cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Valcyte® as an add-on Therapy in Patients With Malignant Glioblastoma and Cytomegalovirus (CMV) Infection

The purpose of this study is to investigate if treatment of CMV infection by antiviral drug Valcyte (R) affects the clinical outcome of glioblastoma multiforme in patients with local CMV infection in tumor tissue. The investigators' hypothesis states that CMV infection promotes tumor development and disease progression and inhibits immune responses against the tumor.


Eligibility Criteria:
Inclusion Criteria:

* Glioblastoma grade IV
* Cytomegalovirus detected in tumor
* At least 90% resection of tumor

Exclusion Criteria:

* Decreased kidney function
* Pregnancy
* Neutropenia
* Thrombocytopenia
* Patient not tolerating the drug
Noninvasive Screening for Affected Pregnancies: Assay Development & Optimization in Affected Pregnancies

To collect samples for the purpose of developing and optimizing an in vitro noninvasive prenatal diagnostic (NIPD) test. The NIPD test employs circulating cell free (ccff) DNA extracted from whole blood samples collected from women who are pregnant with a fetus previously determined to have a chromosomal abnormality. The NIPD result will be compared to the standard test results obtained from other test methods such as karyotype, FISH, QF-PCR, and/or any commercially available NIPD test.


Eligibility Criteria:
Inclusion Criteria:

* Subject is female
* Subject is 18 years or older
* Subject is no less than 8 and no more than 36 weeks gestation
* Subject provides a signed and dated informed consent
* Subject agrees to provide one or more 30-50mL blood sample(s) in accordance with the protocol
* Subject has a current pregnancy in which the fetus is known to have chromosomal aneuploidy (e.g. T13, T18, T21)

Exclusion Criteria:

* Non-singleton pregnancy in which only one fetus is known to have a chromosomal aneuploidy
Biomechanical Effects of Digitally Constructed Subperiosteal Implants

Subperiosteal implants were first introduced in 1940 and then used worldwide for the treatment of edentulous maxilla or mandible with advanced bone atrophy.

With the advancement of digital technology for the fabrication of materials and the emerging of new materials, subperiosteal implants can be fabricated from a wide variety of materials, and there is a lack of evidence regarding which material could be suitable.

Eligibility Criteria:
Inclusion Criteria:

* A 3D image of an edentulous maxilla bone derived from a computed tomography scan of an adult patient.
* Maxilla with Cawood and Howell class 4 or 5 classification

Exclusion Criteria:

* A 2D image of an edentulous maxilla bone
* A non atrophied maxilla
A Registry Study of Palmoplantar Pustulosis (PPP) Treatment Patterns, Disease Burden and Treatment Outcomes in Japan

The purpose of this study is to describe the treatment patterns of participants receiving systemic treatment for of palmoplantar pustulosis (PPP) in Japan.

This is a retrospective study where the historical data on PPP therapy will also be used prior to Visit 1 (baseline).

Eligibility Criteria:
Inclusion Criteria:

* Must have a confirmed diagnosis of palmoplantar pustulosis (PPP) in accordance with local clinical practice
* Has previously been prescribed treatment for PPP
* A decision has been made by the treating physician and the participant to commence treatment with a systemic PPP therapy, having been deemed to have an inadequate response to previous therapy (New users are defined as those participants to commence treatment on baseline visit date. Existing users are defined as those who commenced treatment prior to the baseline visit since 01 November 2019.)
* Must sign a participation agreement/informed consent form allowing data collection and source data verification in accordance with local requirements

Exclusion Criteria:

* Are receiving, or have received within the past 3 months, anti-inflammatory or analgesic systemic therapy such as oral corticosteroid, disease modifying antirheumatic drug (DMARDs), non-steroidal anti-inflammatory drugs, opioids, phosphodiesterase 4 (PDE4) inhibitor, or biologics for any other indication (for example, psoriasis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and asthma)
* Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 3 months before the start of the study or the first data collection time point
* Participation in an investigational study
* Participation in another observational study for guselkumab (including a post marketing surveillance study)
* If the only treatment they have received for PPP has been antibiotics
Dietary Fibre and Chromium Picolinate Efficacy in Overweight and Obese Women

Obesity is one of the greatest causes of preventable morbidity and mortality worldwide with the main treatments requiring significant changes to lifestyle, particularly dieting and physical exercise. Glucomannan is a dietary fibre that expands in the stomach, creating the feeling of fulness, while chromium can regulate insulin response.

The aim of this pilot study was to investigate the effect of agglomerated glucomannan, oligofructose and chromium, as part of a calorie restricted diet plan, on weight loss, satiety, satiation, mood and gut microbiome composition in a human intervention study.

Eligibility Criteria:
Inclusion Criteria:

* healthy female
* aged 18-65 years
* with a BMI between 25 and 35 kg/m2
* not dieting within the previous four months
* not having lost \> 5% body weight in the previous year
* not having increased physical activity levels in the past 2-4 weeks
* intending to modify them during the study
* able to eat most everyday foods

Exclusion Criteria:

* BMI \< 25 kg/m2
* \> 35 kg/m2
* significant health problems
* taking any medication or supplements known to affect appetite
* weight within the past month and/or during the study
* pregnant, planning to become pregnant or breastfeeding
* history of anaphylaxis to food
* known allergies or intolerance to foods and/or to the study materials or any of their stated ingredients.
* Volunteers who were on specific food avoidance diets
* with abnormal eating behaviour
* receiving systemic or local treatment likely to interfere with the evaluation of the study parameters
* smokers and those who have recently ceased smoking
* Volunteers who work in appetite or feeding related areas volunteers who participated in another experimental study or receipt of
A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases

The main purpose of study is to assess the safety, tolerability, and pharmacokinetic (PK) of benralizumab.

This study is open-label, multicentre, basket study to evaluate the safety, PK, pharmacodynamic (PD), efficacy, and immunogenicity of repeat dosing of benralizumab subcutaneous (SC) every 4 weeks (Q4W) in male and female children with rare eosinophilic diseases.

Paediatric participants with eosinophilic granulomatosis with polyangiitis (EGPA) will be enrolled in the first cohort. Additional cohorts in other eosinophilic diseases may be added in future protocol amendments.

The study consists of 3 periods:

1. Screening period: 1 to 4 weeks
2. Open-label treatment period: 52 weeks
3. Open-label extension period: at least 52 weeks (plus safety follow-up \[SFU\] weeks after last investigational product \[IP\] administration)

All eligible participants will receive benralizumab SC Q4W during the 52-week open-label treatment period.

All participants who complete the 52-week open-label treatment period on IP will be offered the opportunity to continue into an extension period. The extension period is intended to allow each participant at least an additional one year of treatment with benralizumab.

Eligibility Criteria:
Inclusion Criteria:

All Cohorts:

* Male or female patients must be aged 6 to \< 18 years of age at the time of signing the assent form and their caregiver signing the informed consent form.
* Body weight greater than (\>=) 15 kilograms (kg).

EGPA Cohort:

* Therapy with corticosteroids: The prescribed dose of oral corticosteroids (OCS) (greater than \[\>\] 0.1 milligrams per kilogram per day (mg/kg/day), max dose of 50 milligrams per day (mg/day) must be stable (that is, no adjustment of the dose) for at least 4 weeks prior to baseline (Visit 2).
* Immunosuppressive therapy: If receiving immunosuppressive therapy, the dosage must be stable for at least 4 weeks prior to baseline (Visit 2).

Exclusion Criteria:

All Cohorts:

* Any current malignancy or history of malignancy.
* History of anaphylaxis to any biologic therapy or vaccine.
* Known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological, respiratory, or any other system abnormalities.
* Previous receipt of benralizumab in an interventional clinical study.

EGPA Cohort:

* Diagnosed with granulomatosis with polyangiitis (previously known as Wegener'granulomatosis) or microscopic polyangiitis.
* EGPA relapse: any deterioration in EGPA and/or organ-threatening EGPA that per Investigator judgement renders patients unstable in their EGPA within 3 months prior to screening (Visit 1) and through first administration of IP at baseline (Visit 2).
* Life-threatening EGPA: imminently life-threatening EGPA disease within 3 months prior to screening (Visit 1) and through first administration of IP at baseline (Visit 2), as per Investigator judgement.
Rapid Optimisation of Performance Enhancement and Skill (ROPES)

Despite innate knowledge of the benefits of regular physical activity, healthcare workers are just as physically inactive as the general population. Physical activity interventions delivered at the workplace seem perfect to improve the health of this large population.

The aim of the study is to deliver an efficacious, minimal time impost training program targeted at optimising health benefit while overcoming time-related barriers to initial uptake of regular exercise.

To evaluate the effectiveness of a 4-week, easily accessible, time-optimised exercise program (ROPES - Rapid Optimisation of Performance Enhancement and Skill) for healthcare workers.

60 staff recruited from Singapore General Hospital (SGH) will be randomly assigned into 2 groups, CONTROL or ROPES group. The ratio to intervention and control group is at 1:1. The staff will be assigned to each group respectively.

Eligibility Criteria:
Inclusion Criteria:

* Age group: 21 - 70 years old
* All participants must be free of musculoskeletal, surgical and/or neurological injury in the past 6 months.
* Participants not engaged actively in regular exercise i.e. exercises less than once a week and at a duration less than 30 mins per session.
* Healthy with stable management of any existing diabetes, cholesterol and/or hypertension.
* They should have no issues with the Physical Activity Readiness Questionnaire (PAR-Q)

Exclusion Criteria:

* Participants under the age of 21 or over the age of 70
* Newly diagnosed diabetes/metabolic syndrome/high cholesterol or uncontrolled high BP \>160 mmHg and under medical supervision.
* Subjects with cardiovascular conditions and on beta-blockers.
* Subjects who are pregnant or with recent (\< 3 months) diagnosis of a medical condition, especially cardiac-related conditions.
Gait Re-education Program in Subjects With Parkinson´s Disease

Randomized controlled study that will include participants diagnosed with Parkinson's disease in mild or moderate stage with altered gait pattern who will be randomized following a simple randomization procedure in which one group will perform an intervention based on a gait re-education program called "TAPIZ FISIOR"- motor control and learning added to a conventional physiotherapy program; and the other group will perform only a conventional physiotherapy program. The evaluators will be unaware of the patient's treatment status.

All participants interested in participating in the present study will be part of the research project. Once recruited, they will be randomly assigned to two intervention groups: A and B. Group A (control group) will perform a conventional physiotherapy treatment 2/3 sessions per week of 30 minutes duration; on the other hand, group B (intervention group) will perform the treatment of group A and a therapeutic supplement of 2-3 sessions per week of about 30 minutes. During the research period, several measurements of the variables studied will be taken: one before the intervention, one immediately after the end of the intervention, and another measurement 12 weeks after the end of the intervention.

The treatment will be carried out and supervised at all times by qualified physiotherapists, who will explain to you what the treatment consists of, the days you should attend, and the schedules. No adverse effects are expected from this therapy that could pose a risk for health.

Eligibility Criteria:
Inclusion Criteria:

* Older than 50 years.
* Diagnosed Parkinson Disease.
* Not to be institutionalized.
* Barthel index scores of ≥ 60.
* Ability to communicate and to get up and walk at least 10 m (33 ft)

Exclusion Criteria:

* Medical criteria for contraindication of treatment.
* Severe behavioral problems that hinder participation in the training program.
An Observational Study of Patients Receiving T-DXd for Treatment of HER2+, and HER2-low Unresectable and/or Metastatic Breast Cancer

This study will collect real-world clinical and patient reported outcomes (PRO) and diary data from eligible patients with documented Human Epidermal Growth Factor Receptor 2 (HER2+) \[globally\] or HER2-low \[North America only\] in routine clinical practice.

This is a multi-center, observational prospective study that will characterize the demographic and clinical characteristics, treatment patterns, effectiveness, tolerability and its management, and patient experience of Trastuzumab Deruxtecan (T-DXd) in a real-world setting. This study is planned to be conducted in several countries and aims to enroll approximately 750 patients eligible patients with HER2+ unresectable and/or metastatic breast cancer (mBC) who has received a prior anti HER2 based regimen in the metastatic setting or in the neoadjuvant or adjuvant setting and has developed disease recurrence during or within 6 months of completing therapy. Approximately 250 eligible patients with HER2-low unresectable and/or mBC who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy will be enrolled into the study in North America only.

The planned duration of patient recruitment is approximately 18 months for HER2+ and approximately 12 months for HER2 low.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years of age at time of consent.
* Histological or cytological confirmed diagnosis of unresectable and/or mBC.
* Documented HER2 status via a validated method.
* Adult patients with unresectable or metastatic HER2+ breast cancer who have received a prior anti-HER2-based regimen in the metastatic setting or in the neoadjuvant or adjuvant setting and developed disease recurrence during or within 6 months of completing therapy.

Or

Adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.

* Decision to newly initiate monotherapy T-DXd per standard of care.
* Capable of providing informed consent and completing questionnaires.

Exclusion Criteria:

* Pregnancy or breastfeeding.
* History of other primary malignancies in 2 years prior to unresectable and/or mBC diagnosis.
* Patients who at time of data collection for this study are participating in or have participated in an interventional study that remains blinded.
Effects of Horticultural Therapy on Asian Elderly' Mental Health

The objective of this study is to determine whether horticultural therapy would improve the psychological well-being of the older adults. 70 healthy elderly were randomized into the active horticultural therapy or the waitlist control group. Sessions will be conducted weekly for 12 weeks, and monthly for 3 months. Participants would be assessed at 3 time-points: at the start, at 3-months and at 6-months.

It was hypothesized that as compared to the waitlist control group, participants in the active horticultural therapy will have (1) lower depression and anxiety symptomatology; (2) higher life satisfaction; (3) feel more socially connected; and (4) improved cognitive functioning.

Participants Study participants are community-dwelling elderly.

Assessments Demographic data will be collected at the start. Psychological tests for depression, anxiety and psychological well-being as well as neuropsychological tests of cognitive functioning will be done at the start, at 3-months and at 6-months. Blood samples will also be collected at all three time points.

Intervention Sessions This is an intervention study with a waitlist control group design. The strength of this design is its experimental nature with randomization.

The Horticultural Therapy intervention is delivered by a trained practitioner at various locations and consists of 1 hour sessions weekly for first 3 months, followed by monthly session for the next 3 months. The extension of monthly sessions for 3 months is to determine sustainability and longer-term changes. The intervention is designed to cultivate an interest in gardening and promote relaxation. This will be achieved in stages, facilitated by trained volunteers and practitioners. The plant would be selected based on subjects' profiles e.g. familiarity, preference, safety and its maintenance would be followed up every fortnight. Park venues were selected based on patients profiles and park features e.g. familiarity, comfort under weather, safety.

The control group will be placed on a waiting list and only be contacted for assessments. They will receive intervention after the active treatment group at a later date.

The horticultural therapy is conducted solely for the purpose of this research.

Eligibility Criteria:
Inclusion criteria:

1. Community-living elderly aged between 60 to 85 years AND
2. able to provide informed consent AND
3. function independently AND
4. With a minimum score of 22 and above on the Montreal Cognitive Assessment.

Exclusion criteria:

1. Those who do not meet the above inclusion criteria (ie. Do not have a MCI diagnosis),
2. Does not have a minimum score of 22 and above on the Montreal Cognitive Assessment OR
3. Currently suffering from or have history of severe medical conditions e.g. cancer, stroke, Parkinson disease OR
4. History of severe psychiatric conditions e.g. schizophrenia, bipolar disorder OR
5. Dementia OR
6. Undergoing another therapy at the same time OR
7. Significant visual or hearing impairment OR
8. Marked upper and lower limb motor difficulties, which may affect their ability to participate in the study.
An Open-Label Study of Atomoxetine in Adolescents With Attention-Deficit/Hyperactivity Disorder

A single arm, open-label, phase 3 multicenter study to evaluate the effectiveness and tolerability of atomoxetine (given once daily, target dose 1.2 mg/kg/day), as perceived by patients, parents and physicians, and its impact on self-esteem in adolescents (aged 12 through 17 years) with Attention-Deficit/Hyperactivity Disorder treated as outpatients in Germany. An 8-week treatment phase is followed by a 16-week extension period.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients who are at least 12 years of age and who will not have reached their 18th birthday
* Diagnosis of ADHD
* Normal intelligence

Exclusion Criteria:

* Weigh less than 30 kg or more than 85 kg at study entry
* Other relevant psychiatric diagnoses
* Are at serious suicidal risk as determined by the investigator
* Have a history of severe allergies
* Alcohol or drug abuse within the past 3 months
* Are female patients who are pregnant or breast-feeding. Sexually active females must use a medically acceptable method of contraception.
New Classification of Stomach Using Probe-based Confocal Laser Endomicroscopy

The aim of the present study was to propose a new pCLE classification of gastric pit patterns and vessel architecture, and to assess the accuracy and interobserver agreement of this new pCLE classification system in the stomach.

Probe-based confocal laser endomicroscopy (pCLE; Cellvizio, Mauna Kea Technologies, Paris, France) is a newly developed endoscopic device which allows the application of laser microscopy with any conventional endoscope and mosaic imaging. Previous studies have demonstrated its application in various GI diseases, including Barrett's esophagus, colonic adenoma, ulcerative colitis, and etc. However, limited data are provided on exploring the application of pCLE in the stomach. Therefore, the aim of the present study was to propose a new pCLE classification of gastric pit patterns and vessel architecture, and to assess the accuracy and interobserver agreement of this new pCLE classification system in the stomach.

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for pCLE examination
* aged between 18 and 80 years old

Exclusion Criteria:

* Esophageal, gastric or duodenal cancer or other malignancy
* History of upper GI tract surgery
* Coagulopathy or bleeding disorders
* Allergy to fluorescein sodium
* Pregnant or breast-feeding (for females)
* Impaired renal function
Arasertaconazole Nitrate Pessaries - Dose Finding Study for the Vulvovaginal Candidiasis (VVC) Treatment

In order to find an optimal dose of arasertaconazole nitrate in the treatment of vulvovaginal candidiasis, a multicenter, randomized, double-blind, parallel, placebo-controlled study will be conducted to compare the therapeutic efficacy, safety and tolerability of three different doses of arasertaconazole nitrate (150 mg, 300 mg or 600 mg, pessaries).


Eligibility Criteria:
Inclusion Criteria:

* Women aged between 18 to 65 years of age who have signed the informed consent.
* Not pregnant, not nursing.
* No indication of other vulvovaginitis or genital infections
* Positive 10% potassium hydroxide (KOH) preparation for budding yeast and/or pseudohyphae.
* Negative wet mount results for T. vaginalis and clue cells.
* Exclusion Criteria:
* Subjects with another vaginal or vulvar condition that would confound the interpretation of clinical response.
* Hypersensitivity to imidazole products administered topically.
* Any other medical condition which in the opinion of the investigator could interfere with study conduct.
COMPARISON OF THE EFFECTS OF TELEREHABILITATION AND FACE-TO-FACE SPINAL STABILIZATION TRAININGS ON GAIT BIOMECHANICS, BALANCE AND JOINT POSITION SENSE IN TRANSTIBIAL AMPUTEES: A RANDOMIZED CONTROLLED, SINGLE BLIND STUDY

After transtibial amputations, biomechanical changes in the trunk, pelvis, and lumbar region cause asymmetrical strength and core muscle activation on the amputated side, which negatively affects the gait biomechanics of individuals. However, routine treatment programs do not use treatment approaches based on the core region. This study will focus on the effects of telerehabilitation and face-to-face spinal stabilization exercise training on gait, balance, joint position sense, core muscle function, and perceived mobility in transtibial amputees, after treatment, and after long-term follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Individuals who use total contact sockets
* have been using prostheses for at least 1 year,
* can walk independently without a walking aid
* functionally at least K2

Exclusion Criteria:

* Bilateral amputation
* Upper extremity amputation
* Neurological problems
* Other orthopedic problems