cyrilzakka/clinical-trials huggingface dataset:
Outpatient Ultrafiltration Therapy in Heart Failure Patients Trial

This trial will look at the effectiveness and patient acceptance of ultrafiltration therapy in an outpatient setting.

The purpose of this study is to determine if ambulatory patients who suffer from heart failure and hypervolemia can be safely and effectively treated in an outpatient infusion clinic. The results from this trial will be useful in planning a larger, randomized trial comparing usual care and ultrafiltration for this patient population in similar ambulatory settings.

This is a pilot study to assess the feasibility, effectiveness, safety and patient acceptance of ultrafiltration in ambulatory patients with heart failure and hypervolemia. The results will be useful in planning a larger clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be recruited from the cardiology clinic at Hennepin County Medical Center. Patients are eligible for the study if they are:

  1. Older than 18
  2. Not pregnant
  3. Have heart failure with worsening hypervolemia despite oral diuretics
  4. Have at least two of the following signs or symptoms of hypervolemia: JVD, edema \>1+, rales pulmonary edema on chest x-ray, orthopnea or PND
  5. Not more than 10 kg above their usual baseline weight
  6. Have, in the opinion of the treating physician, a need for a minimum of 2 liters of volume removal

     Exclusion Criteria:

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  1. Systolic blood pressure \< 90 mmHg
  2. Serum creatinine \> 3.0 mg/dL
  3. Hematocrit \>45 %
  4. Uncontrolled arrhythmias
  5. Need for hospitalization
  6. Require renal replacement therapy
  7. Contraindication to anticoagulation with heparin
  8. Poor venous access.

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Use of On-Q Pump for Pain Post C-Section

The main purpose of this study is to examine if pain levels treated with intrathecal (IT) preservative-free morphine (PFM) after a cesarean section improve with the additional use of continuous subfascial wound infiltration with ropivacaine using the OnQ® elastomeric pump system.

The main purpose of this study is to examine if pain levels treated with intrathecal (IT) preservative-free morphine (PFM) after a cesarean section improve with the additional use of continuous subfascial wound infiltration with ropivacaine using the OnQ® elastomeric pump system. As a double-blinded, randomized, placebo controlled study, women undergoing first, second or third cesarean section will be randomly assigned to one of 3 different groups. Group 1 will receive saline, group 2 will be given ropivacaine 0.1%, group 3 will be given ropivacaine 0.2%, all at a rate of 8ml/hr via the OnQ® pump system. Each group will also receive an 8mL bolus of the previously assigned infusate. The investigator will assess pain at rest and with movement at different time periods during the recovery process through 3 months post operatively. The investigator will also assess if the use of this system decreases the need for other pain medications and reduces the potential side-effects of pain treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Female patients at Emory University Hospital Midtown undergoing non-emergent, scheduled or unscheduled first, second or third Cesarean sections
2. Patients who are American Society of Anesthesiology (ASA) Class I-III
3. Patients are at least 34 weeks pregnant
4. Patients to receive spinal anesthesia for their procedure
5. Patients who are 18 years of age or older
6. Patient willing and able to provide written informed consent

Exclusion Criteria:

1. Patients with 3 or more prior Cesarean sections
2. Patients undergoing emergent cesarean section with or without general anesthesia
3. Patients with known allergy to morphine, ketorolac, and/or amide local anesthetics
4. Patients who will not receive spinal anesthesia
5. Patients who are less than 34 weeks pregnant
6. Patients with significant maternal cardiac, liver or renal disease
7. Patients with maternal history of narcotic abuse or dependency
8. Patient with pre-operative fever (\>100.4 degrees F)
9. Patients less than 18 years old
The Role of NEMS for Post ICU Rehabilitation

The purpose of this study is to investigate the role of NEMS as a rehabilitation tool for muscle weakness following critical illness. The investigators hypothesized that NEMS combined with exercise rehabilitation will have a beneficial role in restoration of muscle strength

Survivors of critical illness are presented with significant physical impairment that is associated with reduced functional ability and health -related quality of life both in the short and long-term.

Neuromuscular electrical stimulation (NEMS) has been proposed as an alternative exercise modality in patients with severe chronic obstructive pulmonary disease and chronic heart failure, who cannot perform active exercise. NEMS has also been used as a preventive tool for intensive care unit (ICU) acquired weakness (ICUAW). Its role as a tool for post ICU rehabilitation has not been evaluated so far.

A randomized intervention study was designed to assess the efficacy of NEMS, as a rehabilitative tool for critical illness survivors. The first day that patients are discharged from the ICU after stratified randomization are assigned to the NEMS group or to the control group. In the NEMS group, NEMS will be applied to both lower extremities of the NEMS -group simultaneously (quadriceps femoris muscle and peroneus longus) on a daily basis, along with a personalized exercise program. NEMS sessions will continue until patient discharge from hospital. In the control group, sham NEMS will be applied along with standard care when it comes to physiotherapy. At hospital discharge patients of both groups of will receive a rehabilitation booklet. Patients on the NEMS group that have significant muscle weakness will have NEMS sessions at home for a period of 2 months. Patients are evaluated at 3 and 6 months after hospital discharge

Eligibility Criteria:
Inclusion Criteria:

* Patients under mechanical ventilation for\> 72hours during ICU stay
* Patients able to perform simple commands (able to be evaluated by MRC scale)

Exclusion Criteria:

* age \< 18 \> 85 years
* pregnancy
* pre-existing neuromuscular disease (e.g. Gravis)
* fractures or skin lesions that do not allow the implementation of NEMS
* presence of pacemaker or defibrillator
* fractures of spine that so not allow mobilization
* BMI \> 35 kg/m2
* terminal disease
Randomized, Double-Blind, Placebo-Controlled, With PHX1149 in Patients With Type 2 Diabetes Mellitus

This will be a 4-week, multicenter, randomized, double-blind, parallel group, placebo-controlled, safety, tolerability, and efficacy study. Patients will be screened and be on one of three doses of PHX1149 (a new drug candidate for the treatment of Type 2 diabetes ) or placebo. The drug is a "DPP4 inhibitor"


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus treatment with metformin +/- TZD

Exclusion Criteria:

* Type 1 diabetes mellitus
Efficacy and Safety of Panitumumab Combined With Docetaxel and Cisplatin as a First-line Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

The clinical hypothesis of this study is that the addition of Panitumumab to the first line treatment combination of docetaxel plus cisplatin will provide benefit to patients with advanced gastric or gastroesophageal junction adenocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent Inclusion:
* Age ≥ 18 years
* Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction with advanced unresectable or metastatic disease.
* Measurable disease per the revised RECIST (Response Evaluation Criteria in Solid Tumor) Guidelines
* ECOG performance score of 0 - 2
* Within seven days prior to initiating study treatment:Haematology:Neutrophils ≥ 1.5x109, Platelets ≥ 100x10/ L, Hemoglobin ≥ 9g/dL. Hepatic functions: Total bilirubin ≤ 1.5 time the upper normal limit (UNL),ASAT ≤ 2.5xUNL in absence of liver metastases, or ≤5xUNL in presence of liver metastases,ALAT ≤ 2.5xUNL in absence of liver metastases, or ≤5xUNL in presence of liver metastases. Renal function: creatinine clearance ≥50 mL/min. Metabolic Function: Magnesium ≥ lower limit of normal, Calcium ≥ lower limit of normal.

Exclusion Criteria:

* Prior chemotherapy or other anticancer therapy for advanced unresectable or metastatic disease (1st line)
* Prior anti-EGFR antibody therapy (e.g. cetuximab) or treatment with small molecule EGFR inhibitors (e.g. erlotinib).
* HER2-positive tumor (centrally assessed)
* Past or current history (within the last 5 years prior to treatment start) of other malignancies except gastric cancer (Patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible)
* Current or prior history of central nervous system metastases
* Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to entering this study
* Known hypersensitivity to any of the study drugs
* Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment
* History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
* Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
* Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment.
Study 102: Multiple Ascending Dose Study of ALLN-346 (Engineered Urate Oxidase)

The purpose of this Phase I study is to evaluate the safety and tolerability of ALLN-346 in in normal healthy volunteers, in an ascending dose design.

