cyrilzakka/clinical-trials huggingface dataset:
Study of Nicotine Replacement Therapy in Pregnancy

The overall objective of this study is to assess the effectiveness of NRT (Nicoderm patches) plus counselling treatment in women in the second and third trimester of pregnancy.

Smoking during pregnancy is a major public health issue, causing miscarriages, prematurity, intrauterine growth retardation, stillbirth, and the Sudden Infant Death Syndrome (SIDS). It is estimated that 25-40% of pregnant smokers try to stop smoking on their own upon learning that they are pregnant. While pregnancy is often a strong motivator for smoking cessation, many nicotine-dependent women cannot quit smoking. The most important factor underlying the inability to quit smoking is strong dependence on a certain level nicotine, which is unique in every individual.

Several publications have shown that the use of the nicotine patch during the second and third trimesters is not associated with maternal or fetal compromise. More importantly, nicotine replacement therapy (NRT) during pregnancy exposes the fetus to lower levels of nicotine than smoking cigarettes does and, moreover, eliminates exposure to numerous other toxic substances.

Presently, counselling is the standard mode of treatment for the pregnant patients willing to quit smoking. Since pharmacologic smoking cessation therapies have been shown to increase significantly up to doubling a successful quitting rate when used in adjunction to brief physician counselling, the use of an appropriate dose of such agents is essential.

Eligibility Criteria:
Inclusion Criteria:

* Women who smoke
* Pregnant women after 12 weeks gestation, confirmed by ultrasound
* On the day of the recruitment, women will be at least 18 years old and no older than 40 years old
* Agree to sign consent form and participate in all aspects of the follow-up

Exclusion Criteria:

* Women who refuse to participate in the study/sign a written consent
* Women with insufficient English language skills to understand the questionnaires and assessment material
* Women with multiple pregnancy
* Women with confirmed cardiac pathology
* Women who receive concurrent treatment with Bupropion
* Congenital malformations visualized by ultrasound
* Objection from the physician caring for the woman to her participation
Triamcinolone Acetonide as an Adjunctive to VPDT in ARMD.

A 24 - month Study looking at the the changes in visual acuity of patients receiving PDT therapy in conjunction with intravitreal triamcinolone.

This study will evaluate the effect of Triamcinolone Acetonide in conjunction with photodynamic therapy for the treatment of sub-foveal choroidal neovascular membranes secondary to age-related macular degeneration.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with predominantly classic, subfoveal CNV secondary to AMD.
* No previous PDT Treatment in study eye.

Exclusion Criteria:

* CNV from conditions, other than AMD.
* Other disease that could be responsible for decreased vision.
Endometrial Cancer Diet and Exercise

This study will evaluate whether the use of the Jawbone wristband monitor, in connection with home-based exercise and nutritional counseling can be safely completed and improve cardiorespiratory fitness (heart and lung health) in women with early stage endometrial cancer who have undergone surgery.


Eligibility Criteria:
Inclusion Criteria:

* Ages \> 18 years.
* Localized endometrial cancer (stage I and II); no evidence of stage III or IV disease.
* At least 2 months was passed since the hysterectomy and enrollment.
* Karnofsky performance status \> 70%.
* Body mass index of 30.0 - 49.9 and body weight \< 300 pounds.
* No plan for adjuvant endometrial cancer therapy.
* Able to exercise safely on a treadmill.
* No absolute contraindications to exercise testing as recommended by the American Thoracic Society. No recent (\<6 months) acute cardiac event unstable angina, uncontrolled dysrhythmias causing symptoms or hemodynamic compromise, symptomatic aortic stenosis, uncontrolled symptomatic heart failure, acute pulmonary embolus, acute myocarditis or pericarditis, suspected or known dissecting aneurism and acute systemic infection.
* The subject is not participating in regular physical exercise (more than 60 minutes of moderate intensity or 30 minutes of vigorous intensity exercise per week) or weight reduction dieting.
* Able to provide informed consent.
* Have reliable transportation to the testing facilities.
* Subjects must be able to speak and understand English to participate in this study.
* Subjects must have a personal mobile device compatible for the activity monitor

Compatible devices for the activity monitors are below:

* Android

  o Activity monitor is compatible with most Android devices equipped with Bluetooth 4.0 and running Android 4.3 (Jelly Bean) or later.
* iOS

  * iPhone 4s (or newer)
  * iPod touch (5th generation or newer)
  * iPad (3rd generation or newer)
  * iPad mini (1st generation or newer)
  * iPad Air (1st generation or newer)

Exclusion Criteria:

-
Acceptability Lactoserum (Dermacyd Delicata - New Fragrance)

The purpose of this study is to demonstrate the safety of the gynecological formulation in normal and usual usage condition of Dermacyd Femina Delicata.


Eligibility Criteria:
Inclusion Criteria:

* Integral skin in the tested region

Exclusion Criteria:

* Pregnancy or breastfeeding women
* Use of Anti-inflammatory or immune-suppression drugs
* Topical medication use at the tested region
* Active cutaneous gynaecological disease which may interfere in study results
* Personal history of allergic disease at the area to be treated
* Allergic or atopic history

The above information is not intended to contain considerations relevant to a patient's potential participation in a clinical trial.
Effect of the Physiological Angular Position of the Resting Knee on Pressure at the Heel/Surface Interface

The main objective of this study is to evaluate the relationship between the angle of knee flexion in a supine position with joint relaxation (DDPD) and the maximum interface pressure at the heel area (PtAl).

The secondary objectives of this study are:

A. To evaluate the relationship between the angle of flexion of the knee in DDPD and the average pressure throughout the heel area (Pmean).

B. To evaluate the relationship between the angle of flexion of the knee in DDPD and the contact surface of the heel area (Stal) where the pressure is greater than 60 mm Hg.

C. To evaluate the inter-operator concordance for the knee flexion angle measurement in DDPD via photos.

D. To evaluate the inter-operator concordance for skin marks used to measure knee flexion angles in DDPD via photos (only one knee for 30 patients).

E. To evaluate the inta-operator concordance (measures on 2 consecutive days) for skin marks used to measure knee flexion angles in DDPD via photos (for 30 patients).

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is in a stable medical state (no complications within the past 10 days)

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient has had medical complications within the ten days preceding study inclusion
* The patient has a bed-sore or bandages on his/her heels
* The patient has had a lower-limb amputation
Development of a Lifestyle Physical Activity Intervention to Reduce Risk for Perinatal Cannabis Use - RCT

The overall goal of this pilot study is to develop and preliminarily evaluate an LPA intervention designed to reduce cannabis use during pregnancy.

In the pilot RCT, we will recruit 50 women between 12-22 weeks gestation from an established network of prenatal clinics, and randomly assign eligible women to either a: 1) LPA+Fitbit intervention or 2) Fitbit Only control condition. Similar to our prior trials with pregnant women, the intervention period will be 12 weeks in duration during pregnancy, with follow-ups extending to the end of pregnancy and into the postpartum period. Major assessments will occur at baseline, end of treatment (EOT), and 4 weeks postpartum; we will also conduct brief phone surveys at three points in between the larger assessments. Participants will complete a 7-day period of accelerometry and urine toxicology screens following each major assessments. Birth record abstractions to collect information about specific outcomes (pre-term delivery, low birth weight) will be conducted by trained staff at one month post-birth.

Eligibility Criteria:
Inclusion Criteria:

1. women 18+ years of age
2. 12-25 weeks gestation with a healthy singleton pregnancy
3. medically-cleared by their prenatal provider for moderate intensity physical activity
4. self-report of cannabis use at least once/week in the 3 months prior to the current pregnancy and desire to not engage in prenatal CU
5. current psychological distress as defined by Edinburgh Postnatal Depression Scale score \>7 and/or Generalized Anxiety Disorder 7 score \>5)
6. English-speaking
7. owns a smartphone to enable use of the Fitbit app
8. current physical activity level does not meet public health recommendations (less than 150 minutes/week moderate intensity physical activity for the past 3 months)
9. expresses interest in reducing or discontinuing CU

Exclusion Criteria:

1. current DSM-5 diagnosis of moderate/severe substance use disorder other than cannabis use disorder or nicotine use disorder
2. use of illicit substances in the last 3 months (other than cannabis)
3. acute psychotic symptoms
4. current or recent suicidality or homicidality
5. current anorexia or bulimia
6. current cognitive impairment
7. physical or medical problems that would not allow safe participation in moderate intensity physical activity
8. has plan to relocate away from the geographic area during the study intervention or assessment period
9. recently started a new form of mental health or substance use treatment within the past 4 weeks
Ocular Safety Of Patients Receiving Macugen For Neovascular Age Related Macular Degeneration

The study will provide additional safety data for specific safety events in persons receiving intravitreal injections. The Committee for Medicinal Products for Human Use (CHMP) is interested in obtaining additional safety information when Macugen is used in real world settings by practitioners in Europe treating patients with neovascular (wet) age-related macular degeneration (AMD). The study will provide information about physician practice patterns and characteristics of patients treated with Macugen.

No comparator Patients with age-related macular degeneration

Eligibility Criteria:
Inclusion Criteria:

* Neovascular AMD patients who are eligible for Macugen therapy based on the approved label

Exclusion Criteria:

* Active or suspected ocular or periocular infection. Known hypersensitivity to the active substance or any of its excipients.
Effectiveness Comparison Between the Drugs TOBRACORT® and TOBRADEX® in Reducing the Signs and Symptoms of Acute Bacterial Conjunctivitis

The primary objective of this study is to evaluate, through clinical parameters, the comparative efficacy between topical Tobracort ® (tobramycin 0.3% dexamethasone + 1% - Chemistry Lab Union) and TOBRADEX ® (tobramycin 0.3% dexamethasone + 1 % - Alcon Lab), using the percentage of improvement (sustained response rate) at the end of treatment.

* Evaluation of signs and symptoms during treatment, with a record of individual scores for each parameter;
* Observation and statistical comparison of drug safety, by recording qualitative and quantitative parameters related to adverse effects occurring during treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients who agree with all study procedures and sign, by his own free will, IC;

  * Adult patients, regardless of gender, ethnicity or social status, with good mental health;
  * Patients who present at screening visit, a clinical picture of acute bacterial conjunctivitis diagnosed clinically.

Exclusion Criteria:

* Patients with clinical diagnosis of conjunctivitis due to any process other than bacterial infection, such as infections by fungi, protozoa, viruses, or allergic conjunctivitis;

  * Patients with a history or clinical diagnosis of other lesions that may affect the outcome, such as glaucoma, corneal ulcer or scars;
  * Patients with known hypersensitivity to any component of the study drug;
  * Concomitant use of ocular medication other than the study;
  * Patients who have made use of systemic anti-inflammatory hormone in the 30 days preceding inclusion;
  * Patients who have made use of systemic antibiotics in the 15 days preceding inclusion;
  * Pregnant or lactating women;
  * Being or having been treated for any type of conjunctivitis is less than 15 days, or have finished treatment at least 7 days
Study to Assess the Efficacy and Safety of Lanreotide Autogel® in Chinese Participants With GEP-NETs

This study will be conducted to support the registration of the lanreotide Autogel 120 mg formulation in China for the treatment of GEP-NETs and treatment of clinical symptoms of NETs.

The study will include a screening period of up to 4 weeks followed by a 48-week intervention period. After completion of the main study period, five participants will continue in a self/partner injection cohort with lanreotide Autogel 120 mg every 28 days for 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Capable of giving signed informed consent
* Male or female of 18 years of age or older when informed consent is obtained
* Has a histologically proven Grade 1 or 2 GEP-NET according to WHO (World Health Organisation) classification
* Has an unresectable metastatic or locally advanced NET.
* Has an Eastern Cooperative Oncology Group (ECOG) performance status lower or equal to 2.

Exclusion Criteria:

* Participants with poorly differentiated Gastroenteropancreatic neuroendocrine carcinoma (GEP-NEC), high-grade GEP-NEC and goblet cell carcinoid.
* Has been treated with octreotide acetate long-acting release or lanreotide acetate Autogel formulation within 8 weeks prior to screening tests or lanreotide PR 40 mg within 4 weeks prior to screening tests.
* Has been treated with subcutaneous or intravenous octreotide acetate within 1 week prior to screening tests.
* Has been treated with mammalian target of rapamycin (mTOR) inhibitors or multi-target tyrosine kinase (MTK) inhibitors within 4 weeks prior to screening tests.
Nitric Oxide Bioavailability and Early Life Stress (NO-Stress)

Cardiovascular disease is the leading cause of death in the United States. Other studies have shown that stress, early in life, could be a risk factor for cardiovascular disease, later in life. This study will look at the effect of early life stressors on your cardiovascular health.

This study will have two parts involved to investigate the role that childhood SES status has on cardiovascular health.

Part one: Subjects will give a blood sample which will be processed and analyzed. Flow mediated dilation (FMD) and Pulse wave velocity (PWV/PWA) will be performed at baseline and 2 hours following either a single dose oral antioxidant cocktail (1000 mg of Vitamin C, 600 IU of Vitamin E, and 600 mg of alpha-lipoic acid) or placebo on two days separated by at least 72 hours. Nitroglycerin mediated dilation (NMD, 0.4mg sub-lingual nitroglycerin spray), will be assessed at baseline.

Part two: Subjects, if interested will undergo a subcutaneous gluteal/hip fat biopsy. Micro vessels will be isolated from the adipose tissue and analyzed by pressurized myography for endothelial function and nitric oxide bioavailability.

Eligibility Criteria:
Inclusion Criteria:

* documented childhood SES
* men and premenopausal women ages 18-40
* lean/overweight/or obese with BMI\< or equal to 39kg/m2

Exclusion Criteria:

* cardiovascular, renal, pulmonary, hepatic, cerebral, or metabolic,disease
* use medications that affect vascular tone
* post menopausal women
* have class 3 obesity or BMI over 40
Facilitated Tucking Position During Endotracheal Suctioning

Aim of the present study The present study will aimed to determine the effect of facilitated tucking position during endotracheal suctioning on physiological criteria and behavioural responses of the preterm neonates.

Research Hypotheses

1. Preterm neonates who receive facilitated tucking position during endotracheal suctioning exhibit more stable physiological criteria than those who do not.
2. Preterm neonates who receive facilitated tucking position during endotracheal suctioning exhibit more stable behavioral responses than those who do not.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age between 32 and 36 weeks, weight 1200 grams or greater.
* Postnatal age: two days after delivery to allow for resolution of analgesia or anesthesia received by their mothers during labor.
* Have endotracheal intubation.

Exclusion Criteria:

* Preterm neonates who have congenital anomalies or neurological malformations, intracranial hemorrhage, seizures.
* Preterm neonates who received sedatives within four hours before the intervention
* Preterm neonates who exposed to any uncomfortable procedure for at least 30 minutes prior to the intervention.
Polydeoxyribonucleotide -Placentex Mastelli(Pdrn) for the Treatment of Diabetic Ulcers

The main objective of the study is to evaluate the efficacy of the polydeoxyribonucleotide in improving the healing of diabetic foot ulcers.

This trial will involve diabetic patients with foot ulcers who meet the inclusion/exclusion criteria. At least 200 patients aged 45-80yrs will be enrolled in the study and randomly allocated to receive the active drug or the placebo in indistinguishable formulations. After 2 months closure rate of the ulcer will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 45-80yrs
* Minimum schooling 5yrs
* Type I or II diabetes since at least 5yrs with a stable metabolic control
* Foot ulcer since minimum 2 weeks
* Ulcer \>1cm and \<16cm at day 0
* Ulcer grade 1 or 2 wagner scale
* Wound free of necrotic debris
* TcPO2 \>29mmHg
* Not pregnant or lactant

Exclusion Criteria:

* Non-consenting patient
* History of alcohol or drug abuse
* Gangrene on any part of the affected foot
* Ongoing untreated infections
* Ulcer over a charcot deformity
* Use of a systemic cicatrizant drug in the past 10 days
* Malnutrition
* Neurological or psychiatric pathologies
* Liver or kidney insufficiency
* Corticosteroid or immunosuppressive or cytotoxic therapy
* Other severe pathologies
* Proven hypersensitivity to the drug or to any related component
Does Normal Brain Imaging Predict Normal Neurodevelopmental Outcome in Fetuses With Proven Cytomegalovirus Infection?

Cytomegalovirus (CMV) is the largest member of the virus family Herpesviridae that infects almost all humans at some point in their lives (Ross, 2004). Congenital CMV infection is most likely to occur when the mother experiences a primary infection during pregnancy, and it is much less common in cases of reactivation of the disease or infection by a different CMV strain (Boppana 1999, Endres 2001). The prevalence of congenital CMV infection varies between 0.15-2.2% (Ross 2004, Ross 2006, Malm 2007). While most infants born with congenital CMV infection are asymptomatic, 10 to 15% show clinical findings at birth (Ross 2004).

It is generally agreed that congenital CMV infection, whether it is symptomatic or not, is a major risk factor for perceptual deficits. However, its influence on children's future neuropsychological functioning is less well established. Symptomatic congenital CMV infection is a major risk factor for poor developmental outcome (Williamson 1982, Kylat 2006, Dollard 2007), but the available data regarding neuropsychological outcome for asymptomatic children is extremely diverse (Conboy 1986, Ivarson 1997, Kashdan 1998, Temple 2000, Zhang 2007).

We evaluated the neuropsychological outcome of children with congenital cytomegalovirus (CMV) infection and normal consecutive fetal neurosonographic examinations and determined whether Magnetic Resonance Imaging (MRI) provided additional information in these cases.


Eligibility Criteria:
Inclusion Criteria:

* CMV PCR positive in the amniotic fluid

Exclusion Criteria:

* US abnormal findings during fetal life
Allograft Reconstruction of Massive Rotator Cuff Tears vs Partial Repair Alone

The investigators hypothesize that the use of an allograft adjuvant to partial repair will lead to improved shoulder outcome measure scores compared to partial repair alone in massive rotator cuff tears.

A total of 30 patients will be enrolled in the study. Subjects will be randomized into two arms, either (1) Partial Repair/Debridement or (2) Allograft Reconstruction.

The patients will complete a structured clinical examination conducted by a sports medicine fellowship trained orthopaedic consultant, Pre-operatively and Post-operatively at 6 weeks, 3, 6, 12, 24 months. The examination will consist of range of motion testing by goniometer as well as strength testing by hand dynamometer. The patient will also complete the Western Ontario Rotator Cuff Index (WORC) questionnaire.

The main benefit of this procedure is that patients who have currently irreparable massive, chronic rotator cuff tears may acquire a means for their cuff to be repaired. This may aid in improving function of the shoulder, restoring ability to complete activities of daily living, while decreasing pain and sleep disturbances. This would allow the participant to become more functional after rehabilitation. It is our belief that this study could provide new information in helping to understand this relationship, which would in turn lead to future study in this area of orthopaedic surgery.

Eligibility Criteria:
Inclusion Criteria:

* Large/Massive rotator cuff tear \>3cm proven on MRI

Exclusion Criteria:

* Non surgical candidate, unable to consent
A Noninterventional Genotype/Phenotype Study of mGluR Mutations in Children and Adolescents With ADHD

This noninterventional study will assess genomic changes in the metabotropic glutamate receptor (mGluR) network in children and adolescents with ADHD.

Male and female subjects 6 to 17 years of age with a primary psychiatric diagnosis of ADHD will be enrolled in this study. The subject and his or her parent/guardian must agree to genotyping to determine whether the subject has disruptive mutations within any of the approximately 274 mGluR-network genes, and complete an interview that will include information about the subject's ADHD history, treatment, and co-morbidities.

Eligibility Criteria:
Inclusion Criteria:

* The subject is male or female ≥6 and ≤17 years of age.
* The subject has ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition.
* The subject, his or her legally responsible representative, and investigator agree to complete ADHD history, treatment, and comorbidity electronic case report form (eCRF).

Exclusion Criteria:

* The subject or parent/legal guardian is in the opinion of the investigator mentally or legally incapacitated and unable to provide informed consent/assent for participation in the study.