cyrilzakka/clinical-trials huggingface dataset:
Randomized Trial of Nordic Walking vs. Standard Cardiac Rehabilitation in Patients With Heart Failure

The main purpose of our project is to see if a 12-week program of Nordic walking is better than standard exercise therapy for increasing exercise capacity (measured by how far people can walk in 6 minutes) and increasing quality of life (measured by having people fill out two questionnaires). We will also see if Nordic walking: improves heart performance (measured by heart ultrasound); improves how active people are (measured by an activity monitor); increases aerobic fitness (measured by a treadmill test); improves body composition (measured by waist size); and reduces hormone levels in the blood.

A single-site, parallel-group, randomized controlled trial will be conducted (Appendix C) at the University of Ottawa Heart Institute (UOHI). Patients with stable HF referred to cardiac rehabilitation will undergo baseline assessment and then be randomly assigned (1:1) to either standard exercise therapy (consisting of regular walking and a resistance exercise program) or Nordic walking. Follow-up measures will be taken at the end of intervention (12 weeks) and after a 14-week no-intervention observation period (26 weeks). After initial randomization to treatment group, participants will be stratified by treatment group and randomly assigned to one of three follow-up measurement conditions at 12 weeks: echocardiograph and cardiopulmonary test (N=80); cardiopulmonary test only (N=60); or no follow-up echocardiograph or cardiopulmonary test (N=76). The primary outcomes will be: a) changes in exercise capacity measured by 6MWT; and b) changes in disease-specific HRQL measured by the MLHFQ. Additional measures will examine the effects of the exercise interventions on: cardiac performance; leisure time activity; cardio-respiratory fitness; body composition; neurohormonal activation; and generic HRQL

Eligibility Criteria:
Inclusion Criteria:

* Patient has a confirmed diagnosis of HF based on a HF admission and/or a clear diagnosis of HF and/or reduced ejection fraction (≤45% measured by echocardiography within the last six months);
* Patient is referred to cardiac rehabilitation program;
* Patient is willing to attend an onsite cardiac rehabilitation program twice weekly for 12 weeks;
* In the opinion of the referring physician, the patient is medically stable, and able to participate in an exercise program
* Patient is able, in the opinion of the qualified investigator, to comprehend and participate in the exercise intervention;
* Patient is 18 years of age or older;
* Patient is willing to provide informed consent.

Exclusion Criteria:

* Patient is unable to read and understand English or French
* Patient intends to begin cardiac rehabilitation within the next 6 weeks
* Patient is unwilling or unable to return for follow-up visits at 12 and 26 weeks;
* Patient is currently using Nordic Walking poles.
A Study of N-Acetylcysteine (N-AC) in People Receiving CAR T-cell Therapy for Lymphoma

The purpose of this study is to test the safety of N-AC when given in combination with Yescarta to people with lymphoma. This study will test different doses of N-AC to find the highest dose that causes few or mild side effects in participants.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be 18 years of age or older
* Patients who will receive axicabtagene ciloleucel for treatment of lymphoma
* Patients must have adequate end organ function to be eligible for this study as defined by the following criteria:

  * ECOG performance status 0-2
  * Hematologic function with ANC ≥ 1000, Hgb ≥ 8, Plt ≥ 50k unless there is disease related hematologic toxicity
  * Renal function with CrCr ≥ 40 ml/min or Cr ≤ 1.5 x ULN
  * Hepatic function with ALT/AST ≤ 2.5 x ULN, TBili ≤ 1.5 x ULN.

Exclusion Criteria:

* Patients with known allergy to N-AC
SUPerficial ENDometriosis In Magnetic Resonance Imaging

The purpose of the study is to determine the correlation between the diagnosis of Superficial endometriosis by the 3DT1 sequence on Magnetic resonance imaging and the histology obtained by laparoscopy.

This is a prospective, multicenter, non-randomized study evaluating the diagnostic performance of Magnetic Resonance Imaging in superficial endometriosis.

The duration of the patient's participation in the study is a maximum of 15 months depending on the length of the screening period and the time between Magnetic Resonance Imaging and laparoscopy.

After selection, the investigator will check the patient's eligibility and offer her the study. If she accepts and signs the informed consent form, the patient will have an exploratory pelvic Magnetic Resonance Imaging lasting approximately 15 to 20 minutes, without systematic injection of contrast product.

After Magnetic Resonance Imaging, the patient will benefit from a laparoscopy under general anesthesia lasting an average of one hour.

Eligibility Criteria:
Inclusion Criteria :

* Age ≥ 18 years;
* Non-menopausal patient;
* Patient scheduled for exploratory laparoscopy;
* Patient requiring a preoperative pelvic MRI
* Patient having been informed and having signed an informed consent form.

Exclusion Criteria :

* Classic contraindications to magnetic resonance imaging;
* Contraindications to anesthesia for exploratory laparoscopy;
* Contraindication to surgery following the findings of magnetic resonance imaging results;
* Patient with endometrioma \> 4 cm;
* Patient with known deep endometriosis;
* Patient uncooperative with protocol requirements or unable to attend the center for scheduled visits;
* Pregnant woman or woman of childbearing age, without effective contraception or breastfeeding;
* Patient participating in another clinical trial, or during a period of exclusion from another clinical trial;
* Patient under guardianship, under curatorship or subject to legal protection, persons deprived of liberty by a judicial or administrative decision, persons subject to psychiatric care and admitted to a health or social establishment;
* Patient not beneficiary of a social security system
* Patient under State Medical Aid.
Patients' Satisfaction in Thoracic Surgery Inpatients

Patient satisfaction is considered a subjective indicator of the quality of care provided during a hospital course. Identifying the factors that affect patient satisfaction across remains essential. Recognizing the growing importance of this metric in assessing medical performance, this study aimed to evaluate the satisfaction and associated factors among inpatients of the thoracic surgery unit of a tertiary care government hospital in Nepal.

A cross-sectional analysis of satisfaction levels was conducted among 122 patients consecutively admitted to the Thoracic Surgery unit. Data were collected by interview using a questionnaire of 23 domains scored on a 4-point Likert scale, adapted from the Health Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey. Descriptive and inferential statistics (independent t-test and Chi-square test) were used for data analysis.

Eligibility Criteria:
Inclusion Criteria:

* all patients (or the guardian if the patient was less than 18 years, or could not consent for some reason) admitted to the study site during the study period

Exclusion Criteria:

* refusing to participate, who were hospital staff or their close family members, and those who could not be contacted for interview
Evaluate SAGE-547 in Participants With Essential Tremor

Stage 1 is a double-blind, proof-of-concept study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of SAGE-547 Injection in male and female participants with essential tremor in the upper limb.

Stage 2 is an open-label arm designed to evaluate the safety, tolerability, PK, and effectiveness of SAGE-547 Injection at a higher dose than in Stage 1. Participants who completed Stage 1 were invited to participate in Stage 2.


Eligibility Criteria:
Inclusion Criteria:

* Males and females, 35-75 years old with a diagnosis of essential tremor with symptoms clearly present in at least 1 upper limb; participant has had tremor present for at least 2 years prior to Screening
* Off medication, or on a stable dose of medication for their tremor for at least 28 days prior to Screening

Exclusion Criteria:

* Recent history or active clinically significant manifestations of metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, musculoskeletal, dermatological, urogenital, eyes, ears, nose, or throat, psychiatric, or neurological (other than essential tremor) disorders
* Medical history of seizures
Hypofractionated Radiotherapy for Recurrent DIPG

This study evaluates the feasibility of hypofractionated radiotherapy (RT) in the palliative treatment of recurrent diffuse intrinsic pontine glioma (DIPG). Participants will receive 15 Gy in 3 fractions as opposed to the standard 20 Gy in 10 fractions.


Eligibility Criteria:
Inclusion Criteria:

1. Patients must be ≤30 years of age
2. Patients must have a diagnosis of progressive DIPG.
3. Received prior IMRT based definitive radiotherapy to a dose of ≥54 Gy.
4. The patient and or parent/legal guardian must be physically and mentally capable of signing the consent form of their own volition.
5. Steroids dosage must be unchanged for 5 days.
6. No Bevacizumab within 21 days (Half-life 11 days \~)

Exclusion Criteria:

1. Patients with incomplete medical records
2. Patients with prior history of reirradiation for DIPG
3. Life expectancy \< or equal to 1 month
4. Pregnant women
5. Age \>30
6. Prisoners
7. Concurrent systemic therapy at the time of reirradiation
8. Physically or mentally incapable of signing the consent form of their own volition
9. \< 6 mos time interval between completion of initial RT to start of reRT.
Case Studies of Patients Who Had Experienced Near Death Experience

An prospective observational study to interview patients who had near death experiences among those who had received intensive care unit intervention during admission in hematology ward.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥19yrs) who are in admission in the Hematology ward of Seoul National University Hospital, and one of the following conditions.