ALLN-346 is an (oral) enzyme that specifically degrades urate in the intestinal tract.

This is a Phase I, 7-day, randomized, double-blind, placebo-controlled, multiple ascending dose study of orally administered ALLN-346 in normal healthy volunteers. Study will take place at a clinical pharmacology unit (CPU). Two sequential cohorts will be dosed and followed for safety through Day 28.

The study will evaluate safety and tolerability (including inflammation and immunogenicity), and pharmacodynamics of ALLN-346.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 18 to 55 years
* Incapable of pregnancy, not nursing, and agrees to use an effective method of contraception; males subjects must agree to abstain from sperm donation
* Good general health as determined by medical history and physical examination
* Normal clinical laboratory test results and ECG

Exclusion Criteria:

* Presence or history of any significant cardiovascular, gastrointestinal, hepatic, renal, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurological, psychiatric disease or history of hyperuricemia
* Any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines
* Positive screen results for drugs of abuse, alcohol, or cotinine or recent history of drug or alcohol abuse, or positive COVID-19 test
* Clinically significant abnormal findings on physical examination, vital signs or on electrocardiogram (ECG)
* Positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) antibody
* Received treatment with or exposure to an Investigational drug or device within 30 days prior to or during Screening
* Prior dosing in ALLN-346 clinical study
* Per Investigator judgment, is not an ideal clinical study candidate
Topical Instillation of Tranexamic Aacid in Bronchoscopy to Decrease Bleeding During Entobronchial & Transbronchial Biopsiy: a Prospective Double Blind Placebo Controlled Study

Bleeding during transbronchial ro endobronchial biopsy is rather a common complication.

Mostly this is an insignificant bleeding, but in 3% of the biopsies there is a substantial amount of bleeding that requires a special treatment or follow up.

The goal of this study is to examine whether submission of tranexamic acid during the biopsy could diminish the amount of bleeding.


Eligibility Criteria:
Inclusion Criteria:

* Patient that are candidates to endobronchial or transcronchial biopsy

Exclusion Criteria:

* S/P MI or CVA or PE or DVT .
* S/P thrombophilia.
* Patients under coagulation therpay
* Chronic Renal Failure
* Pregnancy
A Follow-up Study on Total Endoscopic Thyroidectomy Bilateral Areola Approach

Endoscopic thyroidectomy bilateral areola approach (ETBAA) is one of the most widely applied approach in China, meanwhile its safety and effectiveness has been broadly discussed since being introduced. However, these studies are generally with small sample size and short follow-up duration. The lack of long-term follow-up on oncological outcomes makes it inaccurate to evaluate the effectiveness of ETBAA versus OT. Thus, in this study, we evaluated long-term QoL and outcomes of patients with PTC underwent thyroidectomy via ETBAA versus OT.


Eligibility Criteria:
Inclusion Criteria:

* 1) Female patients under 55 years old; 2) no lateral cervical lymph node or distant metastasis were detected before the operation; 3) postoperative pathology confirmed the diagnosis of papillary thyroid carcinoma.

Exclusion Criteria:

* 1) Previous history of thyroid surgery; 2) lateral cervical lymph node dissection in the operation; 3) past or current history of underlying diseases including hyperthyroidism, hypertension, diabetes, coagulation dysfunction.
Evaluation of an Algorithm for Identifying Persistent Nasal Staphylococcus Aureus Carriage in a Cohort of Healthy Volunteers and Patients Regularly Monitored at the CHU of Saint-Etienne

The nasal carriage of Staphylococcus aureus is a major risk factor of S. aureus infection, notably in hemodialysis patients (HPs). Decolonization strategies were shown able to reduce the rate of S. aureus infection in this category of patients although the risk of emergence of antimicrobial resistance persists. Approximately one quarter of the general population is colonized by S. aureus in the anterior part of the nostril (vestibulum nasi). Three main categories of nasal carriers have been historically identified: persistent carriers (20%, 12-30%\]), intermittent carriers (30%, \[16-70%\]) and non-carriers (50% \[16-69%\]). By contrast to intermittent carriers and non-carriers, persistent nasal carriers have a higher risk of S. aureus infection, especially in continuous peritoneal dialysis and in orthopedic surgery.

Persistent carriers are characterized by a higher nasal bacterial load, a longer duration of carriage, a lower rate of exchange of S. aureus strains, and a particular affinity for the carried strain. However, there is no consensual definition of this persistent carriage state. In previous studies, 5 to 12 nasal sampling episodes were realized for a period ranging from 5 weeks to 8 years. The index of carriage, corresponding to the number of samples positive for S. aureus divided by the total number of samples, has been proposed to standardize the definition of the carriage state. According to standard tools, it is almost impossible to determine the nasal carriage state in routine practice.

Recently, an algorithm based on one or two quantitative cultures from nasal samples taken within 2 days that was able to distinguish accurately persistent and non-persistent nasal carriers of S. aureus has been described; only one nasal sample was needed in more than 9 cases out of 10. The aim of the present study was to assess prospectively the reliability of this algorithm in clinical practice in a cohort of healthcare workers (HCWs) and HPs and to check its ability for identifying patients with the highest risk of S. aureus infection


Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers or hemodialysis patients
* carrier state of S. aureus unknown
* written consent

Exclusion Criteria:

* chronic soft skin tissue infection due to S. aureus or eczema,
* ongoing or completed antibiotic treatment for less than 15 days,
* nasal decolonization by mupirocin or skin decolonization by antiseptic bath for at least 5 consecutive days in the previous year,
* pregnancy,
* HIV infection
* hemostasis disorder.
Changes in Stabilometry After Neural Mobilisation in Foot

Investigation will consist of measuring before and after applying nerve mobilization exercise. Measurements will be made on the same day without the need to go at another time.

In this study, participants will be asked to stand on a pressure platform several times in a relaxed manner and with eyes open and closed before and after a neuromeningeal mobilization technique indicated for the treatment of pain in your feet. Measurements or tests to be carried out are totally innocuous and do not carry any risk to your health and integrity.

Participants will have to remain barefoot for a maximum of 30 seconds, a total of 8 times on a pressure platform


Eligibility Criteria:
Inclusion Criteria:

* Participants were diagnosed with active or latent MTrP in bilateral flexor digitorum brevis.
* MTrPs were the only MTrPs diagnosed in limb or foot.
* Participants had a normal body mass.
* Age range of 20 to 40 years.

Exclusion criteria:

* Diagnosis of lower limb injury.
* History of previous lower extremity surgery.
* Required not to have undergone ankle stretching or any other treatment
* Diabetes due to possible elevation of plantar pressure.
* Deformities of the toes, such as hammer toes and hallux valgus due to their possible alteration in plantar pressure.
Effect of Metformin on Chronic Pain After Thoracic Surgery in Diabetic Patients

Metformin has been found to have more and more functions as a commonly used hypoglycemic drug in clinic. It has been found that metformin has anti-inflammatory, anti-tumor and lipid metabolism regulating effects. Basic studies have shown that metformin as an adjuvant drug combined with gabapentin and tramadol is safe and effective in patients with neuropathic pain. Postoperative chronic pain as a common complication has seriously affected the quality of life and mood of patients after surgery.Some studies have shown that chronic pain after partial operation manifests as neuropathic pain. The effect of metformin on chronic pain after thoracic surgery in patients with diabetes mellitus was observed in this experiment, which was compared with patients taking insulin to control blood sugar.

The analgesic mechanism of metformin may include the following aspects:(1)Metformin relieves neuropathic pain mainly because it can activate adenosine monophosphate-activated protein kinase (AMPK), which plays a crucial role in pain regulation as an important endogenous kinase controlling energy metabolism.(2)In addition, metformin can also inhibit ERK signaling pathway, further inhibit sodium channel, prevent the development of peripheral sensitization and achieve the effect of relieving neuropathic pain. (3)Metformin has been shown to alleviate bone cancer pain in rats by reducing STAT3 phosphorylation.Clinical research in this field is limited to basic research and ethical requirements are rarely reported at home and abroad. Li Chunye et al. of Jiangsu University designed a clinical trial to compare the efficacy of metformin and gabapentin combined with tramadol on neuropathic pain. The results showed that metformin had a better effect.

The incidence of chronic pain after thoracic surgery is higher. Postoperative chronic pain is a complex pain. The nature and mechanism of chronic pain after thoracic surgery are still controversial. Some studies have shown that some chronic pain after thoracic surgery manifests neuropathic pain, the mechanism may be related to surgical incision, nerve injury caused by trauma and increased pain sensitization. Can metformin alleviate chronic pain after surgery? The research on this aspect is still blank at present.This study was designed as a prospective cohort study to observe whether there was a difference in the incidence of chronic pain after thoracoscopic lobectomy between patients taking metformin and patients injecting insulin to control blood sugar.

Eligibility Criteria:
Inclusion Criteria:

1. Aged between 18 and 70
2. Diabetes history. Use metformin or insulin to control blood sugar
3. The type of operation is selective thoracoscopic lobectomy.

Exclusion Criteria:

1. Newly diagnosed diabetic patients at admission
2. Complication of severe cardiopulmonary diseases
3. Refuse to participate in this experiment
4. Participate in other trials
5. Patients with diabetic complications (including diabetic nephropathy, peripheral neuropathy, etc.)
Prevention of CHOP-induced Chronic Cardiotoxicity

The purpose of this study is to assess the protective effect of Valsartan on chronic cardiotoxicity induced by CHOP.

Doxorubicin has been one of the most important key drugs in treatment for malignancies. However, its use is limited by dose-dependent cumulative cardiotoxicity. This multi-centers trial was designed to investigate the preventive effect of Valsartan, the angiotensin II type 1 receptor blocker (ARB) on chronic cardiotoxicity due to doxorubicin based chemotherapy. Patients with untreated non-Hodgkin's lymphoma who are scheduled to receive at least 6 courses of the standard CHOP (-R) will be randomized by the minimization methods to the treatment group with Valsartan (80mg once daily by oral during entire 6 courses of CHOP) or control group. Cardiac function will be evaluated in detail before and after 3 and 6 courses of CHOP (-R).

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of non-Hodgkin's lymphoma (NHL)
* Untreated lymphoma
* Performance status from 0 to 1,
* Total serum bilirubin \< 2.0 mg/dl
* Serum creatinine level \< 2.0 mg/dl
* Ejection fraction of the left ventricle \>50 %
* Systolic blood pressure at rest being 90 mmHg or more

Exclusion Criteria:

* Severe complication including chronic or acute heart failure, angina, old myocardial infarction, liver cirrhosis, and interstitial pneumonia
* Pregnancy, nursing mothers or women of child-bearing potential
* Hypertension under medication
* Diabetes mellitus under medication
* Hyperthyroidism, nephrotic syndrome, Cushing's syndrome
* Atrial arrythmias
* Severe psychopathy
* Cerebrovascular accidents within the past 3 months
* Positive serum HBs antigen or HCV antibody
* A history of renal failure
* A contraindication to A-II antagonists or noncompliance
* Treatment with any of the following drugs within the past 3 months : A-II antagonists, ACE inhibitors, vitamin E, probucol, calcium antagonists, beta-blockers, and steroid pulse therapy.