cyrilzakka/clinical-trials huggingface dataset:
Transcutaneous Auricular Vagal Nerve Stimulation for Functional Dyspepsia With Sleep Disturbances: a Randomized Controlled Trial

Functional dyspepsia(FD) is most common in functional gastrointestinal disorders whose rick factors include sleep disturbances. The medication treatment for functional dyspepsia with sleep disturbances has disadvantages such as addiction and withdrawal symptoms. Transcutaneous auricular vagal nerve stimulation(taVNS) is a new therapeutic method to improve dyspepsia and sleep. Study on taSNS for FD with sleep disturbances has not yet been explored.

Functional dyspepsia (FD) is most common in functional gastrointestinal disorders whose risk factors include sleep disturbances. The medication treatment for FD with sleep disturbances has disadvantages such as addiction and withdrawal symptoms. Transcutaneous auricular vagal nerve stimulation (taVNS) is a new therapeutic method to improve dyspepsia and sleep. The study on taVNS for FD with sleep disturbances has not yet been explored.60 participants who have FD and sleep disturbances are recruited from the department of the Second Affiliated Hospital of Xi'an Jiaotong University. Inclusion criteria follows: meeting the ROME IV diagnostic criteria of FD; Pittsburgh Sleep Quality Index(PSQI)\>7; aged 18-65 years old; not taking related drugs in past one month; from March 2022 to June 2023; sign informed consent. All patients were randomly divided into 2 groups and respectively treated with taVNS and sham-taVNS for four weeks. PSQI, Nepean dyspepsia index (NDI), electrogastrogram (ECG), nutrient drinking satiety test, Hamilton Anxiety and Depression Scale, heart rate variability (HRV) and serum melatonin (MLT) were recorded at baseline and after 4-week treatment. The effect and mechanism of taVNS for FD with sleep disturbances were investigated by comparing the indexes before and after treatment of taVNS and sham-taVNS groups. The study was proved by the medical ethics committee of the Second Affiliated Hospital of Xi'an Jiaotong University.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of Functional bloating/distension with Rome IV;
2. Pittsburgh Sleep Quality Index(PSQI)\>7;
3. Aged 18-65 years old；

Exclusion Criteria:

1. Have taken drugs that may affect gastrointestinal motility and sleep in the past two week;
2. The history of gastrointestinal surgery;
3. With severe heart, liver and kidney diseases;

5.Pregnant and breastfeeding women; 6.Skin allergies.
The Efficacy of the no!no!Back for Chronic Low Back Pain

This pilot study is designed to evaluate the efficacy of the no!no!Back continuous passive motion device in relieving of mild to moderate non-specific low back pain.

The no!no!Back is an electrically operated, continuous passive motion device including a platform that performs angular oscillations. The device is intended to be used at home as an accessory for relieving of mild to moderate low back pain (LBP).

This study is designed to determine the efficacy of daily use home use with the no!no!Back device during 3 weeks and to assess the sustained effect 3 weeks later. Up to 30 subjects will be randomized to either an immediate treatment (IT) group that will receive the no!no!Back device at the baseline visit, or to the wait-list control (WLC) group that will receive the device 3 weeks later. The evaluation will include level of pain using the numerical rating scale (NRS), functional health status by Oswestry disability index (ODI), and subject satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 18 or more
* Level of pain - mild to moderate low back pain (≤5 NRS pain)
* Chronic - symptoms must have been present for at least 12 weeks or more.
* Location - lower tip of scapula to back of pelvis
* Etiology - non-specific

Exclusion Criteria:

* Patients who have low back pain due to specific and known etiological causes (infection, tumor, osteoporosis, ankylosing spondylitis, fracture, inflammatory process, radicular syndrome, cauda equinal syndrome).
* Pregnant or lactating
* Recent history of violent trauma
* History of previous back surgery
* Constant progressive, non mechanical pain (no relief with bed rest)
* Chronic pain other than low back pain
* Past medical history of malignant tumour
* Has taken an investigational drug within the past 30 days prior to entering the study, or currently enrolled in another investigational study
* Mental disorder that would lead to difficulty in questionnaire completion
* Current or future litigation for low back pain
* Prolonged use of corticosteroids
* Physical disability that prevents the subject to lie down/get up
* Drug abuse, immunosuppression, HIV
* Any other condition which in the physician's opinion would make it unsafe for the subject to be treated.
Diastolic Ventricular Interaction and the Effects of Biventricular Pacing in Hypertrophic Cardiomyopathy

The primary aim of this study will be to assess whether Biventricular pacing improves exercise capacity, and Quality of Life in patients with symptomatic drug resistant Non-Obstructive Hypertrophic Cardiomyopathy, using a Biventricular pacemaker.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic Hypertrophic Cardiomyopathy,

Exclusion Criteria:

* Rhythm other than normal sinus Left ventricular outflow tract gradient greater than 30mmHg Inability to exercise v02 max greater than 70% of predicted.
Skeletal Muscle Wasting in ICU Patients

Muscle wasting occurs rapidly in critically ill patients and impacts both short and long term outcomes. Altered protein metabolism drives muscle loss in ICU patients, with muscle protein breakdown exceeding muscle protein synthesis (MPS). Interventions aimed at attenuating muscle loss by stimulating MPS rates are hampered by a lack of knowledge on altered muscle protein turnover rates during critical illness. Only a few studies have specifically assessed muscle protein synthesis by using contemporary intravenous stable isotope infusions, which allows the assessment of MPS over a short (\<9 hours) period of time. Results from such acute studies can be difficult to extend or translate into long-term clinical practice and outcomes. Oral deuterated water (2H2O) dosing provides an alternative method that can be utilized to extend the measurement of muscle protein synthesis over a period