cyrilzakka/clinical-trials huggingface dataset:
The DPP-4 Inhibitor Vildagliptin as Adjunct in Major Depressive Disorder Patients

Vildagliptin, an antidiabetic drug that inhibits the dipeptidyl peptidase- 4 (DPP-4), increases glucagon-like peptide-1 (GLP-1) and regulates blood glucose levels, favoring weight loss and lowering cardiovascular risk. A retrospective longitudinal study by Rizzo et al. showed that DPP-4 inhibitors administration could have protective effects against cognitive decline in diabetic elderly. Is has been observed that GLP-1 affects brain metabolism, increases neuritic growth, and protects neuronal cells from oxidative stress and death.


Eligibility Criteria:
Inclusion Criteria:

* Eighty adult outpatients with the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) diagnosis of MDD based on a MINI Neuropsychiatric Interview (MINI) (American Psychiatric Association., 2000; Sheehan et al., 1998), without psychotic features and a total 17 item HAM-D score of at least 18 with item 1 (depressed mood) scored 2 or greater were eligible (Hamilton, 1960).
* Patients were requested to be free of all the psychotropic and anti-inflammatory medications for at least 4 weeks before participating in the study.

Exclusion Criteria:

* Patients with bipolar I or bipolar II disorder
* Patients with personality disorders
* Patients with eating disorders
* Patients with substance dependence or abuse
* Patients with concurrent active medical condition
* Patients with history of seizures
* Patients with history of receiving Electroconvulsive therapy (ECT)
* Patients with inflammatory disorders
* Patients with allergy or contraindications to the used medications
* Patients with finally pregnant or lactating females
* Cardiovascular disorders
* Severe renal impairment: creatinine clearance of ≤ 25 ml/min
* Moderate or severe hepatic impairment
Bright Light Therapy as Possible Treatment Option for MS-Fatigue

This study aims to investigate the effect of a 2-week trial of bright light therapy (BLT, 10.000 lx) on fatigue in multiple sclerosis (MS) patients. In this randomised placebo-controlled trial, the effect of bright light therapy will be compared to dim red light. MS-fatigue is quantified by patients using a visual analogue scale (VAS) and activity levels, subjective and objective sleep parameters and daytime sleepiness are measured.

Materials and methods:

* visual analogue scale (4x/day for 6 weeks; measuring fatigue)
* wrist actigraphy (6 weeks)
* sleep diaries (6 weeks)
* polysomnography (2x)
* multiple sleep latency test (2x)
* 4 subtests of the TAP (Testbatterie zur Aufmerksamkeitsprüfung; Alertness, Vigilance, Go/No-Go, Split Attention)
* questionnaires (Fatigue Severity Scale, Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, Beck Depression Inventory, Beck Anxiety Inventory, Modified Fatigue Impact Scale, Morningness-Eveningness Questionnaire)

Eligibility Criteria:
Inclusion Criteria:

* MS patients who suffer from fatigue
* Age between 18 and 65 years old
* FSS Score of 36 or greater
* ESS Score of 12 or greater
* MEQ Score between 31 and 69
* BDI Score lower than 19
* BAI Score lower than 27
* EDSS lower than 4

Exclusion Criteria:

* sleep disorders (periodic limb movement disorders, obstructive or central sleep apnea, REM sleep behavior disorders)
* change of antidepressive/fatigue influencing/sleep influencing/photosensizing/MS medication within the preceding 4 weeks
* clinical MS-relapse within the preceding 4 weeks
* consumption of alcohol: more than 1 glass per day
* consumption of caffeine: more than 4 cups per day
* current shift work
* Jet lag (travelled across two or more time zones within 90 days before study screening
* Retinopathy or other visual diseases/abnormalties
* Traumatic brain injury within the preceding 5 years
* pregnant or lactating
* Participation in another clinical trial at the same time
Smoker Extracellular Vesicles Influence on Human Bronchial Epithelial Cells

Cigarette smoking is a habit that has spread all over the world and is a significant risk factor for many diseases including cardiovascular disease, chronic obstructive pulmonary disease(COPD),asthma and lung cancer.

