cyrilzakka/clinical-trials huggingface dataset:
Partial PTEN Deletion in Breast Cancer

* Detection of chromosome 10q23 deletion including PTEN locus in breast cancer patients.
* Correlation between PTEN deletion and clinicopathological characteristics in breast cancer patients.

Breast cancer is the most common carcinoma detected in women, accounting for about one fifth of new cancer cases in females. In Egypt breast cancer is the most common malignancy in women, accounting for 38,8% of cancers in this population, with the estimated number of breast cancer cases nearly 22700 in 2020 and forecasted to be approximately 46000 in 2050. Surgical removal of the cancer represents the standard of care followed by radiation and adjuvant therapy in patients considered to be at particular risk for systemic disease. Estimation of prognosis is of vital importance for tailoring adjuvant therapy in individual breast cancer patients. Conventional pathological parameters such as histological grade, tumor size and presence of lymph node metastasis are not accurate enough to select subsets of patients who are at sufficiently low risk of progression to be spared extensive adjuvant therapy without compromising the prognosis. Much hope is placed on cytogenetic features analysis which might help to improve prediction of patient prognosis.

Fluorescence in situ hybridization (FISH) is a molecular cytogenetic technique that enables the detection of genetic abnormalities such as gene amplification, deletions, and chromosomal rearrangements.

Deletions of chromosome 10q23 including the PTEN (phosphatase and tensin homolog) locus are known to occur in breast cancer patients. The PTEN gene is a phosphatase which metabolises PIP3, the lipid product of PI 3-kinase, directly opposing the activation of the oncogenic PI3K/AKT/mTOR signalling network. Inactivation of PTEN leads to constitutively activated levels of AKT, thus promoting cell growth, proliferation, survival and migration through multiple downstream effectors. PTEN is one of the most frequently deleted genes in various human cancer types. In breast cancer, the frequency of PTEN deletions or reduced expression varies from 4 % to 63 %.

Eligibility Criteria:
Inclusion Criteria:

* all stages of breast cancer in females.

Exclusion Criteria:

* breast cancer in males.
The Efficacy and Safety of Black Rice Bran Extract on Immune Enhancement

This study was conducted to investigate the efficacy and safety of Black rice bran extract on immune enhancement.

This study was a 8 weeks, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Black rice bran extract on immune enhancement.

Eligibility Criteria:
Inclusion Criteria:

* Adult men and women over 19 and under 75 years
* After fully hearing and fully understanding this clinical trials, those who agree to voluntarily decide to participate and to comply with the notice

Exclusion Criteria:

* If screening shows that the white blood cell(WBC) is less than 3000/㎕ or more than 8000/㎕
* Those who received influenza vaccination within 3 months before first intake of intervention
* Those who have a body mass index(BMI) of less than 18.5 kg / m\^2 or greater than 35 kg / m\^2 at the screening
* Those who have a clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, liver biliary system, kidney and urinary system, neuropsychiatry, musculoskeletal system, inflammatory and hematologic and gastrointestinal disorders
* Those who take a medication or health function food that affects your promotion of immunity within 1 month prior to the screening
* Those who have received antipsychotic medication within 3 months before screening
* Those who alcoholic or drug abuse suspected
* Those who participated in other clinical trials within 3 months before screening
* Laboratory test by show the following results

  * Aspartate Transaminase(AST), Alanine Transaminase(ALT) \> Reference range 3 times upper limit
  * Serum Creatinine \> 2.0 mg/dL
* Pregnancy or breast feeding
* Those who doesn't accept the implementation of appropriate contraception of a childbearing woman
* Principal Investigator judged inappropriate for participation in study because of Laboratory test result, etc.
Increased Physical Activity in African-American Women

To conduct a randomized demonstration and education trial of churches in East Baltimore testing a self-help, minimal intervention compared with an intensive physical activity intervention.

BACKGROUND:

The study filled an existing gap by examining how a culturally sensitive physical activity intervention conducted in a community setting was associated with increased daily energy expenditure in African American women -- a group of women who are sedentary and at risk for health problems for which regular physical activity can provide benefits.

DESIGN NARRATIVE:

An evaluation was conducted of the effectiveness of a six-month moderate-intensity physical activity intervention for increasing total daily energy expenditure of sedentary African-American women who were between the ages of 50 and 70 years. The goal of the intervention was to increase total daily energy expenditure by 150 kilocalories per day and time spent in moderate-intensity physical activity by 30 minutes per day. Effects of increased physical activity on selected cardiovascular risk factors (e.g., peak oxygen uptake, blood pressure, HDL cholesterol, serum insulin and plasma glucose) were also determined. Six churches were randomized into intensive or minimal intervention status, and 33 women per church were recruited, for a total of 100 women in each condition. The physical activity intervention consisted of twice-weekly aerobics classes conducted at the churches and additional group-and home-based programming. Volunteer lay leaders were trained as neighborhood exercise specialists to supplement certified aerobics instructors in conducting the intervention.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Binaural Beat Technology and Rhythmical Photic Stimulation

Background Many nurses must shoulder heavy workloads and often develop depressive emotions due to work stress. Previous studies pointed out that binaural beat technology (BBT) and rhythmical photic stimulation can effectively improve negative emotions but there are very few related empirical studies.

Objectives This study examined the effectiveness of BBT combined with rhythmical photic stimulation in improving depressive symptoms in nurses.

Methods This is a randomized controlled trial and nurses in central Taiwan were recruited as participants. These participants were randomized into three groups: BBT combined with rhythmical photic stimulation group, BBT group, and relaxing music group. The intervention period was 2 weeks, with 30 minutes per session. The Beck Depression Inventory (BDI), Pittsburgh Sleep Quality Index (PSQI), vitality and mental health scale (VT\&MH from SF-36), and heart rate variability (HRV) were used as parameters for pre- and posttest evaluation in this study. The Wilcoxon signed-rank test was used to test if there are significant differences in various parameters in the three groups before and after intervention. The Krusal-Wallis test was used to test for significant differences in parameter changes between the three groups.


Eligibility Criteria:
Inclusion Criteria:

* (1) BDI score ≥ 14 points; (2) aged between 20 and 50 years, and (3) did not undergo antidepressant treatment within 3 months before intervention and during intervention.

Exclusion Criteria:

* (1) Subjects with a medical history of mixed psychosis, including schizophrenia, bipolar disorder, and dementia; (2) patients with current acute disease and unstable physiological status; (3) medical history of epilepsy; (4) patients with eye diseases; (5) vertigo (including Meniere's syndrome); (6) hearing loss; and (7) participated in electroconvulsive therapy or transcranial electrical stimulation within 1 month prior to or during intervention.
Anticoagulation and Inferior Vena Cava Filters in Cancer Patients With a Venous Thromboembolism

The development of clots is a potentially deadly complication in many cancer patients. The current optimal treatment is unknown. Evidence supporting the effectiveness of the use of Inferior Vena Caval Filters is lacking. This study will compare the two standard of care treatment options: anticoagulation with or without a inferior vena cava filter. The anticoagulation medication chosen will be Arixtra and it will be given once a day as an injection. Patients will be called at various intervals to monitor their signs and symptoms of new thromboembolisms.

The development of clots is a potentially deadly complication in many cancer patients. The current optimal treatment is unknown. Evidence supporting the effectiveness of the use of Inferior Vena Caval Filters is lacking. This study will compare the two standard of care treatment options: anticoagulation with or without an inferior vena cava filter. The anticoagulation medication chosen will be Arixtra and it will be given once a day as an injection. Patients will be called at various intervals to monitor their signs and symptoms of new thromboembolisms. Patients will be equally randomized to receive either Arixtra with or without placement of an Inferior Vena Cava (IVC) filter. Fifty three patients are expected to be enrolled in each arm. Patients will be monitored for 90 days after study enrollment. Monitoring will include telephone calls and physician visits and repeat radiologists if the patient is symptomatic of a Deep Vein thrombosis (DVT). This will also include completion of a quality of life questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Documentation of cancer.
* The disease may be a solid tumor, Lymphoma or Multiple Myeloma. Pathology reports will be documented in the patient's chart and included in the data.
* Age \> 18 years
* An acute, radiographically confirmed, de novo Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
* No past medical history of a prior thrombus or known thrombophilia

Exclusion Criteria

* Patients are not eligible for this study if they receive therapeutic doses of any heparin for more than 72 hours before randomization 31.
* Already receiving oral anticoagulant therapy 31.
* Severe renal impairment, calculated using the Cockcroft-Gault formula, defined as a creatinine clearance \<30 mL/min 31.
* Platelet count of less than 50,000 per cubic millimeter
* Bleeding from the gastrointestinal tract that requires blood transfusion (s), intracranial bleeding or retroperitoneal bleeding.
* An indication for thrombolysis
* Allergy to iodine
* Hereditary thrombophilia
* Pregnancy
* Likelihood of noncompliance
* It is contraindicated to anticoagulate patients with brain metastasis secondary to melanoma, choriocarcinoma, renal cell and medullary thyroid carcinoma. If these patients have a Venous Thromboembolism (VTE), it is standard of care for these patients to have a CT of their head to evaluate if there is metastasis to the brain before they are anticoagulated 38. If these patients do have brain metastasis, they will not be included in the study.
Natural Killer (NK) Cell Transplantation for AML

The purpose of this study is to assess the safety and efficacy of infusing natural killer cells from a donor as treatment for patients with acute myeloid leukemia in remission or who have experienced relapse.

Natural killer (NK) cells extracted from a \[parental\] donor are infused intravenously. Most patients are given a multi-agent chemotherapeutic conditioning regimen prior to the infusion. The conditioning regimen may be omitted for patients who have previously received traditional stem cell transplant.

Details of Treatment Plan:

Stratum 1 (AML in complete remission)

Cyclophosphamide 60 mg/kg IV Day -7 Fludarabine 25 mg/m2/day IV Days -6 through -2 Donor pheresis Day -1 Start IL-2 on Day -1, then 3 times per week x 2 weeks NK Cell purification and infusion on Day 0

Stratum 2 (AML that is refractory or relapsed or AML with increasing minimal residual disease)

Clofarabine 40 mg/m2 IV, days -6 through -2 Etoposide 100 mg/m2 IV, days -6 through -2 Cyclophosphamide 400 mg/m2 IV, days -6 through 02 Donor pheresis Day -1 Start IL-2 Day -1, and then 3 times per week x 2 weeks NK Cell purification and infusion on Day 0.

For patients who have received prior SCT, the conditioning regimen may be omitted if the NK cells are obtained from the original SCT donor.

Cytokine regimen (stratum 1 and 2): 1 million units/m2 of IL-2 given subcutaneously three times per week for two weeks (6 doses) starting on the evening of day -1.

NK Cell Transplantation (stratum 1 and 2): NK cells from haplo-identical family donor will be infused on day 0.

Eligibility Criteria:
Inclusion Criteria:

* Participants with AML that is in complete remission, is relapsed or refractory, or with increasing minimal residual disease.
* Participants in complete remission must have recovered from toxicity of previous therapy and have evidence of bone marrow recovery
* Participants who had prior stem cell transplant (SCT) must have no evidence of GVHD and 60 or more days have elapsed since the SCT.

Exclusion Criteria:

* Participants who are pregnant
* Participants with inadequate renal, liver, or pulmonary functions
Effects of Cash Transfer for the Prevention of HIV in Young South African Women

Cash transfers to young women for staying in school and its effect on acquiring HIV

The overall purpose of this study is to determine whether providing cash transfers to young women and their household, conditional on school attendance, reduces young women's risk of acquiring Human Immunodeficiency Virus (HIV). The overall goal of the Conditional Cash Transfer (CCT) intervention is to reduce structural barriers to education with the goal of increasing school attendance of young women, thereby decreasing their HIV risk.

Eligibility Criteria:
Inclusion Criteria:

* Female aged 13 to 20 years.
* Enrolled in grades 8, 9, 10 or 11 at the beginning of the study at schools in the AHDSS study site
* Intending to continue to live in the study site until the end of the follow-up period.
* Be willing and able to consent/assent to all study procedures including HIV and HSV-2 testing.
* Able to read sufficiently to use ACASI.
* Have a bank or post office account or have documentation to be able to open a bank or post office account (i.e., birth certificate, South African National Identification Book, or passport and proof of residence). Post Office accounts will only be required for participants in the Intervention arm.
* Parent/Legal Guardian who lives with young woman, willing and able to consent to all study procedures including HIV and HSV-2 testing.
* Parent/Legal Guardian has a bank or post office account or has documentation to be able to open a bank or post office account (i.e. South African National Identification Book, or passport and proof of residence). Note that the account may be opened in the name of any adult who resides in the household with the young woman.

Exclusion Criteria:

* Pregnant by self-report at baseline.
* Married at baseline.
* No parent or legal guardian living in household.
* Any other reason that the staff feels would jeopardize the health or well-being of the participant or staff or would prevent proper conduct of the study.
Effectiveness of Escitalopram in the Treatment of Body Dysmorphic Disorder

This study's primary aim is to compare time to relapse and relapse rates in responders to acute escitalopram who are then randomized to placebo versus continuation treatment with escitalopram.

We propose to conduct the first pharmacotherapy relapse prevention study in body dysmorphic disorder (BDD). BDD, an often-delusional preoccupation with a nonexistent or slight defect in appearance, is a distressing, impairing, and common body image disorder. It is associated with high rates of functional impairment and markedly poor quality of life. It appears that serotonin reuptake inhibitors (SRIs) are often--and selectively--efficacious for BDD and that many BDD patients receive SRIs. It also appears that most patients discontinue an efficacious SRI at some point, as the alternative is life-long treatment. However, no relapse prevention studies have been done. Such a study is important from a clinical and public health perspective, because BDD appears to often be chronic and require long-term treatment. It is therefore critically important to investigate the risk of relapse with SRI discontinuation, and whether continuation SRI treatment decreases relapse risk.

Subjects will be enrolled and first treated openly for 14 weeks with escitalopram; 58 escitalopram responders will then be randomized to double-blind continuation treatment with escitalopram or placebo for 6 additional months. Our primary aim is to compare time to relapse and relapse rates in responders to acute escitalopram who are then randomized to placebo versus continuation treatment with escitalopram. Secondary/exploratory aims will explore 1) Whether subjects who receive continuation escitalopram perform better on secondary outcome measures (e.g., quality of life) than those on placebo; 2) Change in symptoms with continuation of escitalopram during the continuation phase; and 3) Acute treatment response.

In summary, this study will be the first relapse prevention study in BDD and the first study of continuation pharmacotherapy in BDD. It will provide critically important information on relapse with continuation versus discontinuation of an SRI, whether continuation treatment protects against relapse, and change in symptoms with continuation treatment. This study will yield unique and clinically important data, and will fill gaps in knowledge about this common, severe, and understudied illness.

Eligibility Criteria:
Inclusion Criteria:

* Outpatient men and women age 18 and older
* Diagnosis of BDD within 6 months of study start date based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)
* Score of 24 or higher on the BDD-Yale-Brown Obsessive Compulsive Scale
* Lives within driving distance of Boston, MA or Providence, RI

Exclusion Criteria:

* Suicidal or homicidal tendencies
* Alcohol/drug abuse or dependence within 3 months of study entry
Attenuation of D-dimer Using Vorapaxar to Target Inflammatory and Coagulation Endpoints

ADVICE is a randomised, international, double-blind, placebo-controlled trial. The purpose of the ADVICE study is to compare the safety and efficacy of vorapaxar in reducing d-dimer expression and markers of cellular immune activation over a period of 12 weeks among people with HIV infection who are successfully treated with combination antiretroviral therapy containing an HIV integrase inhibitor. A secondary objective of the study will be to demonstrate that following cessation of vorapaxar in patients with well controlled HIV replication there will be an increase in the levels of d-dimer over a 6 week period. 60 participants from 4 clinical sites in Australia and the USA will be recruited and followed for a minimum of 18 weeks.

Consenting participants will be screened and within 14 days randomly allocated to receive either vorapaxar (2.5mg) or matched placebo once daily for 12 weeks (phase 1). Participants will be seen one week after randomisation and then at weeks 4, 8 and 12 (phase 1). At the week 12 visit, patients will not be dispensed any study treatment. In phase 2 all study treatment will stop for 6 weeks. At week 18 patients will be seen for a final study visit.

Eligibility Criteria:
Inclusion Criteria:

1. HIV-1 positive by licensed diagnostic test
2. aged ≥40 years
3. plasma HIV RNA \<50 copies/mL for at least 24 weeks
4. screening CD4+ cell count \> 50 cells/mm3
5. treated for at least 12 weeks with a suppressive regimen of combination antiretroviral therapy that does not include HIV protease inhibitors and/or NNRTIs (except rilpivirine)
6. plasma d-dimer \>200ng/mL (\>0.2μg/mL or \>0.2mg/L) fibrinogen equivalent units or \>100ng/mL (\>0.1 μg/mL or \>0.1mg/L) d-dimer units in the absence of established cause (deep vein thrombosis/embolism)
7. provision of written informed consent

Exclusion Criteria:

1. Absolute neutrophil count (ANC) \<1000 cells/μL
2. hemoglobin \<10.0 g/dL
3. platelet count \<75,000 cells/μL
4. AST and/or ALT \>2.5 x ULN
5. estimated glomerular filtration rate \<30mL/min/1.73m2 ) using CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation
6. history of myocardial infarction or unstable atherosclerotic disease
7. history of ischemic stroke or transient ischaemic attack (TIA)
8. active peptic/duodenal ulcer or other bleeding disorder within the previous 12 months
9. intent to have surgery within the 6 month period after randomisation
10. current use of aspirin or P2Y12 antiplatelet therapy
11. use of anticoagulants, (eg. heparin or warfarin), fibrinolytic therapy, chronic use (more than 5 consecutive days) of nonsteroidal anti-inflammatory drugs (NSAIDS), strong CYP3A4 inhibitors or inducers. See Manual of Operations for full list of medications to avoid.
12. participants unlikely to be able to remain in follow-up
13. pregnant or nursing mothers
14. in the clinical judgement of the investigator, participation in this trial is deemed inappropriate as this may conflict with the well-being of the participant.
Ketamine Tolerated Dose for Postpartum Depression and Pain After Cesarean Delivery (PREPARE 1)

The purpose of this study is to identify a tolerable dose for postpartum ketamine infusion using a maximum tolerated dose (MTD) 3+3 design. A loading dose over 1 hour will be the MTD variable to be tested, as our data suggest that ketamine side effects occur with the loading dose. The investigators hypothesize that subanesthetic ketamine dose will be well tolerated and any noted side effects will be rated acceptable by postpartum women following cesarean delivery.

Pain management for women having a cesarean delivery is rather limited and risks poor pain control, depressed mood, and poor recovery following the cesarean delivery. Current cesarean pain management treatments ignore the multidimensionality of pain, including the influence of mood on pain. Recent evidence suggests that ketamine may provide successful post-surgical pain management, opioid reduction, and rapid reduction of depressive symptoms. The current study aims to identify an appropriate dose of ketamine for post-cesarean pain management while minimizing potential dose-dependent side effects in women following childbirth.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years and older
* Cesarean Delivery
* American Society of Anesthesiologists Physical Status of 2 or 3
* Neuraxial anesthesia with neuraxial morphine
* Term delivery ≥37 weeks gestation
* Either planning not to breastfeed, OR receiving ketamine as part of routine clinical care

Exclusion Criteria:

* General anesthesia
* Allergy to study medications
* ASA PS 4 or higher
* Contraindications to neuraxial anesthesia
* Preterm delivery (\<37 weeks gestation)
* Anticipated fetal-neonatal complex care plan
* Participating in another pain intervention trial
* Hypertensive disorder of pregnancy
* Pre-eclampsia with severe features
* Hemodynamic instability
* Medical History exclusions: ketamine or PCP (phencyclidine) abuse, schizophrenia or psychosis, liver or renal insufficiency, uncontrolled hypertension, chest pain, arrhythmia, head trauma, or intracranial hypertension, uncontrolled thyroid disease, or other contraindications to ketamine