cyrilzakka/clinical-trials huggingface dataset:
DARE: Diabetes in cArdiac REhabilitation

The aim of the DARE study is to see whether strict glycemic control during cardiac rehabilitation may ameliorate the improvement of exercise capacities (VO2 peak, peak workload, ventilatory threshold)in patients with type 2 diabetes with coronary artery disease.

In a recent study, we showed that the benefit of cardiac rehabilitation on the improvement of exercise capacities (VO2 peak, peak workload, ventilatory threshold), after an acute coronary event, was significantly reduced in patients with type 2 diabetes. Moreover ,we showed, in multivariate analysis, that the worse improvement of the capacities to the effort after cardiac rehabilitation, was mainly related to hyperglycemia.

Because the improvement of exercise capacities after cardiac rehabilitation (in particular VO2 peak) has been shown to be an essential factor to reduce short- term and long-term morbidity and mortality, we may think that such benefit on reduction of morbidity and mortality may be significantly less in patients with diabetes.

Thus, we propose to carry out a multicentric intervention study, entitled DARE which goal is to see whether a strict glycemic control, during cardiac rehabilitation following an acute Myocardial Infarction (MI), is likely to improve, the results of cardiac rehabilitation on exercise capacities in patients with type 2 diabetes.

After arrival in cardiac rehabilitation, patients with diabetes, will be randomized into 2 groups: an "intensive treatment" group, in which the patients will treated by insulin under a basal-bolus regimen with strict glycemic control and a "conventional treatment" group, in which the previous anti-diabetic treatment will be continued.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* recent Miocardial Infarction
* HbA1c above 7%
* enrolled in a cardiac rehabilitation program

Exclusion Criteria:

* Type 1 diabetes
* Coronary Bypass Surgery
* Renal Failure (creatinine clearance below 30 ml/min)
* severe Respiratory Failure
Sinonasal Gas Exchange Dynamics

Sinonasal gas exchange is facilitated by the unique anatomy and topography of the sinonasal interface that represents a collection of airfoils creating an aerodynamic structure. The airflow during respiration generates positive and negative pressures that power the gas exchange between the sinuses and the nose. Major surgical alteration of the interface reduces the rate and velocity of the exchange. Minimally invasive procedures aimed at preserving the natural anatomy, topography and aerodynamic configuration of the interface will have negligible effects on sinonasal gas exchange.


Eligibility Criteria:
Inclusion Criteria:

* Control:

  * normal healthy adult volunteers ages 18-65,
* without allergies by history and allergy test,
* non-smoker,
* not using steroids. Study group 1: adult subjects who had maxillary sinus balloon sinuplasty (with intact uncinate and ethmoid complex) Study group 2: adult subjects who had endoscopic maxillary antrostomy and uncinectomy.

Exclusion criteria:

* active acute or chronic infection,
* nasal polyps,
* severe nasal or septal deformity,
* cystic fibrosis,
* systemic illness (diabetes, hypertension etc.),
* vulnerable population (children, pregnant women, institutionalized individuals etc.)
* severe nasal and/or septal deviation,
* hypersensitivity or intolerance to study medications (topical and local anesthetics) any turbinate surgery.
Ondansetron in Preventing Nausea and Vomiting in Patients Undergoing Stem Cell Transplant

RATIONALE: Ondansetron may help lessen or prevent nausea and vomiting in patients undergoing stem cell transplant.

PURPOSE: This phase II trial is studying how well ondansetron works in preventing nausea and vomiting in patients undergoing stem cell transplant.

OBJECTIVES:

I. To determine whether the incidence of nausea and vomiting related to administration of autologous hematopoetic stem cells cryopreserved in DMSO can be reduced by the use of a single dose of intravenous ondansetron prior to the stem cell infusion.

II. To determine the number of patients who experience nausea and vomiting.

OUTLINE: Patients receive ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation.

Eligibility Criteria:
Inclusion

* Autologous PBSC transplant patient
* English-speaking
* Planned cryopreserved PBSC infusion at the SCCA outpatient clinic

Exclusion

* History of prior autologous transplant
* Non-English-speaking
* Planned cryopreserved PBSC infusion at the UWMC inpatient unit
* Infusion of cryopreserved PBSC that are thawed and washed to remove DMSO prior to infusion
* Allergy or adverse reaction to ondansetron
Deep Friction Massage: Symptomatic

Despite DFM being a widely-used technique and the empirical grounding regarding the importance of the pressure applied, there is no study characterizing the pressure applied during DFM, remaining it a discretion of the physiotherapist. Additionally, it is not known how the amount of pressure applied may influence pain mechanisms or function in the symptomatic patellar tendon. Having this, our objective is to characterize the pressure applied during deep friction massage and evaluate the immediate effects of different pressures applied during deep friction massage in the time until analgesia as well as in function, in patellar tendinopathy.


Eligibility Criteria:
Inclusion Criteria:

* The participants should have a symptomatic patellar tendon

Exclusion Criteria:

* History of other previous injuries of the lower limbs;
* Intake of medication that could interfere with pain mechanisms;
* Presence of any factors or conditions that could interfere with the awareness and sensibility to pain.
Pharmacokinetics of Rifabutin Combined With Antiretroviral Therapy in Patients With TB/HIV Co-infection in South Africa

The overall aim of the project is to evaluate rifabutin (RBT) as a replacement for rifampicin (RMP), for the combined treatment of tuberculosis and HIV infection. RBT represents an alternative to RMP for HIV infected patients as its half-life is longer and the enzymatic induction effect appears to be less important on the associated antiretroviral therapy (ART) drugs.

This phase II trial is to determine precisely the pharmacokinetics parameters of RBT in combination with different ART regimens in Vietnamese HIV infected patients with pulmonary tuberculosis, in order to define optimal doses that will be further tested in a larger phase III trial comparing safety, tolerability and efficacy of RBT and RMP regimens.

Patients will be offered to participated in the study after the first 6 weeks of the nationally recommended TB treatment. All the enrolled patients will be switched to rifabutin and randomized, two weeks later, to one of the three study ARV regimens. The RBT doses will be then adapted to the allocated ARV regimen according to a cross over scheme. Three full pharmacokinetics profile will be performed at different time point : before initiation of ARV, after one month of the first RFB dosage and one month after the second RFB dosage.

Eligibility Criteria:
Inclusion Criteria:

* Pulmonary tuberculosis (proven by AFB positive sputum or culture)
* Having completed and adhered to 6 wks of intensive phase TB chemotherapy
* Positive HIV antibody and CD4 count \>50 /mm3 and \<=200
* Weight \> 50 kg
* No ART in the preceding 3 months
* No more than 2 weeks or ART previously
* No grade 3 or 4 clinical or laboratory findings
* Negative pregnancy test and appropriate contraceptive measures during the duration of the trial for female of childbearing age
* Having a firm home address that is readily accessible
* Karnofsky score\>=80%

Exclusion Criteria:

* History of TB within the 3 years preceding the presenting episode of TB
* Previous treatment for MDR TB
* Concomitant OI requiring additional anti-infectious treatment
* Formal contraindication to any drug used in the trial
* Diabetes mellitus requiring drug treatment
* Recreational drug or alcohol abuse
* History of drug hypersensitivity to TB or related medications
* Interrupted TB therapy for more than 1 week
* Less than 90% adherent to first 6 weeks of intensive phase chemotherapy
* Mental illness that could impair ability to give informed consent or result in poor adherence to trial protocol and therapy
* Neutropenia \<1200 /L, anaemia \<6.8 g/dL, liver function test \> grade 2
* Requiring concomitant medications that may potentially interact with study drugs
* Pregnant or lactating women
* Karnofsky score \>80%
* Any condition rendering the patient unable to understand the nature, scope, and possible consequences of thes study and to provide consent
Effects of Extensive Abdominal Lavage on Postoperative Inflammation Following Full Thickness Excision of Deep Endometriosis

Surgical treatment of deep endometriosis with bowel involvement is widely accepted to require complete excision of all endometriosis also when invading the bowel. In case of opening of the bowel a subsequent inflammatory reaction follows the surgery, as demonstrated by the increase in blood levels of C-reactive protein during the first post-operative week. Furthermore it increases the risk of post-operative bowel complications. In case of peritonitis the general surgeons use extensive lavage in order to decreases mortality, morbidity and post-operative adhesions formation, as demonstrated in animal models and clinically in patients with peritonitis. Considering the efficacy of extensive lavage for peritonitis and the inflammatory reaction as judged by the increased C-reactive protein (CRP) following full thickness deep endometriosis resection from the bowel, the study aims to evaluate, in women undergoing this procedure, the effect of extensive abdominal lavage on abdominal inflammation and post-operative bowel complications.

In a consecutive series 20 women with full thickness resection for deep endometriosis received randomly, at the end of the procedure, a standard abdominal rinsing (n=10) or extensive abdominal lavage with 8 Liters of saline (n=10). C-reactive protein and white blood cell count values were collected daily for 7 days. Women were observed for complications during the first post-operative week and during the follow up at 1 and 6 months.

The primary end point was to evaluate the effects of extensive abdominal lavage on post-operative inflammation. Secondary end-point was to explore the potential protective rule against post-operative bowel complications.

Eligibility Criteria:
Inclusion Criteria:

* The patients (aged 18-50 years) were all recruited from a single, tertiary referral hospital at Leuven University, Belgium, specializing in the surgical treatment of severe endometriosis.
* All the women were scheduled for a surgical excision of a rectovaginal nodule.
* Women with a full thickness involvement of the bowel requiring discoid resection were included.

Exclusion Criteria:

* evidence on chest x-ray in the previous 3 months of old or currently active TB, even if adequately treated;
* evidence of serious infections (such as pneumonia or pyelonephritis) in the previous 3 months
* evidence of a documented HIV infection, active hepatitis-B or C, or an opportunistic infection (e.g. herpes zoster, cytomegalovirus, pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) in the previous 6 months
* Previous transplant surgery, a lymphoproliferative disorder or other malignancy
* Positive cervical cytology in the previous 6 months
* Any haematological or biochemical abnormalities on routine screening.
The Dermisgraft Epithelialization and Late Scar Healing

Study Synopsis

Title; The dermis graft: epithelialization and late scar evaluation A Clinical Prospective multicenter trial

Objectives; The objective of this study is to compare a dermal graft with a conventional split thickness skin graft regarding healing quality and scarring.

Design; the study is a prospective, controlled clinical multicenter trial.

Study population; Atleast 20 burn patients (18-80 years) with a full thickness burn that requires permanent skin cover.

Time plan; Enrollment will continue until atleast 20 patients have been included and completed the study.

Background: Donor site morbidity is a major concern such as wound healing disturbances, hypertrophic scarring and hypo-/hyperpigmentation. The dermal graft technique is an alternative to the standard split-thickness skin graft (STSG) technique to minimize donor site morbidity. Immediate cover of the donor site after harvest leaving a non-exposed wound is a big advantage. The aim of the study was to compare the functional and aesthetic outcome between two treatment methods (dermal graft with STSG).

Methods: From February 2017 to December 2020, 21 patients received a dermis graft and a regular split-thickness skin graft in a prospective randomized study design. The recipient and the donor site were compared separately regarding healing time, scarring and patient subjective satisfaction. All sites (both donor and recipient) were analyzed histologically regarding remodeling and scar formation.

Eligibility Criteria:
Inclusion Criteria:

* Thermal \& chemical burns \< 30 % TBSA
* Males \& females between 18-80 years old
* At least one coherent full thickness wound measuring 15 x 7.5 cm
* A minimal of 15 x 7.5 cm coherent undamaged skin located at frontal or lateral side of one of the thighs for graft harvest.

Exclusion Criteria:

* Patients with severe cutaneous trauma at the same site as the burn injury
* Previous burns at the treatment site
* Severe cognitive dysfunction or psychiatric disorder
* Chronic skin disorder
* Chronic use of systemic or local corticosteroid
* Chronic use of anticoagulants or platelets
* Autoimmune disease
* Active hepatitis
* Full thickness burns of head, genitalia, axilla or upper third of medial upper arm
Supraphysiological Doses of Levothyroxine as Adjunctive Therapy in Bipolar Depression

There is growing evidence that thyroid axis dysfunction may contribute to the pathophysiology of bipolar illness. Open-label studies have consistently demonstrated that the behavioral expression of bipolar disorder can be modified by a change in thyroid status, and in many instances the course of illness is improved through the use of adjunct thyroid hormone treatment. Recent evidence emerged from acute intervention studies that add-on treatment with supraphysiological doses of levothyroxine is an effective augmenting agent in patients with a major depressive episode. The primary goal of this international multicenter trial (5 sites) is to determine in a 13-week, randomized, placebo-controlled design (1 week single-blind placebo run-in, 6 week double-blind, 6 week open-label) the efficacy and safety of add-on treatment with levothyroxine (300 mcg/d) in combination with mood stabilizer/antidepressant therapy in the treatment of patients with bipolar depression. The main hypotheses is: treatment with levothyroxine will result in a significantly greater mean reduction of HRSD total score and in a higher number of responders and remitters compared to placebo treatment. This proposal will build on our pilot data and provide evidence for the use of levothyroxine as an effective augmentation strategy in the treatment of bipolar depression.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of bipolar I or II disorder, currently depressive episode according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
* Hamilton Rating Scale for Depression (HAM-D) 17-item score ≥14, a HAM-D item 1 (depressed mood) score ≥2 at the screening and randomization visits
* Young Mania Rating Scale (YMRS) score ≤12 at the screening and randomization visits.
* Pretreatment with a mood stabilizer and/or an antidepressant at standard doses (Bauer et al. 2007a) for at least six weeks since the last dose adjustment, and for at least two weeks before enrollment
* Serum levels of mood stabilizer were required to be within therapeutic ranges
* TSH levels in normal range (serum TSH 0.3 - 4.7 mU/l)

Exclusion Criteria:

* Any axis I disorder other than bipolar disorder
* Recent ultra-rapid cycling course (12 or more episodes in previous year), - - a diagnosis of substance dependence (DSM-IV) or substance use (except for nicotine) within 12 months before the screening visit
* Clinically significant medical illness, especially severe cardiovascular diseases
* Organic brain disorder
* Current serious suicidal or homicidal risk by clinical judgment of the investigator
* History of previous or current thyroid disease
* Thyroid hormone treatment
Effectivenes of Cyanoacrylate (Glubran 2®) in Reducing Seroma Formation in Breast Cancer Patients Post-Axillary Dissection

Glubran 2 as a surgical glue maybe effective in reducing seroma formation post axillary dissection in breast cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* The Patient should be above 18 years old
* The Patients has Node positive breast cancer
* The Patient is eligible for axillary dissection in addition to a surgical intervention for the primary tumor
* Patients whose sentinel lymph nodes test positive during surgery.
* The patient is willing to sign an informed consent to participation

Exclusion Criteria:

* Platelet count is less than 100000
* Obese patients with a BMI of more than 35
* Patients who need immediate breast reconstruction surgery
* Patients who are receiving anticoagulation therapy or have coagulation disorders
* Pregnant or lactating patients
* Patients who are on steroid therapy
* Patients who received chest radiotherapy
* Patients who received neoadjuvant chemotherapy
CompARing Between CO2 Phenylephrine and Phenylephrine Only Treatment in Patients With proGrEssing Cerebral infarctioN

Progressing stroke is associated poor functional outcome and neurological deficit.

Currently, no treatment for progressing stroke is recommended on the guideline.

Carbogen is a mixture of 5% CO2 with 95% O2. Carbogen is safe and it is used for the treatment of sudden sensory neural hearing loss or ocular ischemia.

CO2 dilate cerebral arteriole and concentration of CO2 is correlated with cerebral blood flow.

Increased cerebral blood flow following dilation of cerebral arteriole by CO2 might halt and revert progressing stroke.

Induced hypertension is alternative treatment of progressing stroke. Increasing blood pressure also induce cerebral blood flow. Phenylephrine is an α1 agonist, phenylephrine act on peripheral artery and little effect on cerebral artery or heart. Several studies reported that the effectiveness of phenylephrine on progressing stroke.

Therefore, this study will compare the effectiveness of carbogen + phenyleprhine versus phenlyephrine in progressing stroke patients.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥20 years
* Anterior circulation progressing stroke
* Neurological worsening either 1 point in NIHSS score or MRC grade

Exclusion Criteria:

* Age under 20 years.
* Patients with cerebral infarction who are at risk of cerebral edema as determined by the investigator.
* Patients with Moyamoya disease.
* Patients with severe cerebrovascular reactivity (CVR) impairment due to cerebral vascular stenosis, making study participation challenging as determined by the investigator.
* Patients unable to undergo CO2 treatment (e.g., panic disorder, anxiety disorders, or other psychiatric conditions).
* Patients with hypersensitivity to phenylephrine.
* Patients with persistent bradycardia (heart rate \< 50 bpm).
* Patients with a history of hemorrhagic stroke or at risk of cerebral hemorrhage.
* Patients with a pre-stroke modified Rankin Scale (mRS) score ≥ 2, indicating impaired functional independence.
* Patients ineligible for phenylephrine treatment due to any of the following:

Myocardial infarction or unstable angina within the past 3 months. Cardiac ejection fraction \< 25%. Ventricular arrhythmia. Systolic blood pressure \> 200 mmHg. Serum creatinine \> 2 mg/dL. Pregnancy.

* Use of monoamine oxidase (MAO) inhibitors.
* Patients who do not consent to participate in the study.
Correlation of Narcotrend Index and the Observer's Assessment of Alertness/Sedation (OAA/S) Scale

Narcotrend index is a widely used quantitative parameter for evaluating anesthesia and sedation levels.Dexmedetomidine is a novel sedative,providing sedation while patients remain cooperative and can be easily aroused. This study was designed to explore the correlation of Narcotrend index and OAA/S scale in monitoring sedation level with different single- doses of dexmedetomidine intravenously.

60 patients,aged 20～60,American Society of Anesthesiologists (ASA) physical status ⅠorⅡ, scheduled for electively lower limb surgery undergoing combined spinal epidural anesthesia were randomly divided three group. In each group,a bolus of dexmedetomidine was administered intravenously 15 min after spinal anesthesia. The initial dose in group 1, group 2 and group 3 was started from 0.9 µg/kg,1.0 µg/kg and 1.1 µg/kg, respectively. HR、MAP、SpO2、the Observer's Assessment of Alertness/Sedation（OAA/S）scale and the corresponding Narcotrend index were recorded at 5-minute intervals until 30 minutes after administration. The relationship between OAA/S scale and Narcotrend index was analyzed by a Spearman analysis. The cutoff values of Narcotrend index for OAA/S≤2 were obtained by analysis of receiver operating characteristic curves(ROC).

Eligibility Criteria:
Inclusion Criteria:

1. ASA Ⅰ \~ Ⅱ women undergoing Laparoscopic surgery.
2. Written informed consent from the patient or the relatives of the participating patient.
3. BMI:18.0～25 kg/m2

Exclusion Criteria:

1. Mental illness can not match
2. epidural anesthesia contraindicated
3. People who have Slow-type arrhythmias
4. Chronic renal failure
5. Alcohol or drug abuse
6. Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug
Study of Efficacy of Levofloxacin 0.5% Ophthalmic Solution Administered Three Times a Day for Bacterial Conjunctivitis

The aim of the study is to evaluate the clinical and microbiological efficacies of three times daily administration of levofloxacin 0,5% eye drops as compared to the more frequent dosing (up to 8 times a day during the first 2 days and up to 4 times a day during the next 3 days) in patients with bacterial conjunctivitis.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients between 18 and 70 years of age
* Patients with Conjunctivitis (defined as the presence of three cardinal signs: conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection)
* Patients who have given and signed informed consent
* The ability and willingness to comply with all study procedures

Exclusion Criteria:

* Insulin Dependent Diabetes Mellitus (IDDM)
* Patients with keratitis or hordeolum
* Glaucoma
* Sjogren's Syndrom and "Sick Eye's Syndrom".
* Ectropion, entropion;
* Using contact lenses during the study
* Poor visual acuity in the other eye
* Prior and concurrent concomitant treatment glycocorticosteroids, immunosupressive therapy, if these treatments have not stopped at least 3 months prior to the start of the study;
* Concurrent use of non- steriodal anti- inflammatory drugs (NSAIDs), with the exception of low- dose aspirin. (see par. 11.5)
* Prior and concurrent systemic antibiotic treatment during last 7 days before the beginning the study.(see par. 11.5)
* Concurrent other eye drops
* All ocular surgeries which were performed less than 6 months before the beginning of the study.
* Any clinical condition, which, in the opinion of the investigator would not allow safe completion of the protocol.
* History of any malignancy within the past 5 years prior to study entry, except basal cell or squamous cell skin carcinoma.
* Hypersensitivity to fluoroquinolons and benzalkonium chloride;
* Intended or ascertained pregnancy or lactation;
* Participation in a clinical trial within last 30 days.