cyrilzakka/clinical-trials huggingface dataset:
The Effect of Music Therapy Applied to Pregnant Women on Anxiety and Stress

Anxiety and stress increase in primiparous pregnant women and especially in the third trimester of pregnancy. This study was conducted to investigate the effect of music therapy applied to pregnant women who will give birth for the first time and are in the last trimester of their pregnancy on anxiety and stress. The study is a randomized controlled trial. Pregnant women in the application group were regularly listened to music for 20 minutes a day for 10 days. In the study, pregnant women in the application and control group were trained by the researcher on preparing for normal delivery. The pregnant women who participated in the study completed the Personal Information Form, the State and Trait Anxiety Inventory and the Pregnancy Stress Rating Scale at the beginning. 10, the last day of study. on the day, the scales are repeated.

Aims and objectives: This study aimed to evaluate the effect of music therapy on the anxiety and stress levels of primiparous pregnants in the third trimester.

Background: Anxiety and stress during pregnancy, when not well-managed, can lead to negative birth outcomes.

Design: This study is a randomized controlled trial. Methods: This study was conducted in Turkey with 120 pregnant, 60 of whom were in the music group and 60 in the control group. Research data were collected with Personal Information Form, State-Trait Anxiety Inventory and Pregnancy Stress Rating Scale-36. Pregnants were made to listen to music for 20 minutes every day for ten days. The anxiety and stress levels of pregnant were measured before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women aged 18 and over,
* Primiparous pregnants,
* In the third trimester (28 and above gestational week),
* Speaking and writing in Turkish,
* Having no vision-hearing problems,
* Having and using internet-supported online Web 2.0 tools,
* Volunteering to participate in the study were included in the study within the scope of inclusion criteria.

Exclusion Criteria:

* Pregnant women who did not meet the inclusion criteria and pregnant women who did not listen to music regularly were excluded from the study.
Fatigue and Interleukin-1 (IL-1) Blockade in Primary Sjøgrens Syndrome

Fatigue is a prevalent phenomenon in Primary Sjøgrens syndrome (PSS). Observations indicate that the cytokine IL-1 is of importance for this phenomenon. In this study the investigators block IL-1 by giving Anakinra (an IL-1 receptor antagonist) to patients with PSS.

A double-blind, placebo-controlled, parallel study of the effect on fatigue of daily injections of Anakinra for one month.

Eligibility Criteria:
Inclusion Criteria:

* Primary Sjøgrens Syndrome according to the European-American criteria
* Age 18-80 years
* Written informed consent

Exclusion Criteria:

* Hyper- og hypothyreosis
* Malignant disease
* Parkinsons disease
* Multiple sclerosis
* Conditions or diseases where Anakinra is contraindicated
* Mental depression (BDI \>13)
* Neutropenia (\<1.5\*10.9)
* Frequent infections
* Pregnancy, lactating women.
RibFix Blu Thoracic Fixation System Versus Non-surgical Treatment in Non-flail Chest Rib Fractures

This is a prospective, multi-center, observational, cohort study involving skilled cardiothoracic surgeons who are experienced in implanting the treatment of non-flail chest rib fractures and the use of RibFix Blu Thoracic Fixation System.

The objective of this study is to evaluate the benefits of surgical stabilization of rib fractures (SSRF) in patients with non-flail chest rib fractures using RibFix Blu Thoracic Fixation System when compared to non-surgical (analgesia and symptomatic management) treatment. The study will include up to 167 cases of non-flail chest rib fractures with 95 cases in non-surgical treatment group and 72 cases in the surgical group. Each center may enroll up to maximum 30 cases to permit the assessment of outcome across a variety investigators and clinical settings. Enrolment will be competitive among sites and closed as soon as a total of 167 cases are recruited.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and above (inclusive)
* Simple rib fracture with ≥ 3 consecutive ribs, and the broken ends showed clear displacements
* Indicated for surgical repair of rib fractures using RibFix Blu Thoracic Fixation System or non-surgical treatment (analgesia and symptomatic management treatment)
* Willing and able to complete scheduled follow-up evaluations as described in the study protocol
* Has participated in the Informed Consent process and is willing and able to sign an Institutional Review Board or Ethics Committee (IRB/EC) approved Patient Information/ Informed consent Form (PICF)

Exclusion Criteria:

* Flail chest rib fractures based on radiological or clinical findings
* Previous rib fractures or pulmonary problems, requiring continuous oxygen use at home pre-trauma
* Presence of any serious medical issues that placed patient in generally poor conditions such that he or she could not tolerate the surgery
* Chest trauma associated with severe craniocerebral injury, abdominal organ injury, severe spinal injury, limb fracture, or pelvic fracture requiring long-term bed rest
* Has serious medical disease that is a contraindication for general anesthesia, such as cerebral infarction, myocardial infarction and hemorrhagic syndrome
* Any contraindications listed in the manufacturer's Instruction to use for RibFix Blu Thoracic Fixation System as per below:

  * Spanning a midline sternotomy
  * Active Infection
  * Foreign body sensitivity
* Is known to be pregnant
* Is a prisoner, known alcohol or drug user or mentally incompetent or unable to understand what participation in this study entails.
* Participation in another surgical intervention that may influence any of the outcome parameters.
Study to Assess the Efficacy and Safety of Rifaximin Administered BID in the Treatment of Patients With Diarrhea-Associated Irritable Bowel Syndrome

This is placebo-controlled study of three rifaximin doses in patients with DIBS. Subjects will be randomized to receive daily doses of placebo BID, rifaximin 275 mg BID, rifaximin 550 mg BID, or 1100 mg BID for 14 days. These four groups will subsequently receive an additional two weeks of placebo for a total of 4 weeks of treatment. A fifth group of subjects will receive rifaximin 550 mg BID for a period of 28 days. Subjects who successfully respond to treatment at the end of the 28-day Treatment Phase will be followed in a Post-treatment Phase that includes study visits during Weeks 6, 8, 12 and 16. Subjects who relapse during the Post-treatment Phase will be discontinued from the study.

While IBS is one of the most common chronic medical conditions the etiology of IBS is unknown. Although not a life-threatening illness, IBS is considered to be a serious condition that has a substantial impact on a subject's day-to-day function. IBS is characterized by abdominal pain and altered bowel habits, including diarrhea, constipation, or alternating diarrhea and constipation. Symptoms are typically intermittent but may be continuous.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subject 18 years of age or older.
2. Irritable bowel syndrome confirmed by the Rome II Criteria
3. Lower endoscopic examination that demonstrates normal colonic anatomy

Exclusion Criteria:

1. Subject has exclusively constipation-predominant IBS (CIBS) that is characterized by \< 3 bowel movements/week or hard and lumpy stools.
2. Subject has alternating IBS, but is currently presenting with constipation associated IBS symptoms.
3. Subject has had adequate control of their DIBS and their symptom of bloating the week preceding the screening visit or at the time of randomization. Bloating includes the following symptoms: abdominal fullness, bloating, gas, or swelling.
4. Subjects has a positive stool culture for O \& P (ovum and parasite) and/or Clostridium difficile
5. Subject has failed to record 2 negative weekly global assessments during the past 10 days prior to randomization.
Prevalence of Mullerian Anomalies in Infertile Women

* Mullerian anomalies are congenital structural anomalies in the uterus .
* Its prevalence is not uncommon .

* PCO is very common in gynecological practice
* Women with mullerian anomalies should be properly evaluated for other gynecological and urological problems

Eligibility Criteria:
Inclusion Criteria:

* females with age between 20-42 years with primary infertility

Exclusion Criteria:

* females with age above 42 years or below 20 years females with secondary infertility
Incidence/Magnitude-Haemorrhagic Progression-Cerebral Contusions and Identification (ID) of Safety Issues After Traumatic Brain Injury

This study is conducted in North America. The purpose of this study is to evaluate the occurrence and severity of bleeding in brain injury and to identify important safety issues following traumatic brain injury.


