolar disorder type I;
3. free of concomitant medical or neurological illness (as per review of systems and general physical examination);
4. free of DSM-IV current substance abuse or a history of substance dependence in the last six months;
5. who were initiated on continuous treatment with SGA (clozapine, olanzapine, quetiapine or risperidone) for a period no greater than the last three months prior to their inclusion to the present study.

Exclusion Criteria:

1. were diagnosed with hypertension, diabetes mellitus, dyslipidemia, thyroid disorders or hepatic illness;
2. had a history of hypersensitivity to melatonin;
3. exhibited high risk for suicide or high risk for aggressiveness;
4. women who were not practicing reliable forms of contraception. Patients were eliminated from the study if they suspended SGA or two consecutive doses of the study capsule at any point during the follow up period.
A Study to Evaluate the Single Dose Safety, Tolerability and Pharmacokinetics of IV BCX4430

This is a placebo-controlled, randomized, double-blind study to evaluate the pharmacokinetics of galidesivir following administration of single doses by IV infusion

This single ascending dose study will evaluate the safety, tolerability, and PK of single doses of galidesivir vs. placebo administered as IV infusions in healthy subjects enrolled in up to four dose cohorts of 8 subjects each. A single dose of study drug will be administered per cohort: 6 subjects will receive galidesivir IV, and 2 subjects will receive matching placebo.

Eligibility Criteria:
Key Inclusion Criteria:

* written informed consent
* males and non-pregnant, non-lactating females
* BMI 19.0-32.0
* willing to abide by contraceptive requirements
* normal vitals
* willing to abide by study procedures and restrictions

Exclusion Criteria:

* clinically significant medical condition or medical history or psychiatric condition or history of psychiatric condition
* abnormal cardiac finding, or laboratory/urinalysis abnormality at screening
* known family history of sudden death or long QT syndrome, family or personal history of QT prolongation, or arrhythmia that required medical intervention
* current participation in any other investigational drug study or participation in an investigational drug study within 3 months of screening visit
* use of prescription, OTC, or herbal medications during study or use of any specified medications within 30 days prior to study
* Recent or current history of alcohol or drug abuse
* Regular use of tobacco or nicotine products
* Positive serology for HBV, HCV, or HIV
* history of severe adverse reaction to or known sensitivity to any drug
* pregnant, lactating, or planning to become pregnant within 30 days of the study. Male subjects with pregnant female partners are excluded
Safety and Efficacy of Alogliptin in Indian Participants With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the safety and efficacy of alogliptin tablets when given as monotherapy or add on therapy in participants who are on standard care for management of Type 2 Diabetes Mellitus (T2DM).

The drug being tested in this study is called alogliptin. Alogliptin is being tested to treat people who have Type 2 Diabetes Mellitus (T2DM). This study will look at side effects and glycemic control in people who take alogliptin in addition to standard care.

The study will enroll approximately 300 patients. All participants will receive alogliptin tablets at a dose determined based on the creatinine clearance.

The recommended dose of alogliptin is 25 mg once daily with normal or mildly impaired renal function (creatinine clearance \[CrCl\] ≥60 mL/min), dose of 12.5 mg for participants with moderate renal impairment (CrCl ≥30 to \<60 mL/min), and 6.25 mg for participants severe renal impairment (CrCl ≥15 to \<30 mL/min). Participants with end-stage renal disease (ESRD) (CrCl \<15 mL/min or requiring hemodialysis) will be excluded, in addition to standard care for the management of T2DM.

All participants will be asked to take one tablet every morning each day throughout the study.

This multi-center trial will be conducted in India. The overall time to participate in this study is up to 33 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone 30 days after last dose of study drug for a follow-up assessment.

Eligibility Criteria:
Inclusion Criteria:

1. Participants with T2DM who are dipeptidyl peptidase-4 (DPP-4) inhibitor-naive; including alogliptin.

Exclusion Criteria:

1. Has contraindication or limitation for administration of alogliptin tablets according to the approved label/Prescribing Information.
2. Participants treated with alogliptin tablets outside the approved label/ prescribing information.
3. Has end-stage renal disease (ESRD) (Creatinine Clearance (CrCl) \<15 mL/min or requiring hemodialysis).
Multifunctional Nutrition Tube on Social Condition and Experience in Cerebralvascular Accident

The aim of this clinical trial is to compare the psychological condition and experience of ischemic stroke patients who receive enteral nutrition support through either Intermittent Oro-esophageal Tube or Nasogastric Tube. Patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. The observation group will receive enteral nutrition support through Intermittent Oro-esophageal Tube, while the control group will receive it through Nasogastric Tube. Researchers will then compare the psychological condition and experience of the two groups.

The study will last 15 days for each participant. The goal of this clinical trial is to compare the differences on Psychological Condition and Experience in ischemic stroke patients using Intermittent Oro-esophageal Tube and Nasogastric Tube. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will use Intermittent Oro esophageal Tube for enteral nutrition support, while the control group will use Nasogastric Tube. Researchers will compare Psychological Condition and Experience of two groups.

Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years.
* Meeting the diagnostic criteria for ischemic stroke .
* Dysphagia confirmed by video fluoroscopic Swallowing Study.
* Clear consciousness.
* Stable vital signs.

Exclusion Criteria:

* Dysphagia that might be caused by other diseases that might cause dysphagia, such as head and neck tumors, traumatic brain injury, etc.
* Complicated with severe liver and kidney failure, tumors, or hematological disorders.
* Simultaneously in need to undergo other therapy that might affect the outcomes of this study.
* Pregnant or nursing females.
Finding New Targets by Proteomic Approaches (InnovRT1)

The investigators aim to explore the inter tumor heterogeneity by a proteomic approach of a wide series of rhabdoid tumors, from both intra and extra cranial origins.

Context: Rhaboid tumors (RT) are aggressive cancers of young infants, exposed to the toxicity of heavy treatments often ineffective, which justifies the need to identify new treatment strategies. These tumors are characterized by the biallelic alteration of SMARCB1 gene, encoding one of the subunits of the SWI/SNF complex, a chromatin remodeler. These mutations are the only ones found in these very stable cancers, which offers few therapeutic targets that can be identified by genomic techniques. They are morphologically undifferentiated and pluriphenotypic, suggesting the existence of a cellular diversity still poorly described. To advance on these questions, the investigators' laboratory has developed a model of genetically engineered mouse model spontaneously developing RT, biologically very similar to their human counterparts.

Objectives and methods: The investigators' project aims to describe the proteomic and phosphoproteomic signatures of these tumors, so far described at the genome and transcriptome level; an integration of these pangenomic / pan-proteomic studies will reveal the most relevant features to target. The investigators will fully characterize the proteomic and phosphoproteomic landscape using mass spectrometry on a cohort of clinically, radiologically and histopathologically annoted ATRT, for which methylome and RNAseq profiling will also be done. The investigators will describe the proteomic features of each molecularly defined subgroups, and aim to correlate RNAseq changes with proteomic features.

Patients will be included if they or their legal representative have given a consent to such a study, and if frozen material is stored at Necker Hospital.

Expected results: This analysis helps to identify how to articulate several innovative therapeutic approaches, taking into account both the diversity of the cells to be treated, and the real targets, proteins, to inhibit or restore.

Eligibility Criteria:
Inclusion Criteria:

* Aged 0-17 years old
* Rhabdoid tumor, treated in oncology departments in Ile de France
* frozen samples collected in usual care
* parents' agreement for samples collection in usual care

Exclusion Criteria

* Unconfirmed diagnosis of Rhabdoid tumor with molecular analyses Samples
* paraffin embedded tissues
Study Utilizing BIOZEK COVID-19 Antigen Rapid Test

This is a research study to evaluate the Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test (Saliva) and BIOZEK COVID-19 Antigen Rapid Test (Nasopharyngeal Swab) on samples that are self-collected; and to perform analysis to compare results. In addition, to obtain RT-PCR test results, performed prior to enrollment, and compare all three results.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be ≥18 years of age and have had an RT-PCR test performed prior to enrollment.
* Subjects must be able to understand and willingly sign a written informed consent. Additionally, participants need to meet at least 1 of the criteria listed below:

  * Currently experiencing symptoms of COVID-19.
  * Be clinically diagnosed or suspected to have COVID-19.
  * Recent past (3 weeks) exhibited symptoms of COVID-19.
  * Be capable of performing a self-collection of a nasopharyngeal sample with use of nasal swab kit.
  * Be capable of performing a self-collection of an oral fluid sample with use of oral fluid collection kit.
  * Interacted with a COVID-19 positive individual.

Exclusion Criteria:

Subjects who meet any of the following exclusion criteria may not be enrolled in this study:

* Cannot perform self-collection of a nasopharyngeal sample with use of nasal swab kit.
* Cannot perform self-collection of an oral fluid sample with use of oral fluid collection kit.
* Have a deviated nasal septum.
* Cognitively impaired individuals resulting in the inability to provide informed consent
A Study of Ustekinumab to Evaluate a "Subject-tailored" Maintenance Dosing Approach in Subjects With Moderate-to-Severe Plaque Psoriasis

The purpose of the study is to assess the effect of extending maintenance dosing intervals beyond 12 weeks on the clinical efficacy and safety of ustekinumab in subjects with moderate-to-severe plaque psoriasis.

In this study, a proportion of subjects will receive study agent at its recommended dose and interval (45mg for subjects less than or equal to 100kg, or 90mg for subjects greater than 100kg; every 12 weeks after 2 starter doses at Weeks 0 and 4). The majority of subjects will have the opportunity to receive study agent less frequently during the randomization period depending on the subject's response. The study consists of a 4-week screening period; a 28-week open-label run-in period; a double-blind treatment period from Week 28 to Week 104; a 12 week post-treatment period; and a 20-week safety follow-up. Participants will be randomized for the double blind period into one of two study groups. Group 1 participants will receive an injection of the study medication at a 12 week dosing interval. Group 2 participants will undergo a placebo withdrawal and may receive study agents at an extended interval greater than 12 weeks. During the double-blind treatment period, subjects in Groups 1 and 2 will receive placebo as necessary to maintain the blind.

Eligibility Criteria:
Key Eligibility Criteria

* Male or female
* Have had a diagnosis of plaque-type psoriasis at least 6 months prior to the first administration of study agent (subjects with concurrent psoriatic arthritis may be enrolled).
* Have plaque-type psoriasis covering at least 10% of their total BSA at screening and at the time of the first administration of study agent.
* Have a PGA score of ≥ 3 at screening and at the time of the first administration of study agent.
Comparison Between Conventional Angiocatheter Versus New Anchoring Device (KARAHOC) Used for Paracentesis

Comparison of success rate and complication between conventional angiocatheter versus new anchoring device (KARAHOC) used for paracentesis in cirrhotic patients with ascites.

This study is a multi-center, prospective, interventional study, in which subjects who meet the selection criteria are registered at each institution during the study period from the date of research approval. Regardless of the order, paracentesis using KARAHOC and conventional angiocatheter will be performed once in all patients. The criteria for successful paracentesis is set as 3L or more of ascites drainage. During paracentesis, albumin will be infused in all patients. Heart rate and blood pressure will be measured before the procedure and right after the completion of drainage, and 30 minutes later. The incidence of complications will be compared between two methods. In addition, patient and operator satisfaction will be investigated using a visual analogue scale.

Eligibility Criteria:
Inclusion Criteria:

* Adult over the age of 19
* Patients with pathological or clinical diagnosis of liver cirrhosis
* Patients with Grade 2 or higher grade of ascites as a complication due to portal hypertension
* Patients requiring periodic paracentesis
* Patients consent to this study

Exclusion Criteria:(If at least one of the following conditions apply)

* Patients with ascites due to peritoneal metastasis due to malignant tumor
* Patients with high bleeding risk (PT INR\>3, PLT\<30,000/mm3) difficult to perform ascites puncture
* Patients with hepatic encephalopathy or hepatorenal syndrome(HRS)
* Patients with severe cardiovascular disease, lung disease, or DIC
* Patients refusing paracentesis
* Patients who can control ascites using diuretics
* Pregnancy