cyrilzakka/clinical-trials huggingface dataset:
Thiamine Intervention and Coronary Artery Bypass Grafting

The purpose of this study is to gain a better understanding of the association between brain changes and cognitive deficits in coronary heart disease (CHD) patients undergoing coronary artery bypass grafting (CABG) and whether a low-cost thiamine intervention can be used to reduce post-CABG cognitive issues in CHD subjects.

Using a two-group, double-blind randomized, longitudinal study design, 52 coronary heart disease (CHD) patients undergoing coronary artery bypass grafting (CABG) (ages 60-80 years; 26 thiamine treatment and 26 placebo) will participate in cognitive assessment and evaluation of blood thiamine, lactate, and inflammatory marker levels. The investigators propose that thiamine infusion will help in reducing lactate and inflammatory marker levels, as observed in other conditions. The findings from this study might serve as a novel and innovative treatment strategy for protection against declining cognition, and hence better outcomes, and improved quality of life and daily activities. This clinical trial study will provide required data regarding the benefits of a low-cost thiamine intervention that could be implemented on a large-scale clinical trial to reduce post-CABG cognitive deficits in older CHD, and thus, decrease early dementia, improve social function, increase quality of life and daily activities, and reduce healthcare costs in this serious older CHD patient population.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Coronary Heart Disease (CHD) scheduled for Bypass Grafting (CABG)
* Thiamine deficiency before CABG
* European System for Cardiac Operative Risk Evaluation II (EuroSCORE II) \>1.5%
* Off-pump surgery

Exclusion Criteria:

* Dementia at baseline \[Montreal Cognitive Assessment (MoCA) \<21 within 5 days before CABG\]
* Current in-take of thiamine
* Known thiamine allergy
* Uncontrolled blood glucose levels
* Unable to give consent due to illness
* History of hyperlactatemia
* Recent (within several years and/or up to the judgment of the PI/co-PIs) cerebral incidents (seizure or head trauma resulting in loss of consciousness and/or concussion)
* Stroke
* Diagnosed psychiatric diseases (clinical depression, schizophrenia, manic-depression)
* Patients with history of alcohol or substance abuse
* Acute or chronic infections (tuberculosis, hepatitis, or encephalopathy)
* Diagnosed neuro-degenerative diseases (Alzheimer's or Parkinson's disease)
* Chronic immunodeficiency (including HIV)
* Congenital brain deficits will also be excluded
Home Blood Pressure Monitoring Trial

Design: Community based randomised trial with follow up after 12 months Participants: 360 patients admitted with stroke or TIA within the past 9 months will be recruited from the wards or outpatients and randomly allocated into two groups. All patients will be visited by the specialist nurse at home at baseline when she will measure their BP and administer a questionnaire. The questionnaire and BP will be repeated at 12 months follow-up by another researcher blind as to whether the patient is in intervention or control group.

Intervention: Intervention patients will be given a validated home BP monitor and support from the specialist nurse. Control patients will continue with usual care (BP monitoring by their practice).

Main outcome measures in both groups after 12months: 1.Change in systolic BP 2.Cost effectiveness: Incremental cost of the intervention to the NHS and incremental cost per quality adjusted life year gained.

Study hypothesis. Home blood pressure monitoring with nurse support wil lead to lower blood pressure after 12 months compared with usual GP care

High blood pressure in patients with stroke increases the risk of recurrence but management in the community is often inadequate. Home blood pressure monitoring may increase patients' involvement in their care, increase compliance, and reduce the need for patients to attend their GP if blood pressure is adequately controlled. However the value of home monitoring to improve BP control is unclear and there is now a window of opportunity for evaluation before their use becomes widespread in the UK. Furthermore its use in stroke patients presents unique challenges relating to the consequent neurological disability.

Eligibility Criteria:
Inclusion Criteria:

* Stroke or TIA in last 9 months
* Blood pressure above 140/85 when measured more than 1 week after stroke or on anti hypertensive medication

Exclusion Criteria:

* Severe illness likely to dominate pattern of care
* Already using home blood pressure monitor
* Non-English speaking
* Severe cognitive impairment (AMTS\<7)
* Known secondary hypertension
Acute Psychological Sleep Stabilisation for Patients Hospitalised with Depression

Disturbed sleep occurs in almost all patients in psychiatric inpatient care, and although it is well known that comorbid sleep disorders in depression often persist after treatment of depression and also increase the risk of new depressive episodes, the availability of effective, evidence-based treatments for sleep disorders in hospitalised patients is very limited.

