cyrilzakka/clinical-trials huggingface dataset:
Effect of Saffron Supplementation on Macular Cone-mediated Function in Age-related Macular Degeneration

This is a pilot interventional study whose aim is to determine the effect of a dietary supplementation with a Crocus Sativus extract, Saffron, on macular cone-mediated function in patients with early age-related macular degeneration (AMD). Pre-clinical evidence ( Maccarone R, Di Marco S, Bisti S. Saffron supplement maintains morphology and function after exposure to damaging light in mammalian retina. Invest Ophthalmol Vis Sci. 2008 Mar;49(3):1254-61.) indicates the potential effectiveness of Saffron as a retinal neuroprotectant in animal models of retinal degenerative disorders.The macular function will be tested by visual acuity and macular cone-mediated electroretinogram (focal electroretinogram, FERG) according to a standardized technique (see citations).

A group of 30 AMD patients with typical lesions (drusen and/or retinal pigment epithelial defects) and relatively preserved central retinal function and visual acuity will be enrolled. AMD patients will be randomly divided into two groups: 1. placebo group \[n = 15), taking for three months an oral placebo; 2. Saffron group (n = 15), taking Saffron oral treatment (20 mg/day) for three months. After three months of placebo or Saffron supplementation, patients will be tested with standard ophthalmic examination and FERGs. Then, placebo with Saffron and vice-versa will be changed to the same patients in a cross-over design. After a further three month period of placebo or study drug supplementation, patients will undergo again a standard ophthalmic examination, and FERG. Throughout the study, both patients and experimenters will be masked as to the identity of pills (i.e. whether placebo or study drug), whose identification key number will be kept in a sealed envelope that will be opened only at the completion of the study. Therapeutic compliance will be tested by careful questioning, either at two weeks of treatment (by telephone interview) or at the end of the treatment period, as well as by pill count. Main outcome measures of the study will be FERG amplitude and phase.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 55 yrs
* Diagnosis of Early, non exudative AMD
* Visual acuity of 20/40 or better

Exclusion Criteria:

* Concomitant ocular or systemic disorders which may affect macular function
* Drugs that may affect macular function
The FLOTILLA Study: Providing Continued Access to The Study Medicines Encorafenib and Binimetinib for Participants in Prior Clinical Trials

The purpose of this clinical trial (called the FLOTILLA study) is to give continued access to the study medicines, as well as safety follow-up, for participants in prior clinical trials of encorafenib and/or binimetinib.

All participants who took part in earlier encorafenib and/or binimetinib studies may participate the FLOTILLA study if they are still benefiting from the use of the study medicines. This will be determined by the study doctor. People may not participate in the FLOTILLA study if they have not enrolled in a prior study of encorafenib or binimetinib.

Participants that had enrolled but had stopped receiving the study treatment in a prior study cannot enrolled in this study. Participants in the FLOTILLA study will receive encorafenib and/or binimetinib at the same dose and frequency as in their prior study, for up to about 5 years.

This is an open-label, continuation study for participants receiving study intervention(s) in an encorafenib/binimetinib Parent Study. The study is being conducted under a Master Protocol for Encorafenib/Binimetinib Continuation Sub-Studies with an individual encorafenib/binimetinib continuation sub-study protocol for each eligible Parent Study. Approximately 75 participants from potentially qualifying Parent Studies will be included in this Encorafenib/Binimetinib Continuation study.

This continuation study includes multiple sub-study protocols to allow participants from each of the following parent studies: C4211001 - NCT01320085; C4211003 - NCT01849874; C4221003 - NCT03864042; C4221005 - NCT01543698; C4221006 - NCT03911869; C4221009 - NCT02928224; C4221010 - NCT01436656; C4221013 - NCT02159066; ANCHOR-CRC - NCT03693170

Eligibility Criteria:
Inclusion Criteria:

* Any participant who is receiving study intervention and deriving clinical benefit (as determined by the principal investigator) in an encorafenib/binimetinib Parent Study, with no ongoing NCI CTCAE version 4.03 Grade ≥3 or intolerable Grade 2 AEs considered to be related to study treatment.
* Participants must agree to follow the reproductive criteria as outlined in the applicable Encorafenib/Binimetinib Continuation Sub-Study Protocol.

Exclusion Criteria:

* Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study.
Comparative Study of Antegrade Versus Retrograde Cerebral Perfusion in Acute Type a Aortic Dissection: a Prospective Study

This prospective study investigated the comparison of effectiveness of antegrade cerebral perfusion (ACP) and retrograde cerebral perfusion (RCP) in providing cerebral protection during the surgical treatment of acute Type A aortic dissection (TAAD) Acute type A aortic dissection presents an aortic tear at its ascending portion, posing considerable risk with high morbidity and mortality incidence, especially from neurological insults.

In total, 48 patients of acute type A aortic dissection were randomly assigned to undergo surgical intervention with either ACP through axillary artery cannulation or RCP through superior vena cava cannula placed during deep hypothermic circulatory arrest. Primary objectives focused on measuring and comparing the postoperative neurological complication rates associated with transient neurological deficits (TND) and permanent neurological deficits (PND). Secondary outcomes of interest included the duration of mechanical ventilation, length of stay in the ICU and hospital, and mortality.


Eligibility Criteria:
Inclusion Criteria:

- Patients diagnosed with acute type A aortic dissection (TAAD).

Exclusion Criteria:

* Hemodynamic instability.
* Known ischemic heart disease (IHD).
* History of cerebrovascular stroke.
* Heart failure.
* Renal or hepatic impairment.
* Rheumatic heart disease.
* Previous history of radiotherapy.
Sphenopalatine Ganglion Block and Cold Induced Headaches

The primary objective of this study is to determine if a sphenopalatine ganglion (SPG) block, performed through intranasal atomization of 4% lidocaine, is able to prevent cold induced cephalgia ("Brain Freeze"). Secondary objectives will be to determine the degree of decreased pain/duration of brain freeze after sphenopalatine ganglion block

This study will be performed in two phases. The first phase will include a pre-medicated phase where the subjects will be required to rapidly drink up to ½ of a 32 fluid oz icecold slushy to induce a brain freeze. The flavor will be chosen by the participants. The time to onset, intensity, location, and duration of the headache will be recorded. The second phase will commence when the subjects have returned to their normal pain free state, a minimum of 10 minutes has passed since the resolution of the first cold headache, and they feel ready to move to the next phase. The time from complete resolution of the brain freeze to the start of the second phase will be recorded. Any subject that wishes to drop out from the study at this time is free to do so. They may keep their drink and finish it at a more leisurely pace should they choose.

Then the subjects will receive either 1 mL of 4% lidocaine (0.5mL in each nostril) administered by intranasal atomization or 0.9% normal saline administered by intranasal atomization. The normal saline placebo will be mixed with an edible bittering agent added to blind the participant from recognizing the taste of the lidocaine containing solution.

Only participants that experienced a brain freeze in the first phase will be able to move onto the second phase. Each participant will then rapidly drink up to ½ of a 32 fluid oz ice-cold slushy to induce a brain freeze. The time to onset, intensity, location, and duration of the headache will be recorded.

All pain scores will be recorded using a visual analog scale from 0-100 where 0 is no pain and 100 is the worst pain imaginable. We will also record any side effects that the subjects may experience during or shortly after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Wright State University Emergency Medicine (EM) resident physicians and Wright State Boonshoft School of Medicine medical students
* Over the age of 18 years
* Has gotten at least one brain freeze in their life

Exclusion Criteria:

* Individuals who have never gotten a brain freeze
* Anyone who has had any sort of prior trauma to their oro- or nasopharynx or surgery on their oro- or nasopharynx, not to include dental surgery.
* Pregnant patients
* History of allergy to local anesthetic
Lymphatic Function in Patients With a Fontan Circulation From Brazil

It is suggested that the elevated central venous pressure in patients with a Fontan circulation can provoke manifestation of lymphatic dysfunction, met as plastic bronchitis, peripheral oedema and most feared protein-losing enteropathy (PLE).

An explorative study from our department at Aarhus University Hospital revealed that the function of the lymphatic vasculature in 10 young Fontan patients with no complications was abnormal compared to healthy controls. However, to further describe and confirm these findings we had to investigate the lymphatic circulation in a larger, older and more complicated group of Fontan patients.

The hypothesis is that, patients with a univentricular circulation have a reduced functionality of the lymphatic vasculature and which predisposes them to developing complications such as edema and PLE.

The study population is patients with a Fontan circulation followed at InCor Heart Institute in Sao Paolo and Ribeirão Preto, Brazil. These were matched with and group of healthy controls.

The functional state of superficial lymphatics in the lower leg will be investigated, using near infrared fluorescence (NIRF) imaging. The capillary filtration of fluid and leakiness of the capillaries will be measured using strain gauge plethysmography and the peripheral blood flow will be measured using venous occlusion plethysmography. Furthermore, plasma concentration of noradrenaline will be estimated.

Eligibility Criteria:
Inclusion Criteria:

* Fontan circulation
* Age above 16.

Exclusion Criteria:

* Mental illness
* Syndromes.
XprESS Maxillary Balloon Dilation Study

A prospective, single-arm, post approval pilot study.

This study is evaluating transnasal sinus balloon dilation without tissue removal to treat the maxillary sinuses in patients with sinusitis. The study will be assessing symptomatic improvement post procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Be at least 18 years of age.
2. Must have uncomplicated sinusitis of the maxillary sinuses with or without anterior ethmoid disease.
3. Meet EITHER the Anthem Coverage Guideline OR BlueCross BlueShield of North Carolina Corporate Medical Policy for medically necessary functional endoscopic sinus surgery (FESS) to treat uncomplicated sinusitis.
4. Have a CT scan within 6 months prior to enrollment.
5. Be mentally and physically capable (as per physician discretion) to participate in the investigation.
6. Be willing and able to sign the study-specific informed consent prior to any study-related procedures.
7. Be willing and able to undergo balloon dilation in the clinic setting.

Exclusion Criteria:

1. Have evidence of posterior ethmoid, sphenoid or frontal sinus (excludes presence of mucous retention cysts) disease requiring endoscopic sinus surgery or balloon dilatation.
2. Have presence of features consistent with sinus fungal disease.
3. Have evidence of gross polypoid disease within any of the sinuses or within the infundibulum.
4. Require concurrent nasal surgery (eg, septoplasty, turbinate reduction, etc).
5. Have previous sinus surgery (eg, sinus surgery or balloon sinuplasty).
6. Have nasal surgery (eg, septoplasty, turbinate reduction) performed within 3 months prior to enrollment.
7. Have any anatomical anomaly (ie, severe septal deviation) preventing transnasal access to the maxillary sinus outflow tract.
8. Have a history of primary ciliary dysfunction.
9. Have hemophilia.
10. Be currently undergoing, or have undergone in the past 6 months, chemotherapy for cancer or radiation therapy in the head or neck region.
11. Have a history of cystic fibrosis.
12. Have Sampter's Triad (ie, defined as having all 3 of the following: aspirin sensitivity, asthma, and sinonasal polyposis).
13. Have known sinonasal tumors or obstructive lesions.
14. Be pregnant at the time of enrollment.
15. Be unable to stop anticoagulant medication (eg, warfarin) until the International Normalized Ratio (INR) is below 1.5.
16. Be unable to stop antiplatelet (eg, clopidogrel, aspirin, etc.) for at least 7 days prior to study procedure.
17. Be currently participating in any other drug or device clinical studies excluding postapproval or marketing registry studies.
Effects of Green Propolis Extract (EPP-AF) on Inflammation in Hemodialysis Patients.

End-stage chronic kidney disease is associated with the condition of chronic inflammation. Patients on hemodialysis are known to be predisposed to several factors that predispose to inflammation: dialysis membranes, central venous catheters, oxidative stress, fluid overload, sodium overload, uraemic toxins. Propolis, a natural resin produced by bees from plant materials, has anti-inflammatory, immunomodulatory, and anti-oxidant properties. The aim of this study was to evaluate the impact of Brazilian green propolis extract on inflammation in hemodialysis patients.

Randomized open-label cross-over trial to investigate impact of Brazilian green propolis extract on inflammation in hemodialysis patients.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years;
* Male or female on hemodialysis for at least 1 month.

Exclusion Criteria:

* Pregnant Woman;
* Carriers of active neoplasms;
* Patients undergoing kidney transplantation during the study;
* Infection during the study;
* Patients who underwent parathyroidectomy during the study;
* Patient using immunosuppressive drugs;
* Allergy to propolis or any of its components;
Effect of Gut Microbiota and Its Metabolites on the Efficacy of Immunotherapy in Metastatic Colorectal Cancer

The purpose of this observational study is to understand the effect of gut microbiota on the efficacy of immunotherapy in patients with metastatic colorectal cancer and to explore the specific mechanisms of this process. In this way, it provides new ideas for the clinical treatment of colorectal cancer.

This study is a single-center, prospective, observational study. This study plans to enroll 50 patients with mCRC who received immunotherapy. Stool and blood samples were collected from patients with mCRC before receiving immunotherapy (baseline) and after one cycle of immunotherapy and stored immediately in a -80°C freezer. Six months after treatment with a PD-1 inhibitor in combination with fruquintinib, patients with mCRC were evaluated radiographically according to the modified RECIST1.1 criteria for immunotherapy (iRECIST) and were divided into responsive and non-responsive groups.

In this study, we intend to use metagenomic sequencing to screen the key intestinal microbiota that affect the efficacy of PD-1 inhibitors and predict their possible functional pathways in patients with metastatic colorectal cancer receiving anti-PD-1 immunotherapy. Then, proteomics and metabolomics methods were used to screen differential proteins and metabolites, and the correlation analysis with key intestinal microbiota was carried out, and the efficacy of immunotherapy in patients with mCRC was evaluated. Finally, the above findings were verified in animal models, and then the specific mechanism of intestinal microbiota affecting the efficacy of PD-1 inhibitors was explained by taking the changes in body metabolism and immunity as the starting point.

Eligibility Criteria:
Inclusion Criteria:

* Clinical and pathological diagnosis of metastatic colorectal cancer
* 35-75 years old (both ends inclusive)
* complete clinical information
* signed informed consent

Exclusion Criteria:

* combined with severe respiratory and circulatory diseases
* combined with other malignant tumors
* recent severe active bleeding, uncontrolled active infection or active peptic ulcer
* moderate to severe renal insufficiency
* other circumstances that are judged by the investigator to be unsuitable for participating in this study
Study to Evaluate the Effect of Obicetrapib in Combination With Ezetimibe as an Adjunct to HIS Therapy

This study will be a placebo-controlled, double-blind, randomized, phase 2 study to evaluate the efficacy, safety, and tolerability of obicetrapib 10 mg, both in combination with ezetimibe 10 mg and as monotherapy, as an adjunct to high-intensity statin therapy.

This study will be a placebo-controlled, double-blind, randomized, phase 2 study to evaluate the efficacy, safety, and tolerability of obicetrapib 10 mg, both in combination with ezetimibe 10 mg and as monotherapy, as an adjunct to high-intensity statin therapy. The screening period for this study will take up to 2-weeks. Afterwards patients will be randomized to placebo, 10 mg obicetrapib monotherapy, or 10 mg obicetrapib + 10 mg ezetimibe combination therapy for a 12-week treatment period. After the treatment period, patients will continue for a 4-week safety follow-up.

Eligibility Criteria:
Inclusion Criteria:

* LDL-C \> 70 mg/dL and Triglycerides \< 400 mg/dL,
* Treated with a high-intensity statin therapy

Exclusion Criteria:

* BMI \>= 40 kg/m2
* Significant cardiovascular disease
* HbA1c \>= 10%
* Uncontrolled hypertension
* Active muscle disease
* estimated glomerular filtration rate \< 60 mL/min
* Hepatic dysfunction
* History of participation in any clinical trial evaluating obicetrapib
* Anemia
* History of malignancy
* Alcohol abuse
* Treatment with investigational product
* Treatment with PCSK9
* Clinically significant condition
* Known CETP inhibitor allergy
The Correlation Between Luteal Serum Progesterone and Live Birth Rate

The study design is an observational cohort study. Level of serum P4 will be collected on day OR+4 as well as on the day of embryo transfer (ET) either day OR+3 or OR+5.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* BMI \<35kg/m2

Exclusion Criteria:

* No fresh embryo transfer
* Prior participation in the study
Prospective Study on the Feasibility and Effectiveness of Per-Oral Endoscopic Myotomy (P.O.E.M.) for Treatment of Primary Esophageal Motility Disorders

rimary spastic esophageal motility disorders, though uncommon, induce significant symptoms to patients including dysphagia, spastic chest pain, regurgitation as well as heartburn. The commonest causes of spastic esophageal motility disorders included Achalasia, hypertensive lower esophageal sphincter (LES), Nutcracker esophagus and Diffuse esophageal spasm (DES). Majority of these diseases were diagnosed by manometry. Achalasia is the most common primary esophageal motility disorder in which the LES failed to relax with increased pressure. Currently the standard treatment for Achalasia and spastic motility disorders is Laparoscopic Myotomy. The development of Natural Orifices Transluminal Endoscopic Surgery (N.O.T.E.S.) has lead to a new way to perform myotomy - Peroral Endoscopic Myotomy (P.O.E.M.). Basically, through mucosal incision, a submucosal tunnel is created after identification of the level of gastroesophageal junction. Myotomy will be performed with endoscopic instruments and the entrance site will be closed with clips.


Eligibility Criteria:
Inclusion Criteria:

* All patients with age ranged 18 to 85 who had primary esophageal motility disorders will be recruited. The primary motility disorders included: Achalasia, hypertensive LES, Nutcracker esophagus and Diffuse esophageal spasm.

Exclusion Criteria:

1. Pregnancy
2. Informed consent not available
3. Previous history of esophagectomy or mediastinal surgery
4. Previous history of endoscopic resection for early esophageal cancers, inclduing endoscopic mucosal resection and endsocopic submucosal dissection
5. End-stage Achalasia with dilated esophagus more than 6cm on Barium swllow
Molecular Biomarkers of Response to Radiation Therapy in Breast Cancer

The purpose of this study is to identify potential genetic and other molecular biomarkers of response to radiation therapy in breast cancer that may help to personalize breast cancer radiation treatment in the future.

Monocentric prospective clinical study including DCIS patients treated at the Institute of Oncology Ljubljana. Patients treated with adjuvant radiotherapy and without systemic therapy are eligible for the study.

Adverse events of radiation treatment will be assessed after radiotherapy and during 5-year follow up and classified according to Common Terminology Criteria for Adverse Events v5.0.

Molecular biomarkers will be assessed before radiotherapy, after radiotherapy and during follow up. DNA will be isolated from whole blood samples obtained before radiation treatment. Circulating biomarkers will be isolated from plasma samples before treatment, after treatment and during follow-up. Written informed consent will be obtained from all included patients and the study design was approved by the National Medical Ethics Committee.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer patients with DCIS with an indication for adjuvant radiation therapy

Exclusion Criteria:

* Any specific systemic oncological therapy
Efficacy and Safety of Lercanidipine and Valsartan in Patients With Essential Hypertension

The purpose of this study is to evaluate the safety and efficacy of fixed combination of lercanidipine (10 mg or 20 mg) and valsartan (80 mg or 160 mg), lercanidipine and valsartan alone in reducing blood pressure. The study will investigate the dose response relationship for the combinations and monotherapies.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 20 and 75
* Essential hypertension at screening (-3 week)

Randomization Criteria:

* Essential hypertension at baseline (90mmHg≤sitDBP≤109mmHg, except sitSBP≥180)

Exclusion Criteria:

* Mean sitDBP≥110mmHg or sitSBP≥180
* Secondary hypertension or suspected secondary hypertension
* Uncontrolled diabetes
* Severe heart disease or severe cerebrovascular disease
* clinically significant hematological test results, renal disease (serum creatinine) or liver disease (ALT or AST)
* History of malignant disease
* Autoimmune disease
* Women with a positive pregnancy test result, breast feeding or intention of pregnancy during the trial