cyrilzakka/clinical-trials huggingface dataset:
Complementary Study of the Duration of Post-vaccination Against Yellow Fever Immunity in Children

In a previous study by the researchers' group, the researchers' investigate the duration of yellow fever post-vaccination immunity in vaccinated children between 9 and 23 months of age. However, in this study, samples of children in the pre-vaccine period, also known as unvaccinated children samples (NV) have not been investigated. It is believed that to seek evidence about the immune status in the medium and long term after vaccination against yellow fever is necessary to investigate paired samples of children not vaccinated (NV), with re-evaluation 30-45 days after primary vaccination. The proposed study is to consolidate aspects of humoral (neutralizing antibodies) and cellular (phenotypic and functional parameters of T cells and memory B) by means of complementary longitudinal investigation children, 9-23 months old, unvaccinated (NV) and 30-45 days after primary vaccination.

A sample of 60 children aged 9 to 23 months paired in the pre-vaccine period (NV) and 30-45 post-primary vaccination days will be selected at health facilities in the metropolitan region of Belo Horizonte.

Children whose mothers consent to participate in research, have collected blood and elements of past medical history recorded. Analyses of humoral and cellular biomarkers will be used in a comparative study with other post-vaccination periods previously analyzed in children during the first phase in study funded by the Ministry of Health.

specific objectives:

1. Estimate and compare the proportion of positivity and the geometric mean plasma titers of neutralizing antibodies against yellow fever;
2. Assess lymphocyte frequency T and B memory induced in vitro by the vaccine antigen 17DD substrains, and...
3. Quantify the lymphocytes T CD8 + producers of intracytoplasmic cytokines induced in vitro by the vaccine antigen 17DD substrains in unvaccinated children and primed aged between 9 and 23 months, categorized according to the vaccination time 30-45 days.

Eligibility Criteria:
Inclusion Criteria:

Will be eligible for the study:

* children 9-23 months of age;
* both sexes;
* children who will be vaccinated against yellow fever, whose parents or guardians sign the consent form.

Exclusion Criteria:

* children who received another vaccine within 30 days before or after the yellow fever vaccine;
* children which have permanent or temporary immunosuppression, including those treated with corticosteroids at doses higher than 2 mg / kg, and those with disease autoimmune diseases, transient or permanent immunosuppression induced diseases (cancer, AIDS, etc.) or treatment (immunosuppressive drugs, radiotherapy, etc.). Corticosteroids (such as prednisone, dexamethasone) for less than two weeks, or by inhalation or topical use, do not indicate exclusion from the study, but must be registered in the questionnaire (Annex II);
* children with hemoglobinopathies;
* children with a history of blood transfusion or treatment with hyperimmune serum up to 90 days prior to blood collection.
A Prospective, Observational Cohort Study on the Clinical Impact of Novel Monoclonal Antibodies in B-cell Non-Hodgkin Lymphoma in Italian Clinical Practice

This is a prospective, observational cohort study to evaluate the clinical impact of novel Monoclonal AntiBodies (MAB) in B-cell Non-Hodgkin Lymphoma (NHL) in Italian clinical practice.

This is a large prospective, observational cohort study aimed at collecting clinical information on use, feasibility, short- and long-term efficacy and short- and long-term toxicity of novel MAB that have received approval from EMA since 2020 and are prescribed according to the indications for use authorized for marketing in Italy.

Patients entering the study will be subdivided into different cohorts based on approved treatment indications, type of antibody employed and histological subtype. Additional sub-cohorts will be defined if needed.

Final outputs will be based according to:

* Per indication analysis;
* Pooled analyses by type of antibody and subtype and other parameters;
* A general analysis of the whole cohort.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of B-cell NHL and need of treatment (as per guideline indications), both first-line and relapsed or refractory.
* Patients aimed to be treated in indication with a "novel" MAB (alone or in combination) based on presence of an EMA clinical indication since 2020 and prescribed according to the indications for use authorized for marketing in Italy.
* Signed written informed consent.

Exclusion Criteria:

* Being involved in a prospective interventional trial outside indication.
* Patients treated outside approved indications:

  * 648-approved indication.
  * 5% AIFA support.
  * Compassionate use.
* Age less than 18 years.
* Inability to provide an informed consent.
Fycompa Titration Intervals and Effects on Retention Rate

This study will aim to improve retention and tolerability by slowing the initial titration rate of perampanel from a standard up-titration rate of 2 week intervals to a slower up-titration rate consisting of 3 week intervals. Subjects will be randomized to either perampanel, standard titration interval rate (Group A) or perampanel, slower titration interval rate (Group B).

A total of 60 subjects with a confirmed diagnosis of either partial onset or primary generalized epilepsy will be recruited into the trial. 30 subjects will initiate perampanel at a dose of 2 mg/day and titrate upwards every 2 weeks to a target dose of 6 mg/day. Subjects in this group will be designated Group A. The remaining 30 subjects will also begin perampanel at a dose of 2 mg/day but will titrate upwards every 3 weeks to a target dose of 6 mg/day and will be designated Group B.

Eligibility Criteria:
Inclusion Criteria:

1. Must provide written informed consent signed by the subject or legal guardian prior to entering the study in accordance with ICH and GCP guidelines.
2. Subject has a confirmed diagnosis of medically refractory epilepsy with or without secondary generalization for at least 12 months prior to visit 1.
3. Subjects currently being treated with 1 to 3 antiepileptic medications with or without VNS (does not count as an AED).
4. Subjects aged 18 to 75.
5. Subject's requiring an additional epilepsy medication due to either uncontrolled seizures and/or lack of tolerability with current epilepsy medications.
6. Can be safely treated, in the opinion of the investigator, with Fycompa.
7. Able and agrees to follow the specified titration schedule.
8. Subjects or a legal guardian who is able to communicate effectively with study personnel and considered reliable, able, willing and cooperative with regard to complying with protocol-defined requirements, including completion of the study diary.

Exclusion Criteria:

1. Any history of non-epileptic or psychogenic seizures.
2. Women who are currently pregnant, lactating or have plans to become pregnant in the immediate future.
3. Subjects with active suicidal ideation or behavior as evidenced by positive answers on the Columbia Suicide Severity Rating Scale (C-SSRS) or subject's with a history of suicidal ideation or attempt within 12 months.
4. Subjects with a suicidal attempt in the 12 months prior to Visit 1
5. Any clinically significant medical or psychiatric illness, psychological or behavioral problems, which in the opinion of the investigator would interfere with the subject's ability to participate in the study.
6. Subjects with severe hepatic impairment or severe renal impairment or on hemodialysis.
7. Any use of concomitant medication as listed in the drug insert, including medications known to be inducers of cytochrome P450 (CYP3A).
Bioavailability of Three Oral Formulations for Hormone Replacement Therapy in Postmenopausal Women

This trial is conducted in Europe. The aim of this trial is to determine the extent of bioavailability of two low dose estradiol/norethisterone acetate (NETA) preparations with a marketed estradiol/norethisterone acetate (NETA) preparation.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Postmenopausal
* Caucasian race
* Smoking (up to 5 cig./per day) is allowed
* Good state of health: evidenced by medical history, physical examination including gynecological examination, results of laboratory examination

Exclusion Criteria:

* Known or suspected allergy to trial products or related products
* Previous participation in this trial
* Previous estrogen and/or progestin hormone replacement therapy
* Known, suspected or history of breast cancer
* Systolic blood pressure (BP) at least 160 mm Hg and/or diastolic BP at least 100 mm Hg, currently treated or untreated
* Body Mass Index (BMI) above 35.0 kg/m\^2
Bronx Transthyretin Amyloid Cardiomyopathy Database

Transthyretin amyloid cardiomyopathy (ATTR-CM) is a commonly undiagnosed and potentially fatal disease. Contemporary studies on this condition often underrepresent the female gender and diverse patient populations. This registry retrospectively evaluated patients referred for 99mTc-pyrophosphate (PYP) Single Photon Emission Computed Tomography (SPECT) between 2014 and 2023 at Montefiore-Einstein in the Bronx. The patient population is racially and ethnically diverse and with a high proportion of females. Demographic, clinical (e.g. comorbidities), laboratory, echocardiographic, hospitalization, and mortality data were collected for each patient.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients referred for PYP SPECT at Montefiore Medical Center between 2014 and 2023

Exclusion Criteria:

* Did not have a transthoracic echocardiogram in our medical records
A Long-term Extension Study of Riociguat in Patients With Symptomatic Pulmonary Arterial Hypertension.

To provide riociguat therapy to eligible patients with PAH originating from Bayer-sponsored trials with BAY63-2521/ Riociguat / Adempas® who are currently or recently treated in these trials until lack of patient benefit as assessed by investigator, or commercial availability and reimbursement.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Pulmonary Arterial Hypertension (PAH) participating or having participated in the Bayer-sponsored studies 12935, 16719 or 18588, who have completed the main study phase and are still being treated with riociguat (either while still being on treatment with the respective study drug or by commercial means with Adempas) and who, in the opinion of the investigator, are expected to continue to have an overall positive benefit/risk from continuing treatment.
* Women and men of reproductive potential must agree to use adequate contraception when sexually active. This applies for the time period between signing of the informed consent form and 30 days after the last administration of study drug.

Exclusion Criteria:

* Ongoing serious adverse event (SAE) from originating study that is assessed as related to riociguat
* Pregnant women or breast-feeding women
* Any contra-indication to Adempas treatment listed in the BAY63-2521 / Riociguat Investigators's Brochure
* Concomitant participation in another clinical study with the study drug
* Patients with pulmonary hypertension associated with idiopathic interstitial pneumonia (PH-IIP)
Evaluation of a Specialized Therapeutic Care of Patients Presenting an Intolerance Attributed to Electromagnetic Fields

The purpose of the study is to evaluate efficacy of a 14 months follow-up and individual medical care of electro-sensitive patients: by measurement of health status, sensitivity to electromagnetic fields exposures, and quality of life.

110 patients suffering from Idiopathic Environmental Intolerance attributed to electromagnetic fields (IEI-EMF) are expected in this trial.

Type of trial: Interventional multicenter study, non-randomized, with measurement before and after intervention. Each patient is his own control.

Primary outcome: Efficacy of an individual medical care on electro sensitive (IEI CEM) patients evaluated from the improvement of health status, sensitivity to electromagnetic fields (EMF) exposure, and quality of life.

Scheme:

Visit 1(T0): Patients undergo a specialized medical examination: a standardized medical record is filled in. Physicians evaluate the psychological impact of IEI-EMF and a psychotherapeutic care is proposed if necessary. Patients fill in 2 self-questionaries: quality of life (SF-36) and EMF exposure sensitivity.

After the visit 1, a symptoms self-administrated questionary n°1 is completed during 7 days.

1 month after inclusions (T1), radiofrequencies (RF) are recorded by a dosimeter worn by patients for 7 days; patient fill-in the symptoms self-administrated questionary n° 2 during the same time.

Visit 2: 6 months after inclusion, analysis of symptoms and RF exposure is restituted at patient. An adapted care is proposed.

12 months after inclusion (T12), patients complete the symptoms self-administrated questionary n°3.

Visit 3: 14 months after inclusion (T14), patients have medical examination and complete the quality of life and EMF exposure sensitivity self-questionaries. Standardized medical record is filled in by physicians. Patient and physician discuss the global and comparative analysis of individual results.

Inclusion duration: 24 month; Follow-up: 14 months; Study duration: 38 months.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who declare themselves to be intolerant to electromagnetic fields
* Subjects over 18 years old
* Subjects affiliated to a social security scheme
* Subjects who signed the consent form

Exclusion Criteria:

* Subject with a disorder of the understanding of the French language at the discretion of the investigator
* Pregnant women,
* Persons deprived of their liberty, persons under guardianship, and persons in emergency situations.
The Effect of Metformin on Composition of Human Gut Bacteria

OBJECTIVE: Investigate structural changes in the human gut microbiota and associated changes in metabolic markers in urine, saliva, blood and fecal samples following metformin treatment.

DESIGN: An, 18 week, one-armed cross over intervention trial consisting of a 6-week pre-intervention period, 6-week intervention period and a 6-week post-intervention period. 25 healthy young men will be included in the trial.

INTERVENTION: Six-week Metformin treatment to young healthy men.

An, 18 weeks, one-armed cross over intervention trial consisting of a 6-weeks pre-intervention period, 6-weeks intervention period and a 6-weeks post-intervention period. 25 healthy young men will be included in the trial. The pre-intervention period is the control period with no treatment. During the intervention period participants will receive 500 mg of metformin once daily the 1st week, then 500 mg twice daily the 2nd week, 1000 mg + 500 mg daily the 3rd week and 1000 mg + 1000 mg daily the remaining three weeks. Post-interventional investigators will examine gut microbiota of the participants 6 weeks after completion of the intervention period.

MESUREMENTS: Altered composition of gut microbiota as investigated by 16S rRNA sequencing is the primary outcome of this study. Secondary outcomes are to investigate changes in metabolic and inflammatory markers in blood and fecal samples. Blood, urine, saliva and fecal samples will be stored for future studies.

Eligibility Criteria:
Inclusion Criteria:

* Male
* HbA1c \< 5.7 % (39 mmol/mol)
* Caucasian (self-report of parental ethnicity)
* Weight stabile with 18.5 kg/m2 \< BMI \< 27.0 kg/m2
* Normal kidney function as evaluated by normal p-creatinine for age

Exclusion Criteria:

* Oral intake of any form of prescribed medication two months prior to recruitment
* Chronic or acute illness
* Previous gastro-intestinal operation excluding appendicitis
* Any other significant medical reason for exclusion as determined by the investigator
* Unable to give informed consent
* Need of medical treatment during the study period
Memantine and Postoperative Pain

Memantine is associated with improvement in pain relief after surgery.

This prospective, randomized, controlled trial will investigate whether perioperative memantine has a postoperative analgesic effect following radical retropubic prostatectomy (RRP). 100-110 patients scheduled to undergo RRP at Duke will be assessed preoperatively for allodynia using Von Frey filaments, then stratified into two groups based on the presence or absence of allodynia. Patients in each group will then be randomized to receive either memantine 20 mg or placebo 30-60 minutes preoperatively, followed on postoperative day 1 with either memantine 10 mg in the morning and 10 mg in the evening for memantine patients, or placebo at the same intervals for placebo patients. Data such as morphine consumption, patient satisfaction and pain scores, opioid-related side effects, and the area of hyperalgesia around the surgical incision will be recorded for the initial 48 hours postoperatively, and patient satisfaction with their postoperative analgesia will be assessed after 1 week. At 1, 3, and 6 months postoperatively, patients will be asked about the presence and intensity of any persistent pain related to surgery.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Age 18 to 75 years old

Exclusion Criteria:

* Chronic pain conditions or taking regular analgesics
* Taking psychotropic medications
* Parkinson's disease
* Narrow-angle glaucoma
* Known gastroduodenal ulcer
* History of seizure disorder
* Renal insufficiency, as defined by serum creatinine greater than 2 mg/dL
* Liver disease, including liver failure, cirrhosis, or acute hepatitis
* Significant coronary vascular disease or cardiac conduction system disease, as noted by ECG or history of cardiac symptoms, or cardiac ejection fraction less than 30%
* American Society of Anesthesiologists (ASA) score of 4 or higher
* Allergy to ketorolac or memantine
Relationship Between Prophylactic Drainage and Postoperative Complications (PPOI) in Crohn's Patients After Surgery

For patients with Crohn's diseases，whether prophylactic abdominal drainage is necessary need further exploration. the present study is focusing on the necessity of prophylactic abdominal drainage in CD patients after surgery.

In the past decades, surgical dogma meant the correct placement of a prophylactic drain, with the aim of reducing the incidence of anastomotic leakage, decreasing the needs of reoperation and avoiding potential postoperative ascites. However, recent randomized controlled trials (RCTs) and meta-analyses have suggested that prophylactic peritoneal drains have no benefits on postoperative outcomes.

Crohn's disease (CD), which is definitely different from CRC, is a chronic inflammatory disease with unknown pathogenesis. CD itself was the independent risk factor of multiple postoperative complications, including anastomotic leakage, intraperitoneal abscess and catheter-associated bloodstream infection.

In the present RCT, we hypothesize that non-prophylactic peritoneal drainage is associated with increased incidence of postoperative non-septic complications.

Eligibility Criteria:
Inclusion Criteria:

* Stricturing CD patients with American Society of Anesthesiologists (ASA) score of 1 to 2 undergoing elective small bowel or ileocecal resection and anastomosis.

Exclusion Criteria:

* Coexisting penetrating disease (fistula, abscess or phlegmona), enterostomy, strictureplasty only, short bowel (less than 150 cm), preoperative hypokalemia, diabetes or hyperglycemia (fasting plasma glucose \>126 mg/dL), as well as chronic systemic disease of cardiovascular, respiratory et al.
* Patients who received ≥20 mg/d prednisolone or equivalent for over 6 weeks within 4 weeks before surgery; patients who received steroids, biologics or gastrointestinal motility drugs within 4 w prior to surgery; patients who remained on steroids within 1 day before surgery.
Evaluation of Fluid Resuscitation in Shocked Patients by Electrical Cardiometry in Comparison to Transthoracic Echocardiography.

The aim of this study is to evaluate the diagnostic accuracy of electrical cardiometry (EC) for the noninvasive determination of fluid responsiveness in critically ill shocked patients and agreement of EC compared to transthoracic echocardiography (TTE)

Electrical cardiometry (EC), based on thoracic electrical bioimpedance, can measure SV continuously and non-invasively. The EC"s working principle of estimation of SV is to utilize changes in thoracic electrical impedance, which is mainly influenced by erythrocyte orientation and peak flow velocity in the ascending aorta throughout the cardiac cycle.

Electrical cardiometry (EC) has been validated to monitor SV and other hemodynamic parameters non-invasively compared to different techniques such as thermodilution technique, transesophageal Doppler echocardiography and cardiac catheterization including critically ill patients, intra-operative settings, in pregnant women, in children with congenital heart diseases, even in obese children

Eligibility Criteria:
Inclusion Criteria:

* Age from 25 to 65 years old.
* Both sexes.
* Patients with clinical criteria of shock \[mean arterial pressure (MAP) ≤ 65 mmHg and tissue hypoperfusion (ScvO2 \<70%, P(cv-a) CO2 ≥6 mmHg, CRT ≥4 s and lactate \>2mmol/l).

Exclusion Criteria:

* Refusal to sign the consent by a first degree relative.
* Previous cardiac disease, rhythm other than sinus rhythm or heart rate \> 140 beat/min.
* Renal failure (acute or chronic).
AZD 2066 Single Dose Formulation and Food Effect Study in Healthy Volunteers

A open label two way crossover formulation and food effect study in healthy volunteers to assess the pharmacokinetics of a single dose of AZD2066 new oral solid formulation and an oral solution


Eligibility Criteria:
Inclusion Criteria:

* Clinical normal physical findings, including BP, pulse rate \>45 bpm, ECG and laboratory assessments
* Body Mass Index (BMI) of ≥18 to ≤30 kg/m2 and weight of ≥50 to ≤100 kg

Exclusion Criteria:

* History of hypersensitivity, allergy or atopic/skin disease as judged by Investigator.
* History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study as judged by the Investigator.
Single-dose Iloperidone Pharmacokinetics in Patients With Mild or Moderate Liver Disease, Compared to Healthy Volunteers

This study aims to determine the pharmacokinetic profile and the tolerability of iloperidone in subjects with mild or moderate hepatic impairment comparatively to healthy matched subjects


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria (all subjects):
* Caucasian subjects
* Inclusion criteria (hepatic impaired subjects):
* subjects with physical signs consistent with a clinical diagnosis of stable liver disease, which has been confirmed by imaging techniques, ultrasound, Magnetic Resonance Imaging or Computed Tomogram within 3 months of screening, and a creatinine clearance \> 50 mL/min (based on Cockroft and Gault formula).
* Inclusion criteria (healthy volunteers):
* good general health
* matched by age, gender, smoking status, Body Mass Index, and CYP2D6 phenotype to hepatic impaired subjects.

Exclusion Criteria:

* Exclusion criteria (all subjects):
* Subjects who report smoking a pipe, cigars or more than 20 cigarettes per day .
* History of drug abuse as defined in Diagnostic and Statistical Manual of Mental Disorders, Diagnostic Criteria for Drug and Alcohol Abuse, within the 12 months prior to screening
* History of first-dose response/syncope to alpha1-blocking agents
* Exclusion criteria (Hepatic impaired subjects):
* Patients with symptoms or 6 months past history of encephalopathy.
* Patients with clinical evidence of moderate-severe ascites.
* Patients having a previous surgical porto-systemic shunt.
* Exclusion criteria (Healthy volunteers):
* History of alcohol abuse prior to dosing, or evidence of such abuse during screening.
* Pulse Rate \> 200 msec

Other protocol-defined inclusion/exclusion criteria may apply