cyrilzakka/clinical-trials huggingface dataset:
Randomized Phase II Trial of Anastrozole Plus Metronomic Tegafur-uracil as Neo-adjuvant Therapy in Postmenopausal Breast Cancer

The Aim of this study is to validate a treatment of anastrozole in combination with tegafur-uracil as pre-operative therapy for postmenopausal primary breast cancer. Although pre-operative hormone therapy is a novel therapeutic approach, only hormone therapy has limitation in terms of efficacy. Metronomic chemotherapy, which is the frequent administration of low-dose cytotoxic agents, is not only target tumor cells but also inhibiting angiogenesis. Because there was a report that efficacy of hormone therapy add to metronomic chemotherapy as pre-operative therapy, a randomized phase II trial of anastrozole (ANA) in combination with/without metronomic tegafur-uracil (UFT) as neo-adjuvant for postmenopausal breast cancer will be conducted.


Eligibility Criteria:
Inclusion Criteria:

* Histologically-confirmed diagnosis of invasive breast cancer
* Clinical stage T2, N0 or N1, M0 (TNM Classification)
* Patients must be postmenopausal
* Tumors are estrogen receptor (ER) positive and human epidermal growth factor receptor (HER2) negative
* ECOG Performance status (PS) 0 or 1
* Patients must be able to swallow tablets and capsules
* Candidates for mastectomy or breast-conserving surgery
* Adequate bone marrow, liver and renal function
* Written informed consent was obtained from all patients before randomization.

Exclusion Criteria:

* Inoperable, bilateral or inflammatory breast cancer
* multiple carcinoma
* Personal history of invasive carcinoma
* Patients receive systemic therapy of corticosteroid
* Patients receive estrogen preparation or raloxifene
* Patients with other concurrent severe and/or uncontrolled medical disease
* Patients whom doctors judged inadequate to the enrollment of this study by other reasons.
Pilot Study of Physostigmine-Enhanced Opioid Analgesia

The investigators hypothesize that the administration of physostigmine in the postoperative period after nephrectomy reduces opioid consumption.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* At least 50 kg
* Suitable for PCA
* ASA 1-3

Exclusion Criteria:

* Bronchial asthma/severe or exacerbated COPD
* Iritis
* Stenoses/spasms of intestine, urinary tract, biliary tract
* Closed traumatic brain injury
* Severely reduced left ventricular function (EF\<30%)
* Recent myocardial infarction
* Recent stroke
* Known allergy or hypersensitivity or contraindications against hydromorphone, physostigmine
* History of alcohol or drug abuse
* Patients enrolled in another study
* Women of childbearing age without a negative pregnancy test
A Study of CC-5013 in the Treatment of Complex Regional Pain Syndrome (CRPS)

This is a multicenter, open-label study in adult subjects with Type 1 Complex Regional Pain Syndrome. Subjects diagnosed with unilateral Type 1 CRPS will be enrolled sequentially to receive CC-5013 10 mg/day orally. For each subject the study consists of two phases: Pre-treatment phase(1 wk) and treatment phase (12 wks)

Once the subject completes the 12 week treatment phase the subject is eligible to continue on the trial. Subjects may continue until no further benefit is obtained.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of Type 1 CRPS as defined by modified International Association for the Study of Pain criteria (App 1) for at least one year duration
* Unilateral involvement of a distal hand or foot with or without proximal speed must be present. The most severely affected limb will be designated the index limb.
* CRPS pain severity score in the index limb of 4 or greater on an 11-point (0-10) NRS (Appendix I).
* Opioid analgesics, non-opioid analgesics, non-steroidal anti-inflammatory drugs, anticonvulsants and antidepressant drugs may be continued provided that the subject was on stable doses for at least four weeks prior to the Treatment phase.
* Understand and voluntarily sign an informed consent form
* Able to adhere to the study visit schedule and other protocol requirements
* Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days of starting study drug.
* In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug.
* WCBP must agree to have pregnancy tests every 4 weeks while on study drug.
* The average CRPS pain severity score in the index limb at the end of the Pre-Treatment Phase I (must be 4 or greater) and 2 each of the daily scores over the week must be within +/- one point of this average.

Exclusion Criteria:

* Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
* Prior treatment with CC-5013
* Prior development of an allergic reaction/hypersensitivity while taking thalidomide.
* Prior development of a moderate or sever rash or any desquamation while taking thalidomide.
* Pregnant or lactating females.
* Active litigation, compensation or disability issues related to CRPS.
* Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
* Use of any other experimental drug or therapy within 28 days of the treatment phase.
Tetris to Reduce Intrusive Memories in Parents After PICU

The purpose of this study is to examine the acceptability and feasibility of a brief behavioural intervention involving Tetris gameplay to prevent intrusive traumatic memories in parents after paediatric intensive care. The present acceptability and feasibility study seeks to answer the following questions: (1) Is this intervention acceptable to parents whose children have been admitted to PICU, (2) how practical is it to deliver the intervention in this setting, (3) willingness of hospital staff to be involved in the recruitment of participants, (4) after having taken part in the intervention themselves would parents have been willing to consent to their child taking part in the intervention, and (5) discover any challenges or barriers in carrying out this study. Furthermore, this study aims to estimate recruitment, withdrawal and dropout rate, in order to act as a preliminary test of the effect of the intervention and inform sample size estimation. The findings from this study will inform the design of a randomised control trial.


Eligibility Criteria:
Inclusion Criteria:

* Parent of a child in PICU, therefore exposed to an event meeting DSM-5 criterion for a traumatic event (APA, 2013).
* The parent's child must be near the point of discharge from PICU (site 1 and 2), as identified by a clinician, or on a paediatric hospital ward within 24 hours after discharge from PICU (site 2 only).
* Sufficient ability to read and understand English to provide consent, follow game instructions and complete measures.
* Have sufficient physical mobility to play TETRIS using a computer (e.g. a handheld Nintendo DS).
* Willing and able to complete measures and be contacted one-week and month post-intervention to complete follow-up measures.

Exclusion Criteria:

* Parents will be excluded from the study if their child is due to be discharged to palliative care and/or if nursing/medical staff within the PICU feel it would be inappropriate to contact them/have them participate in this study.
A Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)

This study will evaluate the safety and durability of effect of ALKS 9072 (also known as ALKS 9070) during long-term treatment of subjects with stable schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

(Subjects who participated in ALK9072-003)

* Completed the ALK9072-003 Day 85 visit
* Continues to require treatment with an antipsychotic medication

(New Subjects)

* On a stable dose of oral antipsychotic medication
* Diagnosis of chronic schizophrenia based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria that is clinically stable
* Has been able to achieve outpatient status for more than 3 months prior to screening
* Body Mass Index (BMI) of 18.5 to 40.0 kg/m2 (inclusive)
* Resides in a stable living situation

Exclusion Criteria:

(Subjects who participated in ALK9072-003)

* Abnormal clinical laboratory, vital sign, or electrocardiogram (ECG) finding during participation in study ALK9072-003 that was clinically relevant and related to study drug
* Missed more than 1 scheduled study visit during participation in study ALK9072-003
* Has a significant or unstable medical condition that would preclude safe completion of the current study
* Subject is pregnant or breastfeeding
* Subject expects to be incarcerated in the next 12 months, or has pending legal action which may impact compliance with study participation or procedures

(New Subjects)

* History of poor or inadequate clinical response to treatment with aripiprazole
* History of treatment resistance
* Diagnosis of current substance dependence (including alcohol)
* Pregnant, lactating, or breastfeeding
* Has received any long-acting intramuscular antipsychotic medication within 60 days prior to screening
* Currently under involuntary hospitalization
* Current or expected incarceration

Additional inclusion/exclusion criteria may apply
Liberal or Adhere to Recommendations for PCC Management in Major Bleeding Following Trauma

Severe post-traumatic bleeding remains a major challenge in trauma management . The effectiveness and safety of PCC in the treatment of major traumatic bleeding is controversial, and the indications for use are not clear. Studies on the status of PCC use and the efficacy evaluation of PCC adhere to recommendations are lacking.

