cyrilzakka/clinical-trials huggingface dataset:
Effect of Oral Neuromuscular Training on Swallowing

In this randomized controlled trial the investigators wish to investigate the effect of an oral neuromuscular training device (called IQoro) on swallowing function and time until decannulation from a tracheostomy tube, in patients admitted for neurorehabilitation due to a severe acquired brain injury.


Eligibility Criteria:
Inclusion Criteria:

* Cuff tracheostomy tube

Exclusion Criteria:

* Not able to comply with IQoro exercises
* 3 weeks evaluation stay at the hospital
Informed Decision Users of the Health System and Participation in Organized Screening for Breast Cancer

The aim of this study is to assess the impact of a decision aid leaflet on the participation of women invited to participate in the French national breast cancer screening program.


Eligibility Criteria:
Inclusion Criteria:

* Women, aged between 50 and 74 years old living in 11 French departments

Exclusion Criteria:

-
Salicylic Acid Peels Combined With 4% Hydroquinone in the Treatment of Moderate to Severe Melasma in Hispanic Women

This study will enroll 20 adult Hispanic women. Participants will apply 4% hydroquinone cream twice daily to affected areas on the face for 14 weeks and half the face will be peeled with 20-30% salicylic acid every two weeks for a total of 4 peels. The first two peels will be 20% salicylic acid and the second two peels will be with 30% salicylic acid. The purpose of the study will be to evaluate the safety and efficacy of salicylic acid combined with 4% hydroquinone versus 4% hydroquinone alone.


Eligibility Criteria:
Inclusion Criteria:

* Hispanic women ages 18-65 years of age with moderate to severe melasma
* English and Spanish-speaking women

Exclusion Criteria:

* Pregnant or breast-feeding women
* Subjects who have used 4% hydroquinone within 3 months of study start
* Subjects who have used chemical peels, microdermabrasion or facial laser treatments within 9 months of study start
The Study of Cardiovascular Outcomes in Women With Preeclampsia Using Echocardiography: The SCOPE Study

This study will evaluate the differences in cardiovascular parameters between women with severe preterm preeclampsia and those without preeclampsia using echocardiography and maternal blood. The investigators will also look at associations of abnormal cardiovascular findings and immediate complications among a high risk cohort of pregnant African American women.

This will be a prospective cohort study. Exposed cases will be admitted to the inpatient obstetrical unit (labor \& delivery or antepartum unit) at the Hospital of the University of Pennsylvania with concern for severe preterm preeclampsia. Unexposed controls will be matched by gestational age and other clinical factors and will be obtained from the outpatient setting (Helen O Dickens clinic or Penn ObGyn Associates at 3701 Market Street). The investigators will compare cardiovascular risk factors between these two groups.

Eligibility Criteria:
Exposed cases:

Inclusion Criteria:

* African American women who are admitted to the obstetrical unit with a concern for severe preeclampsia. Patients must be preterm (23-36 6/7 weeks) with a live singleton gestation and at least 18 years old. Women will baseline chronic hypertension and women on magnesium will be included.

Exclusion Criteria:

* Non-African American women, and African women with concern for severe preeclampsia who are admitted 23 weeks or 37 weeks. Women in labor will be excluded. Women with preexisting cardiovascular disease and women who are current smokers will be excluded.

Unexposed controls:

Inclusion Criteria:

* African American women obtaining prenatal care in our outpatient setting who meet matching criteria as noted above.

Exclusion Criteria:

* Non-African American women and women who are not receiving care at our institution.

  * All women who do not speak English and who are unable to be consented will be excluded.
Effect of Different Maternal Hemoglobin and Hematocrit Values on Perinatal Outcome

This study aims to evaluate the perinatal outcome in pregnancies with different levels of hemoglobin/hematocrit to verify which category of women should have iron supplementation if not all.

Anaemia in pregnant women has been reported to have various adverse effects on both the mother and unborn foetus. These effects include preterm birth, a low birth weight and an increase in the risk of maternal and perinatal mortality . Postpartum anaemia impairs wound healing, increases the risk for readmission and/or prolonged hospitalization, and increases the cost of care for families .

Some investigators stated adverse perinatal outcome in pregnant mothers with high haemoglobin and haematocrit values and raised a question about the possible harmful effect of iron supplementation in such pregnancies.

Eligibility Criteria:
Inclusion Criteria:

* 1. Pregnant women scheduled for labor or C.S (at term, 28-42 weeks). 3. Singleton pregnancy. 4. Age range: 18-40 years. 5. Willing to provide informed consent for participation and follow-up.

Exclusion Criteria:

1. Refusal to participate or consent.
2. Presence of non-iron deficiency anemia (e.g., hemoglobinopathies, chronic disease-related anemia).
3. Multiple pregnancies (e.g., twins or more).
4. Antepartum hemorrhage (e.g., placenta previa, placental abruption).
5. PAS.
6. Malformed fetus. -
Telomeres and Reproduction in Women

The purpose of the study is to describe the relationship between leukocyte, granulose cell and polar body telomere length, telomere injury foci (TIFs), polarized light microscopy of oocyte spindles and their frequency in the eggs from older women and associations with aneuploidy.

The chances of conception decrease and miscarriage increase with a women's age, and the locus of reproductive aging is the egg (1). Egg dysfunction affects most women beginning by their late '30's and for many women age related egg dysfunction represents a major cause of infertility. The cause of age related egg dysfunction is poorly understood, but telomere dysfunction may play an important role. Our group has demonstrated that genetic or pharmacologic shortening of telomeres in the eggs of mice, which normally do not exhibit age related egg dysfunction, mimics reproductive aging in women, with cell cycle arrest, apoptosis, spindle dysmorphologies and chromosomal abnormalities (1,2). Moreover, a pilot study the investigators conducted five years ago suggested that telomere length of spare human eggs may predict the outcome of womens' InVitro Fertilization (IVF) cycles (3). Subsequently, other investigators have demonstrated that telomere length of circulating leukocytes predicts miscarriages (4).

Eligibility Criteria:
Inclusion Criteria:

* Ages 18 to 48
* Undergoing InVitro Fertilization
* Willing to donate spare eggs, granulosa cells and blood
* Willing to give written informed consent

Exclusion Criteria:

* Not undergoing InVitro Fertilization
* Not willing to donate spare eggs, granulosa cells or blood
* Not willing to give written informed consent
* Previously donated spare eggs, granulosa cells or blood for this research project
A Clinical Trial to Evaluate the Vision Correction Safety and Efficacy of DSiHy Silicone Hydrogel Soft Contact Lens

This is a prospective, randomized, double-blind, parallel, active-controlled, multi-center clinical study. The purpose is to evaluate the safety and effectiveness wearing "DSiHy Silicone Hydrogel Soft Contact Lens". Subjects will be randomized in 1:1 ratio to wear either the investigational device "DSiHy Silicone Hydrogel Soft Contact Lens" or the control device Daily Silicone Hydrogel Contact Lenses(oB)".


Eligibility Criteria:
Inclusion Criteria:

1. Must be 18 years of age inclusive
2. Beside myopia and astigmatism, subjects with normal eyes and are not using any ocular medications (excluding ocular lubricants and artificial tears)
3. Best spectacle corrected visual acuity greater than or equal to 1.0 for both eyes
4. With +8.00D \~ -12.00 D spherical component myopia, and ≤1.00 astigmatism (based on manifest refraction measurements)
5. Have worn soft contact lens for at least 2 month prior to the study
6. Willing to comply with the required wearing time
7. Agree to comply with all study procedures, sign and date the informed consent form before starting the clinical study

Exclusion Criteria:

