cyrilzakka/clinical-trials huggingface dataset:
The Effect of Individual Counselling Program on Fear of Childbirth

A randomized control trial was made to developing an individual counseling program to help women cope with their fear of childbirth and testing the program for effectiveness.

Fear of childbirth is a common problem among women and one that affects their health and welfare before and during pregnancy and in the postpartum period. The problem can lead to adverse pregnancy outcomes and also cause a woman to experience psychological issues. Fear of childbirth can also influence the determination of the mode of delivery and can amount to a rise in cesarean rates.

The healthcare provided by midwives and other healthcare professionals during pregnancy and childbirth have the power to reduce or exacerbate childbirth fears. The most significant midwifery intervention that can be used to diminish the fear of childbirth is counseling. There is a need to develop and test individual counseling models that require the basic training skills that midwives can use as part of their routine care to address women's fears and expectations about childbirth. The individual counseling program developed in this context may be an easy-to-implement and cost-effective method to use.

This study was conducted for the purposes of developing an individual counseling program to help women cope with their fear of childbirth and testing the program for effectiveness.

It was tested the hypotheses that there is no difference between the intervention and control groups of pregnant women after the intervention in terms of fear of childbirth, childbirth self-efficacy and state anxiety scores and childbirth outcomes (duration of labor, mode of delivery, elective and emergency cesarean rates, postpartum hypertension and need for a blood transfusion, the admittance of the newborn into the intensive care unit, preferences for future births and duration of stay in hospital).

Eligibility Criteria:
Inclusion Criteria:

* Primiparas
* Ages between 18-35
* Lived in Aydın
* In gestational week 28-30,
* Pregnant with a single child
* Minimum a primary school graduate (since the questionnaires would be filled out by self-reporting)
* In a low-risk pregnancy (on the basis of the criteria of the Ministry of Health),
* Willing to divulge their own or their husband's telephone numbers,

Exclusion Criteria:

* High-risk pregnancy who had psychological and mental health problems
* History of infertility
* Speech and hearing disabilities
* Substance or narcotics users
Electrical Impedance Tomography (EIT) and Physiotherapy

To compare the effect of different airway clearance techniques on lung ventilation by electrical impedance tomography.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* Surgery under anesthesia (PEP and incentive spirometry) or healthy subjects
* Intervention time before first bed lift
* Cooperative
* Can perform devices techniques correctly

Exclusion Criteria:

* Patients with pacemaker, implantable pumps or automatic implantable cardioverter defibrillator
* Patients with pulmonary disease (acute or chronic)
* Patients with cognitive problems
* Presence of patches or wounds in EIT belt zone placement
* Patients with initial pain \> 2/10
* Patients with severe obesity (BMI \> 35)
Endoscopic Harvesting in Coronary Artery Bypass Grafting.

This is a retrospective data collection looking at patients who received either an endoscopic vessel harvesting procedure versus the conventional open procedure. Besides looking at cost variables in the 2 groups, other outcomes of interest include length of hospital stay, rates of infection, medication use, re-admissions and compilations.

Since April 2018, the study database has been updated with all patients (currently there are 340 patients per group) and variables - both reflecting effectiveness of the procedure and cost. Preoperative variables being captured include comorbidity factors and variables relating to the Society of Thoracic Surgery (STS) score , which is a pre-procedure assessment of surgical risk.

The postoperative data collection includes a variety of complications and comorbidities the patient could experience during their hospital stay. These variables will provide us with information regarding procedure effectiveness, patient recovery and further costs associated with the procedure. Medications and antibiotics provided during the stay are also being captured. Total hospital costs will include any costs associated with ward stay, separated per level of care: Intensive Care Unit (ICU), Cardiac Surgical Unit (CSU), and regular ward.

The two follow up periods are 30 days and 6 months. Both look at the same effectiveness variables, any emergency room (ER) visits, re-admissions, and their respective reasons. Quality of life will be obtained by looking at the number of complications the patient experienced during these periods. The frequency of home care services provided to each patient, if any, are also being tracked. Cost calculations will be done by obtaining the time, length and number of visits to the ER, re-admissions and clinic visits.

Eligibility Criteria:
Inclusion Criteria:

* any patient at the KHSC undergoing a CABG procedure requiring a vein graft.

Exclusion Criteria:

* undergoing a simultaneous procedure.
SurgiWrapTM to Reduce Soft Tissue Attachment & Incidence Early Post-Operative Bowel Obstruction in Colorectal Surgery

The purpose of this study is to determine if the use of SurgiWrapTM: (1) prevents/lowers the incidence of Grade 2 or higher soft tissue attachments under the incision made during abdominal surgery, (2) reduces post-operative bowel obstruction.


