cyrilzakka/clinical-trials huggingface dataset:
Frozen Embryo Transfer Pregnancy Outcomes Prediction by Microbiome

This study intends to explore the correlation between cervical microbiome, gut microbiome and pregnancy outcomes of frozen embryo transfer patients through a multicenter prospective observational study, and to explore the predictive value of microbiome on pregnancy outcome.


Eligibility Criteria:
Inclusion Criteria:

1. Infertile women receiving assisted reproductive technology treatment, preparing for frozen embryo transfer cycle;
2. Female age: 20-45 years old;
3. Single frozen-thawed blastocyst Transferred
4. Endometrial thickness ≥7mm on the day of luteal transformation
5. Written informed consent.

Exclusion Criteria:

1. Women who have pathologies or malformations that affect the pregnancy outcome:genital malformations, intrauterine adhesions, uterine fibroids (\>4 cm in diameter or compressing endometrial line), adenomyosis, endometrial polyps; untreated tubal pleura Presence of autoimmune disease;
2. Untreated hyperprolactinemia, thyroid disease, adrenal disease
3. Antibiotic use within the past 7 days;
4. Current or recent (within 3 months) drug abuse, including alcohol and tobacco;
5. Refused or unable to comply with protocol requirements;
6. Participation in any experimental drug study within 60 days prior to screening.
Perceptions of Weather Risks and Climate Beliefs Among the Hong Kong General Public

Background: Local abnormal heat events may be used as proxies for communicating the health impacts of climate change when people physically feel the effects to reduce the psychological distance of climate change and improve public engagement with climate and weather risk. However, there are concerns that this strategy may be more effective for climate believers, and that it may somewhat compromise the scientific precision because it may lead to erroneous beliefs that climate change is merely characterized by temperature rises or extreme heat but ignore other extreme weather events such as flood and extreme cold, and that cold spells are interpreted as evidence of no climate change. None of these potential effects and concerns has been tested.

Aims: This proposed study is aimed to explore patterns of climate beliefs and their influences on perceptions of heat-related risks and responses to heat health warnings in the general public of Hong Kong; (2) Test the preliminary effects of a revised heat health warning (RHHW) that incorporates information about the health impacts of climate change into existing heat health warning on perceived heat-related risk and climate beliefs.

Design and subjects: This will be a mix-methods study comprising in-depth qualitative interviews, a population-based cohort survey and a pilot randomized control trial (RCT). Subjects will be the general Hong Kong Chinese adults aged ≥18 years.

Main outcome measures: Latent class analysis will be conducted to examine patterns of climate beliefs while structural equation modelling to test the relationships among climate beliefs, perceived heat-related risks and behavioural responses to heat warnings. Qualitative data will be analysed using thematic content analysis while the effect of RHHW will be tested using t-test and linear regression models.


Eligibility Criteria:
Inclusion Criteria:

* Participants should own a mobile phone and be able to read Chinese.

Exclusion Criteria:

* Participants with no mobile phone or cannot understand Chinese will be excluded.
Vaginal Micronized Progesterone Versus Levonorgestrel for Treatment of Non-atypical Endometrial Hyperplasia

The purpose of this study is to compare the efficacy of the vaginal micronized progesterone and Levonorgestrel-releasing Intrauterine System for treatment of non-atypical endometrial hyperplasia in premenopausal women.

Vaginal use of micronized progesterone in the treatment of endometrial hyperplasia can result in better than oral administration, as it will remain away from the first pass effect, and depending on the local application. In this study, we aimed to compare this local treatment with Levonorgestrel-releasing Intrauterine System for treatment of non-atypical endometrial hyperplasia.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal Patients
* Patients with histologically confirmed endometrial hyperplasia without atypia

Exclusion Criteria:

* Endometrial hyperplasia with atypia
* Endometrial Carcinoma
* Suspected pathology on Physical/Ultrasonographic Examination e.g. fibroids, adnexal abnormality
The Effect of Progressive Relaxation Exercises by Nursing Students Before Clinical Practice

Aim: We conducted this randomized controlled study to determine the effect of Progressive Relaxation Exercises practiced by first year nursing students before clinical practice on their perceptions of stress, psychological resilience and meaning of life.

Background: Progressive Relaxation Exercises has a positive effect on the person's mental/general health, life satisfaction and psychological well-being and enables the person to cope with stress.

Design: In this experimental randomized and controlled study including a control group, we administered a pre-test, post-test one and post-test two to the participating students.

Methods: We are planning the study with 40 first year nursing students in the intervention group, and 40 first year nursing students in the control group. The students in the intervention group took part in eight sessions of Progressive Relaxation Exercises for four weeks, twice a week. We used the Student Introduction Form, Perceived Stress Scale, Brief Psychological Resilience Scale and Meaning and Purpose of Life Scale to collect the study data.


Eligibility Criteria:
Inclusion Criteria:

Who did not have any diagnosed psychiatric diseases, Who had not done Progressive Relaxation Exercises and / or did not have any clinical experience previously were included

Exclusion Criteria:

Who withdrew from the study at any stage, Those who did not participate in the exercise sessions regularly Those who used another relaxation method during this period, Those who took antidepressants, Those who were unwilling to participate in the study, Those who lost one of their loved ones in the last 6 months were excluded from the research.
Technology Assisted Cognitive Behavioural Therapy Intervention for Anxiety in People Living With Cognitive Impairment

This study is a randomized controlled trial (RCT) of a remotely-delivered, technology-assisted psychotherapy program, supported by an innovative software platform for people with cognitive impairment experiencing anxiety.

Despite harmful health and economic consequences, anxiety is a vexing issue in persons with cognitive impairment with inadequate treatment options. What is needed currently is a digital technology option for treating anxiety in persons with cognitive impairment that can be rigorously evaluated and implemented. The objective of the study is to test the efficacy of a newly modified psychotherapy package (Tech-CBT), which incorporates Cognitive Behaviour Therapy (CBT) methods, assisted with technology and telehealth for persons with cognitive impairment experiencing anxiety. This project will also investigate the cost-effectiveness, usability and acceptability of Tech-CBT to enhance delivery of anxiety treatment for people with cognitive impairment. A process evaluation will inform its implementation in the community and memory clinics, and will recommend a strategic translational roadmap to enhance delivery of anxiety treatment in health services with a broad reach.

Eligibility Criteria:
Inclusion Criteria:

* Persons aged 18 years or over
* Persons with a diagnosis of mild cognitive impairment (MCI) or dementia of any aetiology based on a previous diagnosis by a clinician or scoring above threshold (≤32; MCI ≤32 and dementia ≤27) for cognitive impairment in the Modified Telephone Interview for Cognitive Impairment (TICS-M).
* Screening positive for anxiety (scoring ≥9 on Geriatric Anxiety Inventory, GAI), and/or subjective complaints of anxiety and/ or clinician diagnosis of a current anxiety disorder and screening positive for anxiety using the Rating Anxiety in Dementia scale (scoring ≥11 on RAID)

Exclusion Criteria:

* Persons with severe dementia
* Persons unable to communicate or complete questionnaires
* Persons who have a current risk of suicide within the last month as determined by the study clinical expert team.
* Persons with major depression as the primary complaint without reported symptoms of anxiety
* Persons with comorbid psychiatric conditions
Efficacy and Safety of TMZ Plus CDDP in the Patients With Recurrent Malignant Gliomas

Temozolomide is the standard adjuvant chemotherapy of newly-diagnosis malignant gliomas.Cisplatin , a kind of chemotherapeutics, can enforce the anti-tumor effects of TMZ. Up to now, the prognosis of recurrent gliomas is very pessimistic and the standard treatment procedure has not been established yet.