1. Anterior segment infection, inflammation or abnormality
2. Any active ocular disease that would affect contact lens wear or vision (such as acute and subacute inflammation of the anterior chamber of the eye, eye infection, uveitis, serious palpebral abnormality, corneal hypoesthesia, corneal epithelium abrasion, dry eye and tear duct defection, ocular allergies, highly suspected glaucoma) upon evaluation by the investigators or slit lamp findings
3. Currently using systemic or ocular medications that would contraindicate contact lens wear (such as glaucoma eye drops, steroid anti-inflammatory drops, eye ointments, eye gels and other eye medicines)
4. History of herpetic keratitis
5. History of refractive surgery, keratoconus or irregular cornea
6. Slit lamp findings that are not suitable for inclusion (Details of the grading standards for each eye condition are specified in CIP section 5.7.5)
7. A pathologically dry eye (Schirmer test 1 \<5 mm)
8. Have participated in any contact lens or contact lens care product clinical trials within the previous 1 month (excluding questionnaire types and specimen collection)
9. Currently pregnant, lactating, or planning to be pregnant during the trial
10. Have experienced discomfort when wearing silicone hydrogel contact lens, or a known allergy to hyaluronic acid and sodium alginate
11. Corrected visual acuity in either eye does not reach 1.0 when wearing the trial lens
12. Subjects who are judged by the investigators as unsuitable for the study
Risk Factors Associated to Difficult-to-control Asthma

Several studies have demonstrated the efficacy of asthma treatment but despite being correctly diagnosed, conveniently prescribed and adherent to the therapeutics, 5% to 10% of asthmatics do not reach disease control.

The aim of this study is to measure asthma control, evaluate inflammatory and functional characteristics, describe comorbidities and aggravating factors and phenotypes derived from the characteristics of a severe asthmatic population followed at an outpatient university service in Sao Paolo, Brazil.

Study design: interventional

Patients selection:

Seventy-four severe asthma patients, aged between 18 and 65 years old were recruited from the outpatient clinics of the Pulmonary Division of the University of São Paolo Hospital.

Severe asthma were defined according to GINA. Intervention: after 2 weeks screening period patients were treated with high inhaled corticosteroid dose plus long acting beta 2 agonist during 12 weeks plus oral corticosteroid ( prednisone 40 mg/day) during 2 weeks.

Procedures ( baseline, after 2 weeks and 12 weeks): asthma control questionnaire (ACQ), asthma control (ACT) test, lung function test, quality of life questionnaire (SGRQ and SF-36), exhaled nitric oxide (FeNO), induced sputum (IS). After 12 weeks patients underwent the following evaluation: Upper Digestive Endoscopy, Esophageal 24hs pHmetry, High Resolution Chest Tomography, Nasoscope exam,Bronchofibroscopy with endobronchial biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years
* Diagnosis of moderate to severe asthma (GINA) for at least one year
* Presence of airway obstruction reversibility (documented within the last 5 years before the start-up of study)
* Smoking, non-smoking or ex-smoking patients of \<30 pack-years.
* Need of inhaled corticosteroid (IC),\> or equal 1000mcg of Beclomethasone Dipropionate (DPB) or similar in the last year plus beta 2 long duration agonist in the last year.
* At least one exacerbation with the need of oral corticosteroid in the last year.

Exclusion Criteria:

* Pregnant women;
* Co-morbidities that may interfere with the management of the study;
* Patients who cannot understand the procedures of the study or who are not able to provide their free and clarified consent;
* Patients with other pulmonary diseases which may interfere with the evaluation of the study.
Double-Blind Trial of a Probiotic Supplement to Reduce the Symptoms of Schizophrenia

The investigators intend to explore the hypothesis that symptoms of schizophrenia may be reduced by the administration of a probiotic supplement when used in addition to standard antipsychotic medications.

The primary aim of the current study is:

1. To evaluate the safety and efficacy of a supplemental probiotic therapy, containing the microorganisms Lactobacillus rhamnosus GG and Bifidobacterium lanimalis subsp. lactis (BB12), for individuals with schizophrenia who have residual psychotic symptoms of at least moderate severity.

   Secondary aims of the study are:
2. To assess the effect of probiotic treatment on patients' gastrointestinal functioning
3. To study the effect of probiotic treatment in lowering the levels of antibodies to casein and gliadin.
4. To investigate the association between the efficacy of probiotic therapy and initial levels of antibodies to gliadin and casein.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65.
* Capacity for written informed consent.
* Primary Axis I diagnosis (DSM-IV) of schizophrenia, any type, OR schizoaffective disorder (APA, 1994).
* Currently an outpatient at the time of enrollment.
* Residual psychotic symptoms which are at least moderately severe as evidenced by one or more PANSS positive symptom scores, and/or PANSS negative symptom scores of 4 or more; OR a total PANSS score of 50 or more, containing at least three positive or negative items with scores of 3 or more at screening.
* Conformance to PORT Treatment Recommendation re Maintenance Antipsychotic Medication Dose (Buchanan et al., 2010).
* Receiving antipsychotic medication for at least 8 weeks prior to starting the study with no medication changes within the previous 21 days.
* Proficient in the English language.

Exclusion Criteria:

* Diagnosis of mental retardation.
* Any clinically significant or unstable medical disorder as determined by the investigators, including congestive heart failure, abnormal liver function or disease, renal failure, acute pancreatitis, any diagnosis of cancer undergoing active treatment, HIV infection or other immunodeficiency condition.
* History of IV drug use.
* Primary diagnosis of substance abuse or dependence according to DSM-IV criteria within the last three months.
* Participated in any investigational drug trial in the past 30 days.
* Pregnant or planning to become pregnant during the study period.
* Receipt of antibiotic medication within the previous 14 days (as anaerobic organisms residing in the gastrointestinal tract may be minimally affected by antibiotics).
* Documented celiac disease (as such persons should be on a gluten-free diet as this is the standard care).
* Of note, the investigators are not limiting the study to individuals with elevated levels of gliadin or casein antibodies as the investigators intend to look at these levels as a predictor of response.
Efficacy and Safety of Soybean Germ Extract on Decrease of Body Fat

This study was conducted to investigate the effects of daily supplementation of Soybean germ extract on decrease of body fat

This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. 80 subjects were randomly divided into Soybean germ extract 1,600 mg or placebo group. The investigators measured Body Fat Mass, Percent Body Fat, Fat Free Mass, weight, and body mass index, etc.

Eligibility Criteria:
Inclusion Criteria:

* age between 19 and 65 years
* BMI 25\~29.9 kg/m\^2
* After fully hearing and fully understanding this clinical trials, those who agree to voluntarily decide to participate and to comply with the notice

Exclusion Criteria:

* Those who lost more than 10% of their weight within 3 months before the screening
* Those who take a product(body fat improvement health functional foods, birth control pills, steroids, female hormone) that affects your weight within 4 weeks prior to the screening
* Those with clinically significant severe cardiovascular, endocrine, immune, respiratory, liver, biliary, renal and urinary tract, neuropsychiatry, musculoskeletal, inflammatory and hematologic and gastrointestinal disorders
* Diabetic patients taking oral hypoglycemic agents or insulin (based on screening subjects)
* A person with a history of clinically significant hypersensitivity to soybeans
* Those who have received antipsychotic medication within 2 months before screening
* Anyone with substance abuse or suspicion
* Those who participated in other clinical trials within 3 months before screening
* Systolic Blood Pressure(SBP) 180 mmHg, Diastolic Blood Pressure(DBP) 110 mmHg or more
* Menopausal woman
* Laboratory test by show the following results

  * Aspartate Transaminase(AST), Alanine Transaminase(ALT) \> Reference range 3 times upper limit
  * Serum Creatinine \> 2.0 mg/dL
* Pregnancy or breast feeding
* Those who doesn't accept the implementation of appropriate contraception of a childbearing woman
* Principal Investigator judged inappropriate for participation in study because of Laboratory test result, etc.
Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia

The purpose of the study is to assess efficacy and safety of eplivanserin in the population of patients complaining of sleep maintenance insomnia. The patients suffering from that condition frequently wake up during the night, their sleep is nonrestorative and they suffer from a significant distress or impairment in their daily activities consecutive to insomnia.

12 weeks for each patient (double-blind period) + 1 week of run-in (placebo), and 2 weeks of run-out (placebo)

Total Duration of observation: 15 weeks for each patient

Eligibility Criteria:
Inclusion Criteria:

* Out patients
* Each patient must have primary insomnia in accordance with DSM-IV-TR-Axis I (Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition-Text Revision) criteria
* Based on patient's information, the patient must complain of at least one hour of wakefulness after sleep onset for at least 3 nights per week over the preceding month
* Patient must report impact daytime functioning associated with sleep maintenance insomnia as measured by question 3 of Insomnia Severity Index at screening visit and randomization visit.

Exclusion Criteria:

* Females who are lactating or pregnant
* Woman of childbearing potential with a positive serum beta human chorionic gonadotropin pregnancy test at screening and not using an acceptable form of contraception
* Patients presenting with acute or chronic pain resulting in insomnia
* Patients with history of epilepsy or seizures
* Consumption of xanthine containing beverage (i.e. tea, coffee, or cola) comprising more than 5 glasses/day
* Evidence of any clinically significant, severe, or unstable acute or chronically progressive medical or surgical disorder which may affect patient safety
* BMI \>32
* Acute or chronic pain resulting in insomnia
* Patients with current psychiatric disorders according to DSM-IV-TR criteria, mental retardation, or dementia
* Clinically significant and abnormal EKG (QTc interval \>=500 msec)
* Positive for hepatitis B or C
* Serious head injury or stroke within 1 year
* Use of OTC (over-the-counter) medications such as valerian root, kava, melatonin, St. John's Wort, or alluna; prescription sleep medications or anxiolytics within 1 week or 5 half-lives
* Participation in another trial within two month before the screening visit
* Use of any substance with psychotropic effects or properties known to affect sleep/wake
* Unable to complete the study questionnaires
* Night shift workers, and individuals who nap 3 or more times per week over the preceding month
* History of:

  * Primary hypersomnia
  * Narcolepsy
  * Breathing-related sleep disorder (such as sleep apnea)
  * Circadian rhythm sleep disorder
  * Parasomnia (somnambulism)
  * Dyssomnia (such as periodic leg movements)
Mitigating Sexual Stigma Within Healthcare Interactions Improve Engagement of MSM in HIV Prevention

The purpose of this study is to explore drivers and mitigators of anal sex stigma in healthcare, and then to develop and pilot an intervention for health workers that mitigates the deterrent effects of this stigma on the engagement of gay and bisexual men in HIV-related services.

This 5-year study aims to understand determinants that perpetuate and mitigate stigma toward anal sex during healthcare encounters, in order to develop and pilot a strategy that responds to these determinants and thereby improves the quality of care and HIV service engagement among men who have sex with men (MSM). The study team will collect data during in-depth interviews with 20 adult MSM as well as 20 adult healthcare workers (HCWs) to identify strategies that could be readily used in health services to reduce stigma. Analysis of this data will then inform consultation with an advisory board of 4 adult MSM and 4 adult HCWs to develop the content of a set of implementation strategies to mitigate stigma and thereby improve health service delivery. Evaluation of a set of implementation strategies will be performed in two high incidence regions in the United States, by pilot testing with 120 adult HCWs who do not specialize in MSM health and who work in clinical sites where MSM are under-engaged in HIV services.

Eligibility Criteria:
MSM Participants

Inclusion Criteria:

1. be aged 18 or older
2. report being assigned male at birth and identifying currently as male
3. reside in the United States
4. read and communicate in English
5. have had anal intercourse with a man in the past year or intend to in the next year Exclusion Criteria: Not applicable

Healthcare Worker Participants

Inclusion Criteria:

1. be aged 18 or older
2. read and communicate in English
3. bear a role responsibility for HIV-related screening and referral (e.g., as a peer/outreach worker, test counselor, case manager, social worker, medical assistant, nurse, physician assistant, physician) Exclusion Criteria: Not applicable