cyrilzakka/clinical-trials huggingface dataset:
The Use of Shengmai San to Prevent Anthracycline Sequential Trastuzumab Therapy Related Cardiac Toxicity

To evaluate the effectiveness and safety of Shengmai San in preventing anthracycline sequential trastuzumab therapy related cardiac toxicity through a prospective randomized controlled study.

This study is a randomized, controlled, open-label prospective clinical study. This study adopts an optimal design, with the main evaluation indicator being the incidence of cardiac toxicity. Patients who passed the inclusion and exclusion criteria through clinical research were randomly assigned to the experimental group and control group. Experimental(treatment)group: received preventive treatment with Shengmai Powder，and may also receive additional Chinese medicines based on the doctor's judgment and the patient's condition.Control group: during chemotherapy and trastuzumab administration, no Chinese medicine with ginseng, ophiopogon japonicus and schisandra chinensis as ingredients or western medicine with heart strengthening or heart protection function were used. During the treatment process, cardiac function related indicators such as symptomatic congestive heart failure or asymptomatic but decreased left ventricular ejection fraction (LVEF) are evaluated to determine the occurrence of cardiac toxicity.

Eligibility Criteria:
Inclusion Criteria:

1. Non metastatic primary invasive HER2 positive breast cancer stage I-III invasive HER2 positive breast cancer is defined as the tumor invasive component HER2 immunohistochemical IHC+++or IHC++confirmed to be HER2 positive by fluorescence in situ hybridization
2. Plan to use AC sequential TH (P) adjuvant or neoadjuvant chemotherapy with anthracycline containing chemotherapy regimens (A is doxorubicin or epirubicin, C is cyclophosphamide, T is paclitaxel, liposome paclitaxel, albumin bound paclitaxel or docetaxel, H is trastuzumab, which can be combined with pertuzumab (P))，and before using anthracycline drugs, the left ventricular ejection fraction (LVEF) should be ≥ 50%
3. Plan to use trastuzumab or trastuzumab combined with pertuzumab for one year of treatment；
4. ECOG PS: 0-1 points；
5. The patient has good compliance with the planned treatment and follow-up, can understand the research process of this study, and sign a written informed consent form.

Exclusion Criteria:

1. The New York Heart Association (NYHA) classifies patients with heart disease at or above Level II (including Level II)
2. Severe heart disease or discomfort, including high-risk uncontrolled arrhythmia, etc
3. There are contraindications or intolerance to treatment with trastuzumab, including allergies to trastuzumab, and the presence of underlying heart diseases that cannot be treated with trastuzumab as determined by a specialist
4. Previously allergic to ginseng, Ophiopogon japonicus, and Schisandra chinensis
5. Unable to cooperate with treatment and follow-up.
Evaluation of a Prototype Hand Held Hybrid Gamma Camera

The aim of the project is to undertake clinical development of a hybrid compact gamma camera that combines gamma ray and optical imaging. It is an extension of the previous pilot study using a newly developed handheld hybrid compact gamma camera in clinical arena.

This is a single visit study involving patients who have been referred to the Nuclear Medicine Clinic at Nottingham University Hospitals as part of a standard diagnostic test. Each patient's participation will be approximately 30 minutes and not normally longer than one hour. The study will run for 11 months commencing February 2017 and ceasing at the end of December 2017.

As part of their routine care, patients will be sent a letter booking their diagnostic test through a Nuclear Medicine Clinic. Once they have confirmed that they will be attending this diagnostic test, one of the clinical study team trained to take consent will contact the patient by phone. At this point they will be informed of the reason for the study, why they have been approached and the study schedule. If they express interest in participating they will then be sent a copy of the patient informed consent forms. They will be given a minimum of 24 hours before formally signing consent at the study site immediately before participating.

Study plan:

Following the administration of the routine radiopharmaceutical and the standard wait before clinical diagnostic imaging, the patient will have research images acquired using the hybrid prototype gamma camera. All research images will be anonymised and the additional imaging performed as part of this study will fit in with the patient and the diagnostic test schedules. Should the patient wish to stop at any point, the research study procedure will be terminated. Once these images have been acquired then the patient will go home or proceed with the requirements of their diagnostic test. 75 participants will be recruited for this study.

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study;
* Male or Female, aged 18 years or above;
* Be able to understand the study, willing to co-operate with the study procedures and able to attend the study assessment;
* Have been administered a radiopharmaceutical as part of a diagnostic test.

Exclusion Criteria:

* Female participants who are pregnant, lactating or planning pregnancy during the course of the study;
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study;
* Patients who have had a nuclear medicine procedure with administration of a radiopharmaceutical within 72 hours prior to the procedure.
* Patients who do not speak or understand English (since no translator will be available).
A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics With COPD

A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics with Chronic Obstructive Pulmonary Disease.

Pfizer announced in October 2007 that it would stop marketing Exubera. At that time recruitment for study A2171030 was placed on hold. Nektar, the company from which Pfizer licensed Exubera, announced on April 9, 2008 that it had stopped its search for a new marketing partner. Accordingly, there will be no commercial availability of Exubera. As a result, study A2171030 was terminated on June 17, 2008. Neither safety nor efficacy reasons were the cause of the study termination.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes Mellitus (Type 1 or Type 2) currently controlled with injected insulin
* Prior smokers with a fixed airflow obstruction at screening (FEV1/FVC \< 70%) and FEV1 \< 80% predicted and/or a history of chronic productive cough.

Exclusion Criteria:

* Poorly controlled, unstable or steroid-dependent COPD, insulin pump therapy, active smoking
Medical and Surgical Hybrid Treatment of Atrial Fibrillation.

The objective of the study is to investigate the feasibility of a hybrid procedure removal of the atrial fibrillation.

This is a single procedure for both surgical epicardial by minimally invasive route (Thoracoscopy) without even flow controlled and supplemented if necessary by extra corporeal intracavitary route at the same time.

This faster procedure combined with complete lesions have a higher success rate and less frequent re-hospitalizations of patients.


Eligibility Criteria:
Inclusion Criteria:

patients with complex AF defined by the following criteria :

* AF\> 1 week or long term persistent\> 1 year
* AND Symptomatic
* AND after failure of treatment of anti-arrhythmic or against-indication for anti-arrhythmic

Exclusion Criteria:

The exclusion criteria are relevant contraindications thoracoscopy or the non-complex nature of the AF:

* Paroxysmal AF or AF cardioverted anti-arrhythmic test (unless against indicated)
* Recent AF for which a simple gesture is intracavitary considered sufficient
* Permanent AF
* Asymptomatic AF
* Very old AF (\> 5 years) or atrial major ectasia (\> 60 mm)
* Need another surgery (valve bypass coronary)
* Previous history of sternotomy or thoracotomy
* High-risk surgical or anesthetic Patient
* BMI\> 35
* Sleep Apnea
* Ejection fraction \<35%
* Thoracic trauma history
* Veins Pulmonary stenosis\> 50%
* Hyperthyroidism
* Thrombus in LAA
Silymarin Bioavailability Study

This study seeks to evaluate and compare the pharmacokinetics of a novel micellar silymarin formulation with that of a standard silymarin formulation.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 21- 65 years
* Healthy, good physical condition
* Voluntary, written, informed consent to participate in the study.

Exclusion Criteria:

* Serious acute or chronic diseases e.g. liver, kidney, or gastrointestinal diseases
* Contraindication or allergies to milk thistle
* Pregnancy or breastfeeding
* Concurrent use of supplements and/or medications
* Participation in another investigational study
Safety and Efficacy Study of FS 4 IU VH S/D (Fibrin Sealant With 4IU/mL Thrombin, Vapor Heated, Solvent/Detergent Treated) to Adhere Split Thickness Skin Grafts and Improve Wound Healing in Burn Patients

The primary objective of this study is to evaluate skin graft adherence and wound healing in burn patients to evaluate whether FS 4IU VH S/D is equivalent or superior to the current standard of care (staples). The primary endpoint is achievement of complete (100%) wound closure within 28 days.


Eligibility Criteria:
Inclusion Criteria:

* Subjects or their legal representatives, who have read, understood and signed a written informed consent.
* Subjects of either sex.
* Female subjects of childbearing potential with a negative urine or serum pregnancy test on admission.
* Subjects who are \<= 65 years of age including pediatric subjects of all ages.
* Subjects with total burn wounds measuring \<= 40% TBSA.
* Subjects with a contiguous deep partial thickness/full thickness wound, between 2% and 8% TBSA or two comparable, bilateral wounds each measuring between 1% and 4% TBSA.
* Wounds designated as test sites require autologous sheet skin grafts with a thickness of 8/1000" - 16/1000"
* Subjects who are able, and willing to comply with the procedures required by the protocol.

Exclusion Criteria:

* Subjects with electrical burns.
* Subjects with chemical burns
* Digits and genitalia are excluded as test sites.
* Subjects with infection at test area/test sites.
* Subjects with test sites previously randomized and treated in this study.
* Subjects with venous or arterial vascular disorder that directly affects a designated test area/test site.
* Subjects with pre-existing hemolytic anemia
* Subjects with diabetes mellitus.
* Subjects with documented history of pathologically or pharmacologically induced immune deficiency.
* Subjects judged to be chronically malnourished.
* Subjects that are judged to have significant pulmonary compromise.
* Subjects receiving systemic corticosteroids within 30 days prior to skin grafting (not including inhaled steroids).
* Subjects with known or suspected hypersensitivity to bovine proteins.
* Subjects participating in another clinical trial that is evaluating an unapproved drug or device.
The Micheli Functional Scale's Validity and Reliability

The purpose of this study is to assess the reliability and validity of the "Micheli Functional Scale" in the Turkish context.

The study will include a minimum of 80 individuals who are 16 years old or above, have been engaged in the same sports activity for at least two years, participate in physically demanding activities for at least three days a week, and possess the ability to read and write Turkish. Before participating in the study, athletes will be required to sign an informed consent form. Their demographic information will then be recorded.Before conducting the test, we will gather information about the athletes' history of low back pain using the extended Nordic musculoskeletal questionnaire. We will also use this questionnaire to identify any other musculoskeletal issues that the person may have.Two Turkish translators, fluent in English, will independently translate the original Micheli Functional Scale into Turkish. They will then discuss their translations and create a common one. The resulting translation will be translated back into English by two native English speakers who are also proficient in Turkish. These translations will be reviewed and combined into a single version. A Turkish scientist will evaluate the questionnaire for its suitability in the Turkish language. The final version will be tested on a small pilot group to determine its comprehensibility. After this, the questionnaire will be administered to the entire study group. To assess the validity of the Micheli Functional Scale, we will use the Oswestry Functional Questionnaire and the Ronald Morris Disability Questionnaire. One week after the test, we will repeat these surveys.

Eligibility Criteria:
Inclusion Criteria:

* 16 years old and over
* Having been doing the same sport for at least 2 years,
* Participating in sports activities or activities that require a high level of effort at least 3 days a week,
* Able to read and write Turkish

Exclusion Criteria:

* Has a cognitive problem that prevents him from understanding and answering the questions or is taking a drug that may cause them,
* Having a history of orthopedic or neurological injury or pain at a level that may prevent training or competition during the evaluation,
* History of spine/lower and upper extremity surgery,
* Structural deformities such as scoliosis and kyphosis,
* Those with trap neuropathy will be excluded from the study.
A Study of GS-5423 and GS-2872 in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection

The goal of this study is to test the effectiveness, safety, and tolerability of the combination of broadly neutralizing antibodies (bNAbs) (teropavimab (formerly GS-5423) and zinlirvimab (formerly GS-2872)) with lenacapavir (LEN) in virologically suppressed adults with HIV-1 infection.

The purpose of this study is to evaluate the efficacy of switching to a regimen of LEN, teropavimab, and zinlirvimab, versus continuing on baseline oral antiretroviral therapy (ART) as determined by the proportion of participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) ≥ 50 copies/mL at Week 26.


Eligibility Criteria:
Key Inclusion Criteria:

* On stable oral antiretroviral therapy (ART) consisting of no more than 2 drug classes (with the exception of pharmacologic boosters cobicistat or ritonavir) for ≥ 1 year prior to screening visit 2. A change in ART regimen ≥ 28 days prior to screening visit 2 for reasons other than virologic failure (VF) (eg, tolerability, simplification, drug-drug interaction profile) is allowed.
* No clinically significant documented historical resistance to the current ART regimen with the exception of isolated nucleoside reverse transcriptase inhibitor mutations including M184V or ≤ 2 thymidine analog mutations (TAMs: M41L, D67N, K70R, L210W, T215Y, and/or K219Q).
* Plasma HIV-1 RNA \< 50 copies/mL at screening visit 2.
* Documented plasma HIV-1 RNA \< 50 copies/mL for ≥ 12 months preceding screening visit 2 (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL). Virologic elevations of ≥ 50 copies/mL (transient detectable viremia or "blips") prior to screening are acceptable.
* Proviral pheynotypic sensitivity to both teropavimab and zinlirvimab at screening or from protocol GS-US-536-5816 within 24 months prior to screening.
* Screening CD4+ T-cell count ≥ 200 cells/μL at screening visit 2.

Key Exclusion Criteria:

* Comorbid condition requiring ongoing immunosuppression.
* Evidence of hepatitis C virus (HCV) infection (prior infection cleared spontaneously or with treatment is acceptable)
* Evidence of current hepatitis B virus (HBV) infection regardless of HBV surface antigen status, at the screening visit 2.
* History of opportunistic infection or illness indicative of Stage 3 HIV disease.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Effect of an Outpatient Intervention Program in Patients With Chronic Back or Neck Pain

To investigated whether an ambulant intervention program with a behavioral therapy approach would exert a long-term effect on chronic unspecific back or neck pain. Specifically, the effect on patients with pronounced fear avoidance behavior and/or with psychosocial limitations was addressed.

BACKGROUND: Sustained success of ambulant intervention programs consisting of individual and group physiotherapy in patients with with chronic unspecific back or neck pain (cBP) has not been conclusively proven. It's still not clear whether one can achieve such success by devoting greater attention to psychosocial factors.

OBJECTIVE: We investigated whether an ambulant intervention program with a behavioral therapy approach would exert a long-term effect on cBP. Specifically, the effect on patients with pronounced fear avoidance behavior and/or with psychosocial limitations was addressed.

DESIGN: Prospective, randomized controlled trial

SETTINGS, INTERVENTION: 64 patients were assigned to intervention group (IG) and 57 to control group (CG). All were examined, informed about cBP, and were encouraged to stay active and perform exercises according to specific instructions provided in a neck- or back-book. The IG received 9 units of physiotherapy and 2 units of occupational therapy, conducted with a behavioral therapy approach. Efficacy of treatment was evaluated after 6 and 58 weeks.

MEASUREMENTS: Pain (VAS), quantity of painkillers consumed, sick leave days, Oswestry-Disability-Index (ODI), SF-36, FABQ.

Eligibility Criteria:
Inclusion Criteria:

* minimum age 18 years, maximum age: men 55 years, women 50 years.
* the patients had been on sick leave for a minimum of 4 and a maximum of 22 days during the preceding 12 months because of nonspecific spinal symptoms in the back or neck.
* The patients had to be working at the start of the study.

Exclusion Criteria:

* Specific causes of spinal symptoms (after spinal surgery, known vertebral body fractures, disk prolapse with motor deficits or other radicular lesions, tumor, osteomyelitis, spondylodiscitis, rheumatic disease, osteoporosis).
* Retired persons, those in the process of being screened for retirement, unemployed persons,
* pregnancy or persons on maternity leave
* Planned surgery during the phase of intervention
* persons who were unable to participate in the intervention program for other reasons (physical, psychological, linguistic or organizational).
Effect on RLS Symptom Severity After Switching to Neupro® in Patients Who Previously Experienced Augmentation

The objective is to assess the effect of Neupro® on the severity of Restless Leg Syndrome (RLS) symptoms and augmentation in patients with augmentation associated with previous oral dopaminergic therapy. In addition, the change in treatment regimen used when switching to Neupro® will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* The adult patient has a diagnosis of moderate to severe idiopathic Restless Leg Syndrome (RLS)
* The patient must be experiencing augmentation due to a prior dopaminergic treatment
* The decision to prescribe Neupro® has been made by the physician independently of his/her decision to enroll the patient in the study
* Patient is informed and given ample time and opportunity to think about his/her participation in the study and has given written informed data consent

Exclusion Criteria:

* Patients diagnosed with secondary Restless Leg Syndrome (RLS) should not be enrolled in this observational study
The Cartagena Cohort Study

Cardiovascular and respiratory diseases are the first and third cause of death, respectively. Cardiovascular risk is known to increase in groups with impaired lung function; however, the mechanisms behind this association are not fully understood. The aim of CaReS is to elucidate the shared pathophysiology of impaired lung function and cardiovascular risk, and to investigate the risk factors associated with them.

The CaReS Cohort Study includes adults (18-80 years old) from Cartagena de Indias, a tropical city on Colombian Caribbean Coast, where recent population admixture settled a three-hybrid genetic structure (European, African and Ameridian ancestry). At baseline, the cohort will generate extensive data on -omics (e.g., genomics, transcriptomics, metabolomics, and epigenomics), socio-economic wellbeing, lifestyle, medical history, cardiometabolic, inflammatory and liver function markers, as well as objective measures of ventilatory and cardiovascular performance.

The cohort will collect data every three years, for a total period of ten years. Prospective risk of cardiovascular disease and chronic obstructive pulmonary disease (COPD) will be investigated, and their risk factors. Throughout the study period, changes in prevalence, and interactions of various risk factors with these changes will also be ascertained.

A predictive risk score for cardiovascular and chronic respiratory disability will be built, using cross-sectional and longitudinal data.


Eligibility Criteria:
Inclusion Criteria:

* Adults
* Native from Colombian Caribbean Coast

Exclusion Criteria:

* Pregnant women
* Walking physical disability
* Cognitive disability
* Patients under treatment for any type of cancer
* Clinical record of primary chronic endocrine disease
* Clinical record of major respiratory tract surgery
Lapatinib Plus Caelyx in Patients With Advanced Metastatic Breast Cancer Following Failure of Trastuzumab Therapy

The aim of this study is to evaluate the potential of a Lapatinib plus Caelyx combination therapy as an effective and safe therapeutic regimen with a favourable cardiotoxicity profile, in the treatment of metastatic breast cancer following failure of prior trastuzumab.


Eligibility Criteria:
Inclusion Criteria:

* Female patients, age ≥ 18 years
* Advanced or metastatic breast cancer, histologically confirmed
* Documented HER2 overexpression (IHC 3+ and/or FISH positive)
* At least one measurable lesion according to RECIST criteria. Patients with bone-only lesions are not eligible for study entry
* Documented disease progression
* Patients may have no more than 1 line of palliative treatment, however prior therapies must include trastuzumab in adjuvant or metastatic setting
* Life expectancy of at least 12 weeks
* Performance status 0-1
* Cardiac ejection fraction \>= 50% as measured by echocardiogram or MUGA scan
* Adequate hematology, liver and renal function

Exclusion Criteria:

* Pregnant or lactating women
* Serious medical or psychiatric disorders that would interfere with the patient's safety or informed consent
* Severe cardiac disease (uncontrolled angina, arrhythmia, chronic heart failure (CHF) or cardiac disease requiring a device)
* Ejection fraction below the institutional normal limit
* Maximum cumulative dose of 360 mg/m2 for doxorubicin and 720 mg/m2 for epirubicin
* Active bacterial, viral or fungal infection
* Patients with clinically apparent brain metastases
* Positivity for HIV, Hepatitis B or C
* History of other malignancy; patients who have been disease-free for 5 years
* Concurrent cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy) or concurrent treatment with an investigational drug or participation in another clinical trial
* Known hypersensitivity to the study drugs Lapatinib and Caelyx or their excipients