The prospective,multicentre phase II clinical study is to evaluate the efficacy and safety of TMZ and CDDP in patients with recurrent malignant gliomas


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age\>=18 and \<=70years old
* Histological diagnosis of malignant gliomas(WHO III or IV)
* The status of methylation of promotor of MGMT should be detected.
* The time to be enrolled should be more than 90 days after the irradiation.
* The patients with recurrent gliomas were treated with non-dose-dense TMZ therapy before enrollment.
* Performance status(Karnofsky index)\>=60
* Life expectancy more than 3 months

Exclusion Criteria:

* Ages:\< 18 years or \> 70 years
* Abnormal function of liver or renal(value more than 1.5 fold normal upper limit )
* Blood routing: Hb \< 100g/l， WBC \< 4.0×109/l; PLT \< 100×109/l
* Pregnant or lactating women
* Allergic to administered drugs
* Radiation treatment in the previous 90 days or stereotactic radiation surgery within 60 days before enrollment
* The patients with recurrent gliomas were treated with dose-dense TMZ therapy before enrollment.
* Life expectancy less than 3 months
* Participation in other clinical trials in the 90previous days before enrollment
Oslo Antioxidant Study

The primary objective of this study is to test whether increasing the total intake of antioxidants to middle-aged smoking men increases the antioxidant defence, reduces oxidative damage, and improves biomarkers for oxidative stress.

The secondary objectives is to test whether this strategy improves other cardiovascular risk markers including platelet function, lipid levels, inflammation, and markers of endothelial damage.

In this study men smoking 5 or more cigarettes daily will be invited to participate. We will only include individuals with high cardiovascular risk (men rather than women, smokers rather than nonsmokers, middle-aged to elderly rather than young individuals), in order to recruit people with presumed high oxidative stress who might be most likely to show an effect and benefit from our intervention.

at the time of inclusion, participants will be randomized to three groups; control group, kiwi group or phytochemical group. The kiwi group will consume three kiwis a day, whereas the phytochemical group will consume an array of antioxidant-rich food stuffs. The intervention period is eight weeks.

Blood samples will be collected before and after the intervention period.

Eligibility Criteria:
Inclusion Criteria:

* Men aged 45-75 years
* Daily smoker of a minimum of 5 cigarettes a day
* BMI \<35 kg/m2 (because of difficulties that may be experienced by morbidly obese individuals in following the diet)
* Stable weight range of 4 kg or less during the previous 12 weeks

Exclusion Criteria:

* Any symptomatic CVD (myocardial infarction, angina pectoris, CABG, PCI, CHF, NYHA class III-IV)
* Diabetes type I or type II taking drugs for diabetes
* Following a vegetarian diet or near-vegetarian diet currently
* Allergy to nuts, kiwi fruits, chocolate, strawberries or tomatoes
* Clinical disorders including gastrointestinal disease impairing compliance with dietary recommendations
* History of serious or unstable medical or psychiatric disorder
* Current use of or need of lipid lowering drug treatment, aspirin or non-steroidal anti-inflammatory drugs (NSAID), according to assessment of the primary clinical investigator. Any "over the counter" headache/ pain or cold remedies taken during the study must not contain aspirin or aspirin like drugs such as ibuprofen. These are classed as and will interfere with platelet function, making them unresponsive for a period of 10-14 days. Paracetamol, however, can be taken as an alternative if required
* History of alcohol/or drug abuse
* Participation in a drug trial during the previous 30 days
* Use of drugs (Xenical, Reductil), nutritional supplements or herbs for weight loss within the 4 weeks prior to visit 2 or participation in an active weight reduction program
* Use of single vitamin or other antioxidants (must be stopped 4 weeks prior to visit 2)
* Individuals judged by the clinical investigator to be unable to follow instructions and procedures of the study.
Gene Expression Profiling of Breast Cancer Cells Predict the Response of Malignant Pleural Effusion

The investigators want to develop a gene expression profile for the prediction of immunotherapy response of patients with metastatic breast cancer presenting malignant pleural effusion.

