cyrilzakka/clinical-trials huggingface dataset:
Improving Mental Health Following Early PREgnancy Loss Using a Brief Cognitive Task

This is a randomised controlled trial designed to investigate the impact of a brief-cognitive task based intervention on intrusive memories, mental health symptoms and daily functioning, in women following an early pregnancy loss.

Women who have experienced an early pregnancy loss (miscarriage or ectopic pregnancy) will be randomly allocated to either a brief cognitive intervention or a placebo activity. Participants will be followed up at week 1, 1 month and 3 months following the intervention. It is hypothesised that those allocated to receive the brief cognitive task-based intervention will develop fever intrusive memories, less severe mental health symptoms and better day to day functioning when compared to women allocated to the placebo activity.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years and over
2. Diagnosis of early pregnancy loss (EPL) (missed miscarriage, incomplete miscarriage, complete miscarriage, ectopic pregnancy)
3. Fluent in English
4. Access to a smart device (e.g. phone or tablet)
5. Within 72 hours of EPL (including diagnosis of complete miscarriage or completion of treatment for ectopic pregnancy, missed miscarriage or incomplete miscarriage)

Exclusion Criteria:

1. Women who, in the opinion of the researcher, are unable to give fully informed consent to the study due to for example learning impairment or language barrier.
2. Women with a viable intrauterine pregnancy
3. Women with a pregnancy loss occurring after 20 weeks gestation
4. History of severe mental illness or substance misuse
Bilateral Ultrasound Guided Pectoralis Nerve Block Induces Hemodynamic Stability With Reducing Systemic Stress Response for Off-pump Coronary Artery Bypass Graft

Opioids used in attenuation of the neuroendocrine stress response in patients undergoing off-pump coronary artery bypass graft (OPCAB) it produces predictable satisfactory analgesia and sedation but with side effects such as respiratory depression, drowsiness, and myocardial depression. Regional techniques may be encouraged to be anti-stress procedures and produce risk-free postoperative (OPCAB) period. Pectoralis nerve block (pecs block) appears to possess a great deal of promise for patients undergoing (OPCAB) because of low complication rates as it is less invasive regional analgesic technique when compared to paravertebral, thoracic epidural analgesia and parenteral analgesia.

Aims: Ultrasound Guided Bilateral Pecs block would provide attenuation of the neuroendocrine stress response with hemodynamic profile stability, decreased analgesic consumption and improves patient postoperative outcomes after(OPCAB).

Materials and Methods: A prospective, single-blind, controlled study enrolled forty patients between the age groups of 25 and 65 years undergoing (OPCAB) through midline sternotomy under general anesthesia and randomly allocated into two groups with 20 in each group. Group 1 patients did not receive Pecs block (control group), patients were anesthetized to keep the heart rate and blood pressure within 25% of the baseline values. Whereas Group 2 patients received bilateral Pecs block preoperatively. Patients were extubated once they fulfilled extubation criteria. Heart rate, mean arterial blood pressure, Plasma levels of adrenocorticotropic hormone(ACTH) and cortisol, sufentanil consumption were determined at the following points: Basically (T0),immediately before the induction of anesthesia; (T1), immediately after tracheal intubation; (T2),immediately after sternotomy;( T3), 30 minutes after the start of surgery; and (T4), at the end of surgery. Ventilator duration, duration of ICU stay hospital stay were recorded postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing first-time OPCAB surgery.
* patients with good or only slightly reduced left ventricular function (ejection fraction _40%, left ventricular end-diastolic pressure _15 mmHg)
* patients below 75years of age

Exclusion Criteria:

* patients requiring CPB either electively or during the course of surgery
* patients with renal insufficiency (creatinine _1.5 mg/dL) or hepatic impairment (alanine aminotransferase or aspartate aminotransferase _40 U/mL)
* patients who misused alcohol or drugs
* patients with hemodynamic instability
* symptoms of congestive cardiac failure
* preexisting infection at the block site
* allergy to local anesthetics
* psychiatric illness
* patients with prolonged postoperative ventilator course
The Copenhagen Adductor Exercise Trial

The purpose of this study is to investigate the efficacy of a 6-week intervention, using the Copenhagen adductor exercise, on adductor muscle strength in sub-elite male footballers. Secondly, it will also examine the effect of a 3-week detraining period, after stopping the Copenhagen adductor exercise, on adductor muscle strength.

The primary outcome measure is eccentric hip adduction strength measured using a handheld dynamometer. Additionally, peak isometric adductor squeeze strength will also be measured using a handheld dynamometer.

The hypothesis is that strength training of the adductor muscles elicited by the Copenhagen adductor exercise will result in enhanced eccentric hip adduction strength.


Eligibility Criteria:
Inclusion Criteria:

* Sub-elite English football player
* Age 18-26
* Participant can read, speak and understand English.
* Participant can receive and reply to texts on a cell phone using Short Message Services (SMS).
* Able to participate fully in competitive football training at time of testing.

Exclusion Criteria:

* Hip and groin pain resulting in loss of football training and matches in the 2 months prior to commencement of the trial.
* Specific strength training of the adductor muscles (\>/1 week) in the 2 months prior to commencement of the trial.
* Participant cannot attend strength testing sessions during the study.
Optic Nerve Course Variants in Nepali Population

A retrospective study was conducted on 367 patients. CT PNS and head of the patients were evaluated for type of course of optic nerve according to DeLano's Classification.

A retrospective study was conducted on 367 patients aged 13 years and above. Four investigators, each with 2 to 6 years of experience in the field of radiology, evaluated computed tomography scans of the paranasal sinuses and the head of these patients. The optic nerves were classified into four types based on DeLano's classification, and their respective prevalence rates were determined. Additionally, the prevalence of optic nerve dehiscence and pneumatization of the anterior clinoid process was assessed.

Eligibility Criteria:
Inclusion Criteria: Patients undergoing NCCT PNS and Head for chronic rhinosinusitis, headache and vertigo

Exclusion Criteria:

1. Patient less than 13 years age
2. Patients with recent trauma
3. Patient with large mass/ extensive polyposis
Life Skills Training Workplace Prevention Program

A workplace health promotion intervention for youth age 16-24

A workplace health promotion intervention for youth age 16-24, adapted from the school-based Life Skills Training program. The program teaches participants the skills necessary to be productive in work and personal settings while also promoting healthy behaviors and preventing or reducing health risk behaviors. Program content focuses on goal-setting and problem-solving skills, stress and anger management skills, effective communication and conflict management skills, time and financial management, substance use risk reduction, and how to contribute to a healthy, safe, and drug-free workplace.

Eligibility Criteria:
Inclusion Criteria:

* employed at participating store

Exclusion Criteria:

-
The Out-patient, Non Antibiotic Management of Patients With Acute Uncomplicated Colonic Diverticulitis

Previous multicentre study NCT 01008488 indicates that a patient with CT-proven uncomplicated diverticulitis has a very low risk (1.4%) of developing severe complications such as perforations or abscesses. The question is whether or not hospitalization is necessary, and if patients in that case could return home without antibiotics.

The purpose of this study is to evaluate if out-patients managements in uncomplicated colonic diverticulitis is possible without readmission or complications.

At the emergency room all patients with computed tomography verified acute uncomplicated diverticulitis will be asked about participation in the study. If They accept the participation, They will be send home with pain relief medicine. Every morning a nurse from our colorectal unit call the patient asking about the condition. The patients will have a visit at the surgery unit within 10 days.

Eligibility Criteria:
Inclusion Criteria:

* Adults (age above 18 years, acute abdominal pain (Duration\< 3 days), abdominal tenderness, elevated inflammatory parameters, CT- scan sign of uncomplicated diverticulitis(without sign of abscess or free air).

Exclusion Criteria:

* diffuse peritonitis sepsis or abscess, drying Patients who are unable to intake of fluids orally, severe pain with need of repeated parenteral morphine treatment, immunological deficient patients incl. steroid treatment, pregnancy, dementia, patients who need hospitalization of other reasons
Effectiveness Analysis of Ultrasound-guided Intratissue Percutaneous Electrolysis (EPI) in Patient With Chronic Low Back Pain

The main objective of this study is to analyze the effectiveness of the lumbar nerve root stimulation with ultrasound-guided percutaneous electrolysis versus the electrical dry needling of trigger points in patients with chronic low back pain.

Given that recently the effectiveness of intratissue percutaneous electrolysis (EPI) has become of interest in the treatment of chronic musculoskeletal pain, when conventional physiotherapy management is not successful, the EPI can promote the healing biological processes. Several studies have demonstrated that inflammation can play an important role in the progression of muscle degeneration, in addition to potentially contributing to painful symptoms in individuals with chronic low back pain.

This technique involves nonthermal, electrochemical ablation of the lesion via the use of a cathodic fluid. The inflammation provoked is very localized and healing is rapid. Although EPI has been widely employed lately, the literature contains few studies validating its use.

The good results reported in studies of tendinopathies have to the undertaking of the present work, which compares the long-term effectiveness of EPI and dry needling-both ultrasound-guided-for the treatment of chronic low back pain.

A double blind clinical trial will be developed in a sample of 80 subjects with chronic low back pain. Patients of experimental group will receive 1 weekly sessions of intratissue percutaneous electrolysis for 3 weeks, for a total of 3 sessions. The aim is to compare the effectiveness of applying percutaneous electrolysis in the lumbar nerve root versus applying electrical dry needling on trigger points of the gluteus medius, quadratus lumborum, and erector spinae muscles (6 sessions, once a week) on disability, pain, fear of movement, quality of life, resistance of the trunk flexors, lumbar mobility and muscular electrical activity.

Eligibility Criteria:
Inclusion Criteria:

* Low back pain ≥ 3 months.
* Age between 30 and 67 years old.
* Score ≥ 4 points on the Roland Morris Disability Questionnaire.
* Not being receiving other physical therapy.

Exclusion Criteria:

* Presence of lumbar stenosis.
* Diagnosis of spondylolisthesis.
* Diagnosis of fibromyalgia.
* Treatment with corticosteroids or oral medication in recent weeks.
* History of spine surgery.
* Contraindication of analgesic electrical therapy.
* Have previously received a treatment of intratissue percutaneous electrolysis.
* Central or peripheral nervous system disease.
Assessment of sTREM-1 as a Diagnostic Marker in Patients With Neutropenic Fever

The soluble triggering receptor expressed on myeloid cells-1 (sTREM-1) was an established biomarker useful for infection in non-neutropenic patients. In this study, we tested sTREM-1 in the patients with neutropenic fever. Pro-calcitonin (PCT) and C-reactive protein (CRP) were also measured. We planned to investigate and explore the role of sTREM-1 in early diagnosis of infection in patients with neutropenic fever.

Patients with hematological malignancies developed neutropenia after chemotherapy. We checked the serum level of sTREM-1 in patients with neutropenic fever. Those patients were classified to 2 groups: documented infection or low likelihood of infection. Their sTREM-1 level was measured and was compared with other biomarker such as CRP and procalcitonin. The value of sTREM-1 for diagnosis of infection in patients with neutropenic fever was thus evaluated.

Eligibility Criteria:
Inclusion Criteria:

* chemotherapy-related neutropenia (granulocytes \< 0.5 × 109/l or leukocytes \< 1 × 109/l) and fever (body temperature \> 38.0°C over a 6 hour observation period or body temperature ≥ 38.5°C once.

Exclusion Criteria:

* prolonged fever before presenting for admission,
* antibiotics therapy in the past 72 hours,
* more than two sites of infectious focus,
* concomitant solid organ malignancy and blast in hemogram.
Effects of Digital Vaginal Examination During Labor on Pain and Anxiety Levels

Digital vaginal examination is the most common method for assessing progress of labor and delivery. Considering it is the most common intervention women receive during course of labor, evidence for psychological effects of digital vaginal examination on women is surprisingly sparse. Reducing the number of vaginal examination during labor has been proposed by many authors as benefit of more vaginal examination is unclear. However this is unlikely to happen until more research on the topic demonstrates clear detrimental effects of vaginal examination.

Our study is aimed at investigating association of vaginal examination with psychological distress of women during labor. Anxiety during labor is associated with longer labor duration, increased perception of pain, problems with newborn attachment, and increased rates of postpartum depression and post-traumatic stress disorder. In this study, women were assigned to either digital vaginal examination or transperineal ultrasound assessment groups were compared to each other in a randomised controlled setting.


Eligibility Criteria:
Inclusion Criteria:

* Multiparous women
* Spontaneous active labor
* Cephalic presentation

Exclusion Criteria:

* Women with known psychiatric disorders
* Labor induction
* Advanced labor during admission (Dilatation greater than 7cm)
* Presence of a prenatally diagnosed anomaly in fetus
* Admission to neonatal intensive care unit after delivery
* Delayed hospital discharge due to excessive weight loss of neonate
Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) in Korea

This post marketing surveillance study in Korea will evaluate the safety and efficacy of BOTOX (botulinum toxin Type A) in patients who receive treatment according to standard of care for primary axillary hyperhidrosis, focal spasticity or moderate to severe glabellar lines in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice for primary axillary hyperhidrosis, focal spasticity or moderate to severe glabellar lines.

Exclusion Criteria:

* None.
Effects of Obstructive Sleep Apnea Treatment by Fixed CPAP and by Auto-CPAP (Somnosmart2)

The main purpose of this study is to investigate if treatment of obstructive sleep apnea syndrome (OSAS) by continuous positive airway pressure (CPAP) given by a traditional CPAP device administering a fixed air pressure, or by one automatic CPAP device ("Somnosmart2", Weinmann, Hamburg) administering variable pressures, have different effects on sympathetic nervous system tone (as reflected by urinary excretion of norepinephrine and its catabolite normetanephrine) and on blood pressure.

A nocturnal home cardiorespiratory recording will performed for diagnosis of OSA. During the same night, patients will be asked to collect their urines. Twentyfour-hour ambulatory BP monitoring (ABPM) will be performed starting from the next morning. After analysis of the polygraphic recording, subjects with AHI \<15 will be excluded from the study, while CPAP will be proposed as a treatment to the other patients.

Before starting treatment, a full night standard polysomnography will be performed: in subjects assigned to fixed CPAP for attended CPAP titration; in the other subjects during application of the Somnosmart2 device, to verify if obstructive events are adequately eliminated by it.

After analysis of polysomnography, patients will be given a fixed CPAP or the auto-CPAP device for nocturnal home use. Two months later, compliance to treatment will be verified measured by the in-built time counter of the devices. Then, cardiorespiratory monitoring during application of the device used for treatment, nocturnal urine collection and 24-hour ABPM will be repeated.

Eligibility Criteria:
Inclusion Criteria:

* Obstructive sleep apnea syndrome deserving CPAP treatment

Exclusion Criteria:

* current pharmacological treatment
Brief Behavioral Intervention for Comorbid Migraine and Depression

The purpose of this research study is to examine whether a one-day group workshop, integrating principles from Acceptance and Commitment Therapy with Migraine Education, will result in improvements in depressive symptoms and functioning impairment in patients with comorbid migraine and depression.

Migraine affects approximately 35 million US residents (Bigal \& Lipton, 2009) and is associated with excruciating headache and marked functional impairment. Epidemiological and clinical research has shown that people with migraine suffer from psychiatric disorders at a disproportionately higher rate than individuals without. Depression, in particular, is 3-5 times more common in migraine patients than in non-migraineurs. The comorbidity of depression and migraine is a major health concern as it results in poorer prognosis, remission rate, and response to treatment. In addition, an increase in the severity of migraine is associated with a parallel rise in the severity and treatment resistance of comorbid depression.

