cyrilzakka/clinical-trials huggingface dataset:
Ramped and Sniffing Position for Cesarean Section Intubation.

This study will include pregnants who preferred to undergo general anesthesia for elective cesarean section. Ramped and sniffing positions of pregnant women during ventilation and intubation will be compared. The aim of this study is to investigate which position provides easier and faster intubation in pregnant women for cesarean section.

Estimates of the frequency of difficult and failed intubation in the obstetric population vary within a wide range of percentiles. Several times higher than those reported for the general surgery population. Functional Residual Capacity decreases by 10% - 25% in Pregnant women. Pregnant women are more susceptible to hypoxia as a result of this decline, which also encourages intubation to occur more rapidly. Intubation success and shortening of intubation time have improved positively with videolaryngoscopes. On the other hand, the position of the patient during intubation contributes to the speed and success of intubation. It has been shown that intubation is faster and first-pass success is higher in the ramped position in morbidly obese patients.This study will compare the effectiveness of ramp and sniffing positions on intubation time and success in obese patients and pregnant women with similar physical changes.

Eligibility Criteria:
Inclusion Criteria:

* Patients with American Society of Anesthesiologists physical status classification of II-III, who are planned for elective cesarean section, who are between the ages of 18 and 40, and who prefer general anesthesia will be included.

Exclusion Criteria:

* Patients who refuse to participate in the study, have orientation and cooperation disorders, have undergone head and neck surgery, have a history of difficult intubation, have a cervical spine defect, and have a risk of pulmonary aspiration will be excluded from the study.
Esophageal Multisegmented FCSEMS for Malignant Strictures

Objective: To assess the safety and feasibility of the implementation of the esophageal multisegmented fully covered self-expandable metal stent (SEMS) for the palliation of patients with malignant dysphagia.

Study design: Prospective observational nonrandomized clinical study.

Study population: A total of 30 patients with malignant dysphagia will be included. Sample size calculation does not apply for this type of study.

Intervention: All patients will be treated with the esophageal multisegmented fully covered SEMS.

Primary end points:

* Safety: complications and adverse events during follow-up with special attention to stent migration rates;
* Efficacy: technical success of stent placement.

Secondary end points:

* Recurrent dysphagia including its cause;
* Functional outcome: Ogilvie dysphagia score and WHO performance score (measured at baseline, 2 weeks and every 4 weeks until death/stent removal, or until a maximum of 6 months follow-up);
* Tissue ingrowth or overgrowth (measured endoscopically every endoscopic evaluation during follow-up);
* Pain related to esophageal stent.


Eligibility Criteria:
Inclusion criteria:

* Patients presenting with dysphagia due to a non-operable malignant obstruction of the esophagus or esophagogastric junction including extrinsic malignant compression and recurrence in post-esophagectomy patients;
* Requiring treatment for dysphagia (Ogilvie score of 2-41);
* Life expectancy of less than 12 months.

Exclusion criteria:

* Stenosis after laryngectomy;
* Distance between the upper edge of the stent less than 2 cm from the upper esophageal sphincter;
* Esophageal fistula;
* Tumor length of more than 14 cm;
* Previous stent placement for the same condition;
* Inappropriate cultural level and understanding of the study;
* Coagulopathy;
* Patients with eosinophilic esophagitis or an esophageal motility disorder;
* Nickel titanium (Nitinol) allergy.
Evaluating a New Iloperidone Titration Scheme in Bipolar I Disorder or Schizophrenia

This is a single-center open-label study to be conducted in the United States in subjects with bipolar I disorder or schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients 18 to 65 years of age (inclusive)
* Diagnosed with either schizophrenia or bipolar I disorder, manic or mixed type as per DSM-V criteria
* Symptomatically stable within the past two months

Exclusion Criteria:

* Exposure to any investigational medication, including placebo, in the past 60 days
* Non-response to clozapine
Developmental of Clinical Prediction Rule for Females Responding to Proximal Control Exercises

the aim of study is to investigate the effect of body mass index (BMI), age, duration of symptoms, pain severity and knee angle valgus on patient̕̕s response to proximal control exercises.

Patellofemoral pain syndrome (PFPS) is recognized as one of the most common lower-extremity disorders encountered by orthopaedic physical therapists. Females were 2.23 times more likely to develop PFPS than males. Various authors have suggested that hip weakness may be an impairment associated with PFPS, because poor hip control may lead to abnormal lower extremity or patellofemoral motions. Clinical prediction rules (CPRs) are tools designed to improve decision making in clinical practice by assisting practitioners in making a particular diagnosis, establishing a prognosis, or matching patients to optimal interventions.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 35 years.
* Anterior or retropatellar knee pain of non-traumatic origin that was greater than six weeks duration and provoked by at least two predefined activities (prolonged sitting or kneeling, squatting, jogging or running, hopping, jumping, or stair walking).
* Pain on palpation of the patellar facets, or with step down from a 15 cm step, or double leg squat.

Exclusion Criteria:

1. Concomitant injury or pathology of other knee structures.
2. Previous knee surgery.
3. patellofemoral instability (history of sublaxation or dislocation; positive apprehension test).
4. knee joint effusion.
5. Osgood-Schlatter's.
6. hip or lumbar spine pain (local or referred).
7. physiotherapy within previous year; prior foot orthoses treatment or use of anti inflammatories or corticosteroids.
Surgical or Medical Treatment of Breast Cancer Metastasis: A Multicentre Observational Study

The liver represents the third most common site of breast cancer (BC) metastases behind the lymphatics and bone. The primary treatment for BCLM remains chemo-therapy and, more recently, targeted immunotherapy. The role of liver resection in BCLM remains controversial. The primary aim of the study is to compare the efficacy of liver resection vs. medical therapy alone in Breast Cancer Liver Metastasis (BCLM) patients.

In this multicenter observational ambispective study, will be enrolled all patients with BCLM underwent liver resection or medical treatment alone afferent to the Fondazione Policlinico Gemelli IRCSS of Rome (Italy), and other 8 International centers

The study foresees two distinct phases:

* I phase (only retrospective phase): it will cover all patients underwent to either medical treatment or surgery for which all data are available, with a follow up of 5 years at March 31, 2023. All patients data will be recovered from January 1994 till March 31, 2018. At the end of "phase I", is provided an "ad interim" analysis.
* II phase (ambispective): All patients retrieved from the archives between April 1, 2018 and the April 30, 2023 will be included, as well as all prospectively enrolled patients till December 31 2023, so that the last patient enrolled will end the 5-years follow-up phase within December 31, 2028.

The primary endpoint is to analyze the efficacy of liver surgery as compared to medical therapy alone in terms of 5-years overall survival in patients with breast cancer who underwent to liver resection or medical therapy alone.

The secondary endpoints are: recurrence rate; post-operative mortality (in patients who underwent to surgical treatment), post-operative complication (in patients who underwent to surgical treatment). And also: to assess potential predictive factors of 5-years overall survival in patients with breast cancer who underwent to either liver resection or medical therapy alone, to assess recurrence free survival (RFS) of liver surgery as compared to medical therapy alone in terms of 5-years overall survival in patients with breast cancer who underwent to liver resection or medical therapy alone and to assess potential predictive factors of 5-years RFS in patients with breast cancer who underwent to either liver resection or medical therapy alone.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old
* BCLM
* BCLM and extra-hepatic disease
* Any treatment
* Ability to understand and sign the informed consent

Exclusion Criteria:

* Inability to provide the informed consent
* Patient who underwent Best Supportive Care or Palliation
Pilot Trial of Abdominal Core Rehabilitation To Improve Outcomes After Ventral Hernia Repair

This study aims to evaluate the potential role of physical therapy in improving outcomes after ventral hernia repair.

After being informed about the study and potential risks, all patients giving written informed consent will perform assessments of several activities of daily living and complete several surveys detailing their pre-surgical abilities, quality of life, and pain. Immediately after their surgical procedure, patients will be randomized in a single-blind manner (investigator) in a 1:1 ratio to supervised physical therapy (8 weeks, twice weekly) or standard post-surgical precautions. Assessments and surveys will be repeated by the blinded investigator at 30 days, 10 weeks, 6 months, and 1 year after surgery.

Eligibility Criteria:
Inclusion Criteria

* Ages 18+
* Diagnosis of ventral hernia
* Scheduled for elective ventral hernia repair
* Independent functional status
* Transverse hernia width of 2cm or greater

Exclusion Criteria

* Previously diagnosed movement or balance disorder
* Use of ambulatory assistive device (walker or cane)
* Not currently undergoing or planning to undergo physical therapy or other skilled exercise intervention supervised by a medical rehabilitation professional
The Relationship Between Positive End Expiratory Pressure and Cardiac Index in Patients With Acute Respiratory Distress Syndrome (ARDS) Managed on a Fluid Protocol

The objective of this study is to evaluate the association between positive end-expiratory pressure (PEEP) setting and cardiac function, as measured by cardiac index, in patients with acute respiratory distress syndrome (ARDS) who were managed on the NHLBI ARDS Network Fluid and Catheter Treatment Trial (FACTT) fluid protocols.

This is a secondary cross-sectional analysis of the FACTT multi-center randomized controlled trial enrolling adult patients within 48 hours of ARDS onset from twenty medical centers across the US, some of which included more than one hospital. We studied the patients who were randomized to the pulmonary artery catheter arm of the FACTT study. The investigators included patients that had PEEP and cardiac index measurements performed within a short period of each other during the first 3 days of the FACTT study enrollment. Since FACTT had a 2x2 factorial design, half of the patients were in a 'liberal fluids' study arm, and the other half were in a 'conservative fluids' study arm.

Eligibility Criteria:
Inclusion Criteria:

Acute lung injury diagnosis (as defined by The American - European Consensus Conference on ARDS) of \< 48 hours in duration.

Patients in the Pulmonary Artery catheter (PAC) arm of the FACTT study. PaO2 / FiO2 ratio of \< 200. Data from the first 3 days of mechanical ventilation.

Exclusion Criteria:

Select chronic conditions that could independently influence survival (e.g., expected 6-month survival \< 50%) and / or ventilator weaning.

PEEP values missing. FiO2 values missing. PaO2 values missing. Cardiac index values missing Pressors and / or inotropes requirement.
Clinical Trial at Neoadjuvant Peritoneal and Systemic Chemotherapy Plus HIPEC in Gastric Carcinomatosis

Implementation of a curative strategy of treatment in peritoneal carcinomatosis of gastric cancer. The goal is to get 1C level of evidence (patient died with "standard" treatment, with this treatment some of them survive) in terms of disease free survival and overall survival.

Methodology: prospective, phase II, multicentric in Spain. Recruitment of 50 patients(to have 31 on treatment) in three years. This strategy is based on neoadjuvant systemic plus simultaneous intraperitoneal and intravenous chemotherapy(NIPS),to treat peritoneal disease by bi-directional approach; next step is cytoreductive surgery and HIPEC. Once patients are discharged, they will follow a systemic adjuvant chemotherapy protocol.

Patients with peritoneal carcinomatosis with gastric cancer who meet all inclusion criteria(and none of exclusion) will follow the next treatment scheme(40 week period of treatment):

Phase I (after one week of peritoneal catheter implant; total treatment 5-8 weeks): intraperitoneal infusion of Docetaxel(30 mg/m2) and Cisplatin (30mg/m2) in 1000 cc of saline. Intravenous administration 5-FU (200 mg/m2/Day, 7 days a week for 2 weeks) simultaneously with 2 cycles of Intraperitoneal administration.

These patients receive between four and six cycles of NIPS. Until phase II 4-6 weeks.

Phase II:cytoreduction (CR) plus HIPEC (total treatment 4 weeks). Maximal efforts to optimum cytoreduction.

HIPEC: intraperitoneal administration: Mytomicin C (15mg/m2)plus Adriamycin (15mg/m2) at 42-43ºC for 60 minutes.

Intravenous simultaneously administration 5-FU (400mg/m2) plus Leucovorin (20mg/m2) for 10 minutes at the beginning of peritoneal perfusion.

Phase III: adjuvant chemotherapy 8-12 weeks after surgery. Those cases reaching optimum cytoreduction (CC0) will be treated with systemic chemotherapy: First day: Docetaxel (75 mg/m2) Cisplatin (75mg/m2). Days 1-5: 5-FU (750mg/m2/d).

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18-65 years old
* Histological Evidence of peritoneal carcinomatosis from gastric cancer
* No distance metastasis
* ECOG 0-1-2
* No contraindication for complex surgery
* no other malign disease except skin cancer (different from melanoma or cervix cancer CIN III)
* willing to consent and sign ICF.

Exclusion Criteria:

* No Histological Evidence of peritoneal carcinomatosis from gastric cancer
* Previous Gastrectomy due to gastric cancer.
* Patients with gastric cancer and previous systemic chemotherapy
* Peritoneal recurrence due to gastric cancer.
* Distance metastasis
* SP \>2 at recruitment or SP\>1 at surgery
* previous radiotherapy treatment
* pregnant or breastfeeding women
Non-invasive Device for the Screening and Diagnosis of Sleep Apnea Syndrome

This prospective study aims to establish and evaluate a predictive model to diagnose OSA with maxillofacial characteristics 3D acquisition.

Polysomnography is the gold-standard for obstructive sleep apnea (OSA) diagnosis. However, OSA is still undiagnosed. Maxillofacial profile can influence OSA severity. Morphological characteristics can be identified but are not enough measurable and analysable by physicians. 3D acquisition of maxillofacial characteristics with a user-friendly tool, quick and low-priced could be used to obtain a predictive model as an OSA risk indicator. Thus, the aim of this study is to establish and evaluate a predictive model to diagnose OSA with maxillofacial characteristics 3D acquisition.

Eligibility Criteria:
Inclusion Criteria:

* BMI \< 35 kg/m²
* caucasian men
* patients from the sleep laboratory (CHU Grenoble Alpes) admitted for a polysomnography
* Patient who has given free and informed consent in writing

Exclusion Criteria:

* history of maxillofacial surgery
* dental malocclusion
* patient involved in another clinical research study
* patient not affiliated with social security
* patient deprived of liberty or hospitalized without consent
Vaccine Therapy and QS21 in Treating Patients With Metastatic Breast Cancer

RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy together with QS21 may cause a stronger immune response and kill more tumor cells.

PURPOSE: This clinical trial is studying the side effects and how well giving vaccine therapy together with QS21 works in treating patients with metastatic breast cancer.

OBJECTIVES:

Primary

* Determine the safety of sialyl Lewisª -keyhole limpet hemocyanin conjugate vaccine and QS21 immunoadjuvant in patients with metastatic breast cancer.
* Determine the IgG and IgM antibody response to this regimen in these patients.
* Determine the proportion of breast cancer cells expressing this antigen in these patients.

Secondary

* Monitor the presence of circulating tumor cells prior to, during, and after this regimen in these patients.

OUTLINE: Patients receive sialyl Lewisª -keyhole limpet hemocyanin conjugate vaccine subcutaneously (SC) and QS21 immunoadjuvant SC once in weeks 1, 2, 3, 7, and 19 in the absence of disease progression or unacceptable disease.

Blood samples are collected periodically and evaluated for circulating tumor cells and reactivity against sialyl Lewisª antigen in ELISA and/or immunoprecipitation-western blot assays.

After completion of study treatment, patients are followed every 3 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed stage IV breast cancer meeting 1 of the following criteria:

  * No evidence of disease
  * Stable disease on hormonal therapy

    * Stable disease must be present for ≥ 2 months and include \< 30% decrease or \< 20% increase in the sum of the longest diameter of target lesion
    * No new target lesions or unequivocal progression of non-target lesions
    * Elevation in the CA 153 (BR2729) or CEA values allowed
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Female or male
* Menopausal status not specified
* Karnofsky performance status 80-100%
* Lymphocyte count ≥ 500/mm³
* WBC ≥ 3,000/mm³
* Creatinine ≤ 1.5 times upper limit of normal (ULN)
* AST ≤ 1.5 times ULN
* Alkaline phosphatase ≤ 1.5 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No history of allergy to seafood
* No NYHA class III-IV cardiac disease
* No other active cancers except basal cell or squamous cell carcinoma of the skin
* No active infection requiring antibiotic treatment
* No known history of immunodeficiency or autoimmune disease

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* At least 4 weeks since prior chemotherapy
* At least 4 weeks since prior radiotherapy
* At least 4 weeks since prior surgery
* At least 6 weeks since prior immunotherapy
* No prior sialyl Lewisª antigen
* No concurrent immunosuppressive medications (i.e., corticosteroids)
* Concurrent hormonal therapy allowed
Trial of MiStent Compared to Xience in Japan

To compare the MT005 (MiStent) with the XIENCE with respect to target lesion failure (TLF) at 12 months in a non-inferiority trial in a "real world" patient population and to confirm that the domestic extrapolation of the DESSOLVE III study results is valid.

This is a prospective, randomized, 1:1 balanced, controlled, double-blind, multi-center study comparing clinical outcomes at 12 months between MT005 (MiStent) and XIENCE in an all-comers population, including patients with symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes, who qualify for percutaneous coronary interventions.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients ≥20 years;
* Patients who are eligible for percutaneous coronary intervention (PCI);
* The vessel should have a reference vessel diameter ranging from 2.5 mm to 3.75 mm. All lesions of the patient must comply with the angiographic inclusion criteria and no more than 4 stents per patient are to be implanted.
* The patient is judged to be capable of providing voluntary informed consent and has been fully informed of the nature of the study, is willing to comply with all study requirements and will provide written informed consent as approved by the Ethics Committee of the respective clinical site.

Exclusion Criteria:

* Known pregnancy or breastfeeding at time of randomization or planned pregnancy for 12 months after the index treatment. Women of childbearing potential must have a negative pregnancy test within 7 days of randomization;
* Known contraindication or hypersensitivity to sirolimus, everolimus, cobalt-chromium, or to medications such as aspirin, heparin, bivalirudin, and all of the following three medications: clopidogrel bisulfate, ticlopidine, prasugrel;
* Concurrent medical condition with a life expectancy of less than 12 months;
* The patient is unwilling/not able to return for outpatient clinic at 1, 6 and 12 months follow-up;
* Currently participating in another trial and not yet at its primary endpoint;
Reducing Rate of Falls in Older People by Means of Vestibular Rehabilitation (ReFOVeRe Study)

The aim of this study is to evaluate and compare the effectiveness of vestibular rehabilitation developed using computerized dynamic posturography or a mobile posturographic system with vibrotactile stimulation, to improve the balance in older people and reduce the number of falls.

Accidental falls, particularly in the elderly, are one of the most important socio-healthcare problems of ageing western societies. Many factors condition and favour falls; one of them is old age, usually related to a decline in sensorial functions and worsening of balance Vestibular rehabilitation has been shown to be effective to improve balance and reduce the number of falls in older people. Previous studies have demonstrated that exercises in computerized dynamic posturography (CDP) are more effective than other vestibular rehabilitation strategies in this group of age. But CDP is very expensive and not widespread. It would be important to minimize cost of posturographic vestibular rehabilitation.

This study compare vestibular rehabilitation with two different posturographic devices (CDP and mobile posturographic system with vibrotactile stimulation), in people over 65 years. Additionally, we try to assess whether the reduction in the number of vestibular rehabilitation sessions (five) leads to an improvement in balance and in reducing the number of falls similar to those obtained with ten sessions.

Eligibility Criteria:
Inclusion Criteria:

Persons with a high risk of falling shall meet at least two of the following requirements:

* Having fallen at least once in the last 12 months.
* Using more than 15 seconds or needing support in the TUG test.
* Obtaining a mean CDP SOT balance score of \< 68%.
* Having fallen at least once in the CDP SOT.
* A score in Mobile posturography gSBDT \> 60 %.

Exclusion Criteria:

* Cognitive decline or reduce cultural level that prevents the patient from understanding the assessment, vestibular rehabilitation exercises and granting informed consent.
* Organic conditions that prevent standing on two feet, necessary for assessment of balance and performance of VR exercises.
* Balance disorders caused by conditions other than age (neurologic, vestibular,....).
* Current treatment with drugs that potentially disturb balance.