cyrilzakka/clinical-trials huggingface dataset:
The Caregiver Pathway - An Intervention to Support Caregivers of Critically Ill Patients

The aim of the project is to test the efficacy of a systematic intervention for individual follow-up of caregivers at the intensive care unit during a 12 month randomized controlled trial.

Caregivers of patients admitted to an intensive care unit (ICU) often experience the situation as traumatic and stressful. Long term consequences such as fatigue, anxiety, depression and symptoms of post-traumatic stress are reported among 30-50 percent of the caregivers of critically ill patients. The need for supportive interventions is called for.

The overall goal of this project is to improve the support for caregivers of intensive care patients. A systematic intervention for individual support of caregivers, The Caregiver Pathway Intervention, has been developed with a multidisciplinary approach, based on existing evidence, through interviews with former caregivers, workshops with health care personnel and user input and testing. The intervention consist of mapping of caregivers' prioritized symptoms, needs and preferences with a digital assessment tool, followed by a meeting with a nurse to address these issues, a structured conversation at discharge, and an invitation to a follow-up conversation 4-6 weeks after discharge/patients death.

The aim of the project is to test the efficacy of The Caregiver Pathway Intervention among caregivers at the ICU in a randomized controlled trial, using outcome measures such as symptoms of post-traumatic stress, anxiety/depression, cost-utility measures and health-related quality of life. The participants will be randomly assigned to The Caregiver Pathway Intervention or the follow-up as usual group. Both groups will receive outcome measures at baseline and at 3, 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Caregivers of patients admitted to the intensive care unit that is expected to receive invasive mechanical ventilation for at least 48 hours
* Between 18 and 70 years old
* Able to understand and speak Norwegian

Exclusion Criteria:

• None
Comparative Safety and Efficacy of Vaginal Misoprostol Versus Lidocaine-prilocaine Cream in Levonorgestrel IUD Insertion

the aim of the present study is to compare the safety and Efficacy of vaginal misoprostol versus Lidocaine-prilocaine cream in reducing pain during levonorgestrel IUD Insertion in women delivered only by cesarean deliveries


Eligibility Criteria:
Inclusion Criteria:

* women who delivered only by previous cesarean delivery and requesting LNG-IUD insertion

Exclusion Criteria:

* women who delivered vaginally, active vaginal or cervical infections and contraindications to IUD insertion or study drugs
Chest Pain Symptoms Differences Between Diabetic Patients and Non

Cardiovascular disease is the most severe cause of death among all non-infectious diseases and accountable for 17.5 million deaths in the world. Heart mortality in patients with DM is frequently associated with prevalence silent ischemia, which is triggered by autonomic neuropathy, thereby decreasing the chest pain felt by them


Eligibility Criteria:
Inclusion Criteria:

i) Patients diagnosed with STEMI and NSTEMI ii) Both genders iii) above the age of 30 years iv) Patients with acute myocardial infarction with or without chest pain (angina) for 24 hours v) patients who are hemodynamically stable vi) patients without acute decompensated heart failure (ADHF) vii) patients without malignant arrhythmias viii) patients without in Acute Lung Oedem (ALO) condition ix) patients not using ventilator x) patient willing to and become respondents.

Exclusion Criteria:

i) Patients with several complications, thereby making it impossible to interview them ii) patients who have never undergone CABG surgery iii) patients who refuse to be respondents
Inter-observer Variation in Gross Tumor Delineation of Esophageal Cancer on MR, CT and PET CT

The aim of the study is to investigate inter-observer variation in gross tumor volume (GTV) delineation of oesophageal cancer on different imaging modalities - CT, PET CT and MR.Twenty-three consecutive patients with esophageal cancer treated with preoperative or curative chemoradiotherapy were selected. All patients had CT, PET CT and MR imaging in treatment position prior to radiotherapy.Five experienced observers from our institution will independently delineate GTV on CT alone, MR alone, PET CT alone, on co-registered CT and MR and co-registered PET CT and MR. Inter-observer agreement, expressed in generalized conformity index (CIgen) and mean volumes of GTV will be calculated per patient and imaging modality.


Eligibility Criteria:
Inclusion Criteria:

* locally advanced esophageal cancer eligible for treatment with preoperative or curative chemoradiotherapy

Exclusion Criteria:

* contraindications for MR
Cerebellar Metaplasticity in the Swallowing Motor System

Dysphagia is common and leads to significant morbidity and mortality within healthcare settings. Current approaches to dysphagia management involve altering the consistency of food and fluids. However, these approaches are not supported by a robust evidence base. Repetitive transcranial magnetic stimulation (rTMS) offers a non-invasive way to manipulate neuroelectric activity within the brain. Within the swallowing motor system, rTMS at a frequency of 5Hertz (Hz) and above is excitatory while 1Hz is suppressive.

Cortical rTMS targeting pharyngeal motor areas can alter brain activity and swallowing behaviour in healthy participants and has been shown to improve post-stroke dysphagia (PSD). Despite this, it has a small seizure risk. Cerebellar rTMS is a newer and safer technique which is more easily targeted and is effective at altering swallowing related brain activity and behaviour. Recent studies have also shown it can improve PSD.

Critically, individual responsiveness to rTMS is variable, potentially reducing its effectiveness. Metaplasticity whereby the brain is preconditioned with a neuroelectric stimulus before the treating stimulus is administered is a potential way of reducing variability. Metaplasticity has recently been shown to improve responses within the swallowing motor system following cortical rTMS. However, to date no cerebellar rTMS study has applied this approach. This is a gap in our understanding which will need to be addressed.

The overarching aim of the study is to develop a less variable and more effective treatment for neurogenic dysphagia. More specifically the study objectives are to establish:

1. Whether 10Hz Cer-rTMS delivered over hemispheric pharyngeal areas can induce SMS metaplastic changes in healthy participants.
2. If a cerebellar rTMS metaplastic stimulation protocol can affect swallowing behaviour.


Eligibility Criteria:
Inclusion Criteria:

Healthy participants \> 18 years of age

Exclusion Criteria:

Exclusion criteria will be the presence or a history of:

1. Epilepsy
2. Cardiac pacemaker
3. Previous brain surgery
4. Previous swallowing problems
5. The use of medication which acts on the central nervous system
6. Any implanted metal in the head
7. Pregnancy (self-declared)
Pharmacokinetic Response to BPI in Burns

The purpose of this study is to evaluate the safety of a protein called BPI that is naturally made by the body's white blood cells to fight infection.

This study will initially evaluate an FDA approved investigational dosage and will measure the blood levels over time while BPI is being infused through a vein to see if the dose is potentially enough to obtain the desired effect. The drug will be started within 8 hours of burn injury and continued for 48 hours. Patients will be followed on admission and through infusion in the Burn ICU where they will be monitored by ICU standards. They will be seen regularly thereafter on post-burn days 1, 2, 3, 4, 7, 14 and 28 days while in the hospital. If the patient is discharged prior to the 28 day evaluation, they will be evaluated on or around the 28th day in the burn clinic. A blood sample will be obtained to look for potential genetic markers that may increase a burn patients' risk to develop infection in the post burn period.

Eligibility Criteria:
Inclusion Criteria:

* Ages 13 years to 60 years old
* Sustained partial-thickness or full-thickness burn greater than 20% and less than 41% TBSA
* Parental consent (if subject is less than 18 years old) or individual (if subject is equal to or older than 18) signed, informed consent.
* Able to start BPI in infusion within 8 hours of burn injury.

Exclusion Criteria:

* Age \> 61.
* Inhalational injury requiring mechanical ventilation.
* Partial and full thickness burns totaling \> 41% total body surface area
* Cardiac dysfunction, defined as the presence of any of the following:

  1. New York Heart Class 3 or 4 heart failure.
  2. Unstable angina or acute myocardial infarction.
  3. Left ventricular ejection fraction known to be \< 35%.
* Electrical or lightening induced burn injury or any injury that required cardio-pulmonary resuscitation.
* Concomitant non-burn trauma with an ISS \> 9.
* Non-survivable injury secondary to burn size - patients made DNR or comfort care due to burn size.
* Patients with known causes of immunosuppression:

  1. Known history of HIV/AIDS
  2. Chronic steroid use for underlying medical conditions (equivalent to 15 mg prednisone/day).
  3. Active oncolytic therapy for known malignancy
* Known or suspected pregnancy
* Known allergy to rBPI21
Improving Time-Based Prospective Memory in TBI

This research aims to test aspects of a computer-based cognitive rehabilitation program designed to improve thinking skills in individuals with traumatic brain injury (TBI).

This research aims to test aspects of a computer-based cognitive rehabilitation program designed to improve thinking skills in individuals with traumatic brain injury (TBI), particularly improving the ability to remember to do things in the future.

Eligibility Criteria:
Inclusion Criteria:

* Sustained a moderate-to-severe TBI at least one year prior to assessment
* Fluent in English
* Demonstrate impairment in strategic cognitive abilities

Exclusion Criteria:

* Significant neurological history other than TBI
* Significant psychiatric history (e.g., bipolar disorder, schizophrenia)
* Significant substance abuse history
* Steroid and/or benzodiazepine use
Spinal Cord Injury Exercise and Nutrition Conceptual Engagement

Evaluate and compare the health benefits of an at home exercise program using functional electrical stimulation (FES) for lower extremity exercise with diet versus a diet alone group in adults with spinal cord injury.

The purpose of this proposal is to evaluate and compare the health benefits of home-based functional electrical stimulation leg cycle ergometry plus diet (HBFESLCE + Diet) to home-based (HB) Diet alone. This is a randomized, baseline-controlled, prospective, interventional trial to assess the impact of a 16-week exercise and/or diet intervention on selected fitness parameters in adults with high SCI. Primary outcome measures will include body composition by iDXA, insulin sensitivity, glucose effectiveness and BMR, while secondary outcomes will include lower extremity BMC and density, lipid profiles, and hsCRP determined before and after the 16-week interventions. Subjects will be randomly assigned to either HBFES LCE + Diet on an RT300 ergometer or Home-based (HB) Diet Alone intervention. Both groups will be routinely monitored via telemedicine while at home.

Eligibility Criteria:
Inclusion criteria:

* Adults 18-65 years of age (inclusive)
* Sex: male or female
* Women of child-bearing potential who agree to refrain from getting pregnant during the trial
* C4-T4 motor complete (AIS A\&B) spinal cord injury for duration greater than 12 months
* \<5% change in body weight over the past 12 months

Exclusion criteria:

* \<22% body fat
* Unresponsive to neurostimulation
* Those who have participated in an FES or ACE exercise program (\>60 minutes/week) within the past 3 months
* Known orthopaedic limitations
* Coronary artery disease
* Type 1 diabetes mellitus, insulin-requiring Type 2 or untreated diabetes mellitus (fasting glucose\>126 or HgbA1c\>7.0)
* Uncompensated Hypothyroidism (Stable on medication \>1 year or not on medication)
* Renal disease
* Uncontrolled autonomic dysreflexia, recent (within 3 months)
* Deep vein thrombosis
* Pressure ulcers \> Grade II
* Decisional impairment
* Any potential causes of autonomic dysreflexia at the discretion of the PI
* Prisoners
* Pregnant or nursing women
"REDUCE" - A Clinical Research Study To Reduce The Incidence Of Prostate Cancer In Men Who Are At Increased Risk

This 4-year study will compare how safe and effective an oral investigational medicine is (compared to placebo) in preventing the development of prostate cancer in men that are defined by the study entrance criteria as being at an increased risk for prostate cancer. Study visits to the clinic will occur every 6 months for up to 4 years (10 clinic visits), and a prostate biopsy will be performed at 2 and 4 years of treatment.


Eligibility Criteria:
Inclusion criteria:

* Informed consent to participate in study.
* Have had a single negative prostate biopsy within 6 months prior to enrollment in study.
* Have a PSA (prostate specific antigen) between 2.5 and 10 if 50-60 years of age; or a PSA between 3.0 and 10 if over age 60.
* Ability and will to participate in study for 4 years.

Exclusion criteria:

* More than one previous negative prostate biopsy.
* History of prostate cancer.
* Previous prostate surgery.
* Inability to urinate requiring the need of a catheter during the previous 2 years.
* Any condition (other than benign prostatic hypertrophy) which may result in urinary symptoms or changes in urine flow rate.
* Cancer within previous 5 years (other than basal or squamous cell cancers of the skin).
* Any unstable serious medical condition.
* Use within the past 12 months of finasteride (Proscar or Propecia), dutasteride (Avodart), testosterone, or drugs that can block the action of male hormones.
The Effect of Radiofrequency Ablation of Genicular Nerves on Postural Stability in Patients With Knee Osteoarthritis

In advanced knee osteoarthritis, postural stability is also disturbed. There are some concerns about performing radiofrequency ablation to genicular nerves since this may further decrease the postural stability of the patient. The aim of this study is to see if application of genicular radiofrequency causes a significant change in postural stability.


Eligibility Criteria:
Inclusion Criteria:

* Stage 3 and 4 knee osteoarthritis according to Kellgren-Lawrance scale
* Knee pain more than 3 months

Exclusion Criteria:

* Neurological diseases such as polyneuropathies
* Presence of severe psychiatric disorders
* Hemodynamic instability
* History of any surgery from the knee
Conversion Therapy of RAS/BRAF Wild-Type Right-sided Colon Cancer Patients With Initially Unresectable Liver Metastases

The prognosis of patients with metastatic right-sided colon cancer is worse than that of patients with metastatic left-sided cancer. Different guidelines have different recommendations on specific conversion therapy for colorectal liver metastases. The United States NCCN guidelines do not recommend standard chemotherapy combined with anti EGFR monoclonal antibody for patients with right colon cancer. The European ESMO guidelines recommend that patients with Ras / BRAF wild-type right-sided colon cancer should first consider three drugs ± bevacizumab, but considering the objective response rate results, standard chemotherapy + anti EGFR monoclonal antibody is still one of the choices. China CSCO guidelines recommend standard chemotherapy ± bevacizumab, and also recommend standard chemotherapy + cetuximab for patients with right-sided colon cancer.

Therefore, the targeted therapy for RAS / BRAF wild-type metastatic right colon cancer is still controversial. Therefore, we are ready to carry out the clinical trial of cetuximab and bevacizumab in conversion therapy for RAS / BRAF wild-type metastatic right colon cancer. The conversion resection rate is the primary point, and the objective response rate, perioperative safety and long-term survival are the secondary points.


Eligibility Criteria:
Inclusion Criteria:

1. The primary tumor was confirmed by histology as colorectal adenocarcinoma
2. primary right-sided colorectal adenocarcinoma
3. Radiologic evidence suggests that the initial unresectable liver metastases
4. RAS/BRAF gene wild-type states
5. ECOG was 0 \~ 1
6. Life expectancy ≥ 3 months
7. Good hematological function: neutrophil ≥ 1.5x109/l and platelet count ≥ 100x109 / L; HB ≥ 9g / dl (within one week before randomization)
8. Normal liver and kidney function: serum bilirubin ≤ 1.5x normal upper limit (ULN), alkaline phosphatase ≤ 5x ULN, serum transaminase (AST or ALT) ≤ 5x ULN (within one week before randomization);
9. Sign the written informed consent to participate in the experiment

Exclusion Criteria:

1. Patients with liver metastases from colorectal cancer who have previously received targeted therapy, chemotherapy, radiotherapy or interventional therapy
2. Known or suspected extrahepatic metastasis
3. Patients with known hypersensitivity to any component of the study treatment
4. Clinical related coronary heart disease or history of myocardial infarction in the last 12 months or left ventricular ejection fraction below normal range
5. Acute or subacute intestinal obstruction
6. Pregnancy (no pregnancy confirmed by serum / urine β - hCG) or breastfeeding.
7. She had other malignant tumors within 5 years, except for those with skin basal cell carcinoma or cervical cancer
8. Known drug / alcohol abuse
9. No legal capacity or limited legal capacity
10. There is peripheral neuropathy
A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis.

This 2 arm crossover study will evaluate patient reported preference for either once monthly Boniva (150mg p.o.) or once weekly risedronate (35mg p.o.). Patients with post-menopausal osteoporosis will be randomized to receive Boniva for 3 calendar months or risedronate for 12 weeks; they will then cross over to receive the alternative treatment for a further 12 weeks/3 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* ambulatory women with post-menopausal osteoporosis;
* patients who are bisphosphonate-naive, or who have previously received oral daily or i.v. bisphosphonate therapy (fulfilling certain criteria detailed in the protocol).

Exclusion Criteria:

* malignant disease diagnosed within previous 10 years (except for successfully resected basal cell cancer;) breast cancer within previous 20 years;
* inability to stand or sit upright for at least 60 minutes;
* disease/disorder/treatment with drugs known to influence bone metabolism.
The APPROACH Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Patients With Familial Chylomicronemia Syndrome

The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 52 weeks in participants with Familial Chylomicronemia Syndrome


Eligibility Criteria:
Inclusion Criteria:

* History of chylomicronemia
* A diagnosis of Familial Chylomicronemia Syndrome (Type 1 Hyperlipoproteinemia)
* Fasting triglycerides (TG) ≥ 750 mg/dL (8.4 mmol/L) at Screening

Exclusion Criteria:

* Diabetes mellitus if newly diagnosed or if HbA1c ≥ 9.0%
* Other types of severe hypertriglyceridemia
* Active pancreatitis within 4 weeks of screening
* Acute Coronary Syndrome within 6 months of screening
* Major surgery within 3 months of screening
* Treatment with Glybera therapy within 2 years of screening
* Previous treatment with IONIS-APOCIIIRx
* Have any other conditions in the opinion of the investigator which could interfere with the participant participating in or completing the study
Detection of Early Gastric Cancers Using Confocal Laser Endomicroscopy

The purpose of this study is to determine whether endomicroscopy can improve the detection of Early Gastric Cancers (EGC).

Endoscopy is proved to be the best method to achieve early diagnosis of gastric cancer (GC). Confocal laser endomicroscopy (CLE), a new diagnostic modality, has been shown to be valuable in increasing the diagnostic yield of colorectal neoplasias, but it is not clear whether CLE is helpful to find out early gastric cancer (EGC).The aim of the study is to investigate the value of CLE in improving the detection of EGCs.

Eligibility Criteria:
Inclusion Criteria:

* 45 years old ≤ age \< 80 years old
* Patients with dyspeptic symptoms or with gastric premalignant conditions for surveillance gastroscopy

Exclusion Criteria:

* Known cancers or gastrectomy
* Scheduled for endoscopic treatment
* Alarm symptoms such as dysphagia, anaemia, gastrointestinal bleeding or obstruction, marked weight loss
* Under conditions such as:

  * ascites
  * jaundice
  * liver cirrhosis
  * impaired renal function
  * coagulopathy
  * fever
  * pregnancy
  * breastfeeding
* Inability to provide informed consent
* Known allergy to fluorescein sodium
Randomized Study to Evaluate MACE in Patients With Prostate Cancer Treated With Relugolix or Leuprolide Acetate

This was a randomized study to evaluate the risk of major adverse cardiovascular events (MACE) for relugolix compared with leuprolide acetate. Enrollment in this study was discontinued by the Sponsor on 01 Dec 2023. In an effort to mitigate any treatment interruptions, actively enrolled patients will be allowed to remain on study drug up to a period of 12 months ending Dec 2024 if they choose to remain in the discontinuation phase of the study.

Eligible patients were randomized (1:1) to receive either relugolix or leuprolide acetate for prostate cancer or as an adjunct to primary or salvage radiation therapy. The study was intended to collect clinical and cardiovascular risk factor data on patients ages 18 and older who were receiving relugolix or leuprolide acetate for their prostate cancer or as adjunct to radiation therapy with a treatment plan to be on at least 12 months of continuous ADT. Enrollment in this study was discontinued by the Sponsor on 04 Dec 2023. In an effort to mitigate any treatment interruptions, actively enrolled patients will be allowed to remain on study drug up to a period of 12 months ending Dec 2024. During this discontinuation phase, all active investigative sites will be expected to formulate a transition plan for their study patients from this clinical study to SOC as soon as practicable.

The primary endpoint in this study was the time to first adjudicated MACE (nonfatal myocardial infarction, nonfatal stroke, and cardiovascular death). However, with the discontinuation of enrollment in the study on 04 DEC 2023 by the sponsor, the primary endpoint will be to describe the safety of relugolix in the study population while actively enrolled patients remain on study drug.

Eligibility Criteria:
A patient will be eligible for inclusion in the discontinuation phase of the study if the following applies:

1. Was previously enrolled under the original version and amendment 1 of this study
2. Has voluntarily resigned and dated the informed consent form prior to transition to the discontinuation phase of this study