cyrilzakka/clinical-trials huggingface dataset:
Logotherapy Counseling Programme for Palliative Care Patients With Chronic Sorrow

The purpose of this study is to evaluate the effectiveness of logotherapy counseling program on chronic sorrow, meaning of life and dignity of palliative care patients.

Palliative care patients experience psychosocial and spiritual problems such as depressed mood, fear of metastasis, uncertainty, lack of pleasure, fear of suffering, and chronic sorrow. Logotherapy is a meaning-centered intervention helping the individual to discover the meaning of life and increasing the spiritual well-being and quality of life of the individual. In this study, the effect of logotherapy counseling program on dignity, chronic sorrow and meaning of life of palliative care patients will be evaluated.

In this study, the participants will be randomized in a single blind manner (participant) to either intervention (8 session-4 week logotherapy) or control (routine care) groups.

Eligibility Criteria:
Inclusion Criteria:

Hospitalized patients due to advanced cancer Patients informed of cancer diagnosis at least 1 month Patients reporting to have chronic sorrow Patients with palliative performance scale score at least 50% Patients having life expectancy more than 6 months Patients who volunteered to participate in the study and signed written informed consent

Exclusion Criteria:

Clinically diagnosed mental disorder Patients with palliative performance scale score \< 40%
A Controlled Study of Improved Javelin Side Recumbent Position and Conventional Postural Placement

The Da Vinci surgical robot Xi system assisted laparoscopic pyeloureteroplasty uses the improved javelin side lying position, which can alleviate the unsafe factors of falling from the bed caused by the conventional posture, shorten the time of placing the posture5, prevent the possible pressure injuries and intraoperative complications caused by the conventional posture surgery, and the operation is more simple and convenient. The mechanical arm of the Da Vinci robot will not have the potential risk factors of crushing the head, face and trunk of the patient during the entire operation process, It is safe and reliable, making the whole process of positioning convenient and time-saving. It can not only improve the connection efficiency of each operation, but also ease the work intensity of nurses and reduce the incidence of robot secondary berths. Operator satisfaction. It is safe and reliable to achieve good results, improve the operation safety, effectively avoid intraoperative and postoperative complications, and ensure the operation safety of patients, which is worth promoting.

To discuss the comparative study of different localization methods in robot-assisted laparoscopic epirenoplasty.

From December 2021 to January 2022, the researchers selected 60 participants to undergo laparoscopic pyroplasty assisted by the Da Vinci Robotic Xi system. Depending on the order of the surgeries, the researchers randomly assigned them， the subjects into three groups: control group A, control group B and observation group C, each with 20 cases. In control group A, we adopted the conventional lateral position, control group B adopted the lumbar bridge cushion lateral position, and observation group C adopted the modified javelin lateral position, The operation time, secondary berth incidence, operation time, intraoperative blood loss and the incidence of intraoperative complications were compared among the three groups.

Eligibility Criteria:
Selection Criteria:

1. Clinical diagnosis of obstruction at the renal pelvis ureteral junction.
2. Must be able to fit the treatment done under the robot platform

Exclusion Criteria:

1. Patients who can use balloon dilation to achieve the therapeutic purpose
2. Open surgery is required
Clinical Evaluation of the Accuracy of Vitastiq Device for Tracking Vitamin and Mineral Trend in Human Body

This is a single site evaluation study of Vitastiq device accuracy in healthy men and women in ratio 1:1 (approximately) aged between 18 and 64 years. A total of 45 Vitastiq personal devices will be used by volunteers for two months. The Vitastiq device will be evaluated during three site visits: on day 1, 29 ± 4 days and 57 ± 4 days. During site visit days, blood sampling will be collected and analysed and readings using Vitastiq device will be performed. Data will be analysed retrospectively to evaluate Vitastiq performance compared to blood tests results.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent form (ICF) is signed by a volunteer
* Age between 18 and 64 years at the time of the signature of ICF
* A body mass index (BMI) between 18 and 28 kg/m2
* Healthy, meaning absence of any chronic or acute medical therapy for a month prior to the inclusion to the study
* Willing to follow all study procedures, including attending all site visits, and keeping a food diary and diary of activities on a weekly basis

Exclusion Criteria:

* Intake of any drugs to treat chronic disease within 1 month before the beginning and during the study
* Intake of any drugs to treat serious acute disease within 1 month before the beginning of the study and within 5 days of each visit
* Any clinically significant medical history of serious digestive tract, liver, kidney, skin or haematological disease or hormone imbalance
* Pregnant and breastfeeding women
* Women who planning pregnancy during the study
* Inadequate veins (in the opinion of the investigator)
* Known drug or alcohol abuse
* Using any form of nicotine or tobacco
* Mental incapacity that precludes adequate understanding or cooperation
* Participation in another investigational study or blood donation within 3 months prior to or during this study
Deep Neuromuscular Relaxation Optimizing Low-Pressure Bariatric Surgery

This study aims to evaluate the use of deep neuromuscular blockade and low-pressure pneumoperitoneum in bariatric surgery. The investigators propose to conduct a double-blind randomized controlled trial (RCT) comparing deep neuromuscular blockade versus standard blockade, and its impact on operative conditions during bariatric surgery. This trial will be conducted at one of the highest volume bariatric centers in Canada. This study also aims to examine the effects of deep neuromuscular blockade on patient-relevant outcomes, including postoperative pain and narcotic use. The investigators anticipate this study will facilitate the continual improvement of care provided to a growing number of bariatric patients.

This will be a double-blind randomized controlled trial comparing patients undergoing a deep neuromuscular blockade with a paralytic reversal agent versus patients undergoing standard anesthetic protocols in low-pressure pneumoperitoneum bariatric surgery. The study population will include patients aged 18-65 referred to St. Joseph's Healthcare for Roux-en-Y Gastric Bypass (RYGB) after completion of standard work-up for bariatric surgery through the Ontario Bariatric Network (OBN). The investigators plan to recruit and randomize 100 patients in a 1:1 ratio between deep NMB and standard anesthetic in low-pressure pneumoperitoneum bariatric surgery. Once enrolled in the study, patients will be assigned to one of the two groups using computer-based randomization on REDCap software. Allocation will be concealed until the time of the operation and will be provided directly to the anesthetist in opaque envelopes. The anesthetist will be aware of the assigned group, but the patient, surgeon, PACU nurses, ward nurses, research assistants and house staff will be blinded. The primary outcomes to be examined will include maximum intra-abdominal pressure, Leiden-Surgical Rating Scale, and postoperative pain scores. Secondary outcomes will include operative time, postoperative nausea, postoperative narcotic use, and length of stay.

Eligibility Criteria:
Inclusion Criteria:

* The patient meets NIH criteria for bariatric surgery and has not received a previous bariatric surgical procedure
* The patient is aged 18-65 years and has completed the screening and preparation process prescribed by the Ontario Bariatric Network

Exclusion Criteria:

* Inability to give informed consent
* ASA \> 4
* Planned procedure other than RYGB or contraindications to RYGB
* BMI \> 55 kg/m2
* Revisional procedure
* Allergies or suspected allergies to anesthetic medications (rocuronium or sugammadex)
* Renal insufficiency (GFR \< 30ml/min)
* Family or personal history of malignant hyperthermia or personal history of neuromuscular disease
* History of chronic pain needing daily medications for the last \>3 months
Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)

A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anemia in participants with Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)

This is a multicenter, randomized, open-label, active-controlled Phase 3 study of the efficacy and safety of Vadadustat versus Darbepoetin alfa for the maintenance treatment of anemia in participants with NDD-CKD

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Diagnosis of chronic kidney disease (CKD) with an estimated glomerular filtration rate ≤60 milliliters per minute per 1.73 square meter (mL/min/1.73 m\^2) at Screening and not expected to start dialysis within 6 months of Screening
* Currently maintained on erythropoiesis-stimulating agents therapy, with a dose received within 6 weeks prior to or during Screening
* Mean Screening hemoglobin between 8.0 and 11.0 grams per deciliter (g/dL) (inclusive) in the United States (US) and between 9.0 and 12.0 g/dL (inclusive) outside of the US
* Serum ferritin ≥100 nanograms per milliliter (ng/mL) and transferrin saturation (TSAT) ≥20% during Screening

Exclusion Criteria:

* Anemia due to a cause other than CKD or participant with active bleeding or recent blood loss
* Red blood cell transfusion within 8 weeks prior to randomization
* Uncontrolled hypertension
* Severe heart failure at Screening (New York Heart Association Class IV)
* Acute coronary syndrome (hospitalization for unstable angina or myocardial infarction), surgical or percutaneous intervention for coronary, cerebrovascular, or peripheral artery disease (aortic or lower extremity), surgical or percutaneous valvular replacement or repair, sustained ventricular tachycardia, hospitalization for heart failure, or stroke within 12 weeks prior to or during Screening
* Hypersensitivity to Darbepoetin or Vadadustat or to any of their excipients
Speech Rehabilitation Based on Mobile Applications

This study evaluates the efficacy of smartphone-based speech therapy administered at home compared with usual care. Participants will be randomized into the treatment and waitlist control groups with an allocation ratio of 1:1.

Despite the importance of dysarthria intervention in post-stroke rehabilitation, further research in this area remains underexplored. This study builds on previous research on the use of smartphone-based dysarthria interventions based on motor learning principles, such as repetitive training and feedback and neuroplasticity through repetition, motivation, and reward. The treatment duration of 1h, 5 times a week for 4 weeks, is consistent with previous behavioral interventions for post-stroke dysarthria. This study aimed to determine whether the condition of patients with stroke can be improved through the use of smartphone-based interventions. This is a single-center, investigator-blinded, randomized, crossover effectiveness study. In this study, both the objective and subjective measurements will be performed three times: at baseline, post-phase 1 study (week 4), and post-phase 2 study (week 8). The study includes three intervention cycles, and for each research cycle, 12 subjects will be recruited to participate (6 per each group × 3 cycles).

Eligibility Criteria:
Inclusion Criteria:

* Patients must be able to use a smartphone-based speech therapy application, as determined by self-reporting cognitive abilities.
* Speaks English as a native language.

Exclusion Criteria:

* Unable to use smartphone application or conduct speech assessment due to severe speech impairment.
* Self-reported co-existing progressive neurological disorders that can affect dysarthria (e.g., dementia, Pick's disease, Huntington's disease, Parkinson's disease, or Parkinsonism).
* Patient with severe mental disorders as self-reported (e.g., depression, schizophrenia, alcohol addiction, or drug addiction).
* Illiterate patients.
Barrier-Protect Study

This study will evaluate the effect of an iodine impregnated barrier dressing on device pocket swab culture positivity. Minimizing contamination during the implant procedure can be one of the potential improvements to prevent CIED infections. Patients requiring a lead change, battery change or device upgrade will be eligible. This is a randomized, blinded study where participants will be randomized to having the barrier dressing applied before any incision is made (experimental group) or applying the dressing just prior to collecting the culture swab (control group). Patients and the staff taking the culture swab at the end of the procedure are blinded as to which group the participant is randomized to.


Eligibility Criteria:
Inclusion Criteria:

1. Patient aged 18
2. Second or later procedure (including pulse generator change, lead revision and device upgrade procedures) involving manipulation of the pre-existing device pocket.
3. PADIT risk score ≥ 5

Exclusion Criteria:

1. Unable or unwilling to provide informed consent.
2. De novo device implantation.
3. Active device infection.
4. Iodine allergy
5. Life expectancy less than 2 years
Effects of Intraoperative Oxygen Therapy on Oxygenation of Newborns Born Via Elective Cesarian Section

In this study the investigators examine the effects of intraoperative oxygen administration to the mother on certain enzyme functions of the newborn. With this object blood samples are taken from the newborn's umbilical chord - which is otherwise a routine practice at the investigators clinic - and the mother's radial artery in parallel with umbilical clamping and cutting for blood gas and reactive oxygen species analyses. Samples are analyzed locally in a properly equipped laboratory.

Whole-blood superoxide and hydrogen peroxide production was measured from the newborn's umbilical chord.

Eligibility Criteria:
Inclusion Criteria:

* Elective cesarean section.
* Signed informed consent form.

Exclusion Criteria:

* Subject meets the definition of a vulnerable subject as defined in International Organization for Standardization 14155:2011.
Feasibility and Safety of MiWEndo-assisted Colonoscopy

The study involves the planned use of a new microwave-based device during colonoscopy procedures in a small group of patients to assess the preliminary safety of its use and lack of normal clinical practice modification. The device is a final design version, which has been previously tested in several preclinical studies, including: phantom studies, an ex vivo study with human tissues, and an in vivo study with animal model (pig).

This study is designed as a single-center prospective, non-comparative, first in human pilot safety and feasibility study with few patients, whereby data will be subject to an analytical description, rather than to a statistical treatment (refer to Statistical design and analysis).

In this study the principal aim is to assess the clinical safety of the device and the feasibility of its use in assisted colonoscopy. Relevant claims to verify in this study are that the device can be used without ADEs, without any change in the current clinical practice, as well as without any major difficulty by the endoscopist, neither in the preparation nor in the use of the device during exploration.

In addition, the study aims to gather real clinical data with the use of the device to optimise the processing software that will be key to demonstrate MiWEndo's performance on a subsequent clinical investigation (pivotal study).

Consequently, principal and secondary objectives of this investigation, are:

* Principal objectives:

  * To assess the feasibility of performing a complete colonoscopy using the MiWEndo System.
  * To assess the safety of MiWEndo colonoscopy.
* Secondary objectives:

  * To assess the perception of difficulty by the endoscopist when the device is used.
  * To assess the patient's comfort.
  * To collect data on polyp detection performance to guide possible further improvements of the software before starting the pivotal study.

Eligibility Criteria:
Inclusion Criteria:

* Men and women older than 50 years referred for a diagnostic or surveillance colonoscopy and having signed the Informed Consent Form.

Exclusion Criteria:

* Patients at a high risk of having major complications as perforation or hemorrhage or in whom the possibility of performing a complete colonoscopy is reduced, including: patients with known colonic strictures, total colectomy, acute diverticulitis, inflammatory bowel disease, suspected or proven lower gastrointestinal bleeding, non-correctable coagulopathy or anticoagulant/clopidogrel therapy during procedure, inadequate bowel cleansing or previous incomplete colonoscopy.
* ASA-IV patients
* Urgent colonoscopy
Vinorelbine for Recurrent ACLC

The purpose of this study is to assess the efficiency and safety of vinorelbine in the treatment of relapsed / advanced ALCL in children and adolescents.

Anaplastic large cell lymphoma (ALCL) is a rare non-Hodgkin's lymphoma, around 30% patients would get relapse. Vinorelbine(Navelbine) is a third-line treatment option for Hodgkin's disease(HD) after transplantation failed, while both HD and ALCL express CD30. When ALCL recurred, vinblastine monotherapy was used and the 5-year EFS up to 30%, 5-year OS up to 60%. In China vinblastine is unavailable. Vinorelbine is very similar to vinblastine in molecular formula, and is available in China. From November 2016 to March 2017, two patients with recurrent ALCL were recruited in the Department of Hematology and Oncology, Shanghai Children's Medical Center. They received vinorelbine monotherapy and achieved clinical remission (PET CR) at 8 weeks. One patient with bone marrow recurrence showed negative ALK / NPM by PCR . Based on this, the investigators will expand the sample to further investigate the therapeutic efficiency and safety of vinorelbine in children and adolescents with ALCL.

Eligibility Criteria:
Inclusion Criteria:

Children and adolescents with a clear diagnosis of recurrent / progressive ALCL at Shanghai Children's Medical Center or other centers since September 2017 include:

* Diagnosed as ALCL, already received first-line treatment, but get disease progression;
* After receiving ALCL treatment has got CR then diagnosed relapse, need for pathological diagnosis.

Exclusion Criteria:

* Patients with other systemic diseases, severe infections or critically illness.
A Study of Hemp Hull WFI for IBS Diarrhea

The purpose of this study is the effect of a study bar, which contains 15 grams of insoluble dietary fiber total sourced from Hemp hulls, on intestinal permeability in irritable bowel syndrome (IBS)-bile acid diarrhea individuals.

Patients with irritable bowel syndrome-bile acid diarrhea (IBS-BAD) have no evidence of significant histologically-evident inflammation or ulceration. The condition is often unrecognized in comparison with natural variations in bowel function in the general population. Hemp seeds are a complete source of protein, providing all nine essential amino acids, as well as polyunsaturated fats, especially omega-3 fatty acid, fiber, minerals and vitamins. Hemp hulls, the outer shell of the seeds, are typically rich in dietary fiber and phenolics and showed to have a beneficial effect on gut barrier function in vitro.

To demonstrate reduced intestinal permeability after 3 weeks of BB01 (20g of BB01, which reflects 15g of insoluble dietary fiber) consumption in a group of 10 patients with IBS-diarrhea with evidence of bile acid diarrhea, a group that has been previously documented to have increased GI permeability.

Eligibility Criteria:
Inclusion criteria

1. Prior diagnosis of bile acid diarrhea as documented by either

   1. total bile acid in 48 hour stool excretion of 2337 micromoles per 48 hours, or
   2. greater than 1000 micromoles per 48 hours with greater than 4% primary bile acids in stool, or
   3. greater than 10% primary bile acid (CA and CDCA) in stool 48 hour collection, or
   4. serum 7 alpha C4 greater than 52 ng/mL
2. BMI \<40 kg/m2.
3. Prior cholecystectomy, appendectomy, and tubal ligation or hysterectomy will all be permissible for participation in the study.
4. Participants receiving bile acid sequestrant will not be permitted to continue therapy. and need to stop one week before baseline test.
5. No use of oral antibiotics and NSAIDs for 2 weeks prior to study treatment

Exclusion criteria

1. Diabetes mellitus (type 1)
2. Diabetes mellitus type 2 if taking metformin or GLP-1 agonist treatment (exenatide, liraglutide, semaglutide)
3. Uncontrolled hypertension (with BP measured \>140/90mmHg in the CRTU)
4. BMI ≥40 kg/m2
5. Chronic NSAID use (\>1 day/week)
6. Use of oral antibiotics and NSAIDs for 2 weeks prior to and during the entire 21 day study period
7. Use of bile acid sequestrant for 1 week prior to and during the entire 21 day study period
8. Diagnosis of gastrointestinal diseases that are associated with inflammation such as inflammatory bowel diseases and celiac disease or gastrointestinal infection in the prior 4 weeks;
9. Prior intestinal or colonic resection; note prior cholecystectomy, appendectomy, and tubal ligation or hysterectomy will all be permissible for participation in the study
10. Participation in highly vigorous exercise such as running \>5 miles per day in week prior to the permeability test