cyrilzakka/clinical-trials huggingface dataset:
Safety Study of Tipranavir Co-administered With Low-dose Ritonavir (TPV/r) in Patients With Advanced HIV-1 Infection and Limited Treatment Options

This study evaluated the safety and tolerability of tipranavir to improve treatment options for HIV type 1-infected patients who have been previously treated and whose treatment is no longer effective.

The purpose of this open label study is to assess the safety and tolerability of tipranavir co-administered with low-dose ritonavir (500 mg tipranavir/200 mg ritonavir BID) in HIV-1 infected patients who are triple antiretroviral class experienced with at least two previous PI-containing regimens.

The safety assessment will be performed by evaluating:

* The frequency of treatment-emergent adverse events (AEs) , all serious adverse events (SAEs), and additional safety laboratory parameters.
* The occurrence of PI class-specific AEs, such as hemorrhage, dyslipidemia, hepatic events, hyperglycemia, pancreatitis, and rash.

The efficacy assessment will be performed by evaluating:

* The quantity of HIV-1 RNA
* The CD4 cell count.

Study Hypothesis:

The purpose of this open label study is to assess the safety and tolerability of tipranavir co-administered with low-dose ritonavir (500 mg tipranavir/200 mg ritonavir BID) in HIV-1 infected patients who are triple antiretroviral class experienced with at least two previous PI-containing regimens.

Comparison(s):

N.A.

Eligibility Criteria:
Inclusion Criteria:

1. Triple antiretroviral class experienced patients with at least two previous PI-based regimens, who had failed or are intolerant to currently approved HIV-1 treatments
2. Age \>= 18 years
3. Patient is willing to use an effective barrier method of contraception for the duration of study participation and up to three months thereafter
4. Patient voluntarily provides written informed consent to participate, in compliance with local law

Exclusion Criteria:

1. Hypersensitivity to active ingredients or any of the excipients in tipranavir or ritonavir
2. Required use of restricted medications
3. Female patients of childbearing potential who:

   * Have a positive pregnancy test at baseline or
   * Are breast feeding.
4. Any medical condition(s) which, in the opinion of the investigator, would interfere with the patient´s ability to participate in or adhere to the requirements of this protocol.
5. Use of other investigational drugs, within 30 days prior to TPV/r initiation and for the duration of study participation.
6. Hepatic impairment(\*) evidenced by the following baseline laboratory findings:

   * AST or ALT \>5X upper limit of normal (ULN) or total bilirubin \>3.5X ULN or
   * AST or ALT \>2.5X ULN and total bilirubin \>2X ULN

(\*) Patients with liver enzymes outside this range will be restricted from participation in this safety study until more data become available from ongoing phase III clinical studies.
A Phase I, Open Interaction Study Between GLPG0634 and Midazolam in Healthy Subjects

This will be a drug-drug interaction study to evaluate the effect of multiple oral doses of GLPG0634 on the single dose pharmacokinetic profile of midazolam administered in fasted normal healthy males. Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions: on Day 1, before dosing with GLPG0634 and on Day 8, after multiple oral doses of GLPG0634 (daily for 7 days).

Also, the safety and tolerability of multiple oral doses of GLPG0634 co-administered with midazolam in healthy male subjects will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* male, between 40 and 60 years of age, inclusive
* within BMI range 18 to 30 kg/m2, inclusive

Exclusion Criteria:

* Any condition that might interfere with the procedures or tests in this study
* Drug or alcohol abuse
* Smoking
A Study of HRS2543 in Patients With Advanced Tumors

To assess the safety and tolerability of HRS2543 in patients with advanced tumors and to determine the recommended phase II dose (RP2D) of HRS2543


Eligibility Criteria:
Inclusion Criteria:

1. 18-70 years of age, both male and female
2. non standard treatment, invalid the standard treatment or refuse to receive standard treatment in patients with advanced tumors diagnosed by pathology
3. the Eastern Cooperative Oncology Group （ECOG） General status (performance status, PS) of 0-1
4. the expected lifetime ≥ 3 months
5. Has at least one measurable lesion as defined by RECIST v1.1
6. Written informed consent is provided by signing the informed consent form

Exclusion Criteria:

1. Any previous anti-tumor treatment
2. The toxicity caused by any previous anti-tumor treatment has not recovered to ≤ grade 1
3. Any other anti-tumor treatment is planned during the study treatment
4. After imaging diagnosis, there were brain tumor lesions
5. According to the judgment of the researcher, there are factors that can not swallow, chronic diarrhea and intestinal obstruction or other factors that can significantly affect the absorption, distribution, metabolism or excretion of drugs
6. Active heart disease was present within 6 months before the first administration of the study
7. Other malignancies occurred within 5 years before the first administration of the study
8. Active HBV or HCV infection
9. The subject had a history of immune deficiency
10. According to the judgment of the researcher, there are concomitant diseases that seriously endanger the safety of the subjects, confuse the analysis of the test results, or affect the subjects to complete the study
Clinical Validation of New Injection Molded Flocked Nasopharyngeal Swabs in Response to the COVID-19 Pandemic

The SARS-CoV-2 pandemic has resulted in an international shortage of the nasopharyngeal (NP) swabs used to collect sample for virological testing. This shortage has become a crisis as testing capacity is growing, and threatens to become the bottleneck at University of Virginia Health System and in the Commonwealth of Virginia, as it already is in other testing centers. To resolve this crisis, a team in the Clinical Microbiology Laboratories at University of Virginia Medical Center has been working closely with biomedical engineers in the University of Virginia (UVA), School of Engineering and with high volume domestic manufacturers developing injection molded polypropylene flocked nylon NP swab.

This prototype will be tested for non-inferiority relative to existing, already validated NP swabs ("control swab") for purposes of molecular microbiology: i.e. the polymerase chain reaction (PCR) tests used for virological testing for SARS-CoV-2. Specifically, the nasopharynx of patients with Covid-19 and patients under investigation (PUI) for Covid-19, the disease caused by SARS-CoV-2, will be swabbed using a prototype swab and a control swab (the standard of care swab), and test for concordance of SARS-CoV-2. In all cases the swab will be transported in validated FDA cleared viral transport medium (VTM) as per standard operating procedure at University of Virginia Medical Center.


Eligibility Criteria:
Inclusion Criteria:

* Individuals presenting to the site for clinical care will be evaluated for clinical screening for Covid-19 testing or other respiratory infection testing.
* Individuals felt identified clinically as needing Covid-19 testing may be approached for study participation.
* Individuals already under clinical care that have tested positive for Covid-19 will be approached for study participation.
* Volunteer health care workers who have approached the Principal Investigator

Exclusion Criteria:

* Known thrombocytopenia of \<50,000 platelets/μl (risk of mild bleeding).
* Individuals presenting with an anatomically altered nasal cavity.
* Pregnant (self-reported)
* No other patients will be specifically excluded.
Integrated Multidisciplinary Patient and Family Advance Care Planning Trial

The purpose of this study is to compare ways to engage sick patients and their family members in Advance Care Planning (ACP) discussions. Two pathways will be tested, discussions using a Nurse Navigator led pathway versus usual care.

This study is a randomized, pragmatic, comparative effectiveness trial for determining better ways to engage multimorbid patients and their family members in Advance Care Planning through a Nurse Navigator led pathway versus usual care. Investigators propose to utilize Zelen's design (a more recent label/generalization for this type of design is the cohort multiple randomized controlled trial (cmRCT), a pragmatic clinical trial design whereby all participants are randomized prior to informed consent, and then only patients randomized to the interventional arm are approached for consent and subsequently enrolled in the intervention group.

Eligibility Criteria:
Inclusion Criteria:

* Aged 65 or older patient within the Wake Forest/Cornerstone ACO
* Have seen their primary care provider within the Wake Forest/Cornerstone network in the past 12 months
* English speaking
* No documented Advance Directive in the EHR
* Impairments in either physical function, cognition, and/or frailty

Exclusion Criteria:

* No available proxy (e.g. in setting of cognitive impairment)
* Severe/advanced dementia
* Moderate to severe hearing loss
* Non-English speaking
* No phone number available for patient
The Paleolithic Diet and Male Factor Infertility

Prospective studies concerning diet and male fertility are lacking. Observational studies suggest that a diet rich in fruits, vegetables and meats may be associated with higher sperm counts. The investigators wanted to see if a "paleolithic diet" consisting of meat, fish, fruits vegetables and nuts and lacking grains, legumes and dairy products can improve sperm counts.


Eligibility Criteria:
Inclusion Criteria:

* men with male infertility
* willingness to make dietary change for three months
* willingness to be blinded to sperm test results until the end of the experiment

Exclusion Criteria:

* High fever or abdominal or scrotal surgery during three months prior to intervention
* Change in diet, drinking or smoking habits in three months prior to intervention
* regular consumption of more than two servings of alcohol a day
* background ailment preventing dietary change
Efficacy and Safety of Recombinant Botulinum Toxin Type A (Eveotox) for Injection to Treat Moderate to Severe Glabellar Lines

This is a Phase 3 clinical study to evaluate the efficacy, safety, and immunogenicity of single/repeated injections of Eveotox in the treatment of moderate to severe glabellar lines. The study consists of Study Part 1 (randomized double-blind controlled study) and Part 2 (open-label study). Part I is a multicenter, randomized, double-blind, single-injection, active-controlled and placebo-controlled study to evaluate the efficacy, safety, and immunogenicity of Eveotox in the treatment of moderate to severe glabellar lines; Part 2 is an open-label study to evaluate the efficacy, safety, and immunogenicity of repeated injections of Eveotox in the treatment of moderate to severe glabellar lines.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects who are between 18 to 65 years of age
* Moderate or severe glabellar lines during maximum frown based on the Investigator Global Assessment Frown Wrinkle Severity scale
* Moderate or severe glabellar lines during maximum frown based on the Patient Frown Wrinkle Severity scale
* Willing and able to follow all trial procedures, attend all scheduled visits, and successfully complete the trial

Exclusion Criteria:

* Subjects who have a history of oversensitivity to the Botulinum Toxin A type or other components of the study drug
* Subjects who have implanted any permanent materials in the glabellar area or received semi-permanent fillers within the first 2 years of screening
* Subjects with active skin infections at the injection site or systemic skin disease, which the investigator judges can affect the evaluation of efficacy or safety
* Subjects who have a history of injecting drugs similar to the study drug within 6 months prior to selection or are foreseen to use during the study period
Pressure Dependent Tracheal Obstruction in Copd Patients

Background. Do pressure dependent tracheal obstructions (PDTO) often seen during bronchoscopy in COPD patients affect pulmonary function tests and breathing symptoms? Method. Model study. A garden hose was compressed from one side to simulate the posterior wall of the trachea bulging into the lumen. For two obstruction lengths - 3 cm and 12 cm, the hose was increasingly compressed in eight steps. Resistance was measured at each step for airflows 1 l/s through 9 l/s, and digital photos of the luminal area were taken which were used by a computer to estimate the cross sectional area reduction and the corresponding distance between the bulging (posterior)and the opposite (anterior) wall (AP-distance).

Patient study. 104 stable COPD patients studied by pulmonary function tests and bronchoscopy. The tracheal obstruction was observed during forced expiration and cough, and the cross sectional area reduction was estimated using the results from the model study.


Eligibility Criteria:
Inclusion Criteria:

* copd

Exclusion Criteria:

* clinical evidence of malignant disease
* not able to be subjected to bronchoscopy
Environmental Game After Appendicitis Surgery

This study was conducted to determine the effect of environmental play and mobilization on fear and pain levels of children aged 6-12 years who had acute appendicitis surgery.

It was conducted with children aged 6-12 years in the postoperative period in a randomized controlled manner. Children in the intervention (n:50) group were mobilized by playing environmental games.The children in the control group (n:50) underwent routine mobilization of the clinic.

The data were collected with the "Child Follow-up Form", which was created to evaluate the child's demographic characteristics, physiological parameters, pain and fear.

Eligibility Criteria:
Inclusion Criteria:

* Being between 6-12 years old,
* Being open to communication and cooperation,
* No visual or hearing impairment,
* Appendectomy surgery,
* First mobilization after surgery.
* Parent's willingness to participate in the study can be sorted.

Exclusion Criteria:

* Having a mental or neurological disability,
* Children with hearing and vision impairment
Consumption of Eggs Rich in Lutein and Omega-3 Fatty Acids on the Macular Pigment

This study is to determine the impact of the consumption of eggs rich in lutein/zeaxanthin from lucerne protein concentrate and DHA from microalgae on the plasma levels of these compounds but also on the macular pigment optical density, whose elevation may be beneficial in the prevention of Age-related Macular Degeneration (AMD).


Eligibility Criteria:
Inclusion Criteria:

* healthy subjects (male or female),
* 18 to 55 years
* Having signed the consent form,
* Susceptible to accept the stresses generated by the study,
* Insured.

