cyrilzakka/clinical-trials huggingface dataset:
Phase IV Clinical Study of Immunogenicity of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector)

ACYW135 group meningococcal polysaccharide conjugate vaccine produced by Conchino Biologicals JSC is a covalent coupling conjugate of purified meningococcal podococcal polysaccharide of groups A, C, Y and W135 with CRM197 protein of diphtheria bacillus non-virulent mutant. The purpose of this clinical study is to evaluate the immunogenicity and immunopersistence of the ACYW135 meningococcal polysaccharide conjugate vaccine (CRM197 vector).

Meningococci are divided into 12 serogroups, and 95% of meningococcal cases are caused by serogroups A, B, C, X, W, and Y. Meningococcal epidemic flora can change, and the reasons are related to various factors such as meningococcal strain variation, human mobility transmission, and vaccination against different serogroups of meningococci, etc. The emergence of new serogroups of meningococci can cause the original vaccine to lose its immune protective efficacy and require a new vaccine immunization prevention strategy. the ACYW135 group meningococcal polysaccharide conjugate vaccine was approved in 2016 for a whole population The vaccine has been approved by the State Drug Administration for the prevention of epidemic meningoencephalitis caused by meningococci of groups A, C, W135 and Y in children from 3 months to 3 years of age (47 months of age).

Eligibility Criteria:
Inclusion Criteria:

* Children aged 6 to 23 months at the time of screening
* Volunteers who have not received any vaccine containing a epidemic encephalitis component or who have received only the group A polysaccharide flu vaccine and have been vaccinated more than 6 months since their last vaccination. 6 months or more between the last vaccination and the last vaccination
* The legal guardian or delegate has given informed consent, voluntarily signed the informed consent form, and is able to comply with the requirements of the clinical study protocol

Exclusion Criteria:

* Fever before inoculation, axillary temperature \>37.0℃
* History of epilepsy, convulsions or seizures or history of psychiatric disorders or family history
* During an acute illness episode; with a serious chronic illness or a condition that is in a progressive stage that cannot be smoothly controlled (or an acute episode)
* Known allergy to a component of the vaccine, especially to diphtheria toxoid
* Live attenuated vaccine received within 14 days or other vaccine received within 7 days prior to enrollment
* Other circumstances that, in the judgment of the investigator, make participation in this clinical study inappropriate
* Those who had a severe allergic reaction after the previous dose of vaccine
* Those with serious adverse reactions causally related to the previous dose of vaccination
* Newly identified or newly occurred cases after the first vaccination that do not meet the inclusion criteria for the first dose or meet the exclusion criteria for the first dose will be determined by the investigator whether to continue to participate in the study
A 4-Week Safety Study of Oral ELND005 in Young Adults With Down Syndrome Without Dementia

This is a prospective, randomized, double-blind, placebo-controlled, parallel-group, three-arm, multicenter study of the safety and PK of ELND005 administered orally for 4 weeks. This study will enroll Down Syndrome patients 18 to 45 years of age (inclusive) without dementia.


Eligibility Criteria:
Inclusion Criteria:

* 18 - 45 years of age
* Has an IQ of \> 40 (K-BIT)
* Able and willing to have a brain MRI

Exclusion Criteria:

* Symptoms of dementia or worsening cognition over the past year.
* Has a history of hepatitis B, hepatitis C, or HIV
Topical Brinzolamide Ophthalmic Suspension Versus Placebo in the Treatment of Infantile Nystagmus Syndrome

This study is a prospective, single crossover, double-masked, controlled clinical trial that will use topical brinzolamide (Azopt)ophthalmic medication to try to improve the nystagmus and visual consequences of nystagmus in patients with infantile nystagmus syndrome (INS). Subjects will undergo a clinical exam, questionnaire and eye movement recordings on day 1 and then receive either topical Azopt or placebo three times a day in both eyes for days 2,3 and 4 followed on the morning of day 5 by a repeat clinical exam, questionnaire and eye movement recordings. After at least one week, this protocol is repeated with the crossover regimen being taken by the subject. One week after all medications are discontinued, another clinical exam is done before study discharge. The hypothesis is that nystagmus and associated visual symptoms will be improved while on the Azopt compared to the placebo. There will be a total of 5 visits over a 1-2 month period.

5 subjects are expected to be enrolled in the study. Each subject will be in the study for approximately 1 month.

Efficacy will be assessed by:

* ETDRS Visual Acuity Testing of Binocular Best Corrected Visual Acuity In The Nystagmus Null Zone
* The Validated Amblyopia \& Strabismus Ocular Motor Questionnaire
* Eye Movement Recording Data Analysis of The Nystagmus Waveform

Safety will be evaluated by:

* Ocular signs and symptoms
* Visual acuity (uncorrected and best corrected)
* Slit lamp exam and Intraocular Pressure
* Systemic signs and symptoms

Eligibility Criteria:
Inclusion Criteria:

* Age; greater than 12 years old and able to cooperate for full study protocol
* Subject able to understand and sign informed consent
* Subject able to participate in complete ophthalmic and ocular motility evaluation
* Subjects with Infantile Nystagmus Syndrome diagnosed by clinical evaluation and eye movement recordings
* Best-binocular visual acuity in null position 20/50 to 20/200 inclusive using ATS or ETDRS vision testing
* Subject/family able and willing to make the required study visits
* No previous ophthalmic treatment for nystagmus other than for refractive error

Exclusion Criteria:

* Any current use of systemic or topical medications (traditional or non-traditional)
* History of ocular surgery, trauma or chronic ocular disease other than amblyopia
* Systemic diseases requiring medication or other treatments that are known to affect the ocular motor system (e.g., depression, seizure disorders, psychosis)
* Behavioral or neurological disorders which interfere with the study
* Physical or mental impairment precluding study compliance
* Participation in any study involving an IND investigational drug within the past year
* Individual (female) is pregnant, nursing or planning a pregnancy (The safety of Azopt for use during pregnancy has NOT been determined.)
* Periodicity or aperiodicity of INS present on eye movement recordings
* Allergy to sulfa or other components of Azopt solution
Comparation Analgesia Efficiency With Propofol Combine Sevoflurane vs Propofol

This study purpose to compare analgesia efficiency of propofol combine with sevoflurane with propofol only using index of Nociception (NOX)

1. Recently study found sevoflurane plays an important role through spinal nerve peptide receptor (NK.1R), glycine receptor (GlyR), neuron nicotinic receptor (nnAChRs), Methyl-1-methyl-1-day aspartate (NMDA receptor), and TRPV1 receptor (TRPV1 receptor) produce the analgesic efficiency.
2. propofol was traditional sedation reagent.
3. index of Nociception (NOX) was the objective index for analgesia This study purpose to compare analgesia efficiency of Only Propofol and sevoflurane combine with propofol using index of Nociception (NOX)

Eligibility Criteria:
Inclusion Criteria:

* Participants were aged 18-65 years old,
* American Society of Anesthesiologists (ASA) physical status I, II or III
* scheduled to have urological surgery(would last longer than 1 h)
* requiring general anesthesia.

Exclusion criteria:

* refused to participate in this study;
* Unable to communicate normally because of consciousness alterations;
* a history of allergy to opioids
* contraindications to inhalational anesthesia
* a family history of malignant hyperthermia
* a history of alcohol or drug abuse
* received central nervous system-active drugs
* super obese as defined by a body mass index ≥40 kg/m2
* conditions liable to alter the pharmacokinetic and pharmacodynamic behaviors of the intravenous and inhalation anesthetics
* previous head injury
* neurologic
* psychiatric disease
* any disabling central nervous
* cerebrovascular disease
* using psychoactive
* anti-convulsive medications at the time
* unstable angina
* manifested congestive heart failure
* expected difficulty airway management
Scalp Nerve Block and Opioid Consumption in Brain Surgery

Anterior scalp block with 0.5% plain Marcaine 20 ml. may reduce the intraoperative opioid consumption in neurosurgical patients who undergoing the supratentorial craniotomy compared to those who receive 0.9% normal saline solution (placebo).

Anterior scalp block with 0.5% plain Marcaine 20 ml. may reduce the intraoperative opioid consumption in neurosurgical patients who undergoing the supratentorial craniotomy compared to those who receive 0.9% normal saline solution (placebo).

A Prospective Randomized Double Blind Control

Eligibility Criteria:
Inclusion Criteria:

1. Patients who have supratentorial brain tumor
2. Patients have been scheduled to undergo an elective craniotomy to remove tumor in any surgical position
3. Patients have been general anesthetized with endotracheal intubation and control ventilation
4. Patients who have provided consent for the participation in the research and for the use of their medical record in research

Exclusion Criteria:

1. Pregnant patients
2. Patients who have a history of local anesthetic allergy and/ or anaphylaxis
Evaluation of the Effects of Simulation Based Breastfeeding Training

This study is a randomized controlled experimental study conducted to determine the effect of applied breastfeeding training given through Lactation Simulation Model (LSM) in antenatal period on the success of women in breastfeeding, their self-efficacy perception regarding breastfeeding and their attitude towards and knowledge of breastfeeding.

This study is a randomized controlled experimental study conducted to determine the effect of applied breastfeeding training given through Lactation Simulation Model (LSM) in antenatal period on the success of women in breastfeeding, their self-efficacy perception regarding breastfeeding and their attitude towards and knowledge of breastfeeding. The research was carried out with the participation of two groups. In this context, applied breastfeeding training with LSM was given to pregnant women in the intervention group (simulation training group, n=64) during antenatal period, and standard training-video training under the hospital protocol (video training group, n = 64) was provided to pregnant women in the control group. Then, breastfeeding success, breastfeeding self efficacy, attitude and knowledge levels regarding breastfeeding were evaluated in the postnatal period. The data of the research were collected through Participant Description Questionnaire, LATCH Assessment Tool, Breastfeeding Attitude and Knowledge Questionnaire, Breastfeeding Self efﬁcacy Scale and Postnatal Period Follow-up Questionnaire. In addition, LSM was employed in the implementation for the simulation training group. Research data were analyzed by using SPSS 23.0 statistics program.

Eligibility Criteria:
Inclusion Criteria:

32-36 between gestational weeks Primigravida No systemic/chronic disease Planning to breastfeed Who has not received a planned breastfeeding training before Can speak and understand Turkish Pregnant women who agreed to participate in the study were included.

Exclusion Criteria:

Breastfeeding contraindications Having a high-risk pregnancy Preterm delivery (before 37 weeks of gestation) Having a health condition that prevents breastfeeding in the newborn after birth Having mental disability and serious mental disorder Women with multiple pregnancies were excluded from the study.
A Study to Evaluate and Compare Injections of Autologous Mixed Population of Dermal Cells Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0006931)

Evaluate the ability of injections of Ji Gami(TM) CN to induce hair growth in male and female subjects with hair loss.


Eligibility Criteria:
Inclusion Criteria:

* Male and female volunteers 18-50 years old, inclusive.
* Women of childbearing potential must use an adequate form of contraception during study participation.
* Hair loss consistent with Grade III-Vertex, IV, or V based on the based on the Norwood-Hamilton Scale providing there is bridging of hair in the anterior edge of the vertex circle, or class 1 or class 2 based on the Ludwig scale.
* Able to provide informed consent after risks and benefits of the study have been explained.
* Be willing to undergo all study procedures.
* Ability to communicate effectively with study personnel.
* Have no clinically significant disease or abnormal laboratory evaluations taken at the screening visit.
* Agree to abstain from use of any hair growth affecting oral or topical medication including over the counter and herbal medications, minoxidil, finasteride or dutasteride during the course of this study; also agrees to abstain from shaving the head during the course of the study.

Exclusion Criteria:

* Women who are pregnant or lactating.
* Known sensitivity to DMEM/F-12 or any component of the study material.
* Known hypersensitivity to clindamycin hydrochloride, amphotericin B or streptomycin sulfate.
* Subjects who have used minoxidil or any oral or topical medication including over the counter and herbal medications for the treatment of hair loss within 6 months of study screening, or finasteride or dutasteride within 12 months of study screening.
* A history of drug or alcohol abuse within 1 year of study enrollment.
* Participation in any other investigational study within 30 days or six half lives of its biologic activity, whichever is longer, before the scalp excision visit(s), and during the time enrolled in this study.
* Clinically significant medical or psychiatric illness currently or within 30 days of study screening as determined by the investigator.
* Clinically significant symptoms of any acute illness within 30 days prior to excision day.
* Any condition that compromises the ability to understand or comply with study requirements.
* Clinically significant abnormal laboratory parameters.
* A positive result at screening for human immunodeficiency virus (HIV 1 or 2), Hepatitis B or C, HTLV I/II.
* Clinically significant dermatologic condition in donation or study zones.
* Prior surgery in the donor or study zones.
* Insufficient hair or scarring in the donor area that might impact cell growth.
* Any disease or condition (medical or surgical) that, in the opinion of the investigator, might compromise hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system function; or any condition that would place the subject at increased risk.
Safety of the Intramuscular Route of the Anti-Flu Vaccine in Patients Receiving Oral Anticoagulation Therapy

Until now, the best administration route of the anti-flu vaccine for patients receiving long term oral anticoagulation therapy has been the subcutaneous one; the intramuscular route has not been recommended because it may increase the risk of muscular haematoma. Although this practice is widely extended, no significant differences between the safety of both routes have been found. Some authors, analysing a small group of patients, affirm that the anti-flu vaccine can be administered safely by the intramuscular route on patients receiving long term oral anticoagulation therapy, while a previous opinion article recommended the subcutaneous route without any scientific evidence. Due to this, the investigators have done a clinical trial with the aim of determining the safety and effectiveness of the flu-vaccine intramuscular route in patients receiving long term oral anticoagulation therapy and also to analyse the possible interactions between the vaccine and the oral anticoagulant treatment.

Phase IV, simple blind, 2-parallel groups, multicentric randomized trial where each patient will receive a single dose of the recommended by the WHO anti-flu vaccine for the 2003-2004 period, the control group will receive it subcutaneous and intervention group intramuscular. The assignation to each group will be randomized. The study included 4 basic areas of Barcelona city. Three visits have been scheduled for each patient: moment 0, 24 hours and 10 days after the vaccination, and a 7 month follow up period to control the incidence of the flu.

Eligibility Criteria:
Inclusion Criteria:

* Patients with oral anticoagulation therapy
* Patients who agree to be vaccinated
* Patients who agree to participate in the study
* Patients older than 18

Exclusion Criteria:

* Allergy or hypersensibility to egg, chicken proteins, any component of the vaccine (neomycin, octoxinol-9 or formaldehyd)
* INR greater than 4 in the past 2 months
* Previous major bleeding
* Patients with dementia or with legal tutoring
Promoting Adherence to Improve Effectiveness of Cardiovascular Disease Therapies

The purpose of this randomized clinical trial is to determine whether two low-intensity, technology based interventions, when compared to each other and to usual care, improve adherence to selected medications that are used to treat people with cardiovascular disease (CVD) and diabetes.

The frequent failure of patients to adhere to long-term medication regimens remains the single greatest challenge for chronic-disease management. Many studies have linked medication non-adherence to treatment failure; unnecessary and dangerous intensification of therapy; and excess health care costs, hospitalizations, and deaths. Although some interventions have been shown to significantly enhance medication adherence, the strategies used are often complex, labor-intensive, and of variable effectiveness. Simple interventions designed to make small-but-significant improvements in population-based adherence may thus offer a novel, cost-effective, and easily-disseminated alternative to current approaches for enhancing adherence. The proposed PATIENT study will use health information technology (automated phone calls and access to an electronic medical record) to test two such interventions and compare them to each other and to usual care alone.

Eligibility Criteria:
Inclusion Criteria:

* Aged 40 years or older as of time of randomization.
* Flagged in KP's databases as having either diabetes or atherosclerotic cardiovascular disease(defined as coronary artery disease, peripheral vascular disease, or a history of atherosclerotic stroke) at the time of randomization
* At least one dispensing of an ACEI, ARB, or statin from a Kaiser Permanente (KP) outpatient pharmacy during the baseline year.
* Suboptimal adherence ((MPR\<0.9) to either statins or ACEI/ARBs during the baseline year
* Continuous membership in KP for the 12 months prior to randomization.
* Qualified for an intervention call at the time of randomization.

Exclusion Criteria:

* Evidence in the electronic medical record (EMR) of allergy or intolerance to statins or ACE inhibitors/ARBs
* medical conditions that would contraindicate use of statins or ACEI/ARBs
* Absence of either a phone number or mailing address in the EMR
* for Kaiser Permanente Hawaii, clinics whose patients tend to fill prescriptions primarily at non-KP pharmacies
* on Kaiser Permanente's "do not contact" list or in other research studies that could add undue burden
Trimethoprim/Sulfamethoxazole Combined With Caspofungin as First-line Therapy in PCP

This is a prospective, randomized clinical trial. During the study, non-HIV patients who are admitted to ICU due to Pneumocystic pneumonia (PCP) and have not received anti-PCP therapy or have received therapy less than 48hrs will be randomized (1:1) to received caspofungin combined with trimethoprim-sulfamethoxazole or trimethoprim-sulfamethoxazole alone.

The aim of this study is to compare the effectiveness of caspofungin combined with trimethoprim-sulfamethoxazole with that of conventional therapy (trimethoprim-sulfamethoxazole alone) as first-line therapy in the treatment of severe Pneumocystis pneumonia (PCP) in non-HIV patients.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old
2. Non-HIV immunosuppressed patients admitted to the ICU
3. confirmed or suspect PCP

3) Not receiving anti-PCP treatment or anti-PCP treatment \< 48 hours

Exclusion Criteria:

1. Age less than 18 years old
2. Known pregnancy
3. allergy to TMP/SMZ or caspofungin
4. Decision to withhold life-sustaining treatment
5. Patients with advanced pulmonary fibrosis
6. severe liver dysfunction(Child-Pugh C )
Periapical Bone Healing After Apicectomy With and Without Retrograde Root Filling

Ph.D project: Periapical bone healing after apicectomy with and without retrograde root filling.

The aim of this study is to assess periapical bone healing after apicectomy without a filling and apicectomy combined with a retrograde filling material, MTA. Further, we will estimate risk factors in non-healing cases.

Study hypothesis: There is no difference in treatment outcome between:

Periapical bone healing after apicectomy with retrograde root filling and Periapical bone healing after apicectomy without retrograde root filling

Ph.D project: Periapical bone healing after apicectomy with and without retrograde root filling.

60 patients have been selected from a group of 490 patients, who had a full mouth radiographic status taken in connection with a population study of apical periodontitis in Aarhus Community. The selection criteria for the 60 patients were patients with a persisting apical periodontitis, Periapical Index (PAI) score 3-5, on front teeth and premolars in the upper jaw. The orthograde root filling in the tooth must be at least 2 years old and sufficient regarding density and length.

The 60 patients will be randomised into the two groups of apicectomy with and without filling. A radiograph will be taken just before the operation and 6 and 12 months after the operation. In the assessment of bone healing, we will use two different techniques, subtraction radiography and the Periapical Index (PAI).

We will also evaluate the benefits of using the operation microscope during the operation, and if clinical photos can be useful as documentation of treatment result.

Eligibility Criteria:
Inclusion Criteria:

healthy person age 18 or above sufficient root filling sufficient coronal restauration apical infection for at least 2 years Pai Score3, 4, or 5

Exclusion Criteria:

boneless more than 50 % communication between pocket and apical infection no visible root filling material after apicectomy facial bone less than 3 mm