cyrilzakka/clinical-trials huggingface dataset:
A Study to Show That the Change of Attention Measure is Correlated With the Changes of Caregiver's Burden After Treatment With Galantamine in Patients With Alzheimer's Disease

The purpose of this study is to demonstrate that the change of attention measure is correlated with the changes of caregiver's burden after treatment with galantamine.

This is an open-label (all people know the identity of the intervention), prospective (in which the participants are first identified and then followed forward as time passes), observational (study in which the investigators/ physicians observe the patients and measure their outcomes), multi-center (study conducted at multiple sites) study. The study mainly consists of 2 phases including, the screening phase (14 days before administration of study medication) and treatment phase (16 weeks). In the treatment phase, patients will receive galantamine 8 mg/day for the first 4 weeks and later on the dose will be increased up to 24mg (if tolerable). Safety evaluations will include assessment of adverse events. The total duration of the study will be 18 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Alzheimer's disease according to the criteria of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), National Institute of Neurological and Communicative Diseases and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA)
* Measuring standard: K-MMSE is 10 to 24
* Patient with reliable Guardian

Exclusion Criteria:

* Patients with brain tumor, nerve syphilis, meningitis, encephalitis, epilepsy
* Major psychiatric patients such as major depression and schizophrenia
* Patients with treatment-resistant gastric and peptic ulcer
* Patients with clinically serious hepatic, renal, lung, endocrinal or metabolic disease (thyroid, parathyroid, pituitary, renal failure, diabetes mellitus)
The Effect of Vodcasting on Listening Comprehension

Improvement of the internet and its tremendous growth has caused significant progress in transformation of information. Nowadays in any place of the world and in any time of the day by accessing through internet every student can use different kinds of information in World Wide Web which let him to make the best decision what, how and when to study. One of these educational technologies which are beneficial to learners is vodcast or video recording which are accessible through the internet.This paper is going to examine the listening comprehension in EFL learners and whether it may be improved by using vodcasts. So106 language learners of four different classes of Iranian higher intermediate in an English institute were chosen for this study. These learners were pre-tested by IELTS Listening Comprehension. Two classes were chosen as subject group which consisted of 54 learners. The remaining two classes were chosen as control group which consisted of 52 learners. Both groups were taught Listening Impact book, but students in subject group were provided some vodcasts based on the topic of their lessons. After 12 weeks of teaching both groups were post-tested.listening comprehension will be compared using independent t-test and paired t-test.


Eligibility Criteria:
Inclusion Criteria:

* EFL learner
* upper intermediate level

Exclusion Criteria:

* Other levels
Metabolism of Isotonic Versus Hypotonic Maintenance Solutions in Fasting Healthy Adults

The prescription of intravenous maintenance solutions - although widespread - lacks important data on the optimal sodium and potassium content, which has given rise to an important debate in the scientific literature. Our study compares two different infusion fluids in 12 healthy adult volunteers without renal failure in a single-blind randomized crossover design over two 48 hour periods during which subjects are not allowed to eat or drink. Fluid 1 is a premixed solution containing 54 mmol/L of sodium and 26 mmol/L of potassium; fluid 2 is sodium chloride 0.9% in glucose 5% with 40 mmol/L of potassium. Both solutions are administered at 25 mL/kg of ideal body weight, as recommended by current guidelines (NICE 174) and both solutions are widely used in daily clinical practice. The primary hypothesis is that isotonic maintenance solutions lead to more fluid retention than hypotonic fluids. Metabolism of both solutions is assessed by sequential analysis of urine and serum, clinical parameters and bioelectrical impedance analysis.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults, 18-70 years of age
* BMI 17-45 kg/m².
* Creatinine clearance \>60 ml/min (according to eGFR CKD-EPI formula).

Exclusion Criteria:

* Acute medical illness within 3 weeks of first study period
* Chronic medication: under diuretic therapy or other chronic medication that interfere with urine output or induce urine retention. All chronic medication should be declared before being enrolled in the study.
* Medical history:

  * cardiac failure,
  * malnourishment,
  * diabetes mellitus,
  * urological disease preventing spontaneous or complete emptying of the bladder,
* any medical or non-medical issue preventing complaint-free fasting for 48 hours (e.g. active peptic ulcer, psychosis, substance abuse...)
* Pregnancy
Body Mass Index, Academic Stress and Musculoskeletal Disorders Relationships

\[Purpose\] To investigate the prevalence of musculoskeletal disorders among healthy students of Ahlia University and to determine the relationship between the prevalence of musculoskeletal disorders and academic stressors and body mass index. \[Subjects and Methods\]: Self-administered questionnaires were distributed to 94 students aged 18-26 years who were enrolled at various Ahlia University colleges and met other inclusion criteria. The students responded to the standardized Nordic musculoskeletal questionnaire and the modified College Student Stress Inventory regarding musculoskeletal symptoms and academic stressors. Height and weight measurements were also obtained to determine body mass index.

