cyrilzakka/clinical-trials huggingface dataset:
The Step Home Trial: Utilising Physical Activity Data in the Acute Post-operative Setting

This is an observational study, which aims to assess how physical activity levels following surgical procedures correlate with patient recovery and length of hospital stay, as well as the utility of this physical activity data to the postoperative surgical team. Surgical teams frequently enquire about their patients' physical activity levels on postoperative ward rounds. Although this information is often provided anecdotally by nursing staff and junior doctors, there are no objective data made available to the clinician. Such data has the potential to supplement other observations (e.g. heart rate, blood pressure, temperature) to help gain an impression of a patient's recovery and physical status, this in turn could provide evidence to help facilitate early discharge as well as to predict medium to longterm outcomes. Advances in wearable technology allow the investigators to collect detailed information with regard to activity with minimal disruption.

Recent literature has shown that these wristworn sensors can feasibly be worn in hospital pre and postoperatively, with evidence of a correlation between the amount of steps taken postoperatively and the length of hospital stay. This study will provide further evidence for the usability and utility of wearable sensors in the inpatient surgical setting. It will provide supporting evidence for surgeons to confidently analyse and assess patients in hospital, allowing for safe and expedient discharge home as well as identify highrisk patients who are likely to require extra support and surveillance in the community setting.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing elective surgical operative procedure

Exclusion Criteria:

* Unable to mobilise independently Have medical condition characterized by movement disorder e.g. Parkinson's Disease Unable to understand and complete the SF-36 (unless interpreter present) or lack capacity to consent Psychological Disorder Aged less than 18
A Trial of a CPR Video in Heart Failure Patients

This is a randomized controlled trial of a CPR video decision aid in patients with advanced congestive heart failure (CHF).

Aim 1: To compare the care preferences for CPR and intubation among subjects randomized to video and subjects randomized to the current standard of care without the video.

Hypothesis 1: Subjects randomized to the video intervention will be significantly more likely to opt against CPR and intubation compared to those who do not see the video.

Aim 2: To compare code-status documentation in the electronic medical records between subjects randomized to the video and those who are receiving the current standard of care without the video.

Hypothesis 2: Subjects randomized to the video are more likely to have their code status correctly documented in the electronic medical records compared to those who do not see the video.

Aim 3: To compare knowledge and decisional conflict of subjects randomized to video and subjects randomized to the current standard of care without the video.

Hypothesis 3: When compared to subjects randomized to the current standard of care, subjects in the video intervention group will have higher knowledge and lower decisional conflict (lower decisional conflict scores) when asked to choose CPR and intubation preferences.

Eligibility Criteria:
Inclusion Criteria:

1. A diagnosis of advanced heart failure:

   * New York Heart Association Class III or IV (III: marked limitation in activity due to symptoms, even during less-than-ordinary activity; IV: severe limitations, experiences symptoms while at rest). AND
   * Two or more hospitalizations for heart failure in the last year. AND
   * Either a systolic blood pressure ≤ 120 mm Hg OR Na ≤ 135 mEq/L.
2. Ability to provide informed consent.
3. Ability to communicate in English.
4. Age 65 or older.
A Study in Healthy Men and Women to Test Whether BI 1358894 Influences the Amount of Bupropion in the Blood

The main objective of this trial is to investigate the relative bioavailability of a single dose of bupropion when given alone (Reference) compared with co-administration (Test) with BI 1358894 in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 55 years (inclusive)
* Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
* Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
* Male subjects, or female subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 30 days after trial completion:

  * Sexually abstinent
  * Use of adequate contraception, e.g. any of the following methods plus condom: implants, injectables, intrauterine device
  * A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment)
  * Surgically sterilised (including hysterectomy)
  * Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with levels of follicle stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory)

Exclusion Criteria:

* Any finding in the medical examination (including safety laboratory, BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply
Metabolic Surgery Versus Medical Management for Resolution of Type II Diabetes

Best medical management and gastric bypass surgery is a way to treat diabetes as part of regular medical care (standard of care). However, gastric bypass surgery is not a way to treat diabetes as part of regular medical care (standard of care).

Best medical management and gastric bypass surgery are ways to treat obesity as part of regular medical care (standard of care). Best medical management is a way to treat diabetes as part of regular medical care (standard of care). However, gastric bypass surgery is not a way to treat diabetes as part of regular medical care (standard of care). But, studies suggest that diabetes gets better or goes away after gastric bypass surgery. This study is being done to find out if diabetes gets better or goes away completely after a patient has gastric bypass surgery as part of regular medical care (standard of care).

Eligibility Criteria:
Inclusion Criteria:

* Age 25 to 70
* BMI 35 or greater
* HbA1c\>6.5%
* Stable weight
* Stable medications

Exclusion Criteria:

* Coagulopathy
* Liver cirrhosis
* C-peptide \<1 ng/ml (off insulin)
* Diagnosis of severe eating disorder
* Untreated endocrine disorder
* Use of medication for weight loss in the past 6 months
* Use of medication for weight loss in the last 6 months (with the exception of orlistat)
* Pregnancy
* Coagulopathy
* Liver cirrhosis
* Incurable, malignant, or debilitating disease
* Severe eating disorder
* Use of weight loss medication in the last 6 months, with the exception of orlistat
* Untreated endocrine disorder
* Pregnant
* Inability to provide informed consent
Neoadjuvant Toripalimab in Combination With Gemcitabine Therapy in Cisplatin Ineligible Local Advanved Bladder Cancer

This is a pre-surgical study involving subjects with muscle invasive bladder urothelial cancer, who are candidates for cisplatin ineligible neoadjuvant therapy. It is a one-arm phase II study in single center.


Eligibility Criteria:
Inclusion Criteria:

* Be willing and able to provide written informed consent for the trial.
* 18-75 years of age on day of signing informed consent.
* Have histologically confirmed muscle invasive disease of the urinary bladder.
* Histology must be urothelial carcinoma (transitional cell carcinoma) or urothelial carcinoma with mixed histology/features.
* Clinical stage II-IIIB and Have a surgical evaluation that documents the plan for multimodality therapy with a consolidative radical cystectomy.
* ECOG 0-1 and good organ function.
* cisplatin ineligible.

Exclusion Criteria:

* A non-surgical approach recommended by the treating urologist due to any reason.
* Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 28 days prior to study registration.
* Has a diagnosis of immunodeficiency or received systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to study registration.
* Has a known additional malignancy that is progressing or required treatment ≤ 48 months of study registration. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer.
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Has an active autoimmune disease requiring systemic treatment.
* Has known evidence of interstitial lung disease or active, non-infectious pneumonitis.
* Has an active infection requiring systemic therapy.
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
* Has received prior therapy with an anti-PD-1, anti-PD-L1, antibody.
* Has a known history of Human Immunodeficiency Virus.
* Has known active Hepatitis B or Hepatitis C.
Non-Interventional Study on the Tolerability and Efficacy of IVIG

Non-Interventional Study on the Tolerability and Efficacy of octagam® 10%

A Non-Interventional Study on the Tolerability and Efficacy of Octagam 5% or 10% or panzyga. Patients with any indication (replacement and immonomodulation) as prescribed by the treating physician. Marketed Octagam 5% or 10% or panzyga will be used according to the investigator prescription; intravenous (iv) administration.The primary objective is to detect and evaluate adverse drug reactions (ADRs) occurring during or after the administration of Octagam or panzyga in any indication, age group or treatment regimen, where a causal relationship to the administration of Octagam or panzyga is suspected.

Eligibility Criteria:
Inclusion Criteria:

* Any patient who needs to be treated with a product of this class because of his/her medical condition and whom the treating physician decides to prescribe Octagam or panzyga regularly, may be included.

Exclusion Criteria:

* None
Feasibility Trial to Maintain Normal Cerebral Oxygen Saturation in High-Risk Cardiac Surgery

Using the brain and the heart as index organs, perioperative interventions to optimize cerebral oxygen saturation and cardiac contractility in high-risk patients undergoing cardiac surgery should have a beneficial systemic effect for enhancing global tissue perfusion and improve outcomes.

The proportion of high-risk patients requiring cardiac surgery and of high-risk cardiac surgeries is increasing. These populations of patients are at increased risk of perioperative morbidity and mortality. Transesophageal echocardiography (TEE) evaluation in cardiac surgery has been shown to impact on the perioperative management of patients and to improve outcomes. Near infrared-reflectance spectroscopy (NIRS) is a technique that has been employed since the mid-1970's and that can be used as a non-invasive and continuous monitor of the balance between cerebral oxygen delivery and consumption. Two recent randomized trials have shown an association between correction of cerebral desaturation and shorter recovery room and hospital stay in non-cardiac surgery, and with a decrease in major organ dysfunction and in intensive care length of stay after coronary artery bypass. By combining NIRS and TEE in high-risk patients, optimal tissue perfusion could be achieved and perioperative morbidity and mortality could be reduced.

Eligibility Criteria:
Inclusion Criteria:

* Patients with EUROSCORES ≥ 10.
* Planned complex surgery including more than one procedure, or redo procedures.
* Patient able to read and understand the consent form.
* Patients ≥ 18 years of age.

Exclusion Criteria:

* High risk patients undergoing of off pump coronary artery bypass.
* Emergency surgeries less than 6 hours from diagnosis.
* Patient unable to read and understand the consent form.
* Patients with and IABP or a ventricular assist device
* Planned circulatory arrest
* Planned surgery of the descending aorta.
* Patients with acute endocarditis.
A Trial to Compare Pringle Maneuver With Either Infrahepatic Inferior Vena Cava Clamping or Low Central Venous Pressure

The purpose of this study is to better comprehend the benefits and efficacy of portal triad clamping with infrahepatic IVC clamping during complex hepatectomy. A randomized comparative trial was performed to compare PTC(pringle triad clamping) with either infrahepatic IVC clamping or low central venous pressure in complex liver resections.

To better comprehend the benefits and efficacy of portal triad clamping with infrahepatic IVC clamping during complex hepatectomy. A randomized comparative trial was performed to compare PTC with either infrahepatic IVC clamping or low central venous pressure in complex liver resections. 192 consecutive patients were involved in this study and allocated equally to two groups. Preoperative demographic and clinical data, details of surgical procedure, pathologic diagnosis, postoperative course and complications were collected prospectively.

Eligibility Criteria:
Inclusion Criteria:

1. patients who were assessed by preoperative medical imagings to have a high risk of backflow bleeding from the major hepatic veins and the IVC, based on the size and location of the tumor. The tumors were ≥5 cm in diameter and they involved the liver segments 7, 8 and/or the cranial portion of segment 4. These tumors were in close proximity or were compressing, but had not actually invaded, the major hepatic veins or IVC
2. Pugh-Child Grade A
3. Indocyanine green retention rate at 15 minutes (ICGR15) \< 10%;
4. acceptable clotting profile (platelet count ≥ 50 ×109/L and prothrombin activity ≥ 60%)
5. no previous liver resection.

Exclusion Criteria:

1. extrahepatic metastases in patients with malignancy;
2. patients who refused to take part in this study.
Comparison of Zenker's Diverticulum Treatment Using Peroral Endoscopic Myotomy and Flexible Endoscopy Septotomy.

The Zenker's or pharyngo-esophageal diverticulum is an acquired sac-like outpouching of the mucosa and submucosa layers located dorsally at the pharyngoesophageal junction through Killian's dehiscence. It is the most common type of oesophageal diverticula and typically occurs in middle-aged and elderly patients. Patients have a significantly reduced quality of life index and numerous complications.

Treatment is recommended for symptomatic patients and considering the aetiopathogenesis of the disease demands myotomy of the cricopharyngeal muscle. Myotomy may be pursued through either open surgical or endoscopic techniques.

There is a novel technique, called the peroral endoscopic myotomy (Z-POEM) for treatment of Zenker's diverticulum.

The ZIPPY trial designed as prospective, international, multicenter, double-blind, randomized study which will be carried out by experienced endoscopists. The aim of this study will be to evaluate the results of Zenker's diverticulum treatment using peroral endoscopic myotomy and to compare its efficacy and safety to flexible endoscopy septotomy. Patients at least 18 years old with symptomatic Zenker's diverticulum diagnosed on the basis of endoscopic and radiological examinations will be enrolled.

Participants will be randomized into one of two groups: (I) Z-POEM, (II) flexible endoscopic septotomy. Patients with clinical failure will be offered other method of treatment and will be included to observational cohort. The study has been approved by a local bioethics committee

Eligibility Criteria:
Inclusion Criteria:

1. Males and females who are 18 years of age and older and are able to comprehend instructions and follow the study procedures and are willing to sign an Informed Consent Form (ICF).
2. Patients with symptomatic Zenker's Diverticulum.
3. Confirmed diagnosis of Zenker's Diverticulum based on endoscopic and radiological examinations.
4. Size of Zenker's Diverticulum in the range of 1,5 to 4 cm on radiological examinations.

Exclusion Criteria:

1. Lack of written consent for participation in the study.
2. Size of Zenker's Diverticulum \<1,5 cm or \>4 cm on radiological examination.
3. Active cancer.
4. Esophageal stricture.
5. Eosinophilic esophagitis (EoE).
6. Pre-cancerous changes in the esophagus.
7. Previous surgical or endoscopic treatment of Zenker's Diverticulum.
8. Presence of chewing deficiencies and/or neurogenic dysphagia.
9. Presence of other esophageal motility disorders e.g. achalasia and/or spastic motility disorders.
10. Severe systemic diseases which are contraindication to general sedation.
11. Severe coagulopathy.
12. Pregnancy and breastfeeding.
Intervention With Omega-3 in Children With Attention Deficit Hyperactivity Disorder(ADHD)

This study aims to determine if marine monounsaturated and polyunsaturated fatty acids can benefit children aged 6-16 years with ADHD and related symptoms. It is a randomized, double-blind, placebo-controlled study involving approximately 330 children from Norway. The study will assess ADHD symptoms reported by caregivers, teachers, and the child at baseline, after 6 months of treatment, and 6 months post-treatment. Secondary outcomes will include reading and writing difficulties, cognitive functions, and physical health.

Children with ADHD often exhibit low blood levels of omega-3 fatty acids, which are not correlated with their diet. Low omega-3 levels are associated with poor cognition and behavior. Previous research indicates that omega-3 supplements can enhance literacy, behavior, memory, and reaction time in children with ADHD, although the improvements are generally small to modest.

A study on adolescent mental health in North Norway from 2003-2005 revealed that adolescents consuming more fish had lower levels of hyperactivity compared to those with lower fish consumption (unpublished results from The Norwegian Arctic Adolescent Health Study, Siv Kvernmo).

Key limitations in existing studies include small sample sizes, varying methodologies, short intervention periods, and the absence of control groups. This study addresses these limitations by using whole marine oil from the zooplankton Calanus finmarchicus, which naturally contains stearidonic acid (a precursor to EPA) and astaxanthin, a natural antioxidant.

Previous clinical studies did not utilize pure oil from zooplankton such as Calanus finmarchicus. This oil is not chemically processed, retaining its natural antioxidants.

Blood tests will be conducted before and after the 6-month intervention period to measure the omega-3 index and include general hematology and biochemistry.

Eligibility Criteria:
Inclusion Criteria:

- ADHD according to DSM-IV criteria

Exclusion Criteria:

* IQ below 70
* infantil autism, psychosis, bipolar disorders and serious somatic disease
* any abnormal or pathological blood test during trial
* ADHD medication
Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.

The investigators hypothesize that single oral high dose supplementation with vitamin A will reduce the incidence of moderate-severe chronic graft-versus-host disease (GVHD) compared with placebo.

Hematopoietic stem cell transplantation (HSCT) is an effective treatment strategy for many malignancies, marrow failure syndromes, and immune deficiencies in children, adolescents, and adults. Vitamin A and its derivatives regulate growth and differentiation of intestinal cells, and vitamin A deficiency is associated with increased susceptibility to infection in both human and animal models. The investigators' preliminary data suggest lower vitamin A levels were associated with an increased incidence of gastrointestinal graft versus host disease (GI GVHD) in patients undergoing HSCT.

This study is a randomized double blinded comparison of vitamin A supplementation comparing a single large dose of vitamin A with a placebo.

Eligibility Criteria:
Inclusion Criteria:

* Be 18 years of age or older
* Be scheduled for allogeneic stem cell transplant.
* Have a vitamin A level \< upper limit of normal for age.
* Be able to tolerate enteral vitamin dose administration.
* Have a total bilirubin level \< 1.5x ULN and an AST and/or ALT\< 3xULN for age
* Receiving PBSCs as stem cell graft

Exclusion Criteria:

* Ongoing raised intracranial pressure
* Liver cirrhosis
* Patients will be excluded if they are currently pregnant.