cyrilzakka/clinical-trials huggingface dataset:
Menopause Transition, Sex Hormone Deficiency and Autonomic and Vascular Function

This is a longitudinal study to determine the influence of the menopause transition on autonomic and vascular function. PI Keller-Ross has published data demonstrating that postmenopausal females have greater sympathetic neural reactivity during a stressor compared with age-matched males and younger females and males. A paucity of literature exists, however, on the role of the menopause transition in autonomic function because the majority of experimental studies on menopause physiology are cross-sectional and/or focused on older, postmenopausal females .

The influence of age on HTN is robust, whereas the effects of menopause are still unclear. Preliminary data demonstrate a clear association between age and sympathetic activity in females; how the transition through menopause influences these relations, however, remains unknown. The study will enroll 80 midlife (45-55 years of age) females to measure longitudinally the trajectory of autonomic and vascular function during the transition through menopause. The study hypothesizes that through the menopause transition, an increase in sympathetic activity and an impaired baroreflex sensitivity and endothelial function will emerge.


Eligibility Criteria:
Inclusion Criteria:

* Female
* age 45-55 years
* premenopausal
* not using any medications determined to affect autonomic function
* eumenorrheic
* not planning to become pregnant for the duration of participation in the study
* English-speaking, literate, willing and able to provide informed consent.

Exclusion Criteria:

* Diabetes
* pregnant or breastfeeding
* cardiac or pulmonary disorders
* severe obesity (body mass index \[BMI\] ≥ 40 kg/m 2 )
* hypertension
* obstructive sleep apnea
* current use of heart or blood pressure medications, current use of hormonal contraceptives or other forms of exogenous sex hormones
* report of nicotine/tobacco use in the last six months, report of current alcohol abuse,
* history of treatment with chemotherapy/radiation
* coagulopathy disorders and/or use of anticoagulant medications, and current use of anxiolytics and/or antidepressants.
The Safety and Efficacy of a SinuSonic Intervention

This study aims to test the safety and effectiveness of the SinuSonic device on adults with moderate to severe nasal congestion. SinuSonic is a medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion. This device is held over the nose for 3 minutes. This study will use patient responses to measure how effective SinuSonic devices are in treating these moderate to severe congestion in adults. The study will consist of 40 subjects at the Medical University of South Carolina and will take place over the course of 4 to 6 weeks starting with a baseline assessment.


Eligibility Criteria:
Inclusion Criteria:

1. Adults ≥18 years of age
2. Complaints of nasal congestion present for 2 weeks or more and a qualifying nasal congestion score of \>5 (10 point VAS scale)

Exclusion Criteria:

1. Fixed structural cause of nasal congestion (moderate or severe septal deviation, moderate or severe nasal valve collapse, Grade 3-4 polyp)
2. Inability to read and understand English
3. Allergic sensitivity to silicone or any other component of device
4. History of severe nose bleeding within last 3 months
5. Anticoagulation (Aspirin is acceptable)
6. Known pregnancy
7. Current nasal crusting or ulceration revealed on rhinoscopy
8. Inability to perform treatment due to underlying medical condition
9. Topical decongestant use in last week
Pre-operative Consultation on Patient Anxiety and First-time Mohs Micrographic Surgery

To determine if in-office pre-operative consultation has a significant effect on the anxiety level and overall post-operative satisfaction of patients undergoing first time Mohs surgery

This study is designed to determine if having a seperate in-office pre-operative consultation with the dermatologist before having a dermatologic procedure has any effect on patient anxiety levels and satisfaction following the procedure. The goal of the study is to help us understand if pre-operative consultation is beneficial to patients to reduce anxiety and increase satisfaction following the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years old or older

  * Able to provide consent for participation
  * Fluency in English
  * Presenting for first-time Mohs surgery for treatment of a cutaneous malignancy

Exclusion Criteria:

* • Patients under 18 years old

  * Prisoners
  * Patients unable to provide consent
  * History of prior Mohs surgery
  * Patients requiring multi-disciplinary care (i.e. Involvement of other surgical specialties such as Plastic Surgery or Ophthalmology for reconstruction)
Dose Finding Study of BI 6727 (Volasertib) in Patients With Various Solid Cancers

The primary objective of this trial is to identify the maximum tolerated dose (MTD) of BI 6727 in Asian cancer patients, and to provide safety data in terms of drug-related adverse events.


