cyrilzakka/clinical-trials huggingface dataset:
Effect of Electroacupuncture on Sepsis-induced Intestinal Dysfunction

1. Title: Effect of electroacupuncture on sepsis-induced intestinal dysfunction
2. Research center: single center
3. The Design of the study: Randomized, double-blind, controlled study
4. The population of the study: The patients over 18 years that met the criteria of sepsis3.0 and with AGI grade II or above are enrolled in the study
5. Sample size: Enroll 60 patients (30patients in each group)
6. Interventions: Participants in the treatment group underwent 60 minutes acupuncture (0.30mm×70mm) at ST36 (Zusanli) and ST37 (Shangjuxu) twice a day for seven days. After"Deqi",electroacupuncture stimulation apparatus (HANS G6805-2, Huayi Co, Shanghai, China) is connected and maintained the end of treatment.

   Participants in the control group received shallow needling (0.30mm×25mm) at ST36 and ST37(nonacupoints located 1 inch beside acupoints, about 20mm). Specifically, the depth of needle insertion into nonacupoints is 3-5mm and avoided manual stimulation and no "Deqi" without actual current output.
7. The aim of the research: To investigate the effect of electroacupuncture on sepsis-induced intestinal dysfunction.
8. Outcome# 1) Primary outcome: The intestinal function indicators including: 1) Clinical symptoms: bowel sounds, intra-abdominal pressure, time to first exhaust/defecation, daily tolerable enteral nutrition 2) Intestinal motility indicators: the levels of serum motilin and gastrin 3) Intestinal barrier indicators: the levels of serum diamine oxidase (DAO), D-lactic acid and I-FABP 2)Secondary outcome# Duration of mechanical ventilation in patients with endotracheal intubation on ICU admission; Length of stay in ICU and Length of stay in hospital; 30-day life quality and cognitive function after surgery; All-cause 28-day mortality.
9. The estimated duration of the study#1-2years.

This study is a randomized, double-blinded, placebo controlled and long-term follow-up design. In this study, ST36 (Zusanli) and ST37 (Shangjuxu) were selected for electroacupuncture treatment, accompanied with evaluating the effects on intestinal function in septic patients. Meanwhile, the blood biochemical indexes such as heme oxygenase-1(HO-1), PTEN induced putative kinase 1(PINK1), polo-like kinase 1(PLK1) and interleukin-6 are detected. To clarify the effect of electroacupuncture on sepsis-induced intestinal dysfunction is of great significance to the clinical applications and popularization of traditional acupuncture treatment across the world.

Eligibility Criteria:
Inclusion Criteria:

1. Meet the diagnostic criteria of sepsis 3.0
2. AGI grade II or above,
3. At least 18 years old
4. Volunteer to participate in this study and sign the informed consent form

Exclusion Criteria:

1. Patients with bowel dysfunction caused by other diseases or surgical operations
2. Those who have chronic gastrointestinal diseases such as Crohn's disease and ulcerative colitis
3. Those who have recently used gastrointestinal motility drugs and within 5 times the half-life
4. Those who are participating in other drug clinical trials
5. Refuse to participate in this study
The ATLANTA First in Man Study of the Catania Stent

To evaluate the short-term and mid-term safety and efficacy of the Catania coronary stent for the treatment of up to two de novo lesions in native coronary arteries.

This is a prospective, non-randomized, first-in-man single center study. The study requires a 55 patients with documented myocardial ischemia undergoing PCI.

Eligibility Criteria:
Inclusion Criteria:

* Lesion length ≤ 20 mm
* Vessel size ≥ 2.5 ≤ 3.5 mm

Exclusion Criteria:

* Life expectancy \< 1 year
* Left ventricular ejection fraction (LVEF) \<30%
* Anti-thrombotic drug intolerance
Micropulse Diode Laser Treatment for Chronic Central Serous Chorioretinopathy

The aim of this study was to evaluate safety and therapeutic response to micropulse diode 810nm laser treatment in patients with chronic central serous chorioretinopathy.

