cyrilzakka/clinical-trials huggingface dataset:
Effect of Therapeutic Massage on Sleep Quality and Stress Levels in Women With Breast Cancer

This is a randomized control trial to test the effectiveness of therapeutic massage on the sleep quality and the stress levels in women that have completed their treatment for breast cancer.

The period following the completion of treatment for breast cancer (but also for any other type of cancer as well) is once that is accompanied by an increased uncertainty. This can often trigger increased anxiety levels and sleep disturbances. This trial tests the effectiveness of therapeutic massage as a non pharmaceutical intervention that can increase the management of stress and sleep disturbances during this period of time.

Eligibility Criteria:
Inclusion Criteria:

* Women that completed their treatment
* women experiencing insomnia
* women experiencing anxiety
* women that speak and understand Greek

Exclusion Criteria:

* allergy to essential oils
* use of anticoagulants
* presence of edema
* presence of Varicose veins
Regulation of CCL18 by Corticosteroids in Severe Asthma

The majority of asthmatic patients are well controlled by inhaled corticosteroid treatment, however some severe asthma resist this treatment. CCL18 is a target gene for corticosteroids and its dysfunction may correlate with phenotypes of asthma.


Eligibility Criteria:
Inclusion Criteria:

1. control subjects =

   * non-atopic and non-smoking
   * cutting to negative pneumoallergens,
   * Total IgE levels less than 100 ku / L
   * no clinical history of asthma
   * without background treatment
2. patients with intermittent asthma =

   * being asymptomatic between asthma attacks,
   * with symptoms less than once a week
   * having a forced expiratory volume per second (FEV1) of at least 80% of the theoretical.
   * treated by ß2 mimetics on demand and will not have inhaled corticosteroids.
3. severe asthma insensitive to corticosteroid therapy =

   * continuous or nearly continuous treatment with oral corticosteroids (≥ 50% of the year) / or treatment with IC ≥ 1500 microg beclomethasone dipropionate equivalent (BDP)\] airway obstruction fixed with FEV1 ranging from less than 15% after 7 days of oral corticosteroid therapy to 40 mg / day of prednisolone;
   * Followed at the immunoallergology pneumology consultation for at least 1 year will be recruited.
4. Severe corticosensitive asthma = continuous or near continuous treatment with oral corticosteroids (≥ 50% of the year) / or treatment with IC ≥ 1500 microg beclomethasone dipropionate equivalent (BDP)\]

   * reversibility of FEV1 after treatment with oral corticosteroids.
   * Followed at the immunoallergology pneumology consultation for at least 1 year will be recruited.
5. controlled moderate asthma treated with inhaled corticosteroids \<1500μg equivalent of beclomethasone dipropionate and with: ß2 long-acting mimetics (or anti-leukotriene, or theophylline) for at least 6 months.

Exclusion Criteria:

* existence of a chronic inflammatory pathology other than asthma
* active smoking
* pregnant or lactating women
* have received oral corticosteroid treatment in the previous 3 weeks,
* have received non-steroidal anti-inflammatory drugs (NSAIDs) in the previous 2 weeks.
Field Trial of Maternal Influenza Immunization in Asia

This project is designed to assess the efficacy of immunizing women during pregnancy with influenza vaccine on the health of these women during their pregnancy and for 6 months post-partum as well as on the health of their newborn infants during the first 6 months of life. It will be conducted in Sarlahi District in southern Nepal, a rural area where a number of large scale randomized trials have been conducted over the past 20 years.

This is a community-based, placebo-controlled, individually randomized trial in trial among women who are or who become pregnant in 9 Village Development Committees in Sarlahi District, Nepal. The study population for this trial will include all women who are identified as pregnant with gestational age between 17 and 34 weeks gestation during a 12-month period in 9 Village Development Committees (VDC) of Sarlahi District, Nepal. The 9 VDCs include: Dhungre Khola, Karmaiya, Hariaun, Ghurkauli, Sasapur, Netraganj, Lalbandi, Jabdi, and Raniganj.

The vaccine that will be given will be the most current vaccine at the time of subject enrollment. That is, for women enrolled after October in either study cohort, the vaccine will be switched to the newly available vaccine for that year.

The control group will be placebo (saline injection). The justification for the use of a placebo injection in this trial is as follows: There is only one trial (Bangladesh) that demonstrates efficacy of influenza vaccination in pregnancy on perinatal outcomes and respiratory morbidity in early infancy. One of the issues with that study is that it was not placebo controlled. The "control" in that study was adult pneumococcal vaccine. It could be that the Bangladesh study underestimated the impact of influenza vaccine because the mothers and infants receive some indirect protection from the pneumococcal vaccine. In addition, influenza vaccine is not part of national policy or recommendations in Nepal at the current time and Ministry of Health officials are very interested in the results of our study as they consider their immunization program expansion over the next few years.

Eligibility Criteria:
Inclusion Criteria:

* mid to late pregnancy

Exclusion Criteria:

* do not intend to deliver in the study area
* previous pregnancy in this study
Sildenafil Efficacy Study on Time Walk From Peripheral Arterial Desease Patients (Stade II) With Arterial Claudication

Efffect of a single dose oral intake of sildenafil Or placebo on the walking capacity on treadmill of PAD patients with claudication

Sildenafil 100mg or Placebo Oral intake 2 hours before the treadmill test Safety and security control throughout the period of drug efficacy (approx 4 hours) Evaluation of maximal walking distance for a constant load treadmill test (3.2 kml/h 10% slope)

Eligibility Criteria:
Inclusion Criteria:

* Patient with peripheral arterial desease stade II
* Patient with vascular claudication for at least 3 months
* Patient able to perform a treadmill walking test with time to walk \< 5min

Exclusion Criteria:

* Patient suffering from ischemia
* Previous angina or myocardial
* Patient treated with nitrates drugs
* Patient with severe renal insufficiency
* Patient with severe hepatic insufficiency
* Patient with hypotension
Comparing Telehealth-Delivered CBT-I to Web-Based CBT-I to Enhance Sleep, Reduce Fatigue, and Promote Neuroprotection

The objective of this RCT is to assess the efficacy of one-on-one telehealth CBT-I (tCBT-I) compared to web-based CBT-I (wCBT-I) and treatment as usual (TAU) to improve sleep outcomes (Aim 1), fatigue and quality of life (Aim 2), and promote neuroprotection (Exploratory Aim 3), and to explore the characteristics of participants that predict improvement in sleep outcomes (Exploratory Aim 4). Reassessment of outcomes will be completed after the 6-week intervention and 6 months following completion of interventions.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* Diagnosis of relapsing-remitting or secondary progressive MS based on established guidelines21 and verified by their neurologist
* Mild-to-moderately severe disability (≤ 6 on Patient Determined Disability Steps (PDDS) scale)
* Report of difficulty falling asleep, maintaining sleep, or waking up too early at least 3 nights/week for the past 3 months with significant distress and impact on function despite adequate opportunity for sleep and not due to other sleep disorders as indicated in the DSM-5
* ≥10 on Insomnia Severity Index
* English speaking
* ≥31 on Telephone Interview of Cognitive Status
* Has a high school diploma or equivalent to serve as a proxy measurement of reading ability to ensure adequate reading ability to participate in the study
* Report having access to internet service or a data plan and access to a computer, tablet, or smart phone

Exclusion Criteria:

* Known untreated sleep disorder (such as sleep apnea or restless legs syndrome)
* \>3 on STOP BANG indicating increased risk of sleep apnea
* Restless legs syndrome as determined by RLS-Diagnosis Index
* Circadian rhythm sleep-wake disorder as determined by the Sleep Disorders-Revised
* Parasomnia as determined by the Sleep Disorders-Revised
* If taking benzodiazepines, non-benzodiazepines, or melatonin supplements or agonists for insomnia, taking \< 3 months or dose has changed in past 3 months
* Score of ≥20 on the Patient Health Questionnaire (PHQ-9) indicating severe depression or endorsement of suicidal ideation (answer 1, 2 or 3 on #9 of the PHQ-9)
* Score of ≥15 on the Generalized Anxiety Disorder (GAD-7) indicating severe anxiety
* Current or history (up to 2 years) of alcohol or drug or alcohol abuse as indicated by DSM-5 criteria
* History of other nervous system disorder such as stroke or Parkinson's disease
* Currently pregnant or intending to become pregnant in the next 6 months
* Severe mental illness such as schizophrenia or bipolar disorder
* Severe neurological or sensory impairments that would interfere significantly with testing
* Relapse and/or corticosteroid use in the past 8 weeks
* History of (within 5 years) or currently conducting overnight shift work including hours of midnight-4am
* Currently receiving a behavioral sleep health intervention
Oral Enteral Nutrition in Infants With Cerebral Palsy and Dysphagia

This was a randomized controlled study including 80 infants with cerebral palsy and dysphagia. The Participants were evenly divided into the observation group (with intermittent oro-esophageal tube feeding, n=40) and the control group (with persistent nasogastric tube feeding , n=40). Nutritional status and physical development, condition of dysphagia, and pneumonia before and after 3-month treatment were compared.

The efficacy of persistent nasogastric tube feeding is not sufficiently satisfactory, necessitating the exploration for a more effective and safe nutrition support approach. Therefore, this study reports the clinical effect of intermittent oro-esophageal tube feeding compared to persistent nasogastric tube feeding in the infants with cerebral palsy and dysphagia who received systemic therapy.

Method This was a randomized controlled study including 80 infants with cerebral palsy and dysphagia. The Participants were evenly divided into the observation group (with intermittent oro-esophageal tube feeding, n=40) and the control group (with persistent nasogastric tube feeding, n=40). Nutritional status and physical development, condition of dysphagia, and pneumonia before and after 3-month treatment were compared.

Eligibility Criteria:
Inclusion Criteria:

* meeting the diagnostic criteria of cerebral palsy.
* age\<1 year;
* diagnosed as dysphagia confirmed by Dysphagia Disorder Survey or pediatric esophagoscopy;
* with a nasogastric tube inserted at admission;
* enteral nutrition support is required and feasible.

Exclusion Criteria:

* with dysphagia caused by other diseases or factors;
* with progressive neurological disease or degenerative neurological disease;
* with severe heart disease, liver or kidney dysfunction, hematological disorders, or other acute and severe symptoms;
* with abnormalities in the oral cavity, pharynx, esophagus, or other parts of the digestive tract;
* with poor compliance.
Adaptive Versus Non-adaptive Radiotherapy and 2 Bladder Filling Instructions for Patients with Intermediate or High Risk Localized Prostate Cancer (ARP)

The study is being done to compare the side effects between two different radiation techniques, standard non-adaptive radiation therapy vs. daily adaptive radiation therapy and also comparing two different bladder filling instructions to find out if customized bladder instructions may lead to better treatment outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Pathological diagnosis of a primary prostate adenocarcinoma
* NCCN Intermediate or high risk localized prostate cancer and clinically N0 and M0 by conventional imaging
* Intermediate: one or more of cT2b-T2c, PSA 10-20, or Gleason Group 2 or 3

  * High: one or more of: cT3a, PSA \> 20, or Gleason Group 4 or 5.
  * Consented to RT with moderate hypofractionated RT to pelvic nodes (44 Gy) and prostate (60Gy) in 20 fractions using standard BC Cancer regimen
* Able to complete BC Cancer POSI questionnairesWilling to attend adaptive treatment slot timing as required by treating centre.
* Willing and able to have regular per protocol follow up and blood work
* Feasible to start protocol treatment within 120 calendar days of participant enrolment
* Continent of urine (or able to maintain continence with penile clamp/cuff during RT as needed) and able to follow bladder filling instructions.
* Baseline IPSS score \< 20 at time of enrolment.
* ECOG performance Status : 0-2.
* Nodal risk ≥ 20% using the Memorial Sloan Kettering Nodal Risk Nomogram (https://www.mskcc.org/nomograms/prostate/pre_op).
* Negative for bone metastases on bone scan within 3 months of enrolment
* No involved nodes on Abdomen and pelvic CT or pelvic MRI within 3 months of enrolment.

Exclusion Criteria:

* Indwelling urinary catheter.
* Hip prosthesis
* Prior pelvic radiotherapy
* Unable to lie still on RT treatment couch for more than 30 minutes
* Clinical T3b or T4 tumours
* Prior transurethral resection of prostate or radical prostatectomy
* Presence of a pelvic kidney.
* Prior pelvic radiotherapy.
* Significant urinary incontinence: ie \> 1 soaked, or 2 non-soaked pads per day.
* Inflammatory bowel disease, systemic lupus erythematosis, scleroderma, or other connective tissue disorders other than rheumatoid arthritis.
* Metastatic disease identified on staging investigations.
* Any other serious intercurrent illness or medical condition judged by the local investigator to compromise the participant's safety, preclude safe administration of the planned protocol treatment, or prevent the participant from being managed according to the protocol guidelines
* Potentially fertile patient who are unwilling to employ highly effective contraception
Effect of Microteaching Training on the Teaching Skills Level of University Students

The general objective of this study is to evaluate the effect of 12-week microteaching training on the teaching skills level of university students majoring in physical education in China.

The specific objective of this study is to examine the effect of microteaching training on verbal command, movement explanation, movement demonstration, diagnostic error correction, and organization and management skills of university students majoring in physical education in China.

The participants will be divided into an experimental group and a control group. Microteaching and conventional training were used respectively to verify the influence of microteaching training on the teaching skills level of university students majoring in physical education in China.


Eligibility Criteria:
Inclusion Criteria:

1. University student
2. Major in Physical Education
3. Healthy
4. Able to perform all tests
5. Understand the study purposes and procedures
6. No previous experience performing microteaching training

Exclusion Criteria:

1. University students not majoring in Physical Education
2. Exclude participants who have not finished all tests
3. Not understanding the study purposes and procedures
4. Participants with an experience in microteaching
Treatment of Sexual Dysfunction in Hypogonadal Men With Epilepsy With Testosterone and Either Anastrozole or Placebo

The purpose of this study is to determine if treatment using a medication (anastrozole/Arimidex), which lowers estrogen levels in the blood is better than placebo, a tablet that does not contain any active medication, when combined with testosterone replacement to treat reproductive and sexual dysfunction in men with epilepsy. Anastrozole, the medication that is currently under study, does not, at this time, have FDA approval for use for this indication.

This is a three-month study where baseline information is collected at the first visit and then each patient is started on treatment with testosterone supplementation and either anastrozole or placebo. Lab tests, seizure frequency, sexual function and mood will be monitored on a monthly basis.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be a male between the ages of 18 and 50 years.
* Subject must have localization-related epilepsy with complex partial and/or secondary generalized seizures.
* Subject will meet criteria for hypogonadism (abnormally low bioactive testosterone levels and abnormally low scores on questionnaires of reproductive and sexual function).
* Subject will have had a normal urogenital and rectal/prostate exam during the year prior to entry.
* Subject will have had documentation of therapeutic range serum AED levels, a normal CBC, and hepatic enzyme (ALT,AST, alkaline phosphatase) levels that are less than twofold elevated during the 6 months prior to entry.

Exclusion Criteria:

* Subject that has taken hormones, major tranquilizers or antidepressants in the three months prior to entry.
Bipolar H.A Versus Trochanteric Antegrade Nail for Treatment of Displaced Subcapital Femoral Fractures

A retrospective study to compare clinical results of patients that were treated by Bipolar H.A. vs. closed reduction and internal fixation with Trochanteric Antegrade Nail for displaced femoral subcapital fracture.


Eligibility Criteria:
Inclusion Criteria:

* Displaced femoral subcapital fracture.
* Active patient.
* Age 40-85.
* Patient was treated by one of the two methods.

Exclusion Criteria:

* Age out of range.
The Effect of Granulocyte Colony Stimulating Factor (G-CSF) on Myocardial Function After Acute Anterior Myocardial Infarction, a Prospective Double Blind Randomized Placebo Controlled Study

The investigators applied G-CSF to patients 2 weeks after acute anterior MI and successful PCI to evaluate the efficacy and safety of G-CSF in improving myocardial function as cytokine which improve inflammation and mobilize stem cells from bone marrow for regeneration of myocardium.

Ten patients in the treatment group and 10 patients in the control group were enrolled in this prospective, randomized, double blinded study. Two weeks after myocardial infarction that was accompanied by successful recanalization and stent implantation, the patients of the treatment group received 10 μg/kg body weight per day (divided BID) G-CSF subcutaneously for treatment duration of maximum 5.0 days. In both groups, ejection fraction was evaluated with echocardiography and cardiac scan (Gated SPECT method) 10 days after myocardial infarction and after 6 months. Tei index was measured by echocardiography.

Results: No severe side effects of G-CSF treatment were observed. Ejection fraction determined by cardiac scan increased in the treatment group from 0.428 to 0.462 and from 0.470 to 0.496 in the control group but there was no significant improvement of left ventricular ejection fraction when the G-CSF treated group was compared to the controls (p=0.821 for cardiac scan and p=0.705 for echocardiography). Changes in Tei index was not significant in the treatment group (p=0.815) however it reached significant level in the control group (p=0.005), respectively.

Eligibility Criteria:
Inclusion Criteria:

* First anterior myocardial infarction.
* Low systolic ventricular function.

Exclusion Criteria:

* Bleeding tendency
* Contraindication to G-CSF
* Cardiogenic shock
* Hemodynamic instability
* Hepatic or renal disease
* Multivessel disease
Randomized Assessment of Antibiotic Prophylaxis Prior to Port Placement

A randomized, double blind, placebo-controlled clinical trial assessing the utility of antibiotic prophylaxis prior to Totally Implanted Venous Access Device (TIVAD) insertion.

To assess the effectiveness of peri-procedural antibiotic prophylaxis in the reduction of TIVAD placement-related infection, study will compare placebo (normal saline (0.9% NaCl)) 50 cc IV 1:1 to the standard clinical antibiotic prophylaxis dose. The primary endpoint is cumulative incidence of local TIVAD surgical site infection (as determined by the CDC criteria for a deep and/or superficial SSI) or a central line associated blood stream infection at 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients requiring TIVAD insertion for long-term central venous access
* Patients able to give informed consent to participate in the study.

Exclusion Criteria:

* taking long-term antibiotics
* unable to give consent to participate in the study
* Patients that have a known infection at time of the procedure (as documented in e-DH).
* Patients with a planned surgical procedure within 30 days of initial TIVAD insertion.
* Patients that are currently on antibiotics or have received antibiotics within the last week.
* Patients with allergies to cefazolin.
* Patients with an absolute neutrophil count of less than 500/mm3
* Women who are pregnant.
Clinical Assessment of Caries and Dental Plaque Based on Auto-fluorescence Imaging System

The purpose of this study was to evaluate the applicability of auto-fluorescence imaging system to detect and quantify caries and dental plaque. Participants were advised to rinse their mouth with distilled water to exclude any chance of fluorescence from food debris. A well trained physicist majored in optical spectroscopy captured auto-fluorescence images of buccal aspects of two maxillary central incisors and occlusal aspects of four first molars from each patient in a dark room. Then they chewed a disclosing agent to assess the Quigley Hein plaque index modified by Turesky of each tooth. Furthermore, participants were also required to brush their teeth for 3min, then International Caries Detection and Assessment System（ICDAS）codes of relevant teeth to evaluate degrees of caries were recorded by an experienced dentist using a mouth mirror and explorer. The Spearman rank correlation coefficient between colorimetric parameters of fluorescence image and the plaque index and ICDAS code were calculated to evaluate the sensitivity and specificity of auto-fluorescence imaging system.


Eligibility Criteria:
Inclusion Criteria:

Subjects were required to:

* 1. have two maxillary central incisors and four first molars in mouth;
* 2. have caries in their mouth or have a high risk to get caries and need to be treated by dentists ;
* 3. sign informed consent form.

Exclusion Criteria:

* 1.two incisors and four first molars of participants ever received endodontics treatment;
* 2. history of antibiotics, mouthwashes, or any periodontal treatment during the last 3 months;
* 3.with calculus and cementum exposed in tooth cervical;
* 4. active systemic disease;
* 5. physical or mental disability;
* 6. pregnant or lactating.