Eligibility Criteria:
Inclusion Criteria:

* Patient is 18 years of age or older of either gender
* Patient has primary diagnosis requiring a two-stage colectomy or procto-colectomy
* Patient or his/her legal representative has read and signed the Institutional Review Board (IRB) approved Informed Consent form before randomization.
* Patient must be able and willing to follow study procedures and instructions.

Exclusion Criteria:

* Patient is participating in another clinical study which may influence adhesion formation.
* Patient has had barriers, solutions, or anti-adhesive therapy, other than SurgiWrapTM, as planned at randomization, placed in the abdomen at the time of the initial surgery
* Patient who, at the initial surgery, had administration of irrigants containing corticosteroids, heparin, salicylates, nonsteroidal anti-inflammatory drugs, or dextran 70
* Patient has one or more medical condition(s), including severe renal, hepatic, hematologic, neurologic, or immune disease that, in the opinion of the Investigator, would make the patient an inappropriate candidate for this study.
* Patient is taking chronic (i.e., \> 2 weeks) therapeutic doses of medications known to affect healing such as nonsteroidal anti-inflammatory drugs. Prophylactic aspirin (less than or equal to 325 mg once daily) for cardiovascular indications will be permitted in patients.
* Patient has an infection in the intra-abdominal or pelvic area.
Wearable Monitoring Device in Daily Lives of Community-dwelling Older Adults

The aim is to implement an intervention program to promote the continued use of Wearable Monitoring Devices among older adults through a peer support approach facilitating the incorporation of Wearable Monitoring Devices in daily life.


Eligibility Criteria:
Inclusion Criteria:

* aged 60 or above
* own a smartphone
* able to communicate in Cantonese or Mandarin
* able to access the Internet at home or elsewhere

Exclusion Criteria:

* have a confirmed diagnosis of cognitive impairment
* bed-bound
* currently own a wearable monitoring device
* have already engaged in other wearable device studies
LIPS-B: Lung Injury Prevention Study With Budesonide and Beta

This study tested whether inhaled budesonide and formoterol were able to alleviate or prevent pulmonary injury when administered early in hospital course to the patients at risk for developing acute respiratory distress syndrome (ARDS). The FDA has approved many uses for budesonide and formoterol, including asthma and chronic obstructive pulmonary disease (COPD), but the use of these two drugs is experimental for ARDS.

Subjects were randomized to either placebo or combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 calendar days for a total of 10 doses or until hospital discharge or death. Local hospital pharmacies prepared identical appearing solutions and drug was delivered by respiratory therapists blinded to randomization by using standard jet nebulizers that produce aerosol particle size within the respirable range (\<5.5 microns). The first dose was administered within 4 hours after randomization.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age \> 18)
* Admitted to the hospital through the emergency department (ED)
* High risk of developing ARDS (Lung Injury Prediction Score (LIPS) greater than or equal to four)

Exclusion Criteria:

* Inhaled corticosteroid and/or beta agonist treatment on admission or within 7 days prior to admission (history of asthma or COPD necessitating therapy)
* Chronic pulmonary disease requiring daytime oxygen supplementation therapy
* Systemic steroid treatment on admission or within 7 days prior to admission equivalent to more than 5 mg of prednisone daily
* Inability to obtain consent within 12 hours of hospital presentation
* Acute lung injury prior to randomization
* Receiving mechanical ventilation before current hospital admission (patient who is ventilator dependent)
* Presentation believed to be purely due to heart failure without other known risk factors for ARDS
* Allergy or other contraindication to either budesonide and/or formoterol use
* Expected hospital stay and/or survival \<48 hours or admission for comfort or hospice care
* Patient, surrogate or physician not committed to full support (exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest)
* Previous enrollment in this trial.
* Co-enrollment with LIPS-A trial is not allowed.
* An active enrollment in other concomitant trial will be judged on case by case basis by PIs of both trials.
* EKG and/or clinical presentation suggestive of acute coronary ischemia
* New onset cardiac arrhythmia
* Current atrial fibrillation with ventricular rate of \>110/minute
* Persistent sinus tachycardia of \>130/minute despite early goal directed therapy with fluids, pressors, antibiotics and supplemental oxygen
* Pregnant patients
Development of Diagnostic and Treatment Strategy for Resistant Hypertension

This study is a registry study to examine the clinical features, blood pressure control rate, and clinical prognosis of resistant hypertension in Koreans. This study will register patients with resistance hypertension in eight tertiary hospitals in Korea and follow up them for three years. The prognosis will be analysed according to etiologies, achieved blood pressure, and types of antihypertensive medication.

This study will enroll hypertensive patients who are in treatment or those who are referred from primary clinic based on inclusion or exclusion criteria. Basic clinical information, compliance with antihypertensive medications, concomitant use of other medications will be investigated and all patients will perform 24-hr ambulatory blood pressure measurement. Screening for renal artery stenosis and primary aldosteronism will be conducted. Office blood pressure will be taken every 3-6 months. Home blood pressure measurement and 24-hr ambulatory blood pressure measurement will be performed every year. The primary outcome is the newly developed MACE during the follow-up period. The secondary outcomes are newly developed target organ damage (LVH confirmed by echocardiography or EKG, carotid femoral PWV≥ 12m/s, microalbuminuria (Urine albumin-creatinine ratio ≥30 mg/g)) and decline of renal function (doubling of serum creatinine, dialysis). The follow-up period is 3 years.

Eligibility Criteria:
Inclusion Criteria:

1. 20 years and older
2. Office SBP\>130 mmHg or office DBP \>90 mmHg with 3 antihypertensive medications of different classes
3. Treated hypertensive patients with 4 antihypertensive medications of difference classes including diuretics

Exclusion Criteria:

1. desired life time under 6 months due to non-cardiovascular disease (e.g. cancer, sepsis)
2. women with pregnancy or on nursing
3. within the first three months after transplantation
4. acute renal allograft rejection
5. within six months after discharge from hospitalization for acute coronary syndrome (myocardial infarction, unstable angina) or acute stroke
6. systolic heart failure (LVEF ≤40%)
Proposed Research Protocol For Male Infertility

The purpose of this experiment is to test the feasibility of a minimally interventionist protocol for young couples with male factor infertility, which addresses the cause of infertility for these couples which is the inability of the sperm to fertilize the egg.Ultrasound monitoring of natural follicular development utilizing rFSH, GnRH antagonist and rHCG only for the final maturation. Single follicle aspiration and IUI or IVF/ICSI based on sperm charcteristics on the day of fertilization. Fertilized eggs transfered to the uterus on the same day as the aspiration.


Eligibility Criteria:
Inclusion Criteria:

1. Couples with "pure" male factor infertility of six months or more, defined as not pregnant in spite of being desirous of pregnancy for at least six months with normal sexual activity and no birth control. Primary and Secondary infertility included.
2. Abnormality of any one of the sperm parameters according to WHO or Kruger for concentration, motility or morphology.
3. Women aged 18 to 30 with a BMI between 18 and 30
4. Women who testify that they are healthy with regular menstrual cycles between 25-35 days per cycle.

Exclusion Criteria:

1. Uterine fibroids or ovarian cysts or tumors or suspected hydrosalpinx on US on prior fertility workup. Paraovarian simple cysts, OK.
2. Prior PID, abdominal or pelvic surgery or abnormal HSG if done.
3. Known allergy to medications used in protocol
4. Diagnosed or suspected genetic or psychiatric disease in either patient.
5. Azoospermia
6. Female partner with a history of infertility with another partner
7. Elevated FSH (over 10 units/L) in female partner if done.
Effect of Laughter Yoga on Mental Symptoms Frequency and Level of Saliva Cortisol

The aim of this study is to evaluate the effect of laughter yoga on mental symptom frequency and salivary cortisol level among the 1st Year Nursing Students.

This is a randomized controlled study using pre-post-test design with control group. The population of our research; Ankara University Faculty of Health Sciences Nursing Department consisting of 202 students studying at the First Year.

The aim of this study is to evaluate the effect of laughter yoga on mental symptom frequency and salivary cortisol level among the 1st Year Nursing Students.

This is a randomized controlled study using pre-post-test design with control group. The population of our research; Ankara University Faculty of Health Sciences Nursing Department consisting of 202 students studying at the First Year. A descriptive question form will apply to the entire population of the research.191 students fulfilling the criteria of this study will be included. Eleven students who have not fullfilled this criteria the inclusion criteria will be excluded from the study. Power analysis has been performed and the required sample volume for each group has been calculated as 34 with 0,90 power and 0.05 margin of error. Sample of the study consistsof 75 students considering the possibility of students leaving the research. This 75 students will be divided into two groups as intervention group (n=38) and control group (n=37). Intervention and control group have been randomly selected among Ankara University Faculty of Health Sciences Nursing Department.

Eligibility Criteria:
Inclusion Criteria:

* Ankara University Faculty of Health Sciences Department of Nursing to be a 1st year student.

Exclusion Criteria:

* Diabetes mellitus
* Hypertension
* Hypothyroidism
* Hyperaldosteronism
* Pregnancy
* Malignancy
* Congestive heart failure
* Psychotic disorder
* Chronic hepatic failure
* Nephrotic syndrome
* Chronic renal failure diagnosis
* Using medical drug
Consolidation Versus Induction Chemotherapy in Total Neoadjuvant Therapy of Rectal Cancer With High Risk for Recurrence

The purpose of the study is to identify the most promising sequence of modalities in total neoadjuvant treatment of localy advanced rectal cancer with high risk of recurrence

International recommendations for the treatment of LARC with a high risk of disease recurrence are inconsistent, regarding TNT. In Germain randomised study more pCR were achieved with consolidation chemotherapy. We will compare our standard approach (induction plus consolidation CT) with consolidation CT.

Eligibility Criteria:
Inclusion Criteria:- histologically proven rectal adenocarcinoma

* no distant metastases on CT scan (M0 disease)
* at least one high risk factor for disease recurrence identified on MR imaging:

  * T4 tumor (cT4)
  * N2 disease (cN2)
  * extramural venous invasion (cEMVI+)
  * positive lateral lymph nodes
  * distance of tumor to mesorectal fascia or positive lymph nodes is 1 mm or less (cMRF+)
* capacity for informed consent
* willingness to attend regular check-ups during and after treatment

Exclusion Criteria:history of previous irradiation in the pelvic area

* absolute contraindications for MR imaging
* distant metastases cannot be reliably excluded
* synchronous cancer
* chronic inflammatory bowel disease
Enhancing Innate Anti-Viral Resistance Through a Community-Based Intervention - Generation Xchange

This randomized controlled trial will test whether a recently developed community-based intergenerational mentoring program known as Generation Xchange (GenX) can enhance antiviral resistance in older African-American women and men in a low-SES urban community. Additional studies will identify the biological processes that promote resistance to respiratory virus infections and viral disease in older African-American women and men.

This randomized controlled intervention trial (planned n=160) will test whether participation in the Generation Xchange (GenX) intergenerational mentoring program can reduces vulnerability to respiratory virus infections (COVID, influenzas, colds), increase antiviral immune activity (Type I interferon responses), and reduce inflammatory immune activity in older African-American women and men living in a socioeconomically disadvantaged urban community. Blood samples will also be collected to determine which biological factors are most important in protecting older African-Americans from respiratory virus infection, and which of those factors is affected by the GenX intervention.

Eligibility Criteria:
Inclusion Criteria:

* Participating in the GenX intergenerational mentoring program
* All GenX mentors \> 50 years of age are eligible to participate in this research
* GenX program participation requires:
* Reside in neighborhood of GenX schools (South-Central Los Angeles)
* Pass basic literacy and cognitive function tests

Exclusion Criteria:

* Any health condition that would put participant at risk by enrollment/participation
Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids

The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of naldemedine and nor-naldemedine after a single oral dose of naldemedine in pediatric participants who are receiving or about to receive opioids.


Eligibility Criteria:
Inclusion Criteria:

Disease Characteristics

* Participants with cancer or non-cancer pain who are receiving (or who are about to receive) acute or chronic treatment with opioids.
* Participants with either newly diagnosed constipation, a history of constipation treated with laxatives, or are expected to develop constipation after opioid treatment.
* Able to remain in the clinic for blood sampling for at least 12 hours following the first study intervention dose and are able to return for blood sampling at the 24-hour time point.

Weight

* Body mass index within approximately the 3rd to 97th percentile for their age according to the World Health Organization Child Growth Standards.

Exclusion Criteria:

Medical Conditions

* History of a gastrointestinal (GI) neoplasm or an ongoing GI-related issue or any recent (within last 1 year) or planned GI tract surgery.
* Signs or symptoms of GI obstruction or participants with recurrent obstruction who may be at increased risk of GI perforation.
* Inability to eat/swallow or have need of a nasogastric tube.
* No bowel movements reported for 7 consecutive days at the time of obtaining informed consent or on the initial day of study intervention administration (Study Day 1).
* History of more than 1 week of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 neutropenia or thrombocytopenia with clinical sequelae.
* Participants who need mechanical ventilation.
* Severe CTCAE Grade 3 or above hepatic or renal impairment including end-stage renal disease requiring hemodialysis, as determined by the investigator.
* Progressive neurological disorders or potential disruption to the blood-brain barrier (for example, primary brain malignancies, central nervous system metastases, active multiple sclerosis, etc.) considering the risk of opioid withdrawal or reduced analgesia.

Prior/Ongoing Medications

* Currently receiving the first cycle of chemotherapy.
* Previously received naldemedine.

Other Exclusions

- Positive pregnancy test for females of childbearing potential.

Note: Other protocol-defined Inclusion/Exclusion criteria may apply.