cyrilzakka/clinical-trials huggingface dataset:
Comparison of Hemodynamic Effects of Two Modalities of Alveolar Recruitment Maneuvers in Major Abdominal Surgery Patients

The objective of this study is to investigate the hemodynamic effects of two strategies of alveolar recruitment maneuver in patients undergoing major abdominal surgery in the operating room

In practice, after induction of general anesthesia and intubation, patients will be conditioned with the recommended monitoring (arterial catheter, central venous catheter, and transpulmonary thermodilution).

Once conditioning is complete, optimization of blood volume will be performed with volumetric expansions (250 mL of Ringer lactate) to achieve a change in stroke volume of less than 10%, as recommended (RFE SFAR 2013 - Perioperative Vascular Filling Strategy). The patient will then be randomized to one of the following groups: \[ extended sigh then CPAP \] or \[ CPAP then extended sigh \] (random order of ARMs - each patient becoming their own control). In order to homogenize the settings, the mechanical ventilation will be standardized with in particular the use of a PEEP of 6 cmH2O before inclusion and between the ARMs (for a duration of at least 10 minutes in each case).

Hemodynamic values will be recorded during the last 10 seconds of each procedure. Once the two ARMs have been performed, the rest of the management will then be left to the discretion of the practitioner in charge of the patient.

The included patient will be managed according to the recommendations at the time of the study.

Eligibility Criteria:
Inclusion Criteria:

* patient over 18 years old
* patient under general anesthesia
* patient intubated under controlled invasive mechanical ventilation
* patient with invasive hemodynamic monitoring (transpulmonary thermodilution)
* patient sedated (BIS between 40 and 60) and/or curarized with TOF monitoring to avoid inspiratory effort
* patient optimized on the hemodynamic level, in particular with regard to blood volume, following the hemodynamic monitoring data and the recommendations of the French Society of Anesthesia and Resuscitation (RFE SFAR 2013 - Perioperative vascular filling strategy)
* patient covered by a Social Security plan
* patient consent to participate in the study

Exclusion Criteria:

* contraindication to the use of cardiac output measurement
* cardiac arrhythmia
* pace-maker/implantable defibrillator
* severe valvulopathy
* contraindication to the use of the tomographic electroimpedancemetry technique
* thoracic lesions, thoracic dressing
* left ventricular ejection fraction (LVEF) \< 45% and/or right ventricular failure.
* history of pulmonary lobectomy and/or pneumonectomy and/or known emphysema
* patient with restrictive or obstructive lung disease
* body mass index (BMI) \< 16.5 or \> 30 kg.m-2
* pregnancy
* intracranial hypertension or suspected intracranial hypertension
* patient under limitation of care
* patient under legal protection (guardianship, curatorship, safeguard of justice)
Newly Diagnosed Mature B-ALL, Burkitt's Lymphoma and Other High-grade Lymphoma in Adults

The study evaluates the efficacy and tolerability of alternating short cycles of high-dose and conventional chemotherapy in combination with rituximab in CD20 positive patients, followed by local radiation therapy in the case of initial mediastinal or central nervous system (CNS) involvement or a residual tumor after chemotherapy. A dose-reduced regimen is offered for patients estimated to be over 55 years, biologically.


Eligibility Criteria:
Inclusion Criteria:

* Burkitt's leukemia or Burkitt's lymphoma or primary mediastinal large B-cell lymphoma or B-precursor lymphoblastic lymphoma or large cell anaplastic lymphoma
* Age \> 15 years
* Written informed consent

Exclusion Criteria:

* Serious secondary diseases, including psychiatric conditions, under which the required therapy compliance is not to be expected
* HIV infection
* Secondary lymphoma following prior chemotherapy/radiotherapy or active second malignancy
* Known severe allergy to foreign proteins
* Pre-treatment other than 1 cycle CHOP or similar; \< 1 week of another chemotherapy.
* Pregnancy or nursing
* Participation in other studies that interfere with study therapy
Osteocel® Plus in Anterior Lumbar Interbody Fusion (ALIF)

This study is being conducted to determine the percentage of patients with solid spinal fusions after being treated with Osteocel Plus in an ALIF procedure. Due to the unique processing conditions, Osteocel Plus retains a high concentration of stem cells in conjunction with the allograft bone matrix, so it is hypothesized that the fusion rate with Osteocel Plus will be comparable to published data for autograft. The Osteocel product family has already been used in approximately 15,000 cases worldwide.

