cyrilzakka/clinical-trials huggingface dataset:
THE EFFECT OF HAND AND BACK MASSAGE ON PAIN, SLEEP AND SELF-CARE IN WOMEN UNDERGOING HYSTERECTOMY

Postoperative incision pain is an acute pain that begins with the stimulation of neuroreceptors from surgical trauma and usually resolves within a few days. Today, the physiology of acute pain is better understood and new approaches to pain management are emerging. However, studies conducted in recent years have reported that postoperative pain management is inadequate, and therefore approximately 50-80% of patients still experience moderate to severe pain

Self-care is the realization of health activities to maintain one's health, life and well-being (14). Self-care power is at different levels in each person and perceptual, cognitive, interpersonal and psychomotor characteristics are needed for an effective self-care power to be formed. Therefore, self-care power varies according to the ability and health status of the individual (12). According to Orem, the development and maintenance of health are the results to be obtained through self-care. Orem's theory also "values personal responsibility for health and indicates that nursing services may have a key role in prevention and health education". Since self-care is a learnable behavior, nurses can encourage and support people's self-care efforts and increase the individual's participation by providing health education (12).

When the literature is examined, there are a limited number of studies examining the effect of back massage on pain in women undergoing hysterectomy surgery. There are studies examining the effect of reiki on pain in different fields (13,14). Pain is a condition that affects all dimensions of the individual including biophysiologic, psychological, sociocultural and political-economic. Although analgesics are indispensable to alleviate postoperative pain, undesirable effects may occur when overused. Therefore, nurses' use of non-drug methods in addition to pharmacologic methods will increase the effectiveness of pharmacologic methods (15). Pharmacology

Eligibility Criteria:
Inclusion Criteria:

* Age range 25-65,
* Elective surgery,
* Lying in the hospital for at least 2 days after surgery,
* Operated under general anesthesia

Exclusion Criteria:

* No serious complications developed after surgery,
* Never had a back or hand massage before,
* Cognitive, effective and without any problem preventing communication,
* No psychiatric problems,
* Patients receiving a single type of analgesic drug (non-narcotic analgesics) to ensure homogeneity of the groups and to increase the reliability of the study results,
* Patients not using Patient Controlled Analgesia (PCA) will be included in the sample.
A 52-Week Parallel Group Safety Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to measure the safety and tolerability of TD 4208, an investigational drug being developed to treat people with moderate to very severe COPD, compared to tiotropium.


Eligibility Criteria:
Inclusion Criteria:

* Subject is a male or female subject 40 years of age or older

Exclusion Criteria:

* Females who are pregnant, lactating, breast-feeding or planning to become pregnant during the study
Acupoint Stimulation Alleviates Postoperative Nausea and Vomiting

Incidence of postoperative nausea and vomiting (PONV) could be high as 60% after liver surgery. Acupoint stimulation has been proved to decrease PONV. In this study, we will investigate the effect of transcutaneous electrical acupoint stimulation on incidence of PONV after liver surgery.


Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years
* scheduled for elective liver surgery under general anesthesia

Exclusion Criteria:

* body mass index less than 18 kg/m2 or higher than 30 kg/m2
* American Society of Anesthesiologists status higher than Ⅲ
* patients with contraindication to transcutaneous electrical stimulation, including skin damage, infection or implantable electrical device
* suspected or existed abuse of drug or alcohol
* pregnant or breeding women
* history of neurological or psychiatric disease
A Drug-Drug Interaction Study in Healthy Volunteers of the Effects of Tucatinib on Metformin

This study is being done to look at how tucatinib might affect the way another drug (metformin) works. It will look at healthy volunteers and how tucatinib affects how the body absorbs metformin. This will help us find out whether tucatinib is safe to give together with metformin. The study will also look at how tucatinib affects how the kidneys work.

This is a single center, fixed-sequence, drug-drug interaction study to assess the effects of multiple oral doses of tucatinib on the pharmacokinetics of a single oral dose of metformin in healthy subjects. The primary objective of the study is to assess the effects of tucatinib on the single-dose PK of metformin. Secondary objectives of the study are to (1) assess the safety and tolerability of metformin when coadministered with tucatinib and (2) assess the effects of tucatinib on renal function using iohexol as glomerular filtration rate (GFR) marker.

Eligibility Criteria:
Inclusion Criteria:

* Healthy status, as defined by the absence of evidence of any clinically significant findings
* Males must agree to use a barrier method of birth control and not donate sperm during study plus 30 days after last dose of study drug
* Weight of ≥60kg
* Body mass index between 18.0 and 32.0 kg/m² (inclusive)
* Ability to abstain from alcohol-, caffeine-, and xanthine-containing food and beverages from 48 hours prior to admission through study discharge
* All nonregular medication (including over-the-counter medication, health supplements, and herbal remedies) must be stopped at least 28 days prior to admission

Exclusion Criteria:

* Females who are of childbearing potential or lactating
* Males with female partners who are pregnant, lactating, or planning to become pregnant within 30 days of the study
* Use of any investigational drug or device within 30 days of study start
* Use of tobacco products within 21 days prior to admission
* Routine or chronic use of more than 3 grams of acetaminophen daily
* Strenuous activity, sunbathing, and contact sports within 72 hours prior to first admission and for the duration of the study
* Blood transfusion within 90 days of study drug administration
* History of alcoholism or drug abuse within 2 years
* History of alcohol consumption exceeding 7 drinks/week for female participants or 14 drinks/week for male subjects
* History of donation of more than 450 mL of blood within 60 days prior to dosing, or planned donation before 30 days have elapsed since intake of study drug
* Plasma or platelet donation within 7 days of initial study drug administration
* Positive screening test for Hepatitis B, Hepatitis C, or HIV 1 or 2 (human immunodeficiency virus)
* Acute or chronic metabolic acidosis, including diabetic ketoacidosis
* Renal disease or dysfunction as suggested by serum creatinine levels or abnormal creatinine clearance
Development of Attentional Biases for Affective Cues in Infants of Mothers with Depression

The goal of this study is to examine attentional biases for facial displays of emotion as a mechanism of risk in infants of mothers with postpartum major depression, and the potential role of infant arousal in the development of these attentional biases.

As part of the study protocol, infants will complete a computer-based task in which they view facial displays of emotion (angry, happy, sad, neutral) while an eye tracker records their gaze. Mother and infants will also complete a standardized interaction task during which the investigators assess infant gaze and psychophysiology. The task consists of three stages, each of which lasts three minutes. For the first stage (Free Play 1), infants sit in a highchair and mothers are asked to play with their baby as they normally would, without any toys or other objects. In the second stage (Sad), mothers are asked to think about times when they are sad or depressed and do not feel able to effectively play with their child. Mothers are instructed to look at their child but speak in a monotone and minimize body movement or any physical contact with the infant. In the third stage (Free Play 2), mothers again interact with their infants normally for three minutes. These two tasks are consistent with the definition of a Basic Experimental Study in Humans (BESH).

Eligibility Criteria:
Inclusion Criteria:

* The high-risk group (n = 150) will consist of women with at least one episode of MDD since their baby's birth.
* To qualify for the low-risk group (n = 75), women cannot have a history of any depressive disorder or any current psychiatric diagnoses.
* Infants will be required to be singleton children born full-term (\> 37 weeks) and normal weight (\> 2,500 grams) with no birth complications or health problems to avoid medical complications contributing to infants' attention, reactivity, and regulation measures.
* The two groups will be matched on demographic factors (e.g., age, race/ethnicity, income).

Exclusion Criteria:

* Additional exclusion criteria are diagnoses of alcohol or substance use disorders currently or at any point during pregnancy, or lifetime history of bipolar or psychotic disorders.
Safety and Performance Study of the Harpoon Mitral Valve Repair System

The primary objective of this study is to evaluate the safety and performance of the Harpoon Medical Device. It is anticipated, that the Harpoon Medical Device will provide advantages over current surgical interventions including: 1) a small minimally invasive incision, 2) no sternotomy, 3) no cardiopulmonary bypass, 4) no aortic manipulation, 5) a direct path to the valve plane, 6) performed on a beating heart, 7) real-time TEE-guided ePTFE cordal length adjustment and 8) less complicated procedure that is teachable and adoptable.

The device is designed to reduce the degree of mitral regurgitation by delivering and anchoring artificial chordae tendineae to the affected mitral valve leaflet(s) in a beating heart.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patient referred for mitral valve surgery
* Presence of severe MR as read on an echocardiographic study performed within 60 days prior to procedure.
* Estimated post-ePTFE cordal implantation coaptation surface is adequate in the judgment of the operating surgeon and the patient eligibility committee
* Degenerative mitral valve disease associated with anterior, bileaflet, or posterior leaflet prolapse
* Patient is able to sign informed consent and able to return for follow-up and is capable of participating in all testing associated with this clinical investigation
* Women of child-bearing potential have a negative pregnancy test

Exclusion Criteria:

* Age \< 18 years
* Infective endocarditis
* History of Mediastinal Radiation
* Inflammatory (rheumatic) valve disease
* Requirement for concomitant cardiac surgery (e.g., coronary artery bypass grafting (CABG), aortic valve surgery, etc.)
* Symptomatic coronary artery disease
* Cardiogenic shock at the time of enrollment
* ST segment elevation myocardial infarction requiring intervention within 30 days prior to enrollment
* Evidence of cirrhosis or hepatic synthetic failure
* Pregnancy at the time of enrollment (women of child bearing age should have negative pregnancy within 14 days of surgery)
* Severe pulmonary hypertension (PA systolic pressure \> 70 mmHg)
* Previous cardiac surgery, or surgery on the left pleural space
* Left ventricular, atrial or appendage thrombus
* Severely calcified mitral leaflets
* Recent stroke (\< 6 months) with permanent impairment
* EuroScore (for mitral valve repair) \> 8%
* Patients with contraindications to Transesophageal echocardiography
* Severe left or right ventricular dysfunction
* NYHA Class IV
* Renal insufficiency CKD stage 3b or worse (GFR \< 45 ml/min/1.73 m2)
* Patient is participating in another clinical study for which follow-up is currently ongoing. (Co-enrollment in an investigational device or interventional study)
* Patient with non-cardiac co-morbidities and life expectancy \< 1 year
* Patient has a condition or conditions that, in the opinion of the Investigator, preclude participation, including willingness to comply with all follow-up procedures
Effects of Fat-soluble Vitamins Supplementation on Common Complications and Neural Development in Very Low Birth Weight Infants

Vitamins A, D, and E play important roles in humans, such as vision function, immune function, bone metabolism, cell growth and differentiation and oxidation resistance. Deficiencies in these vitamins will result in a high prevalence of cardiovascular disease, infection, bone diseases, etc. Preterm infants, especially very low birth weight infants, are at risk of vitamin deficiency. Intravenous perfusion is the most common and widely used method to supply vitamins for the specific population in early life. However, the current dose of vitamin supplied by intravenous perfusion whether can meet the need of growth and development is not sure and the appropriate dose for preterm infants is still uncertain. The purpose of this study is to investigate whether current dose of fat-soluble vitamin supplementation is enough for very low birth weight infants, the safety of high dose of fat-soluble vitamin supplementation, and compare the differences of prevalence of common complications, such as bronchopulmonary dysplasia, patent ductus arteriosus, sepsis, anemia, and neural development between these two groups.


Eligibility Criteria:
Inclusion Criteria:

* admitted to the neonatal intensive care unit (NICU) within 24 hours after birth
* gestational age younger than 34 weeks
* birth weight less than 1500 gram
* informed consent was obtained from the infants' parents or guardians

Exclusion Criteria:

* congenital malformation
* chromosomal disease, genetic metabolic diseases
* the infants or his/mother has abnormal thyroid function or parathyroid gland function
* neonatal necrotizing enterocolitis, diarrhea
* intracranial hemorrhage of 3 degrees or above
* pulmonary hemorrhage
* liver enzymes elevated by more than 2 times, cholestasis
* death or discharge against medical advice
* refuse to take part in the study
Is Neutrophil to Lymphocyte Ratio a Prognostic Factor of Sepsis in Newborns With Operated Congenital Heart Disease

The use of neutrophil lymphocyte ratio is useful for the detection of infection status in newborns after surgery

The use of neutrophil lymphocyte ratio is useful for the detection of infection status in newborns after surgery and we compare this with other acute phase reactants

Eligibility Criteria:
Inclusion Criteria:

* newborn to be operated with the diagnosis of congenital heart disease

Exclusion Criteria:

* age older than 1 month not to be operated
Postoperative Hypofractionated Intensity-modulated Radiation Therapy with Concurrent Chemotherapy in Cervical Cancer

To investigate the acute toxicities, late toxicities, and treatment results when the early cervical cancer patients are treated by concurrent chemotherapy with hypofractionated intensity-modulated radiotherapy (2.5 Gy X 16 fractions, once a day) after radical hysterectomy.


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed cervical cancer
* radical hysterectomy and pelvic lymph node dissection was done
* histologically indicated adjuvant chemoradiotherapy (more than one as below)

  * positive pelvic lymph node metastasis
  * positive parametrial invasion
  * positive tumor involvement on surgical margin
* ECOG performance status 0 or 1
* Bone marrow function: granulocyte ≥1.0 x 1000/µl, platelet ≥30 x 1000/µl, hemoglobin ≥10 g/dl
* Kidney function: Creatinine \<2.0 mg/dL, Bilirubin 1.5 mg/dl

Exclusion Criteria:

* positive distant metastasis (including retroperitoneal lymph node metastasis)
* previous history of pelvic radiotherapy
* more than 3 months after radical surgery for cervical cancer
* neoadjuvant chemotherapy was done
* previous history of other carcinoma except for thyroid cancer, skin cancer, in situ carcinoma on cervix
A Study to Assess Pharmacokinetics, Safety, and Tolerability of ABBV-903 in Healthy Japanese and Han Chinese Participants

The objective of this study is to assess the pharmacokinetics (PK), safety, and tolerability of ABBV-903 or placebo in healthy adult Japanese and Han Chinese subjects.


Eligibility Criteria:
Inclusion Criteria:

- Healthy Japanese or Han Chinese male or female; age is between 18 and 65 years, inclusive at the time of screening.

* Han Chinese subject must be first-generation Han Chinese of full Chinese parentage residing outside of China. Subjects must maintain a typical Chinese lifestyle, including consuming a typical Chinese diet.

OR

* Japanese subject must be first- or second generation Japanese of full Japanese parentage. First-generation subjects will have been born in Japan to two parents and four grandparents also born in Japan of full Japanese descent. Second-generation subjects born outside of Japan must have two parents and four grandparents born in Japan of full Japanese descent. All subjects must maintain a typical Japanese lifestyle, including consuming a typical Japanese diet.

  * Body Mass Index (BMI) is \>= 18.0 to \<= 30.0 kg/m2 after rounding to the tenths decimal, at screening and upon initial confinement. BMI is calculated as weight in kg divided by the square of height measured in meters.

Exclusion Criteria:

* History of any clinically significant illness/infection/major febrile illness, hospitalization, as determined by the investigator, or any surgical procedure within 30 days prior to the first dose of study drug.
* Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma orlocalized carcinoma in situ of the cervix.
Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Refractory Epilepsy

Evaluate the long-term clinical effectiveness and safety of the PINS Deep Brain Stimulation to patients with refractory epilepsy.


Eligibility Criteria:
Inclusion Criteria:

* age 12-60.
* having tried at least two appropriate anti-epileptic drugs (AEDs) tested to tolerance or to blood levels at upper end of the target range of which at least 2 have been tolerated at normal dose.
* at least 6 seizures per month.
* in good health except epilepsy.
* to with normal MMSE score
* patients or his(her) familys could understand this method and sign the informed consent 7）Patients with good compliance and could complete postoperative follow-up

Exclusion Criteria:

* results of MRI remind epilepsy caused by intracranial space-occupying lesions.
* the vagus nerve lesion and damage
* tumor, cardiopulmonary anomaly, progressive neurological diseases, asthma，mental disease，peptic ulcer，diabetes Type 1，bad health etc, and other surgical contraindication.
Ketogenic Diet and Diabetes Demonstration Project

KDDP is a prospective, 12-month pilot study comparing the effects of a novel lifestyle program, the Ketogenic Diet and Diabetes Demonstration Project (KDDP) to those of the National Diabetes Prevention Program (NDDP). KDDP is modeled to mimic the delivery platform of NDPP with the exception that participants in KDDP will be placed on a medically-supervised ketogenic diet, and participants in NDPP will be placed on a low fat diet.

The purpose of this study is to compare the metabolic effects of the KDDP and the NDPP on glycemic control, lipid parameters, blood pressure, heart rate, weight, and coronary artery calcium scores in individuals with either type 2 diabetes or prediabetes.

KDDP is a prospective, 12-month pilot study comparing the effects of the KDDP vs. CDC NDPP in patients with obesity and dysglycemia. KDDP is the Ketogenic Diet and Diabetes Demonstration Project arm. Individuals enrolled in the KDDP arm will attend a mandatory Weight Management class through the Center for Diabetes and Nutrition Education, and they will participate in a standard comprehensive lifestyle intervention program that is identical to that of the NDPP with the exception of dietary recommendations. Individuals in the KDDP arm will be educated on and follow a ketogenic diet (\<20g carbohydrates/day). They will receive guidance on tracking carbohydrate intake daily, and home point-of-care ketone breath testing will be performed at regular intervals to ensure that ketosis is being achieved and maintained. They will attend weekly educational sessions facilitated by trained dieticians. Individuals enrolled in the CDC NDPP arm will adhere to a low fat diet and receive identical follow up with the dieticians relative to those enrolled in the KDDP arm. Individuals in both arms will be matched for age, sex, weight, and A1c.

Baseline measures at study entry will include weight, height, systolic and diastolic blood pressure, heart rate, hemoglobin A1c, fasting plasma glucose, total cholesterol, triglycerides, HDL cholesterol, and LDL cholesterol. These parameters will be measured every 3 months throughout the study and at study completion. Additionally, participants in both groups will be consented to undergo CAC scanning at baseline and at 12 months to assess for any differences in dietary interventions on CAC scores.

Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥ 18 years old
* BMI ≥27 kg/m2
* Hemoglobin A1c ≥ 5.7% and/or fasting plasma glucose of 100-125 mg/dL

Exclusion Criteria:

* Known clinical cardiovascular disease (i.e. prior stroke, myocardial infarction, peripheral artery disease)
* LDL cholesterol ≥ 190 mg/dL
* Triglycerides ≥ 500 mg/dL
* History of type 1 diabetes
* History of diabetic ketoacidosis
* Individuals requiring insulin
* Advanced renal disease
* Advanced liver disease
* Terminal cancer
* Pregnancy
Genetic Study of Severe Zinc Deficiencies

Given the structural essential, catalytic and co-catalytic played by zinc in many sections of protein metabolism, carbohydrate and lipid (zinc is involved in the function of more than 300 metalloenzymes and metalloproteins), one can imagine the impact of a deficiency or even a sub-chronic zinc deficiency on the health of the individual. Studies multiply that show that, long-term, marginal zinc deficiency is a risk factor for the development of cancer or neurodegenerative complex diseases (eg Alzheimer's disease). In addition, the short-term zinc deficiencies foster the development of skin conditions and susceptibility to viral and bacterial infections. The aim of this project is to identify, in the population of patients with pseudo-acrodermatitis enteropathica (AE) tested in the investigators laboratory, rare variants (mutations "real" epimutations or polymorphisms) located in solute carrier family 39 member 4 (SLC39A4) gene or in 55 other genes chosen for their role in zinc homeostasis.


Eligibility Criteria:
Inclusion Criteria:

* Are included all patients (minors included) with suggestive symptoms and biological signs of a hereditary deficiency of zinc, appeared for the first time at birth or weaning (see description given in the introduction);
* Clinical diagnosis of zinc deficiency must be made by a specialist dermatologist, pediatrician or gastroenterologist;
* Zinc deficiency has been audited by an assay of serum zinc, erythrocyte, plasma, urine or hair;
* The response of all symptoms and signs to zinc oral supplementation should be rapid and complete.

Exclusion Criteria:

* All patients with homozygous or compound heterozygous mutations in the SLC39A4 gene are excluded because they have a proven acrodermatitis enteropathica (AE);
* All patients who developed their first symptoms of zinc deficiency outside the neonatal period, most likely because they have an acquired deficiency and not congenital;
* All patients with probable cause of zinc deficiency that is surgery of the digestive tract, chronic digestive disease, or total parenteral nutrition.