Most of the cases of central serous chorioretinopathy (CSC) recur spontaneously within three months of disease. After 3 months without resolution of acute CSC or in chronic CSC, continuous wave laser photocoagulation or photodynamic therapy should be considered. Direct threshold continuous photocoagulation treatment can shorten the duration of the serous detachment, but it is not appropriate for juxtafoveal or subfoveal leakage point.Subvisible photocoagulation potentially localizes and decreases chorioretinal thermic burn. Subthreshold diode micropulse (SDM) laser using a 810nm diode laser may spare the damage to the neural retina by raising the temperature of the RPE to just below the protein-denaturation threshold so that the thermal wave that reaches the neural retina is insufficient to cause neither damage nor clinically visible end-point. This therapeutic laser modality offers the possibility to minimize the iatrogenic retinal lesion.

Eligibility Criteria:
Inclusion Criteria:

* Chronic active central serous chorioretinopathy lasting more than 6 months
* Leakage at fluorescein angiogram

Exclusion Criteria:

* Opacities of the clear refractive media of the eye
* Any intraocular surgery within the 6 months prior to study entry
* Prior vitrectomy
Phase I Pilot Study of Gene Therapy for Cystic Fibrosis Using Cationic Liposome Mediated Gene Transfer

OBJECTIVES:

Determine whether copies of the cystic fibrosis gene (pGT-1) can be delivered to the cells lining the nose of cystic fibrosis patients using cationic liposome (DMRIE/DOPE) mediated gene transfer.

PROTOCOL OUTLINE: Under direct visualization, patients receive lipid/DNA formulation (pGT-1 lipid complex) by syringe instillation over 30 minutes to the right inferior nasal turbinate.

Patients are followed daily for 7 days, twice a week for 3 weeks, every 2-3 weeks for 10 weeks, then every 3 months thereafter.

Eligibility Criteria:
* Cystic fibrosis patients
* Not pregnant Fertile patients must use effective contraception
Safety and Performance of the Hexanium TLIF System in the Treatment of Degenerative Disc Disease

The goal of this observational study is to confirm the safety and efficacy of the Hexanium TLIF system in the treatment of skeletally mature patients suffering from degenerative disc disease (disease that occurs when the spinal disk break down).

Part of their standard of care, participants will be questioned on their back and leg pains, their disability and if they have encountered any adverse effects since the Hexanium TLIF system implant surgery. Those data will be collected up to twenty four (24) months after the Hexanium TLIF system implant surgery.

The Hexanium TLIF study is a multicentric, international, ambispective, post market clinical follow-up study. This means that either subjects already implanted with the Hexanium TLIF system (retrospective subjects) or subjects planned for treatment with the Hexanium TLIF (prospective subjects) can be enrolled in the study.

Standard of care subjects data up to twenty four (24) months post Hexanium TLIF system implant procedure will be collected; key data include back and leg Visual Analogue Score (VAS), Oswestry Disability Index (ODI) score, and adverse events.

Data will be collected at Month 2, Month 6, Month 12 and Month 24 post surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patient planned for Hexanium TLIF system implant or patient implant with Hexanium TLIF system (not prior to July 2021)
* Patient of 18 years old or more
* Patient has provided signed informed consent, or did not oppose to his/her data collection, per local regulation

Exclusion Criteria: contra-indication

* Infection, local to the operative site
* Signed of local inflammation
* Fever or leukocytosis
* Morbid obesity
* Pregnancy
* Paediatric cases, or patient still having general skeletal growth
* Spondylolisthesis unable to be reduced to Grade I
* Suspected or documented allergy or intolerance to metal
* Any case where the implant components selected for use would be too large or too small to achieve a successful result
* Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality
* Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance
* Prior fusion at the level to be treated
* Any case not needing a bone graft or fusion
* Any abnormality present which affects the normal process of bone remodelling including, but not limited to severe osteoporosis involving spine, bone absorption, osteopenia, primary or metastasis tumours involving the spine, active infection at the site or certain metabolic disorders affecting osteogenesis
* Any other condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumours or congenital abnormalities, fracture local to operating site, elevation of segmentation rate unexplained by other diseases, elevation of white blood count (WBC), or marked left shift in the WBC differential count
* Mental illness
* Any patient unwilling to cooperate with post-operative instructions
Efficacy and Safety of Sugammadex in High-Risk Ambulatory Surgeries

In this randomized controlled study, the investigators hypothesize that sugammadex is superior to neostigmine in higher risk patients undergoing laparoscopic outpatient surgery in an urban, stand-alone ambulatory surgery center.

The primary objective of this study is to evaluate the "fit to discharge time in the PACU." The secondary objectives are PACU adverse events, use of additional medications in the PACU, 0-30 day ED or inpatient admissions for a pulmonary diagnosis and patient satisfaction at discharge.

There is limited published data in the use of sugammadex for high-risk patient populations, such as those undergoing laparoscopic procedures in standalone outpatient surgery facilities. About 90% of the ambulatory surgical patient population at this institution is non-caucasian with the majority of the higher-risk patients having obesity and one or more additional chronic health conditions. In this randomized controlled study, the investigators hypothesize that sugammadex is superior to neostigmine in higher risk patients undergoing laparoscopic outpatient surgery in an urban, stand-alone ambulatory surgery center.

The primary objective of this study is to evaluate the "fit to discharge time in the PACU." The secondary objectives are PACU adverse events, use of additional medications in the PACU, 0-30 day ED or inpatient admissions for a pulmonary diagnosis and patient satisfaction at discharge.

In this double-blinded randomized controlled study, the study team is evaluating the efficacy and safety of sugammadex in patients undergoing ambulatory surgical procedures. Currently, both neostigmine and sugammadex are standard of care in this institution. Other than the emergent need for NMB reversal, practice preference and individual indications dictate the selection of reversal medication.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical score II and III
* Scheduled for a laparoscopic ambulatory surgery
* 21-60 years of age
* Able to understand and sign informed consent

Exclusion Criteria:

* Known allergy to neostigmine or sugammadex
* Active pulmonary diagnosis
* American Society of Anesthesia physical score 4 and above
* Known or suspected neuromuscular disease
* Documented renal or liver insufficiency (2 fold increase in the labs)
* Body Mass Index \>40
* Any surgical case brought into the operating room after 4 PM (to avoid any provider bias related to discharging patients before closure of the ambulatory surgery center for the day)
Mindful SensoriMotor Therapy With Brain Modulation in Highly Impaired Extremities

Brief summary: This single-arm, pilot clinical investigation aims to evaluate Mindful SensoriMotor Therapy (MSMT) enhanced with brain modulation as a treatment of pain due to sensorimotor impairment, such as Phantom Limb Pain (PLP). MSMT consists of consciously retraining the motor and sensory networks used by the missing limb via myoelectric pattern recognition and haptic feedback. In this trial, we further enhance the effect of MSMT by brain modulation, transcranial Direct Current Stimulation (tDCS).

People with upper or lower limb disarticulation (amputation at joint level) or nerve injury will participate in this study. It is a single-arm study in which all participants receive the same intervention. Each participant attends a screening visit, up to 5 baseline assessments, 15 interventions, and 3 follow-ups at 1, 3, and 6 months after the last intervention. Brain imaging will be performed pre- and post-treatment.

Eligibility Criteria:
Inclusion criteria

* The participant has given written informed consent to participate.
* The participant must have chronic neuropathic pain due to sensorimotor impairment (example PLP).
* At least six months should be passed since the date of injury (acute pain cases should not be included in the study).
* If the participant is under pharmacological treatments, there must be no variations on the medication dosages (steady consumption) for at least 1 month before the screening visit.
* If the participant has previously been treated for neuropathic pain, the last session of that treatment(s) must be at least 3 months before the screening visit.
* Any pain reduction potentially correlated to previous neuropathic pain treatments must have been observed at least 3 months prior to the screening visit, as reported by the participant.
* In the case of having a prosthesis, the participant must be in a stable prosthetic situation (i.e. satisfied with the fitting of the prosthesis or not using a prosthesis).
* Participants must have enough contact surface at the site of the amputation or the injured nerves for the system to work, in the researcher's opinion.
* Participants must be able to perceive the haptic stimulation at the time of the screening visit.
* Participants must not experience painful sensations from haptic stimulation in the stump (i.e. allodynia).
* The participant has a sufficient understanding of both Swedish and English to be able to participate in all study assessments, in the researcher's opinion.
* Participants should not have any other condition or symptoms that can prevent them from participating in the study, in the researcher's opinion.
* No mental inability, reluctance, or language difficulties that result in difficulty understanding the meaning of study participation, in the researcher's opinion.
* The participant should not have any condition associated with the risk of poor protocol compliance, in the researcher's opinion.

Exclusion criteria

- The potential participant will be excluded from the study if the person does not meet at least one of the inclusion criteria.
Inspiratory Muscle Training During Pulmonary Rehabilitation in COPD

Demonstrate that IMT associated with a conventional pulmonary rehabilitation program allows a significant improvement of dyspnea in subjects with severe or very severe COPD than a conventional pulmonary rehabilitation program alone.


Eligibility Criteria:
Inclusion Criteria:

* Patients with COPD stage 3 or 4
* Hospitalized in the pulmonary rehabilitation unit in the hospital of Morlaix, with a 3 weeks pulmonary rehabilitation course;

Exclusion Criteria:

* FEV ≥ 50%
* Pneumonectomy, Lobectomy less than 6 months
* Patient with risk of spontaneous pneumothorax or rib fracture
TACE Associated to Systemic Bevacizumab for the Treatment of Refractory Liver Metastases From Colorectal Cancer

Transarterial chemoembolization (TACE) is an effective, minimally invasive therapy that is widely used for unresectable colorectal cancer liver metastases (CRC-LM) treatment. Chemoembolization, however, induces a hypoxic micro-environment, which increases neo-angiogenesis, and may promote early progression. For this reason, efficacy may be improved by associating TACE with an angiogenesis inhibitor, such as bevacizumab.

The use of FOLFIRI associate to Bevacizumab is part of clinical practice and is commonly used for the therapy of patients with CRC-LM both wild type and mutant.

This case-control observational study aim to compare patients treated with TACE using Irinotecan-loaded embolics followed by systemic Bevacizumab versus patients treated with FILFIRI+ Bevacizumab

TACE is indicated for the treatment of unresectable CRC_LM, patients who are refractory to systemic chemotherapy, elderly, or have a poor performance status, and is usually performed using irinotecan (IRI) covalently loaded onto embolics.

Although chemoembolization with irinotecan-loaded embolics results in an objective response, this method creates a hypoxic micro-environment. Hypoxia induces and activates the HIF-1 and HIF 2 hypoxia-inducible transcription factors, which promote high-level VEGF expression and subsequent neo-angiogenesis.

This may provide a mechanism for early relapse and progression following TACE and strongly support a rational for following TACE therapy with a therapeutic inhibitor of angiogenesis, such as bevacizumab.

The use of FOLFIRI associate to Bevacizumab is part of clinical practice and is commonly used for the therapy of patients with CRC-LM both wild type and mutant.

This case-control observational study aim to compare patients treated with TACE using Irinotecan-loaded embolics followed by systemic Bevacizumab versus patients treated with FILFIRI+ Bevacizumab

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* \>18 years old;
* diagnosed with unresectable CRC-LM (for reasons of anatomy, co-morbidity, patient's wishes, lack of response to standard therapy with intravenous or oral fluoropyrimidine, oxaliplatin, irinotecan or biological agents (bevacizumab, cetuximab, panitumumab);
* Eastern Cooperative Oncology Group (ECOG) 0-1;
* measurable tumor size by mRECIST \[6\];
* ≤40% liver involvement;
* a life expectancy of at least 3 months,
* blood biochemistry within the normal range.

Exclusion Criteria:

* contraindication for angiographic catheterization;
* extensive extra-hepatic disease;
* pregnancy or breast-feeding,
* other severe clinical contraindications (e.g. liver failure, ascites, cardiovascular diseases and/or chronic obstructive pulmonary disease).
Optimisation of Primary HIV1 Infection Treatment(ANRS 147 OPTIPRIM)

The purpose of this trial is to assess the impact of raltegravir, maraviroc, darunavir/r, and Truvada® (emtricitabine/tenofovir) vs. darunavir/r and Truvada® on cell-associated HIV-DNA levels in patients with primary HIV-1 infection.

Primary HIV-1 infection is characterized by a phase of intense replication, with a quick dissemination and early changes in the immune system. During primary HIV-1 infection, damages to MALT and GALT promotes a chronic cell activation, which participates in a progressive decay of immune functions.

After HAART initiation, the magnitude and rapidity of cell-associated HIV-DNA decrease are significantly higher in patients with primary HIV-1 infection than in patients with chronic infection (Ngo Giang Huong, AIDS 2004).