Post-traumatic severe bleeding and associated traumatic coagulopathy remains a challenge.

The use of prothrombin complex concentrate (PCC) is being explored in the management of on-going coagulopathy following trauma, with the cited purpose of boosting thrombin generation. Clinical data on the efficacy of PCC as part of a coagulation factor concentrate-based haemostatic strategy showed initial promising results in retrospective studies and meta-analysis.

Certainly, the utility of PCC was a residual question in the management of traumatic coagulopathy. Uncertainty remains on the indication of use.The 2019 guideline on management of major bleeding and coagulopathy following trauma suggest that PCC should be administered to the bleeding patient based on evidence of delayed coagulation initiation using VEM, provided that fibrinogen levels are normal. The recommendation Grade is 2C.Studies on the status of PCC use and the efficacy evaluation of PCC adhere to recommendations are lacking.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old or \< 80 years old
2. Trauma treated in resuscitation unit/emergency room patient
3. Hospital admission within 24h after injury
4. Assessment of blood consumption (ABC) score ≥2 points.

Exclusion Criteria:

1. PCC was used before admission
2. Anticoagulant drugs (such as low molecular weight heparin, rivaroxaban, warfarin, etc.)
3. Previous venous thrombosis (VTE, Patients with a history of coronary artery stents within 3 months of pulmonary embolism and myocardial infarction)
4. Patients with traumatic cardiac arrest in hospital
5. Women during breastfeeding, pregnancy or pregnancy
6. Patients with hemophilia A and other blood system diseases, severe liver disease, cirrhosis and other coagulation dysfunction
Microenvironment of Adipose Tissue in Endocannabinoid System

The purpose of this study is examine the relationship between adipose tissue inflammation and activation of the endocannabinoid system before and after Roux-en-Y gastric bypass surgery. The investigators hypothesize that the metabolic improvements and weight loss are due to mechanisms that antagonize the endocannabinoid system.


Eligibility Criteria:
Inclusion Criteria:

* BMI\>35 kg/m2
* Age 20-60 yrs
* Approved and scheduled for gastric bypass surgery
* Stable body weight for past 3 months

Exclusion Criteria:

* Positive pregnancy test
* Previous gastric surgeries
* Intercurrent infections
* History of ketoacidosis or current metabolic acidosis
* Serum creatinine or liver function tests \> 2 times upper limits of normal
* Taking drugs that are known to affect carbohydrate or lipid metabolism other than anti-diabetes mediations.
Genetic Factors and Interrelationships for Sexual Orientation, Susceptibility to HIV and Kaposi's Sarcoma, Alcoholism and Psychological Traits, and Histocompatibility Antigens

We propose to test, by DNA linkage analysis of family pedigree members, the following interrelated hypotheses: 1) that sexual orientation is genetically influenced; 2) that the development of Kaposi's sarcoma and other outcomes of HIV infection in male homosexuals is affected by host susceptibility genes, circulating sex hormone levels, or HLA haplotype; and 3) that alcoholism and other psychobehavioral conditions are associated with homosexuality on a genetic basis and/or influenced by candidate behavioral loci. The subjects for these studies will be self-identified male and female homosexual probands and their relatives from families in which there are at least two individuals with homosexual orientation. All subjects will be adults, and will be referred through NIH physicians, private practitioners, and gay and lesbian organizations. Subjects will undergo a sexual orientation and behaviors interview, a psychiatric interview, and phlebotomy for HIV testing, HLA determination, endocrine measurements, and preparation of DNA from cultured lymphocytes. The DNA samples will be analyzed for a series of genetic markers that span the human genome and for candidate loci chosen for function.

We propose to test, by DNA linkage analysis of family pedigree members, the following interrelated hypotheses: 1) that sexual orientation is genetically influenced; 2) that the development of Kaposi's sarcoma and other outcomes of HIV infection in male homosexuals is affected by host susceptibility genes, circulating sex hormone levels, or HLA haplotype; and 3) that alcoholism and other psychobehavioral conditions are associated with homosexuality on a genetic basis and/or influenced by candidate behavioral loci. The subjects for these studies will be self-identified male and female homosexual probands and their relatives from families in which there are at least two individuals with homosexual orientation. All subjects will be adults, and will be referred through NIH physicians, private practitioners, and gay and lesbian organizations. Subjects will undergo a sexual orientation and behaviors interview, a psychiatric interview, and phlebotomy for HIV testing, HLA determination, endocrine measurements, and preparation of DNA from cultured lymphocytes. The DNA samples will be analyzed for a series of genetic markers that span the human genome and for candidate loci chosen for function.

Eligibility Criteria:
INCLUSION CRITERIA:

The basic criterion for entering families into the DNA linkage study is the presence of two or more homosexual siblings of the same sex. Additional criteria will be imposed depending on the aims of the particular project.
Development and Evaluation of a Virtual Reality Tool for At-Risk Trauma-Exposed Young People

This is a multi-phased study, funded through a National Institute on Drug Abuse (NIDA) K24 grant that aims to ultimately refine a virtual reality tool through qualitative and quantitative research targeting HIV and substance abuse risk behavior among at-risk young people who have experienced psychosocial trauma. Participants eligible for this study include young men who have sex with men (YMSM)/individuals who are romantically/physically attracted to men and adolescents with substance use disorder (SUD) between the ages of 15 - 30 and have experienced at least one traumatic event in their lifetime. Frontline healthcare workers who work within these populations are eligible for the study as well.

YMSM and adolescents with SUD participants will complete 3 study sessions. During session 1, informed consent and baseline measures are administered. Approximately one week later, during session 2, participants use and assess the virtual reality tool. Approximately one week later, during session 3, baseline assessments are re-administered.

Eligibility Criteria:
Inclusion Criteria for YMSM are as follows:

* Someone who identifies as a YMSM or identifies as someone with romantic or physical attraction to individuals who identify as men
* Is aged 15-30 years
* Have experienced at least one ITE in lifetime (i.e., sexual assault, physical assault, witnessed domestic or community violence)
* Report being consensually sexually active or planning to become sexually active with a partner in the next 12 months
* Live in the Charleston, SC/Tri-county area

Inclusion Criteria for adolescents with SUD are as follows:

* Someone who reports using substances in the past year (for participants ages 15-17) or the past 6 months (for participants ages 18-30)
* Is aged 15-30 years
* Have experienced at least one ITE in lifetime (i.e., sexual assault, physical assault, witnessed domestic or community violence)
* Report being consensually sexually active or planning to become sexually active with a partner in the next 12 months
* Live in the Charleston, SC/Tri-county area

Inclusion Criteria for front line healthcare workers are as follows:

* works directly with adolescents who have experienced ITE and/or
* works directly with adolescents or young adults with SUD and/or
* works directly with YMSM and/or
* works directly with and/or adolescent or young adults who are HIV-positive

Exclusion Criteria for all participants are as follows:

* exhibits psychotic symptoms;
* exhibits significant cognitive disability;
* reports a history of Pervasive Developmental Disorder;
* has active suicidal or homicidal ideations
* self-reports high levels of motion sickness
Fear of Recurrence and Stopping Immunotherapy

The study includes participants experiencing distress with regard to stopping immunotherapy and will utilize cognitive-behavioral therapy to reduce fear of recurrence, depression, and anxiety and improve quality of life.

The intervention will be delivered through telemedicine to reduce the patient-related barriers to treatment including cost, transportation, and being able to maintain appointments while managing the side effects of treatment. The intervention will provide the patient with skills to reduce distress associated with ceasing treatment of a checkpoint inhibitor through the development evidence-based psychological and behavioral strategies that are tailored to the patients' preferences.

Eligibility Criteria:
Inclusion Criteria:

* Age 21 years and older
* Fluent in English
* Diagnosis of cancer and history of treatment with immunotherapy

Exclusion Criteria:

* Active suicidal ideation, delusions or hallucinations
Effect of Vibration Therapy on Hip Girdle Muscles in Healthy People

This clinical trial(prospective, pilot study) is to learn about the effect of whole-body vibration on hip girdle muscles in healthy children as a primary study aiming for a new clinical intervention protocol to prevent hip dislocation in patients with severe cerebral palsy.

