cyrilzakka/clinical-trials huggingface dataset:
Identification of Molecular Signatures of High-risk Oncogenic HPV and Study of Their Associations with the Presence of High-grade Lesions And/or Anal Cancer 10 Years After Inclusion in the ANRS IPERGAY Trial

HPVsign is a cross-sectional, non-comparative, multicenter study involving all participants included in the HPV substudy of the ANRS IPERGAY trial. The study proposes to evaluate the cumulative incidence of high-grade lesions and/or anal cancers using high-resolution anoscopy (HRA) during the HPVsign study and/or diagnosed since the end of participation in the ANRS IPERGAY trial.

The study aims to enrol 80 to 100 participants in French clinical centres. All the participants have participated to the IPERGAY HPV substudy.

The study proposes to evaluate the cumulative incidence of high-grade lesions and/or anal cancers using high-resolution anoscopy (HRA) during the HPVsign study and/or diagnosed since the end of participation in the ANRS IPERGAY trial.

Also, the study proposes to:

* study the association between the presence of HSIL and/or anal cancer and HPV molecular signatures during participation in the ANRS IPERGAY trial and 10 years after.
* study the evolution of HPV molecular signatures from participation in the ANRS IPERGAY to current study
* compare HRA results with anal cytology results
* compare the results of anal cytology concomitant with HRA with those obtained during participation in the ANRS IPERGAY trial.
* study factors associated with the presence of HSIL and/or anal cancer.
* compare the presence of different HPV virus types in the oropharynx concomitant with HRA and during participation in the ANRS IPERGAY trial.

Eligibility Criteria:
Inclusion Criteria:

* Participant in the ANRS IPERGAY clinical trial who was included in the initial HPV sub-study;
* Informed and written signed consent
* Participant with regular health insurance

Exclusion Criteria:

* Participant under guardianship or curatorship
* Participant with free State medical assistance
* Participant who disagrees with the use of data collected as part of their participation in the ANRS IPERGAY trial.
A Cross-sectional and Cohort Study of COVID-19 Patients With Post - Discharge Dysfunction

Post-discharge rehabilitation regimens for covid-19 patients have not been supported by high-quality evidence-based medical evidence.The first part of this study is a cross-sectional study.The contents of the study were the factors related to the dysfunction of COVID - 19 patients after discharge from the hospital in Wuhan.The second part of this study is a cohort study.To observe the functional changes of COVID-19 patients after discharge in hospital rehabilitation, home rehabilitation and no rehabilitation, in order to propose a more safe and effective rehabilitation program.


Eligibility Criteria:
Inclusion Criteria:

* patients with definite diagnosis of COVID-19 normal or severe
* patients who entered the isolation point \<3 days after discharge
* 18-80 years old
* agree to join the queue

Exclusion Criteria:

* body temperature \>38°C
* heart rate \>120 times/min or \<40 times/min, systolic blood pressure \<90mmHg or \>180mmHg, respiratory rate \>25 times/min in calm state.Or above vital signs fluctuate significantly.
* continuous oxygen therapy is required.
* patients with myocarditis, pulmonary hypertension, congestive heart failure, fresh venous thromboembolic diseases, unstable fractures and other inappropriate exercise
* patients with consciousness disorders, severe sequelae of cerebral infarction, cognitive dysfunction, mental disorders, severe balance disorders, and severe bone and joint diseases, which affect evaluation and treatment
* other conditions that cannot be cooperated with rehabilitation treatment
Effect of High Tone External Muscle Stimulation on Peripheral Arterial Disease

to investigate the effect of high tone external muscle stimulation (HTEMS) on endothelial dysfunction and walking parameters in peripheral vascular disease.

The patients will randomly be divided into two equal groups in number:

1. Group A :

   Thirty patients will participate in physical therapy program in form of high-tone external muscle stimulation (HTEMS), with Frequencies continuously will be scanned from 4096 Hz to 31768 Hz, allowing for a much higher power of up to 5000 mW to be introduced 3 times per week, for 10 weeks plus supervised regular aerobic exercise program on stationary bicycle with moderate intensity, ( score 12-14 on Borg scale for rate of perceived exertion) 40 minutes per session, 3 times per week, for 10 weeks .
2. Group B:

Thirty patients will participate in a supervised regular aerobic exercise program only on stationary bicycle with moderate intensity, (score 12-14 on Borg scale for rate of perceived exertion) 40 minutes per session, 3 times per week, for 10 weeks.

Eligibility Criteria:
Inclusion Criteria:

* 1- Both genders are allowed to participate in the study. 2- The age range of patients will be from 50-60 years 3- All patients are diabetic from 5-7 years. 4- ABPI for all patients will be ranged from 0.65 to 0. 9 5- All patients are medically and psychologically stable. 6- Only ambulant patient without any aids will be selected 7- All patients are non smokers.

Exclusion Criteria:

1. Patients with ABPI ( Ankle Brachial Pressure Index ≤ 0.4 )
2. Patients who are unable to walk on treadmill or unable to attend sessions at the physical therapy department at Cairo university hospitals, 3 times a week.
3. Patients with unstable cardiovascular conditions (those with a known history of recent myocardial infarction, uncontrolled hypertension, ischemic attacks, stroke, and congestive heart failure) will be excluded from this study.
4. Patients with neurological problems that cause leg pain and polyneuropathy.
5. Patients with active malignancy will be excluded from study
6. Patients with ischemic ulcers or gangrenes
7. Patients with a vascular surgical procedure or angioplasty within the previous year will be excluded from the study
8. Patients with musculoskeletal disorders (Diagnosed with severe osteoporosis, severe osteoarthritis or joint replacement).

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A Study of ARRY-142886 in Patients With Advanced Cancer

This is a Phase 1 study during which patients with advanced solid tumors will receive investigational study drug ARRY-142886.

This study has 2 parts. In the first part, patients will receive increasing doses of study drug in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Approximately 25 patients from the US will be enrolled in Part 1 (Completed).

In the second part of the study, patients will receive the best dose of study drug, determined from the first part of the study, and will be followed to see what side effects the study drug causes and what effectiveness the study drug has, if any, in treating the cancer. Approximately 35 patients from the US will be enrolled in Part 2 (Completed).


Eligibility Criteria:
Key Inclusion Criteria (Part 2):

* Histopathologically or cytologically confirmed solid tumor that is refractory to standard therapies, or for which no standard therapies exist, or for which the Investigator feels no other active therapy is required for the duration of the study.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.
* Estimated life expectancy of greater than or equal to 3 months.
* Patient must have a tumor that is accessible for biopsy and must consent to paired tumor biopsies and normal skin biopsies being taken pre- and post-dose of study drug.
* Additional criteria exist.

Key Exclusion Criteria (Part 2):

* Uncontrolled or symptomatic brain metastases.
* Use of investigational drug or device within 30 days prior to first dose of study drug.
* Major surgery within 30 days prior to study start.
* Radiotherapy or chemotherapy within 21 days prior to study start (not including palliative radiotherapy at focal sites).
* Pregnancy or lactation.
* Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C.
* Additional criteria exist.
Tulsi Consumption and Its Effects on Cognition, Stress and Anxiety

Tulsi and its effects on facilitative cognitive enhancement through lowering levels of stress and anxiety. A randomised placebo-controlled clinical trial.

Ocimum Sanctum or Holy Basil, commonly called Tulsi is a traditional Indian herb. It is believed to bring about a facilitative enhancement of cognitive ability and lower stress levels in individuals. Stress and an inability to perform at a required level of cognition can induce anxiety. This study is looking at the effects of daily consuming Tulsi among a group of individuals who work in an environment that demands memory, attention and executive functioning.

Eligibility Criteria:
Inclusion Criteria:

* Subjects between the ages of 18 and 50 years, providing written informed consent.

Exclusion Criteria:

Subjects who meet the following criteria

* Education level below 8th grade of schooling
* Unable to read or understand English or having no working knowledge of English
* Known history or neurological conditions that can affect cognition
* Known history of drug abuse or potential for drug abuse, a regular consumer of alcohol or unwilling to withhold consumption of alcohol for the duration of the study.
* A chronic smoker or consumer of other tobacco related products or is undergoing a rehabilitation program for alcohol and or tobacco consumption
* Any history or psychiatric disorders - currently on treatment or treated in within the last 12 months
* Any characteristic that makes the investigator uncomfortable to include the subject in the study.
Home Assessment of Blood Pressure in PregnancY

The goal of this observational study is to evaluate the feasibility and safety of a comprehensive home blood pressure telemonitoring (HBPT) program for pregnant people with hypertensive disorders of pregnancy (HDP).

Participants will receive training on the use of a home BP telemonitor with tele-transmission function for the remainder of their pregnancy and 6 weeks postpartum. Participating obstetric internal medicine (OBIM) clinicians will monitor the transmitted values and adjust anti-hypertensive medications based on the home BP readings.

Our primary goal is to describe the feasibility and safety of a comprehensive HBPT pilot program in British Columbia, Canada (BC).

Secondary research questions will address:

1. What is the end-user acceptability of a comprehensive HBPT pilot program in BC?
2. What are the effects of a comprehensive HBPT pilot program on factors such as:

1. Maternal and neonatal outcomes 2. Home blood pressure (BP) metrics 3. Process measures 4. Anti-hypertensive medications 5. Fidelity to interventions 6. Health Care utilization


Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged ≥ 19 years
* Pregnancy
* Gestational age 20+0 to 36+0 weeks gestational age
* Diagnosed with gestational hypertension (defined as SBP ≥140 mm Hg and/or DBP ≥ 90 mm Hg) after 20 weeks gestation OR Chronic hypertension (defined as SBP ≥140 mm Hg and/or DBP ≥ 90 mm Hg), present at booking or before 20 weeks gestation, or receiving treatment (including lifestyle measures) prior to pregnancy and/or at time of referral OR Transient elevated office BP reading (defined as one time reading of SBP ≥140 mm Hg and/or DBP ≥ 90 mm Hg with risk factors for HDP as per Canadian guidelines).
* Participant is willing and able to give informed consent for participation in the study
* Able and willing to comply with study requirements
* Has smart phone

Exclusion Criteria:

* Anticipated inpatient admission
* Remaining pregnancy less than 2 weeks duration
* Imminent delivery (within the next 48 hours)
* Non-English speaking or no family members who can help translate
Study of IFN-α Combined With CAR-T Cell Therapy in Relapsed and Refractory Acute Lymphoblastic Leukemia（R/R-ALL）

The purpose of this study is to evaluate the safety and efficacy of IFN-α combined with CAR-T cell therapy in relapsed and refractory acute lymphoblastic leukemia (R/R ALL).

This is a phase 2, single-center study. The patients will receive IFN-α combined with infusion of CAR T-cells in R/R B-ALL patients. The study participation will be 5 years including treatment and follow-up periods.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed refractory and relapsed acute B-lymphoblastic leukemia.
2. Age 12-65.
3. Eastern Cooperative Oncology Group (ECOG) score 0-2.
4. Target on leukemia is \>20% positive detected with flowcytometry.
5. Patients with left ventricular ejection fraction ≥ 0.5 by echocardiography or grade I/II cardiovascular dysfunction according to the New York Heart Association Classification.

5.Patients with aspartate aminotransferase or glutamic-pyruvic transaminase \> 3x upper limit of normal or bilirubin \> 2.0 mg/dL.

6.No other immunotherapy was received within 3 months.

Exclusion Criteria:

1. Patients are pregnant or lactating.
2. Patients with congenital immunodeficiency.
3. Patients with central nervous system leukemia.
4. Patients with uncontrolled active infection.
5. Patients with active hepatitis B or hepatitis C infection.
6. Patients with HIV infection.
7. Patients with atrial or venous thrombosis or embolism.
8. Patients with myo-infarction or severe arrythmia in the recent 6 months.
9. Other comorbidities that investigators considered not suitable for this study.
Survival Analysis of Oral Cancer Patients

This study aims to assess the survival rate of oral squamous cell carcinoma (OSCC) patients following immediate mandibular reconstruction with vascularized fibula flap (VFF) and to identify risk factors influencing the overall survival rate and postoperative outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of stage IV OSCC
* Follow-up period more than one year.

Exclusion Criteria:

* Non-neoplastic diseases
* Two-staged reconstruction
* Presurgical distant metastasis
ELDA: Elderly Breast Cancer - Docetaxel in Adjuvant Treatment

The purpose of this study is to compare disease free survival of elderly breast cancer patients treated with standard adjuvant chemotherapy (CMF) versus experimental adjuvant chemotherapy (weekly docetaxel).

Adjuvant combination chemotherapy, given after breast cancer surgery, has been established as the standard approach to reduce the risk of breast cancer recurrence in those patients at intermediate or high risk for recurrence. However, since elderly patients have been underrepresented in past clinical trials, the optimal adjuvant therapy for elderly patients at risk for recurrence has not yet been defined.

Docetaxel is one of the most active drugs for patients with metastatic breast cancer and several trials are evaluating its efficacy in the adjuvant setting. Administration of docetaxel on a weekly schedule is effective and well tolerated in women with metastatic breast cancer.

In this study, patients from ages 65 to 80 will be randomized to one of two treatment strategies:

* standard adjuvant chemotherapy with CMF (cyclophosphamide, methotrexate, and 5-fluorouracil given intravenously on days 1 and 8 of each cycle)
* experimental adjuvant chemotherapy with weekly docetaxel (given intravenously on days 1,8, and 15 of each cycle)

In both treatment strategies:

* 4 cycles of chemotherapy will administered for patients at least 10% positive for ER or PgR, and 6 cycles will administered for patients expressing \< 10% ER or PgR
* patients with any positive expression of ER or PgR will receive adjuvant hormonal therapy with tamoxifen (20mg/day for 5 years) after concluding chemotherapy
* adjuvant radiation therapy will be given to patients who are candidates at the conclusion of chemotherapy and within 6 months of surgery.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed invasive unilateral breast cancer
* Age \> 65 and \< 80 years
* Intermediate-high risk of recurrence according to St. Gallen criteria: ER negative and PgR negative, or axillary lymph node metastasis, or tumor size \> 2 cm, or tumor grade 2 or 3 (intermediate or high)

Exclusion Criteria:

* Performance status \>1
* Distant metastasis
* Concomitant malignancy or malignancy within previous 5 years (except basal cell or spinocellular skin cancer and in situ cervical cancer if they have been adequately treated
* Previous breast cancer treatment
* Neutrophils \< 2000/mm3 or platelets \< 100000/mm3 or haemoglobin \< 10 g/dl
* Creatinine \> 1.25 the upper normal limit
* GOT and-or GPT and/or bilirubin \> 1.25 the upper normal limit
* Concomitant conditions that contraindicate the use of the drugs in the protocol
* Incapacity or refusal to provide informed consent
TAS Test: Online Motor-cognitive Tests for Early Detection of Alzheimer's Disease

Global dementia prevalence is rising. Alzheimer's disease (AD), the most common cause, has devastating effects on people's quality of life. AD has a preclinical (pre-AD) period of 10-20 years when brain pathology silently progresses before any cognitive symptoms appear. Current tests for pre-AD are invasive, costly and unsuitable for screening at population level. Similar to screening for pre-diabetes and carcinoma in situ, it is important to detect AD at the preclinical stage in order to offer early interventions before the pathology progresses to the irrerversible degenerative stage. In the study, research will develop a new scalable test (TAS Test) by combining two innovative ideas: hand-movement tests to detect pre-AD \>10 years before cognitive symptoms begin; and computer vision so people can "self-test" online using home computers. This unique approach builds on recent discoveries that hand-movement patterns change in pre-AD. The research team will use exquisitely precise computer vision methods to automatically analyse movement data from thousands of participants, and combine this with machine learning of overall motor-cognitive performance. The project team has access to 3 well-phenotyped cohorts, \>10,000 existing participants and a cutting-edge assay for a blood AD biomarker, ptau181. The research team will develop a TAS Test algorithm to classify hand-movement and cognitive test data for pre-AD risk (p-taua181 levels) and determine TAS Test's precision to prospectively predict 5-year risks of cognitive decline and AD.

Sub-study 1: Cross-sectional study design: From two established cohorts with pre-existing datasets of up to 10 years of longitudinal cognitive, genetic and demographic data, the team will recruit 500 participants over 50 years old who are confirmed to have normal cognition. At baseline and months 3 and 6, the participants will be invited to complete TAS Test online at home, or in the research centre if preferred. The participants will also have a baseline blood test for ptau181 levels (and APOE4 if required). The research team will integrate movement data to develop a multivariable model that discriminates between pre-AD (positive p-tau181) and normal cognitive ageing (negative p-tau181).

Sub-study 2: Prospective 5-year cohort study design: The researchers will invite 10,000 adults from an established long-term (ISLAND Project) cohort to complete online tests at home: (i) TAS Test every 6 months, and (ii) Cambridge Neuropsychological Test Automated Battery (CANTAB) cognitive tests every 24 months. The prospective 'high risk' predictions of TAS Test at baseline will be validated against CANTAB scores, and also clinically (face to face gold standard consensus diagnosis of AD vs MCI vs normal) in a subsample of 300.

Eligibility Criteria:
Inclusion Criteria: \> 50years old

Exclusion Criteria: established diagnosis of dementia
Follow-up of Patients With Curative-Intent Surgical Resection for NSCLC

The guidelines and institutional practices recommended more frequent visits the two years following curative-intent therapy for non-small cell lung cancer (NSCLC).No international consensus is published concerning follow-up of resected NSCLC patients.Recent studies have outlined that positron emission tomography (PET) scanning may be accurate in early detection of recurrences by comparison to computed tomography (CT). The aim of this study is to compare follow-up by conventional methods versus PET. Patients are randomly assigned to two arms. In the first arm, thorax CT with liver and adrenal gland sections, abdominal ultrasonography and nuclear bone scintigraphy are performed every 6 months after surgery for two years. In the second arm, PET scanning is only. For brain metastasis detection, CT is performed in the two arms. Recurrences are detected during scheduled or unscheduled procedure in asymptomatic patients. PET and CT are interpreted separately by two nuclear physicians and two radiologists. The direct cost of follow-up procedure is determined in the two groups. The calculated sample is composed of 60 patients in each arm to detect significant difference. The Ethics Committee of Universitary Hospital of Limoges approves the study.


Eligibility Criteria:
Inclusion Criteria:

* All patients who underwent resection for NSCLC
* Informed consent

Exclusion Criteria:

* Patients with a mixed histology profile that included small cell carcinoma or neuroendocrine tumor cells.
* Patients with non-resected NSCLC or with metastasis
* Patients who have previous malignancy, except basal cell carcinoma of the skin -
Selective Aspiration Thrombectomy in STEMI

Patients who were diagnosed with ST-elevation myocardial infarction (STEMI) and received primary percutaneous coronary intervention (PPCI) from July 2009 to December 2011 were identified from the National Health Insurance Research Database of Taiwan. The investigators compared the 1-year outcomes of patients with STEMI who received aspiration thrombectomy during PPCI vs. those who received PPCI alone.

Data source and study population Using the National Health Insurance Research Database of Taiwan, STEMI patients from July 2009 to December 2011 who received aspiration thrombectomy during PPCI were defined as the thrombectomy group, and the remaining patients were defined as the PCI alone group. ICD-9-CM codes were used to identify underlying comorbidities. Data regarding the prescription of in-hospital and outpatient medications and the utilization of medical devices were also extracted from the NHIRD using ICD-9-CM procedure codes and pharmacology and device codes.

Study outcomes The primary endpoints of this study were all-cause mortality and stroke during hospitalization and at 30 days and 1 year of follow-up. Ischemic and hemorrhagic subtypes of stroke were further identified according to ICD-9-CM codes. All patientswere followed for 1 year or until the outcomes were achieved, whichever came first.

Statistical analysis Propensity score weighting was used to reduce potential differences between the two study groups. The incidence rates of all-cause mortality and stroke were estimated as the total number of events during the follow-up period divided by the person-months at risk. For all-cause mortality, a Cox proportional hazard model was used to obtain hazard ratios (HRs). For stroke, Fine and Gray's competing-risk regression was used to obtain sub-hazard ratios (SHRs). The cumulative incidence of stroke versus follow-up time was plotted rather than the event-free rate, because cumulative incidence function can take the competing risk of death into account. For the thrombectomy group, 95% confidence intervals (CIs) of the HRs and SHRs were calculated using the PCI alone group as the referent group.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ST elevation myocardial infarction

Exclusion Criteria:

* Missing data on sex or discharge date
* Aged less than 18 years
* Previous stroke
* Patients receiving thrombolytic therapy
* Patients who did not undergo PPCI