Eligibility Criteria:
Inclusion Criteria:

* Ages Eligible for Study: 18 Years - 85 Years
MIRAI-MRI: Comparing Screening MRI for Patients at High Risk for Breast Cancer Identified by Mirai and Tyrer-Cuzick

Accurate risk assessment is essential for the success of population screening programs and early detection efforts in breast cancer. Mirai is a new deep learning model based on full resolution mammograms.

Mirai is a mammography-based deep learning model designed to predict risk at multiple timepoints, leverage potentially missing risk factor information, and produce predictions that are consistent across mammography machines. Mirai was trained on a large dataset from Massachusetts General Hospital (MGH) in the United States and found to be significantly more accurate than the Tyrer-Cuzick model, a current clinical standard.

The primary aim of this study is to prospectively quantify the clinical benefit (i.e. MRI/CEM cancer detection rate) of Mirai-based guidelines and to compare them to the current standard of care.

1. Conduct a prospective study where patients who are identified as high risk by Mirai guidelines are invited to receive supplemental MRI within 12 months.
2. Compare cancer outcomes between patients only identified as high risk by Mirai and patients identified as high risk by existing guidelines The secondary aim is to study the impact of new guidelines by race and ethnicity, to ensure equitable improvements in cancer screening.


Eligibility Criteria:
Inclusion Criteria:

* Women who were identified as high risk on the retrospective study (dating from 2017-2023) using MIRAI will be recruited and consented for the prospective study
* Women over 40 years of age identified as high risk according to traditional guidelines will also be potentially eligible for this study
* Following consent and enrollment in the study, a participant will subsequently receive the following:

  1. These patients will be invited to receive a supplemental MRI examination currently considered the most sensitive test for breast cancer detection.
  2. Any positive diagnosis on MRI will be followed by biopsy to confirm 'truth" of diagnosis.
* To be selected, a given record must include the following:

  1. A report of a routine screening mammogram or diagnostic mammogram, and availability of the DICOM images from that report with the PACS system.
  2. Reports of all follow up screening and diagnostic studies documented on PACS.
  3. Some may have interventional procedures (as long as all of these are done at one of Umass sites) and documentation of these biopsy results in the hospitals EHR.

Exclusion Criteria:

* Under age 40. Women under 40 years are not routinely xrayed with a mammogram.
* Xray breast cancer screening imaging study that has artifacts, corruption, or other image quality degradation.
* Pregnant patients because they do not routinely receive screening mammogram
* Adult male patients with breast cancer
Hyper Adduction of Right Radial Artery/Arm vs Left Drag Over Technique

Several studies have shown that operator exposure via left transradial catheterization has yielded less operator exposure compared to standard right transradial procedure. However, in light of new data, the investigators hypothesize a hyperadducted right arm during right transradial cardiac catheterization will yield comparable, or the same operator radiation exposure.

Few studies have examined operator's radiation exposure tor transradial cardiac catheterization between the left vs right radial artery approach. In light of recent studies (Schiabasi et al) demonstrating adduction of the right arm yields lower operator exposure than that of the right arm positioned away from the body to the operators. The investigators seek to examine if hyper adduction of the right arm yields similar operator exposure to that of the left radial approach.

Historically the left radial approach has been more favorable in terms of operator exposure. However, the primary access site for interventional cardiologists has been the right radial artery due to cardiac catheterization laboratories set up for operators to work on the right side of the table. This study seeks to find if a hyperadducted right arm yields less, more, or similar radiation exposure to the operator in cardiac catheterization laboratory than the left radial artery approach.

This study's primary outcome is to measure the radiation exposure to the primary operator during diagnostic cardiac catheterization at four different anatomical locations (these are Maimonides Medical Center employees -attending physicians in the catheterization lab). Study's secondary outcomes aim to measure Dose Area Product, mGy of radiation dose, \& contrast administration to the patients undergoing the procedure and presence/absence of subclavian artery tortuosity which are recorded automatically and regardless during the diagnostic procedure.

Eligibility Criteria:
Inclusion Criteria:

* All the Cardiac catheterization laboratory physician operators who consent to participate in the study
* Patients of any sex and gender.
* Age \> 18 years old.
* Patients undergoing diagnostic coronary angiogram from in-patient and out-patient settings

Exclusion Criteria:

* History of prior CABG (Coronary Artery Bypass Surgery). CABG patients will be excluded due to inherent increased fluoroscopic time (finding grafts).
* Patients undergoing elective PCI (Percutaneous Coronary Intervention)
Protein Requirements in Male and Female Endurance Athletes

Protein is an essential macronutrient for post-exercise recovery through its ability to provide the amino acid building blocks that support increased rates of muscle and whole body protein synthesis.

Despite the growing understanding of the importance of post-exercise protein in endurance athlete populations, the impact of sex and female menstrual cycle phase on protein metabolism is not fully understood. To date, no studies have examined protein requirements in female endurance trained athletes.

The aim of the proposed study is to utilize the well-established IAAO method to determine protein requirements in endurance trained female and male athletes in a "real-world" and at-home setting.


Eligibility Criteria:
Inclusion Criteria:

* Healthy endurance trained runners. Total weekly running distance of greater than 50km/week and perform endurance exercise for more than 5 hours/week.
* Age 18-35 years old
* Eumenorrheic over last 3 months (one cycle no longer than 42 days and no shorter than 20 days).
* Not using hormonal contraceptives (the pill, implants and injections, hormonal intrauterine devices (IUDs), vaginal ring, skin patch).
* Do not have polycystic ovarian syndrome (PCOS) or other conditions effecting ovarian hormone regularity.
* Not pregnant within the past year.
* Must meet the classification of 'superior' aerobic power for their respective age category based on the ACSM criteria; (women age 20-29 years VO2max \>50ml/kg/min and women age 30-35 years VO2max \>46ml/kg/min) (men age 20-29 years VO2max \>56ml/kg/min and men age 30-35 years VO2max \>54ml/kg/min).

Exclusion Criteria:

* Inability to meet health and physical activity guidelines according to the CSEP 'Get Active' Questionnaire (Appendix G).
* Inability to adhere to study protocol requirements relating to diet and exercise (i.e. alcohol and caffeine consumption, training/exercise prior to beginning a study testing day).
* Regular use of tobacco and/or other recreational drugs/banned substances (i.e. growth hormone, testosterone, marijuana).
* Self-reported intentional or unintentional weight loss (past 6 months) or plan to lose weight (\>5-10kg).
* Amenorrhea (self-reported) in the past 3 months.
* Fewer than 6 menstrual cycles per year.
* Answering yes to any questions asked within the COVID-19 screening questionnaire until 14 days of being symptom free and/or having a negative COVID-19 test
Optimal Dose Escalation Strategy to Successful Achievement of High Dose Donepezil 23mg

This study evaluates the side effects of dose escalation in the treatment of donepezil 23mg for patients with Alzheimer's disease. Investigators randomly divide participants into three groups according to the dose escalation method; no titration, 15mg of donepezil for a month before escalation to 23mg, and alternating of 10mg and 23mg for a month before escalation to 23mg.

High dose of donepezil is currently prescribed for patients with Alzheimer's disease who showed poor response in lower dose, however the side effect profiles according to dose titration method were not clarified yet. This study aims to confirm which titration method would show better safeties and tolerabilities in the high dose donepezil treatment. Investigators include patients with moderate to severe dementia who were diagnosed as probable Alzheimer's disease and treated with donepezil 10mg at least 3 months before the study. The study duration is for 12 weeks and the titration duration is the first 4 weeks of the study. Investigators evaluate the side effects profiles and vital signs at every 4 weeks and measure blood laboratory tests at screening and the last visit.

Eligibility Criteria:
Inclusion Criteria:

* dementia according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV criteria
* probable Alzheimer's disease dementia according to National Institute on Aging-Alzheimer's Association (NIAAA) criteria
* Mini-Mental State Examination (MMSE) score of 20 or less
* General Deterioration Scale (GDS) score of 4 or more / Clinical Dementia Rating (CDR) score of 2 or more
* stable dose of 10mg donepezil at least 3 months before screening
* caregiver who can come together at every visit and give informations about side effects profiles should exist
* patients and caregivers accepted the study

Exclusion Criteria:

* patients receiving other concomitant acetylcholinesterase inhibitor
* uncontrolled psychiatric disorders
* drug overuse or alcohol abuse history within 5 years
* significant uncontrolled or active medical conditions
* uncontrolled epilepsy
* patients who cannot come at scheduled visits
EVEN - Effects of VR on Empathy for Nature in Patients with Psychosis and Depressive Disorders

Study group: Experimental study to evaluate empathy, compassion, and nature connectedness before and after an immersive virtual reality experience in patients with depressive disorder, patients with psychotic disorder and healthy control subjects (subjects between 18 and 65 years of age).

Primary hypothesis: The increase in nature connectedness explored by virtual body ownership of a tree in VR differs depending on the health condition (schizophrenia, depression, healthy controls).


Eligibility Criteria:
Inclusion Criteria:

* age: 18-65 years
* Inpatients and outpatients treated at the Psychiatric University Clinic of the Charité at St.

Hedwig Hospital

* diagnosis of depressive disorder (ICD-10: F32.X, F33.X) or diagnosis of schizophrenia (F20.X) or healthy controls without psychiatric diagnosis
* able to provide written informed consent

Exclusion Criteria:

* Acute suicidality or danger to others
* Primarily treatment-requiring eating disorder
* Acute dermatological condition affecting the hands that can distort skin conductivity measurements
* Control group: psychiatric or psychosomatic pre-diagnoses (except for the psychiatric active control group), other exclusion diagnoses corresponding to the patient group
Eccentric Training With or Without Elbow Brace for Epicondylitis

Lateral epicondylitis is a painful overuse condition also described as lateral elbow tendinopathy. As at the Achilles tendon or the patella tendon, lateral elbow tendinopathy has striking clinically and histologically similarities. As such, neovascularisation closely related to pain-mediating fibers are encountered. Eccentric painful exercise is of clinical use in Achilles and patella tendinopathy. We sought to evaluate the clinical effect of a painful eccentric training (supination and pronation) with or without a orthopedic elbow brace in lateral epicondylitis.

Two study arms are planned with both groups performed a home-based eccentric training using a Thera-Band Flex-Bar device. Supination and pronation are performed with each position on hold for 2s with 15 repetitions. This is repeated in three sets of 15 repetitions each twice daily. In other words, 6x15 repetitions of supination and pronation per day are suggested in the eccentric training using the Thera-Band Flex-Bar.

The combination group performs the same eccentric training. In addition, patients wear a orthopedic elbow brace (Epi-Hit) in order to overcome the elbow pain.

This is a clinical trial, thus pain reduction on a visual analogue scale is the primary outcome parameter. Evaluation will be performed after 12 weeks of intervention.

Eligibility Criteria:
Inclusion Criteria:

* lateral elbow tendinopathy
* 18-80 years informed consent

Exclusion Criteria:

* no elbow tendinopathy \<18 or \> 80 years no informed consent
Faecal Incontinence in Prostate Cancer Survivors Treated Whith Radiotherapy

The objective of the study is to determine the incidence of faecal incontinence in prostate cancer survivors treated with moderately hypofractionated radiation therapy and correlate the dose received by the anal sphincter with the degree of faecal incontinence.

The investigators know that high doses of irradiation in the anal sphincter are associated with more chronic fecal leaks in survivors irradiated by normofractionated radiotherapy prostate cancer.

The safe dose of irradiation of the anal sphincter with radiotherapy modern techniques (volumetric modulated arc therapy with moderately hypofracctionation) is unknown.

Urgency and faecal incontinence greatly affects the quality of life of these patients.

Therefore, it is interesting to implement strategies to protect the anatomical structures involved in fecal continence.

The objective of the study is to determine the incidence of faecal incontinence in prostate cancer survivors treated with modern moderately hypofractionated radiation therapy and correlate the dose received by the anal sphincter with the degree of faecal incontinence.

The investigators also want to evaluate the quality of life of these patients

Eligibility Criteria:
Inclusion Criteria:

* Prostate cancer survivors treated in our department by hypofractionated radiotherapy

Exclusion Criteria:

* Relapse of prostate cancer
* Other active cancer
* Mental disorder