cyrilzakka/clinical-trials huggingface dataset:
Music and Premenstrual Symptoms and Quality of Life

Premenstrual syndrome is an important health problem affecting women of childbearing age. This study is a prospective, single-blinded randomized controlled trial. Participants were randomized into music, and control groups. Immediately post-intervention, the women in the experimental groups had significantly higher reduce premenstraul syndrome levels and increase a quality life.

Premenstrual syndrome is an important health problem affecting women of childbearing age. This study aimed to show that music medicine can be used to reduce premenstrual syndrome levels and increase quality of life. This study is A prospective, single-blinded randomized controlled trial. The study was conducted between January and April 2021 with 97 women who are college students. Participants consisted of women over 20 years of age and with have premenstraul snydrome. Participants were randomized into music, and control groups. Immediately post-intervention, the women in the experimental groups had a significantly higher reduce premenstraul syndrome levels and increase a quality life. Each method (music and control group) is evaluated for The Premenstrual Syndrome Scale and Short form of the WHOQOL-BREF.

Eligibility Criteria:
Inclusion Criteria:

* being between the ages of 18 and 30
* being able to speak and understand Turkish,
* having obtained a score of 45 and above from the PMSS,
* having regular menstruation (between 21-35 days),
* completing the scale forms completely and reading and approving the voluntary consent form

Exclusion Criteria:

* Having any gynecological disease (abnormal uterine bleeding, myoma, ovarian cysts, hormonal treatment, etc.),
* having a chronic or physical disease (serious hearing and vision problems, vestibular disorders that may cause balance losses),
* having any problem that prevents the person from communicating (not being able to speak Turkish, having speaking disabilities, impaired hearing, understanding abilities),
* undergoing a psychiatric treatment (pharmacotherapy or psychotherapy),
* performing one of the pharmacological or non-pharmacological practices aimed at reducing the symptoms of premenstrual symptoms (oral contraceptive use, acupressure, homeopathy, acupuncture) and exercising regularly.
Internet CBT for Antenatal Depression

Pregnant women in pregnancy week 8-29 screening positive for antenatal depression will be randomized to either choose or to be allotted by chance to different forms of diagnostic assessment; i.e. telephone, video or face-to-face assessment.

Those diagnosed with mild to moderate major depression will then be randomized to treatment with therapist-guided Internet-delivered Cognitive Behavioral Therapy (ICBT) adapted for women suffering from antenatal depression or to the same treatment with addition of up to three contacts with extra support by a midwife or experienced perinatal mental health nurse.

The primary aim is to assess whether extrasupport in addition to internet-guided pregnancy adapted ICBT decreases depressive symptoms more than internet-guided pregnancy adapted ICBT only. Secondary aims include effects of extrasupport and assessment mode on treatment satisfaction, fidelity and credibility.


Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate major depression
* Pregnant at treatment start
* Regular contact with maternity mental health clinic
* \> 18 years old
* Being able to start the treatment earliest in gestational week 8 and latest in gestational week 30
* Stable medication for depression and/or other psychiatric conditions for at least 3 weeks.
* Being able to participate in the treatment during the treatment time and having access to and being able to use the internet and mobile phone during the treatment time
* Being able to understand the Swedish language orally and in writing

Exclusion Criteria:

* Montgomery-Åsberg Depression Rating Scale-Self report version (MADRS-S) score below 15 (symptoms of depression to low) or above 35 (severe depression)
* High risk of self harm or suicide (based on semi-structured clinical suicide risk assessment)
* Psychiatric comorbidity, disability, somatic disorder, or pregnancy complications that prevent treatment participation or that can be negatively affected or compose a risk for the fetus by treatment participation
* Ongoing psychological treatment with similar content
Lifestyle and Obesity

The objective of this trial is to determine the effect of different lifestyle interventions such as aerobic exercise and alternative resistance training methods, combined with a hypocaloric diet, on weight, body composition and metabolic risk factors in overweight and obese adults.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index \> 24.9 kg/m²
* age \> 18 y
* pre-menopauzal

Exclusion Criteria:

