cyrilzakka/clinical-trials huggingface dataset:
The Influence of Sleep Education With Social Media Reminders on the Sleep Quality in Adolescents

Objective: This study aimed to determine the effect of sleep education, supported and unsupported with social media reminders, on sleep quality in 14-18 age group adolescents.

Design: This study is in a single-blind randomized controlled design. The study was carried out between October 2019 and January 2020.

Participants: The sample of this study consisted of 60 students randomly selected from three Anatolian High Schools in the city center. The students were divided into 3 groups of 20 people each (Experiment 1, Experiment 2, and Control). According to the scan result, adolescents who have sleep quality (PSQI\>5 and CASQ\>16), use Smartphone and the internet, have no chronic diseases and obesity, and have no mental problems were included in the study. Adolescents who use sleeping pills or any other medication and have communication obstacles were excluded from the study. The study was completed with 55 adolescents due to the separation of 5 adolescents during the experiment.

Intervention: The sleep education group, which was unsupported with social media reminders, was given sleep education for 30 minutes once a week for four weeks at school. In addition to the education at school, information messages and warnings were sent to the sleep education group, which was supported with social media reminders, via WhatsApp. The control group did not receive any intervention other than taking measurements of sleep parameters once a week.

Main Outcome(s) and Measure(s): The data were collected with Pittsburgh Sleep Quality Index, Cleveland Adolescent Sleepiness Questionnaire, Adolescent Sleep Habits Form and MI Band 3 device.

The application of the research was planned according to the literature review and recommendations of the cognitive behavioral therapy approach. Sleep-related CBT practices consist of stimulus control, sleep restriction, relaxation techniques, managing sleep-related concerns, sleep hygiene education, and paradoxical intention. CBT practices consist of stimulus control and sleep hygiene education were used in this study. The sleep hygiene education that is part of the CBT method was used in the sleep education given to the Experiment 1 group. The sleep hygiene education that is part of the CBT method and the written stimulus control applications with WhatsApp was performed twice a day in the Experiment 2 group.

Eligibility Criteria:
Inclusion Criteria:

* Don't have any language and hearing problems
* Use the internet and Smartphone
* Do not have any chronic diseases
* Mental disorders and obesity
* Do not use any medication that causes sleep problems

Exclusion Criteria:

* Use sleeping pills
* Have psychiatric and chronic diseases
* Have mental disabilities were excluded from the study.
The Art of Moving for Sustainable Health

Sedentary behaviour is particularly high among the older and in the presence of a chronic pathology. Physical activity is limited mainly by the lack of accessibility to activities offered in the city and the lack of motivation.

The objective is to study the physical solicitations and the well-being during the visit of a museum (free or guided visit). Our hypothesis is that this cultural activity induces a sufficient physical solicitation for sedentary people and for individuals with a post-stroke motor disability.

All the tests will be carried out during the same day by experienced physiotherapists. Physical and well-being tests will be performed before and after the visits. The number of steps taken during the visit will be measured.

This is a different approach to promote physical activity and this proposal is an original way to stimulate the physical, psychic and social health of sedentary people. If the results are beneficial, museums could become real health partners to stimulate the activity of sedentary people.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 50 years
* Sedentary condition (\<150 minutes of physical activity per week)
* Medical stability
* Mini Mental State Evauation \> 22
* Walking independently with or without assistance
* MiniBESTest \> 20/28
* For individuals with stroke: chronic post-stroke condition.

Exclusion Criteria:

* Refusal to participate;
* Person with other conditions affecting independent walking;
* Contraindications to prolonged standing;
* Pain greater than 4/10 on the NRS;
* Concomitant pathologies that may interfere with the results;
* Inability to follow the study procedure (cognitive disorders, dementia, psychological disorders, language problems...).
The Use of Post-operative NPWT Dressing in the Prevention of Infectious Complications After Ostomy Reversal Surgery

Introduction: Although negative-pressure wound therapy (NPWT) is likely advantageous for wound healing, the efficacy and safety of its prophylactic use remain unclear. We performed a Randomized Control Trial to assess the usefulness of postoperative NPWT in reduction of postoperative wound healing complications and surgical site infections after diverting ileostomy closure, in the group of patients previously operated for colorectal resection due to cancer.

Materials \& Methods: Prospective, randomized study will be conducted. Patients with past history of colorectal cancer laparoscopic surgery with protective loop ileostomy scheduled to undergo ileostomy closure with primary wound closure will be randomly divided into groups with or without NPWT. The primary endpoint are incidence of wound related complications (WRC) (wound healing complications witch required surgical intervention other than suture removal or dressing changing). The secondary endpoints are incidences of Surgical Site Infection (SSI) and length of postoperative hospital stay (LOS) and length of complete wound healing (CWH). Cost analysis will also be performed.

In first step of this study between January 2016 and December 2018 we will asses the usefulness of one of the NPWT devices (NANOVA KCI) in prevention of WHC in established group. The second part of the study will be performed in 2 centers between January 2019 and December 2021. In this step we want to compere other NPWT devices in the same application and to confirm single center outcomes .


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 or older
* Previous colorectal resection with the formation of protective ileostomy due to cancer
* Ileostomy closure surgery as an elective procedure.

Exclusion Criteria:

* Emergency or urgent operation
* Active infection
* Other than ileostomy closure or parastomal hernioplasty operation performed.
* Patents who within 1 week after operation will be re-operated or transferred to Intensive Care Unit or other hospital word due to noninfectious complications
Green Tea Extract and Prostate Cancer

The purpose of the study is to see if a green tea extract can beneficially alter several markers of cancer risk and progression.

To evaluate the short-term effects of a daily dose of Polyphenon E administered during the interval between prostate biopsy and radical prostatectomy in men with recently diagnosed prostate cancer. Endpoints will be changes in serum and tissue biomarkers related to progression of cancer.

The effect of Polyphenon E on tumor cell c-Met expression and phosphorylation is the primary objective. Secondary objectives include the effects on the other tissue and serum biomarkers. Evaluation of the safety and tolerability of Polyphenon E in this subject population is another objective.

1.1 Determine the effects of Polyphenon E on tumor cell c-Met expression and phosphorylation levels in patients with prostate cancer 1.2 Determine the effects of Polyphenon E on PI-3K activation in patients with prostate cancer 1.3 Determine the effects of Polyphenon E on MAPK activation in patients with prostate cancer 1.4 Determine the effects of Polyphenon E on expression levels of other proteins involved in motility and invasion such as Rho GTPases and extracellular proteinases in patients with prostate cancer 1.5 Determine the effects of Polyphenon E on markers of angiogenesis in patients with prostate cancer 1.6 Determine the effects of Polyphenon E on serum Prostate Specific Antigen (PSA) in patients with prostate cancer 1.7 Determine the effects of Polyphenon E on other serum markers: C-reactive protein (CRP), Insulin-Like Growth factor I (IGF-I), Insulin-like Growth Factor Binding Protein 3 (IGFBP-3), Hepatocyte Growth Factor HGF 1.8 Evaluate the safety and tolerability of Polyphenon E in this subject population

Eligibility Criteria:
Inclusion Criteria:

* recent biopsy positive for prostate cancer
* scheduled for prostatectomy
* must be able to swallow capsules
* Palpable mass by digital rectal examination (DRE)
* Ability to give informed consent and willingness to adhere to study protocol
* Age ≥ 18 years and less than 75

Exclusion Criteria:

* abnormal liver function
* Prior hormonal or surgical therapy for prostate cancer
* Liver or kidney problems that would interfere with metabolism of study drug
* Any condition that would hamper informed consent or ability to comply with study protocol
* Participation in another research study in the last three months
* Known malignancy at any site other than prostate
* Recent consumption of green tea (5 or more cups per day, within one week prior to biopsy)
A Study of LN-144 in People With Metastatic Melanoma to the Brain

This is an open label study evaluating lifileucel (LN-144) in patients with melanoma brain metastases.

Lifileucel (LN-144) is an autologous Tumor Infiltrating Lymphocytes (TIL) cell therapy that utilizes a 22-day centralized GMP process. Lifileucel is infused as part of a treatment regimen that includes preparative NMA-LD, followed by one-time autologous TIL infusion, and a short course of high-dose IL-2.

Eligibility Criteria:
Inclusion Criteria:

1. Metastatic melanoma with asymptomatic brain metastases
2. At least one resectable lesion (or aggregate of lesions resected) of a minimum 1.5 cm in diameter post-resection to generate TIL
3. Must be ≥ 18 years of age at time of consent
4. ECOG performance status of 0-1 and estimated life expectancy of ≥ 3 months
5. Adequate hematologic parameters and organ function

Exclusion Criteria:

1. Received organ allograft, except kidney transplant, or prior cell transfer therapy including TIL and CAR-T therapies
2. Ongoing grade 2-4 toxicity from prior immunotherapy (excluding endocrine, ocular toxicity or vitiligo)
3. History of hypersensitivity to any component or excipient of lifileucel or other treatment regimen drugs
4. Symptomatic brain metastases
5. Chronic systemic steroid therapy of \> 10 mg/day
6. Active medical illness(es) that would pose increased risk for protocol participation
7. Must have negative syphilis assay and be seronegative for HIV, positive serology for HBV must have corresponding PCR assay and may be enrolled if viral load by PCR is undetectable
8. Primary immunodeficiency
9. Received live or attenuated vaccine within 28 days prior to beginning NMA-LD
10. Pregnant or breastfeeding
11. Patients who cannot receive gadolinium-enhanced MRI.
Organ Preservation in Elderly Patients With Rectal Cancer

In elderly patients postoperative mortality measured 3-6 months after total mesorectal excision is high. Thus, less toxic treatments may lead to a survival benefit for elderly patients even if a risk of local recurrence is slightly higher compared to the open surgery. The investigators addressed the question whether watch and wait policy is safe in clinical complete responders after (chemo)radiation for elderly patients with small or moderately advanced tumours.

There are two steps of selection. In the first step, the elderly patients with small or moderately advanced tumours who should routinely receive neoadjuvant chemoradiation (or radiation alone in those unfit for chemotherapy) prior to full-thickness local excision using transanal endoscopic microsurgery or prior to total mesorectal excision will be included. In the next step, only patients with clinical complete response obtained 8-10 weeks from completion of (chemo)radiation are selected. Those patients constitute study group and will be observed without further treatment. The remaining patients with residual cancer will proceed to routine management, namely transanal endoscopic microsurgery or total mesorectal excision. Patients undergoing transanal endoscopic microsurgery and having poor response to (chemo)radiation (ypT2-3 disease or positive margin) will proceed to the conversion to total mesorectal excision.

Neoadjuvant chemoradiation: 50 Gy total dose over 5 weeks with 2 Gy per fraction delivered with simultaneous chemotherapy consisting of three cycles of 5-Fu 200 mg/m2 i.v. bolus and leucovorin 100 mg/m2 i.v. short infusion over 2 days given during 1-2, 15-16, and 29-30 days of radiotherapy. Patients unfit for chemotherapy will receive 25 Gy total dose over 5 days with 5 Gy per fraction.

The study hypothesis is that in clinical complete responders after (chemo)radiation treated without initial surgery, the local recurrence rate will be less than 25% and results of the rescue surgery (local and distant recurrence rate) will be not worse (or only slightly worse) than that seen after up-front total mesorectal excision in patients with similar stage of the disease.

Eligibility Criteria:
Inclusion Criteria:

The initial eligibility criteria

* Age ≥70 years or \<70 years in patients with ASA 3+
* Tumour accessible by digital rectal examination
* Maximal tumour size (usually length) not more than 5 cm
* Circumferential bowel wall involvement not larger than 60%

There will be two groups of patients:

1. Candidates for preoperative (chemo)radiotherapy and local excision: tumour ≤3 cm, non-polipoid cT1, or cT2 or borderline cT3, cN0.
2. Candidates for preoperative (chemo)radiotherapy and total mesorectal excision: cT2 tumors requiring abdominoperineal excision, or cT3 or resectable cT4 (slight involvement of vagina, prostate or seminal vesicles); cN+ is allowed.

The final eligibility criterion

• Complete clinical response obtained 8 weeks after chemoradiation or 10 weeks after short-course radiation

Exclusion Criteria:

* Distant metastases
* Fixed tumour on digital rectal examination
Fetal Heart Rate Variability and Fetal Growth Restriction

There is growing evidence in the field of fetal heart rate variability revealing the fetal neurological state. Furthermore, fetal heart rate variability has shown potential as fetal surveillance in fetal growth restriction.

This study aim to investigate the association between fetal heart rate variability and doppler flow changes in growth restricted fetuses.


Eligibility Criteria:
Inclusion Criteria:

* singleton pregnant women with estimated fetal weight below 2 standard deviations (2SD) of mean for gestational age corresponding to minus 22%. Fetal weight assessed by doppler ultrasound.

Exclusion Criteria:

* Fetal malformations
Quality of Life Interventions During Cervical Cancer Treatment

The proposed project will examine the effects of a healing touch intervention in women receiving chemotherapy and radiation for advanced cervical cancer.

Patients receiving chemoradiation for cervical cancer are at risk for distress, chemoradiation-related side effects, and immunosuppression. This prospective randomized clinical trial proposes to examine the effects of a complementary therapy, Healing Touch (HT), versus relaxation training (RT) and usual care (UC) for (1) supporting cellular immunity, (2) improving mood and quality of life (QOL), and (3) reducing treatment-associated toxicities and treatment delay in cervical cancer patients receiving chemoradiation.

Eligibility Criteria:
Inclusion Criteria:

* Women with stage I-IVa cervical cancer pursuing concurrent chemotherapy and radiation therapy.

Exclusion Criteria:

* Greater than Stage IVa cervical cancer
* Metastatic or recurrent cervical cancer
* Patients receiving only chemotherapy or only radiation therapy
* History of cancer of any site
* History of a transplant
* Diagnosed with any immunosupressive disorder (HIV, AIDS).
Study of Remimazolam Tosilate in Patients Undergoing Diagnostic Upper GI Endoscopy

The purpose of this study is to evaluate the safety and efficacy of the sedation for Remimazolam or Propofol in patients undergoing diagnostic upper GI endoscopy.

This is a multi-center, ,parallel-group, single blind study using Remimazolam or propofol for sedation in patients undergoing diagnostic upper GI endoscopy.Subjects are randomized to different treatment groups (including 1 for Remimazolam Tosilate and 1 for propofol). Fentanyl are permitted during a diagnostic upper GI endoscopy.Efficacy and safety profiles of Remimazolam Tosilate are to be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* subjects aged 18-60 years；
* intending to undergo diagnostic upper GI endoscopy;
* ASA( American Society of Anesthesiologists) I or II；
* 18 kg/m²\<BMI(Body Mass Index)\<30 kg/m²;
* the operation time of gastroscopy is not more than 30 min；
* Signed informed consent.

Exclusion Criteria:

* Patients need to be Complicated gastroscopy;
* Patients need to be Tracheal intubation;
* Patients with respiratory management difficulties (Modified Mallampati grade IV）;
* one or more of the laboratory findings fall out of the limitations for this study(platelet,hemoglobin,aspartate aminotransferase,etc.);
* A history of drug abuse and / or alcohol abuse 2 years prior to the screening period；
* allergic to drugs used in the study;
* pregnant women or those in lactation period
* The subject has participated in other clinical trial within the 3 months prior to randomization.
Q-POC SARS-CoV-2 Assay COVID-19 Clinical Evaluation

Q-POC SARS-CoV-2 moderate complexity PCR test performance evaluation

The Q-POC SARS-CoV-2 Assay is a real-time PCR test intended for use on the Q-POC instrument for the qualitative detection of nucleic acids from Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), in nasal mid-turbinate swabs (MTSW) obtained from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity or moderate complexity tests.

The Q-POC SARS-CoV-2 Assay is intended for use by laboratory personnel who have received specific training on the use of the Q-POC SARS-CoV-2 Assay in conjunction with the Q-POC instrument (Q29001).

Eligibility Criteria:
Inclusion Criteria:

* Participants must be over the age of 18 years.
* Participants must present with symptoms indicative of SARS-CoV-2 infection, within 0-5 days of symptom onset.
* Participants must have capacity to give informed consent.

Exclusion Criteria:

* Participant is under the age of 18 years.
* Participant does not have symptoms of SARS-CoV-2 infection.
* Participant lacks capacity to give informed consent.
Randomized Trial of Advanced Provision Emergency Contraception Among Women With Gonorrhea or Chlamydia

The purpose of this trial is to determine whether providing non-contracepting women with gonorrhea or chlamydial infection with advanced provision emergency contraception (APEC) and condoms decreases their risk of becoming pregnant.


Eligibility Criteria:
Inclusion Criteria:

Non-contracepting women \>15 years of age who were reported to Public Health Seattle \& King County with a diagnosis for gonorrhea or chlamydial infection and who were interviewed by public health staff for purposes of partner notification

Exclusion Criteria:

* Use of effective contraception (hormonal contraception, IUD, diaphragm); sex with only one partner in the preceding 60 days who was status post vasectomy; age \<15; inability to speak English; history of tubal ligation, hysterectomy, or menopause.
Action Observation Therapy Versus Mirror Therapy on Upper Limb in Stroke

Stroke is a medical condition which causes the cessation of blood flow to the brain cells and results in cell death and ultimately can lead to motor disorders, perception disorders, language disorders, sensory disturbances.It is well known that stroke is the leading cause of death and one of the greatest causes of long-term motor disability in adults.The incidence of stroke is increasing day by day in low-income countries as compared to high-income countries because of the effects of not using evidence-based practice in health-related conditions in low-income countries. In the last few years, several approaches have been used for the recovery of hand dexterity after stroke. Among them, the Mirror therapy, task-oriented therapy, robot-assisted rehabilitation and action observation has gained greatest attention.Action observation training is one of the new developing rehabilitation technique that targets motor learning by the activation of mirror neurons and is the most important approach that targets the motor and functional recovery in stroke patients. In action observation training, the movements are produced because of the external stimuli in which actually the visual attention recruit the cerebellar-thalamic-cortical circuit of the brain. Action observation is based on activities of the motor neuron system and they discharge mostly in association with complex tasks as compared to simple tasks.


Eligibility Criteria:
Inclusion Criteria:

* Both male and female
* Middle cerebral artery stroke
* 1 to 6 months of stroke onset
* Baseline score of the Fugyl Myer Assessment is between 20 and 60 for the upper limb.
* Modified Ashworth scale with a score of 2 Ability to follow the study instructions-Mini mental state examination (MMSE) score \>25

Exclusion Criteria:

* Participants failing to fall in this category would be excluded from the study.
* Patients who cannot perform the active movement of the upper limb in pre-stroke condition due to musculoskeletal problems
* cardiopulmonary diseases which could hinder their ability to participate in the rehabilitation program in this study
* Patient with impaired cognition
What is an Important Change in the Short Physical Performance Battery (SPPB)?

The purpose of this study is to determine the important change in the Short Physical Performance Battery (SPPB) when used in patients with lung disease. The SPPB is a simple physical test that measures balance and the functioning of the legs. It has been widely used in healthy elderly populations and predicts hospital admission and the onset of disability. The SPPB has not previously been used in patients with lung disease, and it is not clear what change in this test is considered meaningful and worthwhile by patients or doctors (the minimal clinically important difference: MID). Knowing what the MID for the SPPB will allow researchers and doctors to evaluate the effectiveness of current and new treatments, and to detect improvement or deterioration in the condition of patients.


Eligibility Criteria:
Inclusion Criteria:

* All patients entering pulmonary rehabilitation

Exclusion Criteria:

* Any patient in whom mobility and lower limb function have been significantly affected by a neuromuscular cause, severe peripheral vascular disease or amputation.
* Any patient whom the chief investigator feels it is unsafe to exercise (e.g. unstable cardiac disease).