cyrilzakka/clinical-trials huggingface dataset:
Effect of Cervical Discharge Removal During ET on Pregnancy Rate

Pregnancy rate may be affected by multiple factors such as embryo transfer techniques. Even small differences in embryo transfer methods may affect pregnancy rates. There is an inconsistency about the effect of the removal of cervical discharge on embryo transfer outcomes. Some studies showed that cervical mucus removal before embryo transfer can increase pregnancy rate, however the others could not find any significant effect about the removal of cervical mucus on pregnancy or live birth rates. Given to the conflicting evidences, our study aimed to determine whether the cervical discharge removal has positive effect on pregnancy rate.

492 Infertile women who were candidate for fresh embryo transfer during IVF/ICSI cycles were eligible for this study if they had two or more good quality embryos. All categories of female or male factors infertility except uterine factor infertility were eligible for participation in the study. Immediately prior to embryo transfer, women were randomly allocated to either treatment (cleaning the cervical canal) or control groups. In treatment group, excess mucus and debris were cleared from the cervical canal using a sterile cotton swabs. The cervical discharge was scored as mucosal, bloody, combination of mucosal and bloody, or infected. Control group had no cervical cleaning before embryo transfer. Then, the embryos were loaded into the transfer catheter by the embryologist and were deposited into the uterine cavity by one experience physician. The primary endpoint was clinical pregnancy. Fertilization, Implantation, abortion, and live birth rates were the other outcomes of interest or secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Women who were candidate for fresh embryo transfer during IVF/ICSI cycles were eligible for this study if they had two or more good quality embryos and age fewer than 40

Exclusion Criteria:

* The patients with frozen-thawed embryo transfer cycle
* Those with oocyte donation cycle
* The women with uterine abnormality
* The women with submucosal and intramural myoma
* Who does not have good-quality embryos appropriate
Safety and Efficacy of Vilazodone in Major Depressive Disorder

The purpose of this study was to evaluate the efficacy, safety, and tolerability of 2 fixed dose levels of vilazodone compared to placebo in patients with major depressive disorder.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, 18-70 years of age.
* Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for Major Depressive Disorder.
* The patient's current major depressive episode must be at least 8 weeks and no longer than 12 months in duration.

Exclusion Criteria:

* Women who are pregnant, women who will be breastfeeding during the study, and women of childbearing potential who are not practicing a reliable method of birth control.
* Patients with a history of meeting DSM-IV-TR criteria for:

  * Any manic, hypomanic or mixed episode, including bipolar disorder and substance-induced manic, hypomanic, or mixed episode
  * Any depressive episode with psychotic or catatonic features
  * Panic disorder with or without agoraphobia
  * Obsessive-compulsive disorder
  * Schizophrenia, schizoaffective, or other psychotic disorder
  * Bulimia or anorexia nervosa
  * Presence of borderline personality disorder or antisocial personality disorder
  * Mental retardation, dementia, amnesia, or other cognitive disorders.
* Patients who are considered a suicide risk.
Lysergic Acid Diethylamide (LSD) in Palliative Care

Background: Terminally ill patients often experience significant psychosocial distress having depressed mood, death anxiety, pain, and an overall poor quality of life. Recent evidence from pilot studies suggests that serotonergic hallucinogens including lysergic acid diethylamide (LSD) and psilocybin produce significant and sustained reductions of depressive symptoms and anxiety, along with increases in quality of life, and life meaning in patients suffering from life-threatening diseases. Additionally, serotonergic hallucinogens may produce antinociceptive effects.

Objective and Design: The study aims to evaluate effects of LSD on psychosocial distress in 60 patients suffering from an end-stage fatal disease with a life expectancy ≥12wks and ≤2yrs in an active placebo-controlled double-blind parallel study. Patients will be allocated in a 2:1 ratio to one of the two intervention arms receiving either two moderate to high doses of LSD (100 µg and 100 µg or 100 µg and 200 µg) as intervention and two low doses of LSD (25 µg and 25 µg) as active-placebo control.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 22 years.
* End-stage fatal disease of any cause with a life expectancy ≥ 12 weeks and ≤ 2 years
* Sufficient understanding of the study procedures and risks associated with the study.
* Participants must be willing to adhere to the study procedures and sign the consent form.
* Participants must be willing not to drive a traffic vehicle or to operate machines within 24 h after LSD administration.
* Participants must complete an actual "Emergency Medical Directive"

Exclusion Criteria:

* Life expectancy \&lt; 12 weeks
* Known hypersensitivity to LSD
* Requiring ongoing concomitant therapy with a psychoactive prescription drug which might interfere with the study drug, and unable or unwilling to comply with the washout period.
* Current use of a potent drug CYP2D6 inhibitor
* Women who are pregnant or nursing or intend to become pregnant during the course of the study.
* Somatic disorders including CNS involvement of cancer, untreated epilepsy with a history of grand-mal seizures, history of delirium, end-stage heart failure (NYHA IV), untreated hypertension or insufficiently treated hypertension, angina pectoris, severe liver disease or severely impaired renal function, or other that in the judgement of the investigators pose too great potential for side effects.
* Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc. of the participant.
* Participation in another study with an investigational drug within the 30 days preceding and during the present study
* concomitant diagnosis of past or present psychotic disorder, first-degree relative with psychotic disorders
* concomitant diagnosis of past or present bipolar disorder
* current delirium
* substance use disorder (within the last 2 months, except nicotine, opioids used for analgesia, and benzodiazepine treatment for anxiety).
* Weight \&lt; 45 kg
* Suicidal ideation with active intent or plan to act on suicidal thoughts as assessed by the treating investigator.
An Observational Quality of Life Study in Participants With Rheumatoid Arthritis Treated With Rituximab

This multicenter prospective observational study will evaluate the quality of life in participants with rheumatoid arthritis (RA) who are initiated with rituximab (MabThera/Rituxan). Participants will be followed for 6 months from initiation of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants of both genders who are 18 years or older
* Diagnosis of RA for at least 6 months according to the criteria of the American College of Rheumatology (ACR) of 1987 for the RA classification
* Participants with medically prescribed or being administered with unique rituximab infusion in the least 3 days, according to the approved label
* Ability to meet the program's requirements and to voluntarily sign the Informed Consent Term.

Exclusion Criteria:

* Participants who have received any investigational medication within less than or equal to (\<=) 1 year before the first dose of the currently indicated treatment
* Participants with an active infection
* Participants with conditions that may interfere in the ability to understand the requests of data collection and to obey to the study's requirements
* Functional Class IV defined based on the ACR functionality criteria for RA
* Participants who can not or who do not want, for any reason, to answer the questionnaires.
Magnesium Sulfate Versus Nifedipine for the Acute Tocolysis of Preterm Labor: A Prospective, Randomized Trial

To compare intravenous magnesium sulfate to oral nifedipine for acute tocolysis of preterm labor


Eligibility Criteria:
Inclusion Criteria::- Uterine contractions and cervical change or ruptured membranes in a preterm gestation Exclusion Criteria:- placental abruption, fetal distress, placenta previa, maternal medical contraindication to tocolysis
A Single Dose Study of MK-6194 in Healthy Chinese Participants (MK-6194-014)

The goal of this study is to learn how safe MK-6194 is in healthy Chinese adults and how well people tolerate it.


Eligibility Criteria:
Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

* Is in good health
* Has body mass index (BMI) within 18.0 to 28.0 kg/m\^2 (inclusive) and weight ≥50 kg

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

* History of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
* Has a history of opportunistic infection, Human immunodeficiency virus (HIV), hepatitis B, hepatitis C, tuberculosis
A Pilot Study to Evaluate the Effects of Subcutaneously Administered Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor in Pediatric HIV-Infected Patients With Neutropenia Secondary to Azidothymidine

To assess the safety and efficacy of subcutaneous sargramostim ( granulocyte-macrophage colony-stimulating factor; GM-CSF ) in increasing and maintaining the granulocyte count in HIV-infected children who have developed granulocytopenia as a result of continuous intravenous ( CIV ) zidovudine ( AZT ). To assess the short-term and long-term effects of concomitant GM-CSF on other hematologic parameters. To assess the potential therapeutic benefit of concomitant GM-CSF and AZT on the natural history of HIV infection and associated infectious complications.


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Zidovudine (AZT) on NIAID 86-C-175.

Patients must have:

* Diagnosis of perinatal or transfusion acquired AIDS or AIDS related complex.
* Granulocytopenia (\< or = to 800 cells/mm3) associated with the administration of AZT on protocol NIAID 86-C-175.
* Life expectancy \> 3 months.
* Functioning indwelling central venous access device in place.

Prior Medication:

Allowed within 48 hours of study entry:

* Prophylactic antibiotics.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Critically ill or clinically unstable.
* Significant, active opportunistic or other infection requiring specific drug therapy at time of study entry.
* Ongoing IV alimentation.
* Uncorrected nutritional deficiencies that may contribute to anemia and/or leukopenia.
* Past history of or current evidence for any chronic hematologic disorder other than hemophilia A or B, anemia of chronic disease or anemia related to HIV infection.
* Malignancy likely to require systemic treatment during study.

Patients with the following are excluded:

* Critically ill, clinically unstable, or with concomitant diseases listed in Patient Exclusion Co-existing Conditions.
* Hypersensitivity to zidovudine (AZT) or any other nucleoside analog.

Prior Medication:

Excluded within 48 hours of study entry:

* Antibiotics.
* Excluded within 30 days of study entry:
* Antiretroviral agents other than zidovudine (AZT).
* Acyclovir.
* Ganciclovir.
* Any investigational drug.
* Immunomodulating drugs.
* Cytolytic chemotherapeutic agents.
* Corticosteroids.
* Immunoglobulin preparations.
* Excluded within 4 months of study entry:
* Suramin.

Prior Treatment:

Excluded within 6 months of study entry:

* Bone marrow transplantation.
* Excluded within 4 weeks of study entry:
* Lymphocyte transfusions.
* Radiation therapy.
Transcorneal Electrical Stimulation (TES) for the Treatment of Amblyopia

This is a prospective, randomized, parallel group sham-controlled blinded clinical trial to assess the feasibility and efficacy of transcorneal electrical stimulation (TES) in the improvement of visual function outcomes in adults with amblyopia. The trial will assess the treatment effect of TES to Sham TES in the amblyopic eye of affected patients.

Amblyopia is defined as a decrease in visual acuity in one eye, despite the correction of any refractive error with glasses and in the absence of any ophthalmoscopically visible lesion of the retina, especially of the macular region. Amblyopia is associated with histologic and electrophysiologic abnormalities in the visual pathways.

Transcorneal electrical stimulation (TES), through neural stimulation, works by non-invasively stimulating the retina via passage of electrical current directly to the retina, bypassing the usual light activation pathway, resulting in the activation of the same areas of the brain as would be activated with a light stimulus alone. Electrical stimulation with TES has shown potential in recent reports as an efficacious treatment modality to improve visual function.

The success of electrical stimulation in neurodegenerative disorders provides a reasonable rationale and significant precedent to investigate its potential for use in disorders of the visual processing system, which functions via an integration of biochemical and electrical interactions transmitted from the retina.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Diagnosis of amblyopia made by the principal investigators.
3. Best corrected visual acuity in the amblyopic eye equal to or worse than 20/70
4. Willing and able to give informed consent and to participate for the full duration of the study.
5. Strabismus less than 10 prism diopters.

Exclusion Criteria:

1. Any other significant ophthalmologic disorder or condition with relevant effect upon visual function as evaluated by principal investigator. (eg. Retinal degeneration, proliferative diabetic retinopathy, age related macular degeneration, optic nerve abnormality)
2. Women who are pregnant or women with childbearing potential who are unwilling to use medically acceptable means of birth control for study duration.
3. Presence of a pacemaker, any metal artifacts in head and trunk, any history of epileptic seizure or severe psychiatric disease (schizophrenia, etc.)
4. Inability to detect phosphenes above 0.5mA at time of threshold detection.
The Effect of Folic Acid on Atherosclerosis, Cognitive Performance and Hearing

The purpose of this study is to determine if folic acid supplementation can slow down atherosclerotic progression, age-related cognitive decline and age-related hearing loss.

Low levels of B vitamins, in particular folate, and high levels of plasma total homocysteine, have been associated with a variety of age-related diseases and disorders, including cardiovascular disease, dementia and hearing impairment. Extra folate, for example in the form of folic acid, is known to decrease the concentrations of plasma total homocysteine.

We examined whether 0.8 mg/d folic acid could slow down atherosclerotic progression and the above mentioned age-related processes.

Eligibility Criteria:
Inclusion Criteria:

* 50-70 years
* Men and post-menopausal women
* Women with a surgically removed uterus were required to be \>=55 years

Exclusion Criteria:

* Plasma total homocysteine \<13 or \>26 umol/L
* Serum vitamin B12 \<200 pmol/L
* Self-reported current use of drugs which affect folate metabolism
* Self-reported current use of drugs believed to influence intima-media thickening, i.e., lipid-lowering drugs, hormone replacement therapy
* Self-reported medical diagnosis of renal, intestinal, thyroid disease
* Self-reported medical diagnosis of current cancer
* Self-reported current use of supplements containing B vitamins
* Self-reported inability or unwillingness to fast for 12 hours
* \<80% compliance using placebo pills during a 6-week run-in period
* Not giving written informed consent
* Participation in other research studies
Drug Use Investigation of Gadovist.

The objectives of this study are to investigate the safety and effectiveness of Gadovist.

This is a prospective, non-interventional, continuous submission safety study that includes patients who planned Gadolinium (Gd) contrast enhanced Magnetic Resonance Imaging (MRI) in accordance with approved label. The investigator will have made the choice of Gd enhanced MRI (the decision to use Gadovist according the Japanese Package Insert prior to enrolling the patient in this study).

The study period is 3 years. Data analysis period is 1 year. In total, 3300 patients will be recruited.

For each patient, data are collected as defined in the case report form (CRF) at the visit for MRI examination (as per investigators routine practice).

Eligibility Criteria:
Inclusion Criteria:

* Patients who perform contrast enhanced Magnetic Resonance Imaging (MRI) with Gadovist.

Exclusion Criteria:

* Patients who are contraindicated based on approved label.
Glioma Microenvironment an Exploratory Study

Diffuse glioms are primary brain tumors characterized by infiltrative growth and high heterogeneity, which render the disease mostly incurable. Advances in genetic analysis revealed that molecular and epigenetic alterations predict patients´s overall survival and clinical outcome. However, glioma tumorigenicity is not exclusively caused by its genetic alterations. The crosstalk between tumor cells and the surrounding microenvironment plays a crucial role in modulating glioma growth and aggressiveness. In this sense, to understand the tumor microenvironment would elucidate potential treatment alternatives. The focus will be to evaluate myeloid cells and cytokines levels.

The proposal is to study gene expression and early epigenetic changes in myeloid cells from brain tumors and co-culture experiments. Tough RNA-seq, ATAC-seg and subsequent analysis to monitor the differential gene expression through different time points followed by stimuli. The study will compare the obtained results with sequencing data from microglia of full-fledged human tumor samples (glioblastoma and low grade gliomas). Additionally it will evaluated the immunologic characteristic of the tumor through cytokines levels analysis (TNF-α, IL-4, IL-6, IL-8, IL-10, IL-13, IFN-γ, TGF-β e IL-1ra).

Eligibility Criteria:
Inclusion Criteria:

* 18 - 65 years old with brain tumor
* Patients that will be submitted to brain tumor ressection

Exclusion Criteria:

* Chronic neurodegenerative and inflamatory diseases
Computer Controlled Local Anesthesia in Children

• Introduction: Effective pain control is critical in pediatric dentistry. The effectiveness of pain control in children can be influenced by child characteristics .

Objectives: The Purpose of the study is to compare the pain perception and the effectiveness of anesthesia between the computer-controlled local anesthetic delivery system (CCLAD) and the traditional inferior alveolar nerve block (IANB) in pulptomies of the mandibular second primary molars.

Materials and Methodology: The study sample includes 90 healthy children who are selected randomly from the R4 electronic filing system in King Abdulaziz University Hospital (KAUH) with age range from 5-9 years. The child is required local anesthesia for pulpotomies in the mandibular second molars. The sample will be divided randomly to one of these 3 groups: group A is composed of 30 patients who will be anesthetized by the traditional IANB. Group B includes 30 patients will be anesthetized by the IANB using CCLAD. While, the remaining 30 patients will be assigned in group C and will be anesthetized by periodontal ligament injection anesthesia using the CCLAD. The pain perception levels after the injection is assessed by a Wing-Baker faces pain scale. Effectiveness of the anesthesia during each step in pulpotomy is measured using Sounds, eyes and motor (SEM) scale. After the treatment by 24 hours parents will be contacted by the telephone to ask about the presence of postoperative pain or lip biting. Statistical analysis is carried out using SPSS version 16.00.

Ethical Consideration:

The Ethical Committee of King Abdulaziz University KAAUEC approved the study .

Subjects' selection:

The Sample includes children who are randomly selected by the R4 electronic file system in the pediatric dentistry specialty clinics at King Abdulaziz University Hospital (KAUH). A total of 2100 pediatric screening had been registered between April 2013 and November 2013 .These files will be checked for the eligible age in the study which is 5-9 years. Then, the inclusion and exclusion criteria will be checked, and the patients will be selected by systemic random sample.

Study design:

This is a randomized single blind clinical trial study.

Eligibility Criteria:
The inclusion criteria:

1. Age of the children was ranged from 5-9 years.
2. Children were healthy physically and mentally; all children had no contraindications to local anesthesia.
3. Children were assessed as being cooperative, had behavioral ratings "positive" or "definitely positive" according to the Frankl (Frankl et al 1962) behavior classification scale (appendix1).
4. Children were diagnosed with carious mandibular second primary molars that required treatment with pulpotomies.

The exclusion criteria:

1. Disapproved consent.
2. Medically compromised children.
3. Uncooperative children.
Cigarette Smoke and Susceptibility to Influenza Infection

This study will be a descriptive comparison of the effects of live attenuated influenza virus (FluMist) on nasal inflammation and oxidative stress in healthy young adults who are not exposed to smoke vs smokers. It is hypothesized that passive exposure to second-hand smoke (SHS) results in increased susceptibility to the effects of influenza virus in nasal epithelium in humans and that these effects are mediated by SHS-induced oxidative stress

Epidemiologic evidence supports a significant relationship between passive cigarette smoke exposure and increased risk for viral respiratory illnesses. Published and preliminary data suggest that airborne pollutants including tobacco smoke increase susceptibility of respiratory epithelium to infection with influenza A and that this effect is at least partially mediated by oxidative stress. However, no studies have specifically looked at the interaction between smoking and the effects of influenza virus in human volunteers.

Eligibility Criteria:
Inclusion Criteria:

* age 18-35 years
* healthy nonsmoking who are rarely exposed to SHS OR smokers

Exclusion Criteria:

* pregnancy or nursing;
* history of egg allergy;
* aspirin therapy;
* asthma;
* immunodeficiency (HIV or other);
* on immunosuppressive drugs including corticosteroids;
* history of Guillain-Barre Syndrome;
* any chronic medical condition;
* febrile and/or respiratory illness within past 3 weeks prior to entry into study;
* prospective subjects with high baseline antibody titers against influenza will be excluded because they may be less likely to develop viral replication with LAIV.