  1. recovered after cardiopulomary resuscitation
  2. recovered after mechanical ventilator
  3. recovered after ICU care
  4. recovered after emergent operation
  5. recovered after Shock, coma, altered mentality
  6. Other medical conditions approaching death

Exclusion Criteria:

1. Those who do not agree to participate this study
2. Those who can not be interviewed due to insufficient recovery from critical medical problems
Achalasia Patient Reported Outcomes

Patients that are either scheduled to undergo or have undergone an achalasia procedure at the Mayo Clinic Rochester are asked to participate. The purpose of this study is to gather information and determine if one of these procedures is superior to the other.

This is a non-randomized, non-inferiority trial that has been created to compare results of achalasia procedures including but not limited to: POEM + Partial Fundoplication (PF), POEM and Laparoscopic Modified Heller Myotomy + PF and POEM + Peroral Plication of the esophagus. Using a set of consistent evaluation tools for patients undergoing treatment for achalasia allows a standardized evaluation and comparison of these groups of patients. The long term and comparative POEM procedure outcomes are not currently known. Patients undergoing POEM, fundoplication, and/or laparoscopic myotomy report having varying degrees of symptoms of reflux, dysphagia, and pain. Providers also note varying degrees of esophagitis by endoscopy, reflux by impedance or pH scoring, and recurrence by repeat manometry. Many of these issues can be quantified using pH probe testing, upper GI endoscopy, high resolution manometry, CT scans, Endoflip device and esophagrams. There are various validated questionnaires that have been used to assess problem areas of reflux, dysphagia, and pain such as the Promis Global Health Score, Ekhardt Score, Mayo GER Score, Modified Dysphagia Questionnaire-30 Day, Zubrod Score, and pain scale. Each of these symptoms, tests, and questionnaires contributes to the provider's understanding of the patient's postoperative outcome.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* Undergoing a POEM or laparoscopic modified heller myotomy and anti-reflux procedures
* Esophagus diameter less \<8 cm on barium swallow test

Exclusion Criteria:

* Pregnant
* Diverticular disease of the esophagus
* Barrett's esophagus
* Extensive abdominal adhesions
* \<50% predicted FEV1 on pulmonary function testing
* Cardiac ejection fraction \<25%
* Esophageal stricture from prior myotomy
* Sigmoidization of the esophagus
* More than one prior balloon dilation (\>3 cm) or any prior dilation of 3 cm
The Efficiency of HHHFNC Between Unheated Oxygen Therapy in Difficult Weaning Patients After Extubation in RCC

The purpose of this study is to assess the efficacy of Heated Humidified High-Flow Nasal Cannula compared with noninvasive positive-pressure ventilation in the prevention of extubation failure in patients with prolonged mechanical ventilation.

There have been many clinical trials comparing the role of Heated Humidified High-Flow Nasal Cannula or Noninvasive positive pressure ventilation in the prevention of extubation failure.

These review all have similar results summarized here:

Compared with Noninvasive positive pressure ventilation, Heated Humidified High-Flow Nasal Cannula provides better patient comfort, fewer oxygen desaturation episodes, lower likelihood of interface displacement, and, lower reintubation rate than Noninvasive positive pressure ventilation.

However, most of these clinical trials focused on participants experiencing acute respiratory failure.

Investigators of this study want to find something difference between oh these two groups.

Eligibility Criteria:
Inclusion Criteria:

* Age: Over 20 years of age
* the requirement of at least six hours of mechanical ventilation per day for at least 14 consecutive days

Exclusion Criteria:

* Pregnancy
* Status post tracheostomy
* Neuromuscular diseases
* Signed "do not resuscitate" order
* Unplanned extubation
One-stage Bone Lengthening in the Management of Brachymetatarsia

Brachymetatarsia is a shortening in length of a metatarsal exceeding 5mm. This congenital anomaly most often affecting women and the second metatarsal is associated with frequent aesthetic disorders leading patients to consult. The one-time lengthening technique is described for the management of brachymetatarsia with good functional results. However, the metatarsal elongation in one time is limited to 15 millimeters, to avoid complications.

