cyrilzakka/clinical-trials huggingface dataset:
Assessing Physical Function in Sickle Cell Patients Taking Voxelotor

Voxelotor is a novel hemoglobin polymerization inhibitor which has been demonstrated to reduce hemolysis and improve hemoglobin levels. There have been numerous studies examining the clinical impact of voxelotor in sickle cell disease (SCD) patients, but there are few published reports on the effects of treatment on physical function in patients with SCD. The hypothesis to be tested is that anemic SCD patients will have improvements in performance after 6 months of voxelotor treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female,
4. aged 18-65 years
5. Diagnosis of sickle cell disease with HbSS, HbSc, HbS-beta thalassemia genotypes
6. Hemoglobin level of 6 g/dL - 10.5 g/dL
7. Between 0 and 10 vaso-occlusive (VOC) episodes in previous 12 months
8. Ability to take oral medication and be willing to adhere to the voxelotor regimen
9. For females of reproductive potential, they will be educated to avoid pregnancy during study period and for one month after due to limited data surrounding pregnancy and voxelotor
10. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner
11. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration

Exclusion Criteria:

1. Hemoglobin results \< 6 g/dL or \> 10.5 g/dL
2. Patients receiving hydroxyurea who have had a dose change within the prior 3 months
3. Females who are breastfeeding or pregnant
4. Patients who are receiving regularly scheduled blood (RBC) transfusion therapy (also termed chronic, prophylactic, or preventive transfusion) within 30 days of 6MWT
5. Any form of hepatic dysfunction as demonstrated by alanine aminotransferase (ALT) \>4 × ULN or Child-Pugh Class C
6. Acute kidney injury or chronic renal disease with estimated glomerular filtration rate\<30mL/min/1.73 m2
7. Current or previous diagnosis of malignancy within the last two years excluding local therapy for non-melanoma skin malignancy
8. Unstable cardiopulmonary disease within the last 6 months prior to study enrollment
9. Any conditions including behavioral or medical that in the opinion of the investigator, may negatively impact informed consent, participation and study interpretation
10. Current use of commercially available voxelotor
11. Prior hypersensitivity to voxelotor or its excipients
12. Patients with baseline gait and other physical impairments that would limit 6MWT and other functional assessment at discretion of the investigator
13. Patients who on day of assessment present with vaso-occlusive crisis or rate their pain greater than 6 on a scale of 1-10 using the Numeric Rating Scale will not be assessed that day and re-screened at the investigator's discretion.
Evaluation of a 4mmx32G Pen Needle for Injection of Basal Insulin Doses Above 40 Units

The primary purpose of this study is to demonstrate that the BD 4mm x 32G Ultra-Fine Nano pen needle provides equivalent glycemic control to the BD 8mm x 31G Ultra-Fine short pen needle as measured by fructosamine (FRU) among Lantus®, Levemir®, and/or NPH users taking one or more single daily injections of greater than 40 units of insulin.

Glycemic control, injection pain, leakage, preference, comfort, and other parameters will be compared between the 4mm x 32G and the 8 mm x 31 G pen needle after three weeks of use of each device. Sufficient numbers of subjects taking Lantus® as their basal insulin will be enrolled so as to allow for pre-specified analysis of this subgroup.

This is an open-label, randomized two period crossover study. Each subject's participation is expected to last about seven weeks and includes a brief enrolment period followed by two consecutive three week treatment periods (Period 1 and Period 2).

In Period 1, subjects will use the first assigned study pen needle (either the 4mm Nano or the 8mm Short) to self-administer daily all their pen-based diabetes medications. Upon completion of Period 1, subjects will switch to the alternate pen needle for Period 2. The randomization schedule will determine the order of pen needle use.

Blood samples for determination of fasting blood glucose and serum fructosamine concentrations will be collected at baseline (Visit 2) and the end of Period 1 (Visit 3) and Period 2 (Visit 4). Blood samples will be analyzed by a central laboratory.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes mellitus
* Have been using a pen device for all diabetes or diabetes-related medications for at least one month prior to screening
* Use a pen device to self-administer greater than 40 units of Lantus, Levemir, and/or NPH in one or more single injections. For split doses, at least one of the injections must deliver more than 40 units.
* Documented hemoglobin A1c (HbA1c) from 5.5% to 9.5%, inclusive
* Self monitor blood glucose at once daily with a memory blood glucose meter, and willing do so at least twice per day for the duration of the study
* On a stable diabetes regimen (insulin and non-insulin meds, diet and exercise) for at least 1 month prior to screening
* Able to read, write and follow instructions in English

Exclusion Criteria:

* Current administration of insulin with a pump.
* Current use a syringe to inject insulin or any diabetes-related medication
* Participation in clinical study BDDC-08-011 or DBC-10-SQUIR05
* History of intravenous drug abuse.
* Current status or history of a medical condition that would contraindicate treatment with study products or other conditions which, in the opinion of the Investigator, would place the subject at risk or potentially confound interpretation of the study results (i.e., recent history of ketoacidosis, hypoglycemic unawareness, etc).
* Pregnancy
Effectiveness of Sodium Hyaluronate In Relieving Nasal Symptoms Of Children With Seasonal Allergic Rhinitis

Nasal irrigation (NI) is recommended as an add-on therapy in patients with allergic rhinitis (AR). The primary purpose of this study was to evaluate the clinical effectiveness of adding hyaluronic acid (HA) solution and normal saline (NSS) to nasal steroid (NS) therapy as add - on therapy in improving quality of life and reducing nasal symptom scores of children with seasonal AR (SAR) with regards to NS therapy. Our secondary purpose was to demonstrate the effects on eosinophil count in nasal cytology (NEC), nasal airflow (NAF), and resistance (NAR).


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients between 6 to 12-year-old;
* Children must have a clinical history concordant to seasonal allergic rhinitis of the previous year;
* Children must have skin prick test (SPT) positivity to pollen (tree, grass, or weed) (Positive SPT is defined as; skin reaction with within 15 minutes after the test and 3 mm larger swelling compared to the negative control test; ALK, Hørsholm, Denmark)
* Children must have a total nasal symptom score (TNSS) of 4 or more on 4 of 7 days during the run-in period.

Exclusion Criteria:

* Children who were treated with systemic/topical nasal corticosteroids, antihistamines or antibiotics, leukotriene receptor antagonists 4 weeks before the examination,
* those who had upper or lower respiratory tract infections;
* recipients of recent or ongoing allergen immunotherapy;
* active smokers;
* those with cystic fibrosis, immunodeficiency, septal deviation, nasal polyps, and ostio-metal complex, exudation, abnormal nasal diagnostic function, nasal anatomical disorder, metabolic disease, or congenital disease.
* Phone calls will measure children's adherence rate to treatment protocols, and participants determined to have treatment protocol adherence rates below 85% will be excluded.
Cytokine and Eicosanoid Mediators in Coronavirus Disease 2019 (COVID-19)

This study is a prospective, single center, observational, cohort study of patients to (1) describe the kinetics and temporal relationship of changes in eicosanoid and cytokine mediators in patients with severe COVID-19 admitted to the hospital; and (2) correlate the dynamic changes in eicosanoid mediators with available patient clinical status, including measures of severity of illness, routine laboratory tests, and outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Admitted to a hospital with symptoms suggestive of COVID-19.
2. Confirmed infection with SARS-CoV-2 as determined by polymerase chain reaction (PCR) or other commercial or public health assay in the 72 hours prior to hospital admission or any time during hospital admission.
3. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
4. Understands and agrees to comply with planned study procedures.
5. Agrees to the collection of whole blood samples.

