cyrilzakka/clinical-trials huggingface dataset:
Usability Study of a Neuropsychological Intervention Program Based on Virtual Reality in Adults With Parkinson's Disease

Nowadays, several strategies for treating neuropsychologic function loss in Parkinson disease (PD) have been proposed, such as physical activity performance and developing games to exercise the mind. However, few studies illustrate the incidence of these therapies in neuronal activity. This work aims to study the feasibility of a virtual reality-based program oriented to the cognitive functions' rehabilitation of PD patients. For this, the study was divided in intervention with the program, acquisition of signals, data processing and results analysis.

The study highlights implementing new technologies to rehabilitate people with neurodegenerative diseases.

Nowadays, several strategies for treating neuropsychologic function loss in Parkinson disease (PD) have been proposed, such as physical activity performance and developing games to exercise the mind. However, few studies illustrate the incidence of these therapies in neuronal activity. This work aims to study the feasibility of a virtual reality-based program oriented to the cognitive functions' rehabilitation of PD patients. For this, the study was divided in intervention with the program, acquisition of signals, data processing and results analysis. The alpha and beta bands power behaviour were determined by evaluating the electroencephalography (EEG) signals obtained during the execution of control tests and games of the "Hand Physics Lab" Software, from which five games related to attention, planning, sequencing, concentration, and coordination, were taken.

The study highlights implementing new technologies to rehabilitate people with neurodegenerative diseases.

Eligibility Criteria:
Inclusion Criteria:

* Parkinson Disease (Neurologist diagnosed)
* Both gender
* Informed consent accepted
* Adults
* Stage 2 and 3 in the Hoehn Yahr scale

Exclusion Criteria:

* Mental diseases
* Migraines
* Pregnancy
The Effect of Peer-mentor Support for Older Vulnerable Patients With Ischemic Heart Disease

BACKGROUND: Advanced treatment regimens have reduced cardiovascular mortality resulting in an increasingly older Ischemic Heart Disease (IHD) population in need of cardiac rehabilitation (CR) , the majority (74%) is above 60 years. The positive effect of CR is well established; CR reduces cardiovascular mortality, lowers hospital admissions, and improves quality of life among patients with IHD. These positive effects of CR has also been established among older patients. The inherent problem lies in the low attendance rate, often below 50%. Several studies, including studies from Denmark, have shown that low participation in CR is most prevalent among older, vulnerable and female patients. The notion vulnerable covers patients with low socioeconomic position (SEP), patients with non-western background and patients living alone, as these groups have particularly low CR attendance. Effective interventions aiming at increasing CR attendance among these low attending groups are thus warranted and the current study will seek to address this.

AIM: To test the effect of a peer-mentor intervention among older vulnerable IHD patients.

DESIGN AND METHODS: The study is designed as a two arm RCT-study applying mixed methods.

Power calculations were based upon primary outcome 'Cardiac rehabilitation (CR) attendance'. Proportion attending CR in control group was set at 25% and intervention group at 50% based upon previous research. With a 5% significance level and 80% power. 110 patients were required (55 in each group) to have a 80% chance of detecting, as significant at the 5% level, an increase in the primary outcome measure from 25% in the control group to 50% in the experimental group.

Expected dropout was 6%. I.e., in total 117 patients are enrolled.

Patients (n=117) are recruited by a dedicated research nurse before discharge from the cardiology department at Nordsjællands Hospital and randomized (with 1:1 individual randomisation) to peer-mentor intervention or usual care. Data is collected through both qualitative and quantitative data (mixed methods). Data is collected at three timepoints, baseline, 12 weeks and 24 weeks. The patients (mentees) are matched with peer-mentors. Peer-mentoring (i.e. mentoring by a person with a similar life situation or health problem as one self) is a low-cost intervention that holds the potential to improve CR attendance and improve physical and psychological outcomes among older patients. Peer-mentors are role models who can guide and support patients overcoming barriers of CR attendance. Peer-mentoring is unexplored in a CR setting among older, female and vulnerable IHD patients; establishing the novelty of the current study.


Eligibility Criteria:
Inclusion Criteria:

* ≥65 years and diagnosed with IHD and referred to CR and female or low SEP or single living or non-western background

Exclusion Criteria:

* Patients unable to provide written consent
Signaling Mechanisms and Vascular Function in Diabetes Mellitus

Ruboxistaurin is being tested to see if it is effective in treating certain diabetic complications, such as diseases of the blood vessels.

