cyrilzakka/clinical-trials huggingface dataset:
Comparison of ATG to Thymoglobuline in Renal Transplantation

An open, multicenter, randomised, parallel group pilot study to investigate two different polyclonal rabbit immunoglobulin preparations for safety and efficacy: A comparison of ATG-Fresenius S to Thymoglobulin in prophylaxis for immunological high risk patients following renal transplantation. This non-inferiority trial shall demonstrate that ATG-Fresenius S is as efficacious as Thymoglobulin but has a better tolerance and fewer side effects.


Eligibility Criteria:
Inclusion Criteria:

1. Recipients, who are at least 18 years or older and have a high immunological risk defined by:

   The presence of at least one donor-specific antibody (class I and/or II) detected and specified by flow-technology (FlowPRA and single antigen beads), which are
   * For class I below the threshold of detection of a current CDC T-cell-/ and B-cell cross-match
   * For class II below the threshold of detection of a current CDC B-cell cross-match.
2. Patient receives a renal allograft only.
3. Female patients of child bearing age agree to maintain effective birth control practice during the study.
4. Patient has been fully informed and has given written or independent person witnessed oral informed consent.

Exclusion Criteria:

1. Patient is pregnant or breastfeeding.
2. Patient has a low immunological risk constellation, defined by receiving a kidney from a HLA-identical related living donor.
3. Patient and donor have a positive T-cell crossmatch.
4. Patient and donor are ABO incompatible.
5. Patient with combined transplantation.
6. Age of donor \>75 years.
7. Cold ischemia time \>40 hours.
8. Patient has leucopenia, defined as having at transplantation less than 3000/mm3 leukocytes.
9. Patient has thrombocytopenia, defined as having at transplantation less than 75000/mm3 thrombocytes.
10. Patient is allergic or intolerant to ATG-Fresenius S, Thymoglobulin, steroids, Tacrolimus or MMF.
11. EBV risk constellation (recipient EBV negative and donor EBV positive).
12. Patient or donor is known to be HIV positive.
13. Patient has a liver disease, defined as continuously having ASAT (SGOT) and/or ALAT (SGPT) levels greater than 3fold of the upper value of the normal range of the investigational site during the past 28 days.
14. Patient with malignancy or history of malignancy \<2 years, except non metastatic basal or squamous cell carcinoma of the skin that has been treated successfully.
15. Patient has uncontrolled concomitant infections and/or severe diarrhea, vomiting, or active peptic ulcer.
16. Patient is unlikely to comply with the visits schedule in the protocol.
Effect of Metformin on Disease Progression in Patients With Cryptogenic Cirrhosis (NASH-related Cirrhosis) With Diabetes or Impaired Glucose Tolerance or Insulin Resistance

In this study, consecutive patients with cryptogenic cirrhosis (NASH-related cirrhosis), coming to ILBS (Institute of Liver \& Biliary Sciences) OPD (Out patient Department) or getting admitted in the ward will be enrolled on fulfillment of inclusion/exclusion criteria and consent of the patient. These patients will be randomised to either metformin arm or conventional treatment arm. After enrollment these subjects will be monitored every three monthly for total of 12 months or till the primary endpoint is achieved. At the end of the study, outcome will be measured appropriately.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years and above
2. Patients with cryptogenic cirrhosis {NASH (Nash Alcoholic Steatohepatitis)-related cirrhosis}
3. Presence of diabetes mellitus or insulin resistance

Exclusion Criteria:

1. Patients with heart failure
2. Patients with acute kidney injury at the time of enrollment
3. Patients with CKD (Chronic Kidney Disease) or with S. Creatinine \> 1 mg/dL
4. Patient with active upper GI bleeding- not settled
5. Patient with SIRS/sepsis/shock
6. Patient in ICU (Intensive Care Unit)
7. Pregnancy
8. Patients with hepatocellular carcinoma
9. Patients who are not willing to participate in the study
10. Patients with any form of decompensation at the time of enrollment in the study
11. Patient with large esophageal varices/ patients who are on beta blocker other than those patients with HVPG (Hepatic Venous Pressure Gradient) non responder to betablocker
12. Patient who has already been receiving Metformin prior to enrollment in the study
A Study for the Treatment of Painful Diabetic Neuropathy

The purpose of the study is to determine if duloxetine can help patients with painful diabetic neuropathy.

