cyrilzakka/clinical-trials huggingface dataset:
Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects

Upper extremity motor impairment is one of the major sequelae of stroke, resulting in limitation of activities of daily livings. Noninvasive neuromodulation is one of the therapies for motor recovery, which includes transcranial magnetic stimulation and transcranial direct current stimulation(tDCS). Anodal tDCS increases excitability and cathodal tDCS decreases excitability of neurons.

In systematic reviews, tDCS applied over primary motor cortex showed positive results on motor learning and improvements of hand fine motors. Recently, there has been trials of tDCS over cerebellum, considering the connectivity of primary motor cortex and cerebellum in motor controls. However, the results of these trials are yet contradictory, and the study using the functional near infrared spectroscopy to prove the effects of tDCS over distant area is lacking.

Therefore, in this study, we used functional near infrared spectroscopy (fNIRS) to observe the hemodynamic change of primary motor cortex when applying tDCS over cerebellum ascertain their connectivity.

In this crossover design, participants are randomly allocated to "sham tDCS-washout period-anodal tDCS group" or "anodal tDCS- washout period- sham tDCS group". The recording of fNIRS starts 3 minutes before the tDCS stimulation and continues throughout 20 minutes of stimulation, until 30 minutes after the stimulation cessation. After 7 days of washout period, second recording is done as the same protocol. Outcome measures are the changes of concentration of deoxyhemoglobin \[deoxy-Hb\] and oxyhemoglobin \[oxy-Hb\].


Eligibility Criteria:
Inclusion Criteria:

* Age: 19 years or older
* No known brain disorders

Exclusion Criteria:

* Uncontrolled or unstalbe medical condition
* Pregnant
* Scalp problem which interferese with tDCS
* metals in the head (example: clip, coil), cochlear implants
Efficacy of an Advanced Auto-titrating NIV in COPD

Patients with chronic obstructive pulmonary disease (COPD) can eventually progress to respiratory failure, where they cannot adequately exchange oxygen and carbon dioxide, leading to worsening breathlessness, frequent hospitalisations and death. Non-invasive ventilation (NIV) is a ventilator therapy that is used in COPD patients who suffer from respiratory failure. Studies have demonstrated that using NIV at night regularly can result in improved clinical outcomes.

Adherence to this therapy is variable, however. This can be due to poor synchrony between the device and the lungs. A novel ventilator has been designed that delivers NIV but is also incorporated with technology to assess for aberrations in respiratory physiology and correct them, breath-by-breath.

The investigators aim to assess the efficacy, safety and tolerability of this novel ventilator. The primary research question is whether the novel ventilator can improve adherence to therapy, when compared with the usual ventilator.

Patients with COPD who use ventilation at home will be screened for inclusion in the study. Participation will involve a screening visit, and a further two visits to the Lane Fox Respiratory Unit. The first will require a two-night admission and the second a single-night admission. They will undergo detailed assessment of their daytime and overnight respiratory and sleep physiology during these admissions. These visits will be separated by a six-week period during which they will be asked to use the novel ventilator at home.

Patients will be recruited into a sub-study to evaluate the performance of the ventilator in a daytime physiological assessment. This will involve detailed invasive physiological assessment of expiratory flow limitation and how the machine is able to adjust settings to optimise respiratory support.


Eligibility Criteria:
Patient Inclusion Criteria:

* Age ≥ 18 years
* BMI \<30 kg/m¬2
* Confirmed diagnosis of COPD
* Currently using domiciliary NIV with average reported compliance of at least 3hours
* Ability to provide informed consent
* Medical stability confirmed by recruiting physician
* Free of exacerbations for at least 2 weeks prior to enrolment
* Presence of expiratory flow limitation on forced oscillation technique criteria

Exclusion Criteria:

* Current acute illness as determined by recruiting physician e.g. upper respiratory tract infection
* Presence of major medical comorbidity, e.g. severe heart failure (LVEF \<30%), active malignancy, end-stage renal failure (CKD 4), and neuromuscular disease
* Subjects who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days.
* Psychosocial factors that would prevent compliance with study protocol

Healthy participant inclusion criteria:

* Age ≥ 18 years
* No expiratory flow limitation on forced oscillation testing
* No acute illness on study day
* Ability to provide informed consent
Musculoskeletal Pain in Postmenopausal, Early Breast Cancer Patients Receiving Aromatase Inhibitor Therapy - A Pilot Study

In 2005, the EBCIG demonstrated the efficacy of tamoxifen in improving overall survival in hormone receptor positive breast cancers. However, tamoxifen shows partial estrogen agonist activity, which is responsible for the drug's detrimental effects such as endometrial carcinoma, thromboembolism, and tamoxifen resistance. More recently, aromatase inhibitors have been shown to be superior to tamoxifen in the metastatic and adjuvant settings. The ATAC trial demonstrated improved disease-free survival (DFS) for 5 years of anastrozole compared to 5 years of tamoxifen 3. The BIG 1-98 trial results demonstrated that after a median follow-up of 25.8 months, letrozole improved DFS and distant DFS when compared to tamoxifen. Based on these results, adjuvant hormonal therapy with Aromatase Inhibitors (AI) has become the preferred therapy for post-menopausal woman.

However, AI therapy is also associated with toxicities that merit in-depth studies, one of them being an increase in musculoskeletal pain. In the ATAC trial, at a median follow-up of 5.7 years, arthralgia was significantly higher (35.6% vs. 29.4%) and fractures were also increased (11.0% vs. 7.7%) when anastrozole was administered for 5 years following surgery with or without chemotherapy 3. The incidence of arthralgia was also significantly higher in the MA-17 trial, with 25% of patients receiving letrozole developing arthralgia compared with 21% in the placebo group following 5 to 6 years of tamoxifen 5.

Traditionally in cancer clinical trials, the reporting of musculoskeletal pain has been based on the "Common Terminology Criteria for Adverse Events", which covers a wide range of symptoms and does not facilitate the documentation of a pain syndrome in a specific manner. Therefore, there is a need to design a study that will describe the nature of the pain associated with the administration of AI therapy using tools that have been validated for capturing a multidimensional phenomenon such as pain.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Invasive carcinoma of the breast confirmed by needle biopsy or final pathological evaluation of the surgical specimen
* Breast cancer Stage I, II or IIIa
* ER and/or PR+
* No evidence of metastatic disease
* Post-menopausal
* May or may not have received adjuvant or neoadjuvant chemotherapy
* Bilateral infiltrating carcinoma are eligible

Exclusion Criteria:

* Men not eligible
* Other malignancies
* Patients who have received neoadjuvant or adjuvant endocrine therapy with tamoxifen or an aromatase inhibitor
* Ongoing treatment with any sex hormonal therapy (these patients are eligible if this therapy is discontinued prior to entry)
* Therapy with hormonal agent such as raloxifene for osteoporosis
* Patients receiving glucocorticoids
* Psychiatric or addictive disorders
* Inability to read English or French
A Phase 3 Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia

This clinical study will evaluate pilocarpine hydrogen chloride (HCl) ophthalmic solution (AGN-190584) in an expanded participant population to establish efficacy, safety, and tolerability versus the vehicle-control when administered, over a 30-day study intervention period, once daily bilaterally in participants with presbyopia.


Eligibility Criteria:
Inclusion Criteria

Subjective complaints of poor near vision that impact activities of daily living

Exclusion Criteria

Uncontrolled systemic disease

Any clinical condition or previous surgery that might affect the absorption, distribution, biotransformation, or excretion of AGN-190584. History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery, radial keratotomy, or any intraocular surgery. However, participants with history of photorefractive keratectomy (PRK) or laser-assisted in situ keratomileusis (LASIK) with corrected distance visual acuity (CDVA) meeting inclusion criteria will be allowed to enroll.

Known allergy or sensitivity to the study intervention or its components or other cholinergic agonist medications

Concurrent use of any topical ophthalmic medications, including artificial tears, other than the study intervention during the course of the study

Concurrent use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes

Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study

Participation in a blood or plasma donation program within 30 days prior to study intervention administration

Severe dry eye disease (defined as total corneal staining ≥ grade 3 on the 5-point Oxford scale and an ocular surface disease index (OSDI) score of \> 33) at the screening visit

Corneal abnormalities (including keratoconus, corneal scar, Fuchs' endothelial dystrophy, guttata, or edema) in either eye that are likely to interfere with visual acuity

Narrow iridocorneal angles (Shaffer grade ≤ 2 or lower on gonioscopy examination), history of angle-closure glaucoma, or previous iridotomy

History of iris trauma, Adie's tonic pupil, abnormal pupil shape in either eye, or anisocoria \> 1 mm between pupils under mesopic conditions at the screening visit

Lens opacity in either eye that is determined to cause significant disturbance of the central visual axis on screening biomicroscopy

Diagnosis of any type of glaucoma or ocular hypertension

Bifocal or multifocal spectacles or contact lenses for habitual correction. Participants willing to wear study-provided monofocal correction (either spectacles or contact lenses) during the study can be enrolled

Abnormal and clinically significant results according to the investigator or designee, on physical/ophthalmic examination or medical history

Females who are pregnant, nursing, or planning a pregnancy during the study
Pathogenesis of Hematologic Malignancies

The cause of blood and bone marrow cancers is poorly understood; however, most research focuses on how cancer cells grow and develop. Because the causes of these cancers are unknown, current treatments may be unnecessarily harsh and often do not provide a cure. Identifying the causes of blood cancers would allow for the development of treatments that are more likely to provide a cure. To find the causes of blood and bone marrow cancers, we will look for specific cancer cell abnormalities that are responsible for cancer cell growth. We will then look to see if drugs that can reverse these abnormalities can kill cancer cells.


Eligibility Criteria:
Inclusion Criteria:

* Suspected or confirmed diagnosis of AL, LPD, MDS, or MPD
* Male or female of all ages
* Willing and able to sign informed consent
* Willing guardian consent for participants under 18 years of age

Exclusion Criteria:

* No suspected or confirmed diagnosis of acute leukemias (AL), lymphoproliferative disorders (LPD), myelodysplastic syndromes (MDS), or myeloproliferative diseases (MPD)
Effect of Auricular Stimulation on Locomotion in Patients With Parkinson's Disease

The effect of auricular stimulation on the locomotion capability in patients with Parkinson's Disease was investigated.

Effect of the auricular stimulation as a supplementary and alternative usage to Levodopa was investigated in this study. Clinical data were collected through motion capture system while the participants performed the clinical task asked by the investigators.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Parkinson's Disease
* H\&Y Stage \>= 1
* Existing bradykinesia symptoms
* Existence of one of the symptoms below
* Resting Tremor
* Rigidity
* Walking disorder

Exclusion Criteria:

* Cardiac Pacemaker
* Psychiatric diagnosis
* Irregular heart/respiration rate
* Pregnancy
* Alcohol consumption
* Cardiovascular disease history
* Wearing an electro-active prosthesis
* Brain surgery history
* Ongoing TENS/PENS therapy
Geometric-Based Handwriting Intervention: Development, Feasibility and Randomized Clinical Trial

This study will focus on (1) developing the Chinese characteristic-based VMI-focused program, namely visual-perception motor-coordination integration program (CCVPMCI) involving the most Chinese-handwriting-related skills training and (2) investigating the effectiveness of the CCVPMCI program on handwriting performance in children with handwriting difficulties in Taiwan.


Eligibility Criteria:
Inclusion Criteria:

1. poorer handwriting performance than the peers referred from teachers.

Exclusion Criteria:

1. severe neurological or pervasive developmental disorders that might directly impeded writing
2. intellectual disability that might directly impeded writing
3. musculoskeletal, or sensory (hearing, vision) disorders that might directly impeded writing
4. difficulty in reading or expressing
Adherence of Diuretics in Pulmonary Hypertension

In this prospective study, the investigators will implement a systematic assessment of adherence to diuretics in a cohort of patients with precapillary pulmonary hypertension.

This study is designed to:

* determine the overall adherence rates for diuretic regimen
* determine the determinants of non-adherence to diuretics
* assess the risk of PH worsening occurrence in the non-adhesion group

Introduction Precapillary pulmonary hypertension (PH) is characterized by remodeling of small pulmonary arteries leading to a progressive increase in pulmonary vascular resistance (PVR) resulting to right heart failure and ultimately death. The prognosis of PH is closely related to the ability of the right ventricle to adapt to the progressive increase in PVR. The occurrence of acute right ventricular decompensation is associated with a very poor prognosis at short term.

The management of precapillary PH is based on specific therapies combined with general measures and supportive therapies. Diuretic treatment is recommended in PAH patients with signs of RV failure and fluid retention (recommendation class I, level of evidence C). The beneficial effect of diuretics is probably essential for preventing episodes of acute right ventricular decompensation. However, no study analyzed the rate of adherence to diuretic regimen in PH patients and the impact of patterns of adherence to diuretics on the outcomes of patients.

Aim and objectives

The main objectives of this study are to:

* determine the overall adherence rates for diuretic regimen
* determine the determinants of non-adherence to diuretics
* assess the risk of PH worsening occurrence in the non-adherence group

Methodology

Evaluation of subjects and adhesion to diuretics at inclusion are recorded:

* Self-questioning of medication adherence: Girerd questionnaire
* Assessment of the Medication Possession Ratio
* Social and demographic data
* Comorbidities
* PH characteristics
* Clinical evaluation: dyspnea assessed by NYHA functional class (New York Heart Association Functional Classification : I-IV), signs of right heart failure
* Type of treatment regimen
* History of serious events including non-programmed hospitalization for PH and/or worsening of the disease (15% reduction in the 6-minute walking test and worsening of the WHO functional class) and/or the need to reinforce specific PH therapies

Eligibility Criteria:
Inclusion Criteria:

* Men and women over 18 years old
* Precapillary PH
* Diuretics treatment for at least 12 months
* Having given his/her non-opposition to participate

Exclusion Criteria:

* Treatment regimen without diuretics
* Diuretics treatment for less than 12 months
* Postcapillary PH
* People refusing or unable to give informed consent
* No affiliation to a regime of social security.
* Protected patients
Oxidative Stress in Polycystic Ovary Syndrome With Periodontal Disease and Dental Caries Lesions

This study evaluates the oxidative stress parameters in females with polycystic ovary syndrome (PCOS) and clinically healthy. Because of the fact that both oral disease included periodontitis and dental caries, and metabolic syndrome are associated with systemic inflammation, these two disorders may be linked through a common pathophysiologic pathway

Power analysis was performed with the G-Power software package to determine sample size. To cover possible data loss, 10% of a group were added to each group. Medical and dental examination will be performed both of control and experimental groups. Age and body mass index (BMI) will be recorded.

In dental examination decayed, missing, or filled teeth (DMFT) index will be used according to World Health Organization (WHO 1997) criteria. All teeth were visually using the International Caries Detection and Assessment System (ICDAS-II). To analyze the correlation between oral health status and polycystic ovary syndrome linear regression test and for comparison of both the groups (case and control), two sample t test and chi square test were used.

Eligibility Criteria:
Inclusion Criteria:

* females with Polycystic Ovary Syndrome

Exclusion Criteria:

* history of ovarian surgery, patients with thyroid or prolactin hormone level abnormalities, non-classic 21-hydroxylase deficiency and hormonal therapy, steroid drug use past 6 months, obese patients (body mass index, BMI \> 35), acute or chronic upper respiratory tract diseases, dental fluorosis, patients using fluoride supplements or orthodontic appliances will not be included in the study.
Validation of a Food Frequency Questionnaire: VioScreen

The purpose of this study is to learn more about how well a questionnaire about food intake works. The study team will compare questionnaire responses to several other measurements of food intake. There is a special emphasis on fruit and vegetable intake.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-40 as we are aiming to recruit women of child-bearing age
* Pregnant women up to 26 weeks' gestation
* Women assigned female sex at birth who are not pregnant

Exclusion Criteria:

* Women below the age of 18 or over the age of 40 years
* Pregnant women more than 26 weeks' gestation at the time of enrollment
* Women who are experiencing limited or reduced food intake related to nausea will not be approached for recruitment and are considered ineligible
* Women who are unwilling to participate in the study due to time commitment or other reasons
* Women whose capacity for study compliance is diminished due to conditions such as active untreated substance use disorder, untreated/uncontrolled schizophrenia, bipolar disorder, active psychosis will not be approached for recruitment and are considered ineligible
Efficacy and Safety of Nintedanib in the Treatment of Pulmonary Fibrosis in Patients With Moderate to Severe COVID -19

This center intends to conduct a single-center, randomized, placebo-controlled study to evaluate the effectiveness and safety of Nintedanib ethanesulfonate soft capsule in the treatment of pulmonary fibrosis in patients with moderate to severe COVID-19.

This center intends to conduct a single-center, randomized, placebo-controlled study to evaluate the effectiveness and safety of Nintedanib ethanesulfonate soft capsule in the treatment of pulmonary fibrosis in patients with moderate to severe COVID-19. The number of cases is estimated based on the following:

This exploratory trial is expected to complete 80 case studies (randomly divided into control group and test group each with 40 cases), and the expected drop-out rate is not more than 20%, so the total number of cases is 96. Placebo control group:

Empty capsules with the same appearance and ingredients as Nintedanib soft capsules: one capsule at a time, twice a day, with an interval of about 12 hours each time. Continuous medication for 8 weeks.

Nintedanib Nintedanib cloth sulfonate soft capsule treatment: According to the drug manual recommendation, give Nintedanib cloth sulfonate soft capsule 150mg twice daily with an interval of about 12 hours each time, with food. Continuous medication for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. 18-70 years old (including 18 and 70 years old), regardless of gender;
2. Infection with new coronavirus pneumonia was confirmed by throat swab nucleic acid test. Patients with severe and critical illness were clinically judged. The symptoms of acute infection have been alleviated after treatment (at least 14 days after onset, no fever for more than 3 days), and the disease is recovering Within three months;
3. CT examination of patients with multiple fibrotic shadows in both lungs;
4. Blood routine, liver, and kidney functions are within the controllable range: such as the normal upper limit of plasma total bilirubin and creatinine ≤ 1.5 times; AST, ALT, LDH ≤ 2 times the normal upper limit; sufficient hematopoietic function: such as white blood cells ≥4.0 × 109 / L, platelets ≥100 × 109 / L;
5. Signed informed consent.

Exclusion Criteria:

1. Previous history of chronic bronchitis, emphysema, interstitial lung disease or pulmonary heart disease;
2. Combining with other serious diseases: such as those who have suffered myocardial infarction and uncontrollable diabetes within 6 months, and are considered unsuitable to participate in the trial;
3. People with active peptic ulcer;
4. Patients during pregnancy and lactation
5. Patients with mental illness or others who cannot cooperate effectively;
6. Researcher judges uncomfortable to participate in trial
Effect of Inhalational Anesthesia Versus Total Intravenous Anesthesia on Blood Glucose in Type 2 Diabetes Patients

The aim of this study is to compare the effect of total intravenous anesthesia (TIVA) and inhalational anesthesia (IHA) as maintenance anesthesia on blood glucose level and complications in type 2 diabetic patients undergoing thoracic surgery . All participants had to understand and give written informed consent , and ethical committee approval (of Faculty of Medicine, Ain Shams University) will be obtained before participants allocation.

* Type of Study: prospective , randomized .
* Study Settings: Ain Shams University hospitals, Cairo, Egypt.
* Study period: 12 months starting from janurary 2024 .
* Study Population: All adult type 2 diabetic patients (30-70 year old) with class II,III based on the American Society of Anesthesiologists (ASA) physical status undergoing elective thoracic surgeries will be randomly assigned into one of the following groups using computer generated codes and opaque sealed envelopes:

  1. Group A will receive total inravenous anesthesia (TIVA).
  2. Group B will receive inhalational anesthesia (IHA)

Eligibility Criteria:
Inclusion Criteria:

* Age 30 - 70 years
* Sex: Both sexes
* Patients with type 2 diabetes mellitus controlled with oral hypoglycemic drugs
* Patients with ASA classification II,III
* Duration of surgery (≥2 h)

Exclusion Criteria:

* Declining to give written informed consent
* ASA classification Ⅳ to V
* Severe systemic diseases
* Metabolic disorders, diabetic ketoacidosis or hyperglycemia (fasting blood Glucose more than 140 mg/dl)
* Hepatic and/or renal dysfunction
* Neuromuscular disease
* Pancreatic cancer
* History of malignant hyperthermia
* Emergency surgery
* Ischemic heart disease and valvular heart disease
* Body mass index more than 40
* Diabetic patients on insulin therapy