Keywords: Body mass index, Academic stress, Musculoskeletal disorders

\[Purpose\] To investigate the prevalence of musculoskeletal disorders among healthy students of Ahlia University and to determine the relationship between the prevalence of musculoskeletal disorders and academic stressors and body mass index. \[Subjects and Methods\]: Self-administered questionnaires were distributed to 94 students aged 18-26 years who were enrolled at various Ahlia University colleges and met other inclusion criteria. The students responded to the standardized Nordic musculoskeletal questionnaire and the modified College Student Stress Inventory regarding musculoskeletal symptoms and academic stressors. Height and weight measurements were also obtained to determine body mass index.

Keywords: Body mass index, Academic stress, Musculoskeletal disorders

Eligibility Criteria:
Inclusion Criteria:

* A total of 28 male and 66 female students (age, 18-26 years; mean, 21 ± 1.9 years) from various Ahlia University colleges were recruited to participate in this study.
* To be included in the study, all subjects had to be enrolled in an undergraduate program at Ahlia University, Bahrain.
* In addition, they had to be relatively healthy with no diagnosed medical conditions that would cause pain.

Exclusion Criteria:

* Exclusion criteria were previous injury or trauma to body parts, any surgical intervention, history of psychological disorders prior to enrolment at the university, and severe physical disability causing pain.
* In addition, students with blood disorders, such as sickle cell anaemia and thalassaemia, were excluded.
A Phase 3 Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis

A phase 3, randomized, placebo-controlled, double-blind study of TS-172 in hyperphosphatemia


Eligibility Criteria:
Inclusion Criteria:

1. Hyperphosphatemia patients (outpatients) with chronic kidney disease receiving hemodialysis (HD or HDF) 3 times a week for at least 12 weeks prior to Visit 1 (Week -4)
2. Patients aged \>=18 years at the time of obtaining informed consent
3. Patients with a serum phosphorus concentration of \>= 3.5 mg/dL and \< 5.5 mg/dL at Visit 1 (Week -4)
4. Patients whose serum phosphorus concentration at Visit 3 (Week -2) or Visit 4 (Week -1) has increased by at least 1.0 mg/dL compared with the value at Visit 1 (Week -4) and is \>= 5.5 mg/dL and \< 10.0 mg/dL.

Exclusion Criteria:

1. Patients with confirmed serum intact PTH concentration \>500 pg/mL from Visit 1 (Week -4) to Visit 5 (Week 0)
2. Patients with serum phosphorus concentration \>= 10.0 mg/dL from Visit 2 (Week -3) to Visit 4 (Week -1)
3. Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)
Clinical Characteristics of People With Long-term Type 1 Diabetes

Type 1 diabetes (T1D) is characterized by absolute insulin deficiency. Although the discovery and application of exogenous insulin has prolonged the lifespan of T1D patients, the chronic diabetic complications caused by long-term poor glycemic control will still reduce patients' quality of life and the overall life expectancy. According to the studies focused on long-term T1D, part of the patients with long disease duration showed resistance to microvascular complications, and several protective factors have been identified. The prevalence of T1D in China is extremely low compared to that in the western world, and little is known about the characteristics of patients with long-term T1D in China. Therefore, this study is designed to collect variable clinical and laboratory features of patients with long-term T1D, explore the risk and protective factors for the development of microvascular complications, and provide reference for the prediction and prevention of these complications.

This is a single-center, prospective, observational study. The investigators propose to enroll 400 patients with type 1 diabetes (T1D) ≥10 years. The patients will be followed up annually for 3 years.

In order to ensure high quality data, two staff are responsible for the input of original data into the database to check and confirm the accuracy. When the data entered by two people is inconsistent, the auxiliary staff decides which data to use.

Missing data will be filled in with the multiple imputation method. The regression analysis will be used to explore the risk and protective factors for the development and progression of microvascular complications.

Eligibility Criteria:
Inclusion Criteria:

* Individuals diagnosed with type 1 diabetes(T1D) according to the 1999 World Health Organization report
* Insulin dependence from disease onset
* with T1D duration of ≥10 years
* able to understand the procedures and methods of this study, voluntarily participate in the study, and agree to sign the informed consent form

Exclusion Criteria:

* patients with type 2 diabetes, gestational diabetes, or specific types of diabetes
* patients with mental disability or have any other condition or disease that may hamper compliance with the protocol
A Study on the Peripheral Blood in Patients With Acute Coronary Syndrome

The goal of this study is to conduct analyses the changes of cell growth factors, inflammatory factors, metabolites, plasma proteome, etc. in the blood of patients with ACS (acute coronary syndrome), as well as their correlations with the disease prognosis, based on multi-omics or other related research methods. The main questions it aims to answer are:

The growth factors that have significant changes in the peripheral blood of the ACS population, especially fibroblast growth factors? Inflammatory factors and chemokines related to the onset of ACS? The metabolites and proteins that are significantly altered in the peripheral blood after the onset of ACS? Researchers will compare ACS population to control group (patients without coronary artery stenosis, valvular heart disease, structural heart disease, or any other kind of cardiomyopathy).

The peripheral venous blood from the participants will be collected within 24 hours after their admission to the hospital.


Eligibility Criteria:
Inclusion Criteria:

For ACS group STEMI

* cTn\>99th ULN or CK-MB\>99th ULN
* ST-segment elevation with a convex upward morphology
* in conjunction with one or more of the following conditions: persistent ischemic chest pain; echocardiographic evidence of abnormal segmental ventricular wall motion; or abnormal coronary angiography findings.

NSTEMI

* cTn\>99th ULN or CK-MB\>99th ULN
* accompanied by one or more of the following situations: persistent ischemic chest pain; new ST-segment depression or low and inverted T waves; echocardiography showing segmental ventricular wall motion abnormalities; abnormal coronary angiography.

UA

* cTn normal
* ischemic chest pain with an electrocardiogram showing transient ST-segment depression or flattened and inverted T waves
* evidence of coronary artery stenosis (e.g., CTA demonstrating ≥ 50% stenosis) For control gourp
* Patients without coronary artery stenosis, valvular heart disease, structural heart disease, or any other kind of cardiomyopathy

Exclusion Criteria:

* Lactating or pregnant women
* Patients with malignant neoplasms
* Severe hepatic/renal dysfunction
* Severe hematological disorders
* Autoimmune diseases
Measuring the Impact of Real Time fMRI Neurofeedback in Borderline Personality Disorder

This study will test the impacts of real time fMRI neurofeedback in patients with Borderline Personality Disorder. This is a pilot study in a small number of people enrolled in clinical programs at Yale New Haven Hospital.


Eligibility Criteria:
Inclusion Criteria:

1. enrolled in YNHH DBT-IOP
2. must meet specific clinical criteria
3. Inclusion in Experimental group requires participants meet standard safety and quality control requirements for MR scanning
4. For female participants, not pregnant and willing to use a reliable method of contraception during the study

Exclusion Criteria:

1. IQ\<70
2. vision problem not able to be corrected to normal range
3. medication changes w/in one month
4. Lifetime hx of schizophrenia, schizoaffective d/o, bipolar I disorder.
5. illicit substance use within 7 days of MRI scans
6. taking scheduled opiates
7. taking scheduled benzodiazepines
8. taking scheduled anti-histamines
9. history of seizures
10. significant current or past neurologic illness
11. BMI \< 16.5
Alar Batten Graft vs Latera for Nasal Valve Collapse

Nasal obstruction is a common complaint for the patient presenting to the Otolaryngologist and/or the Facial Plastic surgeon. There are numerous potential causes of nasal obstruction, with more easily addressed pathologies such as posterior septal deviation and inferior turbinate hypertrophy often being over-diagnosed. Nasal valve obstruction, particularly dynamic nasal sidewall collapse, is of significant interest to the rhinoplasty surgeon. Traditionally, collapse of the nasal sidewall has been addressed via structural cartilage grafting, with alar batten grafting being the most commonly used method to provide support to the weak nasal sidewall. Recently, an absorbable nasal implant, comprised of a polylactic acid copolymer, has been advocated for supporting the nasal sidewall and relieving nasal obstruction. There are several proposed advantages of the implant over traditional operative techniques, namely the ease of endonasal insertion, which can be performed in the outpatient clinic setting. Preliminary investigations demonstrate subjective improvement in nasal obstruction with use of the implant, however, there has been no direct comparison with traditional techniques utilizing cartilage grafting.

This study is being done at both UVa and in Oregon. This prospective study will randomize patients with nasal obstruction and documented dynamic nasal sidewall collapse into one of two groups undergoing treatment with either endonasal batten grafting or the absorbable Latera nasal valve implant. Preoperative and postoperative nasal obstruction will be assessed with a validated survey for nasal obstructive symptoms, the Nasal Obstruction Symptom Evaluation (NOSE) score. The mean preoperative and postoperative NOSE score between the groups will be compared at 1, 6, 12, and 24 months post-operatively to compare the efficacy of both techniques. Subjects will be blinded to the surgical intervention they receive.


Eligibility Criteria:
Inclusion Criteria:

* Documented physical exam findings of septal deviation
* Bilateral nasal sidewall collapse on inspiration
* Subjective improvement in nasal obstruction with use of the modified Cottle maneuver

Exclusion Criteria:

* Prior septorhinoplasty
* Obvious trauma to the nose causing nasal obstruction
* Inflammatory conditions such as chronic rhinosinusitis with nasal polyposis
* Patients using chronic topical nasal decongestants or illicit intranasal drug use
* Prisoners, cognitively impaired, non-English speaking subjects
Comparison of Two Implant Prosthetic Pathways

To assess and compare the esthetic outcome and clinical performance of anterior maxillary all ceramic implant single crowns based either on prefabricated zirconia abutment veneered with pressed ceramics or on a CAD/CAM (computer-aided design and computer-aided manufacturing) CARES® abutment veneered with hand build-up technique.

Participants will be recruited from the patient population who has previously received dental implant treatment, received a provisional restoration and met the inclusion and exclusion criteria according to the study protocol. After final impression, patients will be randomised into Group A (prefabricated anatomic abutments ): one-piece screw retained single crown using a press technique (fluorapatite glass-ceramic, e.max ZirPress) with cut-back technique or Group B (CAD/CAM CARES® abutments): one- piece screw retained single crown with a hand build-up technique (fluorapatite veneering ceramic, e.max Ceram). One week after final restoration (base line visit) the primary and secondary outcome parameters will be assessed. The patients will be followed up to 5 years after final restoration.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must have voluntarily signed the informed consent form before any study-related action
2. Males and females with at least 18 years of age
3. Single tooth gaps in the anterior maxilla position 14-24 (FDI)
4. Successfully osseointegrated single tooth implant inserted at least 16 weeks after tooth extraction
5. Full mouth plaque index according to O'Leary ≤ 25%
6. Implant axis compatible with transocclusal screw retention (screw access palatal of incisal edges)

Exclusion Criteria:

1. Systemic disease that would interfere with dental implant therapy
2. Any contraindications for oral surgical procedures
3. History of local irradiation therapy
4. Patients who smoke \>10 cigarettes per day or tobacco equivalents or chew tobacco
5. Subjects who had undergone administration of any investigational device within 30 days of enrolment in the study
6. Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance
7. Physical or mental handicaps that would interfere with the ability to perform adequate oral hygiene
8. Pregnant or breastfeeding women
9. Existing implants in the adjacent position
10. Removable dentures or un-restored tooth gaps in the opposing dentition
11. Patients with inadequate oral hygiene or unmotivated for adequate home care
12. Probing pocket depth of ≥ 4 mm on one of the teeth immediately adjacent to the dental implant site
13. Lack of primary stability of the implant
14. Inappropriate implant position for the prosthetic requirements
15. Major simultaneous augmentation procedures
16. Insufficient stability of the implant
17. Screw access position located too close to the planned incisal edge
18. Need of angled abutment due to prosthetic malposition of the implant
19. Height of the abutment is less than 65% of the height of the complete restoration
20. Severe bruxing or clenching habits
Static vs. Articulating Antibiotic Spacer for Periprosthetic Joint Infection in Total Knee Arthroplasty

The primary aim of the study is to compare two techniques for treatment of total knee infection: resection total knee arthroplasty with an articulating (motion in the joint) spacer and resection total knee arthroplasty with a static (no motion in the joint) spacer.


Eligibility Criteria:
Inclusion Criteria

1. Male or female age 18 to 100 years of age.
2. Preoperative diagnosis of bacterial infection by culture which would include a preoperative aspiration and at least three intraoperative cultures. The preoperative aspiration would also be sent for a cell count with differential. All patients would have an erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) drawn in the preoperative phase. Patients with a negative preoperative aspiration, but an actively draining wound or draining sinus tract, would be considered as infected. Intraoperative histopathology would also be obtained in all cases of infected total knee replacement at the time of the resection.
3. Intact extensor mechanism.
4. Adequate soft tissue envelope (no requirement for soft tissue coverage such as a muscle flap or skin graft)
5. Adequate bone stock for knee reconstruction
6. Medical fitness for staged knee reconstruction

Exclusion Criteria

1. Known Atypical infection (mycobacterial or fungal)
2. Extensor mechanism disruption
3. Inadequate soft tissue envelope requiring muscle flap or skin grafting
4. Inadequate bone stock (T3 or F3 by the Anderson Orthopaedic Research Institute (AORI) classification)
5. Medical status precluding staged knee reconstruction
6. Requirement for hinged knee reconstruction at the time of reimplantation
7. Pregnant women - for women of child bearing age, a negative pregnancy test will be needed prior to enrollment to the study.