cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Safety and Efficacy of TOCOSOL(R) Paclitaxel as Initial Treatment for Metastatic Breast Cancer

This is an open label study where each patient will receive TOCOSOL(R) Paclitaxel 120mg/m2 every week for first line treatment of metastatic breast cancer. Patients will be followed to determine the efficacy of treatment (as measured by objective response rate), and the safety associated with weekly administration of TOCOSOL Paclitaxel.

This is an open label, non-randomized Phase 2 study of weekly administration of TOCOSOL Paclitaxel at a dose level, 120mg/m2, known to be tolerated based on Phase 2a studies of this investigational agent in patients with other histological diagnoses. This study is a fixed sample size design with no planned early stopping decision. The goals of the study include the determination of the safety of TOCOSOL Paclitaxel, and the objective response rate, defined by RECIST criteria as complete responses plus partial responses.

Eligibility Criteria:
Inclusion Criteria:

* Female patient with histologic diagnosis of breast carcinoma
* Stage IV (M1) disease
* No prior cytotoxic chemotherapy regimen for treatment of metastatic breast cancer
* Adult (18 years of age or older) patients
* Adequate hematologic function (ANC \>=1500 cells/mm3 and platelets \>100,000/mm3
* Serum creatinine \<=2.0 mg/dL
* Total bilirubin \<=1.5 mg/dL
* AST/SGOT and ALT/SGPT \<=3 times the upper limit of institutional normal values
* PT and PTT within institutional normal range
* ECOG performance status of 0-2
* At least one unidimensionally measurable lesion as defined by RECIST criteria assessable by radiographic evaluation
* A signed IRB/Ethics Committee approved Informed Consent
* Life expectancy of at least 12 weeks
* Fully recovered from any previous surgery
* A negative pregnancy test prior to study entry if premenopausal
* Agree not to take Vitamin E supplementation while receiving study medication

Exclusion Criteria:

* Any prior taxane-containing chemotherapy including Taxol or Taxotere
* Patients who are pregnant or lactating
* Peripheral neuropathy NCI-CTC grade 2 or greater
* Wide-field radiation, hormonal therapy or trastuzumab within 4 weeks of first dose of study drug; cytotoxic chemotherapy within 6 months of first dose of study drug
* Treatment with an investigational agent within 4 weeks of first dose of study drug
* Patients with a history of carcinomas of primary sites which can not be distinguished histologically from metastatic breast carcinoma
* Bone metastasis, effusions, ascites or elevated tumor markers as the only evidence of metastatic breast carcinoma
* Brain metastases
* Active bowel obstruction
* Active, serious infection or other serious medical problems (other than metastatic breast cancer) likely to impair completion of the study protocol
* Concurrent therapy with known substrates or inhibitors of the cytochrome P450 isoenzymes CYP2C8 or CYP3A4
* Concurrent therapy with warfarin or other coumarin derivatives
NEUROMARK Randomized Controlled Trial

The NEUROMARK RCT Study is a prospective, multicenter, randomized, sham-controlled, single-blinded, superiority trial.


Eligibility Criteria:
Inclusion Criteria:

Participant Must:

1. Be ≥18 years of age.
2. Have been experiencing rhinitis symptoms for a minimum of 6 months.
3. Have moderate to severe symptoms of runny nose (individual rTNSS symptom rating of 2 or 3), mild to severe symptoms of nasal congestion (individual rTNSS symptom rating of 1,2, or 3), and a minimum total score of 5 (out of 12) at baseline.
4. Be an appropriate candidate for bilateral NEUROMARK device treatment performed under local anesthesia.
5. Be willing and able to comply with all study elements, as indicated by written informed consent.

Primary Exclusion Criteria:

Participant Must Not:

1. Have clinically significant anatomic obstruction that in the investigator's opinion limit access to the posterior nose, including but not limited to severe septal deviation or perforation, nasal polyps, and/or sinonasal tumor.
2. Have had previous sinus or nasal surgery within 6 months of study enrollment.
3. Have previously undergone RF, cryotherapy, or other surgical interventions for rhinitis.
4. Have rhinitis symptoms that are due to seasonal allergies only.
Safety & Effectiveness of Nurse Performed Colonoscopies Under Supervision

There is no theoretical or practical reason why non-medical personnel such as nurses could not be trained to perform diagnostic colonoscopy with comparable proficiency as medical endoscopists. Nurse endoscopists have been widely accepted in the United Kingdom for the past 15 years as a valuable resource to cope with the increasing demand for endoscopic service, in particular diagnostic colonoscopy for colorectal screening. A pilot study performed in Hong Kong in 2008 has shown that endoscopy nurses can be trained to perform diagnostic endoscopy safely and reliably. This study aims to demonstrate that properly trained nurse endoscopists have a comparable proficiency in performing colonoscopy procedures as their medical counterparts.


Eligibility Criteria:
Inclusion Criteria:

* 1. Subjects receiving screening colonoscopy
* 2. Age ≥ 18
* 3. Informed consent

Exclusion Criteria:

* 1. Subjects have undergone colonoscopy in the past 5 years
* 2. Patients with prior colorectal surgery
* 3. Subjects with a personal history of inflammatory bowel disease, colon adenoma or cancer or family history of Familial Adenomatous Polyposis or Familial non-polyposis syndrome
* 4. Pregnant or lactating women
* 5. Lack of consent
Neuromuscular Eletroestimulation in Torque for Long Distance Recreational Runners

Introduction: The use of neuromuscular electrical stimulation (NMES) in athlete training has become an increasingly common feature among competition teams. Among the main benefits of NMES are the increase in muscular strength and improvement in athletes' performance. Surveys demonstrate the benefits of basketball, volleyball, soccer, swimmers and Olympic lifters using NMES, but no studies have been conducted on runners. Objectives: To evaluate the effects of 6 weeks of training with NMES, on knee peak torque (PT), ventilatory anaerobic threshold, maximum oxygen consumption (VO2max) and running economy in recreational runners. Methods: Randomized clinical trial involving 30 long distance runners, being randomly distributed in 2 groups of 15 participants each. All individuals will perform isokinetic evaluation of the lower limbs and ergospirometry. After these evaluations, all athletes will perform the same running training (CT), in addition to the CT the intervention group will perform NMES on the knee extensors 3 times a week for 15 minutes.

Participants who meet the eligibility criteria will be invited to participate in the study and, after signing the informed consent form, will perform initial clinical evaluation and will be randomized into two groups, being: control group (CG) and intervention group (GI) - using the medium-frequency alternating current. Each group will consist of 15 subjects who will have as dependent variables, the evaluation of the following items: peak muscle torque, analysis of ventilatory anaerobic thresholds, running economy and maximal oxygen consumption.

The intervention with the NMES will be considered as an independent variable. All groups will have the dependent variables evaluated before and after the intervention, which will consist of 18 sessions (6 weeks). The NMES training will be performed 3 times a week and will never be applied for two consecutive days, as shown in the flowchart All individuals, being they of the CG or the GI will perform a running training (TC), between 15 and 40 km per week and will be guided how to perform them, and the GI patients will perform a muscle strengthening protocol with NMES, which will be carried out in a specific place and prepared for intervention, in addition to the TC.

Eligibility Criteria:
Inclusion Criteria:

* Included will be male individuals, aged 30 to 45 years
* recreational funders, who have been performing the activity for at least 1 year.
* Totaling at least 15km and a maximum of 40km of training per week,
* Who do not use NMES for the purpose of muscle training.

Exclusion Criteria:

* Subjects who present muscle injuries and / or joint injuries in the lower limbs (LMI) in the last 6 months can't be part of the study.
* Who are unable to perform the isokinetic test
* Who are unable to do ergospirometric test,
* Who meet the contraindications criteria of NMES
Intralipid Therapy for Recurrent Implantation Failure and Recurrent Miscarriages: Is it a Hope or Myth?A Randomized Clinical Trial

Both organ-specific and systemic autoimmunity are associated with an increased prevalence of recurrent miscarriage and reproductive failure, rendering the role of the maternal immunological system in fertility a key concept. It is believed by some that central to this theme is the maternal cytokine profile, with particularly T-helper (Th) cells. Immune modulating therapies have therefore been mooted as potential therapeutic strategies. Recent reports of high pregnancy rates achievable in women with RIF have added fuel to the debate regarding the effectiveness of intralipids in modulating the immune system.

