cyrilzakka/clinical-trials huggingface dataset:
Increasing Medical Student Well-being Through Gratitude Journaling

Clerkship causes significant stress to medical students. Some interventions to increase well-being have been described but none have been studied prospectively in this context.

The primary objective of this study is to examine the effects of gratitude journaling on medical clerks' perceived well-being.

Students will be randomised to one of two groups: gratitude journaling or no intervention. The participants of the experimental group will be asked to complete an online gratitude journal 3 times per week and will be compared to the participants in the control group.

The students in both groups will answer a standardised questionnaire evaluating well-being before and after their surgical rotation.

Those randomised to the intervention group will perform gratitude journaling three times a week during their surgical rotation. This activity consists of writing something that made them feel happy during their day.

Those randomised in the control group (no intervention) will proceed with their normal rotation, without additional gratitude journaling.

The main outcome will be evaluated by comparing the well-being at the end of the surgical rotation as evaluated by a composite well-being assessment scale between both groups.

Medical education involves 2 years of rotations in different medical and surgical specialties. These cause significant stress to clerks, in particular during the surgery rotation. In other professional fields, mindfulness techniques have shown only small to moderate effect on mental health compared to the control group.

An alternative approach to increasing well-being is gratitude journaling. A study examining this approach in student populations demonstrated enhanced well-being and life satisfaction.

The primary objective of this study is to examine the effects of gratitude journaling on medical clerks' perceived well-being.

Students will be randomised to one of two groups: gratitude journaling or no intervention. The participants of the experimental group will be asked to complete an online gratitude journal 3 times per week and will be compared to the participants in the control group.

The students in both groups will answer a standardised questionnaire evaluating well-being before and after their surgical rotation.

Those randomised to the intervention group will perform gratitude journaling three times a week during their surgical rotation. This activity consists of writing something that made them feel happy during their day.

Those randomised in the control group (no intervention) will proceed with their normal rotation, without additional gratitude journaling.

The main outcome will be evaluated by comparing the well-being at the end of the surgical rotation as evaluated by a composite well-being assessment scale between both groups.

Eligibility Criteria:
Inclusion Criteria:

* Medical students at the University of Montreal about to begin their surgical clerkship rotation.

Exclusion Criteria:

-
Post-Marketing Surveillance Study To Observe INLYTA® Treatment Dosing Pattern, Safety And Effectiveness In Taiwan Real World Routine Practice

This is a post-marketing Surveillance study to observe INLYTA® treatment dosing pattern, safety and effectiveness in Taiwan real world routine practice. The primary objective of this registry is to monitor the dose adjustment of INLYTA® in real world routine practice. The secondary objectives include safety profile, objective response rate, and progression-free rate in real world routine practice.

This is a multi-center chart review registry on mRCC patients treated with axitinib. Primary objective is the dose adjustment. Secondary objectives are safety profile, objective response rate and progression free survival. Efficacy assessment will be based on investigators' judgment. Patients treated with 1st dose of axitinib between May 7, 2013 and June 30, 2015 will be enrolled. The follow-up time is 12 months. Prior therapies should include sunitinib or interferon alpha.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed as advanced RCC by histology or cytology
* Patients using axitinib as therapy after failure of sunitinib or cytokine
* Patients received axitinib treatment and follow up in the health care center participating present registry
* Patients agree to participate and signed inform consent or IRB waiving of signed informed consent document is available

Exclusion Criteria:

* Patients with first dose of axitinib earlier than 7th May 2013
* Patients with first dose of axitinib later than 30th June 2015.
* Patients participating in clinical research involving axitinib
* Patients with hypersensitivity to axitinib or to any other component of axitinib
* Patients under 18-year of age
* Pregnant women.
Can Targeted Elimination of B-cell Depletion Therapy and/or Combination Therapy on Systemic Lupus Erythematosus

This prospective randomized control trial is undertaken to evaluate the safety and efficacy of anti-CD20 monoclonal antibody, rituximab, used as 1. monotherapy, 2. in combination with cyclophosphamide, in the treatment of proliferative lupus nephritis, as compared with standard immunosuppressive therapy with cyclophosphamide and azathioprine.

Twenty patients will be randomized into 3 treatment arms to receive:

* Rituximab of 1000 mg given 2 weeks apart. On day the of rituximab, and 'pulse' methylprednisolone 250mg IV be given followed by prednisolone 30mg/day from Day 2 to Day 5.
* A treatment dose rituximab of 1000mg given 2 weeks apart and 'pulse' methylprednisolone 250mg IV be given followed by prednisolone 30mg/day from Day 2 to Day 5, and 'pulse' cyclophosphamide 500mg/m2 at baseline and day 14.
* Sequential therapy with oral cyclophosphamide (50 to 100 mg/day) for 6 months followed by azathioprine (up to 2.5mg/kg/day) for maintenance up to 12 months. Oral prednisolone will be given at 0.5 mg/kg/day (up to 30 mg daily) for 4 weeks, tapered by 5 mg every 2 weeks thereafter until 5mg /day for the rest of the study period. All patients would be started on angiotensin converting enzyme inhibitors before commencement of the trial and to continue at the same dosage throughout the study period. Patients who are on antimalarial agents and statins at baseline will be allowed to continue.

