cyrilzakka/clinical-trials huggingface dataset:
Comparison of Safety and Efficacy of TOCOSOL(R) Paclitaxel Versus Taxol(R) for Treatment of Metastatic Breast Cancer

The purpose of this study is to compare the objective response rates of patients randomized to receive either TOCOSOL(R) Paclitaxel or Taxol(R) (paclitaxel injection) administered every week to patients with metastatic breast cancer. The study hypothesis is that the objective response rate with TOCOSOL Paclitaxel given every week is non-inferior to that observed with Taxol given every week.

Female patients with first or second line metastatic breast cancer will be randomized to receive either weekly TOCOSOL Paclitaxel or weekly Taxol (paclitaxel injection). Patients will undergo radiographic imaging of their disease to assess response to therapy. The primary endpoint of this study is a comparison of the objective response rates observed in patients receiving TOCOSOL Paclitaxel, to those receiving Taxol. Time-to-disease progression and overall survival will also be compared. The toxicities of the two treatment regimens will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologic diagnosis of breast carcinoma
* Stage IV (M1) disease
* Adult (18 years of age or older) patients

Exclusion Criteria:

* Patients treated with a taxane within the past year
* Patients whose tumor tissue is known to show over expression of HER2/neu
Registry of Patients Treated by Preloaded Fenestrated Stent-graft Designs for Complex Endovascular Aortic Procedures

The aim of the study is to evaluate the outcomes of the preloaded stent-graft design (PLD) in the routine treatment of para-renal and thoraco-abdominal aneurysms. Results and postoperative events are reported in accordance with the current reporting standards for endovascular aortic repair prepared and revised by the Ad Hoc Committee for Standardized Reporting Practices in Vascular Surgery of The Society for Vascular Surgery/American Association for Vascular Surgery.

The Registry will include approximately 300 patients treated from January 2015 to May 2021 (retrospective arm) and June 2021 to June 2023 (perspective arm) for the routine treatment of para-renal and thoraco-abdominal aneurysms. To reach 300 patients, the enrollments can be extended until June 2026.


Eligibility Criteria:
Inclusion Criteria:

-Patients presenting with an acute (up to two weeks from the onset) and subacute (between 3 and 12 weeks from the onset) type B dissection with a proximal suitable non-dissected landing zone in the aortic arch or descending thoracic aorta (supra-aortic trunks debranching may be employed to obtain an adequate proximal landing zone

Exclusion Criteria:

* Anatomy requiring sealing in the distal descending thoracic aorta may not be appropriate for a 50 cm sheath due to the risk of it being too short and the graft not reaching the intended landing zone;
* Celiac trunk or superior mesenteric branch design that makes the graft excessively long;
* Inability or refusal to give informed consent;
* Simultaneously participating in another investigative device or drug study;
* Frank rupture;
* Systemic infection (eg, sepsis);
* Allergy to stainless steel, polyester, solder (tin, silver), polypropylene, nitinol, or gold;
* Untreatable reaction to contrast, which, in the opinion of the investigator, cannot be adequately premedicated.
Biliary Drainage in Patients With Duodenal Metal Stent

This is a retrospective study to evaluate the outcomes of endoscopic biliary drainage according to the timing of distal malignant biliary obstruction (MBO) in relation to gastric outlet obstruction (GOO) and the location of GOO.

This is a multinational multicenter retrospective cohort study to evaluate the outcomes of endoscopic biliary drainage in patients with a duodenal SEMS. Endoscopic ultrasound-guided biliary drainage (EUS-BD), including choledochoduodenostomy, hepaticogastrostomy, antegrade biliary stenting or a combination, and endoscopic retrograde cholangiopancreatography (ERCP) with stenting are to be compared. Specifically, the outcomes are to be evaluated according to the timing of distal MBO in relation to GOO and the location of GOO.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent endoscopic placement of a duodenal SEMS for nonresectable malignant GOO.
* Patients who underwent endoscopic biliary drainage for nonresectable MBO.
* MBO was located ≥ 2 cm from the bifurcation.
* Patients who could be followed up more than three months after completion of both biliary drainage and duodenal SEMS placement.
* Age ≥20 years.
* Irrespective of sex and a primary disease.

Exclusion Criteria:

* Patients who underwent surgical bypass for GOO.
* Patients who underwent percutaneous and surgical biliary drainage prior to the placement of duodenal SEMS.
* Patients with altered gastrointestinal anatomy (Billroth-II reconstruction, Roux-en-Y reconstruction, etc.).
* Patients who would not give a consent to the report of their own data.
* Patients considered ineligible for inclusion in the study by an investigator for other reasons.
Impact of Interscalenous Block Anesthesia on Hearing

Interscalene brachial plexus block (ISBPB) is used frequently in shoulder, clavicle and upper arm surgeries to obtain analgesia in the postoperative period. Our primary aim in this study is to evaluate if interscalene block anesthesia has an effect on hearing levels of patients undergoing orthopedic shoulder surgeries.

Interscalene brachial plexus block (ISBPB) is used for both anesthesia and analgesia purposes in shoulder, clavicle and upper arm surgeries. It is also frequently used to obtain analgesia in the postoperative period especially in patients undergoing shoulder surgeries. Thus, it provides decrease in opioid need and opioid related side effects in the perioperative period. The effect of IBPB on hearing is probably not caused by an effect on the vestibulocochlear nerve because of its central location. The innervation area of the greater auricular nerve, a derivative of the cervical plexus, is often involved in an IBPB. However, this nerve is not known to affect hearing. The nerves supplying the outer ear canal and the tympanic membrane (branches of the mandibular, facial and vagal nerves) are located far enough from the IBPB injection site to make their involvement unlikely. However, sound conduction through the middle ear to the inner ear, and functioning of the spiral organ of the cochlea may be indirectly affected by regional sympathetic block that is most likely seen after IBPB. Sympathetic block may cause vasodilatation and swelling of the mucosal membranes of the middle ear and the eustachian tube with deterioration of hearing.

The patient will be examined by ENT physician on the morning of the operation, after a detailed anamnesis. otoscopic examination will be performed, pure tone audiometry, speech audiometry and tympanometric examination will be performed and recorded.The same tests will be performed at the next day after the surgery but before the discharge and also when he/she applies for the first week check-up. Ultrasaoun guided Interscalene block anesthesia will be applied to all patients. Each patient will be treated with the same multimodal analgesia method at the postoperative period.

Eligibility Criteria:
Inclusion Criteria:

* participants are undergoing a shoulder surgery.
* ASA I and II patients without uncontrolled diabetes and hypertension
* participants have normal or near-normal hearing thresholds in the un-operated ear

Exclusion Criteria:

* participants have hearing loss (PTA \> 35 dB HL) in pure tone audiometry testing before surgery in any side
* participants have medical conditions after the surgery which prevents having hearing tests
* participants have abnormal tympanometric results
* participants with chronic otitis media or a history of ear surgery
Ureteral Stent Length and Patient Symptoms

The Study of whether or not Ureteral Stent Length affects patient comfort after electro-shock wave treatment for kidney stones.

Patients undergoing electro shock wave for treatment of kidney stones are randomized to long or short stent length after signing an informed consent prior to their surgery. They keep a pain diary and medication diary for a two week period after the stent is placed. These are turned in at the two week post-op visit. Patients also complete a quality of life and urinary symptom score questionnaire pre and post operatively.

Eligibility Criteria:
Inclusion Criteria: Male or female over 18 years of age, will be receiving electro-shock wave therapy for kidney stones -

Exclusion Criteria:Under 18 years of age, inability to give informed consent

-
Bioequivalence of IMP 08P1707F0 Relative to Pulmicort® (1.0 Mg/2 Ml Suspension)

This study aims to demonstrate the bioequivalence between the formulation of Budesonide 1mg/2mL nebuliser suspension (IMP 08P1707F0) relaive to the reference product Pulmicort(r) 1.0mg/2mL suspension.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, Caucasian, male and female (16 male, 8 female) subjects 18 - 55 years of age
* Body mass index within the range of ≥ 18.5 and ≤ 30.0 kg/m2
* Female subjects of childbearing potential1) agree to undergo pregnancy tests and to use at least an acceptable effective birth control method during the study and until 90 days after study end
* Negative Covid-19 test result
* Findings within the range of clinical acceptability in medical history (or the clinical investigator considers the deviation to be irrelevant for the purpose of the study)
* Findings within the range of clinical acceptability in physical examination (or the clinical investigator considers the deviation to be irrelevant for the purpose of the study)
* Laboratory values within the normal range (or the clinical investigator considers the deviation to be irrelevant for the purpose of the study)
* Normal Electrocardiograms (ECG) or abnormalities which the clinical investigator does not consider a disqualification for participation in the study
* Normal vital signs (normal blood pressure and heart rate measured under stabilised conditions at screening visit after at least 5 minutes of rest in sitting position: systolic blood pressure 100 - 140 mmHg, diastolic blood pressure 60 - 90 mmHg and heart rate 50 - 100 beats per minute; normal body temperature (Forehead, 35.5 °C - 37.0 °C)) or abnormalities which the clinical investigator does not consider a disqualification for participation in the study (...)

Exclusion Criteria:

* History of hypersensitivity to the study drug or any related drugs or to any of the excipients
* History or presence of any clinically significant cardiovascular, pulmonary, hepatobiliary, renal, haematological, gastrointestinal, endocrinologic, immunologic, dermatologic, neurological, psychiatric, metabolic, musculoskeletal, malignant disease or eye disorders as glaucoma or a family history of glaucoma
* Clinically significant abnormal laboratory values
* Clinically significant ECG findings
* Clinically significant vital signs (...)
Targeting of Immune Response After Pneumococcal Vaccination

Pneumococcal polysaccharide vaccine does not confer protection against noninvasive pneumonia. The study aims to compare lymphocyte homing in pneumonia and in those receiving Pnc polysaccharide vaccine (PPV) or Pnc conjugate vaccine (PCV)

Pneumococcal polysaccharide vaccine does not confer protection against noninvasive pneumonia. The study compares the homing profiles of Pnc-specific plasmablasts in 15 patients with pneumonia and in 15 volunteers receiving Pnc polysaccharide vaccine (PPV) and 12 volunteers receiving Pnc conjugate vaccine (PCV)

Eligibility Criteria:
Inclusion Criteria:

* Males and females ≥ 18 and \<65 years of age.
* General good health.
* Written informed consent.
* No previous vaccination against Pnc
* No previous history of Pnc pneumonia
* In pneumonia: Diagnosis of Pnc pneumonia within a week

Exclusion Criteria:

* \< 18 years, ≥65 of age.
* In vaccinees: Acute disease at the time of enrollment.
* Pregnancy or lactation.
* Known immunodeficiency or immune suppressive treatment.
* Any chronic illness that might interfere with the immune response
* Alcohol or drug abuse
* Any clinically significant history of known or suspected anaphylaxis or hypersensitivity (based on the investigator's judgement).
Integrated Parkinson Care Networks: Assessment of Economics and Socials Barriers

According to the latest public health report in France, Parkinson's disease (PD) affects around 160,000 patients.

It is therefore essential to estimate the overall consumption of medical and non-medical resources by patients with PD in order to characterize the share of medical and non-medical care reimbursed by health insurance, the share of medical and non-medical care not reimbursed. by health insurance, as well as the share of formal and informal care in order to identify potential economic barriers to an optimal care path for patients with PD. It is also necessary to have information on the socio-economic characteristics and the place of residence of the resident in order to estimate the impact of these determinants on an optimal course of care.

According to the latest public health report in France, Parkinson's disease (PD) affects around 160,000 patients

The coordination of the care pathway for patients with Parkinson disease has been improved since the implementation on the national territory of 7 interregional coordination centers and 25 regional expert centers in 2012.

Health insurance reimburses 100% of direct medical and non-medical care as soon as patients are registered in Long-Term Condition n°16. However, we currently have little information about care that is not recognized for financial coverage by health insurance.

It is therefore essential to estimate the overall consumption of medical and non-medical resources by patients with PD in order to characterize the share of medical and non-medical care reimbursed by health insurance, the share of medical and non-medical care not reimbursed. by health insurance, as well as the share of formal and informal care in order to identify potential economic barriers to an optimal care path for patients with PD. It is also necessary to have information on the socio-economic characteristics and the place of residence of the resident in order to estimate the impact of these determinants on an optimal course of care.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Parkinson's disease of any stage of severity
* Patients over 18 years of age
* Patients living at home
* Patient consultant at the expert center Parkinson's at Toulouse University Hospital

Exclusion Criteria:

* Pregnant and lactating woman
* Patient under guardianship, curatorship or safeguard of justice
* Person who does not understand French to be able to answer the questionnaire
* Patient who participated or participated in the iCare PD project
Parecoxib vs Paracetamol in the Treatment of Acute Renal Colic

This study will be conducted to compare the efficacy and safety of Parecoxib versus Paracetamol for treatment of acute renal colic due to ureteric stones.

Eligible patients will be randomized to one of the two treatment groups. Group 1 patients will receive IV 1 g of Paracetamol while group 2 patients will receive 40 mg of Parecoxib IV.

The Visual Analogue Scale (VAS) will be calculated on presentation and at 30 minutes after analgesia administration. Patients who do not respond to an initial dose of the analgesia will receive rescue analgesia in the form of Morphine, 01.mg/kg, IV.

Eligibility Criteria:
Inclusion Criteria:

* Clinical signs and symptoms consistent with acute renal colic

Exclusion Criteria:

* Hypersensitivity to either Paracetamol or Parecoxib.
* History of peptic ulcer.
* Pregnant or breastfeeding females.
* Patients with hepatic impairment (Child-Pugh score \>10).
* Patients with chronic kidney disease (CKD) Stage 4 or 5 (eGFR \<30mls/min).
* History of coronary ischemia, peripheral vascular or cerebrovascular disease.
Comparison Between Two Treatments for Burning Mouth

Introduction: The management of patients with chronic burning mouth is a challenge in clinical dentistry. Objective: To compare the effect of Low Level Laser Therapy (LLLT) and Transcutaneous Electrical Nerve Stimulation (TENS) in the treatment of burning mouth. Materials and Methods: Randomized clinical trial consisting of 25 patients with burning mouth who were treated by TENS (n=12) and by LLLT (n=13). Treatment was carried out weekly for 8 weeks. Two-way ANOVA was used to verify whether there was a significant difference between times T0 (baseline), T1 (after the 4th treatment session), T2 (after the 8th treatment session) and T3 (30 days after the end of treatment) in in relation to symptoms, analyzed using the Visual Analog Scale, unstimulated salivary flow, xerostomia and dysgeusia with TENS and LLLT interventions.

Experimental group: 20 participants with burning mouth were submitted to transcutaneous electrical nerve stimulation using a device at a frequency of 50 Hertz with intensity modulated according to the patient's comfort ranging from 1 - 4 (pulse amplitude) with a duration of 25 minutes per session, with one session per week, totaling eight weeks of treatment at the end of the study. The device's self-adhesive electrodes were fixed on the participant's face, following the path of the trigeminal nerve branch on the side affected by pain and/or burning.

Control group: 20 participants with burning mouth underwent low power laser therapy with punctual applications of infrared laser (L2) (power of 100mW, 808 nm, 6 joules of energy/60 seconds) in the affected region, keeping one centimeter of distance between the points, until the entire area of the complaint was irradiated. being held one session per week, totaling eight weeks of treatment at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or over
* Patients with burning sensation in the oral mucosa or recurrent dysesthetics daily for more than 2 hours a day for more than 3 months, without clinically evident causal lesions (IHS, 2018) were included in the study, as well as those who presented hyposalivation or some systemic alteration that could be related to a burning sensation in the oral mucosa

Exclusion Criteria:

• Patients who did not comply with the study treatment protocol.
Finding Early Rheumatoid Arthritis

Research has shown that early aggressive use of medicines may stop rheumatoid arthritis (RA)or slow its damage. The key to this is to find people with early symptoms which could be RA and have them get a diagnosis, treatment and follow-up.

This study will recruit persons who've gone to the internet looking for information about their symptoms. After answering a screening survey, the person with possible symptoms will be linked to the study website for a more detailed symptom questionnaire.

After completing that questionnaire the person will receive information about the second part of the study which includes an examination with a rheumatologist (arthritis doctor)and laboratory tests.

Based on the joint examination and laboratory tests, the rheumatologist will tell the person the likelihood of having RA, and make recommendations and if needed a referral for care and treatment. Treatment is not a part of this study.

This study will also compare the information on the subject's questionnaires to the doctor's joint examination and the laboratory tests with the hope of developing a simple inexpensive case finding questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Joint pain or swelling for less than 3 months
* Be able to use the internet

Exclusion Criteria:

* Non English speaking
* Diagnosis of rheumatoid arthritis
Prospective Study of Cerebral Palsy Scoliosis

This is a prospective, multi-centre study that will be looking at two groups of males and females over the course of their operative treatment for cerebral palsy (CP) scoliosis and the years following that treatment. The first group the study will be looking at is those individuals who undergo surgery for CP Scoliosis. The second group will be those individuals who do not undergo surgical treatment for CP Scoliosis, either because the family declines surgery or surgery is not recommended during the course of study participation.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 8 and 18 years
* Diagnosis of Cerebral Palsy with total body involvement
* Coronal curve greater than 40 degrees OR a kyphotic curve greater than 50 degrees on sitting film will be included
* Growing rod treatment will also be included

Exclusion Criteria:

* Previous operated scoliotic spine deformity
* Diagnosis of Rett's Syndrome
* Concomitant lower extremity surgery (within 3 months of spinal fusion)
* Cornelia de Lange Syndrome or any pervasive genetic disorder whose effects are due to much more than the static cortical injury
* Ambulatory spastic diplegic without upper extremity impairment or speech, swallowing or other involvement
Feasibility of the Management of Severe Cervical Dysplasia in a Single Visit

1. Implement a single-visit program (SVP) for cervix cancer prevention in clinics serving a multi-ethnic population of women;
2. Set up an efficient system for interpretation of Pap smears for patients in the SVP that will minimize waiting time;
3. Determine the follow-up rates and compare them between women assigned to the SVP and a usual care program (UCP);
4. Determine satisfaction and compare it between women assigned to the SVP and the UCP;
5. Determine the cost-effectiveness and compare it between the SVP and UCP

Women were recruited from underserved communities to participate in this single visit cervix cancer project. Large loop electrosurgical excision procedure (LEEP) was performed on SVP subjects with either a diagnosis of HGSIL/AGUS or suspicion of carcinoma. All other subjects with abnormal Papanicolaou smears were referred to our abnormal cytology clinics or received care in the community.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years
* No history of invasive cervical cancer
* Not pregnant

Exclusion Criteria:

* Absence of a cervix
* Abnormal vaginal bleeding
* Cervical cancer screening within the previous 12 months
* A known bleeding disorder
* Reluctance to be randomized
* Unwillingness to follow the study protocol
The Ability of Perfusion Index and Positional Perfusion Index Variation to Predict Spinal Anesthesia-induced Hypotension in Elderly Patients

In this study, we will test the ability of positional perfusion index variation to predict post-spinal anesthesia hypotension in elderly patients.


Eligibility Criteria:
Inclusion Criteria:

* 65 years of age or more.
* ASA score I \& II.
* Patients scheduled for surgeries under spinal anesthesia.

Exclusion Criteria:

* Negative consent.
* pre-existing hypertension
* Diabetes mellitus or autonomic neuropathy.
* Emergency operations.
* Absolute contraindications or failure to perform spinal anesthesia.