Evaluation and understanding of tobacco health effects are of major interest worldwide and answer to important societal concerns.

Identification of new biomarkers of exposure to tobacco smoke potentially implicated in COPD or lung carcinogenesis would allow a better observation of tobacco exposed population, thanks to screening establishment at reversible stages of pathological processes.

In this study, we question whether cigarettes smoking alters miRNA profiles of extracellular vesicles (EVs) present in human broncho alveolar lavages (BALs), which could affect surrounding normal bronchial epithelial cells status.

Extracellular vesicles (EVs) include a variety of nanoscale membranous vesicles (exosomes, microvesicles, microparticles). EVs are released into the interstitial fluid from a wide variety of normal or diseased cells.

Analysis of EVs and their content maybe useful as disease biomarkers as they reflect the contents of cells of origin, differ between normal and diseased tissue and can be reliably detected.

EVs may thus act as biomarkers of diverse pathologies like cancer, and detection of these biomarkers maybe applied to early diagnosis or assessment of prognosis in patients with cancer. EVs indeed contain both mRNAs and non-coding RNAs, such as small regulatory microRNAs (miRNAs).

Eligibility Criteria:
Inclusion Criteria:

* \>18 year-old

Exclusion Criteria:

* Lack of informed consent
* Drug treatment
* Professional exposure
* Evolutive pregnancy
* Bradycardia
* Respiratory assistance required,
* Diagnosed respiratory distress (e.g. COPD, asthma)
* Infectious pneumopathy
* Bronchial cancer
Pre-oxygenation With High-flow Nasal Cannula in Adults During Rapid Sequence Induction Anesthesia

It has been demonstrated that Transnasal Humidified Rapid Insufflation Ventilatory Exchange used during preoxygenation for emergency surgery is at least equally effective as preoxygenation compared to standard tight fitting mask. Data from a recent study indicates that Transnasal Humidified Rapid Insufflation Ventilatory Exchange might decrease the risk of clinically relevant desaturation below 93% of arterial oxygen saturation. The limitations with our previous study is that it was done only during office hours (Mon-Friday 8 am to 4 pm) and that the power to detect the occurrence of desaturation was too low.

Based on the above, the aim is now to conduct a clinical international multicenter study 24/7 with 450 patients and with a simplified protocol that allows the study to be done 24/7. This study is done with the aim of evaluation before implementing this novel technique of preoxygenation into clinical practice.

The general purpose of this project is to compare a the preoxygenation technique based on Transnasal Humidified Rapid Insufflation Ventilatory Exchange with traditional preoxygenation with a tight fitting mask during rapid sequence induction (RSI) intubation in patients undergoing emergency surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Adult, \>18 years old
2. Emergency intubation where Rapid Sequence Induction is indicated
3. Capable of understanding the study information and signing the written consent.

Exclusion Criteria:

1. Body Mass Index \>35
2. Pregnancy
3. Dependency on non-invasive ventilation to maintain oxygen saturation
Application of 2D and 3D Laparoscopy in Laparoscopic Pancreaticoduodenectomy: a Prospective Randomized Clinical Trial

Pancreatic cancer is extremely malignant, with a low sensibility to chemotherapy and radiotherapy, and a poor prognosis. Surgical treatment is very important for pancreatic cancer. Laparoscopic pancreatoduodenectomy is a standard radical procedure we are going to compare and discuss the advantages of 2D and 3D Laparoscopic pancreatoduodenectomy in our RCT study.

This study is to compare the efficiency and safety between 2D laparoscopic pancreatoduodenectomy and 2D laparoscopic pancreaticoduodenectomy for pancreatic cancer. We design a prospective randomized study. Patients with malignant pancreatic tumor who underwent pancreatoduodenectomy are recruited to the study. After obtaining informed consent, eligible patients are randomly allocated to 2D laparoscopic or 3D laparoscopic group before the operation day . The outcomes evaluated were hospital stay, and blood loss, radicality of surgery, duration of operation and complication rate.