1. The patiets with malignant pleural effusion are randomizned to be treated with cytokins(inteleukin 2) or dendritic cells(DC) plus cytokine induced killer cells(CIK) locally.
2. Malignant pleural effusion from metastatic breast cancer patient is obtained through thoracentesis and is centrifugalized to enrich cancer cells before the therapy.
3. The enriched cancer cells are flash frozen and stored at -80℃ until processing.
4. The gene expression in pleural effusion is detected by microarray to screen gene markers that are differently expressed between groups .
5. Statistical analysis is performed using unsupervised hierarchical cluster.

Eligibility Criteria:
Inclusion Criteria:

* Patients should be histologically confirmed with metastatic breast cancer and malignant pleural effusion
* an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
* At least one measurable lesion;
* Normal cardiac, hepatic, renal and bone marrow functions;
* Life expectancy ≥3 months;
* Discontinuity of previous chemotherapy for a minimum of 4 weeks.
* Not receive chemotherapy in pleural cavity

Exclusion Criteria:

* previous history of other malignancies;
* previous surgery history on the needle biopsy organ;
* Serious or uncontrolled concurrent medical illness.
Telerehabilitation Robotics for Upper Limb Rehabilitation After STroke

There has been an observed decrease in motor and functional ability and non-use of the impaired limb in chronic patients. This is due to the immediate drop in intensive daily therapy (5 days per week for 3 hours/day) that is usually provided during the inpatient (acute) phase upon discharge from the hospital.

In this study, the investigators plan to address the low dosage of therapy in the post-acute discharge phase for stroke survivors.

Current models of care in public healthcare institutions (PHI) cannot provide daily or frequent access to RAT without increasing burden and expenditure in direct healthcare resources. Shifting from the existing hospital-based model of care towards a home-centered model based deploying portable RAT, would ensure that patients can continue to receive intensive therapy after discharge and during the chronic phase of stroke.

More recently, RAT deploying table-top, portable, less complex, upper limb end effectors enable clinic-to-home transitions may offer decentralized therapy, minimally supervised by therapists as a potential means to bridge various gaps in access to RAT such as scheduling, physical or social barriers, distances and hospital lockdowns related to viral pandemics.

This study aims to explore the utilization, feasibility and acceptability using a multi-cluster deployment and adoption of a decentralised robot-aided telerehabilitation (RATR) clinical programme supported by AI-enabled platform, with remote monitoring by clinic therapists

Eligibility Criteria:
Inclusion Criteria:

1. Clinical stroke (ischaemic or haemorrhagic) confirmed by admitting doctors and CT, CT angiography or MRI brain imaging.
2. Age 21 to 90 years, both males and females.
3. At least \> 28 days post stroke.
4. Upper limb motor impairment of Fugl-Myer Motor Assessment (FMA) scale 10 to 60
5. Has a stable home abode and a carer/ NOK to supervise home based exercise.
6. Ability to sit supported continuously for 60 minutes.
7. Montreal Cognitive Assessment (MOCA) score \> 21/30
8. Able to understand purpose of research and give consent.

Exclusion Criteria:

1. Non-stroke related causes of arm motor impairment.
2. Medical conditions incompatible with research participation: uncontrolled medical illnesses (hypertension or diabetes, ischaemic heart disease, congestive heart failure, bronchial asthma, end stage renal/liver/heart/lung failure, unresolved cancers.
3. Anticipated life expectancy of \< 6 months.
4. Inability to tolerate sitting continuously for 60 minutes.
5. Local factors potentially worsened by intensive robot-aided arm therapy and computer-based training: active seizures within 3 months, spasticity of Modified Ashworth Scale grades \>2 skin wounds, shoulder, arm pain VAS \> 5/10, active upper limb fractures, arthritis, fixed upper limb flexion contractures.
6. Hemianesthesia of affected limb.
7. History of dementia, severe depression, agitation, or behavioural problems.
8. Pregnancy or lactation in females
9. Absence of reliable carer to provide supervision during home training
Prevalence and Predictors of Proton Pump Inhibitor Partial Response in Gastroesophageal Reflux Disease in Systemic Sclerosis

Proton pump inhibitor (PPI) twice daily dosing regimen-a standard dose therapy for gastroesophageal reflux disease (GERD)-is an effective therapy for uncomplicated GERD in systemic sclerosis (SSc) but there is no data of response rate of standard dose of PPI and predictors of PPI-partial response (PPI-PR) GERD in SSc.Objectives of the study were to determine the prevalence of omeprazole partial response GERD in SSc and to define the predictors of PPI-PR GERD in SSc. Adult SSc patients having GERD were treated with omeprazole 20 mg twice daily 30 minutes before meal for 4 weeks. Severity of symptom-grading by visual analogue scale (VAS) and frequency of symptoms by frequency scale for symptoms of GERD (FSSG) were assessed at baseline and 4 weeks after treatment. PPI-PR GERD was defined by less than 50% improvement in VAS of severity of symptom and acid reflux score by FSSG after treatment compare to baseline.


Eligibility Criteria:
Inclusion Criteria:

1. SSc patients aged between 18 and 65 years.
2. Clinically diagnosed as GERD
3. Must not receive any PPI or prokinetic drug within 2 weeks before baseline evaluation

Exclusion Criteria:

1. Pregnancy or lactation
2. Previous history of gastroesophageal surgery or endoscopic therapy due to severe erosive esophagitis
3. Present of Barrett's esophagus
4. Bedridden and confined to no self-care
5. Evidence of active malignant disease
6. Present of uncontrolled or severe medical problems such as asthma, angina, hepatic or renal diseases
7. Present of active infection that needs systemic antibiotic
8. Allergic history of omeprazole
9. Receiving prohibit co-medications that may have drug interaction or attenuate GERD symptoms such as tetracycline, ferrous salt, digoxin, isoniacid, oral bisphosphonate
Factors Affecting Success of Vaginal Birth After Cesarean Section

Factors affecting Success of Vaginal Birth After Cesarean Section in Sohag University Hospitals

* Clinical data will be collected from the participants including demographic details such as age, maternal age, parity, BMI, gestational age based on last menstrual period or early ultrasound scans available.
* Full medical and surgical history, previous CS details as an indication, and previous complications.
* Patients' clinical abdominal and per vaginal examination on admission (cervical dilatation, effacement head station, and position).
* CTG attached on admission (to exclude fetal distress).
* Laboratory investigations that will be done before delivery and postpartum, Labor progress on the partogram will be assessed as regard duration of both first and second stages of labor if any instrumental delivery will be done.
* Radiology investigations such as US.
* Records for patients' vital signs, fetal cardiac activity during labor, vaginal bleeding, delivery notes, fetal weight, and 5 minutes APGAR score, and any recorded maternal or fetal complications.
* If failed VBAC: Causes of failure maternal and fetal outcomes will be recorded and immediate CS to be done

Eligibility Criteria:
Inclusion Criteria:

* • Age from 20 to 40 years.

  * Time interval more than 1.5 years from previous caesarean section.
  * Single viable full-term pregnancy in vertex presentation.
  * Reactive cardiotocography (CTG) on admission.
  * Spontaneous labor onset.
  * Clinically adequate pelvis.
  * Single fetus
  * Average AFI fetus

Exclusion Criteria:

* • Women with previous upper segment cesarean section or hysterotomy scar.

  * Any obstetric complications such as fetal malpresentation, placenta previa, or medical disorders like diabetes mellitus or preeclampsia.
  * Presence of any signs and symptoms of scar dehiscence or ruptured uterus, known uterine fibroid or anomaly.
  * Suspected fetal macrosomia (weight more than 4 kg).
  * Multifetal pregnancy.
  * Parturient women who refused the trial of vaginal birth after caesarean section.