cyrilzakka/clinical-trials huggingface dataset:
Effect of Consuming a Mixture of Extracts and DHA on the Mild Cognitive Impairment

The objective of this trial is to evaluate the effect of the consumption of a mixture of extracts and DHA on the mild cognitive impairment.

According to the World Health Organization, around 50 million people in the world have dementia, so developing new strategies to prevent cognitive impairment is an important aspect.

Certain plant extracts have properties related to the improvement of brain function. In addition, adequate levels of DHA are essential for good cognitive functioning throughout the life cycle.

Therefore, the objective of this trial is to evaluate the effect of the consumption of a mixture of extracts and DHA on the mild cognitive impairment.

Eligibility Criteria:
Inclusion Criteria:

* Men and women over 50 years of age at the time of the screening visit.
* Mild cognitive impairment according to multidomain criteria.
* Mini Mental State Examination (MMSE) ≥21.
* Availability of an accompanying who is responsible for the patient taking the study product and attending visits.
* Patients and accompanying who agree to sign the informed consent before performing any study procedure and after they have been informed about the methods and limitations of the study.

Exclusion Criteria:

* Inability to perform neurocognitive tests.
* Intake currently (or in the two weeks prior to the start the study) of nutraceuticals that may alter the results of the study: vitamin complexes, omega-3 supplements, omega-3 fortified foods, ginkgo supplements, or any other specific supplement for memory improvement.
* Consumption of anti-dementia drugs such as memantine or cholinesterase inhibitors (ICE).
* Consumption of benzodiazepines in unstable doses.
* Severe psychiatric pathology.
* Allergy to any of the ingredients of the study product or placebo (lactose intolerance, intolerance to milk protein or allergy to any of the extracts used).
A Trial on Different Dosages of Vitamin D in Preterm Infants With Late-onset Sepsis

This is a randomized controlled trial (RCT) to evaluate the influence of different doses of vitamin D3 (800 IU/d versus 400 IU/d), on serum levels of interleukin (IL)-6, TNF-alpha and C- reactive (CRP) in premature infants with clinical evidence of late-onset sepsis and to assess its influence on clinical outcomes of these infants.

Vitamin D has an important role in the regulation of both the innate and adaptive immune systems. There are very few studies of such roles in the neonatal population. It is potentially an attractive therapeutic agent for sepsis given its low cost and low risk of toxicity and side effects. There is no consensus regarding to the dose of vitamin D supplementation required for preterm infants given the paucity of evidence. AAP and ESPGHAN have recommended different dosages of vitamin D ranging from 400 IU to 1000 IU per day. The influence of different doses of vitamin D on immunological status and clinical outcomes of preterm infants with late-onset sepsis has not been evaluated before. This RCT will evaluate the influence of different doses of vitamin D3 (800 IU/d versus 400 IU/d), on serum levels of interleukin (IL)-6, TNF-alpha and C- reactive (CRP) in premature infants with clinical evidence of late-onset sepsis we will also evaluate their safety and influence on clinical outcomes of these infants

Eligibility Criteria:
Inclusion Criteria:

* Preterm Infants (28-37 wk gestational age)
* Late-onset sepsis defined as clinical signs suggestive of infection after 72 h of birth. Clinical sepsis will be defined as the presence of three or more of the following categories of clinical signs:

  1. Temperature instability (hypothermia, hyperthermia);
  2. Respiratory (grunting, intercoastal retraction, apnea, tachypnea, cyanosis);
  3. Neurologic (hypotonia, lethargy, seizures);
  4. Gastrointestinal (feeding intolerance, abdominal distension).

Exclusion Criteria:

* Major congenital anomalies.
* Chromosomal anomalies.
* Known inborn error(s) of metabolism
Cerebral Oximetry for Carotid EEA

Aim oft he study is to compare two different devices for cerebral oximetry (FORE-SIGHTTM Monitor (CAS Medical Systems, Branford, Connecticut, USA and INVOSTM Somanetics, Troy, Michigan, USA) in patients undergoing surgical carotid thrombendarterectomy (cTEA) with crossclamped internal carotid artery (ACI). All procedures will be performed in regional anesthesia, therefore the patients will be awake and direct neurological examination during the procedure will be possible, giving information how the drop in cerebral saturation (measured with INVOS and FORESIGHT both on the same patient) correlates with any clinical symptoms.

We expect to see a difference in the total drop and in the delay of the drop of cerebral oxygen saturation, making it possible to detect varieties in specificity and sensitivity of both devices compared to neurologic examination in the awake patient.


Eligibility Criteria:
Inclusion Criteria:

- Patients with electively scheduled carotid thrombendarterectomy in regional anesthesia

Exclusion Criteria:

* refusing participation
* age \<18 years
* pregnancy
* any contraindication to regional anesthesia or the use of NIRS
* participation in any other study affecting the study protocol
A Study to Evaluate the Safety and Immunogenecity of LBVE(Multivalent Pneumococcal Conjugate Vaccine) in Healthy Infants

The purpose of this study is to evaluate the safety and immunogenicity of LBVE (Multivalent Pneumococcal Conjugate Vaccine) in healthy infants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy infants of either sex who have reached at least 42 days (6 weeks) of age and not more than 56 days (8 weeks) of age at the time of enrollment.
* The parents or LAR(Legally authorized representative) able to understand and comply with planned study procedures.
* Signed informed consent by subject's parents or LAR(Legally authorized representative)

Exclusion Criteria:

* Previously received any pneumococcal vaccine
* Receipt of immunoglobulin or blood-derived product before the study
* Known or suspected immune disorder, or received immunosuppressive therapy
* Known major congenital malformation or serious chronic disorder
* Participation in another interventional trial
EUS-FNA for Retropharyngeal Lymph Node (RPLN) in Recurrent Nasopharyngeal Carcinoma (NPC) Patients

EUS-FNA for RPLN in NPC

To evaluate the safety and efficacy of a novel minimally invasive sampling technique -- fine needle aspiration (FNA) guided by endoscopic ultrasound (EUS), which aims to sample tissues from retropharyngeal lymph nodes (RPLN) for the diagnosis of patients with suspected recurrent nasopharyngeal carcinoma (NPC).

Eligibility Criteria:
Inclusion Criteria:

1. had undifferentiated, non-keratinizing carcinoma at the initial diagnosis (WHO, 1991 criteria) and no evidence of distant metastasis obtained before radiotherapy;
2. received regular chemotherapy with cytotoxic agents such as cisplatin, carboplatin, 5-fluorouracil, paclitaxel, etc, and coordinated with radiotherapy with standard doses (approximate 50-70 Gy) in nasopharynx and neck respectively. Within 3 months after radiotherapy, no local and distant lesions were found;
3. during regular follow-up , the enlarged RPLN was detected by MRI more than 6 months later since radiotherapy accomplished;
4. didn't receive chemotherapy radiotherapy, immunotherapy or salvage surgery from completion of radiotherapy to suspicious recurrent lesion in RPLN detected;
5. no recurrent lesion in nasopharynx was found by white light endoscopy as well as cancer cell negative in pathology by bite biopsy;
6. single lesion in RPLN, and no other recurrent or metastatic lesion was found in local region or distant organ.
7. the minimum axial diameter of RPLN was more than 5mm.

Exclusion Criteria:

* (1) patients with nasal stenosis; (2) patients with coagulation dysfunction; (3) patients with distant metastasis
Post Stroke Motor Learning

Noninvasive brain stimulations (NIBS) will be used in chronic stroke patients to improve motor learning.

Functional magnetic resonance imaging will be used to evaluate the mechanisms underlying motor learning in healthy volunteers and in chronic stroke patients.

transcranial direct current stimulation will be used for NIBS

Eligibility Criteria:
Inclusion Criteria:

* stroke with at least slight deficit

Exclusion Criteria:

* epilepsy
* contraindication to tDCS and/or to fMRI
* presence of metal in the head
* inability to understand / complete behavioral tasks
* chronic intake of alcohol or recreational drugs
* major health condition
* presence of pacemaker (for the fMRI part only)
* pregnancy
Efficacy and Safety Study of a Test Naproxen Sodium 220mg Tablet in Postoperative Dental Pain

To evaluate analgesic onset, efficacy, and safety of a single dose of 440 mg of naproxen sodium administered as two Test Naproxen Sodium 220 mg tablets compared with two commercial naproxen sodium products (two naproxen sodium 220 mg tablets and two naproxen sodium 220 mg liquid gels capsules) and placebo in the dental pain model following third-molar extractions.

This is a single-dose, randomized, double-blind, placebo- and active- controlled, parallel-group study to evaluate the analgesic onset, efficacy, and safety profile of 440 mg of naproxen sodium administered as two Test NPX 220 mg tablets compared with two commercial products and placebo over a twelve-hour period after third-molar extractions. Subjects will undergo dental extraction of three or four third molars.

Eligibility Criteria:
Inclusion Criteria:

1. 17 - 50 years old
2. Weigh 100 pounds or greater and have a body mass index (BMI) of 17.5 to 30.4 (inclusive) at screening
3. Dental extraction of three or four third molars
4. Meets post-surgical pain
5. Females of childbearing potential and males agree to contraceptive requirements of study
6. Have a negative urine drug screen at screening, and on day of surgical procedure

Exclusion Criteria:

1. Pregnant female, breastfeeding, trying to be pregnant or male with pregnant partner or partner currently trying to become pregnant
2. Have a known allergy or hypersensitivity to naproxen or other NSAIDs, including aspirin, or to acetaminophen, hydrocodone or other opioids
3. Not able to swallow large tablets or capsules
4. History of any condition (s) in investigator's opinion, may jeopardize subject safety, well-being and integrity of study
5. Use analgesics 5 or more times per week
6. History of chronic tranquilizer use, heavy drinking, substance abuse as judged by investigator site staff within last 5 years
7. Use of immunosuppressive drugs within 2 weeks of screening
8. History of endoscopically documented peptic ulcer disease or bleeding disorder in last 2 years
Study of a pd VWF/FVIII Concentrate, Biostate®, in Subjects With Von Willebrand Disease

The aim of this study is to assess the pharmacokinetics (PK), efficacy, and safety of Biostate® in subjects with Von Willebrand Disease (VWD).

Pharmacokinetic Component:

PK parameters will be determined from a subgroup of subjects. Subjects who complete the PK component will subsequently continue in the efficacy component of the study, either continuing on a previously established prophylaxis regimen or continuing to receive on-demand treatment with the occurrence of non-surgical bleeding (NSB) events.

Efficacy Component:

Three treatment arms are defined for the efficacy component of the study. (1) Subjects who are currently being treated on a set prophylaxis regimen with a VWF product at the time of study entry will be enrolled in the "Prophylaxis" arm. (2) Subjects not being treated on a set prophylaxis regimen at the time of study entry who require a VWF product for the treatment of NSB events will be enrolled in the "On-demand" arm and commence using Biostate in the treatment of NSB events. (3) Subjects enrolled in the "On-demand" arm have the possibility to enter the "Cross-over to Prophylaxis" arm to receive an additional 12 months of prophylactic treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with VWD
* Desmopressin acetate (DDAVP) treatment is ineffective or contraindicated or not available
* Evidence of vaccination against hepatitis A and B (or presence of antibodies against hepatitis A and B) within 10 years prior to their first dose of Biostate®
* Written informed consent given

Exclusion Criteria (for participation in the PK component):

* Actively bleeding immediately prior to initial PK period
* Have received DDAVP or a VWF product in the 5 days prior to their first dose of study product
* Have Type 2B, 2N or 2M VWD

Exclusion Criteria (for all subjects):

* Requiring a VWF product for a planned surgical procedure at enrolment
* Have received aspirin or other non-steroidal anti-inflammatory drugs within 7 days prior to their first dose of study product
* Known history of, or are suspected to have, VWF or FVIII inhibitors
* Suffering an acute or chronic medical condition, other than VWD, which may affect the conduct of the study
* Known or suspected hypersensitivity or previous evidence of severe side effects to Biostate®, VWF/FVIII concentrates, or human albumin
* Impaired liver function at screening
* Evidence or a history (within the previous 12 months) of abuse of any drug substance, licit or illicit
* Participation in a clinical study or use of an investigational compound in the 3 months preceding the first day of study drug administration, or plans to enter such a study during the study period.
* Females who are pregnant, breast-feeding or who have a positive pregnancy test at screening
Study on the Safety of BAY 63-2521, How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Study Drug Given as a Single Oral Dose of 1 mg Tablet in Participants With Renal Impairment and Healthy Participants Matched for Age-, Gender-, and Weight

BAY 63-2521 is intended to be used for a disease that affects the blood flow through the lungs. Renal impairment is a common condition in patients with this disease. The goal of the study is to learn more about the safety of BAY 63-2521, how it is tolerated and the way the body absorbs, distributes and gets rid of the study dug given as a single oral dose of 1 mg tablet in participants with renal impairment and healthy participants matched for age-, gender-, and weight


Eligibility Criteria:
Inclusion criteria for all subjects:

* Male and female white subjects with 18 to ≤79 years of age, BMI between 18 and 34 kg/m\^2
* Women without childbearing potential or with childbearing potential but only if the pregnancy test is negative and are under highly effective contraception

Inclusion criteria for subjects with renal failure:

- Stable renal disease, ie. a serum creatinine value determined at least 3 - 6 months before the pre-study visit was not allowed to vary by more than 20% from the serum creatinine value determined at the pre-study visit

Inclusion criteria for healthy subjects:

- Mean age and body weight not allowed to vary by more than +/- 10 years and +/- 10 kg from the subjects with renal impairment, respectively

Exclusion criteria for all subjects:

* Febrile illness within 1 week before the start of the study
* Hypersensitivity to riociguat and / or to inactive constituents
* Smoking

Exclusion criteria for subjects with renal failure:

* Resting heart rate in the awake subject below 45 BPM or above 90 BPM
* Acute renal failure or nephritis
* Any organ transplant
* Diastolic blood pressure (DBP) \>100 mmHg and / or systolic blood pressure (SBP) \>180 mmHg
* Hemoglobin \<8 g/dL, Proteinuria \>8 g/24 hours, Serum albumin \<30 g/L, Platelet count \<100 x 109/L
* History of bleeding within the past 3 months
* Diabetes mellitus with a fasting blood glucose \>220 mg/dL or HbA1c \>10%
* Concomitant use of any medication except medications necessary for the treatment of the kidney disease or related complications
* Concomitant use of phosphodiesterase-5 inhibitors, endothelin receptor antagonists (ERAs, eg bosentan), intravenous or inhalative prostacyclins, or nitrates
* Concomitant use of potent CYP3A4 inhibitors

Exclusion criteria for healthy subjects:

* Conspicuous findings in medical history or pre-study examination
* History of relevant diseases of vital organs, central nervous system, or other organs
* SBP below 100 mmHg or above 145 mmHg and / or DBP above 95 mmHg
* Regular daily consumption of more than 1 liter of usual beer or the equivalent quantity of approximately 40 g of alcohol in another form
Health Responsibility and Family Planning ın Immigrant Women (Ahıska Turks).

Purpose: The aims of the research are to determine the effects of individual trainings on family planning given to migrant women (Ahıska Turks), repetitive trainings via mobile applications, telephone counseling initiatives on women's health responsibility levels, family planning knowledge and attitudes.

Design: This pretest-posttest is an interventional quasi-experimental research. Method: Standard protocol Items: Recommendations for Interventional Trials (SPIRIT) Statement 2013 checklist is used in this study. The CONSORT (Consolidated Standards of Reporting Trials) flowchart is used in this protocol. This study will be carried out with immigrant (Ahıska Turks) women between the ages of 15-49 who are registered in Üzümlü Family Health Center in Üzümlü district of Erzincan province. In this study, individual training on family planning and health responsibility, repetitive training via mobile application and telephone counseling initiatives will be made. The same applications will be applied to the control group after the study data is collected.

Hypotheses: H1: Mobile applications for family planning, telephone counseling and individual training have an impact on the family planning attitudes of immigrant women.

H1: Mobile applications for family planning, telephone counseling and individual trainings have an impact on the family planning knowledge level of immigrant women.

H1: Mobile applications, telephone counseling and individual trainings for health responsibility have an impact on the level of health responsibility of migrant women.


Eligibility Criteria:
Inclusion Criteria:

* To be registered at the family health center
* Being literate
* Ability to communicate verbally
* Volunteering to participate in the research
* Owning a smartphone or a phone belonging to any member of the family that can also be used by the participant
* Having internet access at home or at work
* Internet use
* Able to speak and write Turkish
* Being a migrant woman in the age group of 15-49

Exclusion Criteria:

* Having a physical or mental health problem
* Menopausal, tubal ligation or spouse vasectomy
* Inability to reach by phone/visit
* Relocation of women to another place
* Illness and death of the sampled woman
* To have received training on effective family planning
Effect of Nitropaste in Chest Masculinizing Surgery

Nitropaste is a topical agent that contains 2% nitroglycerin. It is an effective vascular smooth dilator, with more powerful effect on venous vasculature than arterial vasculature. While its main indication is for angina pectoris, there have been many studies showing improved survival of axial and random pattern flaps. Furthermore, recent clinical studies highlight significantly decreased mastectomy flap wound complication and need for sharp debridement. Nitropaste has low rates of side effects and is very well tolerated in general. To this date, there's no study that investigates its utility on patients who are undergoing chest masculinizing surgery. The purpose of this study is to investigate the potential utility of nitropaste in reducing rates of wound complications in patients undergoing chest masculinizing surgery.

Nitropaste is a topical agent that contains 2% nitroglycerin. It is an effective vascular smooth dilator, with more powerful effect on venous vasculature than arterial vasculature. While its main indication is for angina pectoris, there have been many studies showing improved survival of axial and random pattern flaps. Furthermore, recent clinical studies highlight significantly decreased mastectomy flap wound complication and need for sharp debridement. Nitropaste has low rates of side effects and is very well tolerated in general. To this date, there's no study that investigates its utility on patients who are undergoing chest masculinizing surgery. The purpose of this study is to investigate the potential utility of nitropaste in reducing rates of wound complications in patients undergoing chest masculinizing surgery utilizing double incision with free nipple grafting technique. The investigators will conduct a prospective, randomized, single-blinded study and compare nitropaste vs. no nitropaste on mastectomy flaps. Nitropaste will be applied intraoperatively and the patients will not have to re-apply it. Follow up will occur on post-op day 5, 2 weeks, and 6 weeks during their routine postop visits. A study coordinator will document the condition of free nipple grafts and any other wounds at surgical site if present, which will be the primary outcome. Any complications including hematoma, seroma, infection, hypertrophic scarring, need for sharp debridement, 30 day ED visit or admission rates will be documented as secondary outcome.

Eligibility Criteria:
Inclusion Criteria:

* Any adult (18 or older) patients of any gender identity who are undergoing chest masculinizing surgery with double incision and free nipple grafting.

Exclusion Criteria:

* Minor patients (younger than 18)
* Anyone who's not getting free nipple grafting
* Anyone who's not utilizing double incision pattern
* Prisoners, anyone who is allergic to nitropaste
* Anyone who is taking phosphodiesterase inhibitor (ex)Sildenafil, tadalafil, vardenafil)
* Anyone who's taking soluble guanylate cyclase stimulator riociguatdz
Disposition of Intravenous Paracetamol in Young Women

Compared to early postpartum (10-15 weeks) observations, paracetamol clearance was significantly higher (21.1 vs 11.7 l.h-1, + 80 %) at delivery. This higher clearance was due to a disproportional increase in glucuronidation (11.6 vs 4.76 l.h-1, + 144 %), a proportional increase in oxidation clearance (4.95 vs 2.77 l.h-1, 78 %) and primary renal clearance (1.15 vs 0.75 l.h-1, 53 %) \[KUlo et al, Int J Obstet Anesth\]. This increase in glucuronidation clearance may in part be driven by oestradiol, and may explain within and between individual differences in paracetamol metabolism (e.g. oral contraceptives, follicular vs luteal phase, postpartum, pregnancy, or duration of pregnancy) in young women.

Based on a pooled analysis, investigators aimed to further explore the impact of these covariates on paracetamol metabolism based on plasma and urine collections in women at delivery, in postpartum (early, or late) and healthy volunteers, either or not on oral contraceptives (OC) following intravenous (iv) paracetamol administration.

This study aims to perform a pooled analysis of:

1. Paracetamol PK data recently published in 47 pregnant women. In these cases, iv paracetamol was administered q6h after delivery (caesarean) for 24 h. 8 were recruited a second time for an additional single dose pK study in postpartum (Kulo et al, Br J Clin Pharmacol 2013).
2. The PK data as initially published by Gregoire et al, but limited to female volunteers, all on oral contraceptives (n=14) (Gregoire et al, Clin Pharm Ther 2007)
3. A dataset in 8 young women not on oral contraceptives, iv paracetamol, single dose.

Eligibility Criteria:
Inclusion Criteria:

1. informed consent
2. for patients (pregnant women at delivery), there has to be a clinical indication (post caesarean analgesia, NPO) to administer iv paracetamol.

Exclusion Criteria:

1. intolerance to paracetamol
2. withdrawal of informed consent.