cyrilzakka/clinical-trials huggingface dataset:
Molecular Analysis of Breast Cancer

This is a research-based study that is looking at the biologic features of breast tissue, lymph node tissue, or blood in order to study breast cancer development growth, and spread. Through tissue and/or blood samples we hope to gain further knowledge and understanding of how to improve diagnosis and treatment of breast cancer by identifying the molecular markers that predict clinical outcome and response to therapy.

The tissue obtained in this protocol will be used for genome-wide examination of DNA, RNA expression profiling, proteomic analyses, isolation and analyses of normal and cancer stem cells, isolation and analyses of circulating tumor cells, possible analyses of immune cells, and possible analyses of serum factors. The tissue may also be used to develop patient-specific cell culture models or mouse xenograft models of breast cancer for biologic study of tumor progression and metastases and for therapeutic testing. In general, the tissue will be used in studies that will molecularly classify tumors, identify prognostic markers, identify potential therapeutic markers, identify potential treatment targets, and help us better understand the biology and specific role played by different tumor cells in the metastatic process.

The ultimate goal is to use molecular analyses to improve the diagnosis and treatment of breast cancer.

Eligibility Criteria:
Inclusion Criteria:People eligible for this study include anyone older than 18 years who is undergoing one of the following procedures: core needle or surgical breast biopsy, lumpectomy, mastectomy, axillary lymph node surgery, breast reduction surgery, or ductal lavage or ductoscopy. Patients who have had breast cancer in the past who are currently free of disease or who have a breast cancer recurrence are also eligible. All patients who participate must be able to understand and sign the informed consent. Although most patients will be female, any males undergoing the above procedures are also eligible for this study. Exclusion Criteria:Any patient who is less than 18 years old, who is unable to understand the informed consent, or not undergoing the above procedures will be excluded from this research.
A Efficacy and Safety Study of R935788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)

The purpose of this study is to determine whether fostamatinib is safe and effective in the treatment of persistent/chronic Immune Thrombocytopenic Purpura (ITP).


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of persistent/chronic ITP for at least 3 months.
* Average platelet count \< 30,000/µL (and none \> 35,000 unless as a result of rescue therapy) from at least 3 qualifying counts

Exclusion Criteria:

* Clinical diagnosis of autoimmune hemolytic anemia
* Uncontrolled or poorly controlled hypertension
* History of coagulopathy including prothrombotic conditions
Optimal Prophylactic Method of Venous Thromboembolism (VTE)

This study is to define the optimal method of prophylaxis for patients with gastrectomy in Korea and the investigators hypothesized only mechanical method would be enough for preventing VTE on perioperative period.

Venous thromboembolism (VTE) is common and often fatal complication in patients with cancer.

Gastric cancer is the most frequent cancer in Korea.

The incidence of VTE would be increased in patients with gastric cancer, especially associated surgery.

However, the incidence and optimal prophylactic method associated with cancer surgery are not well studied in Asian patients.

Most Korean surgeon concerns regarding the increased postoperative bleeding associated with low molecular weight heparin(LMWH)prophylaxis.

The incidence and adverse event will be examined to define the optimal prophylactic method of VTE in surgical patients with gastric cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed as gastric cancer
* Elective and curative under general anesthesia
* ECOG score 0-2
* ASA score 3 or less than 3
* Informed consents

Exclusion Criteria:

* 2nd primary cancer
* VTE history within one year
* Anticoagulation history
* Allergic to heparin
* Pregnancy or expected pregnancy
Long Term Complications in Head and Neck Cancer Patients

Problem:

With increasing numbers of cancer survivors, strategies to prevent long-term complications in cancer patients become more important. Adolescent and Young Adult (AYA) Head and Neck Cancer survivors treated with radiotheray (RT) are prone to long-term complications, especially vascular and psychosocial complications. Although several studies point to the importance of these long-term complications, structured survivorship care for AYA HNC survivors is still lacking.

Primary objective:

To investigate in AYA HNC survivors treated with unilateral RT at least 5 years before, the long-term vascular complications in terms of carotid wall changes (ultrasonography, MRI), cerebral vascular complications ((silent)brain infarctions, white matter lesions) and Cardiovascular Risk Management profile.

Secondary objective:

To investigate in AYA HNC survivors treated with unilateral RT at least 5 years before, the long-term psychosocial complications (subjective memory complaints, Depression, Anxiety, Fatigue, Speach handicap, Anxiety for recurrence, Quality of Life, objective cognitive failure)

Study design Prospective cohort study.

Patient population AYA HNC survivors ≥ 5 years after unilateral RT, either alone or in combination with surgery and/or chemotherapy.

Controls The ultrasonography (Intima Media Thickness, elastography) and MRI measurements of the irradiated carotid wall will be compared to the non-irradiated carotid wall. Cognitive performance will be compared to normative data. The cognitive performances of the right hemisphere tests will be compared to the cognitive performances of the left hemisphere tests. The frequency of silent brain infarcts and vascular white matter lesions of the irradiated vascular territory will be compared with the non-irradiated territory.

Intervention Structured survivorship care ≥ 5 years after RT conform the Personalized Cancer Survivorship Care Model of the Radboudumc Expertisecenter of late effects after cancer, complemented with carotid ultrasonography (IMT and elastography), MRI of the carotid arteries and brain), neuropsychological assessment battery and self-reported questionnaires concerning depression, fatigue, QoL, positive health and employment status.


Eligibility Criteria:
Inclusion Criteria:

* HNC patient treated with unilateral RT at age 18-40 years 5-10 years before
* Informed Consent

Exclusion Criteria:

* Contra indication MRI
* Able to communicate in Dutch language
Effect of Daily Use Proton Pump Inhibitors for One Month on Kidney Function

The aim of this study to: evaluate the association between prolonged use of PPI and adverse renal outcomes on patients with normal renal function and others with abnormal renal function

Proton pump inhibitors (PPIs) are one of the most widely used classes of drugs and are prescribed primarily for gastric acid-related diseases, eradication of Helicobacter pylori, and prevention of nonsteroidal anti-inflammatory drug (NSAID)-induced gastropathy,and gastroesophagial reflux diseases . Although PPIs have an excellent overall safety profile, some severe adverse effects, which include bone fracture, dementia, myocardial infarction, infections, micronutrient deficiencies, and kidney diseases,PPIs may trigger acute interstitial nephritis,a potentially sever adverse event commonly associated with acute kidney injury The increase in prescription and inadequate use of this class of medication calls for studies on the effects of prolonged PPI therapy on renal function.

Eligibility Criteria:
Inclusion Criteria:

* patients with peptic ulcer disease or gastroesophagial reflux with normal l renal function
* patients with peptic ulcer disease or gastroeosophagial reflux with abnormal renal function

Exclusion Criteria:

* 1- cigarette smoker: Cigarette smoking status was defined categorically as current,former, or never smoker at baseline.

  2-biabetic patients: diabetes mellitus is defined by a fasting blood glucose concentration \>_ 126 mg/dl ,random glucose level of \>200 mg/dl.

  3-patients take corticosteroid 4-patients with hypersensitivity to these drugs
THE EFFECT OF VIRTUAL REALITY APPLICATIONS ON SITTING BALANCE IN HEMIPLEGIA: A RANDOMIZED CONTROLLED STUDY

Objective: The aim of this study was to investigate the effects of virtual reality application on quality of life and functionality, especially sitting balance, in hemiplegic patients.

This study was planned as a single-blind randomized controlled prospective study. Patients over 18 years of age with a diagnosis of hemiplegia who applied to Gaziosmanpaşa Training and Research Hospital PTR outpatient clinic and were hospitalized in the rehabilitation service and started a rehabilitation program; will be evaluated with Modified Ashworth, Tardiue Scale, Brunstrom assessment, Stroke Specific Quality of Life Scale, Beck Anxiety Scale, Functional Independence Scale, Mini Mental State Test (MMDT), Mini Mental Test for the Uneducated, Postural Assessment Scale in Stroke Patients, Rivermead Motor Assessment Scale, Sitting Function Test, Berg Balance Scale, System Usability Scale before and after the program.

Patients who apply to the rehabilitation program will be randomly selected by closed envelope method. The first group will receive conventional rehabilitation program and home program. Conventional exercises\* of the first group will be performed for 30 sessions of 1 hour every day, in addition to this, the patient will be given a home program.

In the second group, conventional exercises will be performed for 30 sessions of 1 hour every day. In addition to conventional exercises, this group will be enrolled in a balance game group using the Becure Balance System application and the WI balance board for 45 minutes 5 sessions a week.The necessary software and equipment for the virtual reality program were donated by Becure GmbH.

Both groups will be reassessed after 30 sessions. The physician performing the evaluation will be completed blindly by physiotherapists who apply the conventional exercises and the virtual reality program.

The study is a single-center clinical study using prospective data. Between 01.05.2024-01.08.2024, 36 patients are planned to be enrolled in the study.

\*:Conventional exercise therapy includes range of motion, stretching, strengthening and balance exercises in patients with hemiplegia.

Eligibility Criteria:
Inclusion Criteria:

* 1. Stable medical condition 2. Over 18 years of age 3. A score of 23 or above on the mini mental state test (MMDT) or the mini mental state test for the untrained (MMDT-E) 4. Within the period of 1-18 months after stroke 5. A score of 3 or 4 on the 3rd item of the Berg Balance Scale (BBS), which evaluates the balance of sitting without support (3= can sit for 2 minutes under supervision, 4= can sit safely for 2 minutes).

Exclusion Criteria:

* 1. Previous history of stroke 2. Aphasic patients in whom information exchange is not possible 3. Patients with impaired vision, hearing and vestibular system 4. Musculoskeletal and nervous system disorders other than stroke that may cause physical disability 5. Patients with a history of epilepsy 6. Cerebrovascular attack involving more than one hemisphere 7. Presence of cerebellar lesions or impaired cerebellar tests
The Effect of Music on the Sedation Quality Among Children in the Emergency Department.

Children presenting to the emergency department frequently experience anxiety and may undergo various painful procedures. While sedative agents are administered to these patients, they do not consistently provide adequate relief to keep the child calm and cooperative during the procedures. Implementing non-pharmacological interventions, such as music, might enhance the efficacy of sedation, resulting in a better experience for these patients and more favorable outcomes.

This is an interventional single-blinded randomized clinical trial on children presenting to the emergency department of Imam Khomeini Hospital in Tehran. The estimated sample size is 42 patients in each group considering a 5% margin of error and 80% power. The efficacy of analgesia and sedation and adverse effects are measured using a predefined form. for the description of qualitative data, frequency will be used and for quantitative data, the T-Test, ANOVA, mean and SD will be employed. For examining differences between the two groups, Chi-Square, T-Test, and ANOVA will be utilized.

Eligibility Criteria:
Inclusion Criteria:

* Children between 0-14 years of age
* Requiring analgesia or sedation for medical procedures

Exclusion Criteria:

* Lack of consent from parents or legal guardian of the child
* Hearing impairment
* Any developmental disorder
Remote Ischemic Conditioning in STEMI to Decrease Infarct Size

Following acute STEMI patients may have significant myocardial damage and subsequent heart failure. There is currently conflicting data regarding the benefit of remote ischemic conditioning to decrease the magnitude of infarction. Remote ischemic condition is a process where by repetitive intermittent limb ischemia is used to decrease the magnitude of myocardial damage caused by coronary artery occlusion and the subsequent reperfusion injury in STEMI patients. RemCon-STEMI is a multicenter randomized trial to test the impact of remote ischemic conditioning in acute STEMI.


Eligibility Criteria:
Inclusion Criteria:

Patients presenting with STEMI within 6 hours of symptom onset and:

1. Are expected to receive reperfusion therapy with either fibrinolysis or primary PCI.
2. Documented informed consent (verbal)

Exclusion Criteria:

1. Cardiogenic shock
2. History of anatomical deformity or vascular complication that limit ability to conduct remote ischemic preconditioning
Adaptive Intervention Model for Hypertension Self-Management in Rural Areas: a Doctor-Patient Interaction Approach

The aim of this project is to develop and validate an adaptive intervention model to improve self-management behavior in rural hypertensive patients. The primary question it seeks to answer is: Can a tailored, interaction-based intervention model, guided by key doctor-patient interaction elements, effectively enhance self-management behavior among rural hypertensive patients and improve long-term blood pressure control? Researchers will evaluate the impact of different intervention strategies on self-management behavior and identify the most effective combination to establish a sustainable intervention model for rural hypertension management.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed hypertension patients who are permanent residents in rural areas.
* No plans for long-term relocation within the next year.
* Willing to participate in this study.
* No cognitive impairment.
* No other diseases that significantly affect self-management behavior, such as malignant tumors.

Exclusion Criteria:

* Age over 80 years.
* Having conditions such as stroke, paralysis, or mental disorders that prevent the completion of self-management behaviors.
* Severe hearing impairment or speech disorders that prevent participation in interviews.
* Likely to relocate or be away from the local area for an extended period within one year.
mPATH for Low-income Older Adults

Although empirical research suggests that physical activity interventions benefit cognition and sleep in older adults in general, the possible benefit of physical activity is understudied in low-income older adults. The study aims to test the immediate and sustaining efficacy of an mHealth-facilitated Physical Activity Toward Health (mPATH) intervention on cognitive function and sleep in low-income older adults.

Low-income older adults (LIOA) are a population at higher risk to develop Alzheimer's disease and related dementias (ADRD) and sleep disturbances. Although empirical research suggests that physical activity interventions benefit cognition and sleep in older adults in general, the possible benefit of physical activity is understudied in LIOA. The growing wearable device and mobile Health (mHealth) provide an innovative approach to deliver individually tailored physical activity interventions at home with flexible schedules to overcome barriers to physical activity in LIOA. In addition, limited research has examined if physical activity interventions impact the individual's Amyloid/Tau/ Neurodegeneration (ATN) Alzheimer's disease biological state and whether physical activity may promote cognition through impacting sleep and AD pathology. This randomized controlled trial is designed to examine the immediate and sustaining efficacy of an mHealth-facilitated Physical Activity Toward Health (mPATH) intervention on cognitive function and sleep in LIOA. mPATH is a personalized physical activity intervention that includes personalized physical activity plans and training sessions, exercise at home by following personalized exercise videos, and biweekly phone coaching over 24 weeks, supported by wearable devices-enabled mHealth strategies. mHealth strategies and exercise videos will be used to support participant's physical activity during 6-12months.

Eligibility Criteria:
Inclusion Criteria:

* self-reported difficulty of sleep
* lack of physical activity/exercise
* low household income
* capacity for moderate intensity exercise

Exclusion Criteria:

* untreated sleep apnea
* severe depression or anxiety
* dementia
* history of neurologic or psychiatric disorders, neurodevelopmental impairment, traumatic brain injury
* current enrollment in another clinical trial
Health App Data Collection Study

Utilization of additional wearable data to improve clinical outcome

In addition to information available from cardiac implantable medical devices, health related data available from commercially approved wearables and devices such as Apple watch, blood pressure monitor and scales could be used to improve predictive analytics of impending clinical events. This study is to merge implantable medical device data with wearable data to evaluate the added benefit of extra data.

Eligibility Criteria:
Inclusion Criteria:

* Patients are willing to be compliant with daily measurements required 18 years of age or older
* Patients who have been implanted with ABT CRT-D devices connected to Merlin.net
* Patients who had at least one HF clinical event during past 12 calendar months
* Must provide written informed consent prior to the commencement of this clinical feasibility study
* Patients are willing to be compliant with daily measurements required

Exclusion Criteria:

* Pregnant and/or lactating mothers will be excluded from the study or have a plan to be pregnant in the next 12 months
* Patients with a life expectancy less than the duration of the study, as per clinician's discretion.
* Patients who will not be able to complete the daily survey questions due to inability to read
Pain Disengagement Training (open Pilot)

The investigators aim to conduct an open pilot trial to determine the initial feasibility of a self-directed writing-based intervention in individuals with chronic musculoskeletal pain and elevated pain catastrophizing. The investigators will assess the feasibility of recruitment, acceptability of the treatment, credibility and participant satisfaction, treatment adherence, and feasibility of assessments following pre-specified benchmarks.

Mind-body interventions are some of the most effective treatments for chronic pain, yet due to lack of resources, many are inaccessible to the patients who need them. The investigators seek to fill this gap by developing and testing Pain Disengagement Training (PDT) for the treatment of chronic pain catastrophizing, a key risk factor for pain interference. The investigators will administer the PDT treatment in a small number (approximately 10) of participants to evaluate initial benchmarks (the feasibility of recruitment, acceptability of the treatment, credibility and participant satisfaction, treatment adherence, and feasibility of assessments) and to assess participants' experience with the intervention using qualitative exit interviews. Results will inform the refinement of the intervention for a future larger trial.

Eligibility Criteria:
Inclusion Criteria:

1. Outpatient adults (i.e., greater than or equal to 18)
2. Has self reported chronic musculoskeletal pain (i.e., pain persisting for at least 3 months)
3. Pain score greater than or equal to 4 (moderate) on the Numerical Rating Scale
4. Pain catastrophizing score greater than or equal to 20 on Pain Catastrophizing Scale
5. Willingness to engage in a writing-based intervention and self-reported ability to write or type for at least 30 minutes in a sitting
6. Received care at Massachusetts General Hospital
7. English verbal and writing fluency

Exclusion Criteria:

1. Clinically significant change in therapy or medication in the past 3 months
2. Severe untreated mental health condition (e.g., psychosis)
3. Active suicidality with history of plan or current intent
4. Serious illness expected to worsen in the next 6 months (e.g., cancer)
5. Untreated substance use problem that, per patient's self-report, would interfere with the ability to complete the intervention.
Safety and Efficacy Study in in Vitro Fertilisation (IVF) Patients

The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety of two different subcutaneous hMG preparations when administered to patients undergoing controlled ovarian stimulation for IVF.


Eligibility Criteria:
Inclusion Criteria:

* Women undergoing ovarian stimulation for IVF with the following characteristics:

  * Able and willing to sign the Patient Consent Form and adhere to the study visitation schedule
  * \>18 and \<40 years old
  * BMI between 18 and 30 kg/m2
  * less than 3 previously completed IVF cycles (i.e. completed cycle = egg recovery)
  * basal FSH \<10 IU/L and E2 \<80 pg/ml (\~290 pmol/l)
  * Within 12 months of the beginning of the study, uterine cavity consistent with expected normal function as assessed through transvaginal ultrasound, hysterosalpingogram, sonohysterogram or hysteroscopic examination
  * Successful down-regulation performed with a standard GnRH-Agonist long protocol (Criteria for successful down-regulation: endometrial thickness \< 7mm or serum E2 level \<50 pg/ml (\~185 pmol/l).

Exclusion Criteria:

* age \<18 and \>40 years
* primary ovarian failure or women known as poor responders (i.e. requiring more than 225 IU of hMG as a starting dose in previous treatment cycles or having less than 3 oocytes retrieved, or with a pre-ovulatory E2 serum concentration \<500pg/ml (\~1800 pmol/l))
* PCOS
* one or both ovaries inaccessible for oocyte retrieval
* ovarian cysts \>10 mm
* hydrosalpinx that have not been surgically removed or ligated;
* stage 3 or 4 endometriosis
* oocyte donation
* implantation of previously frozen embryos
* patients affected by pathologies associated with any contraindication of being pregnant
* hypersensitivity to the study medication
* abnormal bleeding of undetermined origin
* uncontrolled thyroid or adrenal dysfunction
* neoplasias
* severe impairment of renal and/or hepatic function
* use of concomitant medications that might interfere with study evaluations (e.g. non-study hormonal medications, prostaglandin inhibitors, psychotropic agents)