cyrilzakka/clinical-trials huggingface dataset:
Comparing the Safety and Effectiveness of Different Doses of Morphine Administered in Spinal Anethesia for Pain Relief After Hip Replacement Surgery

Pain management after total hip replacement is one of the most important aspects of postoperative care for patients and clinicians alike. One of the most common techniques used in anesthesia for this procedure is spinal anesthesia with concurrent administration of opioids into spinal sac. Addition of opioids not only prolongs the anesthesia but also provides pain relief after the procedure for a limited amount of time. Because of its unique chemical properties morphine provides the longest pain relief amongst currently known opioids lasting up to 24 hours. Unfortunately this beneficial effect is associated with both minor and serious adverse effects, most important of which is respiratory depression.

To limit this potenitialy fatal adverse effect dosing of morphine must be very precise in order to balance advantages and risks.

The aim of the study was to assess effectiveness and safety profile of different doses of morphine administered during spinal anesthesia for pain control.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent to participate in trial
* Qualification for total hip replacement surgery
* ASA physical status I-III
* BMI 19-30
* Lack of contraindications for drugs and interventions used in trial

Exclusion Criteria:

* Incapability to provide informed consent
* Contraindications for spinal anesthesia
* Preoperative chronic pain
* Chronic use of analgesics
* Obesity (BMI\>30)
* Allergies and other contraindications for drugs used in trial
* Mental or physical incapability to operate PCA syringe pump
Acupuncture for Dry Eye

The purpose of this study is to assess whether acupuncture is more effective than artificial tear drop in the treatment of dry eye.

Dry eye is one of the common diseases in ophthalmology. It affects not only patients' daily activities such as reading, carrying out professional work, using the computer, watching television, and driving, but also bodily health conditions such as bodily pain, discomfort and lower energy and vitality.

Currently, artificial tears are easily subscribed or used in the shape of OTC drugs. However, preservatives in artificial tears may exacerbate ocular surface inflammation and the safety of anti-inflammatory treatment is not well established.

Acupuncture, one of the most popular CAM interventions, showed some favourable effects over artificial tears for dry eye in several randomised controlled trials (RCTs). The evidence obtained from these trials is quite limited because all of these RCTs were conducted under high risk of biases. Therefore, well-designed RCTs are needed to establish the efficacy of acupuncture for dry eye.

In a clinical trial, cost-effectiveness and qualitative researches can be carried out parallely. Through this kind of mixed method approaches, various compartments, consisting acupuncture treatment effects are able to be revealed totally.

In this context, the investigators designed a multi-center randomized controlled trial, comparing acupuncture treatment and artificial tear drop with immunoassay for the change of tear cytokine concentration, cost effectiveness study and qualitative research in a mixed method approach.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have had dry eye syndromes in single eye or in both eyes (ICD-10 : H04.1). He or she must have both of the conditions below:

  1. Patients who have dry eye symptoms such as itching, ocular foreign body sensation, ocular burning, ocular pain, ocular dryness, blurred vision, sensation of photophobia, ocular redness, sensation of tearing
  2. Patients whose tear film break-up time is below 10 seconds and Schirmer I test results is below 10mm/5sec.

Exclusion Criteria:

* Patients who have defects of the eyelid or eyelashes
* Acute infection of the eyelid, eyeball or eye accessories
* Stevens-Johnson syndrome
* Vitamin A deficiency
* Eye or accessory defects due to external injuries
* A past history of surgical operation related to the eye in last three months
* Punctual occlusion
* Current usage of contact lenses
* Sequelae of facial palsy,
* Current usage of anti-inflammatory eye drops in the last two weeks
* Pregnancy
* Using history of traditional medicinal treatment such as acupuncture, moxibustion and herbal medicine in the last one month
Pharmacological and Mechanical Support Approaches in the Management of Acute Heart Failure in the Regional Network Model for the Management of Cardiogenic Shock

The goal of this observational study is to understand and describe the epidemiology of cardiogenic shock in Emilia Romagna with a specific focus on outcome stratified by aetiologies, sex and age. The main outcomes are:

* Incidence of cardiogenic shock (CS) over the total CICU admissions, CS-related in-hospital mortality and length of hospitalization, stratified by aetiologies, sex and age
* Epidemiology of patients admitted with CS, regarding age, gender, etiology and modality of presentation (acute or acute on chronic), echocardiographic and haemodynamic data, treatment strategy with inotropes and/or short-term MCS, cardiac arrest.

This is an observational study without intervention. Patients will be treated according to current clinical practice, according to physician judgment and data sheets of each drug used according to clinical practice.

This is a multicenter observational study with both a retrospective and a prospective cohort.

Study population will include all consecutive patients diagnosed with cardiogenic shock and admitted to the cardiac intensive care unit of the participating centers.

For the patients enrolled at IRCCS Azienda Ospedaliera-Universitaria di Bologna this study will involve a collaboration with UO Cardiologia.

For the retrospective cohort, patients will be selected based on ICD9 discharge codes and included if they fulfill inclusion criteria after review of hospital charts. The retrospective cohort will serve as a historical comparison regarding epidemiology, treatment strategies and survival.

Incidence and workload burden of CICU will be studied comparing the number of CS patients and the total number of admissions in the study period.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years old) admitted to a participating CICU with suspected CS of stage from C to E according to SCAI (Society of cardiovascular intervention)classification of cardiogenic shock.
* Signed informed consent.

Exclusion Criteria:

* CS following cardiac surgery (post-cardiotomy), ● Significant polytrauma or neurological injury.
Pentoxifylline Role Against Chemotherapy-induced Neuropathy

Chemotherapy-induced peripheral neuropathy (CIPN) is a common and debilitating side effect of neurotoxic cancer treatment. Estimated to occur in up to 80% of paclitaxel-treated patients with breast cancer, neuropathy symptoms can interfere with function, increasing the risk of falls and reducing quality of life. To date, there are no approved medications for the prevention and/or treatment of CIPN. The objective of the present study is to investigate the beneficial effects of pentoxifylline (PTX) against CIPN in breast cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients\> 18 years old.
* Female patients Breast cancer patients who received paclitaxel-based regimen for 12 weeks.
* Eastern Cooperative Oncology Group (ECOG) performance ≤ 2-Adequate bone marrow function.
* Adequate liver and kidney function.

Exclusion Criteria:

* Children less than 18 years old.
* Evidence of physical diseases or major surgery.
* Patientswith a history of chronic diseases including; renal, hepatic, gastrointestinal, respiratory, hematological, and metabolic or other diseases.
* Patients with preexisting clinical neuropathy.
* Patients with diabetes mellitus.
* Metastatic breast cancer.
* Patients receiving medications that ameliorate neuropathy like; antidepressants, anticonvulsants, opioids, adjuvant or topical analgesics.
* Patients treated with medications that increase the risk of neuropathy.
* Hypersensitivity to pentoxifylline or xanthine derivatives.
* Patients retinal bleeding or active peptic ulcer.
* Patients at high risk for bleeding or taking medications that increase risk of bleeding.
Develop and Implement Asthma Controlling Strategies (1)

To develop and implement asthma controlling strategies for inner city and high risk populations.

BACKGROUND:

Asthma is a serious chronic disease affecting about 12 million Americans; about 3 million are children. The study was part of an initiative, "Developing and Implementing at the State and Local Level Educational Strategies and Interventions for Controlling Asthma in Inner City and High Risk Populations", released in February 1993 by the National Asthma Education Program of the Office of Prevention, Education and Control.

Eligibility Criteria:
No eligibility criteria
A Study of CS1001 in Subjects With Stage IV Non-Small Cell Lung Cancer

This is a multi-center, randomized, double-blind, phase III study to evaluate the efficacy and safety of CS1001 in combination with platinum-containing chemotherapy versus placebo in combination with chemotherapy in first-line treatment-naive subjects with stage IV non-small cell lung cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria:

1. Willing to participate in this trial; fully understand and informed of this trial, and able to provide written informed consent form (ICF).
2. 18-75 years of age (18 and 75 included) on the day of signing ICF.
3. Histologically or cytologically confirmed stage IV non-small cell lung cancer (staged according to the 8th International Association for the Study of Lung Cancer (IASLC) classification.
4. Subjects haven't received systemic treatment for advanced/metastatic NSCLC.
5. Measurable target lesion evaluated by investigators according to RECIST v1.1.
6. ECOG PS of 0-1.
7. Life expectancy ≥ 12 weeks.
8. Subject with prior anti-cancer treatment can only be enrolled when all toxicities except for hearing loss, alopecia and fatigue, of prior anti-cancer treatment has recovered to ≤ Grade 1 according to National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events (CTCAE) v4.03.
9. Subjects must have adequate organ function.
10. Women of childbearing potential (WOBPC, as defined in section 13.5) must have a negative pregnancy test ≤7 days prior to the first dose of investigational product. WOBCP or fertile men and their WOBCP partners must agree to use an effective method of birth control from providing signed ICF and for 6 months after last dose of investigational product.

Exclusion Criteria:

1. Histologically confirmed small cell lung cancer or containing small cell component.
2. Subjects with current active autoimmune disease or prior history of autoimmune disease.
3. Malignancies other than NSCLC within 5 years prior to randomization.
4. Known history of human immunodefiency virus (HIV) infection and/or acquired immune deficiency syndrome.
5. Subject with active hepatitis B or hepatitis C.
6. Subjects with known history of alcoholism or drugs abuse.
7. Has a known hypersensitivity to any component of study treatment, for example pemetrexed, cisplatin, carboplatin or other platinum compounds.
8. Subjects with other conditions that in the investigator's opinion may influence subject's compliance or make subjects not suitable for participating in this trial.
The Efficacy of Trimethoprim in Wound Healing of Patients With Epidermolysis Bullosa

The purpose of this study is to assess the efficacy of trimethoprim in promoting wound healing and decreasing blister formation in patients with Epidermolysis Bullosa.

Epidermolysis Bullosa (EB) comprises a series of hereditary disorders characterized by fragility of the skin and mucous membranes and the tendency of the skin to blister in response to minor friction or trauma. The care of patients with EB is a complex task that has to be carried out by a multi-professional team. In the absence of a cure, the goal of therapy is the prevention and healing of chronic wounds.

In patients with EB, chronic inflammation interferes with proper wound healing. One treatment option is the use of anti-inflammatory antimicrobial agents, such as trimethoprim, to hasten wound healing and decrease blister formation. This treatment may lead to decreased pain and improvement of the quality of life for these patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients younger than 20 years of age
* Diagnosis of Recessive Dystrophic Epidermis Bullosa (RDEB)or Junctional Epidermis Bullosa (JEB)
* Signed consent/assent form

Exclusion Criteria:

-Previous known allergy or intolerance to trimethoprim
Effects of Potatoes on Blood Pressure in Persons With and Without Type 2 Diabetes Who Follow the DASH Diet for 6 Weeks

This study will be a randomized controlled intervention study that will collect pre-intervention and post-intervention anthropometric health data of men and women aged 18-65 years who have type 2 diabetes and who do not have type 2 diabetes. The information collected will be analyzed and used to compare to the post intervention. 12 participants who have type 2 diabetes and 12 participants who do not have type 2 diabetes will be randomized into either the DASH-FP (fried potatoes), DASH-NFP (non-fried potatoes) or DASH-NP (no potatoes) groups, stratifying by sex (male or female) and age range (18 to less than 35, 35 to less than 66 years old) in blocks of three.

Subjects will follow the DASH diet for 2 weeks to establish baseline blood pressure and then will be randomized to a 4-week intervention study with assigned dietary patterns (DASH-NP as a control diet, DASH-FP diet with only fried potatoes, or DASH-NFP diet with only non-fried potatoes) in accordance with the protocol given above. Before intervention, each group will receive a cooking demonstrations, samples, and recipes to show the correct preparation method and seasoning ingredient to use according to each treatment group. The control group will receive a cooking demonstration including DASH diet recipes without potatoes. Potatoes will be provided for participants in the potato groups allowing for one serving a day of potatoes prepared according to their treatment group.

The control diet will be the standard DASH diet but with no potatoes. DASH-FP will include 5 servings of fried potatoes each week. DASH-NFP will include 5 servings of non-fried potatoes each week. Participants will be instructed to maintain the broad requirements of the DASH diet on their own. A 7-day menu cycle from the DASH-Sodium study for each dietary pattern at different energy levels will be used as the basis for the recommended diets. There will be weekly contact with the participants in which the DASH diet will be reinforced. The goal of the weekly sessions will be to assist participants in learning how to buy and prepare the appropriate foods according to their dietary pattern, to enhance their motivation to choose to eat those foods, and to overcome obstacles to following the diet.

Eligibility Criteria:
Inclusion Criteria:

Group 1:

-Well controlled type 2 diabetes as diagnosed by a physician, which is managed by diet and exercise alone or any diabetes medication(s) other than insulin; clinically stable.

Group 2:

-No diagnosis of type 2 diabetes

Group 1 and 2 Exclusion Criteria:

* Use of tobacco
* Self-reported history of chronic diseases other than type 2 diabetes (e.g., cardiovascular, etc.)
* Evidence of severe diabetic complications (such as proliferative retinopathy or diabetic nephropathy)
* Uncontrolled hypertension
* Use of oral steroids, hormone replacement therapy
* Individuals with blood pressure ≥160/100, or HbA1c ≥9%
* Individuals with allergy to potatoes
* Pregnant or lactating
* Individuals on insulin therapy
* Any alcohol or drug dependence
Compare the Same Dosage of Insulin Using a Combination of Cartridges, 30 Units as 2 Cartridges vs. 1 Cartridge

A Phase 1, open-label, randomized, crossover study in 36 healthy normal volunteers (HNVs) to evaluate the bioequivalence of TI Inhalation Powder delivered using the Gen2 Inhaler and administered as one 30 U cartridge versus a combination of one 10 U cartridge and one 20 U cartridge.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 to 45 years, considered healthy based on screening physical examination, medical history, clinical chemistry, and urinalysis
* No smoking in the past 6 months (including cigarettes, cigars, and pipes)
* Urine cotinine testing \< 100 ng/mL
* Body mass index \< 32 kg/m2
* Completion of informed consent form

Exclusion Criteria:

* FBG \> 100 mg/dL
* Clinically significant active or chronic illness
* History of asthma, chronic obstructive pulmonary disease (COPD), or any other clinically relevant chronic lung disease
* Respiratory tract infection within 4 weeks before screening and between the screening visit and dosing visit
* Subjects who are experiencing persistent or recurring cough, wheezing, bronchospasm, or dyspnea
The Effects of Troponin I Surveillance Among Patients Undergoing Acute High-risk Abdominal Surgery

Treatment of disorders such as gastrointestinal tract (GI) perforation, ischemia and obstruction often require acute high-risk abdominal surgery, which is associated with a high risk of complications such as myocardial injury after non-cardiac surgery (MINS) and mortality. The majority of patients with MINS will not experience any symptoms, and thus MINS remains undetected without routine troponin measurements.

The investigators hypothesized that implementing surveillance with troponin I as a standard care might be useful as risk stratification, and that increased surveillance, examinations, and subsequent individually based medical interventions, might improve the outcomes for patients with MINS.


Eligibility Criteria:
Inclusion Criteria:

* Eligible patients were 18 years or older
* Undergoing surgery for gastrointestinal perforation, obstruction, mesenterial ischemia or necrosis, or anastomotic leakage.

Exclusion Criteria:

* Not undergoing surgery for one of the conditions above
Erlotinib, Gemcitabine and Nab-Paclitaxel in Advanced Pancreatic Cancer

This is a phase 1b study to evaluate the combination of gemcitabine and Tarceva (erlotinib) and nab-paclitaxel in patients with advanced pancreatic cancer.

This is a single-arm, phase 1b study to determine the maximum tolerated dose (MTD) of the combination of erlotinib (daily), gemcitabine (weekly), nab-paclitaxel (weekly) in patients with advanced pancreatic cancer.

Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1
* Predicted life expectancy of \>= 12 weeks
* Previous surgery
* Histologically or cytologically confirmed, measurable, locally advanced, unresectable or metastatic pancreatic adenocarcinoma
* No prior therapy for pancreatic cancer
* Adequate organ and marrow function

  * Absolute neutrophil count \>= 1.5 x 10\^9/L
  * Platelets \>= 100 x 10\^9/L
  * Total bilirubin \<= institutional upper limits of normal
  * AST (SGOT)/ALT(SGPT) \<= 2 x institutional upper limits of normal
  * Serum creatinine \<= 1.5 x upper limits of normal
* Negative pregnancy test
* Informed consent
* Patient must agree not to smoke while on study

Exclusion Criteria:

* Significant history of cardiac disease unless the disease is well controlled
* Active or uncontrolled infections or serious illness or medical conditions that could interfere with the patient's ongoing participation in study
* History of any psychiatric condition that might impair the patient's ability to understand or to comply with the requirements of the study or to provide informed consent
* History of smoking within the previous 14 days before enrollment or positive cotinine test at baseline
* Pregnant or breast-feeding females
* Symptomatic brain metastases that are not stable, that require steroids, that are potentially life-threatening, or that have required radiation within the last 14 days
* History of allergic reactions attributed to compounds of similar chemical or biological composition to the study drugs
Use of Blood Biomarkers and Biomarker Index to Aid in the Diagnosis of Obstructive Sleep Apnea (OSA)

This multicenter prospective trial will evaluate the association between obstructive sleep apnea (OSA) and blood biomarkers in a representative population of consecutively enrolled symptomatic patients with a clinical suspicion of OSA.


Eligibility Criteria:
Inclusion Criteria:

* Written Informed Consent
* Male
* 18-70 years old
* Presentation with symptoms suggestive of obstructive sleep apnea
* Diagnostic sleep study
* Blood draw

Exclusion Criteria:

* Prior (within past year) or current therapy for sleep apnea
* Use of opioid pain medication, steroids or allopurinol (within past 30 days)
* Use of chronic anti-inflammatory drugs (within past 7 days)
* Active cancer under current treatment or monitoring
Acute Hamstring Strains in Danish Elite Soccer - Prevention and Rehabilitation

A common soft tissue injury in sports involving sprinting and jumping is the hamstring strain.

Not much evidence-based research has been carried out on prevention of hamstring strains.

Most studies suggest that hamstring strains occur during the later part of the swing phase when the player is sprinting. In this phase the hamstring muscles are working to decelerate knee extension - that is, the muscle develops tension while lengthening. This means that the muscles change from functioning eccentrically to concentrically. We hypothesize that it is during this rapid change from eccentric to concentric function that the muscles are most vulnerable to injuries, and that the injuries can be prevented by increasing the eccentric muscle strength in the hamstring.

This randomized clinical trial will examine the effect of a 10-week preseason strength-training program in Danish elite soccer. The strength-training program focuses on eccentric hamstring training.

60 elite teams (1200 soccer players) will be cluster-randomized to either ordinary training or ordinary training combined with eccentric hamstring strength training. The training group will start the training program in the pre-season (10 weeks) and continue the training once a week during the following season.

Suspected hamstrings strains during the season will be examined within 3 days using ultrasound. Ultrasound verified hamstring strains will be registered, and players will start a standardized rehabilitation program.


Eligibility Criteria:
Inclusion Criteria:

* Male soccer player in one of the top 4 divisions i Denmark in the 2007/08 season
* Minimum 18 years old at the time for inclusion

Exclusion Criteria:

* Current hamstring strain at the time for inclusion
* Under 18 years old