The overall goal of the current project is to translate, adapt and evaluate an acute psychological sleep treatment based on cognitive behavioural therapy for insomnia (CBT-I) for patients hospitalized with depression and comorbid sleep problems in the specialized psychiatric inpatient care in the Stockholm Region. The main hypothesis for the study is that acute psychological sleep stabilization (APS) reduces self-reported sleep complains compared to care as usual reinforced with sleep hygiene advice, and secondary hypotheses are that APS also leads to reduced depressive symptoms and earlier discharge.

The project includes a pilot study, which will be followed by a randomized, controlled trial of APS compared to care as usual with structured sleep hygiene (minimal active control) and treatment effect is evaluated every three days during the hospital stay and 1,2,4 and 12 weeks after randomization. APS will be performed by existing staff in the department with the support of a psychologist.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to the psychiatric inpatient care (Psykiatri Sydväst)
* Depressive symptoms / confirmed depressive episode (uni- or bipolar)
* Reports or is observed to have sleep problems in the form of insomnia, hypersomnia or delayed circadian phase
* Knowledge of Swedish or English that is deemed sufficient to undergo the treatment
* Consent to be included in the study and is judged to have understood what the study entails (care according to the Compulsory Psychiatric Care Act is not in itself an exclusion criterion)

Exclusion Criteria:

* Dementia
* Intellectual disability
* Severe somatic comorbidity with life expectancy \<6 months
* Ongoing mania / mixed-state
* Complex problems that make APS impossible or inappropriate
* Expected discharge within 3 days
Metastatic Colorectal Cancer Database

The metastatic ColoRectal Cancer (mCRC) Database base contains data collected during the regular clinical patient management in Centre Georges Francois Leclerc, Dijon.

The metastatic ColoRectal Cancer (mCRC) Database base contains data collected during the regular clinical patient management (sociodemographic, clinical, pathological, radiological, biological, disease evolution, ...). This database allows easy access to information in a centralized and structured way. This cohort is used to gather insights for research purposes.

All data collected come from medical files of patients managed at Centre Georges Francois Leclerc, Dijon, France.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic colorectal cancer
* Age \>= 18

Exclusion Criteria:

* Non metastatic colorectal cancer
* Objection to the use of medical data records
Da Vinci Transoral Robotic-assisted Surgery of Pituitary Gland

Over the past 30 years, endoscopic transnasal techniques have gained a major interest, and anatomic limits have been widened in order to extend neurosurgical applications. For many years, robotic-assisted surgery using the da Vinci system (Intuitive Surgical Inc, Sunnyvale, California, USA) has been greatly developed, especially in urology and gynecology.

Robotic-assisted surgery has been performed for pharyngeal and laryngeal cancers in a minimally invasive perspective.

A robot-assisted preliminary series demonstrated the ability to approach the sella via oral approach without traumatic injury of nasal or oral cavity. Transoral approach avoids the complications of the endonasal resection: synechia, rhinitis sicca anterior, primary and secondary atrophican rhinitis, and empty nose syndrome.

The investigators recently published a cadaveric study of transoral robotic-assisted skull base surgery to approach the sella turcica (Neurosurgical Rev. 2014; 37:609-17).

In this study, the investigators will propose a new minimally invasive technique of pituitary surgery by transoral approach assisted by the da Vinci robot in patients with pituitary adenoma.


Eligibility Criteria:
Inclusion Criteria:

* Pituitary adenoma with a surgical indication : visual compression and chiasmal syndrome, intracranial hypertension , hormonal syndrome (hypopituitarism and hypersecretion ) , failure of medicamentous treatments for prolactinoma
* No pituitary apoplexy (requiring emergency surgery)
* Spontaneous oral opening greater than 35 mm

Exclusion Criteria:

* Insufficient buccal opening
* Intercurrent pathology of oropharyngeal and nasopharyngeal
* Complicated forms of adenoma pituitary adenoma (invasive adenoma)
* Hemostasis disorder
* Phlebitis or active pulmonary embolism
Effect of Radiotherapy Concurrent of TTFields in Patients With Glioblastoma

TTFields has been approved by the FDA for the treatment of patients with glioblastoma multiforme. However, the clinical effect and safety of radiotherapy concurrent of TTFields is not definite. In this study, the investigators conduct a phase II clinical trial to evaluate the efficacy and safety of this strategy.

the investigators plan to recruit 30 patients to evaluate the efficacy and safety of this strategy.

Eligibility Criteria:
Inclusion Criteria:

* performance status of 0-1 (Eastern Cooperative Oncology Group performance status)
* histologically confirmed glioblastoma
* no cerebrospinal fluid and distant metastatic disease.

Exclusion Criteria:

* with a history of brain radiotherapy
* severe hepatic and renal dysfunction
A Study to Evaluate Safety, Drug Levels and Effectiveness of CC-92480 (BMS-986348) in Combination With Other Treatments in Participants With Relapsed or Refractory Multiple Myeloma

The purpose of this study is to assess the safety, tolerability and preliminary effectiveness of CC-92480 (BMS-986348) in novel therapeutic combinations for the treatment of Relapsed or Refractory Multiple Myeloma (RRMM).


Eligibility Criteria:
Inclusion Criteria:

* Relapsed or refractory multiple myeloma (MM) and must:

  1. Have documented disease progression during or after their last myeloma therapy.
  2. For Part 1 Dose Finding: Be refractory to, intolerant to, or not a candidate for available, established therapies known to provide clinical benefit in MM; For Part 2 Dose Expansion: Be refractory to or have relapsed after at least 2 prior lines of therapy that include an immunomodulatory drug (IMiD), a proteasome inhibitor, an anti-CD38 mAb, and a T-cell redirecting therapy (TRT, eg, a CAR-T or T-cell engaging bispecific treatment) unless the participant is not a candidate for TRT.
* Must have measurable disease.
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
* Agree to follow the CC-92480 Pregnancy Prevention Plan (PPP).

Exclusion Criteria:

* Known active or history of central nervous system (CNS) involvement of MM
* Plasma cell leukemia; Waldenstrom's macroglobulinemia; polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS) syndrome; or clinically significant light-chain amyloidosis.
* Impaired cardiac function or clinically significant cardiac disease
* Previous SARS-CoV-2 infection within 14 days for asymptomatic or mild symptomatic infections or 28 days for severe/critical illness prior to Cycle 1 Day 1 (C1D1)
* For Part 1: received prior therapy with CC-92480
* For Part 2: received prior therapy with CC-92480, tazemetostat, BMS-986158, or trametinib
* Previously received allogeneic stem-cell transplant at any time or received autologous stem-cell transplant within 12 weeks of initiating study treatment
* Received any of the following within 14 days prior to initiating study treatment:

  1. Plasmapheresis
  2. Major surgery
  3. Radiation therapy other than local therapy for myeloma associated bone lesions
  4. Use of any systemic anti-myeloma drug therapy
* Used any investigational agents within 28 days or 5 half-lives (whichever is shorter) prior to initiating study treatment
* COVID-19 vaccine within 14 days prior to C1D1

Other protocol-defined inclusion/exclusion criteria apply
Renji Cerebral Small Vessel Disease Corhort Study

We aim to make clear the impact with the mechanisms of variant pathological injuries on the outcomes of CSVD, to find independent imaging markers and establish prediction model of it.

A cohort of post stroke cerebral small vessel disease (CSVD) patients with different cognitive status are consecutively recruited in this study. Detailed full domain cognitive assessment and multi-modal MRI (including brain morphology , DTI indices, microbleed counts, brain volumes as well as brain network characters, etc.) are performed. Cognitive states(including attention-executive function, memory, language, visuo-spatial and global cognition with the transition to dementia) and the overall prognosis (cardiovascular events, stroke recurrence, death due to cardiovascular event and all cause death) are longitudinally followed up. The correlations between baseline and followed MRI parameters with the outcomes are analyzed in order to make clear the impact with the mechanisms of variant pathological injuries on the outcomes of CSVD, to find independent imaging markers and establish prediction model of it.

Eligibility Criteria:
Inclusion Criteria:

* ①50-85 years; ② at least 6 years of education; ③ CSVD was defined as patients experienced a clinical lacunar stroke at least 1 months ago, and MRI showed responsible lacunar infarcts and white matter lesions; ④ Cooperate with cognitive tests; ⑤Not accept medications that affect cognition; ⑥. Score of modified Rankin scale ≦3; ⑦. Sign informed consent.

Exclusion Criteria:

* ① Etiology due to cardioembolic or large vessel disease (\>50% stenosis in extra- or intra-cerebral arteries); ② Non vasular white matter lesions(WMLs)；③ Cortical and/or cortico-subcortical non-lacunar infarct; ④ Other cognitive diseases (such as Alzheimer's disease, Parkinson disease or thyroid disease, etc. ) ⑤Severe systemic diseases such as heart, liver and kidney diseases or major psychiatric disorders; ⑥Severe depressive state: Hamilton depression rating scale score \>24; ⑦ MRI contraindications.
Effect of Neck Extension Exercise Using 8 Channel Surface Electromyography

Analysis of Abnormal Muscle Activities on Forward Neck Posture Syndrome Patients and Effect of Neck Extension Exercise Using 8 Channel Surface Electromyography

In this study, the investigators investigate the muscle contraction according to posture change in patients with forward neck posture syndrome which was not revealed by 8 channel surface electromyography and provide accurate evaluation of forward neck posture syndrome in comparison with normal group and to be used as basic research data for the development of 8 channel electric stimulation therapy device.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults over the age of 20 who do not have any underlying disease that does not appeal to forward neck posture syndrome 2) Among adults who complained of chronic pain over three months, patients aged 20 years and over who were diagnosed with forward neck posture syndrome in a simple x-ray of the lumbar spine

Exclusion Criteria:

* Patients with severe neurological disorders (procedural hypertrophy), previous cervical surgery, impaired eye diseases, spinal deformations, rehabilitation for strengthening spinal muscles within the last three months and pregnant women
Effect of Short Term Atorvastatin Treatment,80mg/Day on Early Regression of Carotid Artery Atherosclerotic Lesions

Atherosclerosis is a disease in which the blood vessels become blocked by plaques (consisting of fat, calcification, and fibrous tissue), reducing blood flow to vital organs and tissues.Blockage of the carotid arteries in the neck is a major cause of stroke. One way of treating carotid atherosclerosis is with cholesterol-lowering drugs called statins. Statins have been shown to reduce the risk of coronary heart disease by 24-40% and risk pf stroke by 11-30%.The purpose of this study is to determine if short term treatment with atorvastatin causes early favorable changes in the plaques that block blood flow through the carotid arteries. These changes can be assessed 1) by taking pictures of the carotid arteries with MRI and Ultrasound before and after statin treatment, and 2) by special studies of the plaques removed from the carotid arteries by surgery.

Candidates for bilateral carotid endarterectomy (CEA) who meet study criteria will provide informed consent before their randomization. Before the first CEA, the patient will have MRI, US, and EBCT exams of both carotids. The most occlusive plaque will be resected at the first CEA. The patient will then receive atorvastatin 80 mg/day for 3 months. Then the second CEA will be performed. Six weeks after the second CEA, the patient will have another MRI, US, and EBCT exam and at 6, 12, and 18 months thereafter. This protocol will allow comparison of the characteristics of the plaque that has been exposed to drug vs the plaque that has not been exposed. It will also allow monitoring the effect of drug on restenosis after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Men or women
* \>18 yrs old
* Expected to have an endarterectomy on each carotid artery
* No contraindications for atorvastatin
* Stable cardiovascular health
* Lipid lowering treatment less than 6 mo duration
* Diabetic included if diabetes is controlled
* Patient is not claustrophobic
* Patient has evaluable carotid plaques.

Exclusion Criteria:

* Patient has had previous carotid endarterectomy,stenting, or other procedure
* Unstable cardiovascular status
* Hypersensitivity to statin therapy
* Neck anatomy preventing acquiring bilateral evaluable plaques
* Weight over 285 lbs.
Comparison Between Different Ventilator Hyperinflation Maneuvers

The hyperinflation ventilator was performed in different modalities and ventilatory adjustments, with total pressure of 40cmH2O. The inspiratory volume, inspiratory time, mean airway pressure, inspiratory and expiratory flow, and bias flow were evaluated.

PURPOSE: To compare different ways of applying ventilator hyperinflation. METHODS: A randomized crossover clinical trial was performed with 30 patients (66.5 ± 17.3 years) with hypersecretion. The ventilator hyperinflation was performed in five ventilatory modalities for five minutes, with an interval of 2 hours, the order being determined by randomization: controlled ventilation at volume (VCV) with constant flow of 20 (VCV20) Lpm and 40 Lpm (VCV40), controlled ventilation pressure ventilation (PCV), controlled pressure ventilation associated with inspiratory time adjustment (PCV + Tins) and support pressure ventilation (PSV). In VCV mode, the volume was increased every 50mL, until reaching a maximum pressure of 40cmH2O. In the pressure controlled modes, the inspiratory pressure was increased every 5 cmH2O until the total pressure reached 40 cmH2O. The inspiratory time was adjusted so that the inspiratory flow reached the baseline. The following variables were evaluated: tidal volume, inspiratory time (Tins), mean airway pressure (Pmean), peak inspiratory flow (PIFR) and expiratory flow (PEFR), PIFR / PEFR and Bias Flow (PEFR-PIFR).

Eligibility Criteria:
Inclusion Criteria:

* Pulmonary infection
* Mechanically ventilated for more than 96 hours through pressure-assisted ventilation (PSV) or pressure-controlled ventilation (PCV)
* Static compliance between 30 and 70 mL/cmH2O
* PEEP between 5 and 8 cmH2O.

Exclusion Criteria:

* Hemodynamic instability
* Non-drained pleural effusion or pneumothorax
* Intracranial hypertension
* Bronchospasm
* Adult respiratory distress syndrome (ARDS)
* Decompensated congestive heart failure
Effect of Laser Acupuncture on Insulin Resistance in Obese Women With Polycystic Ovarian Syndrome

This study will be conducted to investigate the effect of laser acupuncture on insulin resistance in obese women with polycystic ovarian syndrome.

Women with Polycystic Ovary Syndrome (PCOS) face an increased risk of various health issues, including glucose intolerance, type 2 diabetes, hypertension, dyslipidemia, and subfertility. The prevalence of insulin resistance (IR) in PCOS can range from 44% to 70%, with longitudinal studies indicating that worsening IR over time in obese women with PCOS is associated with an increased risk of early-onset type 2 diabetes.

Conventional interventions, such as oral contraceptives, metformin, and hormonal therapy, have been developed to address the effects of PCOS. However, these treatments can have adverse side effects, including an increased risk of estrogen-related cancers. Consequently, lifestyle modifications to prevent aberrant immune activation and minimize exposure to inflammatory agents have emerged as a more sustainable approach.

Emerging evidence suggests the potential of alternative physical therapy modalities, such as transcutaneous electrical nerve stimulation, electro-acupuncture, and laser acupuncture, in managing PCOS. Laser acupuncture, in particular, has been shown to reduce sympathetic activity, decrease ovarian androgen release, and modulate the activity of higher centers, ultimately influencing gonadotropin-releasing hormone secretion and the menstrual cycle. Additionally, laser acupuncture may reduce the levels of pro-inflammatory cytokines, which contribute to insulin resistance and atherosclerosis.

While a few studies have investigated the effects of laser acupuncture on insulin resistance in obese women with PCOS, further research is needed to provide deeper insights into the benefits of this intervention and its role in managing insulin resistance in this population, which could expand the clinical applications of laser therapy in physical therapy.

Eligibility Criteria:
Inclusion Criteria:

* Forty obese women with PCOS as clinically diagnosed by gynecologist.
* Their ages will be ranged from 20 to 35 years old.
* Their BMI will be ranged from 30-40 kg/m2
* Their waist/hip ratio will be \>0.8
* All of them should have at least two criteria of the Rotterdam diagnostic criteria of PCOS.

Exclusion Criteria:

* Cushing syndrome, diabetes mellitus, Thyroid dysfunction, Hypothalamic amenorrhea, Ovarian hyperplasia
* Respiratory, renal and liver dysfunction.
* Skin diseases and any other condition that may prevent the usage of laser (skin cancer, active acne and skin infections).
* Malignancy