The protocol will assess the efficacy and safety of duloxetine. It will also look at how duloxetine affects quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients at least 18 years of age.
* Patients with pain due to diabetic neuropathy in both legs.
* Females must not be pregnant or plan to become pregnant during the study.
* Stable Glycemic control.
* Average mean pain severity score of at least 4.0 as assessed by completion of a daily diary.

Exclusion Criteria:

* You are related to or work for the physician conducting the study or are employed by Eli Lilly and Company.
* You have a severe or serious medical condition that causes you to be hospitalized often; or you have had a kidney transplant or are on current dialysis.
* You have participated in a study for an investigational drug within the last 30 days.
* You have a history of major depressive disorder, generalized anxiety disorder, or alcohol or eating disorders.
* You have a past medical history or diagnosis of mania, bipolar disorder, or psychosis.
Fan Therapy in COPD Patients

Chronic Obstructive Pulmonary Disease (COPD) is a common smoking related lung disease. The main symptom in breathlessness.

Pulmonary Rehabilitation (PR) - a supervised group exercise and education class - is an effective intervention in COPD to reduce symptoms, improve exercise performance and prevent exacerbations. However some COPD patients are unable to to effectively exercise as they are limited by their breathlessness, despite optimal medical management. By reducing their physical activity to avoid the onset of breathlessness, they become deconditioned and then further attempts at exercise make them more breathless, leading to an inactivity cycle.

There is a growing evidence base regarding the use of hand hold fan therapy or air therapy to relieve breathlessness at rest. Limited studies have looked at the use of fan therapy during exercise, and its role on exercise capacity and recovery time, provisional results which indicate it may also be useful during activity. Logically you might expect patients who are less breathless to be able to exercise more, or recover quicker.

This study aims to investigate the effects a hand held fan will have on sensation of breathlessness and exercise capacity in patients with COPD. This will involve participants undertaking a standardised field walking test ( 6 minute walk test) with and with out the fan and then comparing the distance covered and how they felt during and after exercise. This will better inform how we structure exercise and advice to these patients in the future to empower patients limited by breathlessness.


Eligibility Criteria:
Inclusion Criteria:

* Chronic Obstructive Pulmonary Disease (Forced Expiratory volume in 1 second (FEV1)/Vital capacity ratio \< 70%, with an observed respiratory impairment ( Global initiative for Chronic Obstructive Lung Disease (GOLD) stage II-IV: \< 79% FEV1 predicted)
* Age \> 18 years old
* Exertional breathlessness with a Medical Research Council (MRC) breathlessness scale greater of equal to 2

Exclusion Criteria:

* Recent exacerbation of COPD symptoms requiring antibiotics within the preceding 4 weeks
* Significant cardiovascular or peripheral disease that could influence exercise tolerance and ability to perform exercise test
* Unable to hold fan to face and mobilise
* On Long Term Oxygen Therapy or fulfils criteria for ambulatory oxygen
* Lack of English Language Competency
Correlation of Nasopharyngeal (NP) and Lower Oesophageal (LO) Temperatures in Ventilated Children

Children lose heat under general anaesthesia, thus temperature is routinely monitored during anaesthesia for all but the shortest cases, and active warming can be used to prevent hypothermia and its resulting complications. Temperature can be measured at several sites dependent on the type of surgery and patient factors. Previously a temperature probe has been sited in the lower third of the oesophagus (swallowing tube) but it is difficult to accurately place this without an X-Ray. Consequently it is more common to use a temperature probe placed in the nasopharynx (where the nose and throat meet), when the child is anaesthetised.

However the investigators do not know if the temperature in the nasopharynx correlates well with the real core temperature or not.This prospective, unblinded, agreement study will seek to find an agreement of 2 methods to measure temperature in children undergoing general anaesthesia with a breathing tube that has a leak.

It is known that temperature in the lower third of the oesophagus correlates well with the gold standard of core temperature measurement, namely the temperature of blood in the heart. It is not known if oesophageal and nasopharyngeal temperatures correlate in children on a breathing machine via a tube with leak. If this study were to find a good correlation between oesophageal and nasopharyngeal temperature, this would allow clinicians to confidently use the more feasible nasopharyngeal temperature probes.

For this study 100 children will have both nasopharyngeal and oesophageal temperatures measured during general anaesthesia, both in the presence and absence of a leak around the endotracheal tube.

It is hypothesised that even in the presence of a leak, the temperature difference between the two methods will be less than 0.5 degrees centigrade.

Eligibility Criteria:
Inclusion Criteria:

* Patient requires general anaesthesia with endotracheal intubation for a procedure assisted by radiography (e.g. line insertion, line change).
* Patient requires chest radiograph for procedure.
* Expected anaesthetic time more than 30 minutes.

Exclusion Criteria:

* No written parental written consent.
* Known oesophageal pathology (e.g. tracheo-oesophageal fistula, oesophageal strictures, oesophageal varices, oesophageal atresia).
* Known base of skull or midface fractures.
* Previous gastric bypass surgery or nasal surgery.
* Known coagulopathy.
* Previous alkaline ingestion.
* High aspiration risk.
* Significant respiratory co-morbidity requiring anticipated peak airway pressures \> 25 cm of water
* American Society Anaesthesiologists (ASA) grading 4 - 5.
* Tracheostomy in situ.
* Severe sepsis or septic shock or other other condition (such as bronchopulmonary fistula) that precludes use of tidal volume ventilation over 7 ml/kg.
* Known airway abnormalities (e.g. subglottic stenosis) that preclude placement of a MicroCuff® endotracheal tube.
* Oesophageal or nasopharyngeal probe contraindicated for reasons related to surgery / procedure.
Impact of Heart Rate Characteristics Monitoring in Neonates

Hypothesis: Fewer neonates managed using information from heart rate characteristics (HRC) will require intubation and mechanical ventilation as a result of sepsis and sepsis-like illness.

Infants will be randomly assigned to one of two groups. One group of infants will have the HRC index known to the physicians caring for them, and physicians will use the HRC index as they desire to aid in clinical management.

Infants in the other group will have the HRC index recorded, but this information will not be displayed to the physicians caring for the infants.

Following randomization, infants will be managed as usual practice. The treating physicians of the HRC-display group will be able to utilize the HRC score to assist in the care of the infant. The physicians of the no-display group will provide care as per standard.

Clinical symptoms will be treated according to the medical discretion of each physician. Cultures will be obtained and antibiotics administered as per the medical discretion of the physicians.

Clinical, culture results, antibiotic administration, ventilator use, and outcome at 120 days data will be collected on the infants as well as their HRC score calculated by the HeRO heart rate characteristics monitor.

Eligibility Criteria:
Inclusion Criteria:

* Infants admitted to NICU
* Birth weight \< 1500 grams
* Gestational age \< or = 32 weeks
* Informed consent obtained from parent

Exclusion Criteria:

* Evidence of sustained cardiac arrhythmia
* Use of an electronic pacemaker
Study of the Safety, Tolerability, PK, and PD of ILV-094 Administered IV or SC to Healthy Subjects

The purpose of this study is to assess the safety and tolerability of ascending single IV doses of ILV-094 (an investigational drug) and one SC dose of ILV-094 in healthy subjects.

This is a randomized, double-blind, placebo-controlled, inpatient/outpatient, sequential-group study of ascending single IV doses of ILV-094 administered to healthy Japanese male subjects.

Eligibility Criteria:
Inclusion Criteria:

* Men aged 20 to 45 years inclusive at screening.
* Body mass index in the range of 17.6 to 26.4 kg/m2 and body weight\>45.
* Nonsmoker or smoker of fewer than 10 cigarettes per day. Must be abstain from smoking during inpatient stay.
* Healthy as determined by the investigator on the basis of screening evaluation.
A Study to Evaluate Insulin in the Blood After Inhalation of a Dry Powder Insulin Formulation (Called Technosphere®/Insulin) in Non-diabetic Patients With & Without Chronic Obstructive Pulmonary Disease (COPD)

Trial will include 40 subjects and consists of 3 visits: Screening, Treatment and Follow up. A euglycemic clamp procedure and Technosphere®/Insulin (T/I) administration will occur at Visit 2 for both COPD and non COPD subjects.

Trial objectives are to evaluate the impact of a defined lung disease (COPD) on pharmacokinetic parameters of insulin and fumaryl diketopiperazine (FDKP) after inhalation of Technosphere®/Insulin (T/I), the investigational medicinal product. 40 non diabetic subjects, 20 COPD and 20 age/gender/BMI-matched non COPD subjects will participate in 3 visits: Visit 1 (screening), Visit 2 (subjects will undergo a euglycemic clamp procedure and be dosed with T/I) and Visit 3 (follow up visit).

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects minimum 18 and maximum 70 years of age
* Body Mass Index (BMI) = 36 kg/m2
* Subjects with COPD: Diagnosis of COPD (emphysema and/or chronic bronchitis),
* smoking history =10 years, chronic cough present intermittently or daily with or without sputum and/or dyspnea upon exertion.
* Subjects with COPD: Pulmonary Function Tests - FEV1 =50% (NHANES) III
* Predicted; FEV1/FVC \< 70 % (NHANES) III; TLC =80% of Predicted (ITS) and DLco(unc) =50% of Predicted (Miller)
* Subjects without COPD: PFTs: FEV1 = 70% NHANES III Predicted; TLC =80% of
* Predicted (ITS) and DLco(unc) =80% of Predicted (Miller)

Exclusion Criteria:

* History of pre-diabetes or diabetes
* Previous or current treatment with any anti-diabetic drugs
* Serum creatinine \> 2.0 mg/dL in males and \> 1.8 mg/dL in females
* Active smokers defined as having smoked their last cigarette, pipe, and/or cigar without the previous 6 months
* Previous exposure to any inhaled insulin product or investigational medicines/devices within the previous 30 days prior to entry or participation
* Clinically significant major organ disease
* Female subjects of childbearing potential not practicing adequate birth control
* Subjects with COPD: Significant improvement in pre-to post-bronchodilator spirometry (defined as an increase of 12% AND 200 mL in either FVC or FEV1);
* Any clinically important pulmonary disease except mild or moderate COPD
* Subjects without COPD: Any important pulmonary disease confirmed by pulmonary function testing and/or radiologic findings
DIstal vs Proximal Radial Artery Access for Cath

This single-center, prospective, randomized study will evaluate distal radial artery (dRA) vs. proximal radial artery access (pRA) in regards to hand function and radial artery occlusion.

Primary objective is to evaluate hand function following distal radial artery access compared to proximal artery access in patients undergoing cardiac catheterization.

Hand function will be assessed by:

* QuickDASH questionnaire
* Hand grip test
* Thumb forefinger pinch test utilizing a pinch gauge

Secondary objectives: Vascular access success rates, hematoma, bleeding, complications of vascular access and radial artery occlusion.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. The distal and proximal radial artery must be palpable and non-occlusive flow must be confirmed by (Doppler) ultrasound.
3. Patient should be able to comply with the protocol.
4. Provide written informed consent before study participation

Exclusion Criteria:

1. Obligatory femoral or forearm radial access
2. Previous ipsilateral forearm radial artery occlusion.
3. Patient on therapeutic oral anticoagulation.
4. Very large hand/wrist anatomy that will preclude using the available hemostatic radial bands.
5. Enrolment in another study that competes or interferes with this study.
6. Poor clinical condition like cardiogenic shock, which prohibits pre- and post-procedural function tests.
7. Subject with planned complex PCI or procedure necessitating multiple intervention.
8. Any other condition or co-morbidity which, in the opinion of the investigator or operator, may pose a significant hazard to the subject if he or she is enrolled in the study.
9. History of stroke with residual deficit that affects hand function.
10. Previous radial artery catheterization within 1 year.
Improving Health Outcomes of Migraine Patients Who Present to the Emergency Department

Collectively, evidence shows that a combination of medication and behavioral therapy is most effective for migraine care. The ED is a critical point of contact with the health care system for many migraine patients; in current practice, it is a missed opportunity to initiate and establish a comprehensive migraine management paradigm. Behavioral headache treatments (e.g., progressive muscle relaxation (PMR), biofeedback, cognitive-behavioral therapy (CBT)) are effective migraine treatment options that are essentially free of side effects. PMR has also been successful as a technique that patients can do independently. Studies have shown that combination pharmacological-behavioral therapy is most effective for migraine treatment.

Several aspects of this study are innovative, including: 1. Initiation of preventive medication in a timely manner for migraineurs who present to the ED. 2. Introduction of PM+PMR in the ED at a time that can serve as a teachable moment. 3. Introduction of a smartphone application-based product (a minimal contact based behavioral therapy) in the ED setting to reduce headache disability, frequency, and intensity.

Investigators will conduct a randomized trial to evaluate the impact of a comprehensive migraine treatment program on the quality of life for migraineurs with frequent and disabling headaches who present to the ED. The intervention (PM+PMR) will combine acute treatment, migraine preventive medication-topiramate, and the APP with PMR. Data from patients in the intervention group will be compared with data from an enhanced usual care (EUC) group to examine the efficacy of the combined treatment effects.

Eligibility Criteria:
Inclusion Criteria:

* Meets migraine criteria based on Information in Study Manual or based on Headache expert opinion -4+ migraines a month
* Migraine Disability Assessment (MIDAS) score \>5.

Exclusion Criteria:

* Patients who have had Cognitive Behavioral Therapy, Biofeedback or other Relaxation Therapy in the past year;
* Cognitive deficit or other physical problem with the potential to interfere with behavioral therapy; Alcohol or other substance abuse as determined by self-report or prior documentation in the medical record;
* Opioid or barbiturate use 10+ days a month;
* PHQ9 score of severe depression;
* Unable or unwilling to follow a treatment program that relies on written and audio recorded materials;
* Not having a smartphone.
Precursors of CVD Risk Factors--Project Heartbeat

To elucidate the changes in body size, composition, and configuration occurring in adolescence, because these are important precursors of change in blood pressure and blood lipids.

BACKGROUND:

Project HeartBeat! was uniquely designed to investigate the course of change in cardiovascular disease risk factors and several categories of covariates, including the anthropometric indicators addressed in this study. The data pertained to the 678 participants who entered the Project in 1991-93 at ages 8, 11 or 14 years of age, of whom 49.1 percent were female and 20.1 percent were black. Of the 395 participants who became eligible for 10 or more 4-monthly examinations, 349 (88.4 percent) completed at least 10 occasions; 538 participants of 556 who were eligible for seven or more examinations (96.8 percent) completed at least seven. Multi-level (MLn) analytic methods previously tested with other data were utilized for this analysis.

DESIGN NARRATIVE:

Data from Project Heartbeat were analyzed. Hypotheses tested included: (1) the time patterns of change in several indicators of body size, composition and configuration over the period of observation; (2) the relations between the time patterns of change in these indicators and the corresponding patterns for change in selected endocrine factors; and (3) the explanatory contributions of energy intake and expenditure to variation between individuals in their observed time patterns of change in these indicators. The anthropometric indicators addressed were: weight (total mass), height, body mass index (BMI, wt/ht2), fat-free mass, fat mass, per cent body fat, and fat distribution (waist/hip ratio). Each of these indicators were examined first separately and then in relation to selected endocrinologic measures (testosterone, estradiol, and DHEAS) and to energy intake and expenditure (from interview histories of diet and physical activity). Existing data from up to twelve 4-monthly examinations over the age range from 8-17 years conducted in Project HeartBeat! were analyzed.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria