cyrilzakka/clinical-trials huggingface dataset:
Stepwise for the Treatment of Lateral Incisional Hernias

The best approach for lateral incisional hernia is not known. Posterior component separation (reverse TAR) offers the possibility of using the retromuscular space for medial extension of the challenging preperitoneal plane.

The main objective of the study was to describe the surgical techniques used and their outcomes in the open lateral approach for the treatment of L3-L4 European Hernia Society (EHS) classification Incisional hernias, comparing the results between reverse TAR and pure lateral retromuscular preperitoneal, and analyzing the short- and long- term complications, including patient-reported outcomes measures (PROMs).

The study report followed the recommendations for reporting outcomes in abdominal wall hernias, and the new international classification of abdominal wall planes (ICAP).

A multicenter retrospective observational study was conducted using a prospectively maintained database from three university hospitals in Spain specialized in complex abdominal wall reconstruction. All patients undergoing open abdominal wall repair through the previous lateral incision for L3-L4 IHs between February 2012 and January 2020 were identified. All patients were operated on by the senior surgeons responsible for the complex abdominal wall units of each participating center. Prior to conducting the study, the approval of the local ethics committee was obtained (ID:39/2019). Written informed consent was also obtained.

The diagnosis of IH was based on clinical examination and imaging from a computed tomography (CT). The investigator only included patients with L3-L4 IHs. Patients with primary lateral hernias, such as Spiegel, Grynfelt and Petit hernias were excluded. We also excluded all patients in which the lateral IH was a parastomal hernia.

Demographic data, patient comorbidities, different classifications of hernia complexity, Carolinas Equation for Determining Associated Risks (CeDAR) and intraoperative and postoperative data were collected All patients followed a similar preoperative optimization program, which included endocrinologic and nutritional evaluations, respiratory physiotherapy, and abstinence from smoking at least 1 month before surgery. Weight loss was extremely recommended but without any mandatory prerequisite.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a lateral incisional hernia L3 European Hernia Society classification
* Patients with a lateral incisional hernia L4 European Hernia Society classification
* Patients older than 18 years old

Exclusion Criteria:

* Midline incisional hernia.
* Patients with a parastomal hernia
* Patients with a primary midline ventral hernia
* Patients with a primary lateral hernia.
* Age under 18 years old
Urinary Symptoms After Posterior Tibial Nerve Stimulation

Overactive bladder (OAB) is a common syndrome affecting 7 million people in France, very often of idiopathic origin.

Current therapeutic management of OAB primarily involves hygiene and diet rules, patient education, behavioral measures with bladder reprogramming or even perineo-sphincter rehabilitation. However, the modalities of this conservative non-drug treatment are poorly defined and there is uncertainty as to their effectiveness.

In the event of persistent symptoms, the management of OAB is essentially based on the prescription of an anticholinergic medication. The effectiveness of anticholinergics has been established through numerous randomized clinical trials and meta-analyses. But the side effects of anticholinergics are known and some are very common (particularly dry mouth and constipation).

The principle of the posterior tibial nerve stimulation (TNS) by implanted (percutaneous) or adhesive (transcutaneous) electrode is to stimulate the sensory afferent pathways and to ensure negative feedback on the bladder. Posterior tibial nerve stimulation is a non-invasive therapeutic alternative that has demonstrated its effectiveness through numerous clinical studies mainly using a device for percutaneous use with a weekly stimulation session.

TNS is also possible transcutaneously (TENS) with daily 20-minute stimulation of the ankle, in the form of a self-administered treatment at home, over a period of 3 months. This treatment modality seems equivalent to the percutaneous approach.

Given its numerous advantages, the use of TENS is therefore expanding, and is currently recommended by many learned societies (SIFUD, AFU).

In this study, we wish to evaluate the TENSI+ medical device which uses transcutaneous posterior tibial nerve stimulation and which is offered in routine practice to patients with idiopathic or neurological overactive bladder.


Eligibility Criteria:
Inclusion Criteria:

* women over 18
* patients who have benefited from treatment with the TENSI+ device in the context of overactive bladder
* intervention between April 2023 and February 2024
* person having expressed his non-opposition

Exclusion Criteria:

* inability to understand the information given
* person deprived of liberty
* person under guardianship
Tracheostomy in ICU With a Double Lumen Endotracheal Tube

Percutaneous tracheostomy in Intensive care unit (ICU) is performed with the use of flexible fiberoptic bronchoscope inside the conventional single lumen endotracheal tube owned by the patients. This situation may lead to many disadvantages for ventilation and airway protection of critically ill patients during the procedures. The use of double lumen endotracheal tube dedicated to the percutaneous tracheostomies may:

1. improve the ventilation of patients during the procedure,
2. protect the posterior tracheal wall from damage related to the different step of tracheostomies,
3. protect the lungs from blood and secretions coming down from the chosen site of tracheostomy.

So the aim of this study is to evaluate the oxygenation, gas exchange, ventilation and complications of percutaneous tracheostomies performed in ICU with a dedicated double lumen endotracheal tube.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years and at least one of following criteria:
* prolonged endotracheal intubation
* prolonged mechanical ventilation
* difficult/prolonged weaning
* inability to protect the airway

Exclusion Criteria:

* infection of neck tissues
* previous surgical neck interventions
* recent surgical interventions or fracture of the cervical spine
Effect of Probiotics Consumed During Pregnancy on the Incidence of Mastitis

The aim of the present study is to evaluate the effect of consumption during pregnancy and the lactation period of the probiotic L. fermentum CECT5716 on the incidence of mastitis.

Bacterial load and immunological parameters in breast milk, parameters related to breastfeeding as well as health parameters of the mother and baby will also be evaluated.

Pregnancy and lactation are important moments for the child that will determine their development and future health. One of the key processes is when the microbiota is established in the baby. Contamination during delivery with the mother's vaginal flora, as well as bacteria from the microbiota of breast milk, are important sources for intestinal colonization. However, the mother's microbiota can suffer alterations that affect the health of the mother and can also have an effect on the baby.

Mastitis is a condition of the mammary gland that can affect between 3-30% of women during the period of lactation and is the first cause of abandonment of it. It is associated with a dysbiosis with the proliferation of microorganisms in milk such as Staphylococcus and Streptococcus.

Previous studies carried out with the strain L. fermentum CECT5716 have demonstrated a powerful regulating activity of the microbiota of breast milk that translates into a preventive and curative effect on mastitis. The highest incidence of mastitis occurs during the first weeks after delivery, so the investigator's working hypothesis is that the modulation of the maternal microbiota before delivery would improve the effectiveness of the probiotic strain consumption.

Eligibility Criteria:
Inclusion Criteria:

* Normal development of pregnancy
* Single fetus pregnancy
* Be in week 28-32 of pregnancy
* Intention to breastfeed the child for 16 weeks

Exclusion Criteria:

* Having a breast disease that hinders or prevents breastfeeding
* Have been taking probiotic supplements 2 weeks before starting the study
* Have a low expectation of adherence to the study protocol
Effects of High Frequency rTMS Combined Motor Learning on Upper Limb Motor Function in Subacute Stroke

This study is to present the effect of a program combining high frequency repetitive transcranial magnetic stimulation with motor learning on upper limb motor function and grip strength and activities of daily motion in patients with subacute stroke.

Purpose : This study was to investigate the effects of high frequency repetitive transcranial magnetic stimulation combined with motor learning effects motor function and grip force for upper limbs and activities of daily living of subacute stroke patients.

Subjects : Thirty individuals with subacute stroke, satisfying the selection criteria, were selected for this study. Subject were randomly allocated into 14 high frequency repetitive transcarnial magnetic stimulation+motor learning group(experimental group), 16 sham repetitive transcranial magnetic stimulation+motor learning group(control group).

Intervention : 12 sessions, 3d/wk, 4week Studies : upper limb functional assessment(FMA-U/L, BBT), hand grip force assessment(disital hand dynamometer), activities daily of living assessment(K-MBI) Evaluation : 1)pre test 2)post test


Eligibility Criteria:
Inclusion Criteria:

* Hemiplegia from stroke
* Factors within six months of onset
* Found to have subcortex damage through diagnoses of magnetic resonance imaging(MRI)
* Had motor defects on the damaged upper extremities
* Korean version Mini mental state examination(MMSE-K) score greater than 24 points

Exclusion Criteria:

* Permanent damage such as heart vein
* Upper limb fractures
* Neurological damage such as Parkinson's, multiple sclerosis
* Other reasons limiting upper limb movement
* Epilepsy or family history of epilepsy
* wearing a metal tube in skull or pacemaker
* The lesion at occipital lobe
Directly Observed Hepatitis C Treatment in Methadone Clinics

Drug users account for a disproportionately large burden of hepatitis C virus (HCV) infection. However, HCV treatment adherence rates in drug users may be suboptimal in patients who use drugs regularly during HCV treatment. Because HCV treatment is most effective when patients adhere to at least 80% of the prescribed treatment regimen, interventions to improve HCV treatment adherence need to be developed and evaluated. The investigators designed the HCV DOT trial to test the efficacy of two versions of modified directly observed HCV therapy provided on-site at a methadone clinic. The primary objective of this trial is to determine whether enhanced DOT with both pegylated interferon alfa-2a plus ribavirin (PEG/RBV-DOT) is more efficacious than standard DOT with weekly provider-administered pegylated interferon (PEG-DOT) and self-administered ribavirin for increasing adherence and improving HCV treatment outcomes. The investigators hypothesize that PEG/RBV-DOT is associated with increased adherence and rates of sustained viral response compared with PEG-DOT.


Eligibility Criteria:
Inclusion Criteria:

* HCV-infected
* receive HCV medical care at the methadone clinic
* plan to initiate HCV treatment on-site within the next 3 months
* psychiatrically stable as determined by HCV treatment provider and/or on-site psychiatrist
* attend the methadone clinic between three and six days per week to receive methadone
* stable dose fo methadone for two weeks prior to the baseline visit

Exclusion Criteria:

* unable or unwilling to provide informed consent
* currently receiving HCV treatment
* primary HCV care provider does not agree to their participation in the trial
* psychiatrically unstable
Compression Treatment Effects on Complications and Healing of Achilles Tendon Rupture

This prospective randomized study aims to determine whether intermittent pneumatic compression (IPC), 75 patients, beneath functional bracing compared to treatment-as-usual in plaster cast, 75 patients, can reduce the Venous Thromboembolism (VTE) incidence and promote healing of sutured acute Achilles tendon ruptures.

At two weeks post surgery, the IPC intervention will be ended and both patient groups will be immobilized in an orthosis until follow-up at six weeks.

The endpoint of the first part of the study is VTE events. The primary outcome will be the DVT-incidence at two weeks, assessed using screening compression duplex ultrasound (CDU) by two ultrasonographers masked to the treatment allocation. Secondary outcome will be the DVT-incidence at 6 weeks.

1) Deep Vein Thrombosis (DVT) detected by CDU , 2) isolated calf muscle vein thrombosis (ICMVT) detected by CDU, 3) symptomatic DVT or ICMVT detected by CDU, 4) symptomatic pulmonary embolism detected by computer tomography.

The endpoint of the second part of the study is tendon healing quantified at 2 weeks by microdialysis followed by quantification of markers for tendon repair.

The endpoint of the third part of the study is the functional outcome of the patients at one year post-operatively using four reliable and valid scores, i.e. the Achilles tendon Total Rupture Score (ATRS), Physical Activity scale (PAS), Foot and Ankle Outcome Score (FAOS) and EuroQol Group's questionnaire (EQ-5D) as well as the validated heel-rise test.

The incidence of DVT after Achilles tendon rupture is as high as 30-40% and patients exhibit a prolonged healing process with variable outcome. Moreover, it has been demonstrated that low molecular weight heparin had no effect on preventing DVT after Achilles tendon surgery. Whether intermittent pneumatic compression (IPC) can prevent DVTs and improve healing after Achilles tendon rupture has to our knowledge not been tested before.

Eligibility Criteria:
Inclusion Criteria:

* Achilles tendon rupture operated on within 96 hours of diagnose.

Exclusion Criteria:

1. Inability or refusal to give informed consent for participation in the study
2. Ongoing treatment with anticoagulant therapy
3. Inability to comply with the study instructions
4. Known kidney disorder
5. Heart failure with pitting oedema
6. Thrombophlebitis
7. Recent thromboembolic event (during the preceding 3 months)
8. Recent surgery (during the preceding month)
9. Presence of known malignancy
10. Current bleeding disorder
11. Pregnancy
Rollover Study for Continuing NBI-98854 Administration in Pediatric Subjects With Tourette Syndrome

This is an open-label, rollover study to collect long-term safety, tolerability, and investigator- and participant-reported pharmacodynamic (PD) data after chronic administration of NBI-98854 in pediatric participants with Tourette Syndrome (TS), as well as to provide open-label access to NBI-98854 for the treatment of TS for pediatric participants who have taken part in a Phase 2 NBI-98854 study.


Eligibility Criteria:
Inclusion Criteria:

1. Have a clinical diagnosis of Tourette Syndrome (TS)
2. Have participated in the NBI-98854-TS2004 or NBI 98854-TS2005 Phase 2 studies
3. If using maintenance medication(s) for TS and/or TS spectrum diagnoses (e.g. obsessive-compulsive disorder \[OCD\], Attention-Deficit Hyperactivity Disorder \[ADHD\]), be on stable doses
4. Be in good general health
5. Subjects of childbearing potential who do not practice total abstinence must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment and follow-up periods of the study

Exclusion Criteria:

1. Have an active, clinically significant unstable medical condition within 1 month before screening
2. Have a known history of long QT syndrome or cardiac arrhythmia
3. Have a known history of neuroleptic malignant syndrome
4. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed)
5. Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors
6. Have a blood loss ≥250 mL or donated blood within 56 days, or donated plasma within 7 days, before the start of the study
7. Have a known history of substance dependence, substance (drug) or alcohol abuse within 3 months before the start of the study
8. Have a significant risk of suicidal or violent behavior
9. Have received an investigational drug within 30 days before the start of the study or plan to use an investigational drug (other than NBI-98854) during the study
10. Are currently participating in another NBI-98854 clinical study
11. Are pregnant (for females)
Exploring the Safety and Efficacy of Low-dose Ketamine Infusions for Pain Control in Acute Burn Injury

The purpose of this study is to identify the optimal dosing strategy for low-dose ketamine infusions in adult acute burn injury patients when used with usual pain medications.

This Aim will identify the safest and most optimal dosing strategy for low-dose ketamine infusions. While the hourly rate for low-dose ketamine infusions used for adjunctive analgesia appears to be well-established both in the medical literature and our institutional protocols, there is no information available for this specific population of patients (adult acute burn injury) to know whether the infusions should be utilized for discrete periods of time or should be given continuously. Findings from this study will help provide preliminary data on the optimal dosing strategy of this medication for adjunctive analgesia in this population.

Eligibility Criteria:
Inclusion Criteria:

* Acute burn injury comprising 10-30% of total body surface. Burns severity may include second or third degree burns
* Burn injury must have occurred within 72 hours of enrollment and randomization
* Subjects may be opioid-naïve or opioid non-naïve
* Anticipated stay in the burn unit is greater than 4 days, which is typically the minimum length of stay for patients with this level of burn injury

Exclusion Criteria:

* Burn injury older than 72 hours
* Acute burn injury comprising \>30% total body surface
* Patients who are intubated
* Patients who have contraindication to ketamine administration
The Effect of Digital Breast Tomosynthesis in Breast Cancer Long-term Survival: a Single Institution Study

To investigate whether digital breast tomosynthesis (DBT) benefits survival improvement.

To suggest DBT for specific populations, compare the overall survival rate of women with digital mammography (DM) to the DBT screening for women with particular characteristics.

Eligibility Criteria:
Inclusion Criteria:

* individuals were diagnosed with breast cancer according to the International Disease Classification Criteria

Exclusion Criteria:

* no surgery or incomplete surgical pathology stage
* complete remission after neoadjuvant chemotherapy
* non-breast cancer death
* bilateral breast cancer
* male breast cancer
* no pre-surgery mammography image
Open Dialogue About Complementary Alternative Medicine (CAM) Integrated in Conventional Oncology Care

The purpose of this phase two parallel-group randomized controlled trial is to assess the efficacy of open dialogue about CAM integrated in conventional oncology care. The investigators hypothesize that patients in the intervention group participating in a scheduled open dialogue with a nurse specialist about CAM will experience better physical and mental health compared to patients in the control group receiving standard care alone.

Patients randomized to the intervention group will participate in a scheduled open dialogue about CAM with a specialist nurse, who has completed the Fellowship in Integrative Medicine at the University of Arizona. This is a training program for health professionals in empowering individuals and communities to optimize health and well-being through evidence-based, sustainable and integrative approaches. The open dialogue will be based on the fundamentals of person-centered care according to this program and include patient preferences and wishes, reliable information and counselling and advice about the potential risks and benefits of using CAM as an adjunct to conventional oncology care.

All dialogue, each lasting approximately 60 minutes, will be conducted by the same nurse as soon as possible and at the latest two weeks after enrolment. According to patient needs and wishes there may be a follow-up dialogue over the telephone or in the Oncology Outpatient Clinic. The potential second dialogue is estimated to last approximately 30 minutes.

Participants in the control group will receive standard information including reference to www.KABcancer.dk, which is a website presenting research on CAM, including information about its potential effects and outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or more
* Speaks and reads Danish
* Diagnosed with a new primary cancer or a relapse of cancer within the last 3 months
* Planned or initiated medical oncology treatment at the Department of Oncology, Vejle Hospital
* At least two months of oncology treatment is realistic based on clinical assessment
* Life expectancy of at least six months
* Informed consent

Exclusion Criteria:

-Participation in other trials
Early Administration of Vitamin C in Patients With Sepsis or Septic Shock in Emergency Departments

In this clinical trial the effect of early administration of Vitamin C is investigated in patients admitted at the emergency department with sepsis or septic shock.

When a patient has sepsis, his/her body is causing damage to its own tissues and organs as result of an infection. This can lead to septic shock. The patient has a low blood pressure, his/her organs stop working and the patient may even die.

The aim of this trial is to investigate the efficiency of Vitamin C in sepsis and septic shock. Vitamin C is a vitamin present in various foods and has been approved as dietary supplement by the Belgian authorities. Over the years it has been proven that Vitamin C is very safe. In addition, several studies have shown that Vitamin C can also have a protective effect. It can reduce organ damage and increase survival rates. Although several studies suggest that Vitamin C can help fight sepsis, it is not yet used in practice. This Belgian trial, in which several hospitals participate, hopes to provide a clear answer to the question: "Should Vitamin C be administered to patients admitted in an emergency department with sepsis or septic shock?"


Eligibility Criteria:
Inclusion Criteria:

* Patient has a 'suspected infection': this requires the combination of antibiotic administration and body fluid cultures within the first 6 hours after Emergency Department presentation.
* Patient has a NEWS score ≥ 5.

Exclusion Criteria:

* Patient (≥18 years old) or legally authorized representative didn't provide informed consent. Delayed informed consent can be applied in cases where the patient is critically ill and no LAR is available.
* antibiotic administration as a single dose or as a prophylactic treatment.
* antibiotics administered without an accompanying body fluid culture according to the timeframe (within 6 hours after emergency department presentation).
* 'Do no intubate' or 'comfort measures only' status.
* Failure to randomize within 6 hours after Emergency Department presentation.
* Weight \< 45 kg.
* Pregnant or breastfeeding.
* Known allergy for Vitamin C.
* Known history of oxalate nephropathy or hyperoxaluria.
* Known history of glucose-6-phosphate dehydrogenase deficiency.
* Known history of chronic iron overload due to iron storage and other diseases.
* The patient is already on IV steroids for a reason other than septic shock.
* Proven active COVID-19 infection (positive swab and/or CT scan positive for COVID-19 within 14 days prior to or at ED presentation).
* Participation in an interventional trial with an investigational medicinal product (IMP) or device