The investigators would like to assess if that intralipids therapy is an effective treatment for women undergoing repeated failed assisted reproduction cycles and recurrent miscarriages against traditional methods in randomised clinical trial (RCT).

Eligibility Criteria:
Inclusion Criteria:

1. Recurrent unexplained failed IVF, ICSI.
2. Recurrent unexplained miscarriages.
3. High level of peripheral and uterine NK.

Exclusion Criteria:

1. Age above forty years old.
2. Antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies \[IgG or IgM\]); other recognised thrombophilic conditions (testing according to usual clinic practice).
3. Intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram, or hysteroscopy).
4. Fibroids distorting uterine cavity.
5. Abnormal parental karyotype.
6. Other identifiable causes of recurrent miscarriages (tests initiated only if clinically indicated) e.g., diabetes, thyroid disease and systemic lupus erythematosus (SLE).
Leuprorelin Acetate SR 11.25 mg for Injection Specified Drug-use Survey "Long-term Use Survey on Premenopausal Breast Cancer Patients (96 Weeks)"

The purpose of this survey is to examine the safety and efficacy of long-term use (96 weeks) of leuprorelin acetate SR (slow release) 11.25 milligram (mg) for injection (Leuplin SR 11.25 mg for Injection) in premenopausal breast cancer patients in daily medical practice, as well as to examine factors that can influence the safety and efficacy of treatment with leuprorelin acetate SR 11.25 mg for injection (Leuplin SR 11.25 mg for Injection).

This survey was designed to examine the safety and efficacy of long-term use (96 weeks) of leuprorelin acetate 3 months depot for injection (Leuplin SR 11.25 mg for Injection) in premenopausal breast cancer patients in daily medical practice, as well as to examine factors that can influence the safety and efficacy of treatment with leuprorelin acetate SR 11.25 mg for injection (Leuplin SR 11.25 mg for Injection).

For adults, 11.25 mg of leuprorelin acetate is usually administered subcutaneously once every 12 weeks. Prior to injection, the plunger rod of the syringe is pushed upward with the needle pointed upward, allowing the entire suspension fluid contained to be transferred to the powder. The powder is then fully suspended in the fluid while ensuring that bubbles are not generated.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal breast cancer patients (patients with advanced or recurrent breast cancer and patients who received adjuvant therapy).

Exclusion Criteria:

* Patients with a history of treatment with Leuplin SR 11.25 mg for Injection
Effects of Dietary Nitrate on Age-related Vascular Function

Purpose of the study is to characterize the chronic effect of dietary nitrate on vascular function in healthy volunteers with particular emphasis on age-related alterations.


Eligibility Criteria:
Inclusion Criteria:

\>55 Years Healthy

Exclusion Criteria:

known cardiovascular disease
Effect of High Intensity Electromagnetic Body Shaping on Profile of Metabolism in Obese Men

high intensity focused electromagnetic technology's secondary effects are observed in the fat (adipose). within 8 h of a treatment session, apoptotic levels in adipose increased 91.7%.8 In addition, after the application of the high intensity electromagnetic technique, there is an increase in the rapid release of free fatty acids, so it can be used in weight loss

sixty obese males will be grouped to: first group (30 males) and second group (30 males). first and second groups will undergo dietary caloric restriction (i.e low calorie diet) and will be instructed to walk 10,000 continuous steps every day using the pedometer application for 3 months. only the first group will will undergo high intensity electromagnetic technique on abdomen of males which will be 3 sessions per week for 3 months

Eligibility Criteria:
Inclusion Criteria:

* men with central obesity
* BMI 30-34.9 kg/m2

Exclusion Criteria:

* metabolic /cardiovascular, pulmonary illnesses, musculoskeletal/neurological illness, autoimmune/psychological illnesses
Open-Label Study to Assess the Effect of Omeprazole on the Pharmacokinetics of VELCADE in Patients With Either Advanced Solid Tumors or Non-Hodgkin's Lymphoma.

This is an open-label, randomized, multiple-dose, multicenter Pharmacokinetics drug-drug interaction study in patients with advanced solid tumors, including non-Hodgkin's lymphoma, who are in need of anti-tumor therapy. In addition, the impact of omeprazole on the pharmacodynamics of VELCADE will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:1) Male or female at least 18 y/o 2)Weigh \>/= 50 kg (110lbs) and a BMI of \</= 28kg/m2;3)life expectancy \>/= 3 mos; 4)Karnofsky Performance Status \>/=70%; 5)Women must be menopausal. 3)Men must agree to use an acceptable method of contraception for the duration of the study.4)Must sign an informed consent document indicating understanding of the purpose and procedures required for the study;5)informed consent for genetic testing 6)Subjects have advanced solid tumor (including non-Hodgkin's lymphoma).7)resolution of reversible toxicities considered related to any prior antineoplastic therapies before entry; 8)must be able to swallow capsules whole; -

Exclusion Criteria:1)Prior exposure to VELCADE.2)Has known hypersensitivity or intolerance to omeprazole, boron, mannitol or heparin. 3)Medical history of of liver or renal insufficiency; significant cardiac, vascular, pulmonary, GI, endocrine, neurologic, rheumatologic, pyschiatric or metabolic disturbances. 4)Uncontrolled diabetes. 5)history of hypotension or decreased blood pressure;6)Uncontrolled or severe cardiovascular disease incl. myocardial infarction within 6 mos of enrollment; 7)History of alcohol/drug abuse. 8)Presence of HIV antibodies, hepatitis C antibodies or hepatitis B. 9)active systemic infection requiring treatment; 10)Pregnant or breastfeeding' 11)neuropathy \>/= Gr.1; 12)transfusion dependence; 12)pre-planned surgeries or procedures that would interfere with conduct of study

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Propofol Versus Midazolam as Premedication for Preterm Neonates With Respiratory Distress Syndrome (RDS)

The aim of the study is to compare the intubation conditions among propofol and remifentanil versus midazolam and remifentanil in premature neonates with respiratory distress syndrome. At the same time, to show the group of drugs that could let the neonates with no residual sedation after the use of surfactant (the possibility of the premature neonates to be readily extubated after the use of surfactant).

It has been demonstrated that remifentanil, due to it its very short context-sensitive, has an interesting potential for use in premature neonates with respiratory distress syndrome. Indeed, remifentanil allowed an adequate level of sedation and analgesia as well as rapid recovery after discontinuation. The aim of the present study was to compares the intubation conditions among propofol and remifentanil versus midazolam and remifentanil in premature neonates with respiratory distress syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age between 28-34 wk
* Clinical and radiological features compatible with respiratory distress syndrome that required elective tracheal intubation and surfactant therapy
* Hemodynamic stability before tracheal intubation
* Signature (parents) consent form

Exclusion Criteria:

* The presence of major congenital malformations
* Birth weigh less than 1000 g
* Previous use of opioid or other sedative drug for any reason
* Previous tracheal intubation
* Hemodynamic instability before the indication of tracheal intubation
* Refuse of the parents to enroll the neonate in the study protocol
Access to Healthcare and the Right to Health of People Living in Disadvantaged Neighborhoods Around Cayenne in French Guiana

ACSES aims to describe the health behaviours and vulnerabilities of poor urban communities living in the greater Cayenne area. It was a questionnaire based study conducted around a red cross truck providing testing.


Eligibility Criteria:
Inclusion Criteria:

* living in poor neighborhoods around cayenne

Exclusion Criteria:

* minors
* refusal to participate
Evaluation of FKB238 and Avastin in Patients With Advanced/Recurrent Non-squamous Non-small Cell Lung Cancer

The purpose of this research study is to compare the effectiveness and safety of FKB238 against Avastin® in men and women with advanced/recurrent non squamous non-small cell lung cancer


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older
* Newly diagnosed advanced (stage IV) /recurrent non-squamous NSCLC for which they had not received any systemic anti-cancer therapy for metastatic disease
* Histologically or cytologically confirmed diagnosis of predominantly non-squamous NSCLC
* Existence of at least 1 measurable lesion by RECIST v1.1
* Adequate hematological, renal and liver function
* Eastern Collaborative Oncology Group Performance Status (ECOG PS) 0 or 1
* Life expectancy longer than 6 months

Exclusion Criteria:

* Small cell lung cancer (SCLC) or combination SCLC and NSCLC. Squamous-cell tumors and mixed adenosquamous carcinomas of predominantly squamous nature
* Any unresolved toxicities from prior systemic therapy
* Known sensitizing epidermal growth factor receptor (EGFR) mutations or echinoderm microtubule-associated protein-like 4-anaplastic lymphoma kinase (EML4-ALK) translocation positive mutations
* Previous dosing with vascular endothelial growth factor (VEGF) inhibitor
* Known hypersensitivity to any excipients of the Investigational Products (IPs) and combination chemotherapy
* Use of prohibited concomitant medication
* Known Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV) infection
* Fertile men or women of childbearing potential not using adequate contraception.

Other inclusion/exclusion criteria may apply.
The Effect of Patient Preference on Retention Success

Aim of the Study: To determine whether allowing the patient to choose the type of retainer affects the success of retention in terms of stability and patient satisfaction.

Hypothesis: Allowing the patient to choose their retainer can increase the success of retention.

Design: Two-arm parallel group randomized controlled clinical trial

This study investigates whether allowing patients to choose the type of retainer-fixed or removable-affects the success of orthodontic retention in terms of stability and patient satisfaction. The hypothesis is that patient autonomy in selecting their retainer type can enhance retention success. Conducted as a two-arm parallel group randomized controlled trial, the study involves patients who have completed fixed appliance treatment. Participants are randomly assigned to either the intervention group, where they choose their retainer type after being informed of the pros and cons, or the control group, where the clinician decides the retainer type.

The primary outcome of the study is the stability of the orthodontic treatment, with secondary outcomes including retainer survival, oral health, and patient satisfaction. Stability is measured using indices such as Little's irregularity index, inter-canine width, and overjet, among others. Oral health is evaluated based on caries presence, sulcus depth, and gingival bleeding. Retainer survival is monitored by incidents of losing or breaking the retainer. Patient satisfaction is assessed through a detailed questionnaire covering aspects such as retainer usage, comfort, and perceived value. Due to the nature of the intervention, blinding is not possible for operators, participants, or assessors. This study aims to provide insights into how patient choice influences the outcomes of orthodontic retention, potentially guiding future clinical practices towards enhanced patient satisfaction and treatment success.

This study aims to provide valuable insights into the impact of patient autonomy on orthodontic retention outcomes. By comparing patient-chosen and clinician-chosen retainer types, the research seeks to enhance our understanding of factors contributing to successful orthodontic retention and overall patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

1. Patients older than age 12
2. Patients who have been treated with fixed orthodontic appliances
3. Patients with good standard of oral hygiene

Exclusion Criteria:

1. Patients with initial diastema or other significant spacing
2. Patients with dentofacial syndromes/cleft lip and palate
3. Patients who had orthodontic treatment before
4. Patients with hypodontia (more than one tooth missing, except third molars)
5. Patients who have undergone orthognathic surgery
Oxidative Stress and Hemodialysis Access Failure

Complications of hemodialysis access are the most frequent single reason for hospitalization among patients with End Stage Renal Disease (ESRD). Uremia, and particularly uremia in patients with diabetes, is a state of increased oxidative stress. The central hypothesis to be tested by this project is that oxidative stress is a major (and modifiable) trigger for vascular access complications. We hope to slow or reduce rates of stenosis, thrombosis and access complications by giving Vitamin E supplementation to patients being treated by hemodialysis.

Patients continued their usual treatment on hemodialysis three times per week. This was a double-blinded placebo controlled trial. Patients took either Vitamin E 400 IU bid or placebo. An initial evaluation of access patency was performed and baseline blood drawn before starting Vitamin E. Every 3 months there was a followup evaluation with blood drawn for oxidative stress markers, and with a test of vascular access patency. The study was closed to new participants, vitamin E or placebo stopped, and data analysis performed in 2003.

Eligibility Criteria:
Inclusion Criteria:

Adults, end stage renal disease treated by hemodialysis, patent hemodialysis vascular access (graft or fistula)

Exclusion Criteria:

Temporary catheter dialysis access, inability to be compliant with study medication