cyrilzakka/clinical-trials huggingface dataset:
Chronic Obstructive Pulmonary Disease and Weaning From Mechanical Ventilation in Difficult to Wean Patients

To evaluate and compare two methods of weaning from mechanical ventilation in patients with chronic obstructive pulmonary disease (COPD) where the extubation failed.

A prospective, randomized trial was performed in a multidisciplinary Intensive Care Unit (ICU) for the duration of 2 years. A total of 136 COPD patients who required mechanical ventilation longer than 24 h fulfilled the inclusion criteria and they present the research sample. After fulfilling the criteria for weaning, patients were randomized to a 2-h spontaneous breathing trial with either T-tube or pressure support ventilation (PSV). The patients with successful 2-h trial were extubated and were excluded from further research. Patients with 2-h trial failure were defined as difficult to wean, they had mechanical ventilation reinstated and the same weaning procedure was repeated after 24 h, if the patient again fulfilled the weaning criteria. In these patients, two methods of weaning were compared according to the patients clinical characteristics, objective parameters and procedure outcome.

31 (47%) patient with T-tube and 32 (46%) patients with PSV had 2-h trial failure. Of those patients, successful extubation was in 17 (56%) patients with T-tube and in 23 (72%) with PSV (P \<0.001), whereas extubation failure was in 14 (44%) patients with T-tube and in 9 (28%) patients with PSV (P \<0.001). Mechanical ventilation duration was 186.7 h with T-tube and 163.2 h with PSV (P \<0.001), time spent in ICU was 240.7 h with T-tube and 210.2 h with PSV (P \<0.001).

In patients with COPD who failed the 2-h spontaneous breathing trial, based on parameters of procedure outcome, high advantage of PSV method was confirmed.

Eligibility Criteria:
Inclusion Criteria:

* COPD
* exacerbation of dyspnea \<2 weeks
* signs of respiratory muscle dysfunction

Exclusion Criteria:

* non COPD patients
* age \<18 years
* tracheotomy
* MV duration shorter than 24h
* use of MV on admission to the ICU or transfer to some other ICU for treatment continuation
* patients who died or weaning from MV was discontinued because of another associated disorder
* central nerve system disorders unrelated to hypercapnic encephalopathy or hypoxemia
* cardiac arrest within 5 days
* patients scheduled for organ donation
Swedish Study on STroke After TAVR

This study aims at studying the frequency of late stroke after transcatheter aortic valve replacement/implantation

Since the start of transcatheter aortic valve implnatations/replacements (TAVR/TAVI) implantations in Sweden in 2008 all procedures have been added to a national database, which now contains 5000+ procedures. At the same time, all admissions to the hospital is also recorded with diagnosis in a separate database. We intend to make a nation-wide complete follow up of all TAVR/TAVI patients in swede that has received the diagnosis of stroke after the implantation. In addition data will also be collected from the national stroke database for detailed information of the cases

Eligibility Criteria:
Inclusion Criteria:

All patients that has under TAVR/TAVI in Sweden between 2008 and 2018 Exclusion Criteria: Patients unable to follow up due to emigration or missing social security number

Exclusion Criteria:

Periprocedural stroke
Enzastaurin for Patients With Metastatic Colorectal Cancer

Enzastaurin given daily to participants with colorectal cancer who have Stage 4 disease and have not received prior chemotherapy for advanced colorectal cancer


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with colorectal cancer that is advanced or metastatic (has spread to other parts of the body); able to visit the doctor's office every 28 days for at least 6 months; able to swallow tablets

Exclusion Criteria:

* women cannot be pregnant or breastfeeding; no history of significant heart disease or any other significant medical problems as determined by the participant's physician
The Prognostic Significance of Fibrosis Detection in Cardiomyopathy

The presence of scar within heart muscle can act as a substrate for abnormal rhythm problems and lead to the developement of heart failure

Clinical significance Correlation with biomarkers and genetic markers

Patients will undergo cardiovascular magnetic resonance (CMR) to include measurement of left ventricular volumes, ejection fraction, detection of inflammation (via STIR sequences) where appropriate, early gadolinium enhancement, late gadolinium enhancement, first pass perfusion using pharmacological stress imaging (contraindications to include comorbidities that do not permit pharmacological stress agents e.g. severe asthma, severe or symptomatic aortic stenosis)

Eligibility Criteria:
Inclusion Criteria:

* presence of an ischaemic or non-ischaemic cardiomyopathic process
* no contraindication to contrast enhanced CMR
* GFR \>30

Exclusion Criteria:

* ESRF
* Contraindication to CM R
Tranexamic Acid in Pediatric Scoliosis Surgery

This study aims to investigate whether intraoperative administration of tranexamic acid based on ROTEM® (Rotational Thromboelastometry), in pediatric patients undergoing scoliosis surgery, results in a difference in intraoperative blood loss when compared to the prophylactic administration of tranexamic acid.


Eligibility Criteria:
Inclusion Criteria:

* Children undergoing scoliosis surgery under the age of 18

Exclusion Criteria:

* Patients with coagulation disorders
* Patients at an increased risk of thrombosis
* Patients with a history of epilepsy or brain surgery
* Patients with a previous allergic reaction or anaphylaxis history to tranexamic acid
* Severe liver or kidney impairment
* Other cases deemed inappropriate by the researcher
Tweet4Wellness: An Online Virtual Support Group for Promoting Increased Physical Activity

The purpose of this study is to determine whether a Twitter-based intervention with a private, online support group can significantly increase number of walking steps compared to self-monitoring of physical activity alone or a control group in sedentary women at a women's heart clinic.

Sedentary behavior is a risk factor for heart disease, independent of meeting physical activity guidelines. Tweet4Wellness is an innovative light physical activity, specifically walking, intervention which randomly assigns participants to a 25-person private, online support group that will receive daily, theory-based messages as peer-to-peer discussion prompts. Many text-based interventions do not base the intervention text messages in behavior change theory, but this study will base the daily messages in the behavior change theories such as implementation intentions, social support, mindfulness, and social learning theory.

The trial will be conducted over a 6-month periods. For the first 3 months, there will be 2 groups: Group 1 will receive the Twitter intervention and a "Fitbit" triaxial pedometer to track their steps throughout the day; Group 2 will receive the Fitbit pedometer only.

For the second 3 months: Group 1 an Group 2 will track their physical activity with Fitbit only.

Eligibility Criteria:
Inclusion Criteria:

* Are a woman
* Are over 18 years of age
* Are English speaking
* Have or are willing to purchase a mobile phone with a camera
* Have or are willing to purchase an unlimited text plan
* Are willing to participate in daily tweets or texts for up to 3 months
* Have an active email account
* Have internet access on your mobile phone
* Use or are familiar with Facebook, Twitter, or other social media
* Text at least weekly

Exclusion Criteria:

* Have certain symptoms or conditions that would not be conducive to increasing your physical activity as determined by your physician
* Are planning on becoming pregnant in the next 8 months
* If our screening survey indicates that you are already adequately physically active
* Do not provide all required personal contact information
Probiotics as Adjunctive Migraine Prophylaxis

This study will assess the safety and efficacy of multi-strain probiotics as an adjunctive treatment for episodic migraine

This is a phase 2 and single center, randomized, placebo-controlled double-blind clinical Trial. Episodic migraine patients according to International Headache Society criteria will be allocated randomly into two treatment arms. One group will receive active probiotics and another group will receive placebo for treatment phase. Both groups of patients will consume the treatment twice daily for 12 weeks and assessment will be made at baseline, baseline, week 4, 8 and 12

Eligibility Criteria:
Inclusion Criteria:

1. Subjects fulfilling criteria for episodic migraine as per the Third Edition of The International Headache Society (ICHD-3) (Table 1)
2. Patients diagnosed with episodic migraine (4 or more episodes per month) for a minimum of 3 months.
3. On a steady treatment regimen: preventive and acute migraine medications and therapies unchanged over the last 3 months
4. Adult patients Age \> 18 years old
5. A signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study including any known and potential risks and available alternative treatments.

Exclusion Criteria:

1. Lactose intolerance
2. Previous history of small and large bowel surgery
3. Use of probiotics or antibiotics in 2 weeks before baseline visit.
4. Patients with medical conditions such as severe hypertension, infections,
5. Malignancy, cardiovascular and cerebrovascular diseases, epilepsy, degenerative central nervous system diseases, renal failure, hepatic failure, bleeding diathesis and serious mental illnesses
6. Headache with red flags symptoms that may suggest organic secondary headaches.
7. Onset of headache more than 50 years
8. Prior GI infection in the previous 3-months
9. Morbid obesity (BMI \>40)
10. Pregnant or lactating women
Study of Cipterbin®, Used Alone or With Vinorelbine in Patients With HER2/Neu-overexpressed Metastatic Breast Cancer

The HER2 gene (also known as HER2/neu and ErbB2 gene) is overexpressed in 20-30% of human breast cancers and leads to a particularly aggressive form of the disease. Trastuzumab,a humanized anti-HER2/neu receptor monoclonal antibody, has been proved a valuable treatment for HER2-positive breast cancer patients.The combination of trastuzumab with chemotherapy has been shown to increase both survival and response rate, in comparison to trastuzumab alone. CMAB302, a biosimilar of trastuzumab, was developed by Shanghai CP Guojian Pharmaceutical Co.Ltd. Efficacy and safety of CMAB302 as a single agent or in combination with vinorelbine were evaluated in patients with HER2-overexpressing metastatic breast cancer.

The HER2 gene (also known as HER2/neu and ErbB2 gene) is overexpressed in 20-30% of human breast cancers and leads to a particularly aggressive form of the disease. Trastuzumab,a humanized anti-HER2/neu receptor monoclonal antibody, has been proved valuable treatment for HER2-positive breast cancer patients.The combination of trastuzumab with chemotherapy has been shown to increase both survival and response rate, in comparison to trastuzumab alone. CMAB302, a biosimilar of trastuzumab, was developed by Shanghai CP Guojian Pharmaceutical Co.Ltd. Previous Phase I study showed that CMAB302 was well tolerated as monotherapy and the pharmacokinetic data exhibited a non-linear profile over the dose range of 100 to 500 mg, similar to that of trastuzumab. In this study, efficacy and safety of CMAB302 as a single agent or in combination with vinorelbine were evaluated in patients with HER2-overexpressing metastatic breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* pathologic diagnosis breast cancer
* HER2+ status defined as IHC3+ Staining or in situ hybridization positive at least 1 measurable lesion as per RECIST criteria
* Adequate bone marrow function (absolute neutrophil count \>1500/mm3, platelet count \>100.000/mm3, hemoglobin \>10gr/mm3)
* Adequate liver (bilirubin \<1.0 times upper limit of normal and SGOT/SGPT \<2.5 times upper limit of normal) and renal function (creatinine \<1.5mg/dl)
* Adequate cardiac function (LVEF\>50%). Normal electrocardiogram and absence of significant heart disease
* age from 18 to 70y
* Karnofsky performance score ≥ 60
* Life expectancy of greater than 3 months
* Negative HCG pregnancy test for premenopausal women of reproductive capacity and for women less than 12 months after the menopause.
* signed ICF

Exclusion Criteria:

* prior exposure vinorelbine for breast cancer
* prior exposure trastuzumab for breast cancer
* Prior chemotherapy and radiation therapy within the last 4 weeks before enrollment
* use of any other investigational agents within the last 4 weeks before enrollment
* symptomatic, central nervous system metastases
* Hypersensitivity to trial medications
* breastfeeding or pregnant
Relationships Between Tenascin C, Smoking and Periodontal Status

The goal of this observational study is to determine if there is a relationship between different periodontal conditions (gingival healthy, stage 2 grade B, stage 2 grade C, stage 3 grade B, stage 3 grade C) and the levels of tenascin C, IL-1 beta, IL-4, and IL-6 in saliva samples from smokers and non-smokers. The main questions it aims to answer are:

Is there a difference in the levels of tenascin C, IL-1 beta, IL-4, and IL-6 between smokers and non-smokers with different periodontal conditions? Do these biomarkers correlate with the severity and grade of periodontal disease?

Researchers will compare the saliva samples from smokers and non-smokers across the different periodontal conditions to see if there are significant differences in the biomarker levels. Participants will:

Provide saliva samples. Be categorized based on their smoking status and periodontal condition.


Eligibility Criteria:
Inclusion Criteria:

* The periodontitis groups (Non-smoking and smoking) in the study will include systemically healthy patients who are clinically diagnosed with Stage II and III, generalized, Grade B, C periodontitis based on the consensus report of the 2017 World Workshop on Classification of Periodontal and Peri-Implant Diseases and Conditions.
* Agreeing to participate in the study

Exclusion Criteria:

* use of oral contraceptive drugs
* use of antibiotics, immunosuppressants, or drug therapies in the last 6 months before the study;
* history of excessive alcohol use;
* pregnancy or breastfeeding status;
* periodontal treatment during the last 6 months before the study.
* Not agreeing to participate in the study
* Not meeting the inclusion criteria
Multimodal Pain Management After Wide Awake Local Anesthesia No Tourniquet Orthopedic Hand Surgery: A Randomized Control Trial

The main objective of the study is to measure the efficacy of a multimodal postoperative pain regimen consisting of oral acetaminophen and naproxen compared to a traditional opioid-only pain regimen following elective wide awake local anesthesia no tourniquet (WALANT) hand surgery in a Hispanic population. The study is a randomized control trial comparing the clinical outcomes of patients undergoing elective WALANT hand surgery performed by a board-certified, fellowship-trained orthopedic hand surgeon (Dr. Christian A. Foy).

The study groups are:

* Control group: standard pain control with opioids
* Experimental group: multimodal non-opioid pain control

Study Outcomes are:

* VAS pain scores (7 days),
* Total opioid usage
* Patient satisfaction
* Adverse events

We hypothesize that patients receiving multimodal pain regimens will report lower opioid use, lower pain scores, and greater satisfaction than patients receiving traditional opioid-only pain management.

The main objective of the study is to measure the efficacy of a multimodal postoperative pain regimen consisting of oral acetaminophen and naproxen compared to a traditional opioid-only pain regimen following elective wide awake local anesthesia no tourniquet (WALANT) hand surgery in a Hispanic population. The study is a single-blind, single-center randomized control trial comparing the clinical outcomes of patients undergoing elective WALANT hand surgery performed by a board-certified, fellowship-trained orthopedic hand surgeon (Dr. Christian A. Foy). Patients will be consecutively recruited at the center and randomized in a 1:1 ratio into the control and experimental groups. The control group will receive the standard of care for postoperative pain: 10 pills of 5mg oxycodone Q4hrs as needed. The experimental group will receive 30 pills of 500mg acetaminophen Q4hrs and 30 pills of 500mg naproxen Q4hrs until pain resolves or treatment is completed. The experimental group will also receive 5 tablets of 5mg oxycodone to take Q4hrs as needed for breakthrough pain. Postoperatively, daily pain Visual Analog Scale (VAS) scores, total opioid usage, patient satisfaction, and adverse events will be recorded. We hypothesize that patients receiving multimodal pain regimens will report lower opioid use, lower pain scores, and greater satisfaction than patients receiving traditional opioid-only pain management.

Eligibility Criteria:
Inclusion Criteria:

* Patients 21-70 years of age undergoing outpatient hand surgery
* Patients undergoing surgery with WALANT technique
* Patients who provide written informed consent

Exclusion Criteria:

* Patients aged 20 and younger, or 71 and older
* Patient with chronic pain requiring opioid use
* Pregnant patients
* Patients who do not self-identify as Hispanic
* Patients with known allergy to the medication
* Patients with contraindications for the prescribed medications
Sacral Savers: Study of Prevention and Enhanced Healing of Sacral and Trochenteric Ulcers

The purpose of the study is to investigate the ability of the product "Sacral Saver," to prevent and /or help healing bed sores.

The purpose of this research study is to investigate the ability of the product "Sacral Savers." to prevent and/or help healing of bed sores, in patients in health care facilities.

The Sacral saver device consists of a sheet of strong bubble-wrap-like material, folded at one end and covered by a nylon sham with a pocket in which the bubble wrap is placed. The assembled device is placed under the bed sheet in such a way that the small of the back rests on the fold. This will lift the back and reduce the pressure of the buttocks on the bed. When lying on the side, it will reduce the pressure on the hip.

Participants are being asked to participate in this study because you are at risk for, or already have a bedsore on the buttocks or the hip.

Eligibility Criteria:
Inclusion Criteria:

* Any patient who is immobilized for prolonged periods, either in acute care, or chronic care situations.
* All patients with: paralysis, quadriplegia, paraplegia, trauma patients, requiring prolonged immobilization, patients on ventilators.
* All patients with pre-existing pressure ulcers in the lower back and or hip regions.

Exclusion Criteria:

* There are no age, gender or co-morbidity exclusions
Comparison of Treatment Response to Intravitreal Injection of Combined Propranolol and Bevacizumab Versus Bevacizumab Monotherapy in Patients With Wet Age Related Macular Degeneration :A Clinical Trial

This study is designed to compare the effect of combined intravitreal Bevacizumab and Propranolol injection versus Bevacizumab monotherapy in patients with Age Related Macular Degeneration.

Methods:

In this study patients with Age Related Macular Degeneration who are naïve or had history of previous treatment are included. The eligible patients in randomized in two groups "Bevacizumab" and "Bavacizumab + propranolol" and in injected intravitreally for 3 times monthly. In "Bevacizumab+propranolol" group patients receive two injections at each session Bavacizumab and propranolol. In "Bevacizumab" group patients receive only Bevacizumab. The patients are followed for 6 months and central macular thickness and visual acuity is measured at baseline and monthly for 6 month. Baseline ancillary exams include Fluorescein Angiography and OCT-Angiography which is performed at the final exam as well. Patients needing any therapeutic intervention is addressed during the 6 month follow up period.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Wet AMD and Vision less than 20/40

Exclusion Criteria:

* History of cardiac ,renal, respiratory diseases (due to beta blocker toxicity),
* Associated with other Macular abnormalities such as Diabetic Retinopathy, Macular traction
* History of ocular inflammation
* Subretinal fibrosis
* History of Cataract surgey less than 6 months
* History of Glaucoma Surgery ,Vitreoretinal surgery
* Media opacity
Special Use-results Surveillance on Long Term Use of Sogroya® in Children With Short Stature Due to Growth Hormone Deficiency Where Epiphysial Discs Are Not Closed

The purpose of the study is to investigate the safety and effectiveness of Sogroya® in children with short stature due to growth hormone deficiency where epiphysial discs are not closed under real-world clinical practice in Japan. The study will last for about 1 year (at shortest) to 3 years (at longest) depending on when the participant takes part in the study. The participant will be asked to answer questionnaire(s) about how they feel about the growth hormone (GH) product treatment once during the study (at about 3 months after starting the Sogroya® treatment) and about 3 months after starting the Sogroya® treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
2. The decision to initiate treatment with commercially available Sogroya® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study. Both GH treatment naïve and non-naïve children are eligible.
3. Male or female age 0 to 18 years (exclusive) at the time of signing informed consent.
4. Diagnosis with short stature due to GHD where epiphysial discs are not closed according to local normal clinical practice.

Exclusion Criteria:

1. Previous participation in this study. Participation is defined as having given informed consent in this study.
2. Treatment with any investigational drug within 30 days prior to baseline (the starting date of Sogroya® treatment).
3. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
4. Contraindication described in approved product labelling in Japan.

   1. Patients with hypersensitivity to the active substance or to any of the excipients
   2. Patients with malignant tumour
   3. Female patients who are either pregnant or likely to be pregnant