Clinical examination and laboratory investigations will be performed at 0, 4, 8, 12, 24, 36 and 48 weeks from the time of treatment. At each visit, patients will be evaluated for clinical manifestation of SLE and side effects of therapy. Laboratory parameters measured included the complete blood cell count with differential and platelet counts, chemistries survey, urinalysis, and 24- hour urinary for protein excretion and creatinine clearance.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Active proliferative lupus nephrites
* Biopsy confirmed active proliferative lupus nephritis within 3 months prior to enrollment
* Proteinuria \>= 2g/day
* Active urinary sediments
* Activity index of \>= 6
* Elevated anti-double-stranded(anti-dsDNA) level at baseline
* Agreement to practice birth control
* SLE according to the American College of Rheumatology Criteria
* Informed consent was obtained

Exclusion Criteria:

* Pre-existing renal failure
* History of cancer
* Human immunodeficiency virus infection
* Active hepatitis B or C infection
* Active tuberculosis
* Diabetes mellitus
* A ny other chronic disease
* Unwillingness to comply with the protocol
Pharmacokinetic Study of Intranasal CT001 in Children 1-17 Years of Age Undergoing Elective Surgical Procedures

This is a prospective non-randomized, open-label, single dose (and a second dose if needed), PK study in 25 children age 1-17 years. The proposed number of study participants by subset is: 8 paediatric participants 1-2 years; 8 paediatric participants \>2-6 years and 9 paediatric participants \>6-17 years.


Eligibility Criteria:
Inclusion Criteria:

* Paediatric participants, age 1-17 years at the day of the surgical procedure
* Planned for elective surgical procedures (e.g. hernia, orchiopexy, gastroscopy, cystoscopy)
* ASA (American Society of Anaesthesiologists) physical status classification system score 1-2 as determined by investigator
* Planned for induction of anaesthesia by an intravenous anaesthetic agent, requiring placement of peripheral venous catheter immediately prior to the surgical procedure
* Needs premedication before induction of anaesthesia as determined by investigator
* Informed consent by the legally acceptable representative(s)
* The legally acceptable representative(s) and patients 15-17 years must be able to understand and speak local language
* A female participant who has onset of menarche is eligible to participate if she is not pregnant, not breastfeeding and agree to follow the contraceptive guidance during the treatment period for at least 7 days after administration of study treatment.

Exclusion Criteria:

* Ex-premature infant (born \<37 weeks AND less than 60 weeks post conceptual age at the day of the surgical procedure)
* Mental retardation
* Abnormal nasal cavity or nasal obstruction
* Clinical contraindications to narcotic analgesia including head injury or any condition that can in the opinion of the investigator, deteriorate safety and well-being of the participants, influence PK data or optimal participation in the trial
* Medical history including substance or alcohol abuse
* Has received treatment with sufentanil and/or ketamine during the last 72 hours prior to surgery
* Has planned perioperative administration of sufentanil and/or ketamine
* Has or is suspected of having a family or personal history of malignant hyperthermia
* Has or is suspected of having allergies to ketamine or sufentanil
Miltefosine Plus IL Pentamidine for Bolivian CL

Bolivian cutaneous leishmaniasis due to Leishmania braziliensis was treated with the combination of miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5).

Bolivian cutaneous leishmaniasis due to Leishmania braziliensis was treated with the combination of miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5). Efficacy and tolerance parameters were assessed. Efficacy was assessed at 1, 3, and 6 months post therapy. Tolerance was assessed on each day therapy was administered.

Eligibility Criteria:
Inclusion Criteria:

* one ulcerative lesion ≤ 900 mm2 in total area,
* ≥ 12 years,
* parasitologically diagnosed by visualization of amastigotes or culture of promastigotes from lesion material,
* no antileishmanial therapy in the last 3 months,
* no mucosal lesions,
* no history of significant concomitant diseases including immunosuppression.

Exclusion Criteria:
Neoadjuvant Combination Immunotherapy for Stage III Melanoma

Determine safety and efficacy of pre-operative combination immunotherapy with Talimogene Laherparepvec (T-VEC)/Pembrolizumab given prior to complete lymph node dissection in resectable stage 3 cutaneous melanoma with clinically apparent lymph node metastases.

This is a single arm Phase 2 study of pre-operative combination immunotherapy with pembrolizumab and T-VEC given for 6 months prior to complete lymph node dissection for stage 3 resectable cutaneous melanoma with clinically apparent lymph node metastases.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age, any race or sex, who have pathologically confirmed cutaneous melanoma
* ECOG performance status of 0 or 1
* Adequate hematologic, hepatic, renal and coagulation function
* Must have measurable disease and have an injectable target lymph node for intralesional therapy administration
* Primary melanoma has been resected
* Pathologically confirmed resectable stage III disease, clinically apparent. Resectability is at the discretion of the treating surgeon who is a melanoma specialist.
* Stage III disease can be at time of diagnosis of primary melanoma or a recurrence after initial treatment of stage I-II disease.
* BRAF mutant or wild type allowed (mutations status not necessary for enrollment)
* Signed, written informed consent

Exclusion Criteria:

* Cannot have metastatic (AJCC M1) disease
* No primary mucosal or uveal melanoma
* No evidence of melanoma associated with immunodeficiency state or history or other malignancies (other than non-melanoma skin cancer) within the past 3 years
* May not have been previously treated with T-VEC, any other oncolytic virus, pembrolizumab, or any other PD-1, PD-L1, or PD-L2 inhibitor
* Must not have a history or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, or other symptomatic autoimmune disease, document history of autoimmune disease or syndrome requiring systemic treatment in the past two years (i.e. use of disease modifying agents, steroids, or immunosuppressive agents) except vitiligo or resolved childhood asthma/atopy, or evidence of clinically significant immunosuppression
* Must not have active herpetic skin lesions or prior complications of herpetic infection and must not require intermittent or chronic treatment with an anti-herpetic drug (e.g. acyclovir) other than intermittent topical use
Technology-assisted Upper Extremity Rehabilitation in Subjects with Incomplete Cervical Spinal Cord Injury

The aim of the study is to investigate the effects of 6 weeks of technological-assisted rehabilitation on function of upper extremity and hand in subjects with incomplete cervical spinal cord injury.

In this crossover study, persons with motor incomplete cervical (C2-C8) spinal cord injury (AIS C-D) will be recruited from the Hospital District of Helsinki and Uusimaa. In the first period of the crossover study, other part of the participants will get technological-assisted upper extremity rehabilitation, while the other part of the participants continue their normal lives. The first period is followed by 4-week wash-out period. In the second period, roles of the participants will be switched. The rehabilitation phase lasts for 6 weeks with 3 weekly sessions, each therapy session including at least 30 minutes of technological-assisted upper extremity rehabilitation. Rehabilitation includes passive, active and resistance exercises, and will be carried out by using AMADEO, PABLO and/or DIEGO devices made by Tyromotion.

Eligibility Criteria:
Inclusion Criteria:

* incomplete motor spinal cord injury (AIS C-D)
* injury level C2-C8
* time since injury from 1 to 5 years
* to be able to sit
* motivation and ability to participate in intensive rehabilitation 3 times per week for 6 week period.

Exclusion Criteria:

* participation in other exercise study or technological-assisted upper extremity study
* unlikely completion of intervention and participation in follow up
* injuries that prevent training
* weak tolerance of intense training
* severe joint movement restriction or instability
* irreversible muscle contractures
* grade 4 on Modified Ashworth Scale in glenohumeral, elbow, wrist and finger joints
* recent significant forearm or hand injuries
* memory disorder
* orthopedic, rheumatic or neurological diseases (other than spinal cord injury) that prevent training
The Effect of Moderate CYP3A Inducer Rifabutin on the Pharmacokinetics of Zanubrutinib in Healthy Males

The primary objective of this study was to determine the effect of the moderate cytochrome P450 3A (CYP3A) inducer rifabutin on the pharmacokinetics (PK) of zanubrutinib in healthy males.


Eligibility Criteria:
Key Inclusion Criteria:

1. Males of any race, between 18 and 65 years of age, inclusive.
2. Male participants in good health as determined by past medical history, physical examination, vital signs, ECG and laboratory tests at screening
3. Must have a body mass index (BMI) between 18 and 32 kg/m\^2

Key Exclusion Criteria:

1. Participants with a clinically relevant history or presence of any clinically significant disease
2. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair will be allowed)
3. History of drug or alcohol abuse within 1 year prior to check-in
4. Use or intended use of any nonprescription medications/products including vitamins, minerals, herbal/plant-derived preparations within 7 days prior to check-in
5. A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result and/or a positive human immunodeficiency virus (HIV) at screening
6. Use of tobacco- or nicotine-containing products within 3 months prior to check-in
7. Use or intended use of any prescription medications/products within 14 days prior to check-in

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Study on Effects of Defect Closure in Laparoscopic Repair of Direct Inguinal Hernia

The defect closure was found to have higher pain and less seroma formation at various intervals of time following TEP for moderate-large direct inguinal hernia. Although these findings were statistically insignificant, they may be clinically significant, and further studies with a larger sample size are suggested.

Inguinal hernia is a common and widespread condition from which millions of people suffer. Repair of an inguinal hernia is one of the most frequently performed operations in general surgery. Totally extraperitoneal (TEP) and transabdominal preperitoneal (TAPP) repair are the principal techniques in laparoscopic hernia repair. Laparoscopic hernia repair is recommended for bilateral and recurrent inguinal hernias. It has also been recommended for patients with primary unilateral inguinal hernia, contingent on the availability of surgical expertise and resources, due to a lower incidence of post-operative pain and chronic pain.

Seroma formation is a frequent complication of laparoscopic mesh repair of moderate-large direct inguinal hernia defects. While rates of seroma formation have been reported to be as high as 10-30%. Several attempts have been made to reduce the incidence of seroma formation, such as tacking the transversalis fascia (TF) to the ramus of the pubis, closing the direct inguinal hernia defect via the endoloop technique, and filling the potential dead space with fibrin glue. However, there is a potential increase in the risk of infection and also a risk of chronic pubic bone pain from the tack staples or vasculo-nervous injury if fixing the TF to the abdominal wall, which would lead to extra discomfort for the patient. The closure of a direct hernia defect with a barbed suture not only closes the defect superficially but also exterminates the defect cavity; consequently, the incidence of seroma formation has been greatly reduced.

However, there is still controversial evidence regarding the choice of the two procedures in terms of reducing the rate of seroma formation and pain. Thus, it is ambiguous which surgical technique should be considered best to repair an inguinal hernia. In this study, we tried to evaluate the technical aspect of direct defect closure in laparoscopic TEP inguinal hernia repair and its effect on the primary outcomes in terms of seroma formation and pain at different time intervals, along with the secondary outcomes such as operative time, length of postoperative hospital stay, days to resume normal activities, recurrence, and intraoperative complications like injury to the vas, vessel, and visceral injury or peritoneal tear.

Eligibility Criteria:
Inclusion Criteria:

* age greater than 18 years
* uncomplicated direct inguinal hernia (≥M3)

Exclusion Criteria:

* defect size ≤M2
* complicated hernia (irreducible, obstructed, or recurrent hernia)
* patients unfit for general anesthesia
Comparison of the Efficacy of Rapid-acting Aspart and Faster Acting Aspart Within the Context of Single-hormone Closed-loop Strategy at Regulating Postprandial Glucose Levels

Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings.

The objective of this pilot study is to inform both the decision whether to conduct a confirmatory study and the design of the larger confirmatory trial. In addition, we want to estimate postprandial glucose levels parameters and confidence interval in an 11-hour in-patient study with standardized conditions in adults with type 1 diabetes, estimate the size and direction of the treatment effect.

Faster insulin Aspart (FiAsp) will provide preliminary evidence of efficacy to regulate postprandial glucose levels compared to rapid-acting Aspart in adults with type 1 diabetes using insulin pump therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females ≥ 18 years of old.
2. Clinical diagnosis of type 1 diabetes for at least one year.
3. The subject will have been on insulin pump therapy for at least 6 months.
4. HbA1c ≤ 12%.

Exclusion Criteria:

1. Using a patch-pump (e.g. Omnipod)
2. Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
3. Recent (\< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
4. Ongoing or planned pregnancy.
5. Breastfeeding.
6. Severe hypoglycemic episode within two weeks of screening.
7. Current use of glucocorticoid medication (except low stable dose and inhaled stable treatment).
8. Known or suspected allergy to the trial products or meal contents.
9. Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
10. Failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, not willing to change pump parameters, etc).
11. Problems with venous access.
Improving Motor Skill Development in Infants After Cardiac Surgery

The purpose of this study is to learn more about developmental behaviors and to examine changes in developmental progress related to motor activities among a group of infants who received open heart surgery within the first three months of life.

Congenital heart disease (CHD) and the need for life-saving heart surgery and intensive care during infancy may have effects on infant behavior and development. Children who require open heart surgery before their first birthday are vulnerable to developmental delays, especially related to motor skills (mobility) in the first year of life. Early delays in gross motor functioning (e.g., rolling, crawling, walking) have implications for learning and psychosocial development through adulthood. To date, no interventions to improve the gross motor functioning of children born with CHD have been developed. The purpose of this study is to learn more about developmental behaviors and to examine changes in developmental progress related to motor activities among a group of infants who received open heart surgery within the first three months of life. Activities will be tailored based on the individual infant's motor ability and medical status.

Eligibility Criteria:
Inclusion Criteria:

* All hospitalized infants under age 4 months having cardiac surgery before age 3 months
* Intubation \>/= 24 hours \</= 14 days

Exclusion Criteria:

* Prematurity \</= 36 weeks gestation
* Pre-operative clinical evidence of a central nervous system (CNS) anomaly or history of CNS insult