cyrilzakka/clinical-trials huggingface dataset:
Intravenous Methadone Versus Intrathecal Morphine for Analgesia Following Cesarean Delivery

The purpose of this study is to determine if there is a difference in opioid requirements at 0-48 hours after scheduled cesarean delivery in patients receiving 150 mcg intrathecal morphine compared to 0.2 mg/kg (maximum 20 mg) intravenous methadone.


Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* Age over 18 years old
* Scheduled cesarean delivery

Exclusion Criteria:

* Any contraindication to the administration of a spinal technique for anesthesia
* History of intolerance or adverse reaction to opioid medications
* History of chronic pain, opioid use \>30 OME/day, or substance use disorder
* History of obstructive sleep apnea, chronic obstructive pulmonary disease, or respiratory compromise (SpO2 \<92% on room air, or has a pre-existing oxygen requirement)
* History of liver or kidney failure
* Diagnosis of pre-eclampsia with current pregnancy
* Depression requiring more than one medication
* Planned use of CSE technique
* BMI \>50.0 kg/m2
* ASA status IV, V
* No prior history of an ECG demonstrating QTc \> 440ms
* Surgical complication requiring conversion to general anesthesia
Edwards Cardioband System ACTIVE Pivotal Clinical Trial (ACTIVE)

To establish the safety and effectiveness of the Edwards Cardioband System in patients with functional mitral regurgitation (FMR).

The ACTIVE Trial is a prospective, randomized, multicenter trial. Patients with clinically significant functional mitral regurgitation will be randomized 2:1 to receive either transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT) or GDMT alone. Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years;
* Clinically Significant Functional Mitral Regurgitation (MR);
* Symptomatic heart failure;
* Patient hospitalized due to heart failure during 12 months prior to submission to Central Screening Committee OR elevated Brain Natriuretic Peptid (BNP);
* Patient is able and willing to give informed consent and follow protocol procedures, and comply with follow-up visit compliance.

Exclusion Criteria:

* Primarily degenerative MR;
* Mitral annular calcification that would impede implantation of device;
* Other severe valve disorders requiring intervention;
* Mitral valve anatomy which may preclude proper Edwards Cardioband deployment;
* Life expectancy of less than twelve months;
* Patient is participating in concomitant research studies of investigational products which have not reached their primary endpoint;
* Unwillingness or inability to undergo follow-up investigations/visits;
* Other medical, social, or psychological conditions that precludes appropriate consent and follow-up
Trial of Vitamin D Fortified Milk

Prevalence of VDD is high worldwide, even in sunbathed equatorial regions where it had not been suspected before. The most cost-effective method for reducing population-wide VDD is through fortification of commonly consumed foods. Nevertheless, the efficacy of fortification varies by dose, duration, and population characteristics; and it is currently unknown whether it could be an efficacious public health intervention to curb the VDD epidemic among children living in tropical areas. We propose to conduct a randomized, controlled, double blind trial to assess the effect of vitamin D3 fortification of milk on serum 25-hydroxyvitamin D concentrations in school-age children and their mothers in Bogotá, Colombia. Eighty families with a child participating in an ongoing cohort study will be randomized to receive one liter per day of either skim milk fortified with 600 IU vitamin D3 per 250mL or unfortified skim milk for a six-week period. Caregivers will be instructed to give the index child two cups of milk per day and to distribute the remaining milk to the rest of the family. We will measure serum 25(OH)D concentrations of the children and mothers at baseline and at the end of the intervention period.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 144 and 174 completed months by the time of enrollment.
2. Intention to stay in the city for the next six weeks.
3. Children living with their biological mothers.
4. Families own a refrigerator.

Exclusion Criteria:

1. History of illness involving calcium or bone metabolism, including stones of the urinary tract.
2. Currently taking vitamin D supplements as treatment of any disease.
3. Receiving immunosuppressive therapy (oral corticosteroids, chemotherapy) during the previous year.
4. Known history of lactose intolerance or other contra-indications or aversion to milk intake.
5. Known hypercalcemia.
Safety and Efficacy Study of Brimonidine/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension

This study evaluates the safety and efficacy of brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution compared with concurrent brimonidine 0.2% and timolol ophthalmic solutions


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ocular hypertension or glaucoma
* Patient requires IOP-lowering therapy in both eyes

Exclusion Criteria:

* Uncontrolled medical conditions
* Contraindication to β-adrenoceptor antagonist therapy or brimonidine therapy
Magnetotherapy in Rheumatoid Arthritis Treatment

Participants with rheumatoid arthritis with recommendation to physiotherapy.

Created 3 study groups:

1. Only kinesiotherapy
2. Kinesiotherapy with unipolar magnetic field
3. Kinesiotherapy with bipolar magnetic field

Kinesiotherapy with magnetic field give better effects than only kinesiotherapy.

Participants with rheumatoid arthritis with recommendation to physiotherapy. All participants have dysfunction and pain of hand.

Inclusion criteria:

1. II ° and III ° of advancement of radiological changes
2. II ° and III ° of advancement of functional changes
3. Remission, low or moderate RA activity: DAS28
4. Medical order

   1. Magnetotherapy and kinesiotherapy
   2. Kinesiotherapy
   3. Consent to participate in the study
   4. Completion of the research program

Exclusion criteria:

1. Additional physiotherapy treatments for the hands
2. Change in type or dose of pharmacotherapy used
3. Taking steroid anti-inflammatory drugs
4. Malaise and side effects in the subject

Outcome Measures:

1. Duration of morning stiffness
2. The degree of severity of morning stiffness
3. Pain intensity assessment (VAS)
4. Test Box \& Blocks
5. Measurement of the palmar surface of the hand
6. Measuring the range of motion in the joints of the hand
7. Measurement of compression force in a cylindrical grip
8. Time to maintain maximum pressure during cylindrical grip
9. Hand volume measurement
10. HAQ-20 test

Intervention:

1. Group 1: Only kinesiotherapy
2. Group 2: Kinesiotherapy with bipolar magnetic field
3. Group 3: Kinesiotherapy with unipolar magnetic field

Assessment:

1. Immediately before start therapy
2. Immediately after therapy (10 treatments in 2 weeks)

Eligibility Criteria:
Inclusion Criteria:

* II ° and III ° of advancement of radiological changes
* II ° and III ° of advancement of functional changes
* Remission, low or moderate RA activity: DAS28
* Medical order
* Magnetotherapy and kinesiotherapy
* Kinesiotherapy
* Consent to participate in the study
* Completion of the research program

Exclusion Criteria:

* Additional physiotherapy treatments for the hands
* Change in type or dose of pharmacotherapy used
* Taking steroid anti-inflammatory drugs
* Malaise and side effects in the subject
A Study of Fluzoparib (SHR-3162) and Temozolomide With or Without SHR-1316 in Treating Patients With Replapsed Small Cell Lung Cancer

This research study is a multicentre phase Ⅰb/Ⅱ Study to evaluate the efficacy and safety of the combination of Fluzoparib (SHR-3162) and temozolomide with or without SHR-1316 in small cell lung cancer


Eligibility Criteria:
Inclusion Criteria:

1. Subjects who have recurrent small cell lung cancer confirmed by histology or cytology.
2. Failed one prior line of platinum-based chemotherapy.
3. Subjects must have measurable disease, at least one lesion, by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria (within 28 days prior to administration of study treatment) ;
4. Freshly acquired samples or archived specimens within 12 months before randomization must be provided.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
6. Participant must have a life expectancy ≥ 12 weeks.

Exclusion Criteria:

1. Active or untreated central nervous system (CNS) metastases.
2. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
3. History of autoimmune disease.
4. Positive test result for human immunodeficiency virus (HIV).
5. Active hepatitis B or hepatitis C.
6. Severe infections.
7. Subjects with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment.
8. Significant cardiovascular disease.
9. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
The Effect of Self-Care Education on Self-Care Skills and School Sociality

The aim of this study is to examine the effect of self-care education given to children with educable intellectual disabilities on children\&#39;s self-care skills and school social behaviors.

H1a: There is a difference between the mean scores of the children in the experimental and control groups in the \&#34;Eating Skills\&#34; subscale of the Self-Care Skills Checklist according to time (pretest, posttest, 1st follow-up, 2nd follow-up).

H1b: There is a difference between the mean scores of the children in the experimental and control groups on the \&#34;Dressing Skills\&#34; sub-dimension of the Self-Care Skills Checklist according to time (pretest, posttest, 1st follow-up, 2nd follow-up).

H1c: There is a difference between the mean scores of the children in the experimental and control groups on the \&#34;Personal Care Skills\&#34; sub-dimension of the Self-Care Skills Checklist according to time (pretest, posttest, 1st follow-up, 2nd follow-up).

H1d: There is a difference between the mean scores of the children in the experimental and control groups on the \&#34;Social Competence\&#34; sub-dimension of the School Social Behavior Assessment Scale according to time (pretest, posttest, 1st follow-up, 2nd follow-up).

H1a: There is a difference between the mean scores of the children in the experimental and control groups in the \&#34;Eating Skills\&#34; subscale of the Self-Care Skills Checklist according to time (pretest, posttest, 1st follow-up, 2nd follow-up).

H1b: There is a difference between the mean scores of the children in the experimental and control groups on the \&#34;Dressing Skills\&#34; sub-dimension of the Self-Care Skills Checklist according to time (pretest, posttest, 1st follow-up, 2nd follow-up).

H1c: There is a difference between the mean scores of the children in the experimental and control groups on the \&#34;Personal Care Skills\&#34; sub-dimension of the Self-Care Skills Checklist according to time (pretest, posttest, 1st follow-up, 2nd follow-up).

H1d: There is a difference between the mean scores of the children in the experimental and control groups on the \&#34;Social Competence\&#34; sub-dimension of the School Social Behavior Assessment Scale according to time (pretest, posttest, 1st follow-up, 2nd follow-up).

Eligibility Criteria:
Inclusion Criteria:

* The child has mild and moderate intellectual disability (Determined by the health reports available at the institution. Children with mild and moderate intellectual disability were included in the study).
* Between the ages of 6 and 10
* Volunteering to participate in the study and signing the informed consent form by the child's parent
* Following verbal instructions (determined by the reports given as a result of the evaluation conducted by the Guidance and Research Center)

Exclusion Criteria:

* Physical disability in addition to mental disability
* Getting sick or having an attack during work
* Illiteracy of parents
IVF Offspring Born in Guangzhou

The IVF Offspring Born in Guangzhou Cohort Study (IVF-BIG) was established to investigate the short- and long-term effects of exposure in early life on the health of mothers and offspring in Guangzhou, China. Data are collected regarding assisted reproductive technology (ART), environmental, occupational and lifestyle exposures as well as health outcomes in their later life. Biological samples including blood and tissue samples are also collected from participants.

It has been 40 years since the first IVF baby born in the world. The effects of hormonal drugs used on women and health of IVF offspring have always been concerned in the reproductive field and in public. With the increase of the prevalence of infertility and development of ART, China is facing a IVF babies boom. It has been reported that ART was associated with higher risk of cancers among women undergoing treatment of ART, and an increased incidence of autism and noncommunicable chronic diseases, such as obesity, among IVF offspring. Epigenetics is documented as one of the possible mechanisms, while answers remain to be explored. A birth cohort would provide an opportunity to examine the short- and long-term effects of ART exposure on health consequences of the mothers and babies.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with \<20 weeks of gestation
* Pregnant women intended to eventually deliver in Guangzhou Women and Children's Medical Center
* Permanent residents or families intended to remain in Guangzhou with their child for ≥3 years
* Pregnant women conceived by assited reproductive technology

Exclusion Criteria:

• None
Impact of Different Breakfast Meals on Food Choices, Eating Behaviors and Brain Activation

This project aims to demonstrate that the best breakfast meal is the one able to improve the best postprandial hunger, satiety and adiposity regulators profile as well as the best reward-related gratification, due to hedonistic parameters. To do this, 4 different breakfasts will be tested and blood tests, food choices, and attentional components will be analysed.

Although breakfast seems to be positively associated with healthy eating patterns and food choices later in the day, eating behaviours are a complex interaction of several factors. Nutritional requirements are not only affected by the body homeostasis, but also by environmental signals, as cultural and social habits, lifestyle, etc. These parameters evoke reward-related and motivational signals influencing our daily eating behaviour choices. Most of the theories on food regulation propose two parallel systems interacting with food consumption homeostatic and reward-related systems. For all these reasons, there is an increasing interest on motivational and decisional aspects of food choices, eating behaviours and how they are influenced by food characteristics. This project aims to explore the association between compositional and perceived characteristics of a breakfast meal with nutritional/biochemical/physiological variables. The approach will be the evaluation of appetite, food intake as well as metabolic and compensatory responses to foods consumed during the day. Volunteers (n=15) will be fed with 4 different breakfast meals (one control and three iso-caloric with different glycemic indexes) and several different parameters will be evaluated, as biological parameters linked to satiety, food choices during a free lunch buffet, psycho-physiological and biological mechanisms underlying the compensatory effect and attentional components in the postprandial period. The participants will complete, in randomized order, the four breakfast meals, on four different weeks, separated by at least one week.

Eligibility Criteria:
Inclusion Criteria:

* both gender
* age 19 - 29 y
* BMI 20-24 kg ⁄m2
* healthy
* no metabolic, psychological, or neurological diseases/conditions
* not currently/previously (in the past 6 months) on a weight loss/other special diet
* omnivorous
* chocolate eaters
* right-handed (necessary for the fMRI analyses)

Exclusion Criteria:

* BMI \< 20 or BMI \> 24 kg ⁄m2
* chronic health conditions
* use of medications
* significant change in body weight in the last 3 months
* currently on a diet/food restriction
* food allergy
* celiac disease
* lactose intolerance
* left-handed
* claustrophobic
* do not meet the fMRI criteria established by the MU-BIC (regarding metal implants, etc.)
* pregnant
Brain Functions in Patients Before and After Bariatric Surgery

The project will specifically focus on the examination of the influence of substantial weight loss due to bariatric surgery on brain functions. Our hypothesis is that substantial weight loss after Bariatric Surgery (BS) is also accompanied by changes in the balance of reward and inhibitory networks in diabetic subjects. Therefore the investigators will conduct a functional magnetic resonance imaging (fMRI) study investigating functional measures.


Eligibility Criteria:
Inclusion Criteria:

* bariatric surgery in the past or in the future
* diabetes (at least before surgery)

Exclusion Criteria:

* fMRI contraindications
* claustrophobia
Histology and Ultrasound Pilot Study of HA Gels Adipose Tissue

This study is a single-blind intra-individual comparative study to evaluate the short and medium term tissue response after the injection of 2 brands of hyaluronic acid gels (HA), designed for deep injection, that have been used for several years on a worldwide scale.

The study will be disclosed to patients who present with an indication for either abdominoplasty or bilateral breast reduction with a Wise pattern skin excision (inverted T inframammary scar) Informed consent will be obtained from volunteers at their next consultation, during which the preoperative preparation is finalised and the surgery is booked.

Participants will receive injections for the first time three weeks to four months before the operation and for the second time five to nine days before the operation, in tissue that will be removed during the surgery.

In each session, through one single access point, a linear retrograde, subcutaneous injection will be performed with 0,5 ml of each of the studied hyaluronic acid gels, each in an opposite direction, each parallel to the skin surface.

Both sessions will be monitored by ultrasound examination. After the injections, the 2 cm of injected area which is most remote from the entrance point of the cannula will be remodelled by finger pressure and tissue pinching, to simulate remodelling as commonly performed after filler injection.

At the beginning of the operation, the injected subcutaneous fat will be removed with the overlying skin, to be sent for histologic examination.

The objective of the histologic examination is to assess the tissue response at one week versus three weeks to four months after the injection, as well as to assess the spread of the products, with and without remodelling after injection.

Eligibility Criteria:
Inclusion Criteria:

* patients eligible for and requesting abdominoplasty
* patients eligible for and requesting bilateral breast reduction

Exclusion Criteria:

* Patients prone to hypertrophic scarring or keloids
* Hypersensitivity to hyaluronic acid
* Hypersensitivity to lidocaine or amide type local anaesthetics
* Autoimmune disease
* Severe, multiple allergies or anaphylactic shock
* Epilepsy
* Heart rhythm disorders
* Porphyria, congenital methemoglobinemia, glucose-6 phosphate dehydrogenase deficiencies, treatment with methaemoglobin-inducing substances.
* Previous streptococcal disease (acute rheumatic fever whether or not with heart valve involvement)
* Patients on medication which slows hepatic metabolism (such as cimetidine, beta-blockers)
* Diabetes requiring insulin treatment
* Major system disease.
* Coagulation disorders. Anticoagulation therapy. Chronic use of acetylsalicylic acid.
* Previous surgery in the areas eligible for injections.
* All contraindications to their surgical treatment (such as pregnancy or lactation).
Relationships and Health in the OEF/OIF Veteran Population

The current study will explore relationships and health in the OEF/OIF Veteran population. Specifically, this study will examine PTSD symptom severity, traumatic brain injury, relationship satisfaction, leisure, general health ratings, feelings of burdensomeness and belongingness, and suicidal ideation.

United States military troops returning home from Operation Enduring Freedom and Operation Iraqi Freedom deployments are presenting with "invisible wounds". These "invisible wounds" include mental health conditions such as posttraumatic stress disorder and traumatic brain injury. Recent literature has begun to explore how PTSD affects the service member, as well as their significant others. Several studies have shown that Veteran endorsement of PTSD symptoms is associated with decreased relationship satisfaction. Prior literature has shown that spending time together and engaging in pleasurable activities as a couple are important strategies for enduring relationship quality and satisfaction. Literature has demonstrated moderate relationships between PTSD and suicidal ideation. A previous study conducted by two of the investigators in this population showed that perceived feelings of burdensomeness and belongingness and identification of suicide as a potential strategy for dealing with these feelings. Joiner has hypothesized that acquired capacity of painful experiences, perceived burdensomeness and thwarted belongingness are the three components of increased suicide risk. Yet few studies exist that examine these constructs in the military population, though research indicates the clinical utility for exploring these constructs and related consequences.

Eligibility Criteria:
Inclusion Criteria:

* OEF/OIF Veteran (at least one OEF/OIF deployment)
* Currently receiving or eligible to receive health care services at DVAMC
* In a current, established relationship for a duration of at least one year
* Age of 18-50

Exclusion Criteria:

* Inability to provide informed consent.
* Inability to adequately respond to questions regarding the informed consent procedure.
* Do not meet the inclusion criteria listed above.