cyrilzakka/clinical-trials huggingface dataset:
3 TPV/RTV Doses in Multiple ARV Experienced Patients - Tipranavir Dose Defining Study

A dose defining study of the protease inhibitor tipranavir (TPV), boosted with low dose ritonavir (RTV). Three dose combinations of TPV/RTV are administered to multiple antiretroviral experienced patients and the dose that achieves the best efficacy and safety as determined by evaluation of 2, 8, and 24-week virologic response and adverse event and laboratory profile measures would be selected for further clinical study.


Eligibility Criteria:
Inclusion criteria:

* Signed informed consent prior to trial participation.
* Human immunodeficiency virus 1 (HIV-1) infected males or females \> 18 years of age.
* At least 3 months experience taking Nucleoside reverse transcriptase inhibitors (NRTIs), Non-nucleoside reverse transcriptase inhibitor (NNRTIs), and Protease inhibitors (PIs).
* Current PI-based Antiretroviral (ARV) medication regimen for at least 3 months prior to randomization, and at least 3 months experience taking at least one other PI-based regimen.
* HIV-1 viral load ≥1000 copies/mL at screening.
* Genotypic resistance report indicating one or more primary PI resistance mutation(s), including 30N, 46I/L, 48V, 50V, 82A/F/T, 84V or 90M.
* Availability of 2 or more non-PI ARV medications by genotypic resistance testing, i.e. 2 drugs tested as "no evidence of resistance" or "possible resistance".
* Acceptable screening laboratory values that indicate adequate baseline organ function.
* Laboratory values are considered to be acceptable if severity is no higher than Grade 3 Gamma glutamyl transferase (GGT), Grade 2 cholesterol or triglycerides, and no higher than Grade 1 for all other tests based on the "Division of Acquired Immune Deficiency Syndrome" of National Institute of Health, USA - DAIDS - Grading Scale. All laboratory values outside these limits are subject to approval by Boehringer Ingelheim (BI).
* Further inclusion criteria apply.

Exclusion criteria:

* ARV medication naïve.
* Only one or no available ARV medications as determined by genotypic resistance testing.
* Female subjects who:

  * have a positive serum pregnancy test at screening or during the study;
  * are breast feeding;
  * are planning to become pregnant;
  * are not willing to use two methods of contraception to include at least one barrier method (e.g. latex condom plus spermicidal jelly/foam).
* Any active opportunistic infection within 60 days before study entry.
* Active Hepatitis B (HCB) or Hepatitis C (HCV) disease defined as HBsAg positive or HCV RNA positive with Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) \> Grade 1.
* Prior tipranavir use.
* Use of investigational medications within 30 days before study entry or during the trial.Some expanded access drugs may be acceptable; must be approved by BI. Tenofovir, investigational at time of preparation of this protocol, is acceptable.
* Use of concomitant drugs which may significantly reduce plasma levels of the study medications.
* Further exclusion criteria apply.
Effect of Exercise on Cognitive Function and Mental Health in Heroin Addicts

The goal of this \[type of study: exercise intervention study\] is to test in describe participant health conditions. The main questions it aims to answer are:

* \[Whether physical exercise improves executive function of male heroin addicts\]
* \[Whether physical exercise improves negative thinking/affect psychological experience of male heroin addicts\] Participants will be randomly selected for medium-intensity strength training (resistance exercise,n=30), 30 will be selected for 1-hour long balloon volleyball sessions (aerobic exercise) at 60-70% volume of oxygen uptake during peak exercise, weekly 5 times for 12 weeks; and 30 will be assigned to the no-exercise control group, Participants will perform Executive function tests and the Symptom Checklist-90 Revised questionnaire at pre and post intervention.

Researchers will compare resistance exercise group,aerobic exercise group and no-exercise control group to see if effects of exercise on executive function and negative thinking/affect psychological experience of male heroin addicts.


Eligibility Criteria:
Inclusion Criteria:

* were men who met the Manual of Mental Disorders (DSM)-IV criteria for current heroin dependence

Exclusion Criteria:

* any major mental illness other than heroin addiction
* any exercise taboo
NIRST and ICG-based Perfusion Imaging in Acute Compartment Syndrome

This is a prospective observational study of patients with suspected Acute Compartment Syndrome. The primary objective of this work is to determine whether intensity changes associated with the NIRST signal, reflecting oxy- and deoxy-hemaglobin and water concentrations or ICG fluorescence signal, reflecting tissue perfusion, can be associated with development of Acute Compartment Syndrome and identification of at-risk soft tissue and muscle.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Clinical suspicion of acute compartment syndrome based on orthopaedic provider assessment. Clinical suspicion would be based upon the presence of one or more of these findings:

  * Pain out of proportion to visible findings
  * Escalating doses of pain medication
  * Pain with passive stretch of toes and/or fingers
  * Pallor, paresthesias, pulselessness
  * Tense soft tissues
  * High energy tibia or forearm fracture
* Provision of informed consent

Exclusion Criteria:

* History of allergy to ICG and/or iodine
* Pregnant women or nursing mothers
* Any patient with an open wound for whom NIRST device cannot be applied \>4cm from the open wound will be excluded from NIRST imaging.
New Echocardiographic Parameters for Prediction of Response to Cardiac Resynchronization Therapy

Echocardiography parameters for cardiac dyssynchrony had no predictive value in current multicentric prospective studies concerning cardiac resynchronization therapy. Comprehensive echocardiography and new parameters as 2D and 3D strain, as well as 3D echo have been analyzed, but their definite value has not been proven yet.

In patients with severe heart failure, delays in the conduction system can result in asynchronous contraction impairing cardiac function. By implantation of pacemaker systems with three leads located in atrium, right ventricle and coronary sinus, tracing back this deranged contraction closer to the physiological excitation propagation is aimed (cardial resynchronization therapy \[CRT\]). Despite patient selection according to the guidelines nearly one-third of the patients do not profit, neither clinically nor echocardiographically, from an implanted CRT-device. In addition, recent studies have shown that no reliable prediction may be achieved with the known echocardiographic parameters of dyssynchrony, regarding the response to such therapy. The aim of this study is therefore to assess new echocardiographic parameters, which may allow to better predict CRT response.

Eligibility Criteria:
Inclusion Criteria:

* congestive heart failure, dilated cardiomyopathy, indication for implantation of a CRT-device according to the European Society of Cardiology (ESC)

Exclusion Criteria:

* persons who are incapable of giving informed consent
* acute heart attack
* arrhythmia during the examination (such as atrial fibrillation and frequent VES)
* state after STEMI with an extended scar
* inotropic drug therapy
* pre-existing permanent pacemaker stimulation
Eccentric Exercises for Shoulder Pain

Patients will be randomly assigned to one of two groups using a random number generator. Group 1 will be provided with in-office instruction of standard of care eccentric exercises for rotator cuff tendinopathy. Group 2 will be provided with in-office instruction as well as a instructional exercise video source (DVD) to take home as a reminder on how to perform two specific standard of care eccentric exercises for rotator cuff tendinopathy. Each group will be given a card to track adherence to the standard of care eccentric exercise routine as measured only by the days that they accomplish their exercises. Study exercise diary will be collected after 12 weeks of treatment. Eccentric exercises are taught as part of standard of care for rotator cuff tendinopathy.

DoD beneficiaries age 18 or older will be recruited from the clinics at the Mike O'Callaghan Federal Medical Center (MOFMC). Subjects meeting the inclusion/exclusion criteria will be offered an opportunity to participate:

Screening Visit:

* Obtain signed Informed Consent Document and HIPAA Authorization.
* Verify inclusion/exclusion criteria

Visit 1 (may occur same day as Screening Visit):

* Subjects will be randomly assigned to one of two groups by the Research Coordinator using a random number generator, thus the Investigators will be blinded to the group assignments:

  * Group 1: in-office instruction of the standard of care eccentric exercise regimen for rotator cuff tendinopathy.
  * Group 2: in-office instruction of the standard of care eccentric exercise regimen for rotator cuff tendinopathy and an instructional exercise video source (DVD).
* Subjects will be given a study exercise diary to track adherence to the standard of care eccentric exercise routine.

Visit 2 (12 weeks post Visit 1):

• Study exercise diary will be collected to assess adherence. If the subject is unable to come in, they can return the study exercise diary via mail, or electronic mail.

Eligibility Criteria:
Inclusion:

* DoD beneficiary patient 18 years or older
* Diagnosis of chronic (\>30 days) shoulder pain of any etiology (traumatic vs over-use injury)

Exclusion:

* Patients \< 18 years of age
* Patients with acute injury (fracture or injury within 30 days)
* Patients unable to accomplish eccentric exercise regimen without assistance
* Patients unable to view DVD
* Pregnant women
* Patients unable to read and/or understand English
An Evaluation of Polymer Based Fiducials for Use in Imaging Patients Receiving Treatment for Prostate Cancer

This trial is to determine if prostate target delineation obtained through an ultrasound based system is equivalent in accuracy to the MRI image fusion, and if alignment correction vectors obtained from ultrasound imaging are of equivalent accuracy to orthogonal X-ray imaging for daily prostate positioning.

The investigators will also be assessing the following:

1. Whether polymer-based markers can be adequately visualized on daily stereoscopic imaging compared to gold seed markers.
2. Whether polymer-based markers are visible on ultrasound imaging.
3. To determine if the polymer-based marker produces fewer artifacts on treatment planning CT scans than gold markers.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed prostate adenocarcinoma
* diagnosis of low risk or intermediate risk prostate cancer
* approved for proton therapy treatment at CDH ProCure Proton Therapy Center
* prescribed and consented for the placement of fiducial markers into the prostate as part of the standard treatment procedure
* capable of receiving an MRI of the pelvis region for prostate localization
* the prostate gland of eligible patients must be capable of imaging from an anterior trans-abdominal ultrasound as determined by the treating investigator
* must be fluent in the English language; must be able to provide written study consent

Exclusion Criteria:

* Evidence of a large TURP defect per investigator discretion
* previous prostate cancer surgery including prostatectomy, hyperthermia and cryosurgery
* previous pelvic radiation for prostate cancer
* current grade 2 or above incontinence
* history of orthopedic procedures in the area of the treatment, specifically no prior hip replacement or procedure in which metallic or high density material remains which would be within stereoscopic kilovoltage imaging area
* prior permanent placement of any metallic or high density material within the prostate
* known allergy to ultrasonic gel
Clarithromycin Versus Azithromycin in Treatment of Mild COVID-19 Infection

The current study was conducted at Qena Governorate, Egypt, during the period from May 2020, to July 2020. The study included 305 COVID-19 cases diagnosed by PCR, patients were randomly assigned to one of three study limps, Azithromycin 500 mg/24 h for 7 days, Clarithromycin 500 /12 h for 7 days, or a control group with no antibiotics, All three groups received only symptomatic treatment for control of fever and cough

The current study was conducted at Qena Governorate, Egypt, during the period from May 2020, to July 2020. The study included 305 COVID-19 cases diagnosed by PCR, patients were randomly assigned to one of three study limps, Azithromycin 500 mg/24 h for 7 days, Clarithromycin 500 /12 h for 7 days, or a control group with no antibiotics, All three groups received only symptomatic treatment for control of fever and cough.

All study participants underwent full clinical evaluation including duration of fever, cough, dyspnea, anosmia or GIT symptoms, C-reactive protein (CRP), serum ferritin, D-dimer, Complete blood count (CBC), non-contrast chest computed tomography (CT) which was repeated 2 weeks after the start of treatment.

The Azithromycin group included, 107 patients, mean age 45.8 ±18 years, 73 male and 34 female, the Clarithromycin group included 99 patients mean age 46.1±19 years, 68 males and 31 female, the control group included 99 patients, with mean age 41.1 ± 18 years, 73 male and 28 female.

Eligibility Criteria:
Inclusion Criteria:

* COVID-19 cases
* Oxygen saturation \> 93%
* Age \>18 years

Exclusion Criteria:

* Patients \<18 years,
* patients with Oxygen saturation \< 93%, patients with
* Diabetes mellitus or
* heart failure,
* patients on chemotherapy or immunosuppressive therapy
I-Gel in Out-of-hospital Cardiac Arrest in Norway

The main objective of this trial is to compare the effectiveness of a newer supraglottic airway method (the i-Gel), compared to current airway management practice in out-of-hospital cardiac arrests treated by Norwegian ambulance services.


Eligibility Criteria:
Inclusion Criteria:

* Out-of-hospital cardiac arrest patients requiring and receiving advanced airway management on ambulance missions. Advanced airway management is defined as the attempted insertion of an airway adjunct (I-Gel, laryngeal tube or ETI) or the administration of ventilatory assistance/support (including bag-mask ventilation (BMV) or other ventilatory support.
* Adult patients (\> 18 years).

Exclusion Criteria:

* Non-adult patients / minors (\< 18 years).
* Traumatic cardiac arrest.
A Study to Evaluate AZD2693 in Participants Who Are Carriers of the PNPLA3 148M Risk Allele With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis

A Study to Evaluate the Efficacy, Safety and Tolerability of AZD2693 given by subcutaneous injection in adult participants with non-cirrhotic non-alcoholic steatohepatitis with fibrosis and who are carriers of the PNPLA3 148M Risk Allele


Eligibility Criteria:
Key Inclusion Criteria :

Participants are eligible to be included in the study only if all the following criteria apply:

Age

1. Participant must be 18 to 75 years of age (inclusive) at the time of signing the informed consent.

   Type of Participant and Disease Characteristics
2. Participants who are carriers for the PNPLA3 rs738409 148M risk allele.
3. Participants with histological evidence of NASH based on central pathologist evaluation of a liver biopsy obtained up to 6 months before randomisation, or during screening, fulfilling both criteria:

   1. Definitive NASH with NAS ≥ 4 with ≥ 1 in each component (ie, steatosis, lobular inflammation, and ballooning).

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   1. Presence of fibrosis stage F2 or F3 according to the NASH CRN fibrosis staging system based on central pathologist evaluation.

Key Exclusion Criteria :

Participants are excluded from the study if any of the following criteria apply:

Medical Conditions

1. Liver disease of other aetiologies (eg, alcoholic steatohepatitis; drug-induced, viral or autoimmune hepatitis; primary biliary cirrhosis; primary sclerosing cholangitis; hemochromatosis; alpha-1 antitrypsin deficiency; Wilson's disease)
2. History of cirrhosis and/or hepatic decompensation, including ascites, hepatic encephalopathy, or variceal bleeding.
3. Historical persistent or pre-existing renal disease marked by eGFR \< 40 mL/min/1.73 m2 (as defined by Kidney Disease Improving Global Outcomes guidelines).
4. Confirmed platelet count outside the normal range at the screening visit.
5. Any of the following confirmed at the screening visit:

   1. ALT \> 5.0 × ULN
   2. TBL \> 1.5 mg/dL (TBL \> 1.5 mg/dL is allowed if conjugated bilirubin is \< 1.5 × ULN)
   3. INR \> 1.3
   4. ALP \> 1.5 × ULN (unless the ALP elevation is not from hepatic origin as determined by a bone-specific ALP)
Single Doses GSK159797 On Patient Safety And Lung Function In Patients With Mild To Moderate Asthma

This study was designed to test safety aspects and effects on lung function of a new dry powder version of GSK159797 for asthmatic subjects to inhale. This will allow comparison with previous studies which have only used inhalation of the drug as a vapour.


Eligibility Criteria:
Inclusion criteria:

* Subjects with mild to moderate stable asthma but no other lung problems.
* Male subjects or females who are not able to get pregnant (e.g. post-menopausal or surgically sterile).
* Non-smokers.
* Subjects that show a measurable improvement in the function of their lungs after a single dose of salbutamol.

Exclusion criteria:

* Any significant illness.
* Subjects with heart problems.
* Subjects who have had a cold or chest infection 2-4 weeks prior to the study.
* Subjects who take medication for their asthma, or other conditions, not compatible with the study.
A Research Study Looking at How the Medicine NNC0194-0499 Behaves in Japanese and Non-Asian Men

This study looks at how a new medicine called NNC0194-0499 works in the body of Japanese men and non-Asian men.

Japanese participants will either get NNC0194-0499 or placebo - which treatment participants get is decided by chance. Non-Asian participants will get NNC0194-0499.

Participants will get 1 or 2 injections of the study medicine. It will be injected with a needle into a skin fold on the stomach.

The study will last for a maximum of 66 days. Participants will have 8 scheduled visits with the study doctor. For 1 of the visits participants will stay at the clinic for 6 days (5 nights).

The study includes blood sampling. Participants will not be able to take part in the study if the study doctor thinks there is a risk for participants health.


Eligibility Criteria:
Inclusion Criteria:

* Male, aged 20-55 years (both inclusive) at the time of signing informed consent
* For Japanese subjects only, both parents of Japanese descent. For non-Asian subjects only, both parents of non-Asian descent
* Body mass index (BMI) between 23.0 and 34.9 kg/m\^2 (both inclusive)
* Body weight greater than or equal to 60 kg

Exclusion Criteria:

* Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
* Subjects aged above or equal to 40 years with an estimated 10-year atherosclerotic cardiovascular disease risk (as described in the American College of Cardiology and the American Heart Association Prevention Guideline) greater than or equal to 5 percentage
Effect of Milk Oligosaccharides and Bifidobacteria on the Intestinal Microflora of Children With Autism

The purpose of this study is to determine the tolerability of dietary supplements and if these supplements can promote a healthy bacterial environment in the intestines of children with autism spectrum disorders and gastrointestinal complaints.

This study investigates the feasibility, tolerability, and effects of a dietary supplement on the intestinal flora of children with autism spectrum disorders. This study is divided into two parts, each five weeks long, with a two week break in between. During one part of the study, a prebiotic (milk oligosaccharides from bovine colostrum) will be given. During the other part of the study, the synbiotic composed of the prebiotic and probiotic (bifidobacterium infantis) will be given. Stool will be analyzed at the end of each study arm to determine content of bifidobacteria.

On May 8, 2018, we updated the study start and completion dates to the actual (instead of anticipated) dates.

On May 30-31, 2019, we updated the study results section.

Eligibility Criteria:
Inclusion Criteria:

* Autism
* Diarrhea and/or constipation

Exclusion Criteria:

* Milk protein or other documented food allergy
* Lactose intolerance
* Compromised Immunity
* GI conditions (inflammatory bowel disease, celiac disease, short gut, etc.)
* Systemic steroid, antifungal, or antibiotic use within a month of starting the study
* Failure to thrive
* Medically prescribed diets or supplements (including probiotic use within the past month).
* Vegetarian or dairy restricted diet
* Other medical conditions (seizures, genetic disorders, liver/pancreatic disease, cystic fibrosis, etc.)
* Medications that interfere or alter intestinal motility or microbiota composition.
* Full scale intelligence quotient (IQ) \<40
Clinical Study to Evaluate Pharmacokinetics and Safety of PF-06700841 After Single and Multiple Oral Doses as Modified Release Formulations

The purpose of the study is to evaluate the pharmacokinetics (PK), safety, and tolerability of PF-06700841 following single and multiple oral doses as modified release (MR) formulations in healthy, adult participants under fasted and fed conditions. The objective of Part A is to evaluate the relative bioavailability and food effect of 2 new MR formulations, MR1 and MR2. The objective of Part B is to evaluate the PK and safety/tolerability of MR3 formulation following multiple dose administration over a 7-day period. Overall, results from both parts will facilitate further development of an MR formulation for future clinical studies.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female participants between 18 -55 years of age.
* BMI of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb).
* Participants who are willing and able to comply with all scheduled visits, treatment
* plan, laboratory tests, lifestyle considerations, and other study procedures.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Conditions that affect drug absorption (e.g., gastrectomy cholecystectomy)
* History of venous and arterial thrombosis (ie, deep venous thrombosis, pulmonary embolism) or hereditary clotting disorders (in first degree immediate relatives)
* Positive urine drug test.
* History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.
* History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours