cyrilzakka/clinical-trials huggingface dataset:
Progression of Prodromal Markers of α-synucleinopathy Neurodegeneration in the FDRs of Patients With RBD

This study is a prospective study with a mean of 5-year follow-up interval, aims to monitor the progression of α-synucleinopathy neurodegeneration by the evolution of prodromal markers and development of clinical disorders in first-degree relatives (FDRs) of idiopathic REM Sleep Behavior Disorder (RBD) patients and healthy controls.

Idiopathic RBD is implicated as an integral part of progression of α-synucleinopathy neurodegeneration, and patients with idiopathic RBD have increased prevalence of non-motor symptoms (or prodromal markers) closely related to Parkinson's disease(PD). Moreover, the investigator's previous studies have further confirmed the familial aggregation of RBD, and first-degree relatives (FDRs) of RBD patients had more prodromal markers of Parkinson's disease compared with FDRs of healthy controls.

In these regards, current prospective study aims to map the progression and evolution of prodromal markers (including autonomic dysfunction, olfactory loss, color vision impairment, neurocognitive impairment, neuroimaging of dopamine dysfunction, daytime sleepiness and psychiatric disorders), onset of RBD, and neurodegenerative diseases. Finally, other markers, such as physical activity and circadian rhythm and tonic electromyography (EMG) activity level, which have been found to be reliably associated with Parkinson's disease or other neurodegenerative diseases. In this regard, it is also interesting to investigate whether these indicators will additionally predict the progression of prodromal markers of PD.

Eligibility Criteria:
Inclusion Criteria:

1. Chinese aged 40 or above;
2. Being capable of giving informed consent for participation of the study;
3. Sex-matched.

Exclusion Criteria:

1. Younger than 40 years old (as the supposed neurodegenerative process may not have occurred);
2. Not capable of giving informed consent for participation of the study.
The Biomarker and Cardiac Function in Sepsis

The development and severity of sepsis induced myocardial dysfunction can be monitored from the serum biomarker.


Eligibility Criteria:
Inclusion Criteria:

* Sepsis patients with 2 of the followings when arrival ER and treated \> 6 hours:

  * BT \>38℃ or\<36℃
  * HR \>90/min
  * RR \>20/min or PaCO2 \< 32 mmHg
  * WBC count \>12×109/L or \<4×109/L or immature form \>10％

Exclusion Criteria:

* Age \< 18
* Major trauma patients
* Pregnancy
* Willing to do not aggressive treatment
360 Degree Expanded Diaphragm Exercises in Women With Stress Urinary Incontinence

This study was planned to examine and compare the effects of standard diaphragm exercises with Pelvic floor muscle exercises (PFME) and 360-degree expanded diaphragm exercises with PFME on urinary symptoms, PFM functions and quality of life in women with stress urinary incontinence.


Eligibility Criteria:
Inclusion Criteria:

* Being a woman,
* Participating in the research voluntarily,
* Being between the ages of 18-62,
* Ability to read and write Turkish,
* Not having any mental problems that would prevent cooperation and understanding,
* Having a complaint of stress urinary incontinence or stress-predominant mixed urinary incontinence.

Exclusion Criteria:

* Having received pelvic floor training before,
* Having a neurological disease,
* Pelvic organ prolapse stage is stage 2 or higher,
* Having fecal incontinence,
* Being pregnant,
* Lower extremity problems that may affect the pelvic structure (conditions such as lower extremity inequality, total hip arthroplasty)
* Having an active lower urinary tract infection,
* Having respiratory system diseases such as chronic obstructive pulmonary disease and asthma,
* Having undergone hysterectomy surgery.
Adjuvant Therapy With Neratinib in HER2 Positive Early Breast Cancer

Human epidermal growth factor receptor 2 (HER2) positive breast cancer is a molecular subtype with high malignancy and high risk to recurrence and metastasis. After the appearance of anti-HER2 targeted drugs, the prognosis and survival of these patients were greatly improved. In addition to trastuzumab and pertuzumab, the use of tyrosine kinase inhibitor (TKI) can further improve the survival. The evidence of previous adjuvant TKI anti-HER2 therapy was mainly from ExteNET study. However, due to the limitations of the times, ExteNET research is based on the background of only trastuzumab targeted therapy. Nowadays, there is no evidence that trastuzumab combined patuzumab,use of T-DM1, followed by sequential neratinib can still obtain absolute benefits. Therefore, there is no standard for the use of neratinib in current clinical practice. Investigators want to explore, in the real world, the efficacy and safety of sequential use of naratinib in adjuvant therapy.

Investigators retrospectively recuited patients with early HER2 positive breast cancer treated in Peking University People's Hospital center from January 1, 2019 to November 31, 2024, and prospectively recruit same patients from December 1, 2024 to December 31, 2028. To compare the efficacy and safety of sequential use of neratinib.

Inclusion Criteria:

1. Patients with HER2 positive breast cancer who were diagnosed by core needle biopsy/operation in Peking University People's hospital;
2. The patients were treated in Peking University People's Hospital and underwent radical resection with hospitalization records;
3. Received standard anti-HER2 neoadjuvant/adjuvant therapy (trastuzumab, trastuzumab combined with pertuzumab, T-DM1)
4. Has signed and agreed to participate in the PKUPH breast disease cohort study.

Exclusion Criteria:

1. Lack of clinical and pathological data (such as imaging data and pathological data);
2. Patients with metastatic breast cancer or bilateral breast cancer;
3. Failure to perform radical surgery

patients recieved Neratinib for 1 year or not.

Primary end point: 5-year invasive dieased free survival

Eligibility Criteria:
Inclusion Criteria:

* 1) Patients with HER2 positive breast cancer who were diagnosed by core needle biopsy/operation in Peking University People's hospital;
* 2) The patients were treated in our hospital and underwent radical resection with hospitalization records;
* 3) Received standard anti-HER2 neoadjuvant/adjuvant therapy (trastuzumab, trastuzumab combined with pertuzumab, T-DM1)
* 4) Has signed and agreed to participate in the PKUPH breast disease cohort study.

Exclusion Criteria:

* 1) Lack of clinical and pathological data (such as imaging data and pathological data);
* 2) Patients with metastatic breast cancer or bilateral breast cancer;
* 3) Failure to perform radical surgery
Evaluation of the Nucleus Hybrid™ L24 Cochlear Implant System

The purpose of this study is to evaluate the safety and efficacy associated with the provision of acoustic and electric sound processing to individuals who demonstrate significant residual low-frequency hearing and profound high-frequency (above 1500 Hz) sensorineural hearing loss. Delivery of acoustic-electric stimulation will be provided by the Nucleus Hybrid L24 cochlear implant system.


Eligibility Criteria:
Inclusion Criteria:

1. Eighteen years of age or older at the time of implantation.
2. Severe to profound (a threshold average of 2000, 3000, \& 4000 Hz \> 75dB HL) sensorineural hearing loss for frequencies \> 1500 Hz. Low-frequency thresholds up to and including 500 Hz should be no poorer than 60 dB HL.
3. Consonant Nucleus Consonant (CNC) monosyllabic word recognition score (mean of two lists) between 10% and 60%, inclusive (i.e., 10% \<= score \<= 60%), in the ear to be implanted.
4. CNC word recognition score in the contralateral ear equal to, or better than, the ear to be implanted but not more than 80%.
5. English spoken as a primary language.

Exclusion Criteria:

1. Duration of severe-to-profound hearing loss greater than 30 years.
2. Congenital hearing loss (for the purpose of this study, onset prior to 2 years-of-age).
3. Medical or psychological conditions that contraindicate undergoing surgery.
4. Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array.
5. Conductive overlay of 15 dB or greater at two or more frequencies, in the range 250 to 1000 Hz.
6. Hearing loss of neural or central origin.
7. Diagnosis of Auditory Neuropathy.
8. Active middle-ear infection.
9. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices.
10. Unwillingness or inability of the candidate to comply with all investigational requirements.
11. Additional handicaps that would prevent or restrict participation in the audiological evaluations.
Optimizing Propofol in Obese Patients

An accurate dosage of anesthetics during surgery is important. Usually this is achieved through close observation of the patient, but a new monitor (CSM-monitor) can measure the level of anesthesia more closely.

In obese patients dosage of drugs is difficult due to the change in body composition. The CSM-monitor may provide a more accurate dosage of propofol (an anesthetic agent) during surgery, and as a consequence of that, also reduce the postoperative need for analgesics.

