cyrilzakka/clinical-trials huggingface dataset:
Comparison of Apnea Tolerance in Two Positions of Patients With BMI 30-40

The purpose of this study is to compare the effect of the 25° head-up position versus the 55° head-up position on tolerable apnea time (TAT) after induction of general anesthesia in patients with a body mass index (BMI) of 30-40.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I-III
* Body Mass Index (BMI) of 30-40
* Scheduled for an elective surgery that requires tracheal intubation

Exclusion Criteria:

* Patients with abnormalities of the upper airway that require awake tracheal intubation
* Asthma
* Chronic obstructive pulmonary disease
* Congestive heart failure
* Pregnant patients
Vaginal Birth After Caesarean Section - Effect on Maternal Psychosocial Function

The incidence of caesarean section has reached 15-20% in most developed countries. Encouraging vaginal birth after caesareans section (VBAC) has been considered a key component of a strategy to reduce the caesarean section rate. Most medical literature has focused on the efficacy of VBAC in reducing the caesarean section rate and the physical safety of successful VBAC. However, 30%-40% of these women fail to achieve a vaginal delivery. Little is known about how the uncertainty of labour outcome and a failed VBAC impact on the psychosocial function of these women. We propose to study a cohort of women with a prior caesarean section and presenting with a subsequent pregnancy for care. After consent and recruitment, these subjects will be randomly assigned to have a repeat caesarean section or VBAC. The medical outcomes, overall satisfaction of the subjects with the care they received, and the short-term psychosocial function of these subjects will be studied. The result of this study will provide important information that would be useful in assisting women to decide the mode of delivery after a prior caesarean section.


Eligibility Criteria:
Inclusion Criteria:

All women who:

* Have one prior caesarean section
* No prior vaginal delivery and
* Agree for either vaginal delivery or elective caesarean section
THE EFFECT OF ACUPUNCTURE ON THE BLOOD LACTIC ACID LEVELS

Background: In sports, recovery after exercise is a very important process for athletes. Several studies have shown that the rate of disease associated with athlete's recovery can be increased by several modalities, one of which is acupuncture.

Objectives: The purpose of this study was to see how the effect of press tack needle acupuncture in reducing blood lactic acid levels after exercise in sports students.

Methods: The study design was a randomized controlled clinical trial. Twenty-four sport students were divided into two groups: the acupuncture group (n = 12) and the normal group (n = 12). Press tack needle was attached on PC6 Neiguan and ST36 Zusanli 30 minutes before doing high-intensity exercise. Measurement of lactic acid levels was carried out at 5 minutes and 30 minutes after exercise.


Eligibility Criteria:
Inclusion Criteria:

* willingness to fill out an informed consent form;
* age between 18-25 years;
* male;
* has a BMI value of 18.5-22.9 kg/m2;
* there is no history of injury or history of surgery on the lower extremities in the last three months;
* the individual is in good health.

Exclusion Criteria:

* absence or refusal to be examined and not cooperative.
Craving & Decision-Making

Craving is the strong desire for something, such as for substances in drug addiction and food or other activities in everyday life. Recent work suggests craving can influence how people make decisions and assign value to choice options available to them, yet the neural mechanisms underlying these interactions between craving and valuation remain unknown. To address this, this study uses cognitive decision-making tasks that measure how much individuals will pay (from a study endowment) to have everyday consumer items or snack foods when they crave something specific (opioids or a specific snack, respectively). First, the study will identify the neural mechanisms for how drug craving (craving for opioids) interacts with valuation for consumer items that have associations with drug use or not in people receiving treatment for opioid use disorder (OUD). This will be evaluated in the activity patterns and interactions among brain regions involved in craving and value assignment during decision-making. Then, the study will examine for parallel mechanisms for how food craving (craving for a specific snack) interacts with valuation for snack food items that have similar features to the craved snack or not in people receiving treatment for OUD and non-psychiatric community control participants.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Willingness to follow study requirements, as evidenced by an ability to provide written informed consent and read, understand, and complete the study procedures
* Minimum of 6th grade reading level

Additional inclusion criteria for participants with OUD:

* Primary diagnosis of OUD encompassing heroin and/or painkiller use
* Receiving medications for OUD treatment on an outpatient basis
* At least 12-month history of opioid use

Exclusion Criteria:

* Unable to speak or read English
* Active psychosis or mania
* Current or past schizophrenia diagnosis
* History of intellectual disability or developmental or neurological disorder, seizures or epilepsy, or loss consciousness lasting more than 30 minutes
* Severe medical conditions requiring hospitalization or that, in the opinion of the study staff could compromise study participation
* MRI contraindications (claustrophobia, nonremovable piercings, certain metal in the body etc.) or pregnancy

Additional exclusion criteria for community control participants:

* Positive urine drug screen
* Current or past problematic substance use other than nicotine, and alcohol abuse confined to college or military service
* Current or past bipolar disorder diagnosis
* Use of central nervous system medications within the past 6 weeks (e.g., antidepressants, Ritalin)
Clinical Evaluation of Daily Disposable Etafilcon A Cosmetic Contact Lenses

This will be a randomized, double-masked, bilateral, cross-over, 2 treatment by 2 period dispensing study. There will be 4 visits. There will be a 2 to 5 day washout period between treatments.


Eligibility Criteria:
Inclusion Criteria:

-Potential subjects must satisfy all of the following criteria to be enrolled in the study:

1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form
2. Females between 18 and 29 (inclusive) years of age at the time of screening
3. Appear able and willing to adhere to the instructions set forth in this clinical protocol (i.e. willing to wear only the study lenses and not use habitual lenses during the dispensing periods)
4. Be a current soft contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week over the last month by self-report
5. Be a current wearer of cosmetic/circle lenses in the last 6 months, by self-report.
6. The subject must be willing to be photographed and/or video-taped
7. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 D to -6.00 D (inclusive) in each eye
8. The subject's refractive cylinder must be less than or equal to 0.75 D (inclusive) in each eye
9. Have spherical best corrected visual acuity of 20/25 or better in each eye.

Exclusion Criteria:

1. Currently pregnant or lactating
2. Any systemic disease (eg, Sjögren's Syndrome), allergies, infectious disease (eg, hepatitis, tuberculosis), contagious immunosuppressive diseases (eg, HIV), autoimmune disease (eg, rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study (at the investigators discretion)
3. Use of systemic medications (eg, chronic steroid use) that are known to interfere with contact lens wear (at the investigators discretion)
4. Any previous or planned (during the study) ocular surgery (eg, radial keratotomy, PRK, LASIK, etc.).
5. Any previous history or signs of a contact lens-related corneal inflammatory event (eg, past peripheral ulcer or round peripheral scar), or any other ocular abnormality that would contraindicate contact lens wear (at the investigators discretion).
6. Participation in any contact lens or lens care product clinical trial within seven (7) days prior to study enrollment
7. Employee or family members of clinical site (eg, Investigator, Coordinator, Technician)
8. Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion (at the investigators discretion)
9. Clinically significant (Grade 3 or 4 on FDA scale) tarsal abnormalities, bulbar injection, corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
Efficacy of 3 Nutritional Supplements to Improve Diverse Outcomes in Children Under 2 Years of Age and Pregnant Women

The Mexican poverty alleviation program, Oportunidades provides a fortified food supplement to all beneficiary children under 2 years of age, and all pregnant and lactating women. Consumption of the supplements is well below recommended levels and the impact of the program on child growth and anemia is less than anticipated. This is likely due to a high degree of dilution by sharing of the supplements with other family members. We have also found evidence of a very high prevalence of overweight and obesity among beneficiaries of Oportunidades in both women and children.

Given the micronutrient content of the fortified food, it is likely that the impact of the program on child growth and the micronutrient status of women and children would improve considerable if the supplements were consumed daily in the recommended dose. This may be difficult, given the wide-spread sharing within households - something that has been identified by many beneficiary families as a desirable behavior. At the same time, we do not know whether daily consumption of the food, which contains approximately 20% of daily energy requirements, may contribute to undesirable weight gain in this population.

In this context, we have designed a cluster randomized controlled efficacy trail to compare the nutritional impact, acceptability and use of three nutritional supplements. Supplements were randomly assigned at the community level (n=54), and pregnant women (n=750) and children 6 to 12 mo of age (n=900) invited to participate. The principal objective of the study is to compare the impact of Sprinkles and Nutrisano/Nutrivida using syrup/pills as a positive control group, on child growth, weight gain and retention in pregnant women, and micronutrient status of women and children. We hypothesize that weight gain will be greater in the food group compared to the other two supplementation groups, but impacts on micronutrient status and length growth in children will be similar.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women before 27 wks pregnancy (Arm 1)
* 18 yrs of age and older (Arm 1)
* Children 6 to 12 mo of age (Arm 2)
* Beneficiaries of the Oportunidades programa (Arm 1 and 2)

Exclusion Criteria:

* Severe anemia (Arm 1 and 2)
* Consuming other nutritional supplements and unwilling to descontinue use (Arm 1 and 2)
Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft

This study is a continuation of the pivotal trial studying the safety and efficacy of the Relay thoracic stent-graft system to treat thoracic aortic aneurysms. Efficacy is being evaluated by the device-related adverse event rate of endovascular repair (via the Relay thoracic stent-graft) through 1 year. Safety is being evaluated by comparing major adverse events through 1 year in subjects treated with the Relay thoracic stent-graft to those who underwent surgical repair.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with diagnosed descending thoracic aneurysm or penetrating ulcer
* Subjects whose anatomy can accommodate the Relay device
* Subjects who consent to participate
* Subjects who agree to a follow-up schedule