We hypothesize that an early intervention at different levels of viral replication with potent and well-tolerated new drugs may have a greater impact on cell-associated HIV-DNA levels than conventional triple-drug HAART.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute or primary HIV-1 infection
* Acute infection: negative or slightly positive Elisa, with negative or incomplete western-blot (0 or 1 antibody) and positive HIV-RNA and/or positive Ag p24.
* Primary infection: positive Elisa with incomplete Western-blot (≥ 2 and \< 5 antibodies with the presence of anti-p24 antibodies associated with an anti-gp160 or an anti-gp120 or an anti-gp41antibody) and positive HIV-RNA.
* Symptomatic Primary infection or CD4 \<500/mm3
* written informed consent
* ≥ 18 years old

Exclusion Criteria:

* Prior post exposure antiretroviral treatment within six months before enrolment
* Pregnancy or breast-feeding
* HIV-2 infection
* Current malignancy
* Prothrombin time \< 50%
* Creatinine clearance \< 60 ml/min
* ASAT, ALAT or bilirubin ≥10\*N
* Platelets \< 25000/mm3
Finnish Imaging of Shoulder Study

In the Finnish Imaging of Shoulder study we will recruit 600 participants from a nationally representative general population sample. Participants aged 40 to 75 years will be invited to a clinical visit that includes assessment of general health, shoulder history and symptoms, and bilateral clinical examination and shoulder imaging (both plain radiography and MRI). We aim to assess the prevalence of abnormal imaging findings in both asymptomatic and symptomatic individuals and explore possible risk factors for abnormal imaging findings and shoulder symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory
* Participation in the Health 2000 Survey
* Informed Consent

Exclusion Criteria:

* Dementia
* Terminal Cancer
* Previous shoulder joint replacement
* Contraindications for MRI
Mechanical Bowel Preparation for Elective Colorectal Surgery

Mechanical bowel preparation (MBP) is common practice in elective colorectal surgery. In recent literature the value of MBP is subject of discussion. We conducted a multicenter, randomized study with the goal of comparing outcome of elective colorectal resections and primary anastomoses with and without mechanical bowel preparation in terms of anastomotic leakage and other septic complications.

Within the setting of a multicenter randomized trial,1433 patients were randomized before elective colorectal surgery to receive either MBP or to have no MBP but a normal meal on the day before operation. The primary endpoint was anastomotic leakage. Secondary endpoints were septic complications (wound infection, urinary infection, pneumonia, pelvic abscesses), fascia dehiscence and death.

The incidence of anastomotic leakage was similar in both groups: 5.1% in patients without MBP versus 4.9% in patients with MBP (p=0.93; 95% confidence interval for the difference (no MBP minus MBP) ranges from -2.3% tot +2.7%). There were no significant differences in other septic complications, fascia dehiscence, or mortality. Fecal contamination, number of days until resumption of a normal diet, and duration of hospital stay were similar in both groups.

This study shows that elective colorectal surgery can be safely done without MBP. Therefore, MBP should be abandoned in elective colorectal surgery.


Eligibility Criteria:
Inclusion Criteria:

The main inclusion criterion was elective colorectal surgery with primary anastomosis

Exclusion Criteria:

Exclusion criteria were an acute laparotomy, laparoscopic colorectal surgery, contraindications for the use of mechanical bowel preparation, an a priori deviating (ileo) stoma, and age less than 18 years old.
A Phase 4 Study to Assess the Effects of Aripiprazole Versus Other Atypical Antipsychotics in the Treatment of Schizophrenic Patients With Metabolic Syndrome

258 patients who have been treated for at least 3 months with oral olanzapine, risperidone or quetiapine in the treatment of schizophrenia and currently presenting with metabolic syndrome, will be randomized to: i) aripiprazole for 16 weeks, with flexible dosing within a range of 10 to 30 mg once daily (QD); or ii) continue for 16 weeks on the same atypical antipsychotic treatment prior to the study enrollment.


Eligibility Criteria:
Inclusion Criteria:

Patients:

* with schizophrenia being treated with olanzapine, risperidone, or quetiapine for at least 3 months
* with diagnosis of metabolic syndrome
* not treated for 1 of the parameters of metabolic syndrome