Exclusion Criteria:

* Corrected Visual Acuity \<8/10th,
* History of cardiovascular disease, specifically coronary heart disease,
* Characterized dyslipidemia

  \* Total cholesterol ³ 2.50 g / L, and / or triglycerides ³ 2.00 g / L
* Lipid-lowering treatment,
* Current smoking or person who stopped smoking less than 6 months
* Cataract or cataract surgery,
* Diabetes
* Body Mass Index (BMI)\> 30 kg/m2,
* Taking food supplements in the 3 months preceding the start of the study (carotenoids, omega-3 fatty acids, phytosterols),
* Regular consumption in the three months preceding the start of the study products with added phytosterols.
* Regular consumption of high fatty fish or shellfish rich in omega-3 (4x a week or more): salmon, sardines, mackerel, herring, trout, tuna, red mullet, sea bass, bream, farmed turbot, mussels, squid / squid, anchovies.
* Allergy to eggs
* Dieting
* Difference significant weight over the last 3 months (\> 3 kg)
* Inability to understand or adhere to the protocol
* Persons deprived of liberty
* People in a position to judicial protection
* Pregnant Women.
Feasibility Trial of Extracorporeal Iron Purification in Patients With Myelodysplastic Syndrome or Myelofibrosis

In transfusion-dependent myelodysplastic syndromes patients, regular blood transfusions lead to iron overload, which can cause organ damage, hormonal imbalances, and increased infection risk, ultimately impacting patient survival. Standard oral iron chelation therapies can be intolerable for some patients due to adverse effects. The MEX-CD1 device (class III) could potentially offer an alternative for these patients by reducing serum iron levels through a novel, extracorporeal approach.

MEXIRON clinical investigation focuses on the use of MEX-CD1, a medical device designed for extracorporeal chelation therapy to reduce serum iron overload in patients suffering from transfusion-dependent myelodysplastic syndromes (MDS) and myelofibrosis.

MEXIRON aims to evaluate the device's use feasibility, safety, and effectiveness in reducing serum free iron levels. Transfusions needs, patient experience and quality of life are also assessed.

Each enrolled patients will undergo three low-volume continuous veno-venous haemodialysis cycles within one week.

Following the three- haemodialysis cycles, patients will be monitored through on-site follow-up visits at 7 days, 28 days, and 90 days post-treatment to assess long-term effects.


Eligibility Criteria:
Inclusion Criteria:

* Patient followed for myelodysplastic syndrome or myelofibrosis.
* Patient with platelet count ≥50 giga/L at inclusion.
* Patients with severe anemia and hemoglobin \<70 g/L at baseline.
* Patient with intolerance or contraindication to oral or subcutaneous chelation therapy.
* Ferritinemia \>1000 µg/L or hepatic iron concentration ≥7 mg/g or cardiac T2\* \<20 ms at inclusion.
* Patient able to understand (French-speaking) and comply with protocol, having signed informed consent.

Exclusion Criteria:

* Patients with primary hemochromatosis (transferrin saturation coefficient CS-Tf \> 45%).
* Patients with a contraindication to the use of MEX-CD1: weight \< 30 kg, iron deficiency.
* Patients with a known allergy or contraindication to heparin or citrate.
* Patients undergoing azacitidine or other chemotherapy (or considered as such) for myelodysplastic syndrome or myelofibrosis.
* Patients with indications for allogeneic bone marrow transplantation.
* Patients with a known allergy to shellfish (MEX-CD1 contains chitosan of animal origin) or to one of the other components of MEX-CD1.
* Patients with a peripheral vascular access that is difficult to access or that needs to be preserved.
* Patients participating in other interventional research that could interfere with the results of the study.
* Patients under legal protection or unable to express their consent.
* Patients under psychiatric care.
* Patient deprived of liberty by judicial or administrative decision.
* Pregnant or breast-feeding women.
Japanese Phase I of GSK1605786

This is an double-blind, single dose, four-period, crossover study in Japanese healthy male volunteers to assess the pharmacokinetics and safety/tolerability of single doses of GSK1605786A. Approximately 24 subjects will receive three treatments of 250, 500, and 1000mg GSK1605786 under fasted conditions or 500mg after food intake plus placebo in a dose ascending crossover design. Serial pharmacokinetic samples will be collected following each dose and safety assessments will be performed. The pharmacokinetics and dose proportionality of GSK1605786 after single oral doses of GSK1605786 at the dose levels of 250mg, 500mg and 1000 mg under fasted conditions will be assessed. In addition, a comparison will be made between the pharmacokinetics of GSK1605786 under fed and fasted conditions.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese as
* Japanese defined as being born in Japan, having four ethnic Japanese grandparents, holding a Japanese passport or identity -Male between 20 and 55 years of age inclusive, at the time of signing the informed consent.
* Body weight =\>50kg and BMI within the range 18.5 - 25 kg/m2 (inclusive).

Exclusion Criteria:

- Known coeliac disease or positive serologic testing for anti-tTG antibodies (required to screen for undiagnosed celiac disease)
Efficacy and Safety of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)

The purpose of this study is to demonstrate the effect of IgPro10 on the prevention of serious bacterial infections in patients with primary immunodeficiency.

As secondary endpoints the rate of overall infections, the tolerability and safety of IgPro10 are studied.

A part of the patients are participating in a pharmacokinetic substudy.


Eligibility Criteria:
Key Inclusion Criteria:

* Patients with primary immunodeficiency
* Patients who have received stable IVIG therapy at 3- or 4-weekly intervals for at least 6 months

Key Exclusion Criteria:

* Newly diagnosed PID
* Allergic reactions to immunoglobulins or other blood products
* Administration of steroids (daily ≥ 0.15 mg prednisone equivalent/kg/day) or other immunosuppressive drugs
* Concomitant diseases such as hypoalbuminemia, protein-losing enteropathies, kidney diseases with proteinuria, malignancies of lymphoid cells (e.g. lymphocytic leukemia), and recent history of migraine
* History of cardiac insufficiency (NYHA III/IV), cardiomyopathy, congestive heart failure, severe hypertension
Photomedicine Project 14: PBMT for Performance Enhancement in SOF

Special Operations Forces (SOF) train continually to maintain peak performance. Thus, they are nearly always in a state of recovery, and in need of noninvasive therapies to address the taxing workload. Photobiomodulation therapy (PBMT) is a noninvasive treatment where a low-level laser is applied to the body to enhance healing, recovery, and performance. Army Tactical Human Optimization Rapid Rehabilitation and Reconditioning (THOR3) provides a consistent avenue for implementation of PBMT as a modality. Studies in athletes have shown performance and recovery benefits with pre-and post-workout focal application of PBMT. While there is less evidence on the potential cognitive/behavioral effects of a systematic application of PBMT, self-reported fatigue has also been found to be significantly lower in groups with focal PBMT application as compared to placebo. Further, PBMT research in healthy military tactical athletes is limited. PBMT may be a promising tool for enhancing physical performance by accelerating musculoskeletal and psychological recovery in the SOF population. The investigators aim to study the physiologic and behavioral effects of PBMT application post-exercise on performance in SOF Operators.

The Intent: The investigators propose to conduct a single-blinded randomized-control trial with sham control to investigate the effectiveness of providing PBMT post physical training in a SOF population.

The specific aims of this study are to:

1. Analyze and describe the physiologic effects, if any, of PBMT application post-exercise in Special Forces Operators undergoing coach-led training.
2. Analyze and describe the behavioral effects, if any, of PBMT application post-exercise in Special Forces Operators undergoing coach-led training.
3. Evaluate the overall clinical utility of focal PBMT subsequent to physical training in a US Army SOF, tactical athlete population.


Eligibility Criteria:
Inclusion Criteria:

* Active-Duty Special Forces Personnel (18-series)
* Able to read and understand English language for consent purposes
* Able to commit to study intervention and follow-up
* Able to participate in THOR3 coach-lead training, without restriction

Exclusion Criteria:

* Obese (body fat \> 25%)
* Cardiovascular disease
* Use of select medications (e.g., statins, diuretics, hypertensive agents)
* Female
* Tattoo in treatment area (body region)
* Diagnosis with porphyria (light induced allergy) or photosensitive eczema
* Current use of medications associated with sensitivity to heat or light (e.g., amiodarone, chlorpromazine, doxycycline, hydrochlorothiazide, nalidixic acid, naproxen, piroxicam, tetracycline, thioridazine, voriconazole)
* Use of pacemaker/underlying cardiac disease
* Diagnosed with autoimmune disease(s)
* Albinism
* Peripheral Neuropathy