To test the hypothesis that activation of protein kinase C impairs vascular reactivity in patients with diabetes.

A major cause of death and disability in patients with diabetes mellitus is atherosclerosis. Endothelial dysfunction is an important, if not primary, factor in atherogenesis. Nitric oxide is an important substance made and released by the endothelium. Many prior studies in animals and humans have shown that the ability of the blood vessel to dilate is impaired in diabetes. This process of vasodilation is mediated by a substance, nitric oxide, which is thought to be highly susceptible to destruction by oxidant molecules. In previous studies, we found that acute administration of the antioxidant, vitamin C, improves endothelium-dependent vasodilation in blood vessels of patients with type 1 and type 2 diabetes. This suggests that by scavenging oxidants, such as superoxide, vitamin C may reduce the destruction of nitric oxide and thereby preserve endothelial function. Additional mechanisms, including activation of a substance called protein kinase C, and oxidant stress from excess soluble peroxides may be present in diabetes and interact with oxidant stress to cause endothelial dysfunction in patients with diabetes. Accordingly, we would like to study both of these mechanisms to determine their contribution to endothelial dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with diabetes mellitus will be eligible if they are receiving dietary treatment for hyperglycemia, sulfonylureas, metformin or insulin

Exclusion Criteria:

* Any diabetic subject with a HgbA1C level of \<7% or \>11%
* Evidence of atherosclerosis
* symptoms of angina
* symptoms of claudication
* symptoms of cerebrovascular ischemia
* findings of arterial occlusive disease, as would be suggested by decreased pulses, asymmetric blood pressure, bruits or reduced limb pressure measurements
* hypertension defined as a systolic blood pressure \> = 150 mmHg and a diastolic blood pressure \>= 95 mmHg; (allowable blood pressure medications for diabetic subjects include calcium channel blockers, alpha and beta adrenergic blockers, and diuretics)
* hypercholesterolemia, defined as total cholesterol levels greater than 75th percentile for age and sex and LDL cholesterol levels \>130mg/dL.
* renal insufficiency (serum creatinine \>1.5 mg/dL for men; \>1.2 mg/dL for women)
* hepatic dysfunction defined as liver enzyme abnormalities \> two times the upper limit of normal
* chronic pulmonary disease
* congestive heart failure
* pregnancy (or subjects planning to become pregnant);
* history of cigarette smoking within the last five years;
* history of clinically significant coronary artery or cerebrovascular disease (defined as MI or stroke within 6 months, or presence of unstable angina)

  * use of any, vasoactive, cardioactive, or non-steroidal anti-inflammatory medications within 24 hours of vascular testing visits
A Clinical Performance of Two Soft Toric Contact Lenses

The study objective was to gather short-term clinical performance data for two soft toric contact lenses.

This participant-masked, non-randomized, controlled non-dispensing study was to compare the performance of two soft toric lenses. Participants attended one study visit which lasted for approximately 1.5 hours.

Eligibility Criteria:
Inclusion Criteria:

* They are of legal age (18) and capacity to volunteer.
* They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
* They are willing and able to follow the protocol.
* They currently wear soft contact lenses, or have done so within the past two years.
* They have ocular astigmatism in both eyes of between 0.75DC and 3.00DC.
* They are expected to be able to be fitted with the study lenses within the power range available.

Exclusion Criteria:

* They have an ocular disorder which would normally contra-indicate contact lens wear.
* They have a systemic disorder which would normally contra-indicate contact lens wear.
* They are using any topical medication such as eye drops or ointment.
* They are aphakic.
* They have had corneal refractive surgery.
* They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
* They are pregnant or lactating.
* They have an eye or health condition including an immunosuppressive or infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction.
* They have taken part in any contact lens or care system clinical research within two weeks prior to starting this study.
Postoperative Pain in Lumbar Disc Surgery

This study included 46 patients who underwent lumbar disc herniation surgery under general anesthesia. After the operation, US-guided ESPB was performed on Group E, and WI was performed on Group W. Postoperative pain was assessed, and the time to first analgesic requirement, total analgesic amount in 24 hours, and side effects were recorded. IBM SPSS Statistics 22 was used for statistical analyses.


Eligibility Criteria:
Inclusion Criteria:

* Anesthesiologists (ASA) physical status I-II

Exclusion Criteria:

* Patients with recurrent lumbar disc herniation,
* Obesity (body mass index \>35 kg/m2),
* Infection in the surgical site,
* Known local anesthetic drug allergy,
* Chronic pain, and coagulation disorders were excluded.
Ashtangayoga for IBS Show Positive Preliminary Effects on Symptoms and Well-being

The study aims to test the effect of Ashtanga yoga on well-being in patients with irritable bowel syndrome (IBS). The intervention comprises group sessions on the Ashtanga school of yoga. Participants are recruited from primary care and measurements on well-being and IBS symptoms are conducted at pre-treatment, post-treatment and 6-month follow-up.

The intervention comprises participants with IBS to undergo Ashtanga yoga sessions in a group led by an authorized yoga teacher for a total period of 10 weeks. The first 4 weeks consisted of 1 session/week and the following 6 weeks consisted of 1 session/2 weeks. All movements and exercises are performed based on the individual's personal capacity in order to avoid distinct discomfort or pain. Patients testing positive for IBS will be recruited for the study from primary care. Measurements of IBS symptoms, visceral sensitivity, extraintestinal symptoms and quality of life will be assessed at pre-treatment, post-treatment and 6-month follow-up. Specific statistical methods will be performed to assess changes from pre- to post-treatments and changes from post-treatment to 6-month-follow-up. Effects sizes for within group changes will also be calculated.

Eligibility Criteria:
Inclusion Criteria:

* IBS diagnosis

Exclusion Criteria:

* Prior yoga practise, unable to speak Swedish, other serious illness
Clinical Study on Safety and Efficacy of Anti-CLL1 /+CD33 CAR T Cells in the Treatment of Acute Myeloid Leukemia

This is a single-center, single-arm, open, intravenous drug administration of the safety and efficacy of clinical study.

The primary objective of the clinical trial was to evaluate the safety and efficacy of single dose infusion of anti-CLL1 /+CD33 CAR T cells in patients with refractory/recurrent acute myeloid leukemia. A total of about 5 patients with refractory/recurrent acute myeloid leukemia were enrolled in this study, and the target dose range was 1.00\~2.50x10\^6/kgCAR-positive T cells.

Eligibility Criteria:
Inclusion Criteria:

1. The patient or his/her legal guardian volunteers for the trial and signs an informed consent form;
2. Age range 1-18 years;
3. Acute myeloid leukemia (AML) with CLL1 and CD33 markers (including secondary patients) was diagnosed by pathology, histology and flow cytometry, or complete hematologic remission could not be achieved after 1 course of chemotherapy for hematologic relapse after drug withdrawal ;
4. The main organ functions of the patients were good: (1) liver function: ALT/AST \< 3 times the upper limit of normal (ULN) and bilirubin ≤34.2 μmol/l; (2) renal function: creatinine \< 220 μmol/l; (3) lung function: oxygen saturation ≥95% ; (4) cardiac function: left ventricular ejection fraction (LVEF)≥40% ;
5. The blood flow of peripheral superficial vein was unobstructed, which could meet the demands of intravenous drip and mononuclear cell collection;
6. ECOG score was 0-2.

Exclusion Criteria:

1. The patients had uncontrollable infectious diseases within 4 weeks before the enrollment;
2. Active hepatitis B/C virus;
3. HIV infection, treponema syphilis positive patients;
4. Pathological diagnosis of primary tumors other than acute myeloid leukemia;
5. Suffering from serious autoimmune diseases or immunodeficiency diseases;
6. The patient is allergic to antibodies or cytokines and other macromolecular biological drugs;
7. Pregnant or lactating women;
8. Patients who were considered ineligible for study for other reasons.
Low Density Lipoprotein Cholesterol (CLDL) as a Cardiovascular Disease Risk Factor in Rheumatoid Arthritis

The investigators hypothesize that cLDL levels are elevated in RA patients and represents an important mechanism for accelerated atherosclerosis leading to excess cardiovascular disease (CVD) in rheumatoid arthritis (RA) patients. The purpose of this study is to improve understanding of the reasons for increased cardiovascular diseases (such as heart attack and stroke) seen in patients with rheumatoid arthritis (RA, an arthritis that causes inflammation and destruction of joints). Specifically, the study plans to determine whether a particular type of change in proteins in LDL cholesterol ("bad cholesterol") known as carbamylation is an important risk factor for cardiovascular diseases in RA patients. The study will utilize a case-control study design. A total of 120 subjects (males and females between the ages of 18 and 80) may be enrolled in order to ensure that 100 subjects (50 RA case subjects and 50 age and sex matched controls) complete the study. Procedures will consist of a single visit for each subject during which a screening evaluation, an enrollment evaluation, and a single blood draw will be performed.


Eligibility Criteria:
Inclusion Criteria:

For Cases:

* Fulfill the American College of Rheumatology (ACR) 1987 Classification Criteria for RA
* Have currently active disease as assessed by Clinical Disease Activity Index (CDAI)score (a validated composite RA activity index) of \> 10
* Have ≥ 3 swollen joints

For Controls:

* Control subjects will be age, sex, and 5-year age categories matched to cases
* No historical diagnosis of RA and other primary autoimmune or inflammatory disorders

Exclusion Criteria:

For both cases and controls:

Renal failure (estimated GFR \< 60 ml/min) documented within 3 months of study enrollment (from either subject's self-report or review of available medical records)

* Known clinical history of CVD
* Current cancer (other than skin)
* Current or recent (within past 2 weeks) infection
* Individuals taking lipid-lowering medications
* Any other condition the PI staff feels will jeopardize the health and welfare of the participants
* Rheumatoid vasculitis (for cases only)
Antiemetic Prophylaxis With Fosaprepitant and Ondansetron in Patients Undergoing Thoracic Surgery

The goal of this clinical trial is to compare the efficacy, safety and feasibility of intravenous Fosaprepitant and Ondansetron for the prevention of postoperative nausea and vomiting in thoracicsurgery patients. Participants will be randomized in a 1:1 ratio to the Fosaprepitant and Ondansetron group.The groups were analyzed and compared for frequency of vomiting in 24 h after surgery. In addition, we will further compare the occurrence of postoperative pulmonary complications, length of hospital stay, nutrition and quality of life after surgery in patients treated with different antiemetic prophylaxis.

Postoperative nausea and vomiting (PONV) is a common postoperative complication of general anesthesia. The antiemetic 5-serotonin 3 (5-HT 3) receptor antagonist is widely used in postoperative anti-emesis,However, more clinical studies are needed to confirm whether neurokinin-1 (NK-1) receptor antagonists have better effects on PONV than 5-HT 3 receptor antagonists.We aimed to evaluate the effects of NK-1 receptor antagonists and 5-HT 3 receptor antagonists on PONV through a randomized controlled study. To this end, we took patients undergoing thoracic surgery as the research object, they received an antiemetic prophylaxis with ondansetron or fosaprepitant, and the frequency of postoperative nausea and vomiting the of the two antiemetic prophylaxis regimens were analyzed, and the occurrence of pulmonary complications, length of hospital stay, the nutrition and quality of life after surgery administration were also compared. Through this clinical trial, we hope to obtain a better antiemetic prophylaxis regimen and provide clear information for patients and physicians to guide clinical decisions that enhance treatment efficacy and reduce the occurrence of side effects.

Eligibility Criteria:
Inclusion Criteria:

1. aged between 18 and 70 years
2. physical status classified by the American Society of Anesthesiologists (ASA) scale as I to III
3. Apfel score ≥ 2
4. undergoing thoracoscopic pneumonectomy

Exclusion Criteria:

1. Preoperative disorders of consciousness
2. body mass index (BMI) \> 35 kg/m2
3. occurrence of episodes of nausea or vomiting within 24 h prior to surgery、motion sickness,、previous PONV、people who smoke、people with alcoholism、use of corticosteroids, psychoactive or antiemetic drugs,、hypersensitivity to the study medications
4. serious kidney, liver, lung, heart, brain or bone marrow disease
5. conversion from thoracoscopic pneumonectomy to conventional pneumonectomy
6. participation in another clinical study.
Metal Contamination After Minimally Invasive Repair of Pectus Excavatum (MIRPE)

The purpose of this study is to determine whether there is a metal wear debris after minimally invasive repair of pectus excavatum and if there's a clinical relevance. Our hypothesis is that the metal bar after minimally invasive repair of pectus excavatum leads to a locally and systemic immune reaction due to elevated metal contamination.


Eligibility Criteria:
Inclusion Criteria:

* MIRPE

Exclusion Criteria:

* none
Comparisons of the Astigmatic Power of Toric Intraocular Lens Using Three Toric Calculators: AcrySof, TECNIS, and iTrace Toric Calculator

Purpose of this study is to compare the astigmatic power of the toric IOL obtained from the AcrySof toric calculator, TECNIS toric calculator, and iTrace toric calculator in a group of patients with preoperative with-the-rule (WTR) and against-the-rule (ATR) corneal astigmatism. The study included 100 eyes with cataract and greater than 0.75 diopter of corneal astigmatism, and the subjects were divided into WTR and ATR group. Keratometric value was measured using autokeratometry, IOLMaster partial coherence interferometry (PCI), iTrace incorporating corneal topography and ray-tracing aberrometry. Based on measured values, toric IOL power calculations were performed using AcrySof, TECNIS and iTrace toric calculators.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who planned to undergo cataract removal by phacoemulsification
* Subjects with preoperative corneal astigmatism greater than 0.75 D, as determined by autokeratometry

Exclusion Criteria:

* Subjects with more than 2.74 D of corneal keratometric value from autokeratometry
* a history of intraocular or corneal surgery and ocular trauma
* biomicroscopic evidence of corneal disease that could affect corneal astigmatisms
* contact lens wearer
Changes in Lung Aeration and Inspiratory Effort With and Without Awake Prone

The investigators aimed to investigate the ventilation homogeneity and transpulmonary pressure during treatments of High-flow nasal cannula(HFNC) and (CPAP) on supine and prone position for COVID-19 or non-COVID-19 patients with acute hypoxemic respiratory failure (AHRF).

Awake prone positioning (APP) for non-intubated patients has been reported to improve oxygenation for patients with acute hypoxemic respiratory failure (AHRF),particularly for patients with COVID-19 induced AHRF, APP has been shown to decrease the need of intubation.Similarly, APP with helmet continuous positive airway pressure (CPAP) enables a reduction in the work of breathing and an improvement in oxygenation and sensation of dyspnea in COVID-19-associated acute respiratory distress syndrome (ARDS). Moreover, among intubated patients with ARDS assessed by electro-impedance tomography (EIT), prone positioning was found to reduce alveolar overdistention and collapse, resulting in improvement of ventilation homogeneity.However, the effects of APP on the ventilation homogeneity and work of breathing for non-COVID-19 patients with AHRF remain unknown.

High-flow nasal cannula (HFNC) has been proven to improve oxygenation and reduce intubation rate for patients with AHRF in multiple meta-analyses,and has been recommended to treat AHRF in several recently published guidelines.CPAP provides consistent level of positive end-expiratory pressure (PEEP), in comparison to variable level of PEEP generated by HFNC, thus CPAP was reported to have greater improvement of oxygenation than HFNC in 20 patients with AHRF, more importantly, they found that among patients who avoided intubation, the extent of oxygenation improvement was greater with HFNC+APP than with NIV+APP, in contrast, for patients who were intubated, the extent of oxygenation improvement was greater with NIV+APP than with HFNC+APP.This raised the concerns of the self-inflicted lung injury (SILI) generated by heterogenous aeration and large swings of transpulmonary pressure. Thus, the investigators aimed to investigate the ventilation homogeneity and transpulmonary pressure during treatments of HFNC and CPAP on supine and prone.

Eligibility Criteria:
Inclusion Criteria:

* adult patients (18-90 years) who have acute hypoxemic respiratory failure, requiring FIO2 \> 0.4 to maintain SpO2 at 90-95% during HFNC at 50 L/min

Exclusion Criteria:

* patients who need immediate intubation; refuse to participate in the study; unable to communicate; have contraindication to place the esophageal catheter; unable to use EIT, such as open-chest surgery with chest tube placement; have contraindication for prone positioning, including pregnant, post-abdomen surgery within a week; hypercapnic respiratory failure.