cyrilzakka/clinical-trials huggingface dataset:
Perioral Rejuvenation and Upper Lip Enhancement

To determine if subjects who receive premaxillary injection demonstrate an increase in nasal tip projection and an associated increase in upper lip projection, and vermillion height.


Eligibility Criteria:
Inclusion Criteria:

* 1. Subjects Age 21 to 70. 2. Subjects who demonstrate signs of perioral aging or poor upper lip projection.

Exclusion Criteria:

* 1. Subjects who plan to undergo peri oral neurotoxin treatments or ablative skin treatments, or have had either of these treatments in the previous 6 months, other injectable filler treatments during the course of the study.

  2. Subjects who are pregnant or nursing. 3. Subjects with a known allergy or sensitivity to any component of the study ingredients.

  4. Any history of rhinoplasty or nasal filler injections. 5. Recent history of upper lip augmentation (surgical and non-surgical) within the last 12 months.

  6. Any history of lip lift or other surgical procedures involving the upper lip.

  7. Any history of chin augmentation (surgical and non-surgical). 8. Any history of orthognathic surgery. 9. Any history of bleeding disorders (iatrogenic or otherwise). 10. Current history of chronic drug or alcohol abuse. 11. Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study product (i.e. immunosuppressive therapy).

  12. Subjects who, in the Investigator's opinion, have a history of poor cooperation, non¬compliance with medical treatment or unreliability.
A Study of Trastuzumab Emtansine (Trastuzumab-MCC-DM1, T-DM1) in Combination With Pertuzumab Administered to Patients With Human Epidermal Growth Factor Receptor-2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer Who Have Previously Received Trastuzumab

This was a multi-institutional, multinational, open-label, single-arm Phase Ib/II study designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of trastuzumab emtansine (trastuzumab-MCC-DM1) administered by intravenous (IV) infusion in combination with pertuzumab in patients with human epidermal growth factor receptor-2 (HER2)-positive locally advanced or metastatic breast cancer who had previously received trastuzumab.

There were 2 phases in the study, a Dose Escalation phase (Phase 1b) and a Dose Expansion phase (Phase 2a). In the Dose Escalation phase, 3 patients were enrolled at the first dose level (3.0 mg/kg trastuzumab emtansine) and and 6 patients were enrolled at the second dose level (3.6 mg/kg trastuzumab emtansine). An additional 58 patients were enrolled at the 3.6 mg/kg trastuzumab emtansine dose level in the Dose Expansion phase (Phase 2a) of the study.

Eligibility Criteria:
Inclusion Criteria:

* Histologically documented human epidermal growth factor receptor 2 (HER2)-positive locally advanced or metastatic breast cancer.
* Tumor tissue blocks or 15-20 unstained tissue slides for confirmatory central laboratory HER2 status testing and other exploratory assessments.
* Prior trastuzumab in any line of therapy.
* No prior trastuzumab emtansine (T-DM1) or pertuzumab therapy.
* Measurable disease.
* For women of childbearing potential, agreement to use an effective form of contraception and to continue its use for the duration of the study.
* Life expectancy ≥ 90 days.

Exclusion Criteria:

* Less than 21 days since the last anti-tumor therapy, including chemotherapy, biologic, experimental, immune, hormonal, or radiotherapy for the treatment of breast cancer, with the following exceptions: Hormone-replacement therapy or oral contraceptives; palliative radiation therapy involving ≤ 25% of marrow-bearing bone if administered ≥ 14 days prior to first study treatment.
* History of intolerance or hypersensitivity to trastuzumab and/or adverse events related to trastuzumab that resulted in trastuzumab being permanently discontinued.
* Peripheral neuropathy of Grade ≥ 2.
* History of clinically significant cardiac dysfunction.
* Current severe, uncontrolled systemic disease, eg, clinically significant cardiovascular, pulmonary, or metabolic disease.
* Brain metastases that are untreated, progressive, or have required any type of therapy to control symptoms from brain metastases within 60 days of the first study treatment.
* History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or other malignancy with a similar expected curative outcome.
Effectiveness Of Single Doses Of Ibuprofen In Patients With Osteoarthritis Of The Knee

To demonstrate that new drugs work, many complex multidose studies are often required. The intent of this study is to use Ibuprofen as an example of a marketed pain relief drug to validate a simpler single dose model for future assessment of new pain drugs.


Eligibility Criteria:
Inclusion criteria:

* Subjects diagnosed with primary Osteoarthritis of the knee.
* Have at least 3 months in symptom duration prior to screening visit.
* Regular user of a prescribed non-steroidal anti-inflammatory drug (NSAID) or selective cyclo-oxygenase II (COX2) inhibitor for management of knee pain.
* Pain walking on flat surface within specific interval prior to study start.

Exclusion criteria:

* History of hypersensitivity to NSAIDS.
* Allergy to Ibuprofen.
* Use of assistive devices other than a cane or knee brace.
* History of specified diseases/illnesses.
* Abnormal blood tests pre-study.
Contribution of L-Tyrosine to Human Decision Making in Stressful Situations

L-tyrosine is a chemical precursor of dopamine. Under specific conditions, tyrosine administration can increase brain dopamine levels and therefore several studies have explored whether tyrosine supplementation can have a beneficial effect on cognitive and behavioural performance that is dependent on dopaminergic function. However, the effects of tyrosine supplementation are mixed: some studies show positive effects while others do not. Stress leads to an increase in dopaminergic activity and turnover in the brain, resulting in a decrease in brain dopamine levels. We propose to study the contribution of tyrosine to decision making and more particularly to the processes of response selection (mediated by the prefrontal cortex and under the influence of the dopaminergic system) in stressful situations.


Eligibility Criteria:
Inclusion Criteria:

* From 18 to 65 years of age

Exclusion Criteria:

* Tyrosine intake within the previous 15 days
* History of neurological or psychiatric disorder
* History of nephrological or endocrine disorder or liver failure
* Hereditary tyrosinemia
Follow-up of AKI in Neonates During Childhood Years

The purpose of this study is to learn more about how to identify signs of early chronic kidney diseases in children who were born prematurely with low birth weight (less than 3 ½ pounds). Researchers plan to compare the kidney function in children who experienced acute kidney injury (AKI) in the Neonatal Intensive Care Unit (NICU) with those who did not experience it. Evidence from several studies and our experience at UVA show that older children who experienced AKI while in the Pediatric Intensive Care Unit (PICU) have increased risk of developing early chronic kidney disease, and they also show early changes in the urine and blood that is consistent with early chronic kidney disease. In this study, the investigators hope to determine if any of these changes can be detected in early childhood, and if so, at what age we can start detecting these changes.


Eligibility Criteria:
Inclusion Criteria:

* Premature birth for Premature groups
* UVA NICU admission prior to 2 days of life
* Birth weight less than 1500 grams for premature groups
* Premature AKI Study group: Acute Kidney Injury as defined by KDIGO modified criteria during NICU stay at UVA
* Premature no AKI Control group: No AKI during NICU stay
* Term no AKI Control group: No AKI and born at term
* Parental or legal guardian consent obtained

Exclusion Criteria:

- Patients with Congenital Anomalies of the Kidney and Urinary Tract
Information Presentation Formats

Prevention and early detection of medical problems can greatly reduce health care costs, yet time and again, people avoid or ignore services that could help detect medical problems early enough to prevent or reduce the severity of potential problems. The investigators seek to understand whether the elicitation of symptom admission by patients can predict people's perceived risk of the medical condition and voluntary pursuit of medical information.

We will present individuals with medically accurate information about a medical condition and measure people's perceptions of their own likelihood to having that medical condition. This will include an opportunity for people to pursue more information by directing them to a website that features more information about the condition. The initial information provision will vary slightly in presentation (method of eliciting symptoms will vary), and the rate at which individuals visit the subsequent medical website to receive more information will be recorded as a measure of information seeking behavior. Rates will be compared across symptom elicitation conditions to determine which formats are most effective at encouraging information seeking about health issues. No personally identifying information will be collected, and all results will be reported in aggregate. Critically, no deception will be used: Participants will only be provided with information that is as accurate as possible (given existing knowledge in the health/medical fields).

Eligibility Criteria:
Inclusion Criteria:

* 18 or older
* American

Exclusion Criteria:

* Mechanical Turk approval rate below 95%
Effects of Antipsychotic Medications on Energy Intake and Expenditure

Aim 1: To evaluate the effect of antipsychotic treatment group on Activity Energy Expenditure. The project hypothesizes that subjects treated with olanzapine will demonstrate a greater decrease in AEE over time than subjects treated with ziprasidone, due at least in part to sedating effects of olanzapine.

Aim 2: To evaluate the effect of antipsychotic treatment group on Energy Intake. The project hypothesizes that subjects treated with olanzapine will demonstrate a greater increase in EI over time than subjects treated with ziprasidone, based on higher histamine type 1 (H1) receptor affinity of olanzapine and the relationship between H1 affinity and hunger and/or satiety.

The overall purpose of this research is to determine how two commonly prescribed antipsychotic medications, olanzapine (Zyprexa) and ziprasidone (Geodon), affect weight gain through increasing appetite and/or through increasing sedation that results in decreased activity.

Undesirable changes in body weight, blood sugar control, type 2 diabetes, and blood lipids occur more commonly in people who have schizophrenia than in people without psychiatric conditions. Although differences in glucose regulation were first reported in schizophrenia before the use of antipsychotic medications, antipsychotic treatment may contribute to these problems, though just how this happens is not understood. This study proposes to use a doubly-labeled water (DLW) method to measure the degree to which weight gain (fat mass) is due to increased appetite, decreased physical activity from being tired and sleepy, or some combination of both. Doubly-labeled water contains stable isotopes (non-radioactive forms) of the hydrogen and oxygen that make up all water, isotopes that will be slowly passed out through the urine after participants drink DLW. The number of hydrogen and oxygen isotopes found in the urine samples will tell us how many calories the participant's body has been using.

The DLW method has been used in people with obesity and other types of medical problems. It's recognized as the most accurate measure of the number of calories burned throughout a typical day, and how many calories are taken in from food and drink. By measuring these factors in people who take antipsychotic medications, doctors will gain a better understanding of the effects of antipsychotic medications on body weight and fat mass. This could lead to the development of better ways to prevent or treat weight gain or diabetes in patients who take antipsychotic medications.

Eligibility Criteria:
Inclusion Criteria:

* non-diabetic
* schizophrenic or schizoaffective
* currently prescribed olanzapine or ziprasidone
* 18-80 y.o.

Exclusion Criteria:

* \<18 or \>80 years of age
* diabetic
* not schizophrenic or schizoaffective
* not currently prescribed olanzapine or ziprasidone
Phase I/II Clinical Study of FH-006 for Injection in Patients With Malignant Solid Tumors

Evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of FH-006 in subjects with advanced malignant solid tumors, and determine the maximum tolerated dose (MTD) or maximum administered dose (MAD), recommended dose for phase II clinical trials (RP2D), and preliminary efficacy.


Eligibility Criteria:
Inclusion Criteria:

1. Women aged 18 to 75 (inclusive)
2. Subjects with histologically or cytologically confirmed recurrent or metastatic solid tumors who experience disease progression after standard treatment, or who do not have a standard treatment plan or are not suitable for standard treatment.
3. ECOG score is 0 or 1
4. An expected survival of ≥3 months
5. At least one target lesion according to RECIST v1.1 criteria
6. Has a good level of organ function
7. Patients voluntarily joined the study and signed informed consent

Exclusion Criteria:

1. Have other malignancies within the past 5 years
2. Active central nervous system metastasis without surgery or radiotherapy
3. Presence with uncontrollable third space effusion
4. Have undergone other anti-tumor treatment within 4 weeks before the first dose
5. Has severe infection within 4 weeks before the first medication
6. Any active autoimmune disease or a history of autoimmune disease
7. A history of immune deficiency
8. Has serious cardiovascular and cerebrovascular diseases
9. Clinically significant history of lung disease
10. The toxicity from previous anti-tumor treatment has not recovered to ≤ grade I
11. Having undergone surgery on important organs within 4 weeks prior to the first use of medication
12. Used attenuated live vaccine within 28 days prior to the first use of the investigational drug
13. Presence of other serious physical or mental diseases or laboratory abnormalities
Avon Foundation Program to Improve Quality of Life in Breast Cancer Survivors

Women with breast cancer often suffer significant distress and disability from their disease. A practice of meditation-based stress reduction and cognitive-affective-behavioral learning may help women with breast cancer decrease their suffering and improve their quality of life.

The objective of this study in women recently treated for breast cancer is to determine whether an intervention program consisting of group and individual instruction in a meditation-based practice of stress-reduction and cognitive-affective-behavioral learning has the potential for reducing disabling distress and improving quality of life in a population vulnerable to the progression or recurrence of disease. Quality of life will be assessed at 12 months.

Eligibility Criteria:
Inclusion Criteria:

All women with stage I-III breast cancer who have received treatment within the preceding year will be eligible for inclusion in the study.

Exclusion Criteria:

1. Patients who refuse to participate will be excluded
2. Patients with metastatic (stage IV) cancer are excluded.
Impact of Personality on Satisfaction Following Presbyopic Correction

Primary objective of this study is the exploration of the impact of personality type, social roles and working mandates οn the visual capacity and satisfaction of patients that underwent pseudophakic presbyopic correction.

Personality type, social types and working mandates will be evaluated as a routine procedure to patients that visit the Presbyopia Service of the University Hospital of Alexandroupolis, by means of structured questionnaires. Six months following pseudophakic presbyopic correction surgery, each study participant will be evaluated for his/her visual capacity and vision-specific quality of life. Regression modeling will be attempted in order to identify the exact demographics, social roles and personality type of the patient that is most compatible to receive pseudophakic presbyopic correction.

Eligibility Criteria:
Inclusion Criteria:

* presbyopia, patients of our outpatient ophthalmology clinic, age between 40 and 85 years

Exclusion Criteria:

* inability to cooperate, former diagnosis of mental disease
PIONEER Study of Lifestyle Intervention to Reduced Breast Cancer Risk

A randomised controlled trial in which women discharged from the symptomatic breast clinic, who are above population risk (according to Tyrer Cuzick) will be asked to create lifestyle related goals. They will be told their estimated risk of developing breast cancer and will be randomised to one of three interventions:

* Breast cancer risk leaflet only
* lifestyle website
* lifestyle website plus group coaching.

Fifty per cent of women will also be randomised to have Single Nucleotide Polymorphisms (SNPs) performed, and these will be incorporated into their risk score.

The primary end point will be whether or not women achieve their lifestyle goal.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Aged between 30 and 60 years
* Attending the symptomatic breast clinic at RMH Sutton or Chelsea OR the family history clinics at RMH Sutton or Chelsea, or has heard about the study through other means such as (but not limited to), friends who have been diagnosed with cancer, friends who are already taking part in the PIONEER study, social media, mainstream media, fliers through the doors of houses in the area of RMH.
* Benign or B3 diagnosis if participant has attended clinic
* Agree to receive their personalised breast cancer risk
* Available to participate in a 1 year risk prevention programme
* Able to attend the Royal Marsden for a blood test if randomised to this group

Exclusion Criteria:

* Malignant Diagnosis
* Does not want to find out personalised breast cancer risk
* Not available to participate for the full year
* NOTE: after risk assessment, women who have a breast cancer risk lower than that of population level will be excluded from participating in the behavioural change elements.
Oxaliplatin in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Phase II trial to study the effectiveness of oxaliplatin in treating patients who have relapsed or refractory non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die

OBJECTIVES:

I. Determine the response rate to oxaliplatin in patients with relapsed or refractory non-Hodgkin's lymphoma.

II. Determine the treatment-related toxicity of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to histologic subtype (indolent vs aggressive).

Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A maximum of 72 patients will be accrued for this study within 2-3 years.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed recurrent or refractory non-Hodgkin's lymphoma (NHL) of any histologic subtype

  * Indolent

    * Follicular small cleaved cell
    * Follicular mixed cell
    * Small lymphocytic
    * Mucosa-associated lymphoid tissue (MALT)
    * Monocytoid B-cell
    * Waldenstrom's macroglobulinemia
  * Aggressive

    * Follicular large cell
    * Diffuse large cell
    * Immunoblastic
    * Mantle cell
    * Ki-1+ NHL
    * Peripheral T-cell
    * Angiocentric and angioimmunoblastic
    * Transformed lymphoma
* Bidimensionally measurable disease
* No more than 3 prior treatment regimens as follows:

  * Primary radiotherapy is 1 regimen
  * Combined therapy with radiotherapy and chemotherapy is 1 regimen
  * Alternating therapy is 1 regimen
* No known brain metastases
* Performance status - ECOG 0-2
* Performance status - Karnofsky 50-100%
* WBC count at least 3,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Bilirubin normal
* SGOT/SGPT no greater than 2.5 times upper limit of normal
* Creatinine normal
* Creatinine clearance at least 60 mL/min
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* No neuropathy greater than grade 1
* No history of allergy to platinum compounds or antiemetics
* No uncontrolled illness
* No active infection
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No concurrent colony-stimulating factors during first course of therapy
* At least 4 weeks since prior chemotherapy
* At least 4 weeks since prior radiotherapy
* No other concurrent investigational drugs
* No concurrent antiretroviral therapy for HIV-positive patients
Comparison and Strategy Optimization of Plasma EBV DNA and P85-Ab with VCA/EBNA1-IgA for Screening Nasopharyngeal Carcinoma in High-risk Areas

This study is a prospective, self-controlled, multicenter clinical trial. All participants will be tested for Epstein-Barr virus (EBV) associated biomarkers, including the two-antibody method (VCA-IgA and EBNA1-IgA), BNLF2b total antibodies (P85-Ab), and plasma EBV DNA. Furthermore, novel screening biomarkers, such as next-generation sequencing for EBV and castoff cells using nasopharyngeal swabs, will be explored.

First, it aims to investigate whether plasma EBV DNA testing or the P85-Ab testing can achieve higher sensitivity than the current standard two-antibody method testing while maintaining specificity in NPC screening, thereby identifying the optimal initial NPC screening strategy. Based on the determined optimal initial screening strategy, the study will validate the proposed two-step method (subjects first undergo two-antibody method testing and P85-Ab testing; those positive for either one biomarker above proceed to plasma EBV DNA testing; subjects positive in both steps are defined as high-risk and receive endoscopic examinations with or without biopsy) compared with the single-step method (subjects simultaneously undergo two-antibody method testing, P85-Ab testing, and plasma EBV DNA testing; subjects with any positive biomarker undergo endoscopic examinations with or without biopsy) and each single screening testing. The aim is to determine whether two-step method can further improve the positive predictive value (PPV) while maintaining non-inferior sensitivity, thereby enhancing screening efficiency, reducing the rate of invasive procedures (such as endoscopic biopsies), and lowering medical costs and insurance burdens.


Eligibility Criteria:
Inclusion Criteria:

* Voluntarily signed informed consent.
* Age between 30 and 69 years at the time of screening.
* Residents of Guangdong Province or Guangxi Province.
* Able to cooperate with long-term follow-up.

Exclusion Criteria:

* Severe medical comorbidities, significant organ (heart, lung, liver, kidney) dysfunction, or psychiatric disorders.
* Severe autoimmune diseases or immunodeficiency.
* History of or current malignant tumors.
* Inability to cooperate with the study due to psychological, social, familial, or geographical reasons.
The Research About the ACS After Femoropopliteal Arterial Injuries

Crural Compartment syndrome is a well-known sequela after femoropopliteal arterial injuries in the lower extremity, particularly when there has been a long period of ischemia,need for ligation of a major vein, or when there is severe associated soft tissue.There is conteoversy in the treatment.


Eligibility Criteria:
Inclusion Criteria:

* patients with femoropopliteal arterial injuries
* patients older than 18 years

Exclusion Criteria:

* Patients who did not survive to discharge
* Patients with primary amputation
* patients younger than 18 years