Main objective: To optimise propofol dosing in obese patients undergoing hysterectomy.

Main hypothesis: Monitoring the depth of anesthesia using the CSM-monitor reduces time to opening eyes in obese patients after hysterectomy in propofol anesthesia.

Secondary hypotheses: CSM-monitoring reduce propofol dose in obese patients undergoing hysterectomy. Patients with a high CSM-level during hysterectomy have higher postoperative consumption of analgesics. Supplementary, an algorithm for the dose of propofol that most frequently results in a CSM-level between 40 and 60 is calculated.


Eligibility Criteria:
Inclusion Criteria:

* Elective abdominal non-laparoscopic hysterectomy
* Age \> 18 years
* ASA physical status I-III
* Body Mass Index 30 or above

Exclusion Criteria:

* Allergic towards propofol
* Daily consumption of benzodiazepines (more than at nighttime), opioids or amphetamine preoperatively.
* Disease with expected EEG-abnormality or impaired auditory function: Epilepsy, deafness, previous neurosurgery, previous or actual neurologic disease with neurologic deficit.
Botulinum Toxin and Mesotherapy on Enhancement of Facial Scarring

Most of the body's tissues can undergo wound repair following a disruption of tissue integrity. Upon healing, these wounds result in scar formation. The scars widen when the overlying musculature pulls apart suture lines. Botulinum Toxin A (BTA) is known to prevent fibroblast proliferation and it also induces temporary muscle paralysis. Also, mesotherapy is the non-invasive transdermal injection which can aid the skin to increase collagen and elastin production. Thus, both techniques are eligible for enhancement of facial scars.


Eligibility Criteria:
Inclusion Criteria:

* Patient suffering from vertical or oblique forehead lacerations caused by trauma.
* Recent and fresh wounds.
* Atrophic scar (linear scar).

Exclusion Criteria:

* Infected wound.
* Patient on chemotherapy treatment and history of malignancy.
* Patients suffering from burns on the forehead or complicated lacerations.
* Allergy to drugs used in this study
Particle Sizing of Masticated Tree Nuts - Cashews and Walnuts

The investigators want to understand how oral processing (chewing) of nuts affects particle size and the presence of lipid (fat) on the cut surfaces.

The main objective of the study is to:

Measure the size of nut particles that have been chewed sufficiently to be swallowed.

The secondary objective of this study is to:

Measure any changes in lipid content due to chewing and compare it to a prediction from a theoretical model.

The investigators have developed a theoretical model for determining the release of nutrients from plant foods, specifically lipid (fat) from almonds. The model has been used to calculate the amount of lipid released from chewed almonds. The model shows that only about 10% of the lipid is immediately released. The investigators require information on the particle size distribution (number of particles of each size) for other chewed nuts to calculate the amount of lipid released for other nuts. This will allow us to check the validity of our model for other foods.


Eligibility Criteria:
Inclusion Criteria:

* Must be generally healthy
* Must have eaten nuts within the last month with no adverse effects

Exclusion Criteria:

* Must not be allergic to nuts of any kind
* Must not have any teeth missing (apart from unerupted wisdom teeth)
* Must not have bleeding gums
* Must not have had dental treatment (other than checkups) in the last 3 months
* Must not be currently suffering from any infectious disease that may be passed on via saliva e.g. Glandular fever, flu
The Experience of Affective Touch in Anorexia Nervosa

The aim of the present research will be to verify if the pleasantness of affective touch is comparable between women with AN and healthy women while measuring the level of social anhedonia and the lifespan experience of affective touch.


Eligibility Criteria:
Inclusion criteria:

* Right-handed
* diagnosis of restricting type or binge-eating/purging type AN, according to the Diagnostic and Statistical Manual of Mental Disorders (5th Edition)'s criteria (DSM, American Psychiatric Association, 2013).

Exclusion Criteria:

* Concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders
* Evidence of any skin-related condition possibly affecting sensitivity on the participants' forearm (e.g., eczema, scars).
Comparative Study Between Two Physiotherapy Protocols Conventional X Accelerated in Individuals Undergoing Reconstruction of the Anterior Cruciate Ligament.

The accelerated rehabilitation and early return does not seem to be harmful, but still needs further research to define the rehabilitation time is what shows Kruse and collaborators (2012) in their study of systematic review. The surgical treatment of anterior cruciate ligament injury is the gold standard in the treatment of these injuries in young and active, the postoperative rehabilitation is extensive and full return to sport occurs only after 6 months postoperatively. Based on this gap, the investigators seek to draw properly through our study methods and more complex techniques, that comparing two rehabilitation programs can achieve high precision early rehabilitation. This will include 32 athletes who had complete ACL rupture confirmed by MRI and underwent ACL reconstruction using patellar tendon.All subjects will be followed from the pre-surgery, the fourth and sixth month after surgery with: KT1000 measures the ligamentous laxity, knee function by applying the International Knee Documentation Committee (IKDC 2000); Isokinetic Muscle Strength (Cybex). Through a random draw of sealed envelopes, patients will be allocated in their rehabilitation groups: Accelerated (4 months) or Conventional (6 months). Preoperatively, fourth and sixth month after surgery will be an assessment of laxity by (KT1000), Muscular Strength (CYBEX) and knee function affected by IKDC (2000) and Hop Test. The assessor and the patients were blinded to treatment group. This study will have the locus Institute of Orthopaedics and Traumatology, School of Medicine, São Paulo. The comparative results of the two groups are analyzed using specific statistical tests to prove an improved significative without damaging the integrity of the graft.

All subjects will be followed for a period of six months. During this period will undergo three stages of evaluation.

1. º Preoperative up to two years following injury : assessment will consist KT1000 measures the ligamentous laxity, knee function by applying the International Knee Documentation Committee (IKDC 2000); Hop Test (jumps with one leg); Isokinetic Muscle Strength (Cybex).
2. º 4º months pós-surgery KT1000, International Knee Documentation Committee (IKDC 2000); Hop Test; Isokinetic Muscle Strength (Cybex)
3. º 6º months postoperatively KT1000, International Knee Documentation Committee (IKDC) + Hop Test; Isokinetic Muscle Strength (Cybex)

Eligibility Criteria:
Inclusion Criteria:

* With diagnosis of injury (primary) anterior cruciate ligament confirmed by magnetic resonance may or may not be associated with a meniscal injury or partial ligament medial collateral ligament (MCL) surgery is not indicated.
* Patients undergo surgery for anterior cruciate ligament reconstruction using patellar tendon.

Exclusion Criteria:

* Patients who had changes in diagnosis during surgery.
* Surgical complications
* Patients with More than 30% of lack or abandon physiotherapy.
LUng and Cardiac Ultrasound for REspiratory Distress in ElDerly

Prospective trial to evaluate the impact on the initial therapeutic inadequacy of a management strategy for acute dyspnea in the elderly based on the use of lung and cardiac ultrasonography.

Acute dyspnea is a frequent and serious reason of admission in Emergency Department (ED), with a one-month mortality close to 16%. It is difficult to diagnose in the initial assessment phase since the cause of this symptom can vary (cardiological, pulmonary, infectious, etc.) and the symptoms can be misleading. This difficulty in diagnosing delays the implementation of appropriate therapeutic management even as the timeliness of management is associated with a reduction in mortality. These issues are particularly important in the elderly.

Lung and cardiac ultrasonography performed by the emergency physician, immediately available at the patient's bedside, could reduce the diagnostic and therefore therapeutic delay.

However, the impact of a diagnostic strategy based on lung and cardiac ultrasonography in dyspneic elderly subjects has not been evaluated.

Patients will be randomized in two groups : "standard of care" or "clinical ultrasound" group. Treatments initiated in Emergency Department (ED) will be noted to be compared to final diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 65 years of age
* admitted to Emergency Department for acute dyspnea as chief complaint (defined as: sensation of shortness of breath progressing for less than 2 weeks) with objective signs of respiratory distress (Polypnea ≥ 22 breaths/min and SpO2 ≤ 92% on room air)
* consent to participate in the study or, failing that, a close relative or trusted support person, with the possibility of inclusion via the emergency procedure and the collection of informed consent a posteriori

Exclusion Criteria:

* patient identified at end of life
* patient already included
Glycemic Gap Versus Admission Plasma Glucose Level As Predictors of ICU Out Comes in Type 2 Diabetic Patients With Acute Heart Failure

assess the relation between glycemic gab and adverse clinical outcomes in diabetic patients who hospitalized with heart failure

Hyperglycemia is a common problem in patients wi9non-diabetic patients but not in patients with diabetes . The relationship between admission hyperglycemia and mortality in diabetic patients with AHF or critical illness remains controversial . Those discrepancies could be partly attributed to long-term glycemic control in diabetic patients.

Critical illness can induce stress-induced hyperglycemia (SIH), which results from the excess release of counter-regulatory hormones and anti-inflammatory cytokines, leading to augmented gluconeogenesis and insulin resistance.

In diabetic patients with acute illness, the phenomenon of admission hyperglycemia could be connected with acute physiological stress, poorer glycemic controls, or a combination of both . It is necessary to think about background glycemic control when exploring the relationships between admissions Hyperglycemia and clinical outcomes. Recent studies have shown that hemoglobin A1c (HbA1c)-based adjusted glycemic variables, including glycemic gap and stress hyperglycemia ratio, were linked to severity of disease and unfavorable prognosis in diabetic patients with some infectious diseases, cardiovascular diseases and clinical illness

Eligibility Criteria:
Inclusion Criteria:

* All diabetic patients admitted to ICU of internal medicine department from October 2020 to November 2021 by heart failure

Exclusion Criteria:

* Age ≤18 years.

  1. Hypoglycemia (plasma glucose \<70 mg/dL) at initial presentation.
  2. An admission diagnosis of diabetic ketoacidosis or hyperosmolar hyperglycemic state.
  3. Patients with hemoglobin variants (e.g., sickle cell anemia, thalassemia) or with hematologic conditions (e.g., hemolytic anemia) that could interfere with the accuracy of the HbA1c assay.
Reliability of a Proprioception Test in Swimmers

To evaluate the intra- and inter-rater reliability of a test of active shoulder proprioception with a laser pointer in swimming athletes and to describe the profile of the proprioception measures characterizing the sample according to the specialty within the sport and the category of the athletes.

Introduction: Obtaining the reliability of an evaluative instrument is of paramount importance for its applicability in the field of clinical physiotherapy and in the sports field, providing consistent and real measures. Shoulder proprioception assessments have started to appear on the scientific scene in recent years and several tools, methods and protocols are being studied. However, the lack of standardization of protocols and application in different populations produces inconsistencies in the findings, thus hindering the use of these models. Thus, standardizing the application of the test and investigating a population different from what appears in the scientific scenario in relation to sports, such as swimming athletes, seems to be relevant and would contribute to the use of scientific evaluative models in the clinical environment. Objectives: To evaluate the intra- and inter-rater reliability of a test of active shoulder proprioception with a laser pointer in swimming athletes and to describe the profile of the proprioception measures characterizing the sample according to the specialty within the sport and the category of the athletes. Methods: Study of intra- and inter-rater reliability of the shoulder proprioception test with a laser pointer, composed of 48 young male and female swimming athletes, aged between 12 and 20 years. It will be carried out in three stages: (1) Familiarization, (2) Test and (3) Retest, all stages will take place on the same day, and stages 2 and 3 will be performed by two different evaluators. To characterize the sample, descriptive statistics will be used by means of central tendency and variability, for all variables collected. Relative reliability will be tested by the Intraclass Correlation Coefficient (ICC), with a 95% confidence interval. The ICC will be interpreted as values \<0.5 indicate low reliability, between 0.5 and 0.75, moderate reliability, between 0.75 and 0.9, good reliability and values\> 0.90 excellent reliability. And the absolute reliability will be verified by means of the standard error of the measurement (EPM), by values of minimum detectable change (MMD), and the coefficient of variation (CV).

Eligibility Criteria:
Inclusion Criteria:

* Male and female swimming athletes;
* Between 12 and 26 years old;
* Train regularly and be members of swimming teams in the 4th Region of the State of São Paulo, and athletes from the São Paulo Aquatic Federation (FAP),
* Reporting the absence of anemia, inflammatory process, diabetes, cardiovascular disease, episodes of muscle - tendon or osteoarticular injury in the lower, upper and / or spine members in the last three months.

Exclusion Criteria:

* Practice of sports for less than 1 year.
* Use anti-inflammatory and / or analgesic drugs for less than 24 hours before the test.