No study has presented the consequences of hypocorrection, especially cosmetic. Our hypothesis is that undercorrection (Hypocorrection) is associated with a higher rate of cosmetic dissatisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Patients operated on for a one-time lengthening for isolated brachymetatarsia
* Major patients

Exclusion Criteria:

* Patient refusing to participate in research
Insomnia Treatment and EMA (ecological Momentary Assessment) Outcomes

The goal of this study is to examine the impact of suvorexant, an FDA-approved insomnia medication, on daytime symptoms (as measured by the Daytime Insomnia Symptoms Scale: cognition, positive mood, negative mood, and fatigue/sleepiness) among older adults with insomnia. The primary hypothesis is that relative to placebo, suvorexant will improve sleep and daytime symptoms. The word "placebo" refers to a harmless pill with no therapeutic effect.

The study will take about six to eight weeks to complete. Participants will have a home sleep apnea test (HSAT) and complete a clinical interview. Participants will also complete a baseline assessment, which will take place over one or two days (about 3 hours total).

During the study, participants will complete research questionnaires and cognitive testing at baseline and post-baseline (after treatment). Participants will also complete brief EMA surveys (sleep diary and Daytime Insomnia Symptoms Scale) via mobile device 4 times per day for approximately 16 days; each survey will take about 2 minutes or less to complete. Participants will also wear an actigraph on the non-dominant wrist. This device looks like a wristwatch and measures ambulatory movement, a validated proxy for sleep.

Eligibility Criteria:
Inclusion Criteria:

* Meets Diagnostic and Statistical Manual - Fifth Edition (DSM-5) diagnostic criteria for insomnia disorder.
* Insomnia Severity Index total score \>10.
* Insomnia symptoms must include problems with wake after sleep onset.
* Insomnia symptom duration \> 6 months.
* Baseline self-reported total sleep time \< 6.5 hours per night.

Exclusion Criteria:

* High risk for untreated organic sleep disorders other than insomnia (narcolepsy, periodic limb movement disorder, etc) as determined by structured clinical interview and investigator clinical judgment.
* Current diagnosis of a major untreated psychiatric disorder(s).
* History of serious suicide attempt within past 5 years.
* History of alcohol or substance abuse (including prescription medication abuse) within past 5 years.
* Heavy alcohol consumption (e.g., \>5 drinks per day or \> 14 drinks per week.
* Heavy caffeine use \[(\>2 cups of coffee/day (equivalent).
* Current tobacco or nicotine use.
* History of previous allergic reaction, sensitivity, or severe side effects to sedative hypnotics.
* CYP3A inhibitors.
* Refusal to discontinue or intention to initiate OTC or other sleep aids during study period.
Intranasal Ketamine Versus Intranasal Fentanyl

Abstract Background: Given the inadequate control of pain in patients with injury that refer to the emergency departments, the rapid onset of action of intranasal administration in pain management, and the avoidance of administering opioid medications, the present study aimed at evaluating the effect of intranasal ketamine versus intranasal fentanyl on pain management in isolated traumatic patients Materials and Methods: The current study was performed on 125 patients that were divided into the following three groups: control group (n = 41), 1 mg/kg intranasal ketamine group (n = 40), and 1μg/kg intranasal fentanyl group (n = 44). Then pain scores, HR, RR, BP, and SaO2 were recorded at baseline, 5, 10, 15, 30, and 40 minutes after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* patients with acute limb trauma, aged 15-65 years, with moderate to severe pain (45 mm; visual analog scale (VAS)), with a GCS score of 15, with the systolic blood pressure of lower than 180 mmHg, diastolic blood pressure of higher than 90 mmHg
* lack of pregnancy
* no history of allergy to ketamine, fentanyl (or opioids), or acetaminophen,
* no history of liver diseases,
* no acute or chronic structural or functional nasal obstruction diseases,
* no history of drug or psychiatric addiction,
* no pain medication within the past four hours,
* no history of heart disease,
* and the presentation of the written consent to participate in the study.

Exclusion Criteria:

* a decrease in GCS score to less than or equal to 14,
* an elevated systolic blood pressure to higher than 180 mmHg,
* a decreased diastolic blood pressure to less than 80 mmHg,
* inability to understand the VAS pain rating system,
* symptoms of acute heart disease and respiratory depression (respiratory rate \<8 / min),
* and the patient's dissatisfaction to continue the cooperation in study
Phase II Study of Lactulose and Circadian Rhythms in Patients With Cirrhosis

OBJECTIVES: I. Assess the effect of lactulose on the circadian rhythm of plasma melatonin in patients with subclinical hepatic encephalopathy.

II. Assess the intrasubject variability of circadian melatonin levels and neuropsychological tests.

III. Assess which elements of the neuropsychological test battery show the response to lactulose.

PROTOCOL OUTLINE: Patients are alternately assigned to 1 of 2 treatment groups: no therapy for 3 weeks followed by lactulose for 3 weeks versus lactulose for 3 weeks followed by no therapy for 3 weeks.

A dietician advises patients on a 1 g/kg per day protein diet. The lactulose dose is adjusted to result in 2 or 3 loose bowel movements per day.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Clinical diagnosis of cirrhosis with portal hypertension or portal-systemic shunting

--Prior/Concurrent Therapy--

* No concurrent therapy for hepatic encephalopathy

--Patient Characteristics--

* Age: Under 65
* Performance status: Not specified
* Hematopoietic: Not specified
* Hepatic: See Disease Characteristics
* Renal: Not specified
* Other: No alcohol intake within 1 month prior to entry No requirement for beta blockers No requirement for corticosteroids Not in intercontinental travel
Telemark Polyp Study, a Trial on Colonoscopy Screening

Colonoscopy screening to reduce mortality and incidence of colorectal cancer (CRC) has been implemented in many western countries. The estimated effect is based on case-control and observational studies. There are no randomized trials quantifying the effect of colonoscopy screening on CRC incidence and mortality.

The present study investigates the effect of a population-based once-only colonoscopy screening with polypectomy on the incidence of CRC in an average risk population.

In 1983, 900 individuals 55 to 64 years of age were randomly drawn from the population registry of Telemark county, Norway. 400 of these were invited to a flexible sigmoidoscopy screening examination, and 400 individuals were not offered any screening. In 1996, the remainder, both cohorts from 1983 were invited to a colonoscopy screening examination. A new age and sex matched control group, not being offered screening, was randomly drawn from the same registry. Both groups are to be followed with regard to CRC incidence, CRC mortality and all-cause mortality through national Norwegian registries.

This as a randomized study of once-only colonoscopy screening (n=685) vs/no screening(care as usual)(n=684). Men and women at 63-72 years of age are recruited from the population registry. The intervention group is invited for screening after a bowel cleansing regimen at home. Follow-up is restricted to trace events (colorectal cancer incidence and deaths) through national registries.

Eligibility Criteria:
Inclusion Criteria:

* Age 55 to 64 years old
* Both male and female

Exclusion criteria:

- Colorectal cancer diagnosed before study entry
Magnitude of Changes in 25 OH Vitamin D3 Levels After Vitamin D3 Supplementation

Vitamin D deficiency is common world wide. 25 OH vitamin D level is the best indicator of vitamin D status. The determination of the appropriate dose of vitamin D supplement is essential for management of vitamin D deficiency as well as for designing vitamin D fortification programs. The increments in 25 OH vitamin D levels following various doses of vitamin D supplement for different genders, body weights, and starting 25 OH vitamin D level have not been well defined. The time course of depletion of repleted vitamin D stores is also not known.

The investigators plan to conduct a double blind randomized study on 9 cohorts to determine levels of 25 OH vitamin D following supplementation with different doses of vitamin D3 for 5 months and their withdrawal for 3 months.


Eligibility Criteria:
Inclusion Criteria:

* Adults living in Riyadh area who consume no more than one serving of milk/day, do not take vitamin supplement, habitually have less than 10 hr of sun exposure per week, don't suffer from granulomatous conditions, liver disease, or kidney disease, and don't take anticonvulsants, barbiturates, or steroids.
* Individuals with with total 25 OH vitamin D level exceeding 100 nmol/l will be excluded from the study. Individuals with 25 OH vitamin D levels less than 20 nmol/L will be excluded from the placebo arm.