Eligibility Criteria:
Inclusion Criteria:

Age: \>18yr, \<75yr Patients with pancreatic cancer or non-pancreatic cancers (biliary duct cancer or ampullary cancer) who underwent pancreatoduodenectomy Preoperative imaging assessment is resectable or borderline resectable -

Exclusion Criteria:

- Benign tumors of the head of pancreas Enhanced CT diagnosis revealed that the excess of SMV was more than 180 degrees, or distant metastasis.

conversion to laparotomy because of intraoperative difficulty
Medium to Long Term Outcomes of Selective Dorsal Rhizotomy

The main purpose of this study is to investigate the medium to long-term outcomes (3-10 years) after Selective Dorsal Rhizotomy (SDR) in ambulatory children and young people with cerebral palsy.

The participants will complete a survey, come to hospital for some measurements and tests.

Some parents and children and young people will also be invited to take part in an interview to understand their experiences of SDR.

The aim of this study is to investigate medium (3-5 years) to long-term (6-10 years) outcomes after SDR surgery in ambulatory children with CP and explore how it affects families' (CYP's and parents') lives over time.

A convergent parallel mixed methods study has been designed across two work packages (WPs), which will run in parallel. The International Classification of Functioning, Disability and Health (ICF) will be used as a theoretical framework to guide the data collection and to integrate data from each WP. WP-1 is an observational cohort study and WP-2 is a qualitative study.

In the observational cohort study (WP-1), routinely collected standardised outcome measures will be repeated at one additional time point, more than three years after surgery. This will mirror previous assessments carried out as part of the SDR clinical pathway, which normally concludes two years after surgery. A survey including validated Patient Reported Outcome Measures (PROMs) and a study-specific questionnaire will also be administered in WP-1. The qualitative study (WP-2) will involve an in-depth exploration of parents' and CYPs' views through semi-structured interviews to explore parents' and CYPs' experiences, reflections, and perceptions of outcomes and satisfaction of SDR in relation to previous expectations.

The results from the two WPs will be combined by comparing and contrasting findings from both WPs to provide a more holistic understanding and gain deeper insights into longer-term SDR outcomes. Findings will be used to create evidence-based family resources and decision aids to help families decide whether SDR surgery is the right treatment choice for the child and support their preparation and adjustments after SDR.

Eligibility Criteria:
Inclusion Criteria:

* Children and young people with cerebral palsy (CYPwCP)
* Classified as GMFCS level II and III (ambulatory)
* Aged between 2-15 years at the time of surgery
* Underwent SDR surgery at Great Ormond Street Hospital for Children (GOSH) (between 2013- 2021)
* Had baseline (pre-surgery) assessment and at least one follow-up assessment at 6, 12 or 24 months post-SDR

Parents of CYP with CP who have undergone SDR surgery (and meet the above criteria for CYP)

Exclusion Criteria:

* Children with CP classified as GMFCS level IV, V (non-ambulatory)
* Have any unrelated musculoskeletal problems, such as a recent acute injury
Results of Cross-leg Free Vascularized Fibular Graft

This study aims to evaluate the new technique of cross-leg vascularized fibular graft for reconstruction of post-traumatic long tibial bone defects in terms of restoring normal anatomy and function of the traumatized limb in a series of cases admitted in Assiut University hospital, Orthopedics and trauma surgery department.

Reconstruction of post-traumatic long tibial bone defects is still a major therapeutic challenge faced by orthopaedic surgeons on both anatomical and functional concerns, and it is usually associated with significant long-term morbidity. Historically, Amputation was the treatment of choice for long tibial bone defects because of difficulty of reconstructove management of such cases. Over the last few decades, Limb salvage procedures have been developed. During the second world war, massive cancellous bone autograft has been the preferred treatment. But traditional bone graft procedures in many cases may be limited by uncontrollable graft resorption. To overcome this disadvantage different management options have been developed to address bone defects of various lengths as vascularized fibular grafts, Ilizarov technique using bifocal or trifocal bone transport, acute limb shortening and masquelet procedure. However, In some cases long bone defects are associated with extensive soft tissue lacerations together with poor ipsilateral blood supply. For those cases previous surgical options are associated with many complications and may end up with failure of reconstruction and amputation, in this situation cross-leg vascularized fibular graft may be a good treatment option because it can provide a blood supply away from that of the extensively traumatized limb.

Eligibility Criteria:
Inclusion Criteria:

- Patients who were admitted into Assiut University Hospital, Orthopedics and Trauma Surgery department with big tibial bone defects ranging from 12 cm to 26 cm, associated with extensive soft tissue damage and poor ipsilateral blood supply confirmed by CT angiography and treated with cross-leg free vascularized fibular graft.

Exclusion Criteria:

* Patients with bilateral extensive soft tissue damage and poor blood supply.
* Patients with medical conditions preventing them from general anesthesia for long periods (\>10 hours).
The Comparison of Changes of QTc, Tp-e Interval, and Tp-e/QT Ratio, Tp-e/QTc Ratio on the ECG During Robotic-assisted Laparoscopic Radical Prostatectomy Under Sevoflurane, Desflurane and Total Intravenous Anesthesia -Randomized Controlled Trial

The purpose of this study is to compare the changes of QTc, Tp-e interval, and Tp-e/QT ratio, Tp-e/QTc ratio on the ECG during robotic-assisted laparoscopic radical prostatectomy under sevoflurane, desflurane and total intravenous anesthesia


Eligibility Criteria:
Inclusion Criteria:

1. ASA class I-III
2. patients undergoing elective robot-assisted laparoscopic radical prostatectomy
3. adult (≥19 years old)

Exclusion Criteria:

1. emergency surgery
2. preoperative QTc prolongation
3. Cardiac disease (unstable angina, congestive heart failure, valvular heart disease)
4. uncontrolled hypertension (DBP \>110 mmHg)
5. Patients who take beta blocker
6. Ventricular conduction abnormality
7. Hepatic or renal failure
8. Drug hyperactivity
9. patients unable to understand informed consent (foreigner, illiteracy..)
Measuring Placebo Effect by Elimination and Investigating Mechanism of Action

We propose to measure the effect of placebo by elimination as well as by a "balanced placebo" design, determine its interaction with active drug, and explore whether placebo exerts part of its effect at the pharmacokinetics level.

Placebos have been in use for centuries in medical practice. However, there is continued controversy regarding their effectiveness and mechanisms of action.

The results of the study are expected to further our understanding of a widely used medical intervention, i.e., placebo, and of how to maximize its potential beneficial effect. It will also help assess the appropriateness of measuring the placebo effect by elimination, which has important ethical implications in relation to the design of randomized clinical trials.

Comparison: caffeine vs placebo. Dependent variables:4 hours area under the curve (AUC) of pharmacodynamics endpoints as well as pharmacokinetics endpoints in a subgroup.

Eligibility Criteria:
Inclusion Criteria:

* Males and nonpregnant females 18 and 40 years of age with at least high school education.

Exclusion criteria:

* Include evidence of clinically relevant deviation from normal health (such that it may affect the endpoints, make the ingestion of caffeine dangerous, or affect the pharmacokinetics/pharmacodynamics of caffeine),
* Pregnancy,
* Poor venous access,
* Hypertension (more than 140/90),
* Heart disease,
* History of panic attacks,
* Average daily caffeine consumption of more than 300 or less than 100 mg,
* Smoking,
* Alcohol abuse,
* Taking any medication other than birth control bills (including over-the-counter drugs) within one week from starting the study,
* Hypersensitivity to caffeine or related compounds,
* Hemoglobin of less than 13 gm/L, and recent (one week) acute illness
Study Comparing Pharmacokinetics, Safety and Immunogenicity of CT-P6 and US-licensed Herceptin

This is a double-blind, two-arm, parallel-group, single-dose study.