Exclusion Criteria:

* Subjects with lesions other than thoracic aneurysm and penetrating ulcer
* Subjects with less than 1 year life expectancy
* Subjects who are pregnant
* Subjects with medical conditions that wold complicate the endovascular procedure or confound results (e.g., Marfan's syndrome, morbid obesity, severe coronary artery disease)
* Subjects participating in another investigational study
Study Evaluating the Tolerance of Conjugate Meningococcal C Vaccine in Infants

Infant phase: To determine the safety of and production of antibodies by a group C meningococcal conjugate vaccine (MnCC), when given at 2, 3, and 4 months of age with routine vaccines.

Booster phase: To compare the safety of and production of antibodies by MnCC with and without MMR and to compare the antibody response to that produced by a low dose of plain polysaccharide vaccine as a way of investigating immune memory


Eligibility Criteria:
Inclusion Criteria:

* Healthy infants 7-10 weeks of age eligible to receive routine immunization
Lifestyle Intervention in Pregnant Women With PCOS

Polycystic ovarian syndrome (PCOS) is the most common reproductive disorder in women of childbearing age and is also associated with metabolic abnormalities including obesity, type 2 diabetes, dyslipidemia, etc. Importantly, a number of adverse outcome are seen in pregnancies complicated by PCOS, including gestational diabetes mellitus (GDM), preeclampsia and miscarriage. However, optimal management of PCOS complicated pregnancy is not known. This study seeks to explore whether healthy lifestyle intervention in overweight/obese pregnant women with PCOS could reduce gestational weight gain (GWG) and incidence of GDM.

A randomized controlled trial in PCOS pregnant women will be initiated at 8-12 weeks of gestation util delivery. Participants will be randomly assigned to the control group (standard care) or the intervention group (intensive lifestyle intervention). The intervention will focus on restricting energy intake combined with behavioral lifestyle modification through participation in group sessions and individual counseling. The primary outcome will be GWG and secondary outcome will be the incidence of GDM.

Our hypothesis is that intensive lifestyle intervention in overweight/obese pregnant women with PCOS will decrease GWG and reduce the incidence of GDM.

Eligibility Criteria:
Inclusion Criteria:

* gestational age between 8 and 12 weeks of gestation, pre-pregnancy BMI≥25 (kg/m2)
* age ≥18 years, and a singleton pregnancy.

Exclusion Criteria:

* patients with prediabetes and diabetes, hypertension, chronic renal disease, thyroid disorder
* gestational weeks ≥ 13
* age \<18 years
* multiple pregnancy
* uterine malformation
* or physical restriction that prevents exercise.
Contraceptive Equity Study 2016

The purpose of this study is to assess the impact of a provider counseling training on patient contraceptive behaviors and satisfaction in a clustered randomized trial among 10 Planned Parenthood health centers.

This study builds upon prior research on a contraceptive counseling protocol and training developed and studied by partners at New York University and Planned Parenthood Federation of America. This contraceptive counseling protocol is informed by the literature on contraceptive behavior, expertise in decision and communication science, and formative qualitative research with Planned Parenthood providers and patients. Jaccard et al. (in press) conducted a cluster randomized control study of the counseling intervention with 10 Planned Parenthood health centers, where staff at intervention sites participated in a one-day training on the counseling protocol followed by a day of in-clinic shadowing. Patients were enrolled on-site and contacted for follow-up at six months and 12 months.

Results of this study indicated that patients at intervention sites were more satisfied with their contraceptive counseling and method choice, and at one or both follow-ups there were fewer gaps in contraceptive protection, more dual method use, and less non-use of birth control. There was no significant difference in accurate use of birth control pills.

Planned Parenthood Federation of America (PPFA) adapted and piloted training in this contraceptive counseling protocol during 2016 with 18 Planned Parenthood affiliated organizations across the country. This training was integrated into a one-day event that also included a provider training to address barriers in access to intrauterine devices and implants. A mixed-methods implementation evaluation was conducted to assess outcomes for staff and patients and identify challenges in implementation. Preliminary findings from the program pilot year demonstrated positive trends for outcome measures, produced lessons learned on implementation challenges, and provided support for new adaptations to the training program and counseling protocol. The previous pilot year evaluation was designed to assess patient satisfaction and method choice before and after the training, but could not answer questions about continued impact on other outcomes of interest. The current study will use a cluster randomized control design with 10 Planned Parenthood health centers to assess patient outcomes. Five health centers randomized to the intervention will receive the contraceptive counseling training. As the control group, the other five health centers will conduct usual care. Women will be enrolled onsite at the health center and then contacted for follow-up at approximately 30 and 90 days post-enrollment. Target enrollment is 100 women per site (1000 total).

Eligibility Criteria:
Inclusion Criteria:

* Females who have received contraceptive counseling at participating health centers.
* Ability to understand written and spoken English.

Exclusion Criteria:

* Non-English speakers
Walking and Thinking - Brain Activity During Complex Walking in People With Multiple Sclerosis

Every-day life means being part of a complex environment and performing complex tasks that usually involve a combination of motor and cognitive skills. However, the process of aging or the sequelae of neurological diseases such as Multiple Sclerosis (MS) compromises motor-cognitive interaction necessary for an independent lifestyle. While motor-cognitive performance has been identified as an important goal for sustained health across different clinical populations, little is known about underlying brain function leading to these difficulties and how to best target these motor-cognitive difficulties in the context of rehabilitation and exercise interventions.

The challenge of improving treatments of motor-cognitive difficulties (such as dual-tasking and navigation) is daunting, and an important step is arriving at a method that accurately portrays these impairments in an ecological valid state. The investigators aim therefore to explore brain function during complex walking in MS (in comparison with people with Parkinson's disease and healthy controls) by investigating the effects of neurological disease on motor-cognitive performance and its neural correlates during three conditions of complex walking (dual-task walking, navigation and a combination of both) using non-invasive measures of brain activity (functional near infrared spectrometry, fNIRS) and advanced gait analysis in real time in people with MS (in comparison with people with Parkinson's disease and healthy adults).


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* with an MS diagnosis according to McDonald criteria
* with the ability to walk without a mobility device for ≥5 minutes continuously.

Exclusion Criteria:

* Disease or condition that affects cognition, gait or balance.
* MS relapse or change of disease-modifying treatment within the past eight weeks.
Proton Therapy Medical Registry

Clínica Universidad de Navarra Proton Therapy Unit is establishing a registry to capture the full radiation dosimetry delivered to the patient, baseline clinical data, and disease, toxicity and quality of life outcomes. The objectives are parameters prescribed and to have all patients treated at the proton therapy unit to be included in the registry to enable future analysis of treatment outcomes to assist in understanding, which patients can benefit from the use of protons.

Proton based radiation therapy has considerable dosimetric advantages over the standard photon based external beam radiation therapy, with an increased cost. Now, the clinical advantages, however, may not be identified in general, even with the improved dose distributions. In a large-scale evaluation, in time of personalized/ precision medicine, the impact of dosimetric benefit int clinical benefit meds registration studies.

Eligibility Criteria:
Inclusion Criteria:

* All patients treated at the proton center

Exclusion Criteria:

* Any other than what is supplied in the inclusion criteria
Monitoring Chronic Urticaria Basophil Irritability by Cytometry

A biological tool for quantitative assessment of Chronic Urticaria (CU) is still in need for monitoring biotherapies. CU is considered as a sudden degranulation of Mast cells / basophils without any identified cause. It is considered that Mast cell/basophil have an abnormally high sensitivity in CU and can be triggered with almost nothing (high irritability). In allergy, basophils degranulation can be reproduced in vitro with allergens. Anti-IgE (immunoglobulin E) antibody mimics allergen triggering of basophils in a dose dependent manner. If basophils are abnormally sensitive in CU, it should be reproduced in vitro at very low stimulation. The main objective of this project is to set up a method to evidence abnormal basophil irritability and look for clinical significance. As many markers characterize basophils in different states, researchers shall also look for a profile possibly associated with CU basophile irritability. Such tests could be useful in CU monitoring.

Mast cell is a key factor in Urticaria physiopathology. Several mechanisms have been hypothesized and could be either synergistic or revealing different types of urticaria. But most of these mechanisms seem to converge to Mast cells releasing histamine and other products. These mechanisms include auto-antibody and / or cytokines inappropriate production. However, internal dysregulation of Mast cell have also been reported, that could be either primary or secondary to extrinsic mediators mentioned already. Basophils closely related to Mast cells, easily accessible and usually serve as surrogate for clinical analysis of allergy or urticaria.

Flow-cytometry (FCM) is a recent tool with increasing interest due to its exceptional capacity of analysis of a large number of cells, individually, at high speed and measuring many parameters at a time. FCM has been extensively used in characterization of cell sub populations in several diseases such as hematology disorders or immunology and among them the basophil. FCM is now the gold standard for ex vivo functional analyses of basophil activation as part of the diagnosis of allergy.

The present project aims to explore phenotypic and functional changes that could reflect the dysregulation in Urticaria. This would have diagnosis and physiopathological interest with potential impact on optimizing disease monitoring and treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients :
* Active Chronic Urticaria according to the EAACI 2014 criteria.
* Healthy volunteers :
* Age (approx. +/- 5 years matched with patient group),
* Sexe matched.

Exclusion Criteria:

* Patients
* Treated by Omalizumab
* Healthy volunteers :
* Allergy,
* Atopy,
* Urticaria.