cyrilzakka/clinical-trials huggingface dataset:
A Study of ALXN1830 in Healthy Adult Participants

This trial will study the effects of single and multiple doses of ALXN1830 in healthy adult participants.

This is a Phase 1 study in healthy adult participants. The study will consist of 2 single ascending dose (Cohorts 1 and 2) and 4 multiple ascending dose cohorts (Cohorts 3 to 6). Participants will be randomly assigned to each of the 6 cohorts to receive either single or multiple doses of ALXN1830 subcutaneous (SC) or single or multiple doses of placebo SC. Cohort 6 will enroll only healthy participants of Japanese descent who will be dosed according to the highest tolerated dose (HTD) established in the non-Japanese cohorts.

Eligibility Criteria:
Inclusion Criteria:

* Satisfactory medical assessment.
* Participants must have had vaccination against pneumococcus (Pneumovax 23 \[PPSV23\]) at least 28 days, and maximally 4 years prior to Day 1.
* Participants must have had seasonal influenza vaccination for the current season at least 28 days prior to Day 1.
* Body weight within 60 to 90 kilograms (kg), inclusive, and body mass index within 18 to 30 kg/meter squared, inclusive.
* Must be willing to follow protocol-specified contraception guidance during the study and for 3 months after last dose of study drug.

Exclusion Criteria:

* Current/recurrent diseases or relevant medical history.
* Known exposure to investigational or marketed therapeutic proteins, such as monoclonal antibodies, fusion proteins, bispecific molecules, or antibody drug conjugates, within 60 days or 5 half-lives (whichever is longer) prior to dosing.
* Participants who have prior exposure to ALXN1830.
* Current enrollment or past participation within the last 90 days before signing of consent in this or any other interventional clinical study.
* Participants with hepatitis B or C, or human immunodeficiency virus.
* Participants who are either immunocompromised or have one of the following underlying medical conditions: anatomic or functional asplenia (including sickle cell disease); primary antibody deficiencies.
Piloting IVR (Interactive Voice Response) for Chronic Pain Treatment

This study is designed to develop and test the use of Interactive Voice Response (IVR) technology to deliver pain management treatment. IVR allows individuals to receive and provide information by using their touchtone telephone. This will allow more people with chronic pain to receive treatment even if they are not able to drive to an appointment regularly. In the first part of the study, the investigators will develop new materials like patient handbooks and pre-recorded explanations about common pain control techniques. In the second part of the study, a small number of persons with chronic pain will receive treatment using the new materials. We will ask for their feedback about how well they liked using the new materials and if the materials are understandable. This will allow us to revise the materials if we need to prior to studying them with a larger group of people with chronic pain.

Background:

Cognitive behavioral therapy (CBT) has been shown in two meta-analyses to be effective in reducing pain intensity, disability, and affective distress in persons with chronic pain. Although effective, traditional CBT is time-intensive and requires patients to make frequent office visits. An alternative is to improve treatment accessibility and efficiency of treatment provision through the use of electronic methods such as interactive voice response (IVR) technology.

Objectives:

This pilot project was designed to test the feasibility and perceived value of IVR-based CBT intervention materials for the treatment of chronic pain. The project involved adapting traditional CBT materials for use in a IVR-based chronic pain treatment.

Methods:

The project occurred in two phases. Phase 1 included the revision of materials to support the IVR-based intervention including 1) a patient handbook, 2) a library of IVR-compatible scripts for the presentation of pain treatment topics, and 3) guidelines for providing personalized feedback. Phase 2 included the evaluation of the developed materials by a small group of patients with chronic pain. After the treatment materials were revised, their usability, feasibility and perceived value were tested with a small sample of Veterans with chronic pain.

Status:

This study is complete.

Eligibility Criteria:
Inclusion Criteria:

* Pain for at least 6 months;
* Average pain level of \>3 on a scale of 0 (no pain) to 10 (worst imaginable);
* Access to touchtone phone

Exclusion Criteria:

* Current alcohol or substance abuse;
* Current psychosis;
* Current suicidal ideation;
* Current life threatening or acute physical illness
A Trial to Investigate the Bioequivalence of Norditropin® (Somatropin) Versus Genotropin® (Somatropin) in Healthy Adult Subjects

This trial is conducted in the United States of America (USA). The aim of the trial is to investigate the bioequivalence (the expected biological equivalence of two pharmaceutical drug products with identical active ingredient) of Norditropin® (somatropin) versus Genotropin® (somatropin) in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects at trial entry with no previous exposure to recombinant human growth hormone or IGF-I (insulin-like growth factor-I)
* Body mass index (BMI) 18.0-27.0 kg/m\^2 (both inclusive)
* Considered generally healthy upon completion of medical history, physical examination, vital signs, screening laboratory results, and electrocardiogram (ECG), as judged by the investigator

Exclusion Criteria:

* The receipt of any investigational medicinal product within 1 month prior to this trial
* Current or previous treatment with growth hormone or IGF-I
* Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice) for the duration of the trial
* Known presence or history of malignancy
* Diabetes mellitus
* Use of systemic corticosteroids
* Use of anabolic steroids
* History of drug or alcohol abuse
Predictor of Postoperative Complications After Lengthy Noncardiac Surgery

Many patients undergoing long time surgery will manifest increased level of blood lactate.

Hyperlactacidemia can cause disturbance of internal environment, then leading to increased complications and longer ICU stay, even death. For postoperative patients, we must ensure adequate perfusion in order to minimize the length of hyperglycemia and improve patients' outcomes. With regard to lactate, it provides information about prefusion, but not timely enough for its delay on reflecting hypoperfusion. And it's not real-time and non-invasive.

Peripheral perfusion index (PPI) is an indicator reflecting hypoperfusion in critical patients. It is measured using pulse co-oximetry technology which is characterized by being real-time and noninvasive. PPI is defined as "the ratio of pulsatile blood flow to the non-pulsatile blood flow", mirroring the strength of blood flow and quality of perfusion at sensor site, reflecting perfusion state of the body part . In contrast to lactate value, it's real-time and easy to monitor.


Eligibility Criteria:
* Inclusion criteria
* Adult patients above 18 years of age.
* Both genders
* surgical time planned to be \> 120 minutes .
* surgical time predicted to exceed the planned time and prolongation of surgical time \> 120 minutes occured will be included in the study .
* ASA physical status of I-II
* Patients scheduled for elective surgery under general anaesthesia .
* Exclusion criteria
* Refused to participate .
* patient with disease affecting blood flow to the hands where probe will be applied .
* patient with hand injuries so probe cannot be applied
* Patient with sever renal and liver disease
* Discharging against medical advice or reported death during ICU stay at first 48 hours after ICU admission .
* Pregnancy or emergency surgery .
* shortening of the planned surgical time to be less than 120 minutes
Efficacy and Safety Study of Symbicort Turbuhaler in Chinese Patients With COPD

This study aims at evaluating efficacy and safety of Symbicort® Turbuhaler® in Chinese COPD patients as defined by GOLD treatment guidelines in order to obtain an approval for indication of COPD from Chinese State Food and Drug Administration.


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated inform consent
* Out-patient, clinical diagnosis of COPD
* Men or women at the age of 40 or over

Exclusion Criteria:

* A history of asthma
* Seasonal allergic rhinitis before 40 years of age
* Patients with significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator or other disorder
Trial of Efficacy and Safety of NS-229 Versus Placebo in Patients With Eosinophilic Granulomatosis With Polyangiitis

This study will enroll male and female subjects who are 18 years of age or older with Eosinophilic Granulomatosis With Polyangiitis.

The purpose of this randomized, double-blind study is to investigate the efficacy and safety of NS229 compared with placebo over a 28-week study treatment period in subjects with Eosinophilic Granulomatosis with Polyangiitis (EGPA) receiving background corticosteroid therapy with or without mepolizumab therapy. During the treatment period corticosteroid dose will be tapered.

The key outcomes in the study focus on evaluation of clinical remission, defined as Birmingham Vasculitis Activity Score (BVAS)=0 with a corticosteroid dose of \<=4 mg/day prednisolone/prednisone.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent prior to participation in the study.
* Male or female subjects aged ≥18 years at the time the informed consent form is signed.
* Diagnosis of EGPA: Subjects who have been diagnosed with EGPA based on the history or presence of eosinophilia plus at least a history or presence of 2 of additional features of EGPA.
* Subjects receive background OGC dose of ≥7.5 mg/day with or without stable treatment with mepolizumab.
* Use of adequate contraception.
* Other inclusion criteria may apply.

Exclusion Criteria:

* Current diagnosis of either granulomatosis with polyangiitis or microscopic polyangiitis
* Imminently life-threatening EGPA at the time of screening.
* History or presence of any form of cancer within 5 years prior to screening.
* Serious liver, renal, blood, or psychiatric disease
* Severe or clinically significant cardiovascular disease uncontrolled with standard treatment
* Active systemic infections (including TB, pneumonia, Pneumocystis pneumonia, sepsis, and opportunistic infections)
* Parasitic infection: Subjects with a known parasitic infestation within 6 months prior to screening.
* HIV positive status
* Active hepatitis due to hepatitis B virus or hepatitis C virus
* Known history or presence of venous thromboembolism/venous thrombotic events (deep vein thrombosis and/or pulmonary embolus)
* laboratory parameter exclusions:

  1. Estimated glomerular filtration rate of \<30 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration equations
  2. WBC count \<4 × 109/L
  3. Absolute lymphocyte count \<500 cells/mm3
  4. Absolute neutrophil count \<1000 cells/mm3
  5. Platelet count \<120,000/mm3
  6. Hemoglobin \<8 g/dL (\<80 g/L)
* Subjects who are pregnant, breastfeeding, or planning to become pregnant during the time of study participation
* History of clinically significant drug or alcohol abuse within the last 6 months
* Other exclusion criteria may apply.
Long-Term Follow-Up Study of Patients Receiving ATL001

This is an Open-Label, Multi-Centre Phase II study to evaluate the long-term safety and clinical activity of ATL001, previously administered intravenously to patients in Study ATX-NS-001 (NCT04032847) or Study ATX-ME-001 (NCT03997474).

Up to 90 patients with advanced non-small cell lung cancer ( NSCLC) or metastatic or recurrent melanoma will be enrolled after either: completing 2 years of follow-up visits in study ATX-NS-001 or study ATX-ME-001; or voluntary withdrawal from these studies prior to the completion of the 2 year of follow-up period.

Each patient will be followed up for a minimum period of 5 years, or until death if sooner, in this Long-Term Follow Up Protocol.

For patients who are still alive after 5 years of follow-up, survival data will continue to be collected until the end of the study, which will occur when the last patient has completed 5 years of follow-up withdraws from study or has died.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must have given written informed consent to participate in the study.
2. Patients must have received ATL001 in a previous Clinical Trial.
3. Patients must be considered, in the opinion of the Investigator, capable of complying with the protocol requirements.

Exclusion Criteria:

There are no exclusion criteria.
Hématologie Adulte Prevalence of Adrenal Insufficiency Post-chemotherapy Adrenocorticotropia in Adult Hematology

A recent meta-analysis involving 3753 patients treated with corticosteroids notes that the population with the highest prevalence of biological IS (68%) is onco-hematology. However, it is also the least studied population with no recent and significant prevalence study. A recent multicenter study including patients followed up oncology who received dexamethasone for antiemetic purposes at cumulative doses well below the doses used in Hematology, objective a prevalence of biological IS estimated at 16% at 3 months from the start of chemotherapy. The introduction of a substitution had led to an objective improvement in the quality of life estimated by EORTC QLQ-C30.

A recent meta-analysis involving 3753 patients treated with corticosteroids notes that the population with the highest prevalence of biological IS (68%) is onco-hematology. However, it is also the least studied population with no recent and significant prevalence study. A recent multicenter study including patients followed up oncology who received dexamethasone for antiemetic purposes at cumulative doses well below the doses used in Hematology, objective a prevalence of biological IS estimated at 16% at 3 months from the start of chemotherapy. The introduction of a substitution had led to an objective improvement in the quality of life estimated by EORTC QLQ-C30.

Expected results are prevalence rate of biological adrenal insufficiency between 15 and 20% with improvement of the quality of life in the 2 months post-chemotherapy by Hydrocortisone supplementation

Eligibility Criteria:
Inclusion Criteria:

* Age\> 18 years
* Patient naive to any chemotherapy treatment, re-ceiving a 1st chemotherapy line of RCHOP, RCOP, VTD, VD or MPT type from the Adult Hematology Department
* PS according to WHO = 0,1 and 2

Exclusion Criteria:

* Adrenal pathology, hypothalamus or pre-existing pituitary gland (including metastatic lesions)
* Long-term treatment with corticosteroids or in the previous 6 months
* Refusal or absence of informed consent
Tools for Lasting Lifestyle Changes

Pilot and feasibility study; a complex intervention focusing on lifestyle change to increase physical activity and reduce cardiovascular disease (CVD) risk among high risk individuals.

Interdisciplinary, mixed-method, prospective and single-arm exploratory study aimed to explore study feasibility, responsiveness, participants adherence and adverse events among the participants before deciding to proceed to full-scale evaluation.

Enrollment of max. 20 obese people (BMI\>30) with sedentary lifestyle and increased CVD-risk (NORRISK2)..

Participants general health status including cardiopulmonary fitness will be assessed both before and after the intervention (blood pressure, ECG, spirometry, treadmill tests VO2max, blood tests, body composition by Dual-energy X-ray absorptiometry (DEXA) measurements) Participants´ functional capacity assessed by several range of motion tests. Participants nutritional and psychological status assessed by validated questionnaires.

Several blood-tests and ECG will be recorded at three months.

Daily activity level during and six months after the intervention period monitored by Polar M430 pulse watch.

The participants will be interviewed with focus on their prior health, activity habits and intervention experiences at three months and six months after end of the intervention. Two focus-group interviews at end of intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Age 55-74 years
2. BMI\> 30
3. Moderate elevated NORRISK 2 score
4. Motivation for lifestyle change
5. Has agreed to attend and participate in a student study during the study period

Exclusion criteria: 1.External disease with short life expectancy 2.Diseases that limit physical activity in the project 3.Serious mental illness 4. Previous myocardial infarction 5.EKG changes that show severe rhythm disturbance, unstable angina or heart attack

5.EKG changes that show severe rhythm disturbance, unstable angina or heart attack:
The Effect of Intraoperative Dexmedetomidine on Postoperative Morphine Requirements After Breast Cancer Surgery

Dexmedetomidine is an α2 receptor agonist with sedative and analgesic properties. In previous reports, dexmedetomidine improves smoothness of postoperative recovery and reduces intraoperatory imflammatory responses. As patients receiving breast surgeries are especially vulnerable to postoperative nausea/ vomiting, the dosage of narcotics and associated complications were concerned for not only comfortness but also postoperative oral intake and discharge. The invetigators aimed to compare the effects of dexmedetomidine infusion versus placebo on postoperative narcotics requirement, complications, and oral intake.

Dexmedetomidine is an α2 receptor agonist with sedative and analgesic properties. In previous reports, dexmedetomidine improves smoothness of postoperative recovery and reduces intraoperatory imflammatory responses. As patients receiving breast surgeries are especially vulnerable to postoperative nausea/ vomiting, the dosage of narcotics and associated complications were concerned for not only comfortness but also postoperative oral intake and discharge.

The invetigators aimed to compare the effects of dexmedetomidine infusion versus placebo on postoperative narcotics requirement, complications, and oral intake.

The participantss under general anesthesia and aged from 30 to 65 years old will be enrolled. All subjects were randomized into the dexmedetomidine or placebo group. They received placebo (group P, n = 30) or dexmedetomidine (loading dose of 1 μg kg-1 followed by 0.5 μg kg-1 h-1) (group D, n = 30) to the end of surgery.

Data collected included intraoperative and postoperative opioid consumption. Postoperative questionare including PONV, Pain intensity, I-FEED questionnaire. Prospective analysis will be performed on the prospectively collected data.

We expected to examine if intraoperative dexmedetomidine decreases the postoperative opioid consumption and associated complications, and enhances the gastrointestinal recovery and oral intake with narcotic-sparing effect.

Eligibility Criteria:
Inclusion Criteria:

* Patients who fulfill the criteria of breast cancer under general anesthesia.

Exclusion Criteria:

* Major systemic disease, such as congestive heart failure, liver cirrhosis, end stage renal disease and malignancy.
* Patients who have the risk of difficult ventilation or intubation.
* Pregnant women.
* Coagulopathy.
Home Based Infusions for Ocrelizumab

The goal is to assess the safety and effectiveness of home ocrelizumab infusion.

The safety of home ocrelizumab infusion will be assessed by monitoring for infusion reactions and adverse events, and comparing proportions/rates to existing studies. Patient reported outcomes (PROs) will compare pre to post infusion.

Eligibility Criteria:
Inclusion Criteria:

* Current active patient of Rocky Mountain MS Center at the time of final study consent.
* Between 18-55 years of age at the time of final study consent.
* Diagnosis of primary progressive or relapsing MS as defined by the 2017 McDonald criteria.19
* Has at minimum completed their first 600 mg dose of ocrelizumab.
* Is physically residing in the Denver metro, Fort Collins or Colorado Springs area at the time of final study consent.
* Has a Patient Determined Disease Steps (PDDS) between 0 to 6.5 20
* Can complete patient reported outcomes developed and validated as English written scales.
* Must be able and willing to give meaningful, informed consent via electronic signature prior to participation in the study, in accordance with local and FDA regulatory requirements.
* Whose treating neurologist at the RMMSC feels that continuing ocrelizumab s medically appropriate based on at the time of final study consent.

Exclusion Criteria:

* Not pregnant, intentions to get pregnant or lactating at the time of final study consent and on the day of infusion.
* Has previously not participated in the SaROD trial at the RMMSC site.
* Any of the following abnormal laboratory results as processed by a University of Colorado Hospital laboratory site and deemed clinically inappropriate to proceed with a home infusion by the treating neurologist at RMMSC.
Efficacy of MK0557 in Combination With Sibutramine or Orlistat (0557-015)(COMPLETED)

Study medicine will be given alone, or in combination with either sibutramine or orlistat, to obese subjects to compare the effect on body weight over a six month period.


Eligibility Criteria:
Inclusion Criteria:

* Men and women between the ages of 18-65 who are considered obese (have a body mass index between 30 and 43)

Exclusion Criteria:

* Subject has high blood pressure or is taking any high blood pressure medicine
* History of psychiatric disorder, stroke, or heart disease
Bacteriophage Therapy in Patients With Urinary Tract Infections

This is a phase I/II trial designed to evaluate bacteriophage therapy in patients with urinary tract infections.

This study will evaluate the safety and efficacy of bacteriophage therapy in patients with urinary tract infection (UTI). Patients to be enrolled will have urinary tract infections due to E. coli and K. pneumoniae. This will include asymptomatic patients with neurogenic bladder and symptomatic patients with complicated urinary tract infections who are at risk of UTI recurrence. Patients will be followed for bacterial clearance or recurrence of urinary tract infection.

Eligibility Criteria:
General Inclusion Criteria:

* Males or females ≥18 years of age.
* Female patients of childbearing potential.
* Male patients must agree not to donate sperm up for one month.
* English-speaking.

General Exclusion Criteria:

* Stage 4 or greater chronic kidney disease (CKD).
* Abnormal liver function tests \>3×upper limit of normal (ULN).
* Other conditions which could confound study results.
* Body mass index of \> 40 or weight less than 50 kg.
* Known allergy to phage products.
* Pregnant and/or breastfeeding.
* Immunocompromised.
* Need for antiviral medication.
* History of severe autonomic dysreflexia.