cyrilzakka/clinical-trials huggingface dataset:
Guided Meditation During Radiation Therapy for Brain Tumors

The goal of this interventional treatment study is to assess the anxiolytic effect of providing guided meditation during radiation treatment (RT) in patients with brain tumors.

The main question it aims to answer is:

• What is the change in acute anxiety in participants receiving the mindfulness intervention during radiation therapy compared to standard of care control conditions?

Participants will be asked to participate in a 5-minute, audio-recorded mindfulness practice that will be played during the administration of each RT session. Researchers will compare this intervention to standard of care (no intervention) during RT.


Eligibility Criteria:
Inclusion Criteria:

* Participant aged ≥ 18 years.
* Radiologically confirmed tumor of the brain. Note: Participants may have tumor resected after diagnosis.
* Eligible to undergo radiation treatment for brain tumor for 25-33 treatments.
* Willing to participate in either the guided meditation or standard of care control arm, regardless of treatment assignment.
* Karnofsky performance score ≥ 60 or ECOG performance score ≤ 2.
* MoCA mini score ≥ 11
* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.

Exclusion Criteria:

* Active suicidal ideation or active psychotic state in the opinion of the investigator.
* An unstable illness that, in the opinion of the investigator, would interfere with study treatment.
* Prior radiation therapy to the brain.
* Inability to understand and/or speak the English language.
Evaluation of the Effects of a Low Free Sugar Diet in Patients With Nonalcoholic Fatty Liver Disease

To study the effects of a low free sugar diet on lipid profile, glycemic indices, liver enzymes, inflammatory factors and hepatic steatosis and fibrosis in patients with Nonalcoholic fatty liver disease, 50 patients who referred to Gastrointestinal (GI) clinic with steatosis grade 2 and 3 will be randomly allocated to receive low free sugar diet or regular diet for 12 weeks; both groups will be advised to adherence the investigators' nutrition recommendation and exercise program too. At the first and the end of the intervention, lipid profiles, liver enzymes,glycemic indices, some inflammatory markers, and liver fibrosis will be assessed and compared between groups.


Eligibility Criteria:
Inclusion Criteria:

1. Age of 18 to 60 years
2. Body Mass Index (BMI) between 25-40
3. Sonographic findings compatible with hepatic steatosis (degree 2 or more)

Exclusion Criteria:

1. Alcohol consumption
2. pregnancy or lactation
3. Other liver disease (viral,cirrhosis,...)
4. Use of drugs such as phenytoin,tamoxifen,lithium
5. A history of Cancer, autoimmune disease,Renal disease \& Celiac disease, hypothyroidism or Cushing's syndrome
6. Lack of desire to continue studying
7. Have to use antibiotics with hepatotoxic drugs while studying
8. Non-compliance with diet
A Study of Bi-Level Positive Airway Pressure (BIPAP) Versus Non Invasive Positive Pressure Ventilation (NIPPV) for Neonatal Respiratory Failure

To research the effect of Bi-Level Positive Airway Pressure (BiPAP) for neonatal respiratory failure.

Bi-Level Positive Airway Pressure(BiPAP) is similar to Non Invasive Positive Pressure Ventilation (NIPPV), but also gives some breaths, or extra support, to newborn infants through a small tube in the nose. BiPAP is safe and effective. Nevertheless, BiPAP has never been used in Chinese babies.

Eligibility Criteria:
Inclusion Criteria:

1. Newborn infants with birth weight \> 500 gm.
2. Gestational age \> 24 completed weeks.
3. Intention to manage the infant with non-invasive respiratory support (i.e. no endotracheal tube), where either: the infant is within the first 7 days of life and has never been intubated or has received less than 24 hours of total cumulative intubated respiratory support the infant is within the first 28 days of life, has been managed with intubated respiratory support for 24 hours or more and is a candidate for extubation followed by non-invasive respiratory support.
4. No known lethal congenital anomaly or genetic syndromes.
5. Signed parental informed consent.

Exclusion Criteria:

1. Considered non-viable by clinician (decision not to administer effective therapies)
2. Life-threatening congenital abnormalities including congenital heart disease (excluding patent ductus arteriosis)
3. Infants known to require surgical treatment
4. Abnormalities of the upper and lower airways
5. Neuromuscular disorders
6. Infants who are \> 28 days old and continue to require mechanical ventilation with an endotracheal tube
Italian Validation of the Beaumont Behavioural Inventory (BBI)

Up to 50% of patients affected with amyotrophic lateral sclerosis (ALS) can show behavioral dysfunctions within the spectrum of frontotemporal degenerations (FTD) - namely, apathy, disinhibition, loss of sympathy/empathy, perseverative and stereotyped behaviours, dietary changes \[Strong et al., 2017\].

The Beaumont Behavioural Inventory (BBI) \[Elamin et al., 2017\] is a questionnaire designed for detecting FTD-spectrum behavioural changes in ALS patients. The present study aims at both validating the BBI in an Italian ALS population and determining normative cut-off values of the instrument.


Eligibility Criteria:
Inclusion Criteria:

* possible, probable or definite ALS according to El Escorial revised criteria

Exclusion Criteria:

* Any other clinically significant cardiovascular, gastrointestinal, hepatic, renal, neurological or psychiatric disorder or any other major concurrent illness that in the opinion of the investigator could interfere with the interpretation of the study results
COlon Cancer Laparoscopic or Open Resection

COLOR trial is a randomized, international, multi center study comparing the outcomes of laparoscopic and conventional resection of colon carcinoma with curative intent. Clinical and operative data will be collected centrally in the coordinating centre in Rotterdam, The Netherlands. Quality of life and costs will be assessed on a national basis.

The design involves allocation of all suitable consecutive patients with colon carcinoma to either of the two procedures at a randomization ratio of 1:1. The trial will be stratified according to participating centre, resection type and gender.

Disease free survival for all TNM stages after 3 years is currently about 70%. To detect a difference of 7% in disease free survival rate after 3 years between open and laparoscopic resection of colon cancer, 1200 patients will have to be included (60 vs 67%, two-sided analysis; alfa=0.05, beta=0.20, power=80% and p=0.05). All analyses will be performed on an intention to treat basis.

Eligibility Criteria:
Inclusion Criteria:

* Solitary colon carcinoma observed at colonoscopy or on barium enema X-ray within 28-days before operation (no biopsy required)
* Polyp containing invasive carcinoma according to colonoscopic biopsy, undertaken within 28 days before operation
* Suitable for elective surgical resection by right hemicolectomy, left hemicolectomy or sigmoid resection
* Sigmoid colon tumour cranially to conjugata diagonalis on lateral view of barium enema
* BMI \< 30 kg/m2
* Informed consent according to local requirements

Exclusion Criteria:

* Carcinoma of the splenic flexure
* Carcinoma of the transverse colon
* Signs of acute intestinal obstruction
* More than one colon tumour
* Scheduled need for other synchronous colon surgery
* Synchronous surgery ofr other intra-abdominal organs
* Pre-operative indication of invasion of adjacent organs
* Pre-operative evidence of distant metastases
* Previous ipsilateral colon surgery
* Other malignancies in medical history, except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri
* Absolute contra-indications to general anaesthesia or prolonged pneumoperitoneum, such as severe cardiovascular or respiratory disease
* Pregnancy
Phase 2 Clinical Trial of GH001 in Postpartum Depression

This study is a multicenter, open-label, single-arm Phase 2 clinical trial. Approximately 15 female participants with clinically diagnosed postpartum depression (PPD) will be included in this study. The participants will receive an individualized dosing regimen (IDR) with at least one and up to three doses of GH001 administered within a single day.


Eligibility Criteria:
Inclusion Criteria:

* Is female and in the age range between 18 and 45 years (inclusive) at screening.
* Has a body mass index (BMI) in the range of 18.5 and 35 kg/m2 (inclusive) at screening.
* Meets the trial criteria for PPD as assessed by a trial psychiatrist or registered clinical psychologist.

Exclusion Criteria:

* Has one or more first or second degree relatives with a current or prior diagnosis of bipolar disorder, psychotic disorder or other mood disorder (including MDD) with psychotic features.
* Current pregnancy resulting in termination, still-birth, pre-term delivery (before week complete gestational week 37), need for intensive care therapy of mother or child, or adoption of child away from patient.
* Has taken prohibited medication or prohibited dietary supplements within the specified timeframe prior to dosing.
* Has previously experienced a significant adverse reaction to a hallucinogenic or psychedelic drug according to the investigator's judgment.
* Has a clinically significant abnormality in physical examination, vital signs, ECG, or clinical laboratory parameters which renders the patient unsuitable for the trial according to the investigator's judgment.
* Patient who has a positive pregnancy test at screening or on the pretest day, is pregnant, or plans to become pregnant during the course of the trial and up to 90 days after GH001 dosing.
The Application of Enhanced Recovery After Surgery (ERAS) for Cardiovascular Surgery in Adult

Among adults, patients undergoing elective extracorporeal circulation for cardiac surgery are included in the ERAS strategy intervention plan, which mainly includes preoperative education, preoperative oral intake of multidimensional carbohydrate beverages, multimodal analgesia, blood protection strategies, correction of perioperative hypoalbuminemia, early removal of tracheal intubation, maintenance of blood sugar at reasonable levels, and targeted liquid therapy. The traditional plan group follows the current clinical diagnosis and treatment routine. By comparing the differences in the incidence of major postoperative outcomes (MACCE events, major pulmonary complications, and acute kidney injury) between the intervention group and the non intervention group, as well as comparing other adverse events (including but not limited to pneumonia, massive bleeding, postoperative arrhythmia, incision infection, postoperative nausea, vomiting, and delirium), all cause secondary intubation, and all cause secondary surgery between the two groups, and recording hospitalization time, ICU stay time The removal time of tracheal intubation and drainage tube, as well as the pain score during hospitalization and the total amount of opioid drug use (converted to equivalent dose morphine), hospitalization cost, postoperative recovery quality QoR15 scale score, and patient satisfaction score, were recorded to explore whether the ERAS regimen can reduce the incidence of major postoperative adverse events, improve patient prognosis, and accelerate postoperative recovery compared to traditional regimens.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 to 80 years
* Patients awaiting elective cardiac surgery with cardiopulmonary bypass (CPB)

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) class is above class V
* Patients with cardiac assist device or mechanical ventilation
* The ejection fraction of patients is less than 30%
* Patients with morbid obesity
* Patients with severe obstructive sleep apnea-hypopnea syndrome (OSAHS)
* Patients with severe pulmonary disease, including severe chronic obstructive pulmonary disease (COPD) or respiratory failure
* Patients with severe liver or renal dysfunction, including severe acute or chronic renal dysfunction need renal replacement therapy, and acute or chronic liver failure need artificial liver therapy
* Patients with long-term opioid or sedative utilization
* Patients with a history of alcohol or cigarette abuse
* Patients with long-term hormone therapy
* An international normalized ratio \> 2.0
* Patients with severe malnutrition
* Mental or legal disability
* Current enrollment in another clinical trial
* Patients' refusal or low adherence
Use of Convalescent Plasma for COVID-19

The plan is to transfuse COVID-19 infected patients with convalescent plasma and observe whether this will result in a significant improvement in clinical outcome in comparison to historical experience.


Eligibility Criteria:
Inclusion Criteria:

* Documented COVID-19 infection by nasal pharyngeal sampling
* COVID-19 disease falling into one of the following groups:
* Critical disease: respiratory failure requiring mechanical ventilation, pressor support, or multiple organ dysfunction/failure
* Severe disease: tachypnea \>/=30 per min, O2 sats \</=93% at rest, PaO2/FiO2 index \</=300mmHg
* High Risk: upper respiratory symptoms but no radiographic evidence of disease, immunocompromised, insulin-dependent diabetes, poorly controlled HIV disease, moderate to severe asthma history, severe COPD, morbid obesity (BMI \>/=40, age \>/=65 years
* Health Care Providers: health care providers at risk to exposure to COVID-19 infection or those with mild to non-severe disease

Exclusion Criteria:

* History of IgA deficiency
* History of anaphylatic reaction to blood product transfusion including hypersensitivity to immunoglobulin therapy
Magnetic Resonance Imaging Autopsy Study

The aim of this project is to establish whether magnetic resonance (MR) imaging can provide a minimally invasive approach for post-mortem assessment of the fetus, infant and child, with similar detection rates for anomalies and determination of the cause of death.

