cyrilzakka/clinical-trials huggingface dataset:
Monotherapy Versus Bitherapy in Non-severe Hospitalized Community-acquired Pneumonia

The purpose of this study is to determine whether a monotherapy with a Beta-Lactam is not inferior to an association of a Beta-Lactam and a macrolide in treating adult patients with community-acquired pneumonia.


Eligibility Criteria:
Inclusion Criteria:

* Age \>=18 years
* New infiltrate on chest X-ray, unexplained by another disease process
* Presence of at least two of the following findings suggestive of pneumonia: fever or hypothermia, new or increasing cough, sputum production, pleuritic chest pain, tachypnea, dyspnea or focal signs on chest examination
* Need for hospitalization as defined by the emergency physician in charge of the patient

Exclusion Criteria:

* Allergy to one of the study drugs
* Pregnancy
* Severe immunosuppression
* Recent (\<14 d) hospitalization, or currently hospitalized since \> 48 hours
* Residency in a nursing home
* Previous use of more than 24 hours of any antibiotic
* Severe community-acquired pneumonia
Effects of Increased Muscle Mass on Resting Metabolic Rate

Healthy males are randomized to isometric exercise for three months with either extra protein or extra calories in the form of a fast food meal/day in order to study if increase in muscle mass increases resting metabolic rate and if this is affected by presumed increased caloric intake as compared with only proteins.

Body-composition was measured with Dual-Energy X-ray Absorbimetry (DEXA) and RMR was measured by registration of CO2 production and O2 consumption.


Eligibility Criteria:
Inclusion Criteria:

* healthy males

Exclusion Criteria:

* significant disease
* inability to exercise
Steroids After Spine Fusion Surgery

This trial studies how well low-dose postoperative corticosteroids (FDA approved) affect patient outcomes (patient reported outcomes, pain medication use, length of stay, major complications, and time to first bowel movement) after thoracic and/or lumbar spine fusion surgery.

PRIMARY OBJECTIVES This study aims to compare patient outcomes (patient reported outcomes, pain medication use, length of stay, major complications, and time to first bowel movement) between subjects that receive either 20 mg of PO prednisone or 1 mL of 4 mg/mL of IV dexamethasone sodium phosphate and a control group.

OUTLINE Participants are patients who elect to participate in the study prior to scheduled thoracic and/or lumbar spine fusion surgery at Oregon Health and Science University. Participants undergo their scheduled spine fusion surgery. After surgery, participants are randomized into either the study drug group or the control (non-treatment) group. If randomized into the study drug group, participants will orally take a daily dose of 20 mg of prednisone (1 mL of 4 mg/mL dexamethasone sodium phosphate if unable to tolerate oral administration) on postoperative days one and two.

Eligibility Criteria:
Inclusion Criteria:

* All patients over the age of 50 undergoing thoracic and/or lumbar fusion with a Spine Center surgeon will be included

Exclusion Criteria:

* Patient is already taking chronic steroids
* Patient is pregnant
* Patient is decisionally impaired
* Patient is a prisoner
Long Term Interferon for Patients Who Did Not Clear Hepatitis C Virus With Standard Treatment

The HALT-C Trial is a National Institute of Diabetes and Digestive and Kidney Diseases sponsored, randomized clinical trial of long-term use of Peginterferon alfa-2a (pegylated interferon) in patients who failed to respond to prior interferon treatment. All patients who enter the trial will be treated for 6 months with Peginterferon alfa-2a and Ribavirin. Patients who respond to this 6 month treatment will continue to be treated for an additional 6 months.

Patients who do not respond to this treatment will be eligible for the long-term maintenance phase of this study where patients will be randomly selected to be treated with Peginterferon alfa-2a or to discontinue treatment for 3.5 years. Patients in both arms of this study will be followed closely with quarterly study visits.

The combination of peginterferon plus ribavirin has recently been approved by the FDA for treatment of chronic hepatitis C. Patients who remain HCV-RNA positive after being treated for at least 6 months with peginterferon and ribavirin outside of this study may be eligible to directly enter the randomized portion of the HALT-C Trial.

The HALT-C study is designed to determine if continuing interferon long-term over several years will suppress Hepatitis C virus, prevent progression to cirrhosis, prevent liver cancer and reduce the need for liver transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Age at entry at least 18 years.
* Positive for Hepatitis C.
* Previous treatment with any interferon or interferon and ribavirin for at least 3 months.
* Documented non-response to treatment with interferon.
* A liver biopsy demonstrating significant liver scarring.

Exclusion Criteria:

* No other liver disease.
* No unstable major medical diseases or conditions.
* No major complications of cirrhosis.
* No recent abuse of alcohol or illicit drugs.
Drainage Versus Sealant in Double Blinded Monocentric Open Incisional Hernia Repair

Mesh repair for open incisional hernia repair with fibrin sealant or with drainage


Eligibility Criteria:
Inclusion Criteria:

* All patients with a large incisional hernia \>5cm diameter that needs elective repair with mesh augmentation

Exclusion Criteria:

* no written informed consent
* 'hostile' abdomen
* emergency surgery (incarcerated hernia)
* parastomal hernia
* incisional hernia outside the midline
* recurrent incisional hernia
Daily Vinegar Ingestion and 24-Hour Blood Glucose Control

When linking dietary interventions and blood glucose management, much of the existing research - particularly studies exploring the effects of vinegar - has relied on discrete readings from the conventional testing methods: blood samples or glucometers. These methods lack the capacity to provide insights into blood glucose dynamics 24/7.

Recognizing this gap, the current study aims to utilize continuous glucose monitoring to examine the impact of daily vinegar ingestion on glucose variability in adults identified as glucose intolerant.

Participants are randomly assigned to either Group A or Group B using the Microsoft Excel randomization function. Group A will be instructed to consume 4 tablespoons of red wine vinegar (2 tablespoons diluted in water at the start of the lunch and the dinner meals) for the first 4 days of the trial. Conversely, participants in Group B will ingest the placebo for the initial 4 days, ingesting one pill daily upon waking in the morning. On days 5-9, participants will switch to the opposite treatment. The red wine vinegar dosage (4 tablespoons containing 3.5 g acetic acid - this is the amount of acetic acid in a large 4-inch dill pickle), and the placebo vinegar pill dosage (one pill containing 0.022 g acetic acid) will be taken daily during the trial. On visit 1, anthropometric measurements, including height, weight, and body composition (lean fat mass and body fat mass), will be measured, and the continuous glucose monitor will be placed on the upper arm. The participants will be instructed to fast \>8 hours (no food or beverages with the exception of water) ahead of visit 1. To ensure accurate use and data collection, researchers discussed the operation of CGM devices and that these waterproof devices are to be continuously worn during the entire 9-day trial and will be removed on day 9 (visit 2).

Eligibility Criteria:
Inclusion Criteria:

* glucose intolerance (defined as one of the following: fasting glucose \>99 mg/dl; diagnosis of prediabetes or diabetes; history of gestational diabetes)
* 18 years of age or older
* sedentary or moderately active (defined as a score ≤ 24 on the Godin-Shepard Leisure Time Physical Activity Questionnaire)

Exclusion Criteria:

* currently adhering to a non-typical diet that would impact carbohydrate intake (including weight loss diets)
* medication/drug use that has not been consistent for the previous 3 months or will be discontinued during the trial
* any acute illness
* regular smokers, pregnant or lactating women, or individuals taking insulin
* Unwilling to tolerate vinegar ingestion
Symbiotics to Prevent Postoperative Infection in Colorectal Cancer

This is a double blind randomized trial in which patients with colorectal cancer undergoing surgery will be selected to receive either a symbiotic formulation or placebo. The researchers will compare incidence of surgical site infection between the study groups.

This is a double blind randomized trial in which patients with colorectal cancer undergoing surgery will be randomly selected to receive either a symbiotic formulation or placebo during the perioperative period. The researchers will compare incidence of surgical site infection, detected by clinical examination and complementary tests (CT scans, X-rays, microbiological and hematological tests) between the study groups.

Eligibility Criteria:
Inclusion Criteria:

* Adults between 18 and 85 years old;
* Colorectal cancer patients.
* Ability to understand and signing the informed consent

Exclusion Criteria:

* Pregnancy (early diagnosis)
* Reduced intellectual level that could prevent proper understanding of the objectives of the study
* Patients with rectal cancer undergoing neoadjuvant treatment (chemotherapy and radiotherapy)
* Use of products with prebiotic, probiotic and / or symbiotic function or fiber module; by more than 3x a week
* Refusal to participate and / or to sign the Consent Form Free and Clear
Quality of Life After Laparoscopic Inguinal- Incisional and Umbilical Herniotomy.

LIFE-IN. Quality of life after operation for hernias are not well investigated and lack a good and easy-to-understand-tool to measure it. Carolina Comfort Scale (CCS) is a disease-specific quality of life questionnaire, designed by an American group, to monitor quality of life in patients undergoing operation for hernias.

The investigators wish to test this questionnaire against Visual Analogue Scale (VAS) scores for core-hernia symptoms, to see if the CCS is a good way to monitor the changes in quality of life and other well-known core-symptoms before and after herniotomies.

The investigators include consecutively all in all 140 patients. 100 with inguinal hernias; 50 who is getting a Lichtenstein operation and 50 who is getting a laparoscopic operation. Furthermore minimum 20 patients who is getting a laparoscopic operation for incisional hernia and minimum 20 who went through umbilical herniotomy. The investigators monitor their pain, sensation of mesh, movement limitations, over-all well-being, fatigue and life-quality, with both CCS and VAS questionnaires 5 times. One time preoperative and 4 times after operation, on the 1sth, 7th, 30th and 90th day after operation.

Eligibility Criteria:
Inclusion Criteria:

* elective laparoscopic and open operations for inguinal hernia
* elective laparoscopic operation for incisional- and umbilical hernia
* primary hernia
* uni-bilateral hernias and one or more incisional hernias

Exclusion Criteria:

* expected bad compliance to the study
* acute operations
* re-operations
* secondary operations
* primary operation with reoperation within 30 days
Study Evaluating the Effects of PSI-697 on Platelets in Subjects Who Smoke

This is a single dose inpatient and outpatient study to test whether an effect on the ability of platelets to stick to white blood cells in subjects who smoke.


Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria:

* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12?lead electrocardiogram (ECG).
* Smoker of at least 1 pack or more of cigarettes per day (20 plus or minus 3 cigarettes) for more than 1 year as determined by history.

Exclusion Criteria:

Exclusion Criteria:

* Any diagnosed bleeding disorder.
* Any major surgical procedure within 6 months before study day 1.
* Any history of major bleeding (eg, bleeding peptic ulcer) within 1 year before study day 1.
Dog Hair Extract Study

Liquid allergen extracts contain proteins, such as (but not limited to) tree, weed, cat, cockroach, and nuts, and are used to identify allergies by observing the body's reaction to the introduction of extract underneath the skin. There are a few dog allergen extracts commercially available in the US for allergy testing; however, none of these products are standardized, meaning they are not required to be the same strength. Because some extracts are not as potent (strong) as others, it's possible that some patients' allergies are misdiagnosed. Typically, the most potent (strong), but safe extract should be used so that allergic patients are correctly diagnosed.

The purpose of this study is to compare the safety and potency of an investigational (not approved for use by the United States Food and Drug Administration \[FDA\]) dog allergen extract with two commercially available dog extracts, which are of differing potencies.

This study is designed to assess the potency of a modified dog hair and dander extract in comparison with the two commercially available dog hair and dander extracts. This is a pilot study to estimate a target strength of dog extract in order to proceed to further studies.

Eligibility Criteria:
Inclusion Criteria:

* Patients must sign informed consent before completing any study procedure.
* Age 18 years and ≤60 years.
* Dog-sensitized patients as indicated by a mean wheal \> 5 mm with the AP dog extract.
* Females of child-bearing potential must have a negative pregnancy test the day of skin testing.
* Patients who are able to understand the information given and be compliant with the protocol.

Exclusion Criteria:

* Asthma requiring treatment with medications other than beta-2 inhaled agonists and montelukast inhibitors.
* Patients with a history of asthma or wheezing with an FEV1 \<80%.
* Subjects who have taken an ocular or nasal antihistamine within 5 days prior to the procedures.
* Patients who have received any desensitization for dog allergen in the past 5 years.
* Patients with any past or current clinically significant condition that may affect the patient's participation or the outcome of the study to the discretion of the investigator. These include, but are not limited to, anaphylaxis with cardio-respiratory symptoms, chronic urticaria and angioedema unless related to dog exposure, severe atopic dermatitis, malignancy, cardiovascular, hepatic, renal, hematological, neurological, immunological, and endocrine disease.
* Subjects taking beta blockers, ace inhibitors, continuous systemic corticotherapy, immunosuppressive drugs or monoamine oxidase inhibitors.
* Use of H1 antagonists, tricyclic antidepressants and phenothiazines within 5 days prior to the testing.
Phase 2 Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined or Alone in Patients With Essential Hypetension

A Randomized, Double-blind, Multicenter, Factorial Design, Phase II Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined or Alone in Patients With Essential Hypertension


Eligibility Criteria:
Inclusion Criteria:

* Patients who are 19 years or older / 75 years or younger on screening
* Signed informed consent
* Patients with Essential Hypertension
* Other inclusion applied

Exclusion Criteria:

* Orthostatic hypertension with symptom
* Other exclusion applied
Effects of Inspiratory Muscle Training on Cardiovascular Function in Hypertension.

The purpose of this study is to determine inspiratory muscle training effects on blood pressure, functional capacity and quality of life in hypertensive patients.

The interaction between respiratory function and cardiovascular system, as well as the present alterations in these systems, due to diseases such as Hypertension, diabetes and chronic heart failure, are the factors that potentially participate of the pathogenic frame in these situations. Consequently, it is so related to reduction of functional capacity, endothelial dysfunction of the sympathetic and parasympathetic cardiovascular control and morphologic alterations on the skeletal muscles, including ventilatory muscles.

On the other hand, a proinflammatory state also participates of this dysfunction and reduced function capacity situation. Cardiovascular risk factors, such as hypertension, increased heart rate variability, diabetes and heart failure explain the occurrence of the majority of cardiovascular events in the entire world and so in Brazil. Studies with experimental models and in patients with cardiovascular diseases identified important inflammatory activity associated to risk factors and preceding clinical events.

Inspiratory muscle training (IMT) shows consistent results in the improvement of functional capacity in athletes, sedentary subjects, heart failure patients and in animals submitted to an IMT model.

The study of alterations in cardiorespiratory interaction, functional capacity and cardiovascular control mechanisms (sympathetic, parasympathetic by heart rate variability), altogether, in hypertension, is a single opportunity to identify new pathogenic mechanisms involved in the reduction of functional capacity as well as promote its quantification. Therefore, the effects of IMT on these alterations are still not well understood. In this way, the response to IMT is a complement to epidemiologic and clinical models, as potential source of new possibilities in the research field.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 25 and 70
2. Hypertension in all stages:

2.1. Prehypertension - Systolic blood pressure (SBP) of 120 to 139 and/or diastolic blood pressure (DBP) of 80 to 89 mmHg 2.2.Stage 1 Hypertension - SBP of 140 to 159 mmHg and/or DBP of 90 to 99 mmHg 2.3.Stage 2 Hypertension - SBP ≥ 160 mmHg and/or DBP ≥ 100 mmHg

Exclusion Criteria:

1. Disagreement with consent form
2. Thoracic pain (angina)
3. Hypertension instability
4. Antihypertensive drugs alterations within 30 days before or during the study
5. Diabetes
6. Chronic pulmonary obstructive disease
7. Incapability of executing the functional tests
8. Asthma
9. Chronic Heart Failure
10. Obesity
11. Cardiovascular diseases complications
Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Hip Replacement Surgery (ADVANCE-3)

The purpose of this study is to learn whether apixaban can prevent the blood clots in the leg (deep vein thrombosis) and lung (pulmonary embolism) that sometimes occur after hip replacement surgery and to learn how apixaban compares with enoxaparin in preventing these clots. The safety of apixaban will also be studied


Eligibility Criteria:
Key Inclusion Criteria

* Patients undergoing elective unilateral total hip replacement or a revision of at least 1 component of a total hip replacement.
* Patients who were willing and able to undergo bilateral ascending contrast venography
* Either sex, any race, 18 years and older

Key Exclusion Criteria

* Known or suspected bleeding or coagulation disorder in the patient or his or her first-degree relative
* Known or suspected history of heparin-induced thrombocytopenia
* Known coagulopathy
* Active bleeding or at high risk for bleeding
* Brain, spinal, ophthalmologic, or major surgery or trauma within the past 90 days
* Active hepatobiliary disease
* Alcohol and/or substance abuse within the past year
* Any condition for which surgery or administration of an anticoagulant is contraindicated
* Two consecutive blood pressure readings within 15 to 30 minutes with supine systolic blood pressure \>180 mm Hg or supine diastolic blood pressure \>105 mm Hg
* Clinically significant laboratory abnormalities at the enrollment visit:
* Hemoglobin \<10 g/dL
* Platelet count \<100,000/mm\^3
* Creatinine clearance \<30 mL/min, as estimated by the method of Cockcroft and Gault
* Alanine aminotransferase or aspartate aminotransferase \>2\*upper limit of normal or a total bilirubin ≥ 1.5\*1 (unless an alternative causative factor such as Gilbert's syndrome was identified)
* Need for ongoing treatment with a parenteral or oral anticoagulant (eg, subjects with mechanical valves, warfarin eligible atrial fibrillation)
* Current use of dextrans or fibrinolytics
* Treatment with medications affecting coagulation or platelet function
Protocol Memory Deficit in Patients With Obstructive Sleep Apnea Syndrome

The main objective of this study is to evaluate the evolution of memory deficit (verbal episodic memory, procedural memory, working memory, short-term memory) in Sleep Apnea Obstructive Syndrome (SAOS) patients after treatment by Continuous Positive Airway Pressure treatment (CPAP). For thus, we will compare memory tests in two separate groups of SAOS patients with "effective " versus "ineffective" ( or sham) CPAP, before and 6 weeks after the beginning of the treatment. Thus we will assess the evolution of memory deficit, the effectiveness of the treatment on the evolution of memory deficit before and 6 weeks after the beginning of the treatment by "effective " versus "ineffective" CPAP.

We feel the results of the tests of memory will show greater memory disorders in patients with SAOS before beginning the treatment rather than six weeks afterwards. Thus we hypothesise that, after the treatment by "effective" CPAP, the patients with SAOS will have greater improvement of their memory disorders than those treated by "sham CPAP".

We want to assess the evolution, before and 6 weeks after the beginning of the treatment, of the significant differences of the performances of the various memory tests evaluating several forms of memory (episodic memory, working memory, short-term memory and procedural memory) according to the treatment for patients with SAOS (effective versus sham).

Eligibility Criteria:
Inclusion Criteria:

* Major patients,
* agreeing,
* diagnosed suffering from the SAOS,
* regulation by the specialist in a treatment by CPAP,
* patients do not begin the treatment
* affiliated to the social security,
* fluent in French.

Exclusion Criteria:

* Patients presenting severe depressive disorders (HADS score\>19),
* intellectual deterioration (MMS\< 28),
* a functional failure of the dominant arm upper limb inhibiting realization of graphic tasks,
* an associated oxygen treatment,
* suffering from cancer,
* cerebro-vascular accident,
* pregnant or nursing women,
* adult under supervision or trusteeship,
* patients already included in another research protocol or in period of exclusion,
* antidepressant and anxiolytic treatment.