This is a double-blind, two-arm, parallel-group, single-dose study. A total of 70 healthy male subjects will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male subject
2. Subject voluntarily agrees to participate in this study

Exclusion Criteria:

1. Female.
2. Subject has a medical condition of disease including one or more.
3. Smoker
Circumferential Spread of Anesthetic and Success in Sciatic Nerve Blockade

Current practices when performing any peripheral nerve block may or may not involve ensuring circumferential spread of local anesthetic around the nerve. Ensuring circumferential spread can involve several redirections of the needle above and below the nerve, and potentially could result in either more discomfort for the patient or an increased chance of inadvertent direct trauma to the nerve. Not ensuring spread around the nerve may result in a slower and less complete blockade. The investigators suspect that by ensuring complete spread around the nerve, the speed of block onset would be quicker because it avoids the loss due to diffusion time.


Eligibility Criteria:
Inclusion Criteria:

1. English-speaking
2. ASA physical status I-III
3. 18-85 years of age, inclusive
4. 50-110 kg, inclusive
5. 150 cm of height or grater
6. Scheduled for elective foot or ankle surgery

Exclusion Criteria:

1. Contraindications to sciatic nerve block (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the popliteal area)
2. Significant peripheral neuropathy or neurologic disorder affecting the lower extremity
3. Pregnancy
4. Contraindications to, allergies to, and/or past adverse reactions to study medications (local anesthetics, opioid analgesics)
5. History of alcohol or drug dependency/abuse
6. History of long term opioid intake
7. History of significant psychiatric conditions that may affect patient assessment
Effect of ON-tDCS on Memory Function Improvement and Related Circuits in Stable Depression Patients

So far, antidepressant drugs have limited memory improvement. Transcranial direct current stimulation, as a non-invasive and safe neuroregulatory technique, is a new direction to improve memory.In this study, transcranial direct current stimulation of the greater occipital nerve was used to explore the effect of improving memory function in patients with stable depression, and related studies were conducted on the locus coeruleus-noadrenal loop and the functional connection between locus coeruleus, hippocampus and amygdala.

In this study, a randomized, controlled, double-blind design was adopted. Patients with depression were randomly divided into an intervention group and a control group to receive true or fake tDCS stimulation respectively. Clinical data, memory and other related cognitive function assessment, EEG, resting state fMRI, saliva and blood indicators were collected two weeks before and two weeks after the intervention, and followed up for eight weeks. Finally, data correlation analysis was performed.

Eligibility Criteria:
Inclusion Criteria:

1. Eligible for ICD-10 depressive episode (F32) or recurrent depressive disorder (F33) diagnosis;
2. Antidepressant therapy for at least 8 weeks, with no antidepressant adjustment for nearly 2 months
3. HAMD-17 scores ≤ 7 points at the time of enrollment; CGI score ≦2;
4. Chief complaint of memory impairment, PDQ-D score of cognitive impairment ≧17 points;
5. Right-handed.

Exclusion Criteria:

1. A history of major physical diseases;
2. Have other mental disorders that meet the diagnostic criteria of ICD-10;
3. Hearing, color blindness, color weakness or receive electroconvulsive therapy;
4. Alcohol dependence or substance abuse;
5. Patients with intellectual disability;
6. Pregnant or lactating women or those planning to become pregnant;
7. Patients with contraindications to tDCS.
Phase I Study to Evaluate KP405 in Healthy and Parkinson's Disease Patients

This study will explore the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of KP405 as a potential new treatment for Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

* Healthy as determined by a responsible physician, based on medical evaluation including medical history, physical examination, concomitant medication, vital signs, 12-lead ECG, cardiac Holter monitoring and clinical laboratory evaluations.
* Clinical diagnosis of Parkinson's disease meeting United Kingdom Brain Bank criteria.

Exclusion Criteria:

* Clinically relevant history of abnormal physical or mental health interfering with the study as determined by medical history and physical examinations obtained during Screening as judged by the Investigator (including \[but not limited to\], neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder), excluding Parkinson's disease.
* Clinically significant, as judged by the Investigator, neurologic disorder (other than Parkinson's disease) including history of stroke or transient ischaemic attack within 12 months of Screening, cognitive impairment, seizure within 5 years of Screening or head trauma with loss of consciousness within 6 months of Screening.