Design: Prospective, pilot study Setting: hospital rehabilitation department Intervention: Participants will be asked to walk and jump with a surface electromyography(EMG) attached to their hip girdle muscles. After the participants are positioned(standing) on the platform of whole-body vibration device, the study practitioner will record the sEMG values from the hip girdle muscles during the vibration applied. The mean values of repeating the same process with different vibrations applications and the values before vibration will be compared by using the SPSS using the paired "t-test" or Wilcoxon signed rank test for comparison between before and after vibration in the same group.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children (5 to 15 years old)

Exclusion Criteria:

* Children with cerebral palsy, muscle paralysis, developmental or congenital hip joint abnormalities
* Children who underwent hip joint surgery
Study on Clinical Features, Treatment Mode and Survival of Bone and Soft Tissue Tumors

It is planned to prospectively collect, collate and report real-world clinical data of BSTS patients treated in our hospital in the next ten years to evaluate the changes in clinical characteristics, treatment patterns and survival information of these patients, in order to provide reference for clinical treatment and research of this type of tumor.

It is planned to prospectively collect, collate and report real-world clinical data of BSTS patients treated in our hospital in the next ten years to evaluate the changes in clinical characteristics, treatment patterns and survival information of these patients, in order to provide reference for clinical treatment and research of this type of tumor. This study is a single-center, prospective, real-world observational study that plans to enroll all eligible patients. Basic information, treatment methods, and prognostic information of these patients were collected.

Eligibility Criteria:
Inclusion Criteria:

All ages, male and female.

The pathological diagnosis of BSTS in our hospital was a subtype.

Has received at least one hospitalization in this hospital.

The target lesions could be evaluated according to the efficacy evaluation criteria of solid tumor (RECIST; Version 1.1) Measure diameter changes.

Exclusion Criteria:

No definite pathology.
A Study of Human Rhinovirus Type 16 (HRV-16) Following Administration in the Nose of Healthy Adult Volunteers

The purpose of this study is to evaluate the safety and clinical characteristics of a quantity of human rhinovirus Type 16 (HRV-16) in healthy volunteers. This source of HRV-16 will be subsequently used in viral challenge studies with new compounds that are intended to treat respiratory diseases.

This is an open-label study in which all participants know the investigational substance being tested. Participants will be inoculated in the nose with HRV-16 and evaluated for the occurrence of cold symptoms and other indicators. There will be 3 phases: a screening phase, an HRV-16 infection phase, and a follow-up phase. The dose of virus being tested in this study has been previously used in other challenge studies. The total length of participation in the study will be about 4 weeks. Participant safety will be monitored.

Eligibility Criteria:
Inclusion Criteria:

* Demonstrate an understanding of the study and sign an informed consent form prior to any study-related procedures
* Healthy with no clinically significant abnormalities as determined by medical history
* Women must be neither pregnant nor lactating (producing breast milk) and have a negative urine pregnancy test at Screening Visit 1
* Women of child-bearing potential and all men must agree to use adequate birth control measures (as determined by the investigator) and must agree to continue to use such measures and not plan a pregnancy until after the Day 6 visit
* Men must agree not to donate sperm during the study through the Day 6 visit

Exclusion Criteria:

* Have a documented serum-neutralizing antibody titer of \> 2-fold dilution to HRV-16 in the blood sample within approximately 40 days of Screening Visit 2
* Live with a family member who cares for the elderly, infants, or small children (eg, nursing home or day care provider), or live with someone who has a chronic lung disease, premature infant, or immunocompromised individual
* Require a prescription or over-the-counter medication on a regular basis (3 or more times per week), except contraceptive preparations, hormone replacement therapy, or topical acne medication
* Have a history of chronic disease that the Investigator believes are clinically significant
* Have a history of chronic headaches (eg frequent migraines, cluster headaches) with 3 or more headaches per week