cyrilzakka/clinical-trials huggingface dataset:
Reliability of Chinese Version of Verbal Learning Test and Selective Reminding Test

Mild cognitive impairment (MCI) is distinguished from healthy aging by cognitive difficulties that are greater than expected for one's age and education. Amnestic mild cognitive impairment (aMCI) is a major sub-type of MCI with noticeable impairments in memory. Approximately 12% of aMCI will progress to AD per year. There are two test to evaluate the effects on memory, but both without Chinese version. This study is to know the test-retest reliability of the Chinese version of the Verbal learning test and Selective reminding test among people with mild cognitive impairment.


Eligibility Criteria:
Inclusion Criteria:

1. Age≥50 years
2. Complained of memory impairment
3. Chinese Version Verbal Learning Test 10-minute delays ≤ 6 words
4. MMSE score≥24 and CDR score=0.5
5. Activities of daily living are intact
6. DSM-IV criteria for the diagnosis of dementia is not met

Exclusion Criteria:

1. Any significant neurologic disease other than suspected incipient Alzheimer's disease
2. Psychotic features, contraindication of exercise... which could lead to difficulty complying with the protocol
Prolonged Vasospasm in Subarachnoid Hemorrhage

The prevalence and clinical implications of prolonged cerebral vasospasm in patients with subarachnoid hemorrhage are unknown.

The prevalence and clinical importance of prolonged cerebral vasospasm (after day 21 of bleeding) in patients with subarachnoid hemorrhage is unknown.

Objectives: To determine the prevalence and clinical relevance of prolonged vasospasm in patients with subarachnoid hemorrhage secondary to cerebral aneurysm.

A prospective and observational study was conducted. Adult patients with a diagnosis of subarcnoid hemorrhage CT scan or presence of blood in the cerebrospinal fluid were incorporated. Patients with vasospasm were followed daily with transcranial doppler. Those with technical impossibility to perform transcranial and pregnant Doppler were excluded. Day 0 was defined, the day of the last bleeding.

Evaluation: 1) It was considered in patients with prolonged vasospasm: whether or not it was associated with clinical manifestation (deterioration of the sensory or new neurological deficit) and 2) the magnitude of the vasospasm (mild, moderate or severe) was measured by transcranial doppler.

Eligibility Criteria:
Inclusion Criteria: Subarachnoid hemorrhage -

Exclusion Criteria: Pregnancy

-
Correlation Between Regional Brain Volume and Response to Donepezil Treatment in AD Patients

This study investigate the relationship between regional brain volume measured by MRI and donepezil treatment response in patients with Alzheimer's Disease.


Eligibility Criteria:
Inclusion criteria:

1. Over 60 years old.
2. Probable or possible Alzheimer's Disease according to the DSM-IV and NINCDS-ADRDA.
3. MMSE score of 10\~24, CDR of 1\~2.
4. Patients didn't take acetylcholinesterase inhibitors 4 weeks before screening.
5. Permitted drugs: antipsychiatric drug for BPSD, antidepression drug, tranquilizer, treatment drug for physical disease for example hypertension.

Exclusion criteria:

1. Uncontrolled by donepezil because of adverse events.
2. No longer continuing treatment of donepezil for refuse, drug-drug interaction etc.
3. If they have taken concomitant medication which were not allowed.
A Video Intervention to Improve Patient Understanding of Tumor Genomic Testing in Patients with Metastatic Cancer

This clinical trial tests whether a video intervention improves patient understanding of tumor genomic testing in patients with cancer that has spread to other parts of the body (metastatic). Measuring how the video intervention affects patient understanding of tumor genomic testing in patients with metastatic cancer may help doctors provide patient-centered care by effectively communicating the importance of tumor genomic testing.

PRIMARY OBJECTIVE:

I. To assess change in patient knowledge about tumor next generation sequencing (NGS) following exposure to the video.

SECONDARY OBJECTIVES:

I.To assess changes following exposure to the video, including; Ia. Genomic knowledge via the validated 10 true/false question survey (% correct out of 10).

Ib. 11-item Trust in Physician Survey (TPS) as a single TPS score. Ic. Comparison of results in three patient cohorts: 1) Metastatic breast cancer; 2) lung cancer; 3) metastatic cancer of unspecified type.

EXPLORATORY OBJECTIVE:

I. Assess whether therapies prescribed as a result of tumor NGS achieved clinically favorable result through chart review.

OUTLINE:

Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have biopsy-confirmed metastatic cancer
* Be \>= 18 years of age
* Be undergoing clinical tumor or circulating tumor deoxyribonucleic acid (DNA) NGS

Exclusion Criteria:

* Exclude patients who are not English- or Spanish-speaking
Delayed Cord Clamping at Term Cesarean

The purpose of this research study is to find out how delaying cutting the umbilical cord until one minute after delivery of the baby during a cesarean impacts the amount of blood the mother loses during surgery. The study will also examine the benefits to the newborn from delayed cord clamping during cesarean.

After delivery of a baby, the umbilical cord is cut to separate the baby from the placenta and the mother. The best time to cut the umbilical cord of full term babies is unknown. Traditionally, the umbilical cord is cut immediately at birth. There is however, continued blood flow from the placenta to the baby after delivery and so there may be a benefit to the baby from waiting to cut the cord until one minute after delivery. Studies show that delaying cutting the cord until at least one minute after delivery increases a full term baby's blood count in first two days of life and increases the baby's iron levels. The impact of delaying cutting the umbilical cord on a mother's health is not fully known. Delaying cutting the cord has minimal impact on the mother's health when the baby is delivered vaginally, but it is not known how delaying cutting the cord impacts the mother's health (and specifically the amount of blood a mother loses at delivery) when the baby is delivered by cesarean.

Eligibility Criteria:
Inclusion Criteria:

* Singleton gestation
* Scheduled cesarean delivery at term (\>=37 weeks)

Exclusion Criteria:

* Placenta previa
* Placenta abruption
* Intrauterine growth restriction with abnormal Dopplers
* Fetal anomalies
* Known fetal anemia
* Planned cord blood banking
* Preeclampsia
* Significant maternal anemia (Hgb \<=7)
Risk-adapted Screening in First-degree Relatives of Patients With Colorectal Cancer

BACKGROUND: First-degree relatives of patients with colorectal cancer are at increased risk for colorectal cancer as well. Nevertheless, participation in the German national screening program stagnates at 2-3 percent per year even in this high-risk population.

AIM: The study is aimed to increase the portion of the first-degree relatives on 50% which take up a preventive colonoscopy.

METHODS: Cluster-randomized controlled multi-center trial. Study sites (clusters) are mainly certified cancer centers and office-based gastroenterologists from all over Germany. Index-patients with colorectal cancer of different stages are asked to hand over the study material to their relatives, consisting of an invitation to a nurse-led counseling on preventive colonoscopy and an one-to-one appointment with a clinical expert of one of the study sites next.


Eligibility Criteria:
Inclusion Criteria:

* aged 18 and over
* being first-degree relatives of patients with diagnosed colorectal cancer
* able to understand German

Exclusion Criteria:

* Familial Adenomatous Polyposis
* utilization of diagnostic colonoscopy within the past 5 years
* being ever treated for colorectal cancer
* actual inflammatory bowl disease
* comorbidities associated with reduced further life expectancy (ECOG performance status \>3
Risk Factors for Anterior Cruciate Ligament (ACL) Injury

The anterior cruciate ligament (ACL) is located inside the knee joint and provides stability to the knee. ACL injuries occur more frequently in women than men; the reason for this is unknown. The purpose of this study is to determine gender-specific anatomical, hormonal, and demographic risk factors for ACL injury. This observational cohort study will only enroll incoming cadets at the U.S. Naval, Air Force, or Military Academies.

Study hypothesis: Human movement factors, including key kinetics and kinematics of the knee during a jump-landing task, are associated with the rate of ACL injury.

The ACL stabilizes the knee joint by preventing the shinbone (tibia) from sliding forward beneath the thighbone (femur). A hard twist or excessive pressure on the ACL can tear or rupture the ligament, resulting in high levels of short-term disability and extensive rehabilitation. Previous data indicate that women who participate in sports or who are otherwise physically active have higher rates of ACL injury than men; the reason for this is unknown. There are four groups of potential risk factors for ACL injury: environmental, anatomical, hormonal, and biomechanical or neuromuscular. In particular, poor technique when landing from a jump (also known as jump-landing) is proposed as a specific neuromuscular risk factor of interest in this study. This study will determine gender-specific anatomical, hormonal, and demographic risk factors for ACL injury, as well as quantify gender-specific differences in jump-landing technique and other neuromuscular risk factors.

This observational cohort study will enroll 4,800 cadets at the three large U.S. military academies; approximately 50% of those enrolled will be women. Only incoming cadets at the U.S. Naval, Air Force, or Military Academies will be able to participate. Each study participant will undergo a baseline assessment that will include measurement of neuromuscular risk factors using motion analysis, strength testing, and standardized assessment of poor jump-landing technique using the Landing Error Score System (LESS). All participants will be followed for up to 4 years. ACL injuries will be prospectively identified; an injury questionnaire is administered to participants who sustain an ACL injury while they are cadets. Otherwise, there is no further contact.

Eligibility Criteria:
Inclusion Criteria:

* Incoming cadet at the U.S. Naval, Air Force, or Military Academies
A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis With Randomized Withdrawal and Retreatment

The purpose of this study is to evaluate the efficacy, safety, and tolerability of guselkumab (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis (scaly skin rash).

This is a randomized (assignment of study drug by chance), double-blind (neither the participant or study staff will know the identity of study drugs), placebo- (inactive substance identical in appearance to study drug) and active-comparator-controlled (use of an approved drug to compare with study drug) study of guselkumab. The active comparator study drug is adalimumab, an approved drug for the treatment of moderate to severe plaque psoriasis. Participants who satisfy all inclusion and exclusion criteria will be randomly assigned in a 2:1:1 ratio to one of three treatment groups (arms): Group I (guselkumab 100 mg dose regimen), Group II (placebo then crossover to guselkumab at Week 16), or Group III (adalimumab at standard psoriasis dosing). From Week 28 up to Week 76, treatment for all participants will be based on their level of response. All participants will receive guselkumab every 8 weeks from Week 76 through Week 252 with a final safety follow-up visit at Week 264 (open label treatment period). The end of the study is defined as the time the last participant completes the Week 264 visit. The total duration of the study will be approximately 268 weeks (includes a 4-week screening period). Participants will be monitored for safety throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of plaque-type psoriasis (with or without psoriatic arthritis) at least 6 months before the first administration of study agent
* Have a Psoriasis Area and Severity Index (PASI) greater than or equal to (\>=) 12 at Screening and at Baseline
* Have an Investigator's Global Assessment (IGA) score \>=3 at Screening and at Baseline
* Have an involved body surface area (BSA) \>=10 percent (%) at Screening and at Baseline
* Must be a candidate for either systemic therapy or phototherapy for psoriasis

Exclusion Criteria:

* Participants with nonplaque forms of psoriasis (for example, erythrodermic, guttate, or pustular) or with current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
* Participants who have ever received guselkumab or adalimumab
* History or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
* Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (for example, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments
* Is pregnant, nursing, or planning a pregnancy (both men and women) within 5 months following the last administration of study drug
Brachial Plexus Nerve Block Versus Fracture Haematoma Block for Closed Reduction of Distal Radius Fracture in Adults - the BLOCK Trial. A National Multicentre Randomised Controlled Trial

The aim of the project is to evaluate the beneficial and harmful effects of a nerve block (plexus brachialis block) for patients with a wrist fracture in need of realignment of fractured bone fragments without cutting the skin, in comparison to standard care.

Every participant will receive one of the following types of anaesthesia for the realignment of the wrist fracture:

1. A nerve block of the arm (plexus brachialis block)
2. The current type of standard anaesthesia at the hospital the participant is treated at


Eligibility Criteria:
Inclusion Criteria:

* Adults (age ≥ 18 years) with a distal radius fracture in need of closed reduction

Exclusion Criteria:

* Patients who would never qualify for surgery according to local guidelines
* Lack of informed consent
* No Danish Central Person Register (CPR) number
* Allergies to the trial medication
* Distal radius fracture initially deemed to require surgery regardless of the outcome of the closed reduction
* Open fractures (fracture-related wound requiring sutures)
* Other fractures on the same extremity ((NOT including distal ulna fracture(s))
* Bilateral distal radius fractures both requiring closed reduction
* Concomitant medical or surgical condition taking priority over the closed reduction of the distal radius fracture.
Comorbidities of Epilepsy

Epilepsy is the second commonest chronic neurological disorder in developed countries, Comorbidity refers to the co-occurrence of two conditions with a greater frequency than found in the general population


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed as primary epilepsy either newly diagnosed or on AEDs
* Aged above 18 years old
* Males and females

Exclusion Criteria:

* Patients diagnosed as secondary epilepsy (post stroke, trauma, tumor, encephalitis, etc).
* Patients diagnosed as epilepsy syndrome
Probiotics After Discharge

The influence of the preterm gut microbiota in health and disease has been well established. However, relatively little is known about how the microbiome changes after discharge and its relationship with growth, health and disease outcomes in the preterm population. This study aims to follow a cohort of preterm infants and explore the relationship of the later microbiome ('after discharge') with later growth and health outcomes in infancy. The study will also explore the effect of timing of stopping routinely administered probiotics on the post-discharge microbiome, infant feeding and outcomes such as colic.

The investigators aim to longitudinally follow 40 infants born before 32 weeks gestation who have also taken part in the investigators microbiome study during their NICU stay (SERVIS REC No: 10/H0908/39) and where microbiomic sampling has been adequately achieved. The investigators will collect stool at and beyond the time of anticipated discharge (beyond 34 weeks) targeted to include pre- and post-weaning, and again at a year. Actual discharge timing of these infants varies, and is usually latest in the most immature infants, allowing an assessment of the influence of physical location (NICU vs home) as well as increasing age. Using 16S ribosomal RNA amplicon analysis, the investigators will assess bacterial colonisation of the gut and measure infant weight, length and head circumference at each time point. The investigators will use a parent questionnaire to assess daily crying time, parents' perceptions of colic severity using a visual analogue scale as well as vomiting and constipation for the two weeks before sampling.


Eligibility Criteria:
Inclusion Criteria:

* \<32 weeks Corrected Gestation
* Followed up in Newcastle Region

Exclusion Criteria:

-
Effects of Dietary Nutrients on Liver and Adipose Tissue Metabolism

In health,adipose tissue stores fat from the diet. If the fat tissue stops storing dietary fat then this increases the chance of it being stored in the liver, which is related to increased risk of heart disease and type 2 diabetes. It has been suggested that having a diet high in sugars or certain fats, may cause the fat tissue and liver to change how they function; we would like to investigate this in detail.

This research aims to investigate how the overconsumption of specific macronutrients may effect adipose tissue and liver metabolism and function. Liver and heart fat content and adipose tissue and liver metabolism fasting and postprandial lipid metabolism will be assessed before and after the specific dietary intervention.

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged ≥18 or ≤65 years.
* Body Mass Index ≥19 ≤35 kg/m2
* No medical condition or relevant drug therapy known to affect liver or adipose tissue metabolism.
* Weight stable for the previous 3 months

Exclusion Criteria:

* Patient is unwilling or unable to give informed consent for participation in the study
* A blood haemoglobin \<135mg/dL for men and \<120mg/dL for women
* Donated (or lost) ≥250 ml of blood in the previous two months.
* On a weight loss diet or have decreased their body weight by \>5% in the previous 3 months.
* Have increased their body weight by \>5% in the previous 3 months.
* Any metabolic condition or relevant drug therapy
* Current smoker
* History of alcoholism or a greater than recommended alcohol intake (\>30 g of alcohol daily for men and \>20 g of alcohol daily for women)
* Haemorrhagic disorders
* Anticoagulant treatment
* History of albumin allergy
* Pregnant or nursing mothers
* Women who are taking any contraceptive agent or device including oral contraceptives, hormone replacement therapy (HRT) or who have used these within the last 12 months
* History of severe claustrophobia
* Presence of metallic implants, pacemaker, or are unwilling to remove any piercings
* History of an eating disorder or any other psychological condition that may affect the participants ability to adhere to study intervention/experimental diets.
Japan Long-term Safety for Tiotropium Plus Olodaterol

The primary objective of this study is to assess the safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC and olodaterol (delivered by the RESPIMAT Inhaler) in Japanese patients with Chronic Obstructive Pulmonary Disease (COPD).


Eligibility Criteria:
Inclusion criteria:

1. Diagnosis of chronic obstructive pulmonary disease.
2. Relatively stable airway obstruction with post FEV1\< 80% predicted normal and post FEV1/FVC \<70%.
3. Male or female Japanese patients, 40 years of age or older.
4. Smoking history of more than 10 pack years.

Exclusion criteria:

1. Significant disease other than COPD
2. Clinically relevant abnormal lab values.
3. History of asthma.
4. Diagnosis of thyrotoxicosis
5. Diagnosis of paroxysmal tachycardia
6. History of myocardial infarction within 1 year of screening visit
7. Unstable or life-threatening cardiac arrhythmia.
8. Hospitalization for heart failure within the past year.
9. Known active tuberculosis.
10. Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
11. History of life-threatening pulmonary obstruction.
12. History of cystic fibrosis.
13. Clinically evident bronchiectasis.
14. History of significant alcohol or drug abuse.
15. Thoracotomy with pulmonary resection
16. Oral ß-adrenergics.
17. Oral corticosteroid medication at unstable doses
18. Regular use of daytime oxygen therapy for more than one hour per day
19. Pulmonary rehabilitation program in the six weeks prior to the screening visit
20. Investigational drug within one month or six half lives (whichever is greater) prior to screening visit
21. Known hypersensitivity to ß-adrenergic drugs, anticholinergics, BAC, EDTA
22. Pregnant or nursing women.
23. Women of childbearing potential not using a highly effective method of birth control
24. Patients who are unable to comply with pulmonary medication restrictions
25. Patients with narrow-angle glaucoma or micturition disorder due to prostatic hyperplasia etc.