Eligibility Criteria:
Inclusion criteria:

1. Patients with histologically or cytologically confirmed diagnosis of advanced solid cancer
2. Age 18 years or older
3. Written informed consent
4. Eastern Cooperative Oncology Group (ECOG) performance score 2 or less

Exclusion criteria:

1. Serious illness or concomitant non-oncological disease.
2. Pregnancy or breast feeding
3. Active infectious disease
4. Absolute neutrophil count less than 1,500/cubic millimeter
5. Platelet count less than 100,000/cubic millimeter
6. Bilirubin greater than 1.5 mg/dL (\> 26 µmol/L, SI unit equivalent)
7. Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal
8. Serum creatinine greater than 1.5x ULN.
Study of the Effect of Vedolizumab on Intestinal Microecological Changes and Its Efficacy in the Treatment of Ulcerative Colitis

Inflammatory bowel disease is a group of chronic, non-specific inflammatory diseases of the intestinal tract whose etiology has not yet been fully elucidated, including ulcerative colitis and Crohn's disease. Vedolizumab, a novel biologic agent, is a recombinant humanized monoclonal antibody that specifically antagonizes intestine-selective α4β7 integrins on the surface of leukocyte subsets, thereby preventing migration of leukocyte subsets from the blood to the intestinal mucosa and reducing local inflammation in the gut. In this study the investigators propose to build on an existing cohort and analyse, by means of a multi-omics approach, the baseline gut microbial composition and abundance, intestinal and serum metabolome characteristics of UC patients and their changes during treatment, to predict the functional mechanisms by which these changing characteristics influence the therapeutic response to vindolizumab.

Stool and blood samples etc. were taken from a cohort of patients with ulcerative colitis treated with Vedolizum at the Department of Gastroenterology, Second Affiliated Hospital of Zhejiang University School of Medicine as well as from a cohort of normal volunteers. Stool and blood samples from UC patients were analyzed at baseline and at 14, 30, and 52 weeks after starting treatment. Analysis of changes in gut microbial composition and abundance, gut and serum metabolome characteristics during 52 weeks of treatment in patients with UC. A model for predicting the efficacy of vedolizumab treatment by baseline gut microbial composition and abundance, and gut and serum metabolomic characteristics in patients with ulcerative colitis was developed in conjunction with clinical information from patients in the cohort. Based on the model developed, clinical and gut microbial composition and abundance, gut and serum metabolomics data from other UC patients published in public databases were combined to confirm the results already found using the UC cohort at our center.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older, with moderate to severe ulcerative colitis, with an indication for vedolizumab treatment;
2. Consent to participate in the study, read and sign the informed consent form;
3. No previous treatment with vedolizumab;
4. Never undergone biologic therapy or at least suspended previous biologic therapy for more than 12 weeks;
5. Not taking antibiotics or probiotics within the past 4 weeks.

Exclusion Criteria:

1. younger than 18 years of age;
2. pregnant or breastfeeding women;
3. patients who require the assistance of a surrogate, witness, or who are otherwise unable to complete the trial unaided;
4. other conditions that, in the opinion of the investigator, are unsuitable for enrollment or affect the subject's ability to complete the study;
5. have taken antibiotics or probiotics within the past 4 weeks;
6. have received prior treatment with vedolizumab.
The Effect of Direct Cyclophotocoagulation Using Endolaser in Silicon Induced Glaucoma: a Pilot Study.

Transcleral cyclophotocoagulation has been used to treat glaucoma secondary to silicone oil


Eligibility Criteria:
Inclusion Criteria:

. Patients above 18 years of age. .Silicon filled for more than 2 months. .IOP more than 21 mmHg on triple topical antiglaucoma eye drops.

Exclusion Criteria: . History of glaucoma prior to the initial retinal surgery. . Immediate rise of IOP after SOI. . History of previous laser application to the ciliary body. . Any contraindications for silicone oil removal.
Trial Evaluating Efficacy and Safety of Bevacizumab (Avastin®/Zeribev®) in Patients With COVID-19 Infection, Nested in the Corimmuno-19 Cohort

Bevacizumab, ZERIBEV® (Pfizer)/AVASTIN® (Roche) 25 mg/ml ®, is a recombinant humanised monoclonal IgG1 antibody It seems interesting to use bevacizumab in severe patients infected with SARS-CoV-2 requiring hospitalization in conventional unit or in ICU.

This protocol CORIMUNO19-BEVA will evaluate the efficacy and safety of AVASTIN®/ ZERIBEV® (bevacizumab) COVID-19 patients hospitalized in conventional units.

This phase 2 randomized clinical trial aimed at evaluating the efficacy and safety of AVASTIN®/ ZERIBEV® (bevacizumab) alone versus standard of care (SoC) in patients hospitalized in conventional units.


Eligibility Criteria:
Inclusion Criteria:

* Patients Requiring more than 3L/min of oxygen
* WHO progression scale = 5 to 8

Exclusion Criteria:

* Patients in 9 WHO progression class
* Patients with exclusion criteria to the CORIMUNO-19 cohort.
* Hypersensitivity to Bevacizumab or to any of their excipients.
* Pregnancy
* Active Cancer with undergoing treatment
* Oxygen patient requiring long-term oxygen before hospitalization
* Patient already included in a therapeutic trial; however, inclusion should be discussed case by case with the trial coordinator.
* Contraindication to bevacizumab, risk of bleeding especially hemoptysis, active venous or arterial thromboembolic disease and recent surgery.
* Hypersensitivity to the active substance or one of the excipients
Clinical Study to Assess the Long-term Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension

The main objective of the AC 055 303/SERAPHIN OL study, which will follow the AC 055 302/SERAPHIN study, will be to assess the long-term safety and tolerability of ACT 064992 in patients with symptomatic PAH.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent prior to initiation of any study-mandated procedure.
* Patients with pulmonary arterial hypertension and having completed the event-driven study, AC 055 302/SERAPHIN, or Patients who have experienced a clinical worsening of PAH in AC 055 302/SERAPHIN and for whom a written approval to roll over into this study has been obtained from the Sponsor.
* Women of childbearing potential must have a negative pre-treatment serum pregnancy test and must use a reliable method of contraception during study treatment and for at least 28 days after study treatment termination.

Exclusion Criteria:

* Any major violation of protocol AC 055 302/SERAPHIN.
* Pregnancy or breast-feeding.
* AST and/or ALT \> 3 times the upper limit of the normal range.
* Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results, such as drug or alcohol dependence or psychiatric disease.
* Known hypersensitivity to ACT 064992 or any of the excipients.
NP202 for Treatment of Post -STEMI Left Ventricular Systolic Dysfunction

NP202 is an experimental drug being developed by Armaron Bio Pty Ltd for potential use as a treatment for people after they have had a heart attack (MI).

After someone has a MI, their heart 'remodels', which means that it changes in size and shape. This damage can lead to it being weaker and less efficient, and ultimately to major heart problems. There are some drugs currently available which help prevent remodelling and are used for treatment post-MI. However, there is still a high rate of remodelling and major heart problems in people post-MI. NP202 works in a different way to the drugs that are currently approved, and has been shown in animal studies to prevent post-MI remodelling.

This study will assess NP202 versus placebo on remodelling over a 3 month treatment period, with 1 month follow up

Eligibility Criteria:
Inclusion Criteria:

* Have had a confirmed ST elevation myocardial infarction (STEMI) in the previous 5 days, which met all of the following criteria;

  * ≥ 0.2mV ST elevation in 2 or more V1 - V6 leads with presentation in a maximum of 12 hours of onset of symptoms
  * Troponin levels \>10 x upper limit of normal (ULN) at the site's local laboratory.
  * Successful revascularisation by Percutaneous Coronary Intervention (PCI)
* Have left ventricular dysfunction post STEMI as evidenced by left ventricular ejection fraction (LVEF) ≤40% confirmed by echocardiogram at screening.
* Are receiving guideline-directed medical therapy for acute MI and post-MI left ventricular (LV) dysfunction according to national cardiology society/heart association STEMI guidelines.

Exclusion Criteria:

* Known cardiomyopathy or heart failure prior to MI.
* Cardiogenic shock and/or systolic blood pressure \<85mmHg at Screening.
* Clinical history of ejection fraction ≤40% prior to this MI, or multiple prior MIs.
* Daily use of non-steroidal anti-inflammatory drugs (NSAIDs) and/or cyclooxygenase-2 (COX-2) inhibitors in the past month.
* Presence of device/hardware incompatible with MRI
* Estimated glomerular filtration rate (eGFR) \<30ml/min
* Liver function tests 3 x ULN due to non-cardiac disease
* Have received any investigational research agent within 30 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product.
Doxycycline in Therapy of Erythema Migrans

The investigators will compare the outcome of three groups of erythema migrans patients treated with doxycycline: a group without any accompanying symptoms, with mild symptoms and with severe symptoms that require lumbar puncture.

Patients with erythema migrans treated with doxycycline for two weeks will be followed-up for one year (at 2 weeks, 2, 6 and 12 months) clinically and also by filling in the questionnaire to assess the presence of certain symptoms. Also the control group of their friends or relatives without a history of Lyme borreliosis will be included. The presence of their (unspecific) symptoms will also be recorded by the questionnaire at the time of enrollment and at 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* presence of erythema migrans
* \>15 years old
* informed consent

Exclusion Criteria:

* pregnancy
* lactation
* multiple erythema migrans
* already treated with antibiotic for this episode of Lyme borreliosis
* allergy to doxycycline
* treatment with drugs with known interactions with doxycycline
* cerebrospinal fluid pleocytosis
Combination of Continuous Low Doses of Vinorelbine, Cyclophosphamide and Interferon Alpha 2b (" Metronomic Chemotherapy ") for Antiangiogenic and Antivascular Effect. Trial With Pharmacodynamic Study in Adult Advanced Neoplasm

Purpose:

This phase I trial estimates the antiangiogenic and antivascular effect of 4 different levels of continuous low doses of the combination of Vinorelbine, Cyclophosphamide and Interferon alpha 2b (" metronomic chemotherapy ")in adult advanced neoplasm.

This study is non randomized, monocentric, and with a pharmacodynamic part.

Primary objective:

Estimation of the toxicity of the combination of continuous low doses of Vinorelbine, Cyclophosphamide and Interferon alpha 2b.

Secondary objectives:

Estimation of the antiangiogenic and/or antivascular effect (VEGF measurement) in radiography (DEC-MRI), biology and immunohistochemistry of the treatment.


Eligibility Criteria:
Inclusion Criteria:

* patients aged from 18 and older,
* with metastatic or advanced solid tumor who received all standard treatments,
* who ended their chemotherapy or radiotherapy treatment within 4 weeks (6 weeks for mitocyne)prior entry in the study.
* All patients are included after being given written informed consent.

Exclusion Criteria:

* patients with stable disease,
* history or presence of another cancer,
* contraindication to administer the treatment,
* contraindication to perform MRI,
* pregnancy or breast feeding.
Positive Psychology Intervention for Hematopoietic Stem Cell Transplantation Survivors

This randomized clinical trial is evaluating the impact of a positive psychology intervention (PATH) on anxiety symptoms, depression symptoms, and quality of life in survivors of hematopoietic stem cell transplant (HSCT) compared to usual care.

Patients undergoing hematopoietic stem cell transplantation (HSCT) deal with numerous physical and psychological symptoms during acute hospitalization and recovery. Of the few psychosocial interventions tailored to the needs of the HSCT population, most focus on the needs of patients in the pre-transplant phase or during the HSCT hospitalization, but not during the acute recovery period starting at 100-days post-HSCT. Hence, the investigators developed a remotely-delivered positive psychology intervention, Positive Affect in the Transplantation of Hematopoietic Stem Cells (PATH). This intervention encourages patients to perform simple and enjoyable structured activities that increase the intensity of positive thoughts and emotions. With this multi-site randomized clinical trial, the investigators aim to find out whether PATH can improve psychological distress and quality of life in HSCT survivors, compared to usual care, using validated assessment tools.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (aged 18 years and older) undergoing allogeneic HSCT and are approaching 100-days post-HSCT
* Ability to speak, read, and respond to questions in English or Spanish to complete study procedures
* Access to a basic telephone

Exclusion Criteria:

* Patients who underwent allogeneic HSCT for benign hematologic conditions
* Patients who received outpatient HSCT
* Patients with severe psychiatric or cognitive conditions, such as dementia, determined by their transplant oncologist to make them unable to provide informed consent or comply with study procedures
Functional Treatment Planning Utilizing 18-FDGal PET/CT in SBRT for Liver Metastases

Background: Anatomical (traditional) stereotactic body radio therapy(SBRT) treatment planning assumes homogenous distribution of function in the normal liver tissue. In functional treatment planning, additional information on distribution of the function derived from functional imaging of normal tissue is taken into account. by functional treatment planning it becomes possible to prioritize and spare the best functioning part of an organ.

Aim: To test whether functional treatment planning based on 18-FDGal PET/CT may spare the best functioning liver tissue.

Endpoints: Reduction in hepatic systemic clearance (K) in the dynamic 18-FDGal PET/CT scan one month after SBRT compared to the baseline status in sub-volumes recieving 15 Gy or higher. Secondly, the investigators will evaluate the toxicity to SBRT by a toxicity scoring system that includes biochemical measures as well as symptomatic scores.


Eligibility Criteria:
Inclusion Criteria:

* Performance status \>2
* liver metastases refereed for SBRT

Exclusion Criteria:

* pregnancy
* claustrophobia
Immediate Dental Implant Installation with and Without Socket Shield Technique in Aesthetic Zone

20 patients with non-restorable anterior teeth underwent extraction with immediate implant installation using either the immediate implant with socket shield technique or the conventional immediate dental implant.

the socket shield technique group (study group): 10 patients will have immediate implant placement with the socket shield technique.

* conventional immediate dental implant technique (control group): 10 patients will have immediate implant placement with conventional technique.

20 patients with non-restorable anterior teeth underwent extraction with immediate implant installation randomized to two groups immediate dental implant with the socket shield technique group (study group): 10 patients will have immediate implant placement with socket shield technique.

* conventional immediate dental implant technique (control group): 10 patients will have immediate implant placement with conventional technique without socket shield technique.

preparation of shield: the root will be sectioned in a mesio-distal direction along its long axis, sectioning divided the tooth root into one facial third and two palatal thirds, Periotomes will then be inserted between the palatal root section and the alveolar socket wall to sever the PDL and this section of root was then carefully delivered so as not to disturb the facial root section, the remaining root section was then reduced coronally to 1 mm above the alveolar crest.

The tooth socket's palatal wall and apex will be then curetted to remove any tissue or infective remnants and the root section was checked for immobility with a sharp probe.

After completion of the previous steps, the tooth root here will be known as the socket- shield (SS). An osteotomy was then sequentially prepared according to manufacturer instructions and a suitable implant then inserted palatal to the SS.

Eligibility Criteria:
Inclusion Criteria:

- 1. Non restorable maxillary anterior teeth without periapical pathology that may affect the success of dental implants.

2. Interarch space enough for prosthetic rehabilitation. 3. Presence of posterior teeth or prosthesis that maintain occlusal bite. 4. Adult patients. 5. Good oral hygiene.

Exclusion Criteria:

- 1. Edentulous anterior maxillary region. 2. Bad oral hygiene. 3. Patients with any relevant systemic diseases that affect soft tissue or bone healing.

4. Patients with parafunctional habits (bruxism and clenching). 5. Uncooperative patients. 6. Heavy smokers.