This is a prospective, non-randomized multi-center study to compare the use of Osteocel Plus in subjects who receive ALIF surgery at one or two levels. These subjects will present with degenerative conditions in the lumbar spine that are amenable to surgical treatment and will be screened prior to study enrollment. Subjects will receive Osteocel Plus during their ALIF operation. Subjects will be followed for 24-months following surgery to determine the number of study subjects that are solidly fused at or before 24 months postoperatively, and to determine the mean time to fusion. This data will be compared to published and/or retrospective data for autograft, synthetic ceramics and BMP.

Eligibility Criteria:
Inclusion Criteria:

1. Persistent back and/or leg pain unresponsive to conservative treatment for at least six (6) months, unless clinically indicated earlier
2. Indicated for interbody fusion of one or two contiguous lumbar segments (L1 to S1)
3. Objective evidence of primary diagnosis must be confirmed by appropriate imaging studies
4. 18-70 years of age at the date of written informed consent
5. Able to undergo surgery based on physical exam, medical history and surgeon judgment
6. Expected to survive at least 2 years beyond surgery
7. Willing and able to return for post-treatment exams according to the follow-up called for in the protocol
8. Signed and dated Informed Consent Form

Exclusion Criteria:

1. Patient has a mental or physical condition that would limit the ability to comply with study requirements
2. Lumbar spine abnormality requiring treatment at more than two levels
3. Systemic or local infection; active or latent
4. Previous failed fusion at the operative level
5. Diseases that significantly inhibit bone healing (osteoporosis, metabolic bone disease, uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease)
6. Undergoing chemotherapy or radiation treatment, or chronic use of steroids (defined as more than 6 weeks of steroid use within 12 months of surgery, other than episodic use or inhaled corticosteroids)
7. Pregnant, or plans to become pregnant during the study
8. Subject is a prisoner
9. Involvement in active litigation relating to the spine (worker's compensation claim is allowed if it is not contended)
10. A significant general illness (e.g., HIV, active metastatic cancer of any type) is present; subject is immunocompromised or is being treated with immunosuppressive agents
11. Participating in another clinical study that would confound study data
Retrospective Data Collection and Prospective Clinical Investigation for the Augmentation or Reinforcement of the Rotator Cuff Using the Pitch-Patch

This is a clinical investigation study. It will verify the long-term safety and performance of the Pitch-Patch when implanted to reinforce partially repairable rotator cuff tears and used as described by the manufacturer's instructions.

The medical device in this study is already on the market and is manufactured by Xiros Ltd.

The Pitch-Patch is a single-use polyester prosthesis available in two sizes (30x20mm and 35x25mm). It is reinforced around the perimeter and around each eyelet to provide strength and stability to the device and repair.

The study will collect data on patients who meet the entry criteria and have received the device.

This is a single-armed study, meaning all patients will have a Pitch-Patch. The total length of the is expected to be 4 years; this includes a recruitment period of 2 years, and a follow-up period (for the prospective clinical investigation) of 2 years.

A minimum of 32 patients will be enrolled into the study. Follow-up data will be collected at (if available for retrospective data) 3 months, 6 months, 1 year, 2 years and final follow-up (maximum 2.5 years for prospective study; maximum of 5 years for retrospective study).

This is a clinical investigation study with both a prospective and retrospective study design. It will verify the long-term safety and performance of the Pitch-Patch when implanted to reinforce partially repairable rotator cuff tears and used as described by the manufacturer's instructions.

The medical device in this study is already on the market and is manufactured by Xiros Ltd.

The Pitch-Patch is a single-use polyester prosthesis available in two sizes (30x20mm and 35x25mm). It is reinforced around the perimeter and around each eyelet to provide strength and stability to the device and repair.

The study will collect data on patients who meet the entry criteria and have received the device.

This is a single-armed study, meaning all patients will have a Pitch-Patch. The total length of the is expected to be 4 years; this includes a recruitment period of 2 years, and a follow-up period (for the prospective clinical investigation) of 2 years.

A minimum of 32 patients will be enrolled into the study. Follow-up data will be collected at (if available for retrospective data) 3 months, 6 months, 1 year, 2 years and final follow-up (maximum 2.5 years for prospective study; maximum of 5 years for retrospective study).

Eligibility Criteria:
Inclusion Criteria:

* Treated using Pitch-Patch device for augmentation or reinforcement of the rotator cuff since 2012.
* If applicable, patient is willing to participate in the study (beyond standard of (routine) care) and have been informed of the nature of the study, agree to its follow-up and have provided written informed consent as approved by the Ethics Committee (EC).

Exclusion Criteria:

* There are no exclusion criteria; the aim of this study is to collect all data to see how the device is used in the real world setting.
Comparing the Effects of Different Doses of Dexamethasone to Treat Inpatient COVID-19

This open label clinical trial is to evaluate two different doses of dexamethasone on the health outcome using World Health Organization ordinal scale at day 28 in hospitalized patients with COVID-19.

The coronavirus disease 2019 (COVID-19) pandemic is a serious global health threat. Multiple antiviral or immunomodulatory therapies have failed to show any mortality benefit for patients with COVID-19. Dexamethasone was shown in prior studies to improve mortality and ventilator free days. However, it is unclear what dose of dexamethasone is most beneficial in hospitalized patients with COVID-19. This randomized single center open label clinical trial is to evaluate two different doses of dexamethasone (20mg vs. 6mg) on the health outcome for hospitalized patients with COVID-19. The intervention arm is dexamethasone 20mg daily for 5 days, followed by dexamethasone 10mg daily for 5 days. The comparator is dexamethasone 6mg daily for 10 days. Three hundred participants will be enrolled. The primary outcome is clinical improvement using World Health Organization ordinal scale at day 28.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* RT-PCR confirmed COVID-19 infection
* Positive pressure ventilation (non-invasive or invasive) or high flow nasal cannula (HFNC) or need supplemental oxygen with oxygen mask or nasal cannula

Exclusion Criteria:

* Underlying disease requiring chronic corticosteroids
* Severe adverse events before admission, i.e. cardiac arrest;
* Contraindication for corticosteroids;
* Death is deemed to be imminent and inevitable during the next 24 hours
* Recruited in other clinical intervention trial
* Pregnancy
* Patient on judicial protection
Local Non-salvage Radiotherapy for Synchronous Oligometastatic Non-small-cell Lung Cancer.

Aggressive therapy may improve survival in synchronous oligometastatic NSCLC and the goal of this clinical trial is to assess the efficacy and safety of local definitive radiotherapy in this subset of patients.

For NSCLC patients with synchronous oligometastases, first line chemotherapy or targeted therapy concurrent with non-salvage radiotherapy on metastatic or primary thoracic tumor contributed a longer progression-free survival than chemotherapy or targeted therapy alone.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged 18 to 70 years old;
2. Histologically or cytologically confirmed non-small cell lung cancer;
3. Stage IV patients with measurable primary tumor and distant metastases number ≤5；
4. PS score 0-2；
5. Have never received local or systemic anti-cancer treatment, including surgery (biopsy is allowed), first line chemotherapy, targeted therapy or immunotherapy;
6. Life expectancy of \>3 months;
7. Organ function levels must meet the following requirements:

(1)Bone marrow: White blood cell (WBC)≥4.0G/L；neutrophile granulocyte (NEU)≥1.5G/L；platelets (PLT)≥100G/L; hemoglobin (HGB)≥9g/L； (2)Liver and kidney: total bilirubin (TBIL), aspartate aminotransferase (AST), alanine aminotransferase (ALT)≤2.0 × the upper limit of normal (ULN)；creatinine≤1.5×ULN; 8.Patient must be willing and able to provide written informed consent.

Exclusion Criteria:

1. The amount of metastatic focus \>5;
2. Patient can't tolerate chemotherapy or targeted therapy;
3. Local or systemic anti-cancer treatment had been used for the primary foci and metastatic lymph nodes, including surgery (biopsy is allowed), first line chemotherapy, targeted therapy or immunotherapy;
4. Previous or concurrent suffered from other malignancies;
5. Concurrent with other serious disease that can not be controlled;
6. Women who are breast-feeding or pregnant;
7. Have an allergy to pemetrexed, cisplatin, taxanes, targeted medicine and contrast agent;
8. Patients with poor obedience or researchers think that the patient may not be able to accomplish the whole trial.
Trans Radial Versus Transfemoral Route for Coronary Angiography

The purpose of this study was to assess and compare the feasibility, success and safety of Transradial approach (TRA) verses Transfemoral approach (TFA) for diagnostic and therapeutic coronary angiography and coronary interventions, in terms of procedural time, access time, fluoroscopy time, procedural failure, , length of hospital stay in terms of days in hospital, Complications in terms of thrombophlebitis, hematoma, ecchymosis, infections thrombosis of vessel, MACE, Stroke and others.

Background: PCI has been done traditionally through transfemoral route. But now transradial and transbrachial routes are also coming up in practice. We compared transradial versus transfemoral routes for ease of operability, time for procedure, complications, and failure rates through a prospective study. Methods: 400 Patients admitted in department of cardiology for percutaneous interventions were enrolled in the study. 200 patients were assigned to each group randomly. A single team did all the procedures. Pre procedure, intra procedure and post procedure data of all the patients was collected, tabulated and analysed properly.

The variables studied include Access time ,Fluoroscopy time and overall procedure time, post procedure complications( ecchymosis ,Thrombophelibites, Hematoma, procedure access bleed), Failure rates,post procedure myocardial infarction, stroke, acute renal failure and infections.

Eligibility Criteria:
Inclusion Criteria:

* diagnostic angiography of coronary vessels, PCI

Exclusion Criteria:

* Patients with impaired renal function tests.

  * Lack of informed consent.
  * Severe infection.
  * Previous contrast allergy.
  * Severe intrinsic/iatrogenic caogulopathy INR\>2.
  * Abnormal modified Allen's test.
The Effect of Telerehabilitation-Based Structured Exercise Program in Video Game-Addicted Adults

The increasing use of computers and mobile devices due to advancing technology has brought with it some negative consequences such as video game addiction. Research has shown that playing video games for too long can lead to a number of acute and chronic serious musculoskeletal problems that can negatively affect health. The aim of the present study is to investigate the effect of telerehabilitation-based structured exercise program in video game-addicted adults and compare these effects with the effect of brochure-based exercise. Postural assessments, pain assessments, fine motor skill assessments, grip strength measurements, and reaction time assessments were performed. All assessments were repeated before and after the 8-week program for both groups. Participants in the EG were given a telerehabilitation-based structured exercise program for an average of 40 minutes three days a week for 8 weeks. Participants in the CG were given brochure-based exercises three days a week for 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Being between 18-40 years old
* Having a score of ≥30 on the Game Addiction Inventory for Adults (GAIA)
* Volunteering to participate in the study
* Having high-speed internet, a camera, and a microphone

Exclusion Criteria:

* Having a neurological/orthopedic condition that would prevent exercise
* Having a cognitive impairment
* Having a vision or hearing loss
Beta-alanine Supplementation and Its Effects on Performance, Muscle Carnosine Content and Safety in Athletes With Spinal-cord Injury

Paralympians competing in wheelchair sports may experience a very high glycolytic demand (and therefore acidotic environment) in their upper-body muscles, particularly in high-intensity disciplines. Previous studies from our group have shown that upper-body exercise is very sensitive to the ergogenic effects of β-alanine supplementation and to other nutritional supplements capable of increasing buffering capacity. In line with this, have shown that upper-body muscle groups benefit more from artificially induced alkalosis than lower-body muscle groups. Although β-alanine appears to be an interesting and potential ergogenic supplement for paralympians, no study to date has assessed its potential in wheelchair athletes.In this study, we will evaluate the effects of β-alanine supplementation on upper-body performance in wheelchair athletes.


Eligibility Criteria:
Inclusion Criteria:

* Paralympian training for any exercise modality for at least one year;
* A weekly training volume of 6 hours or more;
* Have a spinal cord injury accompanied by loss of motor function in the lower limbs for at least one year;
* Available for carrying out the experimental procedures.

Exclusion Criteria:

* Use of creatine or beta-alanine for at least 3 and 6 months before the trial;
* Cardiovascular or respiratory disease;
* Clinical condition that result in malabsorption of nutrients;
* Any other medical condition that prevents the realization of experimental procedures.
Secondary Prevention Trial of Rapamycin in Patients With Resected Non-muscle Invasive Bladder Cancer

The study is a multi-site Phase 3 double-blinded randomized placebo-controlled trial. Subjects are randomly assigned to receive either a placebo or oral Sirolimus: 0.5 mg daily. All subjects will be treated for 2 years or until disease recurrence. Patients will undergo endoscopic evaluation of the bladder every 3 months for the first 2 years following enrollment and then every 6 months for an additional 2 years on study. Selection of BCG immune therapy is at the discretion of the treating urologist but in general is reserved for high-risk patients. Patients concurrently receiving BCG immune therapy will receive standard BCG therapy including induction (weekly for 6 weeks) and maintenance (weekly for 3 weeks at 3 months, 6 months, and then every 6 months following tumor resection).


Eligibility Criteria:
Inclusion Criteria:

* Pathologically (histologically) proven diagnosis of non-muscle invasive (Ta, Tis or T1) bladder cancer within 60 days prior to enrollment
* Be able to give informed consent
* Be age 18 or older
* Not be in an immunosuppressed state (e.g. HIV, use of chronic steroids)
* Not have active, uncontrolled infections
* Not be on agents known to alter rapamycin metabolism significantly
* Not have a reported history of liver disease (e.g. cirrhosis)
* Not have a prior history of non-bladder cancer unless the cancer is clinically stable and not requiring active treatment except basal cell carcinoma or squamous cell carcinoma of the skin.
* Not pregnant, or taking effective contraception before rapamycin therapy, during therapy and for 12 weeks after discontinuation of therapy.

Exclusion Criteria:

* Have muscle-invasive (≥T2) bladder cancer
* Unable to give informed consent
* Age \< 18
* Immunosuppressed state (e.g. HIV, use of chronic steroids)
* Active, uncontrolled infections
* On agents known to alter rapamycin metabolism significantly
* Another cancer requiring active treatment (except basal cell carcinoma or squamous cell carcinoma of the skin)
* Patients at risk of pregnancy who are unwilling or unable to take effective contraception before rapamycin therapy, during therapy, and for 12 weeks after discontinuation of therapy.
* Individuals with a reported history of liver disease (e.g. cirrhosis)
Pilot Study of the Effectiveness of Probiotics and Lactitol for the Decolonization of OXA-48 (Carbapenemase) Producing Klebsiella Pneumoniae Among Rectal Carriers

The combination of Lactitol and Probiotics (Lactobacillus acidophilus and Lactobacillus Biphidus) administered orally is an effective strategy of intestinal decolonization of Enterobacter produced OXA-48-type carbapenemase.

The purpose of this study is to determine the effectiveness of Lactitol and Probiotics for the intestinal decolonization of people who carried Klebsiella pneumoniae produced OXA-48-type Carbapenemase.


Eligibility Criteria:
Inclusion Criteria:

* Men and women over 18 years old
* Have signed the informed consent to participate.
* Have evidence of intestinal colonization by KP-OXA-48 during the period of screening.
* Start of intestinal colonization by KP-OXA-48, \> 6 months of starting treatment.
* Absence of exclusion criteria

Exclusion Criteria:

* Be hospitalized for an acute process at the time of inclusion.
* Take antibiotics (oral , intramuscular or intravenous ) at the time of inclusion.
* Having diarrhea in the two weeks prior to the inclusion.
* Baseline electrolyte abnormalities requiring supplementation : Hypokalemia (K \<3 mEq / L), hypomagnesemia (Mg \<1.8 mEq / L ), hypocalcemia (Ca \< 8mg/dL )
* Suffering from digestive diseases : Crohn's disease, ulcerative colitis , celiac disease, irritable bowel syndrome , intestinal resection, colostomies.
* Neutropenia ( neutrophil count \< 1.00 x 10 3 / uL ) or other situations of severe immunosuppression , including continued use of systemic steroids (at least 1mg/kg/day of prednisone or equivalent for more than 1 month) and other forms of pharmacological immunosuppression deemed by the investigator.
* Diabetes mellitus poorly controlled ( HgA1c \> 8 mmol / mol ).
* Taking antisecretory inhibitors, proton pump or anti -H2.
* Advanced chronic renal failure (GFR \< 30 ml / min)
* Being a carrier of endovascular prosthetic devices, including long-term central catheters.
* Having significant valvulopathy on the opinion of the investigator.
* Surgical intervention of gastrointestinal tract in the last three months.
* Treatment with systemic corticosteroids or immunosuppressive.
* Allergy or intolerance to lactose or lactitol or Infloran .