* Body mass index \> 40 kg/m²
* Pregnancy
* Diabetes
* Joint replacement surgery
Evaluation of Cerebral Small Vessel Disease in Patient With Primary Aldosteronism

Hypertension is known to be the major risk factor for stroke. The most common cause of secondary hypertension, primary aldosteronism (PA), is characterized by the excessive secretion of aldosterone and is related to hypertension and hypokalemia. PA accounts for 3-10 % of hypertensive patients, and a higher incidence of vascular complications compared to patients with essential hypertension was observed in several studies. The vascular injury from excessive aldosterone can occur via oxidative stress and collagen remodeling, causing endothelial dysfunction and fibrosis in the vasculature.

The association between cerebral small vessel disease (cSVD) and hypertension has been well studies in the past decades. However, not much study has focused on the cSVD burden in patient with PA. The goal of this study is to understand the features of cSVD in patients with PA and for the purpose of understanding the underlying pathophysiology of cerebrovascular injury in this particular patient group.


Eligibility Criteria:
Inclusion Criteria:

* age between 20-90 years-old
* patient with primary aldosteronism or healthy control
* consciousness clear
* willing to receive brain MRI

Exclusion Criteria:

* renal failure or Creatinine \> 2mg/dl
* coagulopathy or hepatic insufficiency
* unstable vital sign under inotropic agents
* pregnancy
* metal implant or cardiac pacemaker
* major brain surgery
The MIGHT Trial - an Exploratory Clinical Trial of IVIG in Anti-HMGCR Immune Mediated Necrotizing Myopathy

This is a randomized, placebo-controlled, double blinded phase 2 exploratory clinical trial of intravenously administered pooled human immunoglobulin (IVIG) in anti-3-hydroxy-3-methylglutaryl-CoA reductase (HMGCR) immune mediated necrotizing myopathy (IMNM). Planned enrollment is 12 individuals with active anti-HMGCR IMNM meeting inclusion and exclusion criteria. Assuming 20% drop-out, the investigators anticipate 10 participants will complete all study assessments. Enrolled participants will be randomized 1:1 to either IVIG 2g/kg or placebo (0.9% sodium chloride at equivalent volume) at weeks 0, 4, and 8. The primary efficacy and co-primary safety and tolerability endpoints will be assessed at week 12. After the randomized phase of the trial, all participants, except those who were randomized to IVIG and met the clinical deterioration criteria, will be offered to continue on to an open-label extension phase in which participants will receive IVIG at weeks 12, 16, and 20. Participants will then return at week 24 for a final non-infusion visit to reassess safety, tolerability, and efficacy outcome.


Eligibility Criteria:
Inclusion Criteria:

* 16 years of age or older
* Anti-3-hydroxy-3-methylglutaryl-CoA reductase (HMGCR) antibody positive
* Serum creatine kinase \> 5x upper limit of normal
* Anti-HMGCR Immune Mediated Necrotizing Myopathy (IMNM) disease duration \< 36 months at screening
* No moderate or severe respiratory or swallowing dysfunction due to Immune Mediated Necrotizing Myopathy at screening
* No history of dermatomyositis rash

Exclusion Criteria:

* Oral glucocorticoid daily dose \> 15mg at screening
* Change in oral glucocorticoid dose \< 2 weeks prior to screening
* Prior IVIG treatment for anti-HMGCR Immune Mediated Necrotizing Myopathy
* \> 1 oral conventional synthetic disease-modifying antirheumatic drug (DMARD) (e.g., methotrexate, mycophenolate mofetil, azathioprine) use at screening
* Change in concomitant DMARD dose \< 4 weeks prior to screening
* Rituximab treatment within 6 months prior to screening
* Plasma exchange, cyclophosphamide, or biologic immunosuppressive medication within 3 months prior to screening
* Use of statin medication at screening
* History of anaphylactic reaction to intravenous immunoglobulin (IVIG)
* History of angina pectoris, myocardial infarction, transient ischemic attack, or stroke within 12 months prior to screening
* Females of child-bearing potential who are pregnant, breastfeeding, or are unwilling to practice a highly effective method of contraception during the study
* Wells' Criteria for Pulmonary Embolism score of 4 or more at screening
* Wells' Criteria for Deep Vein Thrombosis score of 2 or more at screening
* Any medical condition which, in the investigator's judgment, makes participation in the clinical trial unadvisable or which would interfere with evaluation of the study treatment
Dexmedetomidine or Dexmedetomidine Combined With Dexamethasone on Postoperative Nausea and Vomiting in Breast Cancer

Previous reports demonstrated that dexmedetomidine could reduce the incidence of postoperative nausea and vomiting (PONV). Dexamethason also had been commonly used for ajuvant drugs for preventing and reducing PONV. So investigator want to study about the effect of dexmedetomidine only or combined with dexamethasone for preventing PONV.

Previous reports demonstrated that dexmedetomidine, a alpha 2 selective agonist could reduce the incidence of postoperative nausea and vomiting (PONV). Dexamethason also had been commonly used for ajuvant drugs for preventing and reducing PONV. So investigator want to study about the effect of dexmedetomidine only or combined with dexamethasone for preventing PONV.

Eligibility Criteria:
Inclusion Criteria:

* ASA Physical status I or II female scheduled for breast conserving surgery of modified radical mastectomy.

Exclusion Criteria:

* uncontrolled cardiovascular disease
* history of chronic pain
* smoker
* previous history of steroid administraion
* neoajuvant chemotherapy
Metabolic Assessments of Neurostimulation to Reduce Apnea

Hypoglossal nerve stimulation (HGNS) is an implantable therapy that treats obstructive sleep apnea.

The study will evaluate the effect of this treatment on metabolism-related outcomes and measures of inflammation to see if it lowers patients' risk of medical problems associated with obstructive sleep apnea (OSA).


Eligibility Criteria:
Inclusion Criteria:

* English-speaking adults (18+ years) who have met surgical efficacy criteria with HGNS, as defined by at least a 50% reduction in apnea-hypopnea index (AHI) to \<20 (with hypopneas defined by 4% oxyhemoglobin desaturations)
* Have been using HGNS therapy for at least 3 months and used HGNS for \>20 hours/week during the past 4 weeks
* Were not using any OSA therapy for at least one month prior to HGNS activation or have had a one-month period of untreated OSA after HGNS activation

Exclusion Criteria:

* Chronic use of opiate medications, illicit drugs, or alcohol dependency
* Women who are pregnant or planning to become pregnant
* Shift workers, heavy machinery operators, or unable to avoid driving during the HGNS withdrawal portion of the study (e.g. commercial drivers)
* Lack of a sleep study at their current HGNS voltage within the last three years
* History of severe excessive daytime sleepiness (Epworth Sleepiness Scale score \>16 at time of screening or prior to HGNS), motor vehicle accidents or near-miss incidents due to drowsy driving
* Significant cardiopulmonary (such as home oxygen requirement), liver, renal, or oncologic disease; neurodegenerative disease; active or recent history of an eating disorder (within the last 5 years)
* Inability to provide informed consent
Intraoperative Anaesthesia Awareness Following Induction of Anaesthesia

A primary aim of anaesthesia is to prevent awareness of surgery; ablation of the experience of surgery is the most secure way to prevent awareness with recall. Fortunately the incidence of awareness with recall (the patient can spontaneously remember the intraoperative event) is very rare (0.1-0.2%). However the investigators systematic review suggests that consciousness of intraoperative events may occur in approximately 37% of patients in experimental studies (as identified by the validated clinical procedure the isolated forearm test that does not require postoperative recall of the event). In this international cohort study, recruiting a minimum sample of 200 patients, the investigators will investigate the incidence of anaesthesia awareness (as identified by the isolated forearm test) following the induction of anaesthesia and before surgery.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients clinically requiring intubation will be included in this cohort.
* Patients must be able to follow the isolated forearm technique commands when awake and prior to their operation will be included in this cohort.

Exclusion Criteria:

* Contraindication to isolated forearm technique test such as unable to have tourniquet on arm for the isolated forearm technique (e.g. lymphedema or operative site).
The Biodistribution of 1-L-(2 Deoxy-2,- 18 Fluoroarabinofuranosyl) Cytosine ([18F]L-FAC) in Healthy Subjects and Patients With Cancer, Autoimmune and Inflammatory Diseases

The purpose of this study is to determine the biodistribution of a new agent 1-L-(2 deoxy-2,-18fluoroarabinofuranosyl) cytosine non-invasively in healthy humans and to evaluate whether it can be used to image cancer, autoimmune disease, and inflammation


Eligibility Criteria:
Inclusion Criteria:

* greater than 18 years of age
* women of childbearing potential will undergo a pregnancy test free of charge
* patients with hematological malignancies, solid tumors or autoimmune disorders
Hiatal Hernia Repair by Tension-free Mesh Closure or Simple Suturing

One-hundred and fifty-nine patients undergoing Nissen fundoplication for symptomatic gastro-oesophageal reflux disease (GORD), who had a concomitant hiatal hernia of \> 2 cm axial length, were randomized to closure of the diaphragmatic hiatus with either crural sutures alone or tension-free closure with a non-absorbable mesh. Primary outcome variable was the incidence of radiologically verified recurrent hiatal hernia. Secondary outcomes were per-and postoperative complications and courses, symptomatic recurrence rate, use of PPI, postoperative oesophageal acid exposure and Quality of Life.

The basic principles behind successful surgical repair of the anatomy and function of the gastro-oesophageal junction (GOJ) in gastro-oesophageal reflux disease (GORD) is not only to encircle the distal oesophagus and GOJ by the fundic wrap but also to complete a transhiatal reduction of a concomitant hiatal hernia (type I, HH), aiming for a 2 - 3 cm intra-abdominal length of the of oesophagus and to transact a tension-free hiatal closure. The physiological and morphological characteristics of the diaphragmatic hiatus, however, carry a challenge for the selection of the ideal technique for surgical repair. The diaphragmatic hiatus consists of a three-dimensional structure in constant motion, which creates a border between the counteracting pressures prevailing in the abdominal and chest cavities, respectively. Following hernia reduction, the structural quality of the diaphragmatic pillars is usually weak, offering poor support for the subsequent closure with risk for high recurrence rates. These and other considerations have encouraged the exploration of mesh reinforcement to enhance the durability of the hiatal closure.

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for elective laparoscopic total fundoplication
* symptomatic gastro oesophageal reflux disease (GORD) and HH of \> 2 cm in axial length
* total esophageal acid exposure for more than 4 % of monitored time

Exclusion Criteria:

* if insufficient capacity prevailed to understand the study protocol,
* if the patient had undergone previous major upper gastrointestinal surgery (except for GORD or HH)
* ASA classification of \>2 .
Multimedia First Aid Program for Families

Unintentional injuries are the leading cause of death for children and infants under 14 years of age. Many of these deaths are preventable, in part by promoting injury prevention behaviors but also by administering effective emergency first aid techniques until advanced care arrives. This project created a web site program that paired video-based instruction with interactive skills training to teach parents of children birth to 12 years old basic first-aid and CPR skills, and that included the option to practice skills as needed.

Program content was based on the American Heart Association's (AHA) 2010 guidelines for CPR and first aid training. The Online IMM course was designed to teach participants in six modules: Principles of care; CPR for infants; CPR for children; How to relieve infant choking; How to relieve child choking; and Preventing injuries. Participants were also able to view text articles on first aid topics, such as Wound care or Caring for burns. Although the users of the Online IMM training program did not have direct contact with a manikin during their training, there were opportunities to practice CPR skills through the use of interactive animations. These animations demonstrated and then encouraged users to practice key functions similar to actual CPR skill delivery: including the location, depth and rate of compressions, opening the airway and giving breaths. Participants were encouraged to view the entire program; however, they could navigate and review all program content as much or as little as desired.

Eligibility Criteria:
Inclusion Criteria:

* Parents or guardians of children aged newborn to 12 years old could potentially be as young as 18 years old. Parents or legal guardians could potentially be as old as 65 or older.
* Children under the age of 18 were not included, even with parental consent, because of the online nature of the study and inability to verify parental consoent.

Exclusion Criteria:

* Only English-speaking participants were accepted because the program was developed only for English speakers.
* All English-speaking parents of children aged newborn - 12 years old who wished to participate were included.
* There were no exclusions based on race/ethnicity.
Evaluation of Safety and Efficacy of Dapagliflozin in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Background Combination of Metformin and Sulfonylurea

This study intends to compare the efficacy and safety of dapagliflozin versus placebo in patients with type 2 diabetes who have inadequate glycaemic control on a background combination of metformin and sulfonylurea.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* Men or women age ≥ 18 years old
* Stable dose combination of metformin and sulfonylurea
* HbA1c ≥7.7% and ≤11.0%

Exclusion Criteria:

* Type 1 diabetes mellitus or diabetes insipidus
* Recent cardiovascular events
* Kidney or urological disorders
* Hepatic disorders
Transcranial Doppler Ultrasound and Minimal Hepatic Encephalopathy

Minimal hepatic encephalopathy (MHE) is a subclinical complication of liver cirrhosis with a relevant social impact. Thus, there is urgent need to implement easy to use diagnostic tools for the early identification of affected patients.

This study was aimed to investigate cerebral blood flow, systemic hemodynamics as well as endothelial function of cirrhotic patients with MHE, and to verify their change after treatment with rifaximin.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of liver cirrhosis on the basis of clinical, laboratory and ultrasound findings

Exclusion Criteria:

* active alcohol abuse (excessive alcohol intake stopped more than 6 months before the enrollment);
* chronic pulmonary diseases; ongoing infections; cerebrovascular diseases; primary or secondary cerebral neoplasm; primary liver neoplasm; heart function failure; chronic kidney disease; peripheral vascular disease; treatment with rifaximin or systemic antibiotics in the previous 15 days;
* smoking habit;
* grade 1 or overt hepatic encephalopathy.
NAC-003 P.L.U.S. Program (Progress Through Learning Understanding & Support)

This study will be an observational study in which patients who have been prescribed CerefolinNAC® are invited to participate in surveys regarding their experiences with CerefolinNAC®. CerefolinNAC® is a medical food indicated for the distinct nutritional requirements of individuals under treatment for early memory loss with particular emphasis for those individuals diagnosed with or at risk for neurovascular oxidative stress and/or hyperhomocysteinemia; mild to moderate cognitive impairment with or without vitamin B12 deficiency, vascular dementia or Alzheimer's disease. The purpose of this study is to increase the understanding of the role of CerefolinNAC® in managing proper neuronal function in the brain, provide patients with personalized education and support, and contribute to the overall understanding of the needs and concerns of patients being treated for early memory loss.

Surveys used to conduct this study will be administered via telephone by InfoMedics, Inc., a company with an established system for developing such patient-physician feedback programs. Participating physicians will ask their patients to participate in the program after CerefolinNAC® has been prescribed and provide them with a brochure containing an introduction to the program and instructions on how to enroll. Patients self-enroll, take a brief survey before starting their CerefolinNAC® prescription, and then two brief follow-up surveys at 6 weeks and 12 weeks. As patients complete surveys within the study, their physician will receive individualized feedback reports outlining their patient's treatment experience and progress. Patients will also receive a copy of their own reports, to help encourage them to continue taking CerefolinNAC® as directed. Patients will also receive educational materials about managing their early memory loss.

Eligibility Criteria:
Inclusion Criteria:

* New CerefolinNAC® Start
* Only for patients who have been prescribed CerefolinNAC® to help metabolic management of early memory loss.

Exclusion Criteria:

* If a participant indicates that he or she did not get a prescription for CerefolinNAC®, he/she will not be able to complete the survey(s).
* For follow-up surveys, if the participant indicates that he/she has not been taking CerefolinNAC®, he/she will not be able to complete the survey (s).