cyrilzakka/clinical-trials huggingface dataset:
Clinical Trial of CT1812 in Mild to Moderate Alzheimer's Disease

This is a multi-center, randomized, double-blind, placebo-controlled, parallel group study of two doses of CT1812 in adults with mild to moderate Alzheimer's Disease to evaluate the safety and tolerability of oral CT1812, administered for 28 days. This trial may include up to 8 qualified investigator sites in Australia.

Screening procedures will occur up to 42 days. Eligible subjects will randomized at the clinic on Day 1 and receive the first dose of study drug. Dosing for 28 days thereafter off-site and a total of 5 clinic visits over the treatment period for safety and lab assessments. Then a 7 day post-treatment completion follow-up visit (Day 35) and End of Study for last safety assessments (Day 49).

Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to provide written informed consent prior to initiation of any study-related procedures. For subjects unable to provide written consent, consent will be provided by the Person Responsible per local regulations.
2. Men and women, 50-80 years in age inclusively with a diagnosis of mild to moderate Alzheimer's disease according to the 2011 NIA-AA. Women must be neither pregnant nor nursing, and are either surgically sterile, postmenopausal or premenopausal using an acceptable method of contraception.
3. Previous decline in cognition for more than six months.
4. Neuroimaging (MRI) obtained within the previous 6 months or during screening, consistent with the clinical diagnosis of Alzheimer's disease.
5. MMSE 18-26 inclusive.
6. No active depression and a Geriatric Depression Score (GDS) of \< 6.
7. Modified Hachinski Ischemia score ≤ 4.
8. Formal education of eight or more years.
9. Living at home or in a community setting (assisted living) without continuous nursing care. Each subject must have a reliable caregiver who sees them at least 3 times weekly, can oversee the administration of study drug, and is willing and able to participate in all clinic visits and some study procedures. Responsible caregiver must provide written informed consent to participate.
10. Concurrent use of acetylcholinesterase inhibitors or memantine must be stable for 90 days prior to screening and not expected to change.

Exclusion Criteria:

1. History of or screening brain MRI scan indicative of significant abnormality, including, but not limited to, prior hemorrhage or infarct \> 1 cm3, \>3 lacunar infarcts, cerebral contusion, encephalomalacia, aneurysm, vascular malformation, subdural hematoma, hydrocephalus, space-occupying lesion (e.g. abscess or brain tumor such as meningioma).
2. Clinical or laboratory findings consistent with:

   1. Other primary degenerative dementia,
   2. Other neurodegenerative condition
   3. Seizure disorder
   4. Other infectious, metabolic or systemic diseases affecting the central nervous system
3. A current DSM-V diagnosis of active major depression, schizophrenia or bipolar disorder.
4. Clinically significant, advanced or unstable disease that may interfere with outcome measures, and which may bias the assessment of the clinical or mental status of the patient or put the patient at special risk
Preventing Catheter-related Bacteremia When Administering Injectable Medications in Premature Infants.

This study evaluates the potential interest of a new multi-lumen infusion access device (Edelvaiss® Multiline NEO) in the prevention of catheter-related bacteremia when administering injectable drugs in premature infants. This device will be compared to the standard infusion set of each center.

Edelvaiss® Multiline NEO is a multi-lumen infusion access device, adapted to the neonatal population. It has five ports connected to five lumens separated in a single tube of 90 cm, combined with a small single tube called annex port. Four ports numbered 1 to 4 are connected to four peripheral lumens (residual volume per lumen: 0.6 mL). The fifth port, called central access (indicated by the HF icon (High Flow)), is reserved to the administration of parenteral nutrition. It is connected to the central lumen (residual volume: 4.5 mL). The sixth port on the annex way allows an administration closer to the infant (residual volume: 0.40 mL). It is thus reserved for emergencies and direct intravenous injections.

The innovative technological design of Edelvaiss® Multiline NEO device should enable secure administration of injectable drugs by preventing variations in drug mass flow rate and the occurrence of drug incompatibilities. This device would reduce the number of perfusion incidents and therefore, the frequency of manipulations of infusion lines within the incubator, direct source of occurrence of bacteremia.

Moreover, its main interest lies in neonatology in the possibility of being positioned outside of the incubator and to have a lifetime of 21 days, contributing to the prevention of catheter-related bacteremia. All manipulations are therefore made outside the incubator at the room temperature and the relative humidity, and at a distance from the device/catheter junction.

Eligibility Criteria:
Inclusion Criteria:

* Infants with gestational ages between 24 and 29 weeks.
* Infants carrying a single-lumen central venous catheter.
* Obtaining the informed parental consent.

Exclusion Criteria:

* Infants carrying a multi-lumen central venous catheter.
* Infants carrying a umbilical venous catheter.
* Infants carrying two central venous catheters.
* Refusal of informed parental consent.
Application of Ectoin® Rhinitis Nasal Spray in Patients With Acute Rhinosinusitis

This is a comparative, open label, parallel group, non interventional study to further demonstrate the effectiveness and tolerability of Ectoin® Rhinitis Nasal Spray. In addition the effectiveness and safety shall be compared to a Sinupret forte. The patient applies Ectoin® Rhinitis Nasal Spray or takes Sinupret forte according to the instructions for use. The observation takes place over a period of 14 days. Response to treatment is recorded at day 7 and day 14 by the physician and in daily by the patient in a dairy.


Eligibility Criteria:
Inclusion Criteria:

* Female or male individuals ≥ 18 years
* Patients with acute Rhinosinusitis which are treated with Ectoin® Rhinitis Nasal Spray or Sinupret forte during the observational period

Exclusion Criteria:

* Contra indications according to the label
Post-Marketing Non-Acute Safety Study in Japan After Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) mRNA-1273 COVID-19 Vaccine in Persons at High Risk of Severe COVID-19

The goal of this study is to assess serious adverse events associated with hospitalizations in the non-acute phase after vaccination with the mRNA-1273 vaccine in persons with underlying diseases who are considered to have a high risk of severe exacerbation of COVID-19.

Data collected from the JMDC Claims database from May 2020 to October 2022.

Eligibility Criteria:
Inclusion Criteria:

* Participants registered to receive the mRNA-1273 vaccine in the Pep Up vaccination history Database
* Participants who have a history of vaccination with the mRNA-1273 vaccine in the Pep-Up vaccination history Database and the observation start date is at least 6 months prior to vaccination with the mRNA-1273 vaccine and have underlying diseases.

Exclusion Criteria:

* Underlying diseases that were determined undetectable by the pre-screening of JMDC
* Participants who did not consent to the questionnaire.
Brief Telehealth Cognitive Rehabilitation Following Mild TBI

In the United States, more than a million people sustain a mild traumatic brain injury (mTBI) every year. Although many recover fully, emerging literature suggests a high number of individuals report chronic, and functionally disabling, cognitive difficulties. Among Veterans, a nationwide survey found that more than 75% of 55,000 Veterans with a history of mTBI reported persistent moderate to severe levels of forgetfulness and poor concentration.

Reduced cognitive functioning following mTBI contributes to significant functional impairment, including underemployment, relationship difficulties, and reduced community integration for years post injury. Despite the significant individual and societal impact, evidence to guide interventions and treatment for this population remains limited. Even more limited are validated telehealth options for these symptoms, a critical means by which access to care can be improved, especially during the COVID-19 pandemic. The proposed pilot study will address this gap by evaluating the feasibility, acceptability, and preliminary effectiveness of a brief (5-session) cognitive rehabilitation intervention that was developed for individuals with mTBI and that will be administered over video-based telehealth technology. The development of this intervention was supported by a grant from the Department of Defense, with critical elements identified through surveys completed by clinicians and veterans with a history of mTBI, and also the clinical expertise of the team.


Eligibility Criteria:
Inclusion Criteria:

* Age 18+;
* Read, speak, understand English;
* History of at least one mTBI;
* Endorses moderate to severe cognitive difficulties in one or more of Neurobehavioral Symptom Inventory items M-P;
* Ability and willingness to participate in audio recorded sessions over video telehealth platform in a private setting, including equipment and internet access;
* Lives within 2 hours of VA Puget Sound or affiliated clinics/University of Washington;
* Will be in Washington State when engaging in treatment sessions

Exclusion Criteria:

* Significant cognitive impairment that would limit ability to engage on treatment;
* Neurologic injury or illness that affects cognitive functioning, including history of moderate or severe TBI;
* History of TBI in the past 3 months, from the date of screening;
* History of serious mental illness involving psychotic symptoms;
* Current psychotic or manic symptoms;
* Current or active flag, or documentation in medical record, for behavior or suicide risk;
* Current (within the past 3 months) Substance Use Disorder (not including caffeine or nicotine disorder)
Airway Hyper-responsiveness Study In Asthma Using Salmeterol/Fluticasone Propionate Combination Product

This double-blind, stratified, parallel group study is to determine whether aiming for 'Total control' results in better airway hyper-responsiveness than maintaining the treatment level at which 'Well-controlled' asthma was achieved. The primary endpoint is the mean change in PC20 methacholine. Well controlled subjects (as assessed after a 12 week run-in period) will enter a 24 week treatment period during which they will record PEF(Peak Expiratory Flow), symptoms, rescue beta2-agonist use over 24 hours, night time awakenings, asthma exacerbations, emergency visits due to asthma and Adverse Events. At every visit lung function measurements and airway hyper-responsiveness will be measured.

A multi-centre, randomised, double blind, stratified, and parallel group study to evaluate whether a treatment strategy based on aiming for 'Total control' results in better airway hyper-responsiveness than a treatment strategy based on maintaining the treatment level at which 'Well-controlled' asthma was achieved.

Eligibility Criteria:
Inclusion criteria:

* History of asthma of at least 6 months.
* Subjects who have received fluticasone propionate at a dose of 100 mcg bd to 250 mcg bd or equivalent with or without a long acting beta2-agonist for at least 4 weeks before the start of the run-in period, at a constant dose.
* Subjects who are able to understand and complete an electronic diary card.

Exclusion criteria:

* Subjects who have been hospitalized for their asthma within 4 weeks of study entry.
* Subjects who had an acute upper respiratory tract infection within 4 weeks or a lower respiratory tract infection within 4 weeks prior to study entry.
* Subjects who received oral, parental or depot corticosteroids within 4 weeks prior to study entry.
* Subjects who have a known respiratory disorder other than asthma and/or systemic/thoracic abnormalities which influence normal lung function.
* Subjects who have more than 5 pack years.
* Subjects who currently smoke.
68Ga-BNU-PSMA PET/CT in Patients With Various Types of Cancer

To evaluate the potential usefulness of 68Ga-BNU-PSMA positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer.

Subjects with various types of cancer underwent 68Ga-BNU-PSMA PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga-BNU-PSMA PET/CT were calculated.

Eligibility Criteria:
Inclusion Criteria:

* (i) adult population (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled 68Ga-BNU-PSMA PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee; (v) healthy volunteers(aged 18 years or order).

Exclusion Criteria:

* (i) patients with pregnancy; (ii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Treatment of Malaria in Gabon With Fosmidomycin-Clindamycin

Some antibiotics are also effective against malaria parasites. Fosmidomycin is an antibiotic that has been shown to be effective against malaria, although it cannot achieve a total cure in all patients. A previous small study has shown that in combination with clindamycin, an commonly used antibiotic, it is highly effective and safe, in asymptomatic carriers of malaria parasites. The current study will evaluate the efficacy and safety of the combination given for three days in children with uncomplicated malaria in Gabon.

The treatment of malaria is becoming increasingly difficult due to the development of Plasmodium falciparum strains resistant to commonly used antimalarials. Fosmidomycin was shown to be well tolerated and fast-acting in paediatric outpatients and adults, but late recrudescences preclude its use as monotherapy. Clindamycin was identified as a suitable combination partner following the demonstration of synergistic inhibition of plasmodial growth by in vitro and animal studies.

In this study, the safety and efficacy of fosmidomycin-clindamycin (30 mg/kg plus 10 mg/kg) twice daily for three days is assessed in children with acute uncomplicated P. falciparum malaria.

Eligibility Criteria:
Inclusion Criteria:

* Uncomplicated P. falciparum malaria with acute manifestation
* Asexual parasitemia between 1,000-100,000/μL
* Body weight between 5-65 kg
* Ability to tolerate oral therapy
* Informed consent, oral agreement of the child if appropriate
* Residence in the study area for the duration of at least 4 weeks

Exclusion Criteria:

* Adequate anti-malarial treatment within the previous 7 days
* Antibiotic treatment for a concurrent infection
* Haemoglobin \<7g/dL
* Hematocrit \<25%
* Leukocyte count \>15,000/μL
* Mixed plasmodial infection
* Severe malaria, any other severe underlying disease
* Concomitant disease masking assessment of treatment response
* Inflammatory bowel disease, and any other disease causing fever.
Profile of Human Milk Oligosaccharides and FUT2 Polymorphism of Mothers in Indonesia

Human milk oligosaccharides (HMOs), the third most abundant constituent of breastmilk, are known to have beneficial effects on infant immunity. Maternal genetic polymorphisms cause HMO variability. The FUT2 gene determines the secretor status, whereas the FUT3 gene is responsible for the expression of Lewis fucosyltransferase. Therefore, breastmilk can be classified to four groups according to the variation. To date, this variability has not been investigated in Indonesia. This study aims to evaluate the association between FUT2 gene polymorphism and 2'-Fucosyllactose (2'-FL) secretor phenotype. In addition, infant FUT2 gene polymorphism and short chain fatty acid (SCFA) profile from stool samples are also analysed.

Eligible mother-infant pairs are explained about this study. Those willing to participate in this study are asked for written informed consent. Mothers are interviewed about their baseline characteristics, family pedigree, nutritional intake, and routine drug consumption. Infants are checked for their birth history. Both are measured for weight and height.

Four specimens are collected from the subjects:

1. Mother

   1. Breastmilk

      Breastmilk is expressed at 8-11 AM to avoid variability due to circadian rhythm. One breast is emptied, 30 mL of breastmilk is stored in a sterile container, and the rest is returned for feeding. Breastmilk is divided to five 2-mL cryovials and stored in a -80°C freezer. The remaining is stored in a -20°C freezer.
   2. Blood

   Blood samples (3 mL) are collected for DNA extraction.
2. Infant

   1. Buccal cells

      Buccal swab kits are used to obtain samples for DNA extraction.
   2. Stool

Stool specimens are collected at the age of four weeks in a sterile container and stored in a -80°C storage before short chain fatty acid profile analysis.

Eligibility Criteria:
Inclusion Criteria:

* Mother

  1. Minimum of 18 years old
  2. With term infants aged 2-5 weeks
  3. Exclusively breastfeed
  4. Healthy condition
  5. Agree to participate and sign the informed consent
* Infant

  1. Infant with mother who fulfil the eligibility criteria

Exclusion Criteria:

* Mother

  1. Has a Caucasian ancestor in two generations above
  2. Infant has multiple congenital anomalies
* Infant

  1. Has ever received antibiotics
Comparative Effects of Dry Needling and Cross Friction Massage on Patients With Plantar Fascitis, RCT

Effectiveness Comparative Effects of Dry Needling and Cross Friction Massage on Patients With Plantar Fascitis


Eligibility Criteria:
Inclusion Criteria:

* Patients With Plantar Fascitis

Exclusion Criteria:

* Other Health Issues
Assessment of Heart Rate Variability, Performance and Dehydration in Muay Thai Athletes

Known as "Thai boxing," Muay Thai utilizes a combination of upper limb strikes (such as punches and elbow strikes) as well as lower limb strikes (such as kicks and knee strikes), and is thus referred to as the "art of eight limbs." It is practiced worldwide and is a prominent discipline in many mixed martial arts (MMA) training camps. In this sport, training load control involves monitoring and adjusting the quantity and intensity of training according to each athlete's capacity. In the context of combat sports, such as Muay Thai, heart rate variability (HRV) and assessment of body composition by bioelectrical impedance analysis can be used as tools to evaluate training responses. Additionally, HRV can also serve as a tool for assessing recovery after training or competition. If HRV does not return to baseline after training or competition, it may be a sign that the athlete is not fully recovered and may need more time to recuperate before returning to training or competition. Due to the absence of studies in the literature that have assessed a possible association between HRV and dehydration and rehydration processes in amateur Muay Thai athletes, it becomes essential to evaluate this correlation. Given the growing interest in practicing Muay Thai in gyms, assessing the sympathetic-vagal balance, body composition, and performance of these athletes becomes of utmost importance. Therefore, the aim of this study is to investigate the relationship between dehydration indicators, HRV parameters, and performance in the frequency speed kick test (FSKT). Participants will be assessed before and after an eight-week training program, conducted three times a week. Assessments will include resting HRV measurement and FSKT; in addition, bioimpedance will be used to estimate the body composition of participants pre- and post-training. It is expected that the results will reveal changes in HRV, performance, and body composition of the athletes after training.


Eligibility Criteria:
Inclusion Criteria:

- 1. Amateur Muay Thai athletes from the city of Curitiba and metropolitan region, aged ≥ 18 years old, male.

2. Amateur Muay Thai athletes for a minimum period of 6 months.

Exclusion Criteria:

* 1. Pregnant women. 2. Uncontrolled high blood pressure. 3. Inability to perform performance tests 4. Interrupting any test spontaneously
Risk Factors for the Development of Diabetes Mellitus After Distal Pancreatectomy

Glucose homeostasis changes after distal pancreatectomy are not well understood. This study aim to identify the incidence of and risk factors for, a change in glucose homeostasis in patients who underwent distal pancreatic resection.

The development of sophisticated surgical procedures, improved postoperative care, and the capacity for early diagnosis of disease, have prolonged life expectancy after pancreatic resection. For these patients, the endocrine function of the pancreas is a critical factor that influences quality of life. In this study, the investigators recruit patients who underwent distal pancreatectomy in Peking Union Medical College Hospital within the last 10 years. Demographic characteristics, operative parameters and short-term postoperative outcomes were collected in a prospective database maintained by the Pancreatic Surgical Centre, Peking Union Medical College Hospital. These patients are followed up regularly by outpatient visiting or telephone for long-term outcomes. The primary outcome of this study is new-onset diabetes mellitus; second outcomes include impaired fasting glucose, impaired glucose tolerance, exocrine insufficiency and disease recurrence. This study aim to determine the cumulative rates of endocrine insufficiency, and identify risk factors for DM development in a large cohort of patients undergoing distal pancreatectomy.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing distal pancreatectomy

Exclusion Criteria:

* Patients undergoing pancreaticoduodenectomy, middle pancreatectomy and enucleation
* Patients with preoperative DM
* Patients with functioning insulinoma and multiple endocrine neoplasia type 1
A Non-interventional Study to Evaluate the Use of Pliaglis in Daily Practice

A multe-center, non-interventional study in Europe to evaluate Pliaglis in daily practice

A multi-center, non-interventional study, including up to 700 subjects at approximately 70 sites in 5 European countries to evaluate the post-market safety profile of Pliaglis and the efficacy of Pliaglis in terms of pain reduction, satisfaction with the product and daily practice use prior to pre-defined aesthetic procedures.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Patient treated with Pliaglis by the Investigator or other healthcare professional according to label (refer to SmPC)
* Patient had already consented to receive any one or more of the following aesthetic procedures after Pliaglis administration:

  1. Pulsed-dye laser therapy
  2. Laser-assisted hair removal
  3. Non-ablative laser resurfacing
  4. Dermal filler injection
  5. Vascular access

Exclusion Criteria:

* Patient treated with other injectable or topical anaesthetic(s) for the pre-defined aesthetic procedure
* Previous participation in this study