cyrilzakka/clinical-trials huggingface dataset:
HighCycle Study: Effect of Acetazolamide on Acute Mountain Sickness in Women Compared to Men

Millions of people travel to high altitude for work or leisure activities and are exposed to reduced inspiratory oxygen partial pressure and hypoxemia that may lead to altitude illness, among which the most common form is acute mountain sickness (AMS). The main AMS symptoms are headache, malaise, weakness, and fatigue. Prospective studies have shown that 20-60% of newcomers at 2500-4000m develop AMS requiring them to take medications, while, at very high altitudes, AMS may progress to high altitude cerebral oedema. Whether women are more susceptible to AMS remains insufficiently understood since no prospective study controlled for sex hormones, use of hormone contraception or assessed menstrual cycle phase (MCP) at altitude. Therefore, women remain underrepresented and poorly characterized in high altitude studies. In addition, the efficacy and safety of 250 mg/day acetazolamide, the standard recommendation for AMS prevention, has never been compared between sexes, although, women have presumably higher acetazolamide plasma concentration due to lower blood volume. Given the known dose-dependent preventive but also side effects of acetazolamide and equal proportion of women and men among mountain travellers, there is an urgent need to conclusively quantify the efficacy and safety of pre-ventive acetazolamide therapy against AMS in women compared to men.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, non-smoking men and women, age 18-44 years, without any disease and need of regular medication (including oral contraceptives).
* BMI \>18 kg/m2 and \<30 kg/m2
* Born, raised and currently living at altitudes \<1000 m
* Written informed consent
* Premenopausal women with an eumenorrheic cycle

Exclusion Criteria:

* Other types of contraceptvies (contraceptives (hormonal intrauterine device, vaginal ring, subcutaneous injections or implants, among others)
* Pregnancy or nursing
* Anaemic (haemoglobin concentration \<10g/dl)
* Any altitude trip \<4 weks before the study
* Allergy to acetazolamide and other sulfonamides
Dexamethasone Versus Placebo in Optimizing the Postoperative Period After Laparoscopic Inguinal Hernia Repair

Does corticosteroid (dexamethasone) have an effect on the postoperative period after laparoscopic hernia repair, when it comes to pain, postoperative nausea and vomiting and convalescence. This randomized, double-blinded study compares dexamethasone versus placebo. The patients are recommended one day of convalescence. The medicine or placebo is given before operation. The patients fill out questionnaire before operation and three hours after operation and in the following three days. The patients also register when they return to normal activities and work.


Eligibility Criteria:
Inclusion Criteria:

* patients planned for elective laparoscopic hernia repair (TAPP)
* Unilateral inguinal or femoral hernia
* ASA class I-II
* Read and speak Danish

Exclusion Criteria:

* Acute hernia operation
* Operation for other hernias with mesh during the same procedure
* Endocrine disease (diabetes, adrenal insufficiency etc.)
* fever/infection within the first 10 days before operation
* Poor compliance
* No signed consent form
* Daily intake of opioids or anxiolytic drugs
* Manic episodes
* Use medicine against glaucoma
* Use thiazide or loop diuretics
* Vaccination within the last 14 days
Brown Adipose Tissue as Nutrient Buffer Through Diet Induced Thermogenesis

To test the hypothesis that active BAT improves metabolic health by buffering postprandial metabolites plasma metabolites and energy expenditure will be compared in volunteers with and without active BAT. Both groups will receive test meals with protein, fat and carbohydrates separately, so that the individual impacts of these macronutrients on diet induced thermogenesis and the buffering function of BAT can be derived. BAT biopsies will be taken before and after the test meals for molecular analysis.

In this prospective interventional study healthy individuals will be screened for presence of active BAT: Maximal BAT activity will be achieved by a mild cold stimulus over 2 hous and quantified by 18F-FDG-PET/CT 30 min after injection of 75 MBq of 18F-FDG.

Individuals with FDG-PET positive BAT will be included as BAT-positive subjects (n=15) and individuals with absence of FDG-positive BAT will be included as BAT-negative subjects (n=15) and then take part in three study visits in random order.

During the study visits participants will consume a standardized isocaloric liquid meal consisting of A) glucose (OGTT) B) fat and C) protein.

Energy expenditure will be measured by indirect calorimetry before as well as hourly after the meal for 5 hours. Blood samples will be taken before and at 30 minute intervals after the meal for 5 hours for analysis of blood glucose, triglycerides, FAAs, representative amino acids, insulin and noradrenaline.

Subjects will undergo ultrasound-guided biopsy of the supraclavicular fat depot in the fasting state and after one of the test meals so that biopsies from 5 individuals in each group after each test meal will be obtained.

Eligibility Criteria:
Inclusion Criteria:

* BMI 18.5 to 28 kg/m2
* Able to give informed consent as documented by signature

Exclusion Criteria:

* Concomitant medication other than prescription free analgesics (paracetamol and NSAID) and oral contraceptives
* Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, diabetes mellitus)
* Hyper- or hypothyroidism
* Smoker / habitual tobacco use
* Weight change of \>5% within 3 months prior to inclusion
* Hypersensitivity to cold (e.g. Raynaud syndrome)
* Known or suspected non-compliance, drug or alcohol abuse
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Enrolment of the investigator, his/her family members, employees and other dependent persons
* Enrolment into another study using ionizing radiation within the previous 12 months
* Enrolment into another study including a pharmacological or nutritional intervention
* Pregnancy or lactation
* Lab parameters

  * Serum-Creatinine: above 1.5x upper limit of normal (ULN)
  * Glycated Hemoglobin (HbA1c): above 6.0%
  * Random plasma glucose \>11 mM
Ultrasound-guided Biopsy of the Pleura as a Supplement to Extraction of Fluid in Patients With One-sided Fluid in the Pleura

The research group will investigate the diagnostic effect of early introduction of ultrasound guided pleural biopsy in the work-up of patients with one-sided pleural effusion, suspected of malignant pleural effusion.

Patients with unilateral pleural effusion with high protein content (exudative pleural effusion) are likely to have malignant pleural effusion. In the Danish guidelines, patient undergo two thoracentesis before more invasive procedures, due to the relatively low incidens of pleural TB and mesothelioma. The aim of the research group is to investigate the effect of early introduction of ultrasound-guided pleural biopsy taken at the optimal sport for thoracentesis. The research group will randomise half of our patients with unilateral pleural exudate to up-front ultrasound-guided biopsy and the other half usual care eg. a second thoracentesis, to see if there is a benefit of early pleural biopsy in the work-up of patients with unilateral pleural effusion, suspected of malignant pleural effusion.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Patients with a previous thoracentesis of a unilateral exudative pleural effusion according to Light's criteria (1) without malignant cells.
* CT thorax or PET-CT with contrast performed.
* Clinical suspicion of cancer such as (but not limited to) weight loss or PET-CT results or former cancer diagnosis.
* Patients must be able to give informed consent.

Exclusion Criteria:

* Bilateral pleural effusions.
* Known cause of pleural effusions.
* Life expectancy \<3 months.
* Inability to understand written or spoken Danish.
Real-Time Artificial Intelligence Assissted Colonoscopy to Identify and Classify Polyps

To investigate the degree of the real-time detection and classification system for increasing the adenoma detection rate during colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

Aged 18 to 85 years old. Colonoscopies for primary CRC screening of the subjects are required.

Exclusion Criteria:

History of CRC,inflammatory bowel disease, previous colonic resection, antithrombotic therapy precluding polyp resection.
Prescribed Sternal Precautions vs. Self-Guided Restrictive Care (PEEERC)

Our study aims to compare postoperative outcomes, postoperative pain and postoperative quality of lives in patients who receive the standard sternal precautions to those in patients who received self-managed sternal precautions following sternotomy for cardiac surgeries. The purpose of the study is to see if self-managed sternal precautions following sternotomy for cardiac surgeries lead to better quality of lives while maintaining same postoperative pain and rate of postoperative adverse events than standard sternal precautions. Postoperative pain and postoperative quality of lives will be assessed by phone call surveys. Postoperative outcomes will be measured by following the patients for up to a year using electronic medical record.

Patients who are recruited in this study will be randomized (1:1) into one of two groups/arms. The ?rst arm (Arm 1) will receive instruction to use pain and discomfort as the safe limits for their upper limb use during daily activities at post operative discharge. The second arm (Arm 2) will receive the standard sternal precautions at time of post operative discharge. Standard sternal precautions in study arm (2) include:

Don't reach both arms overhead Don't reach both arms out to the side Don't reach behind your back Don't lift more than 5 to 8 pounds Don't push with your arms Don't pull with your arms Don't drive

Each arm will receive weekly phone calls for 8 weeks. Information including pain, quality of life, and adherence to the sternal precaution protocol will be collected. Please refer to supporting documents (Pain Scale, Quality of Life Questionnaire, and Sternal Precaution Checklist) for the specific questions that will be asked at the patients. We will also investigate any adverse events related to the medical care.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing a sternotomy, English speaking, 18-70 years old, able to ambulate independently

Exclusion Criteria:

* Sternotomy due to VAD implantation or cardiac transplantation, discharge over 1.5 weeks after surgery, prior sternotomy
Life Satisfaction of Fathers of Children With Cerebral Palsy

The purpose of this study is to examine the determinants of life satisfaction among fathers of children diagnosed with Cerebral Palsy.


Eligibility Criteria:
Inclusion Criteria:

* to be literate and to have no communication problems
* to be the father of a child with Cerebral Palsiy (CP) and no other medical diagnosis (aged between 1-18 years)
* to have a child with CP who regularly receives physiotherapy and rehabilitation
* to live in the same house with his wife and child/children
* to be willing to participate in the study

Exclusion Criteria:

* to care for individuals in need of care (such as disabled, elderly, chronically ill) additionally to the child with CP
* to have a chronic disorder (such as neurological, rheumatologic, psychiatric disorder) that would affect life satisfaction.
Expanded Access Program to Provide Bamlanivimab (LY3819253) for the Treatment of COVID-19

The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.


Eligibility Criteria:
Inclusion Criteria:

* Reside in a country where there are ongoing Lilly-sponsored clinical trials (currently this is only the United States)
* Present within 10 days of symptom onset
* Have severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) confirmed by reverse transcription polymerase chain reaction (RT-PCR) within the last three days
* Participants greater than or equal to (≥) 65 years of age OR
* Participants ≥ 12 years of age who weigh at least 40 kilograms AND have at least one of the following:

  * Cancer
  * Chronic kidney disease
  * Chronic obstructive pulmonary disease (COPD) or other chronic lung disease
  * Immunocompromised state (weakened immune system or on immunomodulatory medications)
  * Obesity (body mass index \[BMI\] of 35 or higher)
  * Serious heart conditions such as heart failure, coronary artery disease or cardiomyopathies
  * Sickle cell disease
  * Diabetes mellitus (Types 1 or 2)

Exclusion Criteria:

* Require hospitalization greater than (\>) 24 hours or hospice care. Residents in long term care or skilled nursing facilities that meet the inclusion criteria and are not on mechanical ventilation will be considered
* Bamlanivimab should not be used in patients hospitalized with severe COVID-19 respiratory disease
FOB in HSCT and Leukemia Patients With Acute Respiratory Symptoms and Pulmonary Infiltrates

Pulmonary infiltrates frequently complicate the care of hematopoietic stem cell transplant (HSCT) and leukemia patients. Bronchoalveolar lavage (BAL) is frequently used to evaluate new pulmonary infiltrates in this population, however utility is limited by a historically low diagnostic yield for infection.

In an effort to improve diagnostic yields, this study will complete a Fiberoptic Bronchoscopy (FOB) within 8 hours of radiographic documentation of pulmonary infiltrates, prior to initiating new antibiotic therapy. To further improve detection of microbiological pathogens, the study will utilize PCR testing with rapid turnaround time to detect atypical pneumonia (M pneumoniae, C. Pneumonia, Legionella species, and respiratory viruses) and aspergillosis.

Proper diagnosis and prompt treatment favorably impacts survival in the post transplant setting, but is often difficult and frequently results in inappropriate or late therapy. Low yields may be linked with empiric antibody therapy begun prior to the procedure, delayed time to procedure, procedure technique, the presence of graft versus host disease (GVHD), neutropenia, and diffuse infiltrates (as opposed to localized infiltrates or focal masses and nodules). One recent study found that early FOBs (less than or equal to 4 days between detection of pulmonary infiltrates and FOB) were 2.5 times more likely to establish a diagnosis of pneumonia compared to late examinations. Delaying this procedure(greater than 5 days between detection of pulmonary infiltrates and FOB) was associated with drug resistant organisms, polymicrobial infections, and worsened patient prognosis.

Eligibility Criteria:
Inclusion Criteria:

* Autologous or allogeneic stem cell patients with new acute respiratory symptoms or pulmonary infiltrates
* leukemia patients with new acute respiratory symptoms or pulmonary infiltrates thought to be unrelated to disease

Exclusion Criteria:

* Patients unwilling to undergo FOB
* Patients unable to undergo FOB due to clinical status
* Patients unable to undergo FOB within 8 hours of radiographic report of pneumonia
* Patients unable to wait until completion of FOB to implement antibiotic changes
* Adults unable to provide informed consent
A Study to Survey Adults in South Korea With Cancer Who Receive PADCEV Injection

Enfortumab vedotin (or PADCEV Injection) is a treatment for cancer in the bladder lining (urothelial cancer). PADCEV Injection is now available to treat this cancer.

People in this study will be adults in South Korea with locally advanced or metastatic urothelial cancer. Metastatic means the cancer has spread to other parts of the body. During their care, the person's doctor will have prescribed PADCEV Injection and other medicines to treat their cancer. People in the study will be treated according to their clinic's standard practice. This study is about collecting information only.

This study will survey people who know they are receiving PADCEV Injection. The aims of the study are to check outcomes of treatment with PADCEV and record any medical problems during the study.

Once a doctor has prescribed PADCEV Injection, a person in the study will be observed for up to 48 weeks (about 1 year) after their first dose. During this time, a person's medical records will be reviewed to check for any medical problems and to follow the condition of their cancer. If a person in the study stops taking PADCEV Injection sooner than 48 weeks, records will be reviewed until 30 days (1 month) after each person's last dose of PADCEV Injection or until they start a different medicine for their cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients who receive treatment with PADCEV Injection, according to the approved local label.

Exclusion Criteria:

* Patients with any contraindication for PADCEV Injection, according to the approved local label.
* Patients who receive or are going to receive any investigational medicine during the observation period.
A Study With Peptide Vaccination in Treating Patients With Esophageal Cancer

The purpose of this study is to evaluate overall survival and immunological monitoring for peptide vaccination therapy using novel cancer testis antigens for locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC).

The phase I vaccination study using peptides derived from TTK, LY6K, and IMP-3 for locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) who had failed for the standard therapy indicated that the vaccine treatment were well tolerated and feasible, and that antigen-specific T cell responses were strongly induced by the vaccination with some objective clinical responses. Thus, we are currently initiating the randomized phase II clinical vaccination study for the same cohort with ESCC to evaluate the survival benefit of the cancer vaccination.

Eligibility Criteria:
Inclusion Criteria:

DISEASE CHARACTERISTICS

* Locally advanced, recurrent or metastatic esophageal squamous cell carcinoma who had failed for the standard therapy

PATIENTS CHARACTERISTICS

* ECOG performance status 0-2
* Age≧ 20≦ 80years
* WBC≥ 2,000/mm³ Platelet count ≥ 75,000/mm³ Total bilirubin ≤ 2.0 x the institutional normal upper limits AST, ALT, ALP ≤ 2.5 x the institutional normal upper limits Creatinine ≤ 1.5 x the institutional normal upper limits
* No therapy 4 weeks prior to the initiation of the trial
* Able and willing to give valid written informed consent

Exclusion Criteria:

* Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
* Breastfeeding
* Serious bleeding disorder
* Serious infections requiring antibiotics
* Concomitant treatment with steroids or immunosuppressing agent
* Decision of unsuitableness by principal investigator or physician-in-charge
A Randomized Control Trial Assessing the Effect of Topical Tranexamic Acid on Risk of Hematoma in Breast Surgery

This trial is being completed to evaluate the safety and efficacy of topical tranexamic acid use in preventing hematomas in routine breast plastic surgery operations.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing bilateral breast reduction or bilateral gender-affirming mastectomy
* For patients undergoing bilateral breast reduction, any skin incision pattern or pedicle is acceptable.
* For patients undergoing bilateral gender-affirming mastectomy, any skin incision and mastectomy type is acceptable

Exclusion Criteria:

* Active thromboembolic disease or history of intrinsic risk of thrombosis or thromboembolism, including retinal vein or artery occlusion
* Current use of systemic anticoagulation
* Hypersensitivity to tranexamic acid
* Concomitant use of combined hormonal contraceptives
* Use of factor IX complex concentrates, anti-inhibitor coagulant concentrates or all-trans retinoic acid
* History of acquired defective color vision
* History of subarachnoid hemorrhage
* Pregnancy
* History of renal impairment or serum Creatinine \>1.5 milligrams per deciliter (mg/dL)
Changes in Inter-joint Coordination and Muscle Activation After Cruciate Ligament Injury of the Knee Joint

Stair negotiation is an important activity of daily living. Patients with cruciate ligament injury may have difficulty in stair negotiation because of the proprioception deficit and neuromuscular deficit caused by ligament injury. However, the influence of knee cruciate ligament injury on the control of movement is still unclear. Since inter-joint coordination can provide the information of relationship between angle position and angle velocity, it may be useful to analysis the change of movement pattern.This current study aimed to investigate the change of inter-joint coordination and muscle activation in patients with cruciate ligament injury during stair negotiation.


Eligibility Criteria:
Inclusion Criteria:

* unilateral cruciate ligament injury or unilateral cruciate ligament reconstructed after 3 month
* able to climb up and down with step-over-step pattern
* BMI within 18 to 30

Exclusion Criteria:

* complex ligament injury
* lower limb fracture in recent years
* meniscus injury
* systematic disorder which would affect the balance and ambulation