cyrilzakka/clinical-trials huggingface dataset:
Protective Versus Conventional Mechanical Ventilation for Peripheral Vascular Surgery.

Background and goal of the study: Postoperative complications following major surgeries are associated with a significant increase in costs and mortality. There is increasing evidence that mechanical ventilation with a protective strategy using low tidal volume prevents postoperative pulmonary complications. Peripheral vascular surgeries include particularly surgeries for arterial revascularization of the lower limbs in patients with advanced peripheral vascular disease. These procedures are strongly associated with major cardiovascular morbidity postoperatively. In this specific group of patients, the presence of postoperative pulmonary complications (PPC) may be associated with worsening of clinical outcomes with a consequent significant increase in perioperative morbidity.

Subjects and methods: In this study, the investigators aimed to compare the effects of controlled mechanical ventilation with the use of a protective strategy (low tidal volume associated with elevated PEEP) when compared to the conventional strategy (higher tidal volume associated with reduced PEEP levels) on the rate of PPC in patients undergoing peripheral vascular surgery. This study was delineated as a prospective trial, compared to the control group (conventional ventilation strategy). Patients and researchers were blinded during data collection. The investigators included adult patients, ASA status II to IV, aged over 18 years, scheduled to undergo lower limb arterial bypass surgery. Patients were randomized to treatment with conventional mechanical ventilation (tidal volume between 9 to 10 ml.kg-1 of predicted body weight and PEEP between 3 and 5 cmH2O - Group I or control) or treatment with protective ventilation strategy (tidal volume of 6 to 7 ml.kg-1 of predicted body weight and PEEP of 6 to 8 cmH2O - Group II or treatment). The primary outcome was PPC and the secondary endpoint included hemodynamic and metabolic changes perioperatively. Statistical analysis was performed using the intention-to-treat method.


Eligibility Criteria:
Inclusion Criteria:

* This study enrolled only patients displaying peripheral occlusive arterial disease and scheduled to undergo an elective peripheral artery bypass surgery.

Exclusion Criteria:

* The illiterate or who do not understand Portuguese language, those who had a body-mass index (BMI) higher than 35 kg/m2, had severe pulmonary comorbidities or another disorder that might compromise a safe trial procedure and those who refused to participate of the study or who had already participated in other studies.
Study on the Therapeutic Effect and Mechanism of Transcranial Plasma Stimulation in the Treatment of Chronic Insomnia

This study is a single center study, led by Dr. Ma Qinying from the Department of Neurology at the First Hospital of Hebei Medical University. This study is an intervention study on plasma stimulation, involving patients with insomnia disorders to observe the effectiveness of plasma stimulation on insomnia disorders. Collect the Hamilton Anxiety Scale, Hamilton Depression Scale, Pittsburgh Sleep Quality Index Scale, Insomnia Severity Index Scale, and Somatization Symptom Self Rating Scale from patients before and after intervention. Transcranial magnetic stimulation synchronous electroencephalogram (TMS-EEG) and functional magnetic resonance imaging data. The research period is from December 2023 to July 2025, and a total of 40 patients are planned to be included in the study.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years old, gender is not limited;
2. right-handed;
3. the audiovisual level is sufficient to complete the examinations required for the study;
4. No medication for 1 month before enrollment, or stable taking sleep-improving drugs but poor treatment effect;
5. Informed consent signed by the patient or family member.

Exclusion Criteria:

1. Substance abuse/dependence within 6 months prior to enrollment;
2. Have had other mental illnesses within 6 months prior to enrollment;
3. Those with severe or unstable organic diseases;
4. pregnant or lactating women;
5. Those with a score of 3 (suicide) in 17 items of the Hamilton Depression Rating Scale ≥ 3;
6. Those who have participated in any other clinical trials within 1 month before enrollment;
7. In the opinion of the investigator, there is a situation that is not suitable to participate in this study.
Skin-to-skin Contact During the Transfer From the Delivery Room to the Neonatal Intensive Care Unit: Impact on Very Preterm Infants and Their Parents

Developmental care are recognized as a standard of care for preterm infants in neonatal intensive care units. Regular skin-to skin contacts during the neonatal stay show short and long-term beneficial effects on preterm infants and their parents. Skin-to-skin contact provides hemodynamic and thermal stability in preterm infants. Regarding parents, skin-to-skin contact sustains the parental bonding, and reduces stress and anxiety related to hospitalization. As a result, early skin-to-skin contact has been associated with an improvement of neurological outcome in very preterm infants.

Thermal stability is crucial during the first hour of life in preterm infants. A temperature at admission in the neonatal intensive care unit below 36.5°C or above 37.2°C has been associated with an increase in neonatal morbidity and mortality.

Early skin-to-skin contact between a newborn and his/her mother in the delivery room significantly decreases the occurrence of hypothermia below 35.5°C.

The practice of skin-to-skin transfer from the delivery room is emerging in France. Pilot studies have been carried out by French neonatal teams that showed the feasibility of this practice in late-preterm, near-term and term infants. Although skin-to-skin contact routinely involves very preterm infants in neonatal intensive care units worldwide, the feasibility and safety of skin-to-skin contact during the transfer from delivery room to the neonatal unit is poorly documented in very preterm infants. Previous data of our team showed that transfer of preterm infants with non-invasive ventilation using skin-to-skin contact was feasible and safe but concerns emerged about the thermal conservation during the procedure.

The main hypothesis of this study is that skin-to skin contact during the transfer from the delivery room to the neonatal intensive care unit could prevent heat losses in preterm infants as well as the transfer in incubator. Another hypothesis is that very early skin-to-skin contact could positively influence the neonatal course and the parental experience in the neonatal care unit.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age \< 34 weeks
* Singleton pregnancy
* Inborn birth, i.e., in the maternity ward of investigating centres
* Need of hospitalization in the neonatal intensive care unit
* Oral and written information of parents and written parental consent to participate in the study (by the father if the mother is unable to participate)

Exclusion Criteria:

* Single parent or homosexual couple
* Absence of the father in the delivery room
* Parents not speaking French
* Skin temperature of the newborn \< 36°C at the time of randomization
* Conditions not allowing the early skin-to-skin contact: omphalocele, gastroschisis, desquamating dermatological conditions (Harlequin syndrome, Collodion)
* Clinical condition requiring a specific transfer mode according to the pediatrician in the delivery room
* Parents under legal protection
* Minor parents
BIOFREEDOM Stent Versus ORSIRO Stent: SORT OUT IX

The aim of the Danish Organization for Randomized Trials with Clinical Outcome (SORT OUT) is to compare the safety and efficacy of the polymer-free Biolimus-eluting BIOFREEDOM stent with a biodegradable-polymer Sirolimus-eluting ORSIRO stent in a population-based setting, using registry detection of clinically driven events

SORT OUT IX is a randomized, multicenter, all-comer, two-arm, non-inferiority trial comparing the polymer-free Biolimus-eluting BIOFREEDOM stent with a biodegradable-polymer Sirolimus-eluting ORSIRO stent in treating atherosclerotic coronary artery lesions.

Patients will be enrolled by the investigators and randomly allocated to treatment groups after diagnostic coronary angiography and before percutaneous coronary intervention. Block randomization by centre (permuted blocks of random sizes (2/4/6)) will be used to assign patients in a 1:1 ratio to receive the polymer-free Biolimus-eluting BIOFREEDOM stent (Biosensors) or the biodegradable-polymer Sirolimus-eluting ORSIRO stent (Biotronik). A web based Trial Partner randomization system will be used.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or over with chronic stable coronary artery disease or acute coronary syndromes, and at least one coronary artery lesion with more than 50% diameter stenosis, requiring treatment with a drug-eluting stent.

Exclusion Criteria:

* Life expectancy of less than one year; an allergy to aspirin, clopidogrel, ticagrelor, prasugral, biolimus or sirolimus; participation in another randomized trial; or inability to provide written informed consent.
The Results of Pars Plana Vitrectomy in Diabetic Macular Edema

This study will be a retrospective analysis of vitrectomy results in patients suffering from diabetic macular edema.


Eligibility Criteria:
Inclusion Criteria:

* Diabetic macular edema patients after vitrectomy

Exclusion Criteria:

* All others
Knee Stability Training for Knee Osteoarthritis (OA)

People with knee osteoarthritis (OA) frequently complain of knee instability. This study will test whether certain exercises can improve knee stability, reduce pain, and improve physical function in people with knee OA.

Study hypotheses: 1) Participants in the stability training group will demonstrate less pain and higher levels of physical function, based on self-report measures of pain and function (WOMAC, Lower Extremity Function Scale), and less time to complete the Get Up and Go test, a physical performance measure of function. 2) During walking and the step down task, participants in the stability training group will demonstrate greater knee motion during weight bearing, greater vertical ground reaction forces and loading rates, and reduced ratios of co-contraction between quadriceps/hamsting and tibialis anterior/gastrocnemius muscle pairs compared to the standard group. Participants in the stability group will also demonstrate greater step lengths, single limb support times, and average walking velocity compared to the standard group.

Traditional exercise therapy for knee OA primarily focuses on lower limb strength and joint motion deficits. Recent evidence has suggested that changes in lower limb biomechanical factors during weight bearing activities may have substantial impact on physical function and disease progression in individuals with knee OA. The effectiveness of exercise therapy programs might be improved by incorporating balance and agility training techniques (knee stability training). The aim of this trial is to test the effectiveness of supplementing traditional exercise therapy with knee stability training techniques tailored for individuals with knee OA.

Participants will be randomly assigned to one of two groups. The first group will participate in a standard rehabilitation program of traditional exercise therapy for knee OA. The second group will participate in a standard rehabilitation program supplemented with a knee stability program. Study visits will occur at study entry, 2 months, 6 months, and 1 year. At each study visit, changes in pain, physical function, and biomechanical factors will be assessed. This study will last for one year.

Eligibility Criteria:
Inclusion Criteria:

* Meet the 1986 American College of Rheumatology (ACR) clinical criteria for knee osteoarthritis
* Grade II or greater Kellgren and Lawrence radiographic changes

Exclusion Criteria:

* History of two or more falls within the year prior to study entry
* Unable to walk a distance of 100 feet without an assistive device or a rest period
* Total knee arthroplasty
* Uncontrolled hypertension
* History of cardiovascular disease
* History of neurological disorders that affect lower extremity function such as stroke or peripheral neuropathy
* Corticosteroid injection to the quadriceps or patellar tendon in the past month, or 3 or more within the past year
* Quadriceps tendon rupture, patellar tendon rupture, or patellar fracture that could place them at risk of re-injury during quadriceps strength testing
* Pregnancy
Gastric Cancer Metastasized to the Central Nervous System (CNS)

Descriptive registry to investigate frequency of HER-2 positive gastric cancer involving CNS.

Exploration of additional prognostic factors for brain involvement from gastric cancer.

HER2 Status E-Cadherin Status

Eligibility Criteria:
Inclusion criteria:

* in order to be eligible for the study, the diagnosis of gastric cancer and/or lower esophageal cancer must be confirmed histologically. CNS involvement must be confirmed either via independent neuroradiological and/or positive CSF cytology.

Exclusion criteria:

* Patients whose diagnosis is not confirmed upon pathological review or where the CNS involvement cannot be confirmed after neuroradiological review will be excluded from this study.
Tetracycline (Doxycycline) and Post Myocardial Infarction Remodeling

The aim of the study is to assess the efficacy of an antibiotic treatment with tetracycline (doxycycline) in the early stage of large reperfused acute myocardial infarction (AMI), in preventing left ventricular (LV) remodeling.

A myocardial interstitial matrix, that provides structural support and integrity to the myocardium, is a key element to determine post infarction left ventricular remodeling (LVR).

The metalloproteinases (MMPs), an enzymatic system secreted in the extracellular medium by macrophages, has been shown to be able to degrade the most important extracellular matrix components.

Various animal experimental models have demonstrated that MMP specific inhibition in the first phase of myocardial infarction is able to contrast LVR. Doxycycline, a member of the tetracyclines, has been shown to block various inflammation mediators and to attenuate MMP-2 and MMP-9 expression and activity at a sub-antimicrobial dosage. Some experimental studies on rat models have suggested an anti-remodeling effect of doxycycline in myocardial infarction.

In the present study we want to evaluate if a treatment with doxycycline (100 mg b.i.d.) in the first seven days after a reperfused large (ejection fraction less than 40%) acute myocardial infarction, is effective in preventing six-month LVR.

Eligibility Criteria:
Inclusion Criteria:

* Acute myocardial infarction
* Left ventricular ejection fraction less than 40%

Exclusion Criteria:

* No written consensus
* Allergy to tetracycline
* Mechanical complication of AMI
* Previous myocardial infarction
* Valvular and/or myocardiopathy known or suspected
* Renal failure (creatinine above 2 mg/dL)
* Connective tissue disease
* Pregnancy
Study to Investigate the Effect of an Oral Diamine Oxidase Substitution (DAOsin) in Histamine Intolerant Patients on the Low Endogenous Diamine Oxidase Serum Activity

DAOsin is a food supplement for special medical purpose for the treatment of food intolerance provoked by histamine intake. In this uncontrolled, interventional pilot study the effect of an oral diamine oxidase substitution (DAOsin) on the reduced endogenous diamine oxidase activity in histamine intolerant patients will be examined.

Patients with a low endogenous diamine oxidase activity (below 10 Units/ml) take DAOsin for one month 3 times a day. During this month the diamine oxidase activity is tested biweekly. Afterwards a follow up period of one month without taking DAOsin follows. Again the diamine oxidase activity is tested biweekly.


Eligibility Criteria:
Inclusion Criteria:

* diamine oxidase activity \< 10 U/ml
* \>= 2 symptoms of histamine intolerance after consumption of histamine containing food
* 18 to 80 years
* no lactose intolerance
* no fructose intolerance
* no tissue transglutaminase antibodies in serum

Exclusion Criteria:

* pregnancy and nursing
* cardiopathy
* instable hypertonie
* asthma bronchial
* lactose intolerance, fructose intolerance, coeliac disease
* severe liver and kidney diseases
* Known food and other allergies
* participation in clinical study the last 4 weeks
* recent (3 months) operation affecting the gastrointestinal tract
* maligne, infectious or autoimmune gastrointestinal diseases (e.g. IBD)
* taking histamine liberating drugs on a regular basis
* taking diamine oxidase inhibiting drugs on a regular basis
* taking diamine oxidase supplements on a regular basis in the last 4 weeks
* H1 blocker or Montelukast Therapy 4 month before study start
* Taking anti histaminica
* Taking zinc preparations
* drug, alcohol, pharmaceutical abuses
* heavy smoking (\>15 cigarettes a day)
* Known HIV infection
* known acute or chronic hepatitis B and C infection
Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis (UC)

This study included two topics: one was to test the efficacy and safety of fecal microbiota transplants plus partial enteral nutrition (PEN) in refractory pediatric UC where conventional therapy has failed, and the other was to explore the efficacy and safety of FMT plus PEN as first-line therapy for pediatric active UC

Recent studies have suggested that gut imbalance and deregulation of immunological responses plays a pivotal role in the disease development of UC, and that FMT could be a useful treatment. In the refractory ulcerative colitis group, our study is aims to explore FMT plus PEN in the treatment of refractory pediatric UC. In the induction stage of UC, standard therapy remained unchanged, FMT and PEN treatment are added, and the investigators hope the withdrawal of conventional drug therapy was gradually reduced. Refractory UC is defined as refractory to standard therapy (e.g., steroids, immunomodulators, cyclosporine, tacrolimus, or anti-TNF agents).

As a first-line treatment group for UC, our study is aims to explore FMT plus PEN as a first-line treatment for active UC in children. participants treated with FMT coupled with PEN are defined as the FMT group, and those treated with PEN coupled with mesalazine served as the PEN group.

FMT treatment is given for at least one course of FMT treatment. If repeated FMTs are received, it is usually at a 2 month interval.

All the participants received PEN (80% of total calories as a polymeric diet, Peptamen, Nestle, Vevey, and Switzerland) intervention to help induce and maintain clinical remission.

Eligibility Criteria:
Inclusion Criteria:

age of older than 2 years and younger than 16 years with no genetic diseases; as a first-line treatment group for UC, newly diagnosed with mild-to-moderate UC (defined by the PUCAI of \>10 and≤64); In the refractory ulcerative colitis group, all refractory pediatric with mild-to-moderate UC (defined by the PUCAI of \>10 and≤64) defined by children who failed conventional treatment (hormone, immunosuppressant, biologics); agree to received regularly colonoscopy

Exclusion Criteria:

Children who were treated by PEN (80%) less than 8 weeks; As a first-line treatment group for UC, patients who were treated with corticosteroids, methotrexate, thiopurines, and anti-TNF agents as their first-line treatment; Known contraindication to all FMT infusion method such as nasoduodenal tube insertion, oesophago-gastro-duodenoscopy (OGD), enteroscopy, colonoscopy, enema and Fecal capsule; Unwilling to give informed consent/ assent
Bladder Perforation Post-TURBT: Definition, Incidence and Natural HistoryStudy

In view of sparse data of precise definition, risk factors, natural history and management of bladder perforation following Transurethral resection of bladder tumour (TURBT). We aim to correlate the relation between the site, depth and extent of resection with bladder perforation. Also, correlation between vertical depth, horizontal extent of resection and recurrence and progression of tumor


Eligibility Criteria:
Inclusion Criteria:

* papillary bladder tumor (denovo or recurrent)
* resectable nodular bladder tumor

Exclusion Criteria:

* Refuse to complete study requirements
* muscle invasive bladder tumor
In-vivo Wettability Grading and Assessment Study

The purpose of this study is to investigate the front surface wettability of soft contact lenses while on eye.


Eligibility Criteria:
Inclusion Criteria:

* is at least 17 years of age
* has read and signed an information consent letter
* is a current daily wear contact lens wearer
* has acceptable fit with the study lenses
* has had an ocular exam in the last two years
* other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* has any ocular disease
* has undergone corneal refractive surgery or is aphakic
* has any systemic disease affecting ocular health
* is pregnant or lactating
* other protocol-defined exclusion criteria may apply
An Efficacy Study of MORAb-009 in Subjects With Pancreatic Cancer

The purpose of this study is to investigate the activity of MORAb-009 when added to a standard regimen of gemcitabine in patients with previously untreated unresectable stage 3 or 4 pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Female or male subjects, ≥ 18 years of age, with cytologically or histologically confirmed diagnosis of pancreatic adenocarcinoma.
2. Must have measurable disease, as defined by RECIST or evaluable by clinical signs/symptoms (e.g. ascites, pleural effusion, or lesions of less than 2 cm) supported by biomarker, radiologic, or pathologic studies conducted within 4 weeks prior to study entry.
3. Must have unresectable disease and have received no prior chemotherapy or radiation therapy for their pancreatic cancer.
4. Karnofsky performance status of greater than or equal to 70 %.
5. Female subjects of childbearing potential and all male subjects must be surgically sterile or consent to use a medically acceptable method of contraception throughout the study period.
6. Other significant medical conditions must be well-controlled and stable in the opinion of the investigator for at least 30 days prior to Study Day 1.
7. Laboratory and clinical results within the 2 weeks prior to Study Day 1 as follows:

   Absolute neutrophil count (ANC) ≥ 1.5 x 109/L Platelet count ≥ 100 x 109/L Hemoglobin ≥ 9 g/dL Serum bilirubin ≤ 2.0 mg/dL Aspartate transaminase (AST)\* ≤ 5 x upper limit of normal (ULN) Alanine transaminase (ALT)\* ≤ 5 x ULN Alkaline phosphatase\* ≤ 5 x ULN Serum creatinine ≤ 2.0 mg/dL Stenting to reduce liver functions to qualifying levels is permitted.

   \* Subjects with liver function abnormalities greater than the ULN are eligible only if in the opinion of the investigator they are due to disease obstruction of the bile ducts or metastatic disease.
8. Must be willing and able to provide written informed consent.

Exclusion Criteria:

1. Known central nervous system (CNS) tumor involvement.
2. Evidence of other active malignancy requiring treatment.
3. Clinically significant heart disease (e.g., congestive heart failure of New York Heart Association Class 3 or 4 angina not well controlled by medication, or myocardial infarction within 6 months).
4. Electrocardiogram (ECG) demonstrating clinically significant arrhythmias (Note: Subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia \[SVT\], are eligible).
5. Active serious systemic disease, including active bacterial or fungal infection.
6. Active viral hepatitis or symptomatic human immunodeficiency virus (HIV) infection.
7. Prior chemotherapy or radiation therapy for their pancreatic cancer.
8. Breast-feeding, pregnant, or likely to become pregnant during the study.
9. No other concurrent immunotherapy (e.g., immunosuppressants or chronic use of systemic corticosteroids with the exception that low-dose corticosteroids are allowed)
10. Known hypersensitivity to a monoclonal antibody or biologic therapy.