cyrilzakka/clinical-trials huggingface dataset:
Skin Ulcers Treatment With an Handicraft Topical Device

The aim of this study was to evaluate the efficacy of a handicraft topical device of negative pressure versus traditional healing treatment for skin ulcers in lower limbs; in patients with diabetes mellitus, venous stasis and arterial insufficiency.

The hypothesis of this trial is that the handicraft topical device of negative pressure is even better for the treatment of skin ulcers located in the lower limbs of patients with diabetes mellitus, venous stasis and arterial insufficiency. We anticipate that in a sample of 144 patients with ulcer, will heal or at least improve with this treatment

Eligibility Criteria:
Inclusion Criteria:

1. Patients with cutaneous leg ulcers due to diabetes mellitus, venous stasis and arterial insufficiency requiring healing or tissue debrided sent to managing their disease to regional general hospital No. 17, Instituto Mexicano del Seguro Social, Benito Juárez, Quintana Roo.
2. Patients of both sexes.
3. Patients over 18 years.
4. Patients that have basic laboratory at admission (complete blood count with differential).
5. Patients with comorbidities associated as Diabetes Mellitus , Hypertension, stroke, heart disease, nephropathy, venous insufficiency and arterial insufficiency, etc.

Exclusion Criteria:

1. Hemodynamically unstable patients.
2. Patients with septic shock from any source.
3. Patients with deep skin ulcers with exposed some organ, data osteomyelitis, vascular-nervous exposure.
4. Patients with secondary cutaneous ulcer enteral fistula.
5. Patients with cutaneous ulcer or cancer tumors.
6. Patients with cutaneous ulcer with active bleeding.
7. Patients with cutaneous ulcer necrosis.
8. Patients with cutaneous ulcer leishmania, insect bite.
9. Patients with cutaneous ulcer burns.
10. Patients who do not accept their participation in the study through informed consent.
KD019 Versus Erlotinib in Subjects With Stage IIIB/IV Non Small Cell Lung Cancer With Progression After First- or Second-Line Chemotherapy

This study involves treatment with KD019 or erlotinib in patients with Non-small cell lung cancer (NSCLC) who have progressed after first- or second- line chemotherapy. It is hypothesized that KD019 can prolong survival compared with erlotinib.


Eligibility Criteria:
For Eligibility subjects must have:

* failed one or two previous courses of therapy.
* have no active brain metastasis. Treated non-active brain metastasis are acceptable.
* cannot have received an Epidermal Growth Factor Receptors inhibitor (Tarceva \[erlotinib\] or Iressa \[gefitinib\]) in the past.
* has demonstrated progressive disease.
To Evaluate KC1036 in the Patients with Advanced Digestive System Tumors

The purpose of this study is to evaluate the preliminary efficacy, safety, tolerability and pharmacokinetics of KC1036 in participants with advanced recurrent or metastatic digestive system tumors.

This is an open label, non-randomized，phase 1b/2 study to explore the preliminary antitumor activity of KC1036 in patients with advanced recurrent or metastatic digestive system tumors under BID or QD regimen.

The study will consist of two parts:

Part 1: QD regimen

To evaluate the efficacy and safety of KC1036 in the treatment of advanced recurrent, unresectable and / or metastatic digestive system tumors under 60mg QD regimen.

Part 2: BID regimen

Dose-Escalation part : To explore the safety of KC1036 under 20mg BID, 30mg BID and 40mg BID in patients with advanced recurrent or metastatic digestive system tumors.

Dose-Expansion part : According to the results of Dose-Escalation, an appropriate BID regimen was selected for Dose-Expansion to evaluate the effectiveness and safety of KC1036 in patients with advanced recurrent, unresectable and / or metastatic digestive system tumors.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed malignant digestive system tumors;
* Patients with advanced recurrent, unresectable and / or metastatic digestive system tumors who have failed standard or conventional treatment:( definition of treatment failure: intolerable toxic and side effects, disease progression during treatment recurrence after treatment);
* Eastern Cooperative Oncology Group performance status score of 0 or 1;
* Life expectancy \> 12 weeks;
* BMI≥18.0;
* Has adequate Hematologic, renal, and hepatic function;
* Patients should participate in the study voluntarily and sign informed consent.

Exclusion Criteria:

* Any patient who is known to have central nervous system (CNS) metastasis with clinical symptoms;
* Other kinds of malignancies;
* Gastrointestinal abnormalitiest;
* Cardiovascular and cerebrovascular diseases;
* Previous treatment with small molecule vascular targeting inhibitor；
* Prior anti-tumor therapies with chemotherapy, radiotherapy, hormonotherapy, biotherapy, immunotherapy, operation within 4 weeks before enrollment;
* Involved in other clinical trials within 4 weeks before enrollment;
* Major surgical procedure, open biopsy, or significant traumatic injury 4 weeks before enrollment;
* Uncontrolled massive ascites,pleural/pericardial effusion;
* Uncontrolled ongoing or active bacterial, viral or fungal infectious; Fever of unknown cause (\> 38.5 ℃) occurred within 2 weeks before enrollment;
* Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection ;
* Pregnant or lactating women or those who do not take contraceptives, including men;
* Any other metabolic dysfunction, abnormal physical examination findings, or clinical laboratory findings;
* Inability to comply with protocol required procedures.
Exparel Injection for Postoperative Orbital Pain

After surgery to remove the eye, either by enucleation or evisceration, patients have variable levels of pain for several postoperative days. Some patients have almost no discomfort while others require significant amounts of oral narcotics and report pain of 10 out of 10 on a numerical rating scale. The current operative standard is to infiltrate the eye socket with 0.5% bupivacaine during surgery leading to several hours of postoperative analgesia. In 2011, Pacira Pharmaceuticals released a bupivacaine liposomal injectable suspension (Exparel, 1.3%) which offers sustained release of bupivacaine giving postoperative pain control for up to 72 hours. This medication has been used in numerous surgeries including inguinal hernia repair, hemorrhoidectomy, bunionectomy, breast reconstruction, and orthopedic surgery, and the literature reports improved pain control, decreased use of oral opioids, and increased patient satisfaction. There are no reports of the use of Exparel in the ophthalmic literature. The investigators propose a randomized, controlled trial to compare the postoperative pain control offered by sustained release bupivacaine to that offered by standard plain bupivacaine after enucleation or evisceration.


Eligibility Criteria:
Inclusion criteria:

1. All patients undergoing enucleation or evisceration of the eye whose surgery is performed by the Department of Ophthalmology at Mayo Clinic Rochester
2. Willing and able to comprehend a numerical rating scale system and provide a score to assess pain, nausea, and satisfaction level.

Exclusion criteria:

1. Age less than 18 years (Exparel has not been tested in a pediatric population)
2. Pregnant or nursing (Exparel has not been tested in this patient population)
Postprandial Blood Cell Transcriptome of Normal Weight and Obese Subjects to 3 Caloric Doses of a High-fat Meal

The study will quantitatively evaluate the metabolic response of normal weight and obese subjects to three high-fat meals differing in caloric dose by analysing the postprandial blood transcriptome.


Eligibility Criteria:
Inclusion Criteria for normal weight subjects:

* age 25-50
* 20\<BMI\>25
* waist circumference \<94cm

Inclusion Criteria for obese subjects:

* age 25-50
* 30\<BMI\>40
* waist circumference \>102cm

Exclusion Criteria for both groups:

* physiological or psychological diseases
* allergies to food or intolerance to high-fat meal
* vegetarians, vegans
* chronic intake of drugs
* smokers
* diabetes mellitus type I and II
* debiliating kidney disease
* debiliating liver disease
* clinically established coronary heart diseases
* ingestion of vitamins or dietary supplements during the course of the study
Interferon-alpha Treatment of Chronic Cough in Chronic Obstructive Pulmonary Disease and Idiopathic Pulmonary Fibrosis

The purpose of this study is to determine whether lozenges containing interferon-alpha can reduce the frequency and severity of coughing in patients with chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF).

Both chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF) frequently lead to a chronic cough that negatively impacts the quality of life (QOL) for patients and those around them. This is a randomized, double-blind, placebo-controlled trial to determine whether interferon-alpha, delivered in low doses via orally dissolving lozenges given 3 times per day for 4 weeks, can reduce the frequency and severity of chronic cough in patients with COPD or IPF. Cough frequency will be assessed via 24-hour digital audio recordings made prior to entry, and at weeks 2 and 4 of treatment. Cough severity will be assessed via a 100-mm visual analog scale questionnaire completed by the subject prior to entry and then weekly during treatment. Subjects will also complete questionnaires regarding cough frequency, duration and intensity, QOL, dyspnea, and antitussive medication usage weekly during treatment. All questionnaires will be repeated weekly during a 4-week post-treatment observation period to assess durability of response.

Eligibility Criteria:
Inclusion Criteria:

For all patients

* history of clinically significant chronic cough for \> 3 months
* For COPD patients
* \>40 years of age
* 20-pack-year history of smoking
* GOLD classification of Stage 1 or higher
* For IPF patients
* \> 50 years of age
* history of unexplained dyspnea on exertion of \> 3 months
* exhibits coughing and bilateral, basilar, inspiratory crackles on physical exam
* presents as being in a stable phase of IPF
* lung biopsy or HRCT indicative of IPF

Exclusion Criteria:

* ACE inhibitor use
* GERD
* current cancer or history of lung cancer
* non-ambulatory
* hospitalized in the previous 12 months for heart failure
Trulimax (Azithromycin ) Non-Interventional Study In Acute Bacterial Upper Respiratory Tract Infections

To assess effectiveness of Trulimax (Azithromycin) in Acute Bacterial Upper Respiratory Tract Infections (URTIs).

Prospective, Open-label, Non-interventional and Multi-center Study NA

Eligibility Criteria:
Inclusion Criteria:

* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
* Patients with acute URTI, presumed to be of bacterial origin as per the clinical judgment of the investigator.

Exclusion Criteria:

N/A
Adult Weight, Genetics and Lifestyle Factors

Childhood obesity leads to adulthood obesity, demonstrated in many retrospective and longitudinal studies. Genetics as a predictor of obesity is less established. Morandi et al, (2012) assessed whether lifestyle and genetic factors can be used to predict childhood obesity, concluding that genetics had minimal predictive effect. More recently Seyednasrollah, (2017) demonstrated that genetic information, when alongside clinical factors for cardiovascular disease, increased the predictive accuracy of obesity risk in adults. This study aims to investigate if known lifestyle and genetic risk factors are associated with BMI and if they can be used as predictors of overweight/obesity in adults.


Eligibility Criteria:
Inclusion Criteria:

* European Citizen.
* Aged between 18-65 years.
* Female.
* Caucasian

Exclusion Criteria:

* Currently following a diet or weight loss plan or have not been for over 6 months of the previous year.
* Suffering from diabetes (type I or II).
* Cancer, or have had cancer in the past.
Evaluation of Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in Women

The Essure System is indicated for women who desire non-incisional permanent birth control (female sterilization) by occlusion of the fallopian tubes. The objective of the study is to evaluate the safety and effectiveness of the Essure System (Model ESS505) for permanent birth control in preventing pregnancy. The Essure ESS505 System includes a design modification that will be studied to determine if it provides immediate birth control, thereby removing the three months waiting period required for the commercially available Essure System Model 305 to be effective.


Eligibility Criteria:
Inclusion Criteria:

* Female, 21 to 44 years of age, inclusive
* Body weight within range of 90-300 lbs (40 - 136 kg)
* Sexually active (minimum of 4 coital acts per cycle)
* Willing to accept the risk of pregnancy while relying solely on the inserts for contraception
* Medical history indicates bilateral viable and patent fallopian tubes
* Agrees to fulfill local requirements for counseling and consent to contraception and sterilization, including any required waiting periods

Exclusion Criteria:

* Post-menopausal woman
* Suspected or confirmed pregnancy
* Post-partum or pregnancy termination ≤6 weeks of scheduled insert placement
* Past fallopian tube sterilization procedure and/or total or partial salpingectomies
* Diagnosis of any of the following: tubal, endometrial, or myometrial pathology (which may prevent fallopian tube ostia access), proximal tubal occlusion in either fallopian tube, unicornuate uterus, active or recent upper or lower pelvic infection, gynecologic malignancy
* Currently taking corticosteroids
* Known allergy to all contrast media available for use in hysterosalpingogram
* Scheduled to undergo concomitant intrauterine procedures at the time of insert placement (intrauterine device removal is not considered a concomitant procedure)
* Any general health condition or systemic disease that may represent, in the opinion of the physician, a potential increased risk associated with device use or pregnancy
Her-2/Neu in Patients With Metastatic Breast Cancer (AdHERe)

The purpose of this study is to determine the maximum tolerated dose and/or maximum attainable dose of a vaccine consisting of human autologous dendritic cells transduced by an adenovector expressing rat Her-2/neu (AdHer-2/neu) in patients with metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Metastatic or locally recurrent breast cancer
2. 18 years of age or older
3. Her-2/neu positive (3+ by immunohistochemistry or fluorescence in-situ hybridization \[FISH\] +)
4. One of the following:

   1. currently receiving hormonal therapy or are candidates for such, or
   2. being considered for trastuzumab, or
   3. cancer has progressed on trastuzumab.

Exclusion Criteria:

1. Pregnant or lactating women.
2. Prior or concurrent malignancies except for treated basal cell or squamous cell carcinoma of the skin or in situ cancer of the cervix or any other cancer treated and presumed cured for more than five years prior to study entry.
3. Currently receiving chemotherapy, immunotherapy, adenoviral gene therapy or biological cancer therapy. \[Note: concurrent hormonal therapy (tamoxifen, aromatase inhibitors, or megace) is permitted.\]
4. Treatment with trastuzumab within 4 weeks prior to first dose of vaccine therapy.
5. Hemoglobin \< 80 g/L or granulocytes \< 1.5 × 10\^9/L or lymphocytes \< 1.0 × 10\^9/L or platelets \< 100 × 10\^9/L.
6. Baseline liver enzymes (AST or ALT) greater than 3 times the upper limit of normal or greater than 5 times the upper limit of normal if liver metastases are present and/or bilirubin is greater than 50 mmol.
7. CD4 cells \< 0.5 ×10\^9/L
8. Patients with documented brain metastases.
9. Patients with any acute illness that would interfere with the collection of CD34+ cells or administration of vaccination cellular therapy (i.e. unstable angina, renal or liver failure, or severe chronic obstructive airway disease).
10. Any patients requiring concurrent immunosuppressive therapy (e.g. corticosteroids).
11. Eastern Cooperative Oncology Group (ECOG) performance status of \> 2.
12. Patients with a life expectancy of less than 6 months.
13. Geographic inaccessibility which would preclude follow-up. Patients registered on the trial must be treated and followed at the Juravinski Cancer Center and the Henderson site of the Hamilton Health Sciences.
14. Failure to give written informed consent.
15. Baseline left ventricular ejection fraction (LVEF) \< 55% by echocardiography or multigated acquisition (MUGA) scan.
Precision Radiotherapy for Tumours Using Magnetic Resonance-guided Linear Accelerator (MR-Linac)

Aim to observe the application of MR-Linac for precision radiotherapy of tumours, analyse its therapeutic effect, toxic and side effects,Characteristics of dosimetric parameters etc.

Primary endpoint:

· Overall response rate (ORR) : It refers to the proportion of patients whose tumor volume reduction reaches the pre-specified value and can maintain the minimum time requirement, which is a Complete Response (CR) and a partial response (PR). Partial Response) sum of the proportions.

Secondary points:

* Progression-free Survival (PFS) : the time from the start of treatment until objective tumor Progression or all-cause death of the patient.
* Disease Control Rate (DCR) : The percentage of patients whose cancer shrinks or remains stable over time.
* Overall Survival (OS) : the time from the start of treatment to all-cause death.
* Incidence of adverse reactions: toxicity according to Common Toxicity Criteria for Adverse Events (CTCAE).
* Quality of life: The EORTC Quality of Life measure -QLQ-C30-(V3.0) was used, and the higher the score, the higher the quality of life.
* Dosimetric parameters： include gross target volume（GTV）， clinical target volume（CTV），internal target volume(ITV),planning target volume（PTV），γ-passing rate，and limited dose of organs at risk (including average dose, maximum dose, etc.)

Eligibility Criteria:
Inclusion Criteria:

* Patients are undergoing or have undergone imaging or treatment at the MR linac;
* Age 18-75 years, male or female;
* ECOG score 0-2, life expectancy \> 6 months;
* Patients provide written informed consent.

Exclusion Criteria:

* Contraindications to MRI, such as claustrophobia and metallic or electronic implants incompatible with MRI;
* The presence of severe comorbidities that, in the opinion of the investigator, · preclude the toleration or completion of radiotherapy;
* Acute inflammatory disease requiring systemic therapy;
* The presence of active infectious disease;
* Pregnant women, nursing mothers, and patients planning to have children during the study period.
Dose-finding Study of APD403 to Prevent Nausea and Vomiting After Chemotherapy

Comparison of efficacy of APD403 at preventing delayed sickness in patients who have received cancer chemotherapy


Eligibility Criteria:
Inclusion criteria

* Male or female patients ≥ 18 years of age
* Ability and willingness to give written informed consent
* Patients scheduled to receive, on day 1 of their chemotherapy, either: (i) a first cisplatin chemotherapy infusion at a dose of ≥70 mg/m2 (males and females); or (ii) a first infusion of cyclophosphamide at a dose of 500-1500 mg/m2 in combination with either epirubicin at a dose of 60-100 mg/m2 or doxorubicin at a dose of 40-60 mg/m2 (females only)
* Karnofsky performance score ≥ 60%
* Adequate cardiac, hepatic and renal function

  * QTc interval \< 500 ms
  * Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \< 5 x upper limit normal (ULN)
  * Bilirubin \< 5 x ULN
  * Creatinine \< 3 x ULN
* Adequate haematological function

  * Haemoglobin ≥ 8 g/dL
  * White blood count ≥ 3.0 x 109/L
  * Platelet count ≥ 100 x 109/L
* For females of child-bearing potential: ability and willingness to use a highly effective form of contraception (e.g., abstinence from sexual intercourse, surgical sterilisation (of subject or partner) or a double-barrier method of contraception such as either an intra-uterine device (IUD) or an occlusive cap with spermicide, in conjunction with partner's use of a condom) during the study and for a period of at least 48 hours afterwards

Exclusion Criteria

* Patients scheduled to receive, prior to or in the 120 hours after cisplatin or AC, any other chemotherapeutic agent with a high or moderate emetic risk
* Patients who have previously received anti-neoplastic chemotherapy
* Patients scheduled to receive paclitaxel or docetaxel during the first cycle of their chemotherapy
* Patients undergoing abdominal or pelvic irradiation within 48 hours prior to screening or scheduled to receive abdominal or pelvic irradiation between screening and 24 hours after cisplatin or AC administration
* Patients with a known prolactin-dependent tumour (e.g. pituitary gland prolactinoma or confirmed prolactin-dependent breast cancer) or phaeochromocytoma
* Patients with a pre-existing vestibular disorder
* Patients being treated with regular anti-emetic therapy including corticosteroids
* Patients receiving inhaled corticosteroids, unless started more than one month prior to the expected date of study entry
Open-Label Safety and Tolerability Study of Oxymorphone for Acute Postoperative Pain in Pediatric Subjects.

When post-operative parenteral analgesia is discontinued, oral dosing with study medication may begin once the subject has developed a moderate level of pain as defined by a 100 mm VAS (pain intensity score greater than or equal to 40).

This post marketing study was required by the FDA. Endo Pharmaceuticals Inc. no longer promotes opioids and no longer markets Opana® ER.


Eligibility Criteria:
Inclusion Criteria:

* Male or female \> 12 to 17 years of age, inclusive
* Weigh at least 50 kg
* Postoperative oral opioid analgesia required for at least 24 hours or 48 hours following postoperataive parenteral analgesia
* Are expected to be hospitalized for the duration of the study

Exclusion Criteria:

* Known allergy to, or a significant reaction to, oxymorphone or another opioid
* Life expectancy of \< 4 weeks
* Positive pregnancy test at screening