Recent research in behavioral medicine suggests that the pain experience per se does not necessarily lead to depression or impairment. Instead, it is the preoccupation with avoiding aversive stimuli associated with pain (i.e., activities, places, movements) that results in depression and disability (e.g., McCracken et al., 2005). Therefore, given that patients with migraine and/or depression exhibit more avoidance behaviors and lower activity levels than healthy controls (e.g., Stronks et al., 2004), an intervention aimed at optimizing willingness and acceptance and minimizing behavioral avoidance may be beneficial at improving both their depression and migraine and, consequently, their daily functioning.

Acceptance and Commitment Therapy (ACT) is an empirically based behavioral therapy that incorporates acceptance and mindfulness strategies with behavioral change strategies. ACT (in group and in individual settings) is effective in treating psychiatric disorders commonly associated with migraine, including depression, anxiety, and stress (e.g., Hayes, 2001) as well as chronic illnesses like pain and diabetes (Dahl et al, 2004; Gregg et al., 2006). Importantly, ACT resulted in positive long-term outcomes even when presented in brief form. For example, a two-day ACT workshop, in a group setting, led to improvements in depression and distress experienced by parents of children diagnosed with autism and these gains were retained 3 months later. Parents also exhibited a reduction in avoidance behaviors (Blackledge \& Hayes, 2006).

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75
* 4 to 12 migraines in the previous month
* Major or Minor Depression
* English-speaking

Exclusion Criteria:

* Patients with other major psychiatric disorders such as bipolor disorder, schizophrenia, and current illicit drug use.
* Patients with major head injuries.
* Patients with serious medical illnesses.
* Patients who have started a new medication in previous 4 weeks or plan on starting a new medication in the next 4 weeks.
* Patients expressing significant suicidal ideation.
Sex Steroid Hormones and Risk of CHD in Women

To investigate the relationship between endogenous estrogen and androgen levels and risk of coronary heart disease among postmenopausal women in the Women's Health Initiative-Observational Study (WHI-OS).

BACKGROUND:

The role of endogenous gonadal hormones in the etiology of atherosclerotic disease needs clarification. Previous studies of women have been small, rarely prospective, and had other methodological problems. Results have been inconsistent. Observational and clinical trial data on exogenous hormones, also inconsistent, are probably irrelevant to endogenous hormonal effects.

On the other hand, despite hormonal differences being evoked as the reason for women having less atherosclerotic disease than men, it is not apparent from existing data that between-person variability in endogenous hormones is likely to be a strong risk factor for atherosclerotic disease in women. Furthermore, the atherosclerotic process begins early in life, and postmenopausal hormone differences are only one aspect of possible hormonal effects on disease. Nevertheless, this study has the potential to provide important new information on the role of endogenous hormones on atherosclerotic disease in postmenopausal women.

DESIGN NARRATIVE:

The study used a nested-case control design to measure baseline sex steroid hormone levels (serum total and free estradiol, estrone sulfate, total and free testosterone, dehydroepiandrosterone sulfate) and sex hormone binding globulin to determine whether these predicted subsequent risk of coronary heart disease (CHD). A total of 350 case subjects and 350 control subjects were selected from women who were free from cardiovascular disease and cancer at study entry and were not using hormone replacement therapy at baseline. Cases were those women who subsequently developed a documented myocardial infarction or underwent coronary artery revascularization (N=350), while control subjects were selected from study participants who remained free from CHD during follow-up. Controls were matched 1:1 for age, ethnicity, smoking and follow-up time. The study also examined correlations between sex steroid hormone levels and other previously funded analyses of biomarkers, including thrombotic and inflammatory markers, lipoproteins, fasting glucose and insulin. Detailed baseline data including anthropometrics and behavioral factors allowed control for confounding.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria