cyrilzakka/clinical-trials huggingface dataset:
A Phase I Study of BMS-690514 in Patients With Advanced or Metastatic Solid Tumors

The purpose of this research study is to determine the highest dose of the drug (BMS-690514) that can be safely given to patients with advanced cancer.


Eligibility Criteria:
Inclusion Criteria:

* Men and women 18 and older
* Diagnosis of any solid tumor
* ECOG performance status score 0-1
* Prior chemo-therapy, immunotherapy or radiotherapy with at least 4 weeks since the last treatment
* Treatment with VEGFR2 or HER1 TKI allowed but not both (for instance Avastin or Tarceva, but not both)

Exclusion Criteria:

* Treatment with other TKIs within the past 4 weeks
* Patients with brain metastasis
* Patients with centrally located squamous cell carcinoma of the lung
* Major gastrointestinal surgery which may affect absorption of the drug
* Any surgery within last 4 weeks
* History of thromboembolism
* Severe unmanageable diarrhea
* Subjects in Part B will have Non-Small Cell Lung Cancer (NSCLC)
* Part B/Cohort I erlotinib-naive subjects
* Part B/Cohort II subjects who have experienced disease progression while receiving erlotinib (erlotinib-resistant subjects)
A Multi-centre Evaluation of the Performance of Window Dressings on Subjects With High Risk Pressure Ulceration

This study will be conducted in approximately 26 subjects in UK to yield 20 evaluable subjects at 3 sites with approximately 5-10 subjects/site. Subjects with acute vascular, surgical and orthopaedic medical care in the elderly admission, with a high risk to develop skin breakdown or subjects with category 1 pressure ulcer can be enrolled in this investigation.

The rational for this study is to evaluate the potential for Window in the prevention of pressure ulcers because of its ability to reduce shear and friction forces.


Eligibility Criteria:
Inclusion Criteria:

1. acute vascular, surgical, orthopaedic, medical or care of the elderly admission
2. aged 18 years or over
3. have an expected total length of stay of 5 or more days
4. at high risk of PU development due to one or more of the following

   * bedfast/chairfast AND completely immobile/very limited mobility
   * category 1 PU on any pressure area skin site (see appendix G)
5. give their written, informed consent to participate
6. expected to be able to comply with follow-up schedule

Exclusion Criteria:

1. risk area which doesn't fit the dressing size 6\*7cm, 10\*12 cm and 15\*20cm
2. subject has category 2-4 pressure ulcer
3. subject has documented skin disease at time of enrolment, as judged by the investigator
4. known allergy/hypersensitivity to any of the components in the dressing
5. previous enroled in the present study
6. subject included in other ongoing clinical investigation at present, as judged by the investigator
Gut Microbiota in Patients With Peripheral Arterial Disease and Chronic Limb-threatening Ischemia

Microbiota has been associated with risk factors for cardiovascular diseases (hypertension, obesity, dyslipidemia, diabetes mellitus, heart failure). In animal models, the gut microbiota produces pro-inflammatory proteoglycans that increase the extent of myocardial infarction, reduced by treatment with probiotics (Lactobacillus). TMAO, a blood metabolite directly dependent on the gut microbiota is related to atherosclerotic plaque instability and major adverse cardiovascular events (MACE) in humans. Recent data demonstrate that blood levels of TMAO directly correlate with the risk of major MACE and mortality in patients with peripheral arterial disease (PAD).

The goal of this observational study is to evaluate the association between gut microbiota and TMAO serum levels and MACE and major adverse limb events (MALE) in patients with PAD and chronic limb threatening ischemia (CLTI) requiring a procedure of endovascular revascularization.

The main questions it aims to answer are:

* association between gut microbiota and TMAO serum levels and MALE after lower extremity revascularization.
* association between gut microbiota and TMAO serum levels and MACE after lower extremity revascularization.

Patients with CLTI requiring lower extremity endovascular revascularization will undergo stool sampling for determination of gut microbiota and blood sampling for the dosage of circulating TMAO before the endovascular procedure.

Incidence of MALE and MACE will be collected in a 24-months follow-up and will be associated with gut microbiota and TMAO serum levels.


Eligibility Criteria:
Inclusion Criteria:

* age of at least 18 years
* Ankle/Brachial Index (ABI) of less than 80
* at least one lower limb stenosis greater than 50% documented by Ultrasound Color Doppler (US)
* stage 4 or 5 PAD diagnosis according to the Rutherford classification
* presence of chronic limb-threatening ischemia
* indication for LER of the target arterial stenosis

Exclusion Criteria:

* acute infections at present or in the previous month
* antibiotic treatment in the previous month
* primary hyperparathyroidism
* revascularization of the lower limb in the previous 3 months
* diabetic foot ulcers with signs of active infection or osteomyelitis
* organ transplantation
* active cancer
* liver disease at functional status B or C according to Child-Pugh
* absolute contraindication to antiplatelet therapy
* thrombophilia
* contraindication to endovascular revascularization
Cyberknife Precision Radiation Delivery System for Tumors of the Spine

The purpose of this study is to determine the usefulness of Cyberknife precision radiation in eliminating or preventing the further growth of spinal tumors and lesions.


Eligibility Criteria:
Inclusion Criteria:- Intra-axial, extra-axial, or vertebral spinal lesion

* Age \> 5
* Histologic confirmation of malignant primary lesion or radiographic diagnosis of benign or vascular spinal lesion
* No rapidly deteriorating symptoms of spinal cord compression
* No instability of the spine
* Life expectancy \> 6 months Exclusion Criteria:- Patients without tumors of the spine
* Patients younger than 5 years old
Loxapine in the Management of Restlessness During Mechanical Ventilation Weaning

This study aims to assess the efficacy of a drug (loxapine, a neuroleptic) in calming patients down in a situation of restlessness during mechanical ventilation weaning. This drug is used for several years to quieten restless patients. Its purpose is to restore spontaneous breathing sooner and therefore to reduce the risks of intubation and mechanical ventilation.

This study aims to assess the efficacy of a drug (loxapine, a neuroleptic) in calming patients down in a situation of restlessness during mechanical ventilation weaning. This drug is used for several years to quieten restless patients. Its purpose is to restore spontaneous breathing sooner and therefore to reduce the risks of intubation and mechanical ventilation. 300 patients will participate in the study and will be randomized, after informed consent, to receive either loxapine or a placebo.Patients whose proxies refuse participation will be sedated according to standard care procedures.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years,
* sedated
* under mechanical ventilation through intubation probe for more than 48 hours
* no contra-indication to naso-gastric probe- with criteria for potential weaning
* with social security
* important restlessness at sedation withdrawal, defined as RASS score (Richmond Agitation Sedation Scale)= 2. This restlessness has no potential danger for the patient but requires a level of sedation. This re-sedation implies administration of morphinomimetics and benzodiazepines at dosages that does not allow to pursue mechanical ventilation weaning attempts.

Exclusion Criteria:

* extreme restlessness at sedation withdrawal ((RASS\>2)
* allergy to loxapine or one of its component
* dopaminergic agonists
* extubation planned in the following 24 hours
* antecedent of comitiality
* known pregnancy at admission
* proxies opposed to study participation
Relaxation and Heart Rate Variability

Primary:

* To characterize the physiologic changes of the autonomic nervous system, demonstrated by heart rate variability (HRV) high frequency (HF) spectral analysis, before and after a 15 minute, one-time, guided relaxation program for cancer patients.

Secondary:

* To assess whether change of HRV correlates with subjective feeling for anxiety, based on visual analog scale scores.

Rhythm changes in your heart rate are part of the "autonomic" nervous system. This is the part of your nervous system that controls the body functions that you do not have to think about. Researchers want to find out if a "guided relaxation" session will make your heart rate more variable, with more rhythm changes.

If you are found to be eligible to take part in this study, you will first answer a brief questionnaire that will measure several symptoms, such as pain and anxiety (worry). This questionnaire will take less than 5 minutes. You will also be asked questions about your alcohol and smoking history, and if you have ever used relaxation or meditation techniques in the past. This will also take less than 5 minutes.

You will then be asked to lay on your back, on a hospital bed or exam table. Electrodes will be placed along your chest, the same way they are placed for an electrocardiogram (ECG--a test to measure the electrical activity of the heart). You will be asked to rest for 15 minutes, and then your heart rhythm will be recorded for 5 minutes. After this first recording, you will begin the relaxation program by listening to an audio recording for about 15 minutes, using headphones. After the relaxation program has ended, your heart rhythm will be recorded for another 5-minute period while you are resting.

You will then be asked to complete the same questionnaire as before.

The entire procedure will take about 45-60 minutes. After this second questionnaire, your participation on this study will be over.

This is an investigational study. Up to 20 people will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent
2. Normal cognition (per treating physician's assessment)

Exclusion Criteria:

1. Dementia
2. Psychosis
3. Delirium
4. Not fluent in English
5. Cardiac dysrhythmia
6. Inability to lay supine
7. Pacemaker
Eccentric Exercise in Treatment of Achilles Tendinopathy

The purpose of the present study is to examine the long-term effect of eccentric exercises compared with stretching exercises on patients with achillodynia.

Patients with achillodynia for at least 3 months are randomly allocated to one of two exercise regimens. Exercise is performed daily for a 3-month period. Symptom severity is evaluated by tendon tenderness, ultrasonography, a questionnaire on pain and other symptoms, and a global assessment of improvement. Follow-up is performed at time points 3, 6, 9, 12 weeks and 1 year.

Eligibility Criteria:
Inclusion Criteria:

1. Pain in the Achilles tendon area with one of the two following findings. a) Distinct tenderness of Achilles tendon with no pain in the neighboring structures. b) Ultrasonographic changes defined as local thickening of the symptomatic tendon or a globally more than 2mm thicker tendon on the sick side.
2. Diffuse pain in the posterior region of the ankle with local tenderness of the Achilles tendon and ultrasonographic changes (as described above).

Exclusion Criteria:

1. Treatment of achillodynia with stretching or eccentric training for more than 2 weeks within the last 2 years.
2. Other injuries in the lower extremity or the knee, which by the examining doctor was evaluated to influence the evaluation of symptoms or the ability to perform the training program.
3. Acute symptoms with ultrasonographic changes consistent with a partial rupture of the tendon.
4. Age less than 18 years or over 70 years.
5. Previous operation on the tendon or steroid injections.
Ceftolozane-tazobactam for the Treatment of Respiratory Infections Due to Extensively Drug-resistant Pseudomonas Aeruginosa Among Critically Ill Patients: a Retrospective Study.

The aim of this study is to report our experience with ceftolozane-tazobactam and to evaluate its safety and efficacy in the treatment of ICU dependent nosocomial respiratory tract infections due to extensively drug resistant Pseudomonas aeruginosa. Different dosing regimes of ceftalozane-tazobactam is evaluated and compared to the standard therapy of Colomycin.

Ceftolozane-tazobactam (C/T) is a novel type of beta-lactam/beta-lactamase inhibitor antibiotics targeting nosocomial infections caused by Gram-negative bacteria. In recent years, ceftolozane-tazobactam was prescribed for treating complicated urinary tract infections (cUTI) and complicated intraabdominal infections (cIAI). Following the results of ASPECT-NP trial in 2019, it was approved as a therapeutic option in nosocomial pneumonia including hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP).

The drug shows an excellent activity against ESBL-producing Enterobacterales and multidrug-resistant (MDR) and extensively drug-resistant (XDR) strains of Pseudomonas aeruginosa. The latter is widely recognized as a common pathogen of nosocomial respiratory tract infections.

There is still a need for observations of clinical experiences to better define the risk-benefit profile of ceftolozane-tazobactam. The aim of this study is to report our experience with ceftolozane-tazobactam and to evaluate its safety and efficacy in the treatment of ICU dependent nosocomial respiratory tract infections due to extensively drug resistant Pseudomonas aeruginosa. Different dosing regimes of ceftalozane-tazobactam is evaluated and compared to the standard therapy of Colomycin.

Eligibility Criteria:
Inclusion Criteria:

* Hospital-acquired pneumonia caused by extensively drug-resistant Pseudomonas aeruginosa
* ≥ 72 hours of targeted antibiotic therapy against Pseudomonas aeruginosa with either Colomycin or Ceftolozane-Tazobactam

Exclusion Criteria:

* Participation in an interventional trial aiming nosocomial infections
* Treatment was not with the intent to cure the infection
A RCT for Y-Knot All-suture Anchor in Ankle Ligaments Injury Repair

Purpose of this study is to evaluate the effectiveness and safety of Y-Knot all-suture anchor by comparing patients' clinical outcome after ankle ligaments repair surgery.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female, no less than 18 years old;
* Patient was diagnosed as Collateral Ligament injury or Achilles tendon injury based on MRI or X-Ray who need to conduct foot\&ankle repair surgery by investigator;
* Patient willing to sign a written consent form participating in this study；
* Subject is able to understand study, willing to comply the study procedures, and willing to return to hospital for follow-up up to 6 months postoperative；
* Life expectancy is more than 2 years post-operationally;

Exclusion Criteria:

* Conducted surgery at index ankle and possibly influence the outcome evaluation;
* Bilateral ankle surgery;
* Suffering concurrent ankle disease that may leads to a surgery during the study phase;
* known or suspected allergies to implant and/or instrument materials;
* pathological conditions of bone which would adversely affect the anchor fixation; with concurrent severe injury at index leg that may influence the outcome evaluation; Severe obesity;
* With concurrent disease that may influence the index ankle function;
* Patients with active sepsis or infection;
* With concurrent disease that may influence the stability of device and rehabilitation;
* Immune suppression, impairment of immune function, or autoimmune disease;
* Pregnant or lactating women;
* Known noncompliance or lost follow-up risk;
* Participated other drug, biologic, or device clinical trial 12 months before enrollment;
* Alcohol or drug abuser;
* Other inappropriate condition based on investigator determination;
Magnetic Resonance-guided High-intensity Focused Ultrasound Treatment of Locally Advanced Pancreatic Cancer

Patients with unresectable pancreatic cancer in most of cases cannot benefit from percutaneous ablation modalities, due to high risk of procedure-related complications. Ultrasound-guided high intensity focused ultrasound (HIFU) ablation has been introduced as a feasible treatment option in these patients. However, in other anatomical regions US-guided HIFU has been replaced by the more accurate MR-guided focused ultrasound (MRgFUS) ablation, but the applicability of this latter technique to the treatment of pancreatic cancer is still unexplored. The aim of this study is to explore feasibility and clinical performance of MRgFUS ablation of unresectable pancreatic cancer. Two are the main end-points: Pain palliation and local tumor control.

As compared to conventional US-guided HIFU, MRgFUS could represent a more accurate, non-invasive ablation modality even for unresectable pancreatic cancer although, to date, no cases of pancreatic MRgFUS ablation have been reported.


Eligibility Criteria:
Inclusion Criteria:

* biopsy proven unresectable pancreatic adenocarcinoma;
* unable or not willing to undergo chemo-radiation therapy
* Celiac plexus alcoholization failed to control pain symptoms

Exclusion Criteria:

* contraindication to MR or general anesthesia
Individualization of Ovarian Stimulation Using AMH Maximizes the Benefits and Minimizes Complications and Risks

The purpose oh the study is to determine the usefulness of anti-Mullerian hormone (AMH) to identify women at risk of excessive and poor response in controlled ovarian stimulation (COS) for in vitro fertilization (IVF), and the clinical impact of applying individualized COS strategies in these subsets of patients.

A group of 130 women undergoing conventional COS after pituitary down-regulation for IVF will be studied to determine the best cut-off points of AMH, using receiver operating characteristic (ROC) analysis, to discriminate excessive (≥20 oocytes retrieved) and poor response (≤4 oocytes retrieved). The inclusion criteria is any patient with indication of IVF treatment. Subsequently, a different group of 120 women (with the same criteria) will be assessed using AMH before starting COS, and treatment strategy will be individualized according to AMH results (iCOS). Mild stimulation using daily doses (112.5 to 150 IU) of recombinant follicle stimulation hormone (rec-hFSH) or rec-hFSH combined with recombinant luteinizing hormone (LH) supplementation (375 IU total daily dose) will be given to patients identified as at risk of excessive and poor response, respectively. It will evaluated: number of oocytes, clinical pregnancy rates (defined as fetal heartbeat on ultrasound performed 4 weeks after the transfer of embryos) and occurrence of Ovarian hyperstimulation syndrome). Outcomes will be compared between the groups who received conventional and iCOS using chi-square and Fisher exact tests.

Eligibility Criteria:
Inclusion Criteria:

* women with in vitro fertilization treatment indication

Exclusion Criteria:

* none
Special Investigation in Patients With Intestinal Behcet's Disease (All Case Investigation)

This investigation was conducted to obtain the following information regarding the use of Adalimumab (Humira®) 40mg Syringe 0.8mL for Subcutaneous Injection in patients with Intestinal Behcet's Disease.

1. Incidence and conditions of occurrence of adverse reactions in clinical practice
2. Factors likely to affect the safety and effectiveness


Eligibility Criteria:
Inclusion Criteria:

* All patients who received Adalimumab for the treatment of Intestinal Behcet's disease (not sufficiently responsive to existing therapies, e.g. steroids, immunomodulator)

Exclusion Criteria:

Contraindications according to the Package Insert include patients who had any of the following:

* serious infections
* tuberculosis
* a history of hypersensitivity to any ingredient of Humira®
* demyelinating disease or a history of demyelinating disease
* congestive cardiac failure
Self-sampling and Human Papillomavirus (HPV)-Testing for Unscreened Women in Cervical Cancer Prevention

Scientific Context:

High-risk types of human papillomavirus (HPV) are the causative agents for cervical cancer. Cervical cancer screening strategies rely on periodic Papanicolaou (Pap) testing. It's well-known that this test has significantly contributed to the reduction of mortality and morbidity due to cervical cancer. In France, it now seems that the screening strategy could be optimized. The two main ways are to reach the 7 million underscreened women (organized screening, self-sampling for HPV DNA testing) and to improve the screening test (HPV DNA testing, computer-assisted cytology). Self-collected vaginal samples (SCVS) for HPV DNA testing could be a relevant screening option: this technique appears reliable and it could allow to reach women who are never or seldom screened. The performance of the SCVS to detect cervical HPV infection has been assessed by the first part of the whole study: APACHE-1.

The goal of this study is to compare the attitudes of women not attending organized cervical cancer screening face to different strategies: further invitation to make a cervical smear or kit for self-collected vaginal sample sent at home.

Description of the project :

Nine months after a primary invitation to make a cervical smear, a random sample of 6000 women not attending organized cervical cancer screening will be randomly assigned to one of the following arms:

* Intervention arm 1:

Women will receive a further invitation to make a cervical smear

* Intervention arm 2:

Women will be directly sent the kit for self-collected vaginal sample at home. The women who will send the self-sample to the laboratory for analyse will receive their results at home as well as their general practitioner if the HPV DNA test is positive (infection by a high-risk HPV).

For them who will have a HPV DNA test positive, it will be necessary to complete the screening action with a cervical smear. That's why those women will receive an invitation to make a cervical smear if they won't do it during the 9 months following the first mail.

* Control arm: Those women will receive complete information about the study, the main results and the screening recommendations at the end of the study.


Eligibility Criteria:
Inclusion Criteria :

* Women from 30 to 65 years
* Living in Indre-et-Loire (french territorial division 37)

Exclusion Criteria :

* Women who attend organized cervical cancer screening or who answer to the invitation
* Cervical smear made in the three last years
* HPV linked cervical condition undergoing treatment
* Hysterectomy (including cervix)
Web Based Follow up Intervention in Obesity Treatment for Women

This study is designed to verify that web based follow up intervention after a classic multidisciplinary face-to-face obesity treatment will reinforced nutrition and exercise self-efficacy, improve drop out rate and advance sustainability after weight loss of obese women.

Research Questions and Hypotheses

* How does a web based follow up intervention change self-efficacy of women participating in an obesity intervention?
* How does a web based follow up intervention affect the drop out rate of women participating in an obesity intervention?
* How does a web based follow up intervention influence sustainability of women participating in an obesity intervention?


Eligibility Criteria:
Inclusion Criteria:

* Women
* Age 18-80
* BMI 30-40
* Internet access
* Motivation and psychological stability to stay in a long term obesity intervention
* No medical conditions prohibiting moderate physical exercise

Exclusion Criteria:

* Men
* Age under 18 years
* BMI under 30 and above 40
* No Internet access
* No motivation and psychological stability to stay in a long term obesity intervention
* Medical conditions prohibiting moderate physical exercise