cyrilzakka/clinical-trials huggingface dataset:
A Study Comparing Laparoscopic/Robotic Stoma Reduced-Port Fusion Surgery with Traditional Surgery in Patients with Temporary Ileostomy

The traditional positioning and surgical methods for temporary ileostomy no longer meet the requirements of minimally invasive surgery: (1) Conventional stoma positioning often leads to the trocar incision being too close to the stoma site, increasing the risk of baseplate leakage and skin infection. (2) Since stoma positioning is required to be within the rectus abdominis, the proximity between the stoma and auxiliary incision can heighten difficulties in stoma bag attachment and raises the risk of fecal leakage. (3) Stoma retraction surgery within the rectus abdominis is more traumatic and complex. We introduce for the first time a modified stoma positioning and surgical method, termed Reduced-Port Fusion Surgery. This technique includes preoperative trocar/stoma fusion positioning and intraoperative trocar/stoma fusion surgery. The procedure is based on the 3R principles: Reposition - the stoma is repositioned within the Joint Trocar/Stoma Zone, allowing for more lateral placement to meet surgical needs without being confined to the rectus abdominis. Reduce Port - the same fusion point is used for both trocar insertion and stoma creation, enabling dual use of one site. Recognize - surgeons participate in stoma positioning, recognize the positioning, and follow the procedure. This prospective, randomized, parallel-controlled clinical study aims to evaluate whether Reduced-Port Fusion Surgery can reduce stoma-related complications, postoperative pain, improve quality of life, and facilitate stoma retraction surgery compared to traditional methods. A total of 80 participants will be randomly assigned in a 1:1 ratio. The experimental group will undergo Reduced-Port Fusion Surgery while the control group will receive traditional surgery.


Eligibility Criteria:
Inclusion Criteria:

1. After preoperative evaluation, patients scheduled for laparoscopic/robotic colorectal surgery (rectum, sigmoid colon, left colon) who are planned to undergo prophylactic ileostomy.
2. No serious systemic infection or immunosuppression.
3. Over 18 years of age.
4. Eastern Cooperative Oncology Group Performance Status: 0-1
5. The expected survival time \> 6 months.
6. The subjects voluntarily participate and sign the informed consent

Exclusion Criteria:

1. Any skin infectious diseases in the abdominal wall.
2. Use hormones and immunosuppressive drugs within 1 month before surgery.
3. The time between operation and the last chemotherapy was less than 1 month.
4. Any previous ostomy surgery.
5. Any serious active infection or uncontrollable infection that requires systematic treatment.
6. A clear history of neurological or psychiatric disorders.
7. Subjects may not be able to complete the study for other reasons.
Multisite Pacing With a Quadripolar Lead

The purpose of this study is to evaluate the effects of multisite left ventricular (LV) biventricular (BiV) pacing on LV hemodynamics in CRT patients. It is hypothesized that the effect of simultaneous BiV pacing utilizing multisite LV pacing on LV hemodynamics will be superior to conventional BiV pacing.


Eligibility Criteria:
Inclusion Criteria:

* Have a scheduled CRT implantation at the participating clinical study site
* Have NYHA functional class III or IV, ejection fraction less than or equal to 35%, and QRS duration greater than 120ms
* Be undergoing a new St. Jude Medical CRT-D device system (including LV lead) implantation
* Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed perioperative evaluations

Exclusion Criteria:

* Have persistent or permanent atrial fibrillation
* Have an intrinsic heart rate of \<50 beats per minute
* Have a recent myocardial infarction within 40 days prior to enrollment
* Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures
* Have had a recent CVA or TIA within 3 months prior to enrollment
* Have had intravenous inotropic support in the last 30 days
* Have ischemic etiology and are unable to tolerate stress echocardiography
A Low-osmolaric Glucose Polymer Drink for Gastric Distress and Running Performance

The objective of this study is to investigate whether two newly developed sports drink will affect gastric distress (GD) and running performance (RP) compared to an iso-caloric control drink both in a short and longer distance run. Furthermore, the effect of the newly developed sports drinks on gastric emptying will be investigated.

The study will consist of 3 parts. Firstly, a randomized cross-over design is used for the short distance run and the effects on GD and RP. Secondly, a parallel design is used to study the effects of the drinks on GD and RP during a longer distance run. Thirdly, the gastric emptying tests will be performed in a randomized cross-over design. Participants will be asked to fill in questionnaire on the gastric distress they experience. 40 participants will be enrolled to participate in part 1 and part 2. 10 out of 40 will participate in part 3 of the study.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 35 years
* A BMI between 18.5 and 25 kg\*m-2
* Intermediate level runners with at least 1 year of running experience, performing moderate to intensive running exercise consistently (two or more times per week for a minimum of 30 minutes each time)

Exclusion Criteria:

* Pregnancy
* Having diseases, such as diabetes, kidney, liver, lung, or bowel disease, cardiovascular disease, or mental illness
* Abuse of alcohol (\>20 alcoholic consumptions per week)
* Use of medication and/or drugs
* Smoking/having smoked in the last six months
* Participating in any scientific intervention providing a treatment potentially interfering with this study's treatment (to be decided by the researchers)
* Allergic to one of the components present in the drinks, including milk (incl. lactose), soy and gluten
A Dose Finding Study of Debio 4228 in Participants With Locally Advanced/Metastatic Prostate Cancer

The primary purpose of this study is to determine the pharmacokinetics (PK) and pharmacodynamics (PD) of Debio 4228.


Eligibility Criteria:
Inclusion Criteria:

1. Participant with histologically confirmed locally advanced/metastatic prostate cancer
2. Participant judged by the Study Investigator to be candidate for continuous androgen deprivation therapy (ADT)
3. Baseline morning serum testosterone levels \>150 ng/dL at screening visit
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
5. Life expectancy of at least 6 months
6. Adequate bone marrow, hepatic, and renal function at the screening visit

\[Note: Other protocol and subprotocol-defined criteria apply\]

Exclusion Criteria:

1. Previous ADT (neoadjuvant or adjuvant hormonal therapy) for ≥6 months duration and \<6 months treatment-free interval before start of screening
2. Indication for androgen deprivation combination therapy
3. History of bilateral orchiectomy, adrenalectomy, or hypophysectomy
4. Received chemotherapy or cryotherapy within 8 weeks prior to the start of screening for the treatment of prostate cancer
5. Abnormal cardiovascular function or diabetes
6. Use of exogenous testosterone within 6 months before the start of screening
7. Major surgery within 4 weeks before the start of screening
8. Cancer disease within the last two years except for prostate cancer and some skin cancers

\[Note: Other protocol and subprotocol-defined criteria apply\]
Study on the Safety of Risperidone on Obese or Overweight Patients With Schizophrenia

The purpose of this study is to evaluate the safety of risperidone treatment in patients who are overweight and/or obese.

This is an observational, multicenter, open and prospective study. The primary objective is to evaluate safety of risperidone in patients who are overweight and/or obese. It is expected to enroll 1500 patients with Schizophrenia or Schizoaffective disorder, in which physicians considered the use of risperidone as treatment under clinical practice with a BMI (Body Mass Index) \>25, or for patients that have increased their body weight \>7% in the last year with the previous treatment (even with a BMI\< 25), and for patients that have shown intolerance to a previous antipsychotic treatment. The study drug is risperidone, 3-6 mg per day, orally, during the study period (6 months). All data collected will be prospective and will include the following: demographic data, psychiatric history and comorbidities, concomitant treatment, body weight, treatment history , other illness related to obesity ( such as diabetes mellitus I \& II, hypertension and hypercholesterolemia) and adverse events. Observational Study: Risperidone, 3-6 mg per day, orally, during the study period (6 months).

Eligibility Criteria:
Inclusion Criteria:

* Patients with Schizophrenia or Schizoaffective disorder, in which physicians considered the use of risperidone as treatment under clinical practice with a BMI \>25
* Patients have increased their body weight \>7% in the last year with the previous treatment even with a BMI\< 25
* Patients that have shown intolerance to a previous antipsychotic treatment

Exclusion Criteria:

* Pregnant or lactating patients
* Patients with psychiatry pathology other than Schizophrenia or schizoaffective disorder
* Patients with neurology pathology except Parkinsonism induced by neuroleptics
* Patients with other severe concomitant pathology
* Patients treated with Risperidone in the last 30 days.
Qualitative and Quantitative Evaluation of Vascular Flows of Radial, Ulnar and Interdigital Arterial Trees Under Normal and Pathological Conditions by 3 Tesla MRI

Allotransplants of vascularized composite tissues are subject to chronic vascular rejection, which can lead to graft loss. Currently, no imaging technique allows a reproducible quantitative exploration of the arterial trees of the hand, and therefore a satisfactory monitoring of transplants. Since 2014, flow MRI has been applied to the analysis of small-calibre arteries by the Image Processing Team at the Amiens-Picardie University Hospital. Between 2015 and 2017, several acquisitions were made in 3 patients who received facial allotransplantation, and the team recently developed a flow MRI protocol dedicated to the study of arterial trees in the hand.

The main objective is to measure vascular flows of radial, ulnar and interdigital arterial trees in normal (healthy volunteers) and pathological situations (patients with radial forearm flap reconstruction and patients with hand allotransplantation) using the specifically developed flow MRI protocol.


Eligibility Criteria:
Inclusion Criteria:

* Adult (≥ 18 years old)
* patients who has received appropriate information and provided informed consent
* patients benefiting from social security insurance
* patients with no contraindications to magnetic resonance imaging
* healthy volunteer or patient requiring radial forearm flap reconstruction or having received hand allotransplantation.

Exclusion Criteria:

* Person with a contraindication to MRI
* pregnant or breastfeeding woman
* minors (\< 18 years)
* person under guardianship or deprived of liberty by a judicial or administrative decision
* person with upper limb arteriopathy with the exception of the hand transplant patients group.
Training Given to Mothers With Physically Disabled Children

Although there are many studies evaluating the effects of earthquakes and earthquakes on humans in our country and in the world, studies evaluating the effects of earthquakes on children with physical disabilities and parents of children with physical disabilities are limited. It is reported that the psychological resilience levels of mothers with disabled children and their level of preparedness for disasters (earthquake, flood, etc.) are low. For this reason, it is important to raise awareness about earthquake preparedness in mothers. This study aims to evaluate the effect of earthquake preparedness training to be given to parents with physically disabled children on the psychological resilience and disaster preparedness levels of mothers.

Earthquakes are recognized as one of the most destructive disasters that cause many people to lose their lives in the world and in Turkey. Due to earthquakes, societies can be exposed to serious economic, social, physical and psychological effects. It has been stated that the most vulnerable members of society are the elderly, children and the disabled. As a matter of fact, it is obvious that the most vulnerable individuals in earthquakes are disabled people with special needs. It was stated that both being a child and being disabled in earthquakes significantly increases vulnerability. In addition, when the studies are examined, it is stated that parents with disabled children are disadvantaged in terms of quality of life, care burden, psychological, economic and social aspects. It has been reported that the disadvantages of parents with physically disabled children increase in earthquakes and they need support in many areas.

Although there are many studies evaluating the effects of earthquakes and earthquakes on humans in our country and in the world, it is seen that studies evaluating the effects of earthquakes on children with physical disabilities and parents of children with physical disabilities are limited. There are studies in which the psychological resilience levels of mothers with disabled children and their readiness levels for disasters (earthquake, flood, etc.) are low. The aim of this study was to evaluate the effect of earthquake preparedness training to be given to parents with physically disabled children on the psychological resilience and disaster preparedness levels of mothers.

Eligibility Criteria:
Inclusion Criteria:

* Having a physically disabled child,
* Literate mothers
* Willing to participate in the study voluntarily,
* The mother who will participate in the study does not have any physical and psychological disorders,
* Mothers who were open to communication were determined as inclusion criteria.

Exclusion Criteria:

* No children with physical disabilities,
* Illiterate,
* Mothers with any physical or psychological illness,
* Mothers who did not want to participate in the study and who were closed to communication were determined as exclusion criteria
DIRECT-SAFE: A Randomized Controlled Trial of DIRECT Endovascular Clot Retrieval Versus Standard Bridging Thrombolysis With Endovascular Clot Retrieval

The study will be a multicentre, prospective, randomized, open label, blinded endpoint (PROBE) phase 3 trial (2 arm with 1:1 randomization) in ischemic stroke patients within 4.5 hours of stroke onset. Randomised patients will be stratified for site of baseline arterial occlusion into one of three groups: 1. internal carotid artery (ICA) 2. middle cerebral artery (MCA) 3. basilar artery (BA). Patients will be randomised to either bridging intravenous thrombolysis with endovascular clot retrieval (ECR), or direct endovascular clot retrieval.

The DIRECT-SAFE trial will include patients with acute ischemic stroke, who are ≥18 years of age and are eligible for standard intravenous tPA therapy within 4.5 hours of stroke onset. Patients will be assessed for large vessel occlusion to determine their eligibility for randomization into the trial. Eligible vessel occlusions include the internal carotid artery, basilar artery or middle cerebral artery (M1 or M2). Patients will be consented after large vessel occlusion is confirmed based on standard care multimodal imaging.

Patients will be recruited in Australia, New Zealand, China, Taiwan, Vietnam, Singapore and Europe. Randomisation either direct to ECR or standard thrombolytic therapy and ECR shall be in a 1:1 ratio.

All patients will have a multimodal MR (or CT/CTP at investigator's discretion if MRI not possible) at 18 to 30 hours post treatment to assess reperfusion, recanalization, ischemic core growth and hemorrhagic transformation. Final follow up will occur at Day 90.

Eligibility Criteria:
Inclusion Criteria:

1. Patients presenting with acute ischemic stroke eligible using standard criteria to receive IV thrombolysis within 4.5 hours of stroke onset
2. Patient's age is ≥18 years
3. Intra-arterial clot retrieval treatment can commence (groin puncture) within 6 hours of stroke onset.
4. Arterial occlusion on CTA or MRA of the ICA, M1, M2 or basilar artery

Exclusion Criteria:

1. Intracranial hemorrhage (ICH) identified by CT or MRI
2. Rapidly improving symptoms at the discretion of the investigator
3. Pre-stroke mRS score of ≥ 4 (indicating previous disability)
4. Hypodensity in \>1/3 MCA territory on non-contrast CT
5. Contra indication to imaging with contrast agents
6. Any terminal illness such that patient would not be expected to survive more than 1 year
7. Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
8. Pregnant women
ACURATE TA™ Valve Implantation Registry: SAVI 2

Post-market registry on ACURATE TA™ Transapical Aortic Bioprosthesis and ACURATE TA™ Delivery System implantation in patients presenting severe symptomatic aortic stenosis to collect continued surveillance data pertaining to safety and performance of the device.

The SAVI2 registry is a single arm, prospective, multicenter, non-randomized and open registry up to 1 year follow-up with the Symetis ACURATE TA™.

The ACURATE TA™ is an aortic bioprosthesis for minimal invasive implantation via transapical access to treat patients with severe symptomatic aortic stenosis where conventional aortic valve replacement (AVR) via open surgery is considered to be associated with high surgical risk.

The primary objectives of the registry is to further evaluate the safety and performance of the implantation and the safety at 30-Day Follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patient has severe aortic stenosis
* Native aortic annulus diameter from ≥ 21mm up to ≤ 27mm
* Patient willing to participate in the study and provides signed EC-approved informed consent
* The subject and treating physician agree the subject will return for all required post-procedure follow-up visits

Exclusion Criteria:

* Patients are excluded from the registry if they are not eligible for transcatheter treatment of severe aortic stenosis with the ACURATE TA™ and Delivery System as per the Instructions For Use.
Adult Patient Outcomes After Spine Surgery with Fibergraft BG Putty/Viper Prime

The Viper Prime/Expedium spine systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracolumbar and sacral spine. The Fibergraft Bioactive Glass (BG) is engineered to mimic the body's natural bone healing process. While previous studies have compared the use of Viper prime/Expedium spine system in minimally invasive and open surgeries, these studies did not specifically study the clinical and radiographic outcomes of patients who have received these implants in addition to Fibergraft. We aim to recruit patients with degenerative disc disease, spondylolisthesis, trauma, and/or pseudarthrosis who require spine surgery under standard of care and use these implants. We will then follow these patients for a duration of two years to report their clinical and radiographic outcomes to determine fusion, complication rate, and revision surgeries if any.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Have a radiograph-based diagnosis of degenerative disc disease, spondylolisthesis, spinal trauma (i.e., fracture or dislocation), spinal stenosis, or deformity (i.e., scoliosis, kyphosis, and/or lordosis), spinal tumor, or pseudoarthrosis/failed fusion.
3. Pathology of the thoracolumbar or sacral spine.
4. Patients requiring fusion of 1-3 levels
5. Patients receiving the surgery/devices as standard of care prescribed by the treating physician.

Exclusion Criteria:

1. Patients \< 18 years
2. Patients with a cervical spine pathology
3. Patients with spinal tumors
4. Patients with bone density (DEXA) scores \< 2.0 will be excluded.
5. Current smokers and patients who quit smoking within 6 weeks prior to presentation will be excluded.
6. Patients with a BMI \> 40kg/m2
7. Patients requiring fusion for more than 3 levels will be excluded
RECHARGE Sub-Study to the Implantable Systems Performance Registry (ISPR)

The purpose of this study is to assess the recharge feature of the Activa RC System in patients who are receiving Deep Brain Stimulation (DBS) for Parkinson's Disease (PD), Essential Tremor (ET), or dystonia.


Eligibility Criteria:
Inclusion Criteria:

* Patient is enrolled in the Implantable Systems Performance Registry (ISPR) and will receive one Activa RC as their first implantable neurostimulator or as a replacement implantable neurostimulator for DBS.
* Patient must meet the indications in the Activa RC labeling.
* Patient (or patient's legally authorized representative) signs and dates the appropriate RECHARGE Informed Consent Form and/or Informed Assent Form and Authorization to Use and Disclose Health Information (HIPAA, US only).
* Patient has a diagnosis of Parkinson's Disease, Essential Tremor, or dystonia that meets the approved indication for Activa RC in the applicable geography.
* Patient with dystonia is 7 years of age or older (EU only).
* Patient with either PD or ET is 18 years of age or older.
* Patient (or caregiver) is able to use the patient programmer and correctly interpret the icons.
* Patient (or caregiver) is able and willing to regularly monitor the status of the rechargeable battery and respond appropriately.
* Patient (or caregiver) is able to locate the INS, position the recharge antenna for sufficient coupling, put on the recharge holster/belt, and monitor progress during the recharge session.
* Patient (or caregiver) is able to perform recharging activities for sufficient duration and frequency to maintain therapy and to perform recharging activities on an ongoing basis.
* Patient is willing and able to comply with protocol requirements.

Exclusion Criteria:

* Patient has a contraindication identified in the Activa RC labeling.
* Patient who is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound the results of the RECHARGE study.
* Patient has or will be implanted with a non-Medtronic Deep Brain Stimulation system component.