This will be achieved by acquiring a database of whole-body, post-mortem MR images in approximately 400 fetuses, infants and children, over a 3 years period. Images will be acquired on a dedicated 1.5T research MR scanner. MR images will be reported by an expert group of paediatric radiologists, and compared, in a blinded fashion, with reports from conventional autopsy performed by expert perinatal and paediatric pathologists. Importantly, the post-mortem information will be assessed with reference to the needs of the parents, referring clinicians and HM Coroners. The detection of central nervous system abnormalities will be assessed separately.

The study will be performed across two sites: A dedicated children's hospital (Great Ormond Street Hospital) and a teaching hospital, with large obstetric, fetal and neonatal departments (University College London Hospital), which are linked academically by University College London.

Co-ordination of the project will be managed by a steering committee, which will ensure accurate collation and comparison of the data.


Eligibility Criteria:
Inclusion Criteria:

* Fetuses, newborns and Infants undergoing conventional autopsy

Exclusion Criteria:

* Lack of parental consent
Multicentre Study to Investigate the Performance of the Padd Device in the Assessment of Peripheral Arterial Disease

The study will compare Padd, a non-invasive automated optical device which uses a functional test to assess peripheral arterial disease (PAD), and Ankle brachial pressure index (ABPI) in the detection of PAD using as a gold standard, colour duplex ultrasound, in participants drawn from general practice, a hospital diabetic clinic and a tertiary vascular disease referral centre. The study hypothesis is that Padd performs at least as well as ABPI in detecting PAD.

400 participants, with a minimum of 200 participants per site, will be recruited from two centres. At the Royal Free Hospital, London, the inclusion criterion is simply attendance at the vascular clinic; in Leicester patients \>70 years or 50-69 years with a history of diabetes, smoking, known PAD or at least 2 risk factors (previous ischaemic event, hyperlipidaemia, hypertension, family history of cardiovascular disease) will be recruited from both primary care and the hospital diabetes clinic. The anticipated peripheral arterial disease detection rates are approximately 75% in London and 25% in Leicester.

In addition to standard questionnaires, participants will undergo bilateral Padd and resting ABPI. CDU will be performed by an accredited vascular technologist who will employ a scoring method consistent between both sites. The vascular technologist will be blind to the Padd and ABPI results. The results obtained with Padd and ABPI will be compared with CDU as the gold standard for this study.

The primary objectives are:

1. Performance: to compare Padd and ABPI for detecting PAD against a gold standard, CDU, performed by an experienced vascular technologist.
2. Safety: to compare adverse events using Padd, ABPI and expert CDU

The secondary objectives are:

1. to compare time taken to perform Padd and ABPI
2. to calculate specificities for Padd and ABPI
3. to investigate the impact of subject posture on the Padd results
4. to determine if skin colour has any impact on Padd performance

There are no treatments or interventions determined exclusively from the Padd readings.

Eligibility Criteria:
Inclusion criteria:

1. Royal Free Hospital - patients \>50 years old referred to the vascular clinic for suspected peripheral arterial disease
2. Leicester

   * age 70 years or older
   * age 50-69 years with a history of smoking, diabetes or peripheral arterial disease
   * 50-69 years with at least two peripheral arterial disease risk factors (hyperlipidaemia, hypertension, family history of cardiovascular disease, previous ischaemic event: myocardial infarction, stroke and TIA)

Exclusion Criteria:

1. bilateral amputation that precludes placement of the Padd sensors on the feet
2. acute deep venous thrombosis, within the previous six months (application of ABPI pressure cuff on legs is not advisable for these patients)
3. skin damage or infection that precludes placement of sensors
4. active psychotic illness or severe cognitive impairment
5. inability to lie supine
NEUROMARK Registry Study

The NEUROMARK Registry Study is a prospective, multicenter, single-arm, post-market, interventional registry study to collect real-world evidence of the NEUROMARK System in subjects with chronic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

Subject MUST:

1. Be ≥18 years of age.
2. Be scheduled to receive treatment with the commercially available NEUROMARK System consistent with the device's indications for use.
3. Have moderate to severe symptoms of running nose (individual rTNSS symptom rating of 2 or 3), mild to severe symptoms of nasal congestion (individual rTNSS symptom rating of 1, 2, or 3), and a minimum total score of 5 (out of 12) at screening.
4. Be willing and able to provide consent and comply with all study elements, as indicated by written informed consent.

Exclusion Criteria:

Subjects Must Not:

1. Have a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) in the past 3 months.
Xyrem and Brain Dopamine in Narcolepsy

The overall aim of this investigation is to establish whether an action of Xyrem® on the brain dopamine system in patients with narcolepsy, and in a comparison control group, might explain part of the anti-narcoleptic effect of the drug.

Trial Objective is to establish, using positron emission tomography (PET), in Xyrem®-naïve narcolepsy with cataplexy patients, and in matched controls, whether a single dose of Xyrem® causes changes in striatal binding of 11C-raclopride and 11C-DTBZ that would suggest altered activity of brain dopamine neurones.


Eligibility Criteria:
Inclusion Criteria:

* current diagnosis of narcolepsy with cataplexy OR healthy control

Exclusion Criteria:

* use of any sedative hypnotics, tranquilizers, anticonvulsants, antihistamines (except non-sedating), benzodiazepines, clonidine or any medication known to affect dopamine at start of baseline period
* significant unstable or uncontrolled medical/psychiatric disease
* significant history of head trauma/surgery or seizure disorder
* radiation exposure exceeding 20mSv in last 12 months
* pregnancy
* substance abuse/dependence (including alcohol)
* have sleep apnea, or are shift workers
* on a sodium-restricted diet
* has ever taken Xyrem / sodium oxybate / GHB at any time
* claustrophobia
* metal implants / objects in the body that may interfere with MRI
* succinic semialdehyde dehydrogenase deficiency
Effects of Octreotide Acetate on Circulating Levels of Chromogranin A in Advanced Prostate Cancer Patients

The present study will provide information on whether the somatostatin analog, octreotide acetate, could have an inhibitory effect on circulating chromogranin A. The demonstration of an antisecretory effect of somatostatin analogs could offer a rationale for a large scale randomized study.


Eligibility Criteria:
Inclusion Criteria:

1. Male patients aged \>18
2. ECOG performance status \< 3
3. Patients with metastatic prostate cancer currently receiving 1st line hormonal therapy (LHRH agonists or surgical castration) and failing with raising serum PSA
4. Biochemical progression documented by three consecutively rising serum PSA measurements, each separated from the other by at least 2 weeks, with the last measurement being 50% or greater than the nadir PSA achieved after the last therapeutic maneuver (i.e. first line hormonal therapy noted above)
5. Demonstrated tolerance to a test dose of s.c. octreotide acetate injection at Visit 1
6. Elevated (\> 40 U/L according to DAKO Elisa kit) chromogranin A plasma levels documented by at least two consecutive measurements
7. Liver function tests \< 2.5 ULN, serum creatinine within normality
8. Serum PSA (50% increased value) above 4 ng/mL for patients with intact prostate and \> 0.8 ng/mL for post prostatectomy patients at study entry
9. Immediate history of rising PSA \< 10 months
10. Castrate levels of testosterone (\< 30 ng/dL)
11. Life expectancy of \> 6 months
12. Signed informed consent prior to initiation of any procedure

Exclusion Criteria:

1. Prior chemotherapy or other systemic anticancer therapy except for LHRH agonists, and/or non-steroidal anti-androgens (eg, flutamide, bicalutamide or nilandron)
2. Palliative radiotherapy less than 6 weeks (42 days) prior to planned entry date
3. Other investigational drugs within the past 28 days
4. Long-term (\> 3 months) treatment with proton pump inhibitors
5. Uncontrolled blood hypertension
6. Other malignancies within 5 years prior to study entry, except for curatively treated non-melanotic skin cancer
7. Patients with another non-malignant disease which would confound the evaluation of the primary endpoints or prevent the patient from complying with the protocol