Exclusion Criteria:

1. Inability to obtain informed consent.
2. Anticipated transfer to another hospital which is not a study site within 48 hours.
3. Inability to obtain sequential blood samples due to patient's characteristics (i.e. difficult vascular access).
4. Obstetric patients.
5. Prisoners.
Nanomotion-based Resistell AST to Determine the Antibiotic Susceptibility of Gram-negative Bacteria Causing Bacteremia and/or Sepsis

Blood culture samples from bacteremia patients positive for Gram-negative bacteria will be tested for antibacterial susceptibility using Resistell Phenotech device. The results will be compared with current AST gold standard tests to calculate sensitivity, specificity, and accuracy of Resistell Phenotech device.

NANO-RAST: Nano-motion based Resistell AST to determine the antibiotic susceptibility of bacteria causing bacteremia and sepsis.

Study population: patients admitted at the study site with bacteremia considered to be due to a pathogenic strain (E. coli or K. pneumoniae).

Study design: prospective, observational, single arm study.

Eligibility Criteria:
Inclusion Criteria: The patients meeting all the following criteria can be recruited in the study:

* patients over the age of 18 years who sign, or their relatives / legal representatives sign the informed consent form;
* patients with bacteremia considered to be due to a pathogenic strain;
* patients hospitalized at CHUV at the time of blood culture inoculation;
* patients whose positive blood cultures were not older than 24 hours at the time of AST start.

Exclusion Criteria The patients meeting any of the following criteria will be excluded from the study:

* patient is diagnosed with polymicrobial bacteremia;
* samples can be excluded from the study during the processing of samples in case of technical errors e.g. failure with attachment of cells, technical problem with the device or sensor, operator's error, etc.

Note: in the event that the capacity of the Resistell instruments is reached for the day, no more ICFs will be obtained for the day.
A Study of Pitolisant in Patients with Prader-Willi Syndrome

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, global clinical study to assess the efficacy and safety of pitolisant in patients living with Prader-Willi syndrome.

The primary objective of this study is to evaluate the efficacy of pitolisant in treating excessive daytime sleepiness (EDS) in patients ≥6 years of age with Prader-Willi syndrome.

Secondary objectives include assessing the impact of pitolisant on:

* Irritable and disruptive behaviors
* Hyperphagia
* Other behavioral problems including social withdrawal, stereotypic behavior, hyperactivity/noncompliance, and inappropriate speech

The study will consist of an up to 45-day Screening/Baseline Period, a Double-Blind Treatment Period, and an optional Open-Label Extension Period.

After completion of all Baseline assessments, patients who meet all eligibility criteria will be randomized 1:1 to receive once daily pitolisant or matching placebo. During the Double-Blind Treatment Period, in-person visits will be at Day 29, Day 57, and Day 77. Patients who do not elect to enter the Open-Label Extension Period will have follow-up visits 15 days and 30 days after the final dose of study drug.

During the optional Open-Label Extension Period, in-person visits will be at Day 113, Day 260, and Day 441. Patients will have follow-up visits 15 days and 30 days after the final dose of pitolisant.

Eligibility Criteria:
Inclusion Criteria:

* Genetically confirmed diagnosis of PWS
* Excessive daytime sleepiness
* Has a consistent parent/caregiver (preferably the same person throughout the study) who is willing and able to complete the required study assessments.
* In the opinion of the Investigator, the patient/parent(s)/caregiver(s)/legal guardian(s) are capable of understanding and complying with the requirements of the protocol and administration of oral study drug.

Exclusion Criteria:

* Has a diagnosis of sleep apnea (OSA, CSA) that is not adequately controlled
* Has a diagnosis of hypersomnia due to another sleep/medical disorder
* Participation in an interventional research study involving another investigational medication, device, or behavioral treatment within 30 days or 5 half-lives (whichever is longer) of the investigational medication prior to Screening
Sutures in Orbital Implants in Retinoblastoma Patients

The purpose of this study is to evaluate different sutures for orbital implants in retinoblastoma patients.

To evaluate the effectiveness and complications of 4-0 and 5-0 sutures for orbital implants in retinoblastoma patients.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed as retinoblastoma
* enucleation and orbital implantation in the same surgery

Exclusion Criteria:

* death during follow-up
A Randomized Phase III Study of Adjuvant Chemotherapy With or Without Chemo-radiotherapy in Patients With Local Advanced Gastric Cancer After D2 Resection.

The purpose of this study is to explore the role of adjuvant chemo-radiotherapy in patients with local advanced gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

* Gastric cancer;
* D2 and R0 resection;
* Pathologically confirmed stage anyT, N+, M0 (AJCC Cancer Staging);
* Karnofsky performance score (KPS) \>= 70 or Eastern Cooperative Oncology Group(ECOG) score 0-1;
* Adequate blood counts: White blood cell count ≥3.5 x 109/L Haemoglobin levels ≥100g/L Platelet count ≥100 x 109/L Creatinine levels ≤1.0× upper normal limit（UNL） Urea nitrogen levels ≤1.0× upper normal limit（UNL） Alanine aminotransferase(ALT) ≤1.5× upper normal limit（UNL） Aspartate aminotransferase(AST) ≤1.5× upper normal limit（UNL） Alkaline phosphatase(ALP) ≤1.5× upper normal limit（UNL） Total bilirubin(TBIL) ≤1.5× upper normal limit（UNL）
* No allergic history of 5-Fu or Platinum drugs;
* No history of chemotherapy or other anti-cancer therapy;
* Informed consent should be signed.

Exclusion Criteria:

* GEJ adenocarcinoma
* Concomitant malignancies;(except basocellular carcinoma or in-situ cervical carcinoma)
* Allergic to Fluorouracil or Platinum drugs;
* Concurrent uncontrolled medical condition;
* Known malabsorption syndromes or lack of physical integrity of upper gastrointestinal tract;
* Severe postoperative complications such as anastomotic leakage, etc.;
* Symptoms or history of peripheral neuropathy.
Dietary Absorption of Garlic Metabolites Following Garlic Consumption

The study will consist of a single 5-day dietary treatment period. Subjects will consume an Allium-free diet for 3 days. Alliums are vegetables such as garlic, onions, chives, shallots, and leeks. On day 4, subjects will consume a breakfast consisting of garlic and will then provide blood and urine samples for 10 hours, and on the following morning.


Eligibility Criteria:
Inclusion Criteria:

* Men and women of age 25 to 75 years at beginning of study
* BMI between 18.5 and 30 kg/m2
* Fasting glucose \< 126 mg/dl
* Blood pressure \< 160/100 (controlled with certain medications)
* Fasting total blood cholesterol \< 280 mg/dl
* Fasting triglycerides \< 300 mg/dl

Exclusion Criteria:

* Younger than 25 years old or older than 75 years old
* Use of blood-thinning medications such as Coumadin (warfarin), Dicumarol (dicumarol), or Miradon (anisindione)
* Presence of kidney disease, liver disease, gout, certain cancers, thyroid disease, gastrointestinal, other metabolic diseases or malabsorption syndromes.
* Have been pregnant during the previous 12 months, are currently pregnant or lactating, or plan to become pregnant during the study
* Type 2 diabetes requiring the use of oral antidiabetic agents or insulin
* History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
* Use of prescription or over-the-counter antiobesity medications or supplements (e.g., phenylpropanolamine, ephedrine, caffeine) during and for at least 6 months prior to the start of the study or a history of a surgical intervention for obesity
* Active cardiovascular disease (such as a heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within the last three months, stroke, or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in the past six months).
* Use of any tobacco products in past 6 months
* Unwillingness to abstain from herbal supplements for two weeks prior to the study and during the study
* Known (self-reported) allergy or adverse reaction to garlic
* Inability to tolerate garlic
* Unable or unwilling to give informed consent or communicate with study staff
* Self-report of alcohol or substance abuse within the past twelve months and/or current acute treatment or rehabilitation program for these problems (Long-term participation in Alcoholics Anonymous is not an exclusion)
* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
Clinical Trial of Pioglitazone for Prevention of Cardiac Allograft Vasculopathy After Heart Transplantation

The purpose of this study is to determine the benefit of using the FDA-approved insulin-sensitizing agent, Pioglitazone, on human heart transplant recipients. The objectives of this project are to (1) determine if pioglitazone effectively treats insulin resistance in heart transplant recipients, and (2) to determine whether pioglitazone therapy after heart transplantation impacts the development or progression of cardiac allograft vasculopathy (CAV), a form of chronic rejection after heart transplantation.

CAV, a rapidly progressive obliterative disease involving the graft coronary arteries, is the leading cause of morbidity and mortality beyond the first year after heart transplantation. This common complication occurs in almost half of recipients within 3 years after heart transplantation, and is associated with high rates of graft failure and mortality. Clinical care of heart transplant recipients in the current era is greatly limited by the lack of effective treatment options to prevent or retard the progression of CAV. CAV appears to be strongly associated with the state of insulin resistance, which is present in over half of heart transplant recipients and is characterized by metabolic abnormalities including glucose intolerance, dyslipidemia, endothelial dysfunction, and high levels of circulating inflammatory markers. Insulin resistance can be effectively treated with pioglitazone, a TZD compound which directly affects tissue insulin sensitivity. In this study, we will enroll 32 insulin-resistant heart transplant recipients and will randomize them to pioglitazone or placebo for a one-year period. We will determine the efficacy of pioglitazone for the treatment of insulin resistance and prevention of the development and progression of CAV after heart transplantation. The data generated from this study will provide important preliminary data for future, larger-scale clinical investigations.

Eligibility Criteria:
Inclusion Criteria:

1. Heart transplant recipients, years 1-4 post-transplant
2. Age \>= 18 years
3. Fasting TG/HDL ratio\>=3.0 or Fasting TG\>=150 mg/dL

Exclusion Criteria:

1. Diabetes mellitus
2. Severe liver dysfunction (ALT\>=2.5 x upper limit of normal)
3. Severe renal dysfunction (GFR\<30 or Stage IV CKD)
4. Moderate-severe fluid retention
5. Clinical or echocardiographic signs of left ventricular dysfunction
6. Contraindication to coronary angiography and/or IVUS
Feasibility of Vaginal Progesterone to Reduce HIV-Associated Preterm Birth

More than 1.5 million HIV-infected women become pregnant each year. Approximately half have access to antiretroviral therapy (ART), but all are at increased risk of preterm birth (PTB). Vaginal progesterone (VP) is a promising and cost-effective intervention to prevent PTB that should be studied in this high-risk population. This pilot study will provide critical insight into the feasibility of a phase III trial by determining whether women are willing to participate, to adhere to study drug, and to complete follow-up.

This will be a mixed method study to evaluate the feasibility and acceptability of a trial of VP to prevent PTB among HIV-infected Zambian women. To assess the feasibility of a full-scale clinical trial, the investigators will implement a pilot two-arm, double-masked, placebo-controlled trial of VP among HIV-infected women in antenatal care in Lusaka, Zambia. Participants will be randomly assigned to either daily self-administered VP or indistinguishable placebo prior to 24 weeks gestational age. In this pilot study, the investigators will be able to estimate study uptake, adherence to study product and protocol, and study retention. To assess the acceptability of a trial to test VP among HIV-infected women in Zambia, the investigators will employ a qualitative approach of longitudinal semi-structured interviews among women agreeing to trial participation and one-time semi-structured interviews (SSIs) among those who decline to participate.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. viable intrauterine pregnancy confirmed by ultrasound
3. presentation to antenatal care prior to 24 weeks gestation
4. antibody-confirmed HIV-1 infection
5. initiating or continuing ART treatment in pregnancy
6. ability and willingness to provide written informed consent
7. willing to adhere to study visit schedule

Exclusion Criteria:

1. multiple gestation
2. non-research indication for antenatal progesterone (i.e. prior spontaneous PTB and/or cervical length \<20mm on screening ultrasound)
3. planned or in situ cervical cerclage
4. evidence of threatened abortion, preterm labor, or ruptured membranes
5. major fetal anomaly detected on screening ultrasound
6. known uterine anomaly
7. known or suspected allergy or contraindication to VP or placebo components