cyrilzakka/clinical-trials huggingface dataset:
Human Milk Profiles and Dietary Intake of Chinese Lactating Mothers During Early Lactation Period in Shanghai

This study aims to investigate breast milk composition and dietary habits of Chinese lactating mothers. Further understanding of the composition of human milk will help to understand the nutritional needs of mothers and their infants in their early phase of life which eventually will help to support breastfeeding.


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy mothers who give birth to a healthy term infant (37-42 weeks) whose birth weight is \>10 and \<90 percentiles gestational birth weight chart.
* Aged 20 - 40 years.
* Mothers who intend to exclusively breastfeed the infant for more than 6 weeks.
* Chinese ethnicity, including both parents.
* Mothers who sign the informed consent form in writing.

Exclusion Criteria:

Mothers:

* Participation in any other studies involving investigational or marketed products concomitantly or two weeks prior to entry into the study.
* Difficult to follow up and/or locate (e.g. known transfer to other hospitals, residing outside Shanghai, plan to move out of Shanghai).
* Current smoker or having smoked during the pregnancy.
* Having consumed alcoholic drinks during pregnancy or lactation.
* Illegal drug abuser: cannabinoids (marijuana, hashish), stimulants (cocaine, amphetamine, methamphetamine), opioid (heroin, opium).
* Acute infection disease or neoplastic disease or any kind of weakening or debilitating conditions (no history of positive HBV, HCV or HIV serological test at any time during the pregnancy).
* Use of drug or pharmacologically active substances (e.g. herbal products, traditional medicine) to treat a particular disease or medical condition from the beginning of lactation ( those who consume herbal/traditional medicine for maintaining or improving well-being will still be included).
* Presence of mastitis, fungal infections of the nipple or areola; reactivation of herpes simplex (HSV) or varicella zoster infection in the mammary or thoracic region at the time of enrolment.
* Presence of endocrinology diseases, particularly diabetes mellitus and gestational diabetes.
* Presence of obesity (pre-pregnancy BMI \> 28).
* Presence of chronic diseases such as cardiovascular, renal, respiratory and hepatic diseases.
* Presence of psychosis and severe post-partum depression.
* Presence of autoimmune disease such as systemic lupus erythematosus, systemic scleroderma, ulcerative colitis, Crohn's disease, celiac disease.
* Women whose health condition, according to the investigator's judgement, could interfere with the study conduct and assessment.
* Mothers who have given birth to twins or multiples or infant conceived with Assisted Reproductive Technology (ART).
* Elimination diet due to chronic allergic diseases or vegan.
* Incapability of subject to comply with study protocol or investigator's uncertainty about the willingness or ability of the mothers to understand and comply with the protocol requirements.

Infants:

* Any congenital abnormality, chromosomal disorder or severe disease which could interfere with the study conduct and assessment.
Host Response to Pessaries in Microbial Communities of the Postmenopausal Vagina

The ability to determine the postmenopausal vaginal environment and the impact of pessary use could help to maximize pessary therapy and non-surgical treatment for such a prevalent problem.

The study will advance the care of elderly patients through providing data to maximize non-surgical options to those at high risk for having surgery and its attending morbidity. In characterizing substantive differences in the vaginal environment of successful and unsuccessful pessary users, the investigators can identify elderly patients at higher risk of adverse events with pessary use as well as novel targets for the pharmacologic treatment of the altered vaginal microbiota and endogenous AMP levels, potentially allowing patients to continue with non-surgical therapies rather than pursuing surgical intervention.

Eligibility Criteria:
Inclusion Criteria:

* must be English speaking
* appropriate for pessary treatment
* pelvic floor conditions such as POP (with or without the presence of a uterus), stress urinary incontinence, urge urinary incontinence, or any combination of the above.

Exclusion Criteria:

* a history of current, symptomatic vaginal stricture
* a history of current, radiation therapy,
* or current treatment with auto-immune suppression agents.
* if they have eroded mesh in the vagina from prior pelvic floor surgery
Assessment of Performance and Safety of an Asymmetric Balloon in the Treatment of Intranasal Bleeding Managed in an Emergency Setting

Between 10 and 12% of the general population suffers from epistaxis, out of which 10% would need to be medically managed. Most of patients treated for epistaxis are managed through emergency departments. The involvement of the ENT (ear, nose and throat) surgeon might be required in more complex situations in order to control bleeding.

Usually, nasal packing packing is used as a first line option after failure of digital compression. Epistaxis balloons are often used after failure of nasal packing Balloons are effective in approximately 60% of the patients with a rapid control of bleeding by compression followed by an absence of rebreeding after balloon removal.

The main challenges for patients treated with this device are i) pain upon balloon introduction and inflation ii) discomfort upon introduction in the nasal cavity as well as during balloon maintenance during 24 to 72 hours of tamponade iii) blood retention between distal and proximal balloons that favors infection iv) limited breathing capabilities through the nostrils which increases general discomfort v) negative aesthetic impact for the patient vi) septal and alar necrosis risk in case of prolonged compression.

Moreover, epistaxis leading to an hospitalization between 24 to 48h are not rare (\>11 000 in France in 2017 according to ATIH). Those hospitalizations are often decided in order to ensure an optimal patient monitoring following packing or epistaxis balloon placement.

In order to address those adverse events while keeping the same efficacy and avoiding hospitalizations or reducing their duration, the use of an asymmetric, more physiological, easy to use and mainly intranasal (discreet proximal extremity) is studied.


Eligibility Criteria:
Inclusion Criteria:

* Age \> or = 18 years
* Male and female
* bleeding uncontrolled with digital compression
* Patient registered at social security
* Patient who gave informed consent

Exclusion Criteria:

* Allergy to xylocaine
* Impossibility to give patient information (severe massive epistaxis, difficulty to understand, non awaken patient...)
* Patient in custody of court
* Patient under guardianship or curator
Reversal of Neuromuscular Blockade With Sugammadex or Usual Care in Hip Fracture Surgery or Joint (Hip/Knee) Replacement (P07038)

This study will assess the effect of reversal of neuromuscular blockade with sugammadex compared with reversal according to usual care (neostigmine or spontaneous reversal) on the incidence of post-surgical bleeding events and on coagulation parameters in participants undergoing hip fracture surgery or joint (hip/knee) replacement surgery with neuromuscular blockage induced by rocuronium or vecuronium.

Participants will be randomized to sugammadex or usual care in a 1:1 ratio.

Eligibility Criteria:
Inclusion Criteria:

* Must be American Society of Anesthesiologists (ASA) Class 1, 2, or 3
* Must be scheduled for a hip fracture surgery or joint (hip or knee) replacement surgery under general anesthesia including the use of rocuronium or vecuronium for neuromuscular blockade
* Must be:

  * Currently receiving thromboprophylactic (anti-clotting) therapy with low molecular weight heparin (LMWH) or unfractionated heparin (UFH), or
  * Planned to initiate thromboprophylactic therapy with LMWH or UFH prior to or during surgery, or
  * Currently receiving ongoing thromboprophylactic therapy with a vitamin K antagonist that has been temporarily substituted with peri-operative LMWH or UFH, and/or
  * Currently receiving ongoing thromboprophylactic therapy with low-dose aspirin or other antiplatelet therapy
* Platelet count above the lower limit of normal range
* Appropriate candidate for rapid reversal of neuromuscular blockade
* Sexually active females must agree to use a medically accepted method of contraception through seven days after receiving protocol-specified medication

Exclusion Criteria:

* Anatomical malformations that may lead to difficult intubation
* Neuromuscular disorder that may affect neuromuscular blockade
* History of a coagulation disorder, bleeding diathesis, systemic lupus erythematosus or antiphospholipid syndrome
* History or evidence of active abnormal bleeding or blood clotting within 30 days prior to screening
* Significant hepatic dysfunction
* Severe renal insufficiency
* History or family history of malignant hyperthermia
* Hypersensitivity or hypersensitivity-like reaction to sugammadex, muscle relaxants, or other medications used during general anesthesia
* Planned intravenous administration of toremifene and/or fusidic acid within 24 hours before or within 24 hours after study medication
* Recent, severe trauma
* Body Mass Index (BMI) \> 35
* Any contraindication to administration of sugammadex or neostigmine/glycopyrrolate (or neostigmine/atropine)
* Pregnant or intends to become pregnant between randomization and the Day 30 follow-up visit
* Breast-feeding
* Previously treated with sugammadex or participated in a sugammadex clinical trial
* Has an active hip/knee infection and is scheduled for revision surgery
Primary Hyperparathyroidism: Does a Systematic Treatment Improve the Calcium and Bone Metabolism After Surgery?

Primary Hyperparathyroidism (pHPT) increases bone turnover and resorption and thus calcium efflux out of bone. After successful surgical treatment of pHPT, bone takes up calcium again which may result in secondary hyperparathyroidism or even "hungry bone syndrome". Until today there are no studies about this problem helping to develop recommendations or guidelines how to prevent these symptoms.

Study hypothesis: Calcium and vitamin D intake after surgery for PHPT protects the bone by keeping PTH in the normal range (less secondary, reactive hyperparathyroidism), prevents hungry bone- syndrome and improve bone-turnover markers (osteoporosis protection).


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women
* Male patients
* Biochemically proven PHPT, PTX planned
* No evidence for osteoporosis

Exclusion Criteria:

* Postoperative hypocalcemia needing substitution with calcium and vitamin D/ 1-25-OH-Vitamin D
* Cancer (lung, breast, prostatic, parathyroid cancer and thyroid carcinoma \>1cm)
* Persisting or recurrent PHPT (postoperative hypercalcemia)
* Four-gland hyperplasia
* Multiple endocrine neoplasia (MEN) or hereditary PHPT
* Familial hypercalciuric hypercalcaemia (Ca/creatinine ratio \< 0.01)
* Phenylketonuria
* Renal impairment (creatinine clearance \<30ml/h)
* Severe hepatic disorder
* Severe systemic disorder
* Thyroid dysfunction
* Immobilisation
* Intake of drugs with potential effects on BMD like glucocorticoids, lithium, estrogen-replacement therapy, selective Estrogen-receptor modulators (sERMs), bisphosphonates in the last three months
* Intake of drugs containing digoxin or digitoxin
* Known allergy against any component of the study medication
Project RAP: Reaching Adolescents for Prevention

The purpose of the study is to determine if a brief motivational interview in the context of an emergency health care visit will reduce high-risk drinking and drug-taking and associated health consequences among adolescents ages 14-21 years old.

Many studies have shown that a brief motivational interview in the context of a routine or emergency health care visit may assist adults to reduce high-risk drinking and drug-taking. Center researchers are conducting a 1,400-person, randomized clinical trial involving teen patients at the Boston Medical Center Pediatric Emergency Department in order to determine if a similar approach will be effective with youth. All patients aged 14 to 21 get a brief alcohol and drug screen, and those whose scores indicate they drink or use marijuana are invited to participate in the study. One-third of the enrollees will receive an assessment, a brief motivational interview performed by a trained peer counselor, direct referrals to community-based resources for adolescents, and a 10-day follow-up phone call. One-third will receive only the assessment and a list of community resources; and the final third will receive only the list of resources. All participants will be followed over time and re-screened to measure the impact of the initial brief intervention on their drinking and drug-taking. The key hypothesis is that individuals who receive the brief motivational interview in the emergency department setting will have lower rates of alcohol and illicit drug use and fewer health consequences over time.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric emergency department patients
* Aged 14-21
* An Alcohol Use Disorders Identification Test (AUDIT) score above selected cut-point for age or with history of alcohol-related consequences

Exclusion Criteria:

* Not resident in area or able to provide contact information for 12 month follow-up
* Medically unstable
* Not oriented to person, time and place
Children, Perennial Allergic Rhinitis (PAR), l-t Growth

The purpose of this study is to compare the effect of Rhinocort nasal spray with placebo on growth in children with perennial allergic rhinitis over 12 months.


Eligibility Criteria:
Inclusion Criteria:

* In the opinion of the investigator, is a candidate for treatment with nasal steroids based on a history of either a) inadequate control of symptoms with antihistamines, decongestants and/or immunotherapy, or b) prior successful treatment with nasal steroids.
* A documented history of at least one year of perennial allergic rhinitis.
* A positive response to a skin prick test for perennial allergens that must be present in the subject's environment.
* Height and weight within normal limits.

Exclusion Criteria:

* Any disease which may affect growth
* Sexual development later than Tanner stage I.
* Nasal candidiasis, rhinitis medicamentosa, acute or chronic sinusitis, influenza, upper respiratory tract infection or structural abnormalities of the nose (e.g., septal deviation, nasal polyps) symptomatic enough to cause significant nasal obstruction as judged by the investigator.
The Effects of Jing Si Herbal Tea Liquid Packets on Fatigue in Patients With Inflammatory Arthritis

Fatigue is a common feature in patients with rheumatic conditions. Fatigue can lead to a decline in physical function, self-confidence, cognitive status, and work performance and significantly impact the quality of life. While pain and inflammation of arthritis can be well controlled nowadays attributed to the advances in anti-rheumatic medications, fatigue remains a challenge. Even with proper therapies for arthritis, the prevalence of severe fatigue is more than 30%, which is a significant burden to both physicians and patients. However, there is no regimen to alleviate fatigue among patients with inflammatory arthritis. Finding a way to combat fatigue will significantly help improve patients' physical and mental state and family society.

To investigate the efficacy of Jing Si Herbal Tea Liquid Packets on fatigue in patients with inflammatory arthritis, the investigators propose a two-year research project to recruit approximately 150 patients with fatigue and inflammatory arthritis, including rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis. This project is designed as a randomized, double-blind, placebo-controlled study. The recruited patients will be randomized to receive Jing Si Herbal Tea Liquid Packets or a matching placebo in combination with the background regular anti-rheumatic therapy. The severity of fatigue will be obtained by questionnaire. Clinical parameters, including demographic data and disease activities, will be collected during each visit.


Eligibility Criteria:
Inclusion Criteria:

* inflammatory arthritis, any of the following diagnosis

  1. Rheumatoid arthritis, based on ACR (American College of Rheumatology) classification criteria
  2. Ankylosing spondylitis, based on modified New York Criteria
  3. Psoriatic arthritis, based on 2006 CASPAR (ClASsification criteria for Psoriatic ARthritis) criteria

Exclusion Criteria:

1. active infection or chronic infection
2. uncontrolled disease status of inflammatory arthritis
3. unwilling to take herbal tea
4. with difficulty for return visits
Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo in Generalized Anxiety Disorder

The purpose of this study is to demonstrate that quetiapine SR (SEROQUEL®) is efficacious and safe in the acute treatment of patients with Generalized Anxiety Disorder.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.


Eligibility Criteria:
Inclusion Criteria:

* Patient has a documented clinical diagnosis of Generalized Anxiety Disorder.
* Be able to understand and comply with the requirements of the study.
* Able to understand and provide written informed consent

Exclusion Criteria:

* Patients (female) must not be pregnant or lactating
* Current or past diagnosis of stroke or transient ischemic attack (TIA).
Health Behaviors in Patients Who Have Finished Treatment for Stage I, Stage II, or Stage III Colorectal Cancer

RATIONALE: Gathering information over time from patients who have finished treatment for colorectal cancer may help doctors predict which cancer survivors will improve their physical activity and diet.

PURPOSE: This clinical trial is studying health behaviors in patients who have finished treatment for stage I, stage II, or stage III colorectal cancer.

OBJECTIVES:

Primary

* To characterize patterns and identify predictors of post-treatment physical activity and dietary changes made by colorectal cancer survivors.

Secondary

* To identify the affective and cognitive effects of post-treatment physical activity and dietary changes in these patients.
* To identify these patients' preferences regarding diet and physical activity health promotion programs.

OUTLINE: This is a multicenter study.

Patients complete surveys at baseline and at 3 and 6 months. A randomly selected subset of 84 patients also receive an activity monitor to be use at each of the 3 time points. The acceptability of their use is assessed and whether activity levels change across the 3 time points and the extent to which they are convergent with self-reported physical activity are examined.

During each survey, questionnaires are administered to assess the following areas: physical/medical characteristics (self-reported), self-efficacy for physical activity, fruit and vegetable consumption, and dietary fat intake; outcome expectations for physical activity, fruit and vegetable consumption, and dietary fat intake; physical activity and diet behavioral self-regulation; illness representations (causal attributions and controllability of recurrence); perceived risk of colorectal cancer (CRC) recurrence; emotional representations of CRC (cancer-related anxiety and worry about cancer recurrence); healthcare provider recommendations to alter physical activity and dietary intake; social influence from important others; current physical activity and dietary intake; and diet and physical activity program preferences. Patients who received the activity monitor are asked feedback on acceptability of them.

Measures of sociodemographics and disease/treatment characteristics (via medical chart review) are recorded.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of localized or regional colorectal cancer

  * Stage I, II, or III disease
  * Completed treatment within the past 6 weeks
* No previous diagnosis of colorectal cancer

PATIENT CHARACTERISTICS:

* English speaking
* No current evidence of neoplastic disease except for nonmelanoma skin cancer
* No evidence of severe cognitive impairment

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Hypoglossal Nerve Stimulation on Cardiovascular Outcomes

A new, well-tolerated treatment for obstructive sleep apnea - tongue stimulation - is a device which opens the airway during sleep and can provide treatment for patients unable to use the mask and hose treatment. The study will evaluate the effect of this new treatment on blood pressure and heart-related measures to see if it lowers patients' risk of heart problems.

Obstructive sleep apnea, repetitive airway blockage during sleep, affects 1 in 10 Americans. If left untreated, it results in decreased quality of life and increased risk of heart problems. Only half of these people are able to use the main treatment, continuous positive airway pressure (CPAP) therapy, which involves wearing a mask and hose at night. A new, well-tolerated treatment - tongue stimulation - is a device which opens the airway during sleep and can provide treatment for patients unable to use the mask and hose treatment. The study will evaluate the effect of this new treatment on blood pressure and heart-related measures to see if it lowers patients' risk of heart problems.

Eligibility Criteria:
All patients recruited into the study will have already been implanted with the Inspire® HGNS device.

Additional Inclusion Criteria include:

* As tolerating the therapeutic level during sleep can take time (weeks to months), all patients must be able to use the device at the therapeutic setting (\> 20 hours/week for \> 1 month) prior to enrollment, based on compliance data.
* All patients will be English-speaking and able to give written informed consent.

Exclusion Criteria include:

* Inspire® remote Model 2500 or later is required. Patients with older remotes are not candidates due to limited adherence monitoring capabilities.
* Patients who have fallen asleep while driving resulting in accident or "near miss" accident within 1 year prior to HGNS implantation.
* Actively using positive airway pressure (PAP) therapy for treatment of OSA.
* Patients in whom the difference between sham and therapeutic voltages is less than 30% the therapeutic voltage.
* Pregnant women will be excluded.\*

  * Women of childbearing potential must NOT be pregnant or plan on becoming pregnant. This study involves temporarily stopping treatment of obstructive sleep apnea, which may harm the fetus. If applicable, the patient will need to take a urine pregnancy test after enrollment (prior to washout #1), and again prior to washout #2.