cyrilzakka/clinical-trials huggingface dataset:
Tumor Metabolism of Lung Cancer in Patients Who Underwent Percutaneous Radiation Measured With F-18-FDG-PET

The purpose of the study is to describe the regional and global FDG-kinetics in non-small-cell lung cancer (NSCLC) during percutaneous radiation therapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed NSCLC not curable by surgery
* Karnofsky \> 80%
* Tumor volume and localization allow curative radiotherapy
* Written consent

Exclusion Criteria:

* Metastases
* Diabetes
* Pregnancy
* Psychiatric impairment
Aerobic Vs Neuromuscular Exercise for Knee OA

The study aims to compare the effects of an education and High Intensity Interval Training program (eHIIT) with the widely used Neuromuscular Exercise and education program (NEMEX-e) on knee OA symptoms and risk factors for cardiovascular disease in people with knee OA and at least one risk factor for developement of cardiovascular disease. The main research questions the study aims to answer are:

* Is the eHIIT program better than the NEMEX-e program for reducing the risk of cardiovascular disease?
* Are the two programs equally good at providing improvement in knee symptoms?


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18- years
* Diagnosis of tibiofemoral knee OA according to the American College of Rheumatology criteria
* Radiographically confirmed diagnosis of tibiofemoral OA based on radiographs not older than 6 months.
* Average knee pain level ≥ 4 (0=No pain and 10=Worst pain) over the past week (7 days)
* At least one of following risk factors for development of cardiovascular disease:

  * Body mass index ≥ 30 kg/m2
  * Hypertension (or in treatment of): Systolic ≥ 135 and/or diastolic ≥ 85 mm Hg
  * Elevated HbA1c (or in treatment of): ≥ 130.7 mg/dL (44 mmol/mol)
  * Elevated Triglycerides (or in treatment of): ≥ 150 mg/dL (1.7 mmol/L)
  * Elevated Cholesterol (or in treatment of) (Low density lipides, LDL): LDL ≥ 54 mg/dL (3.0 mmol/L)

Exclusion Criteria:

* Contraindication to exercise (e.g., resting systolic blood pressure \> 200 or diastolic blood pressure \> 115, acute or reoccurring chest pain)
* Unstable body weight the last 3 months (gain/loss outside +/- 5 kg)
* Planned weight loss (non-pharmacological, pharmacological, and surgical) during study participation
* Known current cancer
* Major cardiovascular event within the last 5 years
* Insulin dependent type 1 or type 2 diabetes
* Psoriatic, rheumatoid, or gouty arthritis disease
* Generalized pain syndromes such as fibromyalgia
* Lumbar or cervical nerve root compression syndromes
* Scheduled surgery during study participation
* Treatment with biological medication
* Impairments that prevent performance in high intensity aerobic exercise
* Current or planned participation in other health research intervention studies
* Pregnant/considering pregnancy
* Any other condition or impairment that, in the opinion of the investigator, makes a potential participant unsuitable for participation or which obstruct participation, such as a large knee joint effusion, uncontrolled diabetes/hypertension, psychiatric or cognitive disorders, language barriers, or opiate dependency.
MI Practice and tDCS With Aging

The mental repetition of movements - or motor imagery (MI) practice - facilitates motor learning. It allows avoiding fatigue that occurs during physical practice; this method is thus particularly interesting for elderly people. Transcranial direct current stimulation (tDCS) is a noninvasive method of neurostimulation during which a low direct current is applied to the brain via electrodes placed on the scalp. This method has been successfully used to enhance motor learning in both young and elderly subjects.

The main aim of this study is to assess the impact of MI practice combined with tDCS on the learning of a complex finger sequence, in young and elderly subjects.

For that purpose, young and elderly healthy subjects will be randomly assigned to Stimulation and Sham groups. There will thus be a total of four groups: Young Stim, Young Sham, Elderly Stim, and Elderly Sham.

All subjects will participate to three training sessions spread over five days, and a retention test one week after the third training session.

During training they will mentally repeat a complex finger sequence with the left hand, for 13 min:

* Subjects of the Stimulation groups (Young Stim and Elderly Stim) will receive in parallel an anodal tDCS of the primary motor cortex.
* Subjects of the Sham groups (Young Sham and Elderly Sham) will receive in parallel a sham tDCS of the primary motor cortex.

Immediately before (pretest) and after (posttest) each training session, as well as during the retention test, subjects will repeat the sequence as many times of possible, for 1 min. During these tests (pretests, posttests and retention test) electroencephalographic activity will be recorded to assess the Mu rhythm power.


Eligibility Criteria:
Inclusion Criteria:

* Being aged between 20 and 35 years for the young subjects / between 65 and 80 years for the elderly subjects
* For elderly subjects: Mini Mental State Examination (MMSE) ≥ 24
* Being a male or a female
* Being right handed
* Taking an effective method of contraception for the women of childbearing age
* Having signed the consent form
* Being registered with a social security scheme

Exclusion Criteria:

* Presenting a neurologic, psychiatric or motor trouble
* Practicing or having practiced at least 5 hours by week an activity involving a high manual dexterity (e.g. piano)
* Showing any contraindication to tDCS:

  * History of epilepsy
  * head trauma with loss of consciousness
  * Implanted material (pacemaker, surgical clips, metal specks in the skull, etc.)
  * Past neurosurgical intervention
  * Open sore on the scalp
  * Consumption of more than three glasses of alcohol daily
  * Use of drugs
  * Pregnancy (positive pregnancy test)
Innovation of Audio-Visual Triage System in Combating the Spread of COVID-19 Infection and Its Efficacy: A Novel Strategy

During the novel coronavirus pandemic, also known as SARS-CoV-2 or COVID-19 pandemic, frontline healthcare professionals suffered psychological as well as pathological trauma due to the lack of preparation to cope with this unforeseen situation. The protocols to prevent the spread of this disease proved to be less effective than anticipated. In these circumstances, improvement of the existing triage system was felt and an AUDIO-VISUAL TRIAGE (AVT) system was introduced to enhance confidence as well as increase the safety of frontline healthcare professionals. The current analysis was performed from March 21, 2020, to April 28, 2020, until the completion of sixty response forms, at Bahria Town International Hospital, Lahore. Thirty participants (Group A) deployed on visual triage and other thirty (Group B) on Audio-Visual triage for screening suspected cases of COVID-19 infection. Anxiety levels were measured by using the GAD-7 scoring system and the participants of both groups were periodically tested for COVID-19 infection by PCR. Independent t-test was used to evaluate the significance of different variables at a confidence level of 95%.

A novel strategy 'Audio-Visual Triage' was introduced to boost up the confidence levels, lower down the anxiety levels and the most important factor is to reduce the risk of COVID-19 infection spread. This Triage system included Audio system to communicate with patients and access the COVID-19 infection status at recommended distance of 6 feet. The main disturbing factors that were noted on Visual triage system were, 1). Close contact of healthcare professionals with patients and attends, 2). Fear of transmission of infection lead to higher levels of anxiety. To assess the efficiency of AVT Anxiety level were analyzed by using Spitzer et al., 2006, General Anxiety Disorder-7 (GAD-7) scoring system and outcomes were assessed where a score less than 5 is taken as no anxiety, 5-9 interpreted as mild anxiety, 10-14 moderate anxiety, and ≥ 15 as severe anxiety levels.

Eligibility Criteria:
Inclusion Criteria:

* Participants performing their duty on visual triage.

Exclusion Criteria:

* Those participants having previous psychological illness, frequently used to use the washroom, had non-serious attitude and poor compliance with the protocols of wearing PPEs were excluded from the study.
Corticosteroid-induced Lipodystrophy and Adipokines

Hypothesis: systemic therapy with corticosteroid induces morphological changes (e.g., moon face, buffalo neck) called lipodystrophy (LD). We hypothesize that this LD is associated with variation of adipocytokines (e.g., adiponectin, leptine, IL6) levels

Primary objective: To show a 50% decrease in adipocytes adiponectin's expression in patients who developed LD versus those who did not developed LD during the first 3 months of a systemic therapy with corticosteroids

Secondary objectives: To look for differences in the mRNA expression of 11bHSD1, SREBP1c and PPARg in fat samples of patients before and after treatment with systemic corticosteroids and between LD+ and LD-patients To compare the fat morphology before and after treatment with glucosteroids

Design: Monocentric, cross-sectional analytical study

Subjects: 32 HIV-free and Cushing disease-free adult patients for whom a prolonged treatment (³3months) with glucosteroids (³ 0.5 mg/kg/day) is initiated

Methods: At treatment initiation and 3 months after: comparison of fat sample mRNA expression of adipokines (adiponectin, leptin, IL6, TNFa), 11bHSD1, SREBP1c and PPARg, fat morphology and seric concentrations of adiponectin, leptin, IL6, sTNFR1 between patients LD+ and patients LD-. The diagnosis of LD will be performed by 3 experts using patients photographs

Aims of this study:

* To gain a better understanding of the pathophysiology of glucosteroids-induced LD
* To compare this pathophysiology to the one of HIV-associated LD for which the hypothesis of a local, cellular, hypercorticism has been put forward and for which related treatment have been prescribed.

Eligibility Criteria:
Inclusion Criteria:

* adult patient
* starting therapy with prednisone
* corticosteroid therapy lasting more than 3 months
* baseline prednisone dosage \>= 0.5 mg/kg/d

Exclusion Criteria:

* Cushing disease
* HIV +Pregnancy
* Recent weight lost (\> 5% of the usual weight)
* Therapy with glucocorticosteroids during the past 6 months
Psychoeducational Intervention Against Support Groups for Caregivers

Background: To explore the effectiveness of a psychoeducational intervention against support groups and the usual care in caregivers. Providing care involves major changes in the lives of caregivers, with far-reaching repercussions. There is evidence that acting upon its mediator variables reduces its effects.

Methods: A randomised controlled trial will be carried out. The study will be conducted at the Faculty of Psychology of the University of Salamanca (USAL) in Spain. Family caregivers of people with dementia will participate in this study. The participants will be divided into three groups: the intervention group (IG), which will undergo a psychoeducational intervention programme, the support group (SG) (control group - placebo), which will undergo a support group intervention programme, and the control group-waiting lists (CG), which will only be assessed at the different measurements points, and after the end of the programme they will be offered the intervention of the experimental group. The programme (IG) will comprise eight sessions over a period of two months. All participants will be assessed at the outset and conclusion of the study, as well as after three and six months, during which time data regarding their socio-demographic characteristics and responses to the different scales will be collected. Both mediator and negative outcome variables will be assessed.

Discussion: Effective interventions need to be developed to improve the biopsychosocial state of caregivers. The presented psychoeducational intervention may help family caregivers because it could be more effective than others. The psychoeducational intervention has the aim of improving quality of life, problem-solving and social skills, leisure time, self-efficacy and social support of caregivers; and decreasing their depressive symptomology, dysfunctional thoughts, burden and stress.


Eligibility Criteria:
Inclusion Criteria:

* Be the main caregiver of a family member with dementia, either as a spouse or as an offspring.
* No previous involvement in studies/programmes like this one.
* The family member lives at home (not institutionalised).

Exclusion Criteria:

* Not be the main caregiver of a family member with dementia, either as a spouse or as an offspring.
* Previous involvement in studies/programmes like this one.
* The family member not lives at home (the family member is institutionalised).
Comparative Study Between Hydrocortisone and Mannitol in Treatment of Postdural Puncture Headache

Fifty patients of both sex, aged 18-50 years and ASA I and II undergoing elective lower abdominal and pelvic surgery under spinal anesthesia were included in this randomized double-blind study. Patients were randomly divided into 2 groups 25 each; group (I) received intravenous hydrocortisone 100mg every 8 hours for 48 hours and group (II) received intravenous infusion of mannitol 20% 100ml over 30 minutes followed by 100ml every 12hours. Mean (+/- SD) of headache intensity at 0, 6, 12, 24 and 48 hours after beginning of treatment was assessed using visual analog scale.


Eligibility Criteria:
Inclusion Criteria:

* aged 18-50 years old.
* both sex.
* ASA physical status I and II.
* 70-90 kg body weight.
* height 160-180 cm.
* Elective lower abdominal and pelvic surgery e.g. repair of inguinal hernia, repair of incisional hernia, varicocele and hydrocele.

Exclusion Criteria:

* Patients with impaired kidney or liver functions.
* history of cardiac or central nervous system disease.
* uncontrolled medical disease (diabetes mellitus and hypertension)
* history of intake of non-steroidal anti-inflammatory drugs or opioids within 24 h before surgery
* allergy to the used medications
* patient's refusal
* duration of surgery more than 120 minutes.
Aerobic Exercise on Improving Sleep in Systemic Lupus Erythematosus.

The purpose of this study is to determine the effectiveness of exercise training on improving sleep in patients with systemic lupus erythematosus.

This study will test the effectiveness of aerobic exercise on improving sleep in patients with systemic lupus erythematosus. The subjects will do treadmill 2 times per week, from 15-20 min. with low to moderate(55-65% maxCF) intensity exercise, so 30 min. until 4ª week. From the 5ª to 8ª week they will be able to make greater efforts to 35-40 min. totalizing 16 weeks. The control group will not do exercise and will receive education class about disease, health, sleep, 1 time per month.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Systemic Lupus Erythematosus (SLE) according American College of Rheumatology (ACR) Criteria revised in 1997;
* Pittsburgh sleep quality index (PSQI) ≥ 5;
* Free and Clarified Consent Term signature.

Exclusion Criteria:

* Patients who have other rheumatologic diseases (rheumatoid arthritis, sjogren syndrome, fibromyalgia, ankylosis spondylitis), excerpt mild osteoarthritis;
* Systemic Lupus Erythematosus Disease Assessment Index (SLEDAI) \> 8;
* Untreated diseases: Hypertension, diabetes mellitus (DM), dyslipidemia, thyroid dysfunction, cardiorespiratory diseases, malignancies;
* Patients who do not accept the study rules as time and/or follow-up exercise program time proposed;
* Suspected or pregnancy confirmation;

  \* Patients who are taking sleeping medication;
* Patients who won´t sign the Free and Clarified Consent Term informed;
* Patients engaged in physical activity (defined as previously sedentary individuals, or that which do not perform any type of regular physical activity at least six months);
Gastric Tolerability and Pharmacokinetics of DMMET-01

The purpose of this study is to determine the gastric tolerability and the pharmacokinetics of a new drug for the treatment of type 2 diabetes, DMMET-01, in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Mexican healthy subjects with normal clinical laboratory test results and imaging (hematology, blood chemistry, urine test, VDRL, Hepatitis B, HIV, chest radiography and electrocardiogram)

Exclusion Criteria:

* Familiar or personal history of diabetes
* History of drug or alcohol abuse within the 2 years prior to the study
* A smoking habit greater tha 10 cigarettes per day
* Intercurrent disease
* Intercurrent treatment with any drug
Safety Observation on hESC Derived MSC Like Cell for the Meniscus Injury

human embryonic stem cell derived mesenchymal stem cells like cell for the meniscus injury, and observe the safety of the cells for meniscus injury

Three different dosage of human embryonic stem cell derived mesenchymal stem cells like for meniscus injury patients, and observe the safety of the cells for meniscus injury.

Eligibility Criteria:
Inclusion Criteria:

* Grade Ⅰ-Ⅱ meniscus injury of knee joint
* The patients who still have the pain of knee joint and/or limitation of the function after accepted 3 months of nonoperative treatment

Exclusion Criteria:

* Recent history of lower limb fractures or intra-articular drug injection
* The patients who have meniscus injury of knee joint need the surgical repair
* The patients who have the severe coagulation disorders, cardiopulmonary failure and so on
* The women who are pregnant or nursing
* There are electronic implants such as pacemakers in the body
* The patients who are infected the HIV, the virus of hepatitis or syphilis
* The patients who are alcoholism or drug user
* The patients who have vestibular and balance disorders
* The patients with severe cognitive impairment who cannot follow instructions to complete the treatment
* The patients who don't sign the informed consent
* The patients who have tumor
* Immunodeficiency patients
* The patients who have congenital or acquired knee malformation
* Patients or researchers who are participating in other clinical trials believe that other reasons are not appropriate for clinical trials
Efficacy of a Microalgae Extract PhaeoSOL Combined With Natural Stimulant on Cognitive Function and Gaming Performance of Video Gamers

Considering the important growing development of gaming in the world, this research area has developed considerably over the last few years. Even if it seems to be well admitted that video gamers showed better cognitive functions (e.g. visual selective attention, cognitive flexibility, task switching) parameters compared to non video gamers there is a constant concern for optimizing performance as for all other kind of athletes. However to our knowledge, only one randomized controlled trial have investigated the potential benefits of dietary supplementation on cognitive function and performance in video gamers. The use of microalgea as molecule of interest sources is a recent promising approach also to meet societal challenge as the maintain of biodiversity/landscape.

Thus, the purpose of this study is to examine whether acute (single-dose) and chronic (1 month) supplementation of Microphyt's phaeosol ingredients (BrainPhyt) ingested with or without a natural stimulant, would affect cognitive function and gaming performance in experienced video gamers.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy men and women;
2. Between 18 and 40 years;
3. Self-reported history of playing video games for 5 or more hours per week for 6 months prior to screening;
4. BMI between 18 and 34.9 Kg/m2 ;
5. Subjects agreed to supply their own operator-oriented action or strategy video game that they had played at least 21 times over the last 3 months;
6. No recent ingestion (\<2weeks) of dietary supplement that affect cognitive function;
7. Be able to give written informed consent and to consume the investigational product daily for the duration of the study;
8. Is free-living (living in a private home, alone or with family, and able to maintain their health and hygiene without assistance)
9. Willing to maintain consistent sleep duration the evening before study visits.
10. Are agreed to continue their patterned use of the game between study visits

Exclusion Criteria:

1. refrain from caffeine and alcohol for 12 hours prior to each study visits;
2. consume dietary supplements that may affect cognition and/or with a stimulant effect (e.g. guarana, cocoa, ginseng, bacopa, Gingko biloba, guayusa, yerba mate, energy drinks, other products containing fucoxanthin) at least 7 days before Visit 2 ;
3. are women who are pregnant, breastfeeding, or wish to become pregnant during the study;
4. have an untreated psychotic or major depressive disorder or any history of cognitive deficit;
5. have an uncontrolled hypertension/diabetes/thyroid/heart disease disease, cancer etc.);
6. have a significant neurological disease;
7. have planned major changes in lifestyle (i.e. diet, dieting, exercise level, travelling) during the duration of the study;
8. have a history within previous 12 months of alcohol or substance abuse;
9. have known allergy to any of the ingredients in the supplement product
10. are not willing to supply their own gaming system and/or game
Safe Surveillance of PCI Under Mechanical Circulatory Support With the Saranas Early Bird Bleed Monitoring System

The objective of this study is to establish the safety of complex high-risk Percutaneous Coronary Intervention (PCI) using Mechanical Circulatory Support (MCS) and surveillance with the Saranas Early Bird Bleed Monitoring System (EBBMS).

To demonstrate that patients undergoing complex high-risk PCI using MCS and surveillance with the Saranas Early Bird Bleed Monitoring System will have relative incidence rate reduction of access site related BARC type III or V bleeding. An optimal outcome will show a a reduction in access-site related bleeding rate when using MCS with the Saranas EBBMS in high-risk PCI patients compared to historical incidence rate.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Planned complex high-risk PCI using MCS with Impella from a femoral access and use of Saranas Early Bird Bleed Monitoring System
* The study patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the institutional review board of the respective clinical site.

Exclusion Criteria:

* Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication
* Active bleeding
* Incapacity to access safely femoral artery or femoral vein
* Significant femoral, iliac, abdominal, or thoracic aortic disease which precludes placement of MCS
* Anemia (Hgb \<9 g/dL), thrombocytopenia (Plt \<50,000 cell/mL), history of bleeding diathesis or coagulopathy, or hypercoagulable states
* Active infection not controlled with antibiotic therapy
* Currently pregnant or women of child-bearing potential without documented negative pregnancy test
* Estimated life expectancy \< 24 hours
* Patient is in cardiogenic shock at the time of enrollment
Non-coding RNA in the Exosome of the Epithelia Ovarian Cancer

This study aims to analyze the expression of micro-RNA (miRNA) and long non-coding RNA (lncRNA) by next-generation sequencing in patients with high grade serous ovarian cancer (HGSOC) and benign gynecologic diseases. The candidate miRNA/lncRNA will be validated as biomarker for the detection and prognosis of HGSOC.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed primary high grade serous ovarian cancer
* Willing to accepted debulking surgeries and adjuvant chemotherapy
* Good performance status
* Aged 18 years or older
* Signed an approved informed consents

Exclusion Criteria:

* Not meeting all of the inclusion criteria