cyrilzakka/clinical-trials huggingface dataset:
Synchronized Intermittent Mechanical Ventilation Versus Open Lung Ventilation With Spontaneous Respiration

The purpose of this study is to collect data on patients who are on breathing machines (ventilators) in the Trauma Surgical Intensive Care Unit (TSICU). This data may help us to determine if one form of assisted breathing is better than another. The two forms of assisted breathing being compared in this study are called BiVent and SIMV. (7) BiVent and SIMV are both delivered by a ventilator but differ in how they assist breathing. SIMV is an older form of mechanical breathing that blows air into the lungs to inflate the lungs. BiVent is a newer form of mechanical ventilation that permits the patient to pull air into the lungs as we normally do. Both BiVent and SIMV are currently being used on a regular basis in the TSICU. The investigators hope that this study will determine if one method of assisted breathing is better than another in preventing complications associated with mechanically assisted breathing.

SOLV Hypothesis:

A prospective, randomized trial directly comparing open lung ventilation (OLV) with spontaneous breathing (SB) utilizing BiVent on the Maquet Servo-I versus synchronized intermittent mechanical ventilation (SIMV) will be conducted in the trauma-surgical intensive care unit at the University Hospital (TSICU). Both OLV-SB and SIMV protocols have been designed according to lung protective strategies. The primary goal of the SOLV trial is to see determine if the early application of open lung ventilation will less ventilator days. In addition, several secondary endpoints will be evaluated. It is not anticipated that this study will be powered to show a mortality difference.

Eligibility Criteria:
Inclusion Criteria:

* \>/=18 years of age, ISS \>/=25, on ventilator for more than 48 hours

Exclusion Criteria:

* less than 18 years of age, die or come off ventilator in less than 48 hours
Effects of Local Insulin on Varicose Ulcers for Wound Healing

A randomized, split-plot, double-blind, placebo-controlled trial. The varicose ulcer is divided into two (side A and B). Half of the wound's surface is treated locally with insulin (Glargine) applied at an approx depth of 3-4 mm. Treatment with insulin is administered for 7 days. Biopsy specimens of the two sides are obtained on days 0 and 7. A thermographic photograph of the wound is taken at days 0 and 7. The number of blood vessels and fibroplasia is evaluated as the main outcome.

A randomized, split-plot, double-blind, placebo-controlled trial. Chronic Varicose Ulcers measuring more than 4 cm in any of its dimensions, and that comply with candidate criteria are included in the present study. A split-mouth model is used.

The ulcer is divided into two (sides A and B). The side in which treatment is applied is randomized. Half of the wound's surface is treated locally with insulin (Glargine) applied at an approx depth of 3-4 mm. Both halves are covered with dressings and compression therapy is applied. Treatment with insulin is administered for 7 days. Biopsy specimens of the two sides are obtained on days 0 and 7. A thermographic photograph of the wound is taken at days 0 and 7, as control of the local temperature of the wound. This is to asses the process of healing and to correlate with our outcome measures. The number of blood vessels will be evaluated as the main outcome. Fibroplasia and thermal asymmetry between wound sides will be evaluated as secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Any gender
* Presence of varicose ulcer in lower extremities with a size greater than 25 cm2
* Absence of infection

Exclusion Criteria:

* Presence of diabetes or glycated hemoglobin \>6.5%
* Comorbidities that affect wound healing
* Malnutrition
* Active smoking
The Effect of High Dose Salbutamol on Muscle Performance

Many athletes use beta2-agonists as treatment of airway hyperresponsiveness during exercise. High dose beta2-agonists may have an ergogenic effect on exercise performance. We hypotheis that the beta2-agonist, salbutamol, taken in high doses can improve muscle power and recovery during exercise in well-trained athletes.


Eligibility Criteria:
Inclusion Criteria:

* Males
* age 18-45
* training frequency \> 10 hrs/wk
* informed consent

Exclusion Criteria:

* smoker or former smoker
* chronic diseases, as well as asthma
* allergy to the study drugs
* intake of any form of medicin or inhibited drugs during the study
* use of beta2-agonist 14 days before the intervention
Repeated Administration of Cannabis Varying in THC and CBD

The majority of the \>3 million medical cannabis patients in the U.S. use cannabis products to manage pain but many questions remain. This project is designed to answer three questions that will fill important voids in the field's understanding of sustained cannabis use: 1) is abrupt cessation of cannabis associated with increased pain sensitivity; 2) does tolerance develop to the analgesic and abuse-related effects of repeatedly administered cannabis with varying ratios of THC and CBD, and is this tolerance reversible following a period of abstinence; 3) how does repeated cannabis use affect levels of endocannabinoids, and are these changes associated with changes in pain sensitivity and abuse liability? In this study, the investigators will enroll participants (N=100 healthy, cannabis-using men and non-pregnant women, ages 21-65) inpatient for 15 days. They will be randomized to one of four cannabis conditions (n=25/group). Following a day of standardization on which participants will receive their assigned cannabis condition (Day 1), cannabis will be administered repeatedly for 14 days (Day 2-15). The investigators will measure abuse-related effects ("Good Drug Effect"), endocannabinoid levels and two distinct types of experimental pain: The Cold Pressor Test and Quantitative Sensory Testing Thermal Temporal Summation. Given the widespread use of cannabis for pain, understanding the consequences of daily repeated administration of cannabis with THC:CBD ratios that are representative of most medical cannabis products on pain, abuse liability, and endocannabinoids is imperative.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females, 21-65 years old
2. For females: not pregnant or breast-feeding, and uses an acceptable form of birth control (e.g., condoms, IUD)
3. Uses cannabis on a near-daily basis
4. Not seeking treatment for cannabis use
5. Able to provide informed consent
6. Able to perform study procedures

Exclusion Criteria:

1. Meets DSM-V criteria for any Substance Use Disorder other than cannabis, nicotine or caffeine
2. Uses other illicit drugs ≥1 day/week in the prior 4 weeks
3. Medical history, physical, psychiatric examination, or significant illness at the clinical discretion of the study physician; for example, history of heart disease, diabetes, hypertension (BP \> 140/90) or uncontrolled asthma

5. Use of any prescription or daily use of over-the-counter medications 6. Recurrent, ongoing pain 7. Insensitivity to the thermal stimuli of the Cold Pressor Test or Quantitative Sensory Testing 8. History of physical violence or paranoia during cannabis withdrawal
Towards Optimal Fertility, Fathering and Fatherhood studY

This case-control study involving fertile and subfertile couples aims to identify male factors related to pregnancy likelihood, create a fertility index measure combining male and female factors to predict pregnancy likelihood, and examine how male factors relate to the semen physical and biological characteristics.

Paternal contributions to fertility and reproductive health outcomes have been understudied, despite promising evidence from animal studies. This study aims to investigate the male contribution to pregnancy likelihood and explore the underlying biological mechanisms. Specifically, the investigators aim to (1) identify male factors associated with pregnancy rate; (2) develop a fertility index combining modifiable factors for both males and females to predict pregnancy rate; and (3) explore the relationship of male modifiable factors with semen physical and molecular characteristics. This is a case-control study with 480 fertile and subfertile males (along with their female partners), recruited from KK Women's and Children's Hospital. The investigators will use questionnaires to collect data on socio-demographic characteristics, clinical, lifestyle, and environmental factors; analyze metabolic and stress biomarkers from blood samples; and measure semen parameters including sperm motility, density, morphology, volume, DNA fragmentation, DNA methylation, gene expression, and seminal plasma oxidative status. Findings from this proposed study will pave the way for developing lifestyle-based or medical interventions to enhance male and couple reproductive health, and potentially benefiting future offspring health.

Eligibility Criteria:
Inclusion Criteria:

Subfertile couples:

* men aged ≥21-49 years
* men with a female partner aged 21-39 years
* couples who are not able to conceive for at least 12 months
* couples who are Singapore citizen or permanent resident

Fertile couples:

* men aged 21-49 years
* men with a female partner aged 21-39 years
* men with proven fertility defined as those female partners who are currently pregnant and with viable intrauterine pregnancy at gestational weeks of less or equal to 16 at the time of the study
* couples with attempted time to conceive within 12 months to achieve this pregnancy or with unplanned pregnancy
* couples who are Singapore citizen or permanent resident

Exclusion Criteria:

Subfertile couples:

* male infertility of a known aetiology including azoospermia, retrograde ejaculation, genetic disorders, cancer treatment, or testes trauma
* female infertility diagnosis as confirmed by diagnostic imaging or having severe endometriosis
* female partners with irregular menstrual cycle \>35 days
* couples with known chromosomal abnormalities

Fertile couples:

* couples who achieve pregnancy after oocyte or spermatozoa donation
* couples with known chromosomal abnormalities
* female partners with known uterine abnormalities
Protocol for Drug Use Investigation of Follistim Injection (Study P06132)(COMPLETED)

The main purpose of this investigation is to collect information about safety and efficacy of Follistim Injection from actual clinical use to induce ovulation in patients with anovulation and oligoovulation due to hypothalamus-pituitary dysfunction.

Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent IVF

Exclusion Criteria:

* Patients with tumors of ovary, breast, uterus, pituitary or hypothalamus
* Pregnant or possible pregnant women, or lactating women
* Patients with undiagnosed atypical vaginal bleeding
* Patients with a history of hypersensitivity to any of the ingredients of this product
* Patients with ovarian cysts or enlarged ovaries, not related to polycystic ovarian disease
Reducing Work-related Screen Time in Health Care Workers During Leisure Time

The purpose of this study is to determine the effect that uninstalling work email applications from mobile devices during leisure time has on health care worker stress levels.

Burnout is more common in physicians than in the general population. The recent COVID-19 pandemic has increased burnout and stress levels among health care workers, leading to a peak of 34% of health care workers experiencing burnout symptoms. But even before the COVID-19 pandemic, the prevalence of burnout symptoms among health care workers was trending upwards. In fact, most health care workers experience burnout to some degree.

Managing email inboxes and working with electronic health records (EHR) can increase screen time levels for health care workers who use them. High amounts of screen time have been linked to depression and stress in teenagers and adults. EHR digital work is a noted burden on physicians, and inbox management has been linked to physician stress and burnout. A study that measured physician stress during electronic health record inbox work found that accessing and responding to EHR inbox outside of work hours increased stress levels in physicians.

The effect of an intervention that lowers screen time usage in health care workers during leisure time has not been measured. Determining this effect can influence new protocols on inbox and work email management during leisure time for health care workers. This can benefit organizations by improving employee performance, employees by reducing stress and burnout levels, and patients by providing more refreshed patient care. This study aims to determine the effect that uninstalling email from mobile devices during leisure time has on health care worker stress levels.

Eligibility Criteria:
Inclusion Criteria:

* 1) be an active health care worker
* 2) be ≥ 19 years old
* 3) routinely use a smartphone
* 4) have a work email application (e.g., Outlook) installed on their smartphone.

Exclusion Criteria:

* None
THIN Database Study: Resource Use and Outcomes in Patients With Adrenal Insufficiency Prescribed Hydrocortisone: Immediate, or Modified Release, or Prednisolone

To describe clinical outcomes and both primary and secondary care health care resource use in patients who have been prescribed either immediate-release (IR) hydrocortisone or modified-release (MR) hydrocortisone or prednisolone in the UK.


Eligibility Criteria:
Inclusion Criteria:

1. Cohort 1 (IR hydrocortisone): All patients with a Read code for AI and a prescription of IR hydrocortisone between 2010 and data extraction but no prescription for MR hydrocortisone at any time during this period, and no earlier prescription for IR prednisolone during this period
2. Cohort 2 (IR prednisolone): All patients with a Read code for AI and a prescription of IR prednisolone between 2010 and data extraction but no prescription for MR prednisolone at any time during this period, and no earlier prescription for IR prednisolone during this period
3. Cohort 3a (MR Hydrocortisone): All patients with a Read code for AI and a prescription of MR hydrocortisone between 2010 and data extraction
4. Cohort 3b (IR to MR hydrocortisone): A sub-set of patients from cohort 3a, who have switched from IR to MR hydrocortisone.
5. A list of pre-defined READ codes will be used to identify all patients with primary or secondary AI or CAH in the THIN database.

Exclusion Criteria:

1)Patients who have not received a prescription of hydrocortisone or prednisolone in the past five years will be excluded as the aim of the study is to describe recent experience.
Long-term Airway Clearance Therapy in Non-cystic Fibrosis Bronchiectasis

The main aim is to analyze whether the routine use of chest physiotherapy in non cystic fibrosis bronchiectasis (NCFB) improves the cough severity and the quality of life in this population. In addition, the secondary end-points include incidences of exacerbations, changes in lung function, exercise capacity, airways inflammation, sputum analysis and eventual adverse events.

The present project will be a single-blind , randomized, controlled trial of 12-month daily performing chest physiotherapy compared with usual care, followed by a 3-month intervention-free in non-cystic fibrosis bronchiectasis.

Intervention group will perform daily autonomous airway clearance techniques (positive expiratory pressure technique through Acapella device and autogenic drainage technique). Patients will receive professional sessions once a month.

Control group will receive their usual care and educational sessions about their disease. Physiotherapist will call them once a month.

During the study period the patients' pharmacological treatment remained unchanged

Eligibility Criteria:
Inclusion Criteria:

* Chronic sputum production during at least 3 months previous enrolment
* At least two confirmed exacerbations during the last year
* Patients able to understand how to perform the airway clearance techniques
* Clinically stable at time of study entry (defined as no requirement for antibiotics or change in respiratory medication in the preceding 4 wk)
* To be able to provide written, informed consent

Exclusion Criteria:

* Cystic Fibrosis
* Carry out regular chest physiotherapy.
* Active haemoptysis during the previous month or recurrent hemoptysis during the last year (more than 4 episodes)
* Waiting a pulmonary transplant
Vaccine Therapy in Treating Patients With Recurrent Soft Tissue Sarcoma

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have recurrent soft tissue sarcoma.

OBJECTIVES: I. Determine the efficacy of autologous tumor cell-derived heat shock protein peptide vaccine in terms of the rate of complete and partial response and time to progression in patients with recurrent soft tissue sarcoma. II. Determine the safety and tolerability of this treatment regimen in this patient population. III. Determine the anti-tumor response to this treatment regimen in these patients.

OUTLINE: At approximately 5 weeks after surgery, patients receive autologous tumor cell-derived heat shock protein peptide vaccine intradermally weekly for 4 weeks. Patients receive subsequent vaccinations once every 2 weeks for at least 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with improving or stable disease or without recurrence continue on therapy for up to 1 year.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed recurrent soft tissue sarcoma Incompletely or completely resected metastatic or locally recurrent disease (surgery must be performed with intent of complete resection) No active brain metastases

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 70-100% Life expectancy: At least 16 weeks Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,000/mm3 Platelet count at least 80,000/mm3 Hepatic: Not specified Renal: Creatinine no greater than 2.5 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease Other: No active infections requiring antibiotics within 2 weeks of study No other serious medical illness requiring hospitalization No history of primary or secondary immunodeficiency or autoimmune disease No contraindications to MRI (e.g., aneurysm clips or cardiac pacemakers) Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 weeks since prior immunotherapy and recovered Chemotherapy: At least 6 weeks since prior chemotherapy and recovered Endocrine therapy: No concurrent systemic corticosteroids Radiotherapy: At least 6 weeks since prior radiotherapy and recovered Surgery: See Disease Characteristics No prior splenectomy Other: At least 6 weeks since other prior experimental anticancer therapy and recovered No concurrent non-steroidal anti-inflammatory drugs or other immunosuppressive drugs No other concurrent participation in a clinical trial
Effect of Feeding Frequency on Glucose and Insulin Metabolism and Substrate Partitioning in Impaired Glucose Tolerant (IGT) Men

The purpose of this study is to determine the effect of feeding frequency on glucose and insulin metabolism and substrate partitioning in impaired glucose tolerant (IGT) men.


Eligibility Criteria:
Inclusion Criteria:

* BMI: 20-35 kg/m2
* Gender: Male
* Age: subjects has to be older than 18 and younger than 70 years old
* Impaired Glucose Tolerant (IGT) = plasma glucose, two hours after consuming 75g glucose, appears to be superior to 7.8mmol/l (normal level) but remains inferior to 11.1mmol/l (diabetes level) and fasting plasma glucose is less than 7.0mmol/l.
* Caucasian

Exclusion Criteria:

1. Lactose intolerant
2. Diabetes Mellitus
3. Cardiovascular diseases
4. Stomach and intestinal diseases
5. Normal glucose levels after 2 hours
6. Anticoagulants
7. Medication that has a effect on energy and glucose homeostasis and absorption of foods
8. Conditions or situations when subjects can't lose 500 ml blood
Predicting Survival After Surgical Resection for the Entire Spectrum of Anatomically Resectable HCC

Clinical outcomes after surgical resection in HCC is a continuum and is clearly related to tumor burden but needs better definition. The researchers describe the use of the "metro ticket" approach to analyze surgical outcomes over the whole spectrum of anatomically resectable HCC to define overall survival including intermediate stage tumors (BCLC B). The analysis the researchers provide in this study enables the clinician to select the optimal surgical resection candidate based on robust long term survival data.

In addition, study compares outcome for open surgery vs laparoscopic surgery, survival outcome for viral and non-viral HCC using Albumin-Bilirubin (ALBI) for more comprehensive study result.

Patients who underwent surgical resection (both open surgery and laparoscopic surgery) for HCC from 1st January 2000 to 30th June 2018 by the joint hepato-pancreato-biliary surgery service at the Singapore Healthcare Group of Hospitals (Singapore General Hospital and the National Cancer Centre Singapore) were retrospectively identified from a prospectively kept institutional database.

The assessment of the size, number of nodules and vascular invasion of HCC were based on pre-operative CT/MRI imaging and pathological assessment of the resected specimens. All resections were histologically confirmed as HCC. Patients with macrovascular invasion and extrahepatic invasion were excluded from analysis as were patients resected for other palliative intents (e.g. ruptured HCC).

Eligibility Criteria:
Inclusion Criteria:

1. Unequivocal diagnosis of Hepatocellular Carcinoma (HCC) by histology
2. Patients who underwent surgical resection for HCC

Exclusion Criteria:

1. Patients who underwent liver resection for other malignancies ie cholangiocarcinoma
2. Patients with HCC who did not undergo liver resection.
3. Patients with HCC who underwent liver transplant.