cyrilzakka/clinical-trials huggingface dataset:
Proof-of-Concept Study to Determine the Flow Changes When Stimulating Two Neural Targets for the Treatment of Obstructive Sleep Apnea

This proof-of-concept study will evaluate the impact of surgically placing and stimulating the hypoglossal nerve and/or a second neural target Ansa Cervicalis, with a set of off-the-shelf electrode arrays.


Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years not under guardianship, under curatorship or under judicial protection.
* Body Mass Index (BMI) \< 35 kg/m2.
* Subject suffers from OSA (15 \< AHI \< 80) documented by a sleep study performed during the past 36 months.
* Subject must be eligible for a diagnostic or surgical procedure.
* Written informed consent obtained from the patient prior to performing any study specific procedure.
* Willing and capable to comply with all study requirements, including specific lifestyle considerations, evaluation procedures and questionnaires for the whole duration of the trial.

Exclusion Criteria:

* Major anatomical or functional abnormalities that would impair the ability of the electrode arrays to be positioned
* Significant comorbidities that contraindicate surgery or general anesthesia
* Significant tongue weakness
* Any other chronic medical illness or condition that contraindicates a surgical procedure or general anesthesia in the judgment of the investigator.
* Prior surgery or treatments that could compromise the placement and effectiveness of the electrode array systems:
* Airway cancer surgery or radiation,
* Mandible or maxilla surgery in the previous 3 years (not counting dental treatments),
* Other upper airway surgery to remove obstructions related to OSA in the previous 3 months (e.g., uvulopalatopharyngoplasty (UPPP), tonsillectomy, nasal airway surgery),
* Prior hypoglossal nerve stimulation device implantation.
* Currently pregnant, or breastfeeding during the study period
Influence of the "Atelier du rêve" (Dream Workshop) on the Quality of Falling Asleep in the Operating Room.

A "dream workshop" is organized for the children by nurses specialized in anesthesia in the CHI Creteil. During this workshop, the anesthesia process is explained to the children using games, drawings, songs, etc. The impact of this workshop on the child stress and acceptance of the mask during induction is studied in this research.

For more than two years, nurse anesthetists have developed a personalized treatment of children who will be asleep using the theoretical bases of hypnosis in children and distraction, in order to improve the conditions of falling asleep, especially by promoting the acceptance of the mask during inhalation induction, or by preparing it for an Intra Venous induction, if it so desires or if it is obligatory.

Indeed, the announcement of a surgical intervention is sometimes experienced as a real emotional shock by the parents and / or the child, whatever the gravity or the stake of the surgical gesture. To all this is added the phobic fear of anesthesia and all conditions are met to generate a climate of maximum stress. The work of nurse anesthesists prior to this surgical procedure was to establish a relationship of trust with the child through this "dream workshop", to restore a more serene climate.

Thus, is it the idea of this "workshop of the dream", allowing thanks to the imagination of the child, to recreate a universe of confidence full of colors, songs and perfume ...

After consultation with the pediatric surgeon or the anesthesiologist, parents and children are invited to meet nurse anesthesists, if they wish, in a room dedicated to this purpose and specially designed to accommodate children; they will find a playmobil model, photographs of the patient circuit as well as different games or activities that can be performed during induction; the nurse anesthetist will take care to explain to them the progress of the hospitalization and help them to choose a pleasant dream, a perfume adapted to their taste, a distraction adapted to their age (animated book, soap bubbles, favorite song ...) ; he can customize his mask and choose the blanket he wants to take; the most recalcitrant or special sites (autism, long-term hospitalization) will be able to be accompanied by a parent during sleep.

Eligibility Criteria:
Inclusion Criteria:

* Children who need an ambulatory surgery
* benefiting from a health care insurance

Exclusion Criteria:

* surgery planned in another hospital
* hospitalized children
* refusal to participate
Iron Supplementation for Acute Anemia After Postbariatric Abdominoplasty

The purpose of this study is to determine whether intravenous or oral iron are effective in the treatment of postoperative anemia and iron deficiency in patients submitted in postbariatric abdominoplasty.

Multicenter open randomized clinical trial with allocation ratio 1: 1. 56 adult patients undergoing post- bariatric abdominoplasty will be evaluated. The study group will receive 200 mg of intravenous iron in the immediate postoperative period and a second application on day 1 postoperatively. The control group will receive 100 mg of oral iron twice daily for 8 weeks. Haematological variables , iron 's profile , quality of life ( SF -36 and FACT- An) and adverse events will be assessed preoperatively and on the first , fourth and eighth weeks postoperatively .

Eligibility Criteria:
Inclusion Criteria:

* Women
* 18 a 55 years
* Prior open or laparoscopic standard limb Roux and Y gastric bypass
* BMI \< 32 kg/m2
* Stability of weight loss for at least 6 months
* grade 3 abdominal deformity on the Pittsburgh scale

Exclusion Criteria:

* Illiterate
* Current smoking
* Prior IV iron use in the last 3 months
* Uncontrolled systemic diseases
* Hemoglobin \< 11 g/dL
* Ferritin \<11 ng/mL
* Ferritin \> 100 ng/mL
* transferrin saturation \<16%
* transferrin saturation\> 50%
* B12 \< 210 pg/mL
* Folic Acid \< 3.3 ng/mL
* Albumin \< 2 g/dL
* C reactive protein\> 5 mg/L
* Prior Anaphylactic reaction to IV iron
Effects of Acupressure at Sanyinjiao Point on Primary Dysmenorrhea Among University Students.

The goal of this non-invasive interventional study is to explore the university students' experience of living with primary dysmenorrhea and evaluate the effect of acupuncture at the Sanyinjiao point on their physiological discomfort. The main questions it aims to answer are:

* Is there any difference in pain before and after the intervention of the Sanyinjiao point acupressure for dysmenorrhea among female college students?
* Is there any difference in the average number of Menstrual Distress Questionnaire scale before and after Sanyinjiao acupressure in female college students with dysmenorrhea? Participants will be acupressure at Sanyinjiao point triple times during the study.

This study will employ a quasi-experimental research design, using pre- and post-intervention surveys in intervention. In the universities of central Taiwan as a place to collect cases. Target 50 university students with primary dysmenorrhea will be recruited by using a purposive sampling. After taking the informed consent and basic information of the study participants, the observation will be measured before and after the intervention of the Sanyinjiao point acupuncture, which were performed during two consecutive menstrual cycles (eight days per cycles). The data collection will be obtained by demographic questionnaire, the Visual Pain Scale (VAS) and the Menstrual Physiological Infrequency Table (MDQ). Descriptive statistics (mean, standard deviation (SD), frequency, mean difference), Chi-square test and ANOVA statistical testswere used for data analysis.

Eligibility Criteria:
Inclusion Criteria:

A. Dysmenorrhea in the past six months, lower abdominal pain one or two days before menstruation or the first and second day of menstruation.

B. Dysmenorrhea will affect women's daily life, and those whose VAS score is greater than 5 points are female college students with moderate to severe pain.

C. The menstrual cycle is 21-35 days, and menstruation lasts 3-7 days. D. Female college students aged 18\~30

Exclusion Criteria:

A. Pregnant women or women who have given birth, breastfeeding, taken contraceptives, and have contraceptive devices.

B. Previous uterine or pelvic surgery, severe uterine and pelvic infection. C. Have a major disease: cancer, heart disease, hyperthyroidism, etc. Strong pain will affect the performance of menstrual pain and other diseases.

D. There is wound, inflammation or skin damage on the skin of Sanyinjiao acupoints on both sides.

E. Use of traditional Chinese medicine for dysmenorrhea in the past three months.
The Effects of Mastication on Energy Release From Walnuts

With an emphasis on oral processing, this study seeks to characterize the mechanisms that account for the high satiation properties of walnuts and low energy yield during digestion.

Recent evidence indicates up to 20% of the energy from walnuts is not absorbed. This low bio accessibility is comparable to almonds with markedly different physical properties and much higher than for pistachios with similar physical characteristics. These counter-intuitive findings require mechanistic explanations so they may be accepted and used to formulate policy and clinical recommendations. It is proposed that the differences in the structure of nuts accounts for the energy yield results. In addition, the whole nut yields superior effects on fullness and this leads to focus on oral processing. It may be that the mechanical act of chewing generates satiety sensations or it may be that the mechanical disruption of the parenchymal call walls releases lipid and protein and their higher concentrations activate the release of gut peptides associated with satiety.

Visit 1: Participants will report the Laboratory of Sensory and Ingestive Studies following and overnight fast, and having refrained from using oral care products for at least two hours prior to the visit. Participants who meet the BMI requirements, will have electrodes placed on their wrist, upper, and lower jaw and will be asked to chew the following stimuli: walnuts, almonds and pistachios for 15 seconds and expectorate the bolus into a beaker. However, when presented with 5 g walnuts participants will be asked to chew until the point where they would normally swallow and then spit the bolus into a beaker. The chewing conditions are randomized and include: 1) 5 g nuts alone, 2) 5 g nuts with 5 ml water, 3) 5 g nuts with 5 ml apple juice, 4) 5 g nuts with 5 g plain yogurt, 5) 5 g nuts with 5 g sweet yogurt. Following each chewing condition, participants will rate hedonic preference on a 9-point scale.

Visit 2 and 3: Following an overnight fast, the participant will be placed in a semi-supine position and a catheter will be placed in a vein in the antecubital space of one arm. A 9 ml baseline blood sample will be collected. Participants will complete a validated appetite questionnaire on a palm pilot right after the baseline blood draw. The participants will then consume 28 g of walnuts or 28 g walnut butter given in random order. Additional blood samples and appetite questionnaire will be taken at 15, 30, 45, 60,120, and 180 minutes. The blood will be stored in a minus 80 freezer to be analyzed at a later date for insulin, glucose, GLP-1, Ghrelin, and PYY.

Eligibility Criteria:
Inclusion Criteria:

* Natural dentition and no oral pathology
* Rate hedonic value of all study foods between 3 and 7 on a 9-point category scale.

Exclusion Criteria:

* BMI between 18-35 kg/m2
C Scope Visualization System Prospective Study

Evaluation of the performance and safety of the C Scope Visualization System

The C Scope Visualization System Prospective Study is a post-market, single-arm, prospective, multicenter study conducted in the United States.

The purpose of the study is to evaluate the performance and safety of the C Scope Visualization System in the illumination and visualization of joints from diagnostic procedure through 1-week and 1-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 years of age or older
* Subject can fluently speak and read English
* Subject is able to provide informed consent
* Subject agrees to all protocol-required follow-ups
* Subject meets the C Scope Indications for Use according to approved labeling

Exclusion Criteria:

* History of open surgery to the index joint resulting in scarring that might inhibit evaluation with the C Scope Visualization System
* Suspected fracture of joint structures
* Subject has any contraindications listed in the approved labeling including active infection
* In the opinion of the investigator, it is not in the subject's best interest to participate in the study
Effect of Ketoconazole on Breathlessness

Beta-endorphins, which are naturally occurring narcotic substances, have been shown to alter the perception of breathlessness. Oral ketoconazole, an antifungal antibiotic, increases blood levels of beta-endorphins. The study hypothesis is that oral ketoconazole will reduce ratings of breathlessness induced by resistive breathing loads.

Beta-endorphins are naturally occurring narcotic substances (like morphine) that are released by the brain under stressful conditions, such as exercise and when breathing through a resistive load (a tube containing fine wire mesh). In one study of 8 patients with coronary artery disease, ketoconazole, an oral medication used to treat fungal infections, was administered (1,200 mg at 12 midnight and 600 mg at 6 am) and increased blood levels of beta-endorphins five fold. In a recent study performed at Dartmouth-Hitchcock Medical Center, we found that ketoconazole increased blood levels of beta-endorphins in all eight patients with chronic obstructive pulmonary disease (COPD). Mean values increased by 2.5 times at four hours compared with baseline values (p = 0.0078). Based on this significant response, we propose to study the effect of ketoconazole on patients' perception of breathlessness induced by resistive breathing loads in a randomized clinical trial. The hypothesis of the study is that ketoconazole will reduce ratings of breathlessness as mediated by the increased levels of beta-endorphins.

Eligibility Criteria:
Inclusion Criteria:

* 50 years of age or older;
* diagnosis of COPD;
* current or former smoker of at least 10 pack-years;
* post-bronchodilator FEV1 greater than or equal to 30% predicted and less than or equal to 80% predicted; post-bronchodilator ratio \< 70%

Exclusion Criteria:

* any concomitant disease that might interfere with study procedures;
* use of a drug that may cause a possible drug interaction with ketoconazole
28mm Ceramic-on-Ceramic Total Hip Replacement Study

This study is intended to gather medium (0-5 years) and long-term (6-10 years) information regarding the performance and safety of the commercially available Ceramax™ Ceramic on Ceramic Total Hip System. This is a two-phased study consisting of a clinical follow-up phase and a clinical outcomes phase.

In Phase One (0-5 years), diagnostic, demographic and operative information will be gathered for each subject enrolled in this study. In addition, Harris Hip Evaluations, subjective evaluations and radiographs will be completed annually.

In Phase Two (6 - 10 years), a subjective outcomes questionnaire and a SF-12 Health Survey will be mailed to subjects annually.

This is a prospective, non-randomized study of the 28mm Ceramic on Ceramic (COC) device. This study will follow each subject through 10 years postoperatively and will consist of:

1. a clinical follow-up phase and
2. a clinical outcomes phase.

Radiographic and clinical follow-up exams will take place at six-weeks, six-months and then annually through year 5 for each subject. For years 6 - 10, a communication will be sent to each subject in order to collect survivorship and general health information. This communication will ask whether the COC device is still in vivo and, if not, when the revision surgery took place, why, and which components were removed, if applicable. In addition, subjects will be asked to complete a SF-12 Health Survey at each 6 to 10-year follow-up interval. A self-addressed, stamped envelope will be provided to facilitate information return and privacy.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who were previously enrolled in the COC28 IDE study, or
* Newly recruited individuals who are qualified based on the approved labeling of the device, and;
* Individuals who are willing and able to provide informed patient consent for participation in the study;
* Individuals who are willing and able to return for follow-up as specified by the study protocol; and
* Individuals who are willing and able to complete the Hip Outcomes questionnaire and SF-12 Health Survey as specified by the study protocol

Exclusion Criteria:

* In the opinion of the Investigator, the individual does not qualify based upon approved labeling requirements.
Evaluation of Preoperative Oral Rehydration Solution in Colectomy

Elective colectomy procedures typically require bowel preparation starting 2 days prior to the surgery. Osmotic laxatives such as Colyte® are administered 2 days prior, and Nothing by mouth (NPO) is required 1 day prior to ensure no fecal residue is left in the bowel. Though it may ensure a cleaner and safer surgery, this longer period of starvation increases insulin resistance and may increase post-op complications. However, there is evidence that administration of oral rehydration solution(ORS) prior to surgery reduces insulin resistance. Our purpose is to evaluate the difference of insulin resistance in those who received ORS 1 day prior to surgery and those who did not.

1. Enhanced Recovery After Surgery (ERAS) Enhanced Recovery After Surgery(ERAS) was introduced in the early 2000s by Kehlet et.al., and was applied primarily to patients receiving colectomy. As the knowledge and understanding of this concept continues to grow, we are now able to change the way we treat pre- and post- operative patients. In Europe, it has been proven that applying this concept to patients resulted in decreased length of post-operative hospital stay, post-op complications and overall hospital costs.
2. The change in HOMA-IR with shorter preoperative Nothing by mouth (NPO) period in ERAS patients

   1. HOMA-IR Index equation (evaluation of Insulin resistance)

      = Insulin (μU/ml) X blood glucose (mg/dl) / 405
   2. HOMA-IR was statistically proven to have been lowered in patients who received ORS 2hr prior to surgery.
   3. Reference

      * Increased insulin resistance induces hyperglycemia
      * Toxicity of post-op hyperglycemia and their relation to post-op complications
      * Insulin resistance increases in procedures such as herniorrhaphy or laparoscopic cholecystectomy. Administration of preoperative carbohydrates decrease post-op nausea and vomiting
      * Conventional pre-op 8hr fasting increases insulin resistance and influences increased glucose levels
3. Additional benefits of shorter preoperative fasting

   1. Relieve of stress of fasting
   2. Help stabilize post-op triglyceride, cortisol, and glucose levels
   3. Reduce infectious complications

Eligibility Criteria:
Inclusion Criteria:

* ASA grade I\~II (DM, CVA, COPD, ESRD, MI, TIA etc. excluded)
* Age: adults age 19\~75
* Patients undergoing elective colon cancer surgery
* Able to take the ORS per orally. Able to swallow without trouble of aspiration tendencies
* BMI of less than 27.5
* Child-Turcotte-Pugh Classification score of less than 6

Exclusion Criteria:

* emergency cases such as obstruction or perforation
* food allergy
* abdominal distension at present
* prior gastric surgery
The Moxibustion-Induced Thermal Transport Effect Between The Heart And Lung Meridians

Although some important progresses were made in the field of the meridian research, no breakthroughs have been achieved. Besides,there are some problems in meridian researches. Particularly, previous research of meridian phenomenon involved lots of subjective elements and outcomes. Researches that use modern scientific techniques to investigate the biological characteristics of meridian phenomenon are urgently needed. Therefore, this study was designed to assess the heat transport characteristics of meridian phenomenon for the Heart and Lung meridians by using infrared thermography. Thus, the biological characteristics of meridian phenomenon could be presented objectively in a scientific methodology.

80 eligible subjects were finally included. Among them, 40 participants were assigned to the lung meridian intervention group, and 40 participants were assigned to the heart meridian intervention group. All 80 participants completed the trial.

Eligibility Criteria:
Inclusion Criteria:

* Had recent medical examination records confirming the absence of cardiovascular, respiratory, digestive, urinary, hematological, endocrine and neurological diseases
* 20 ≤ age ≤ 40 years, male or female
* Had the ability to communicate with others normally
* An understanding of the entire study protocol
* Signed written informed consent

Exclusion Criteria:

* Had mental illnesses, severe depression, alcohol dependence or a history of drug abuse
* Pregnant or lactating
* Were participating in other trials
Possible Therapy by Phone for Caregivers

Caregivers of adults with dementia report higher stress, including anxiety and depressive symptoms, burden, and existential suffering, than caregivers of people with other chronic diseases.

Acceptance and Commitment Therapy (ACT) is a behavioral intervention designed to increase psychological flexibility in the face of challenges. The Investigators are trying to determine proof of concept that suggests that ACT is effective in reducing anxiety and associated psychological distress in dementia caregivers. This study will recruit N=20 dementia caregivers to receive 6 weekly 1-hour telephone-based ACT sessions

Eligibility Criteria:
Inclusion Criteria:

* 21 years or older
* Able to communicate in English
* Able to provide informed consent
* Listed as primary caregiver in the chart of a patient with Alzheimer's disease or related dementia (DARD)
* Intends to continue caregiving form ADRD patient for at least 12 months or greater
* Clinically elevated anxiety score (score of 10 or higher on GAD-7)

Exclusion Criteria:

* Non-family member of the ADRD patient
* Has ADRD or other serious mental illness diagnosis such as bipolar or schizophrenia as determined by ICD-10 code
Overminus Lens Therapy in Intermittent

In this prospective study, entitled "The Long-Term Efficacy of Overminus Lens Therapy in Intermittent Exotropia",the investigators examined the long-term impact of overminus lenses on the management of intermittent exotropia (IXT), treatment effect after overminus treatment has been discontinued and also investigated if overminus lenses cause myopia in long-term.

Purpose: To evaluate the long-term impact of overminus lenses in intermittent exotropia (IXT), to determine if the treatment effect would persist after overminus minus lenses are discontinued and also to investigate if overminus lenses cause myopia.

Materials and Method: Sixty-five consecutive cases of IXT followed for at least 48 months were included. Patients with a history of previous surgery, ocular pathology, convergence insufficiency, severe myopia (\>-5.0 D), severe hyperopia (\>+5.0 D), moderate or severe amblyopia and poor compliance with spectacles were excluded. Data was collected including near stereoacuity, AC/A ratio, control of IXT measured with Newcastle Control Score (NCS) at baseline and in all follow-up visits. Baseline values without overminus threapy were compared with postintervention values at every visit.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with IXT
* prescribed overminus lenses

Exclusion Criteria:

* a history of previous surgery, ocular pathology
* convergence insufficiency type IXT
* presence of any type of ocular deviation except IXT
* presence of severe myopia (greater than -5.0 D)
* presence of severe hyperopia (greater than +5.0 D)
* presence of moderate or severe amblyopia
* poor compliance with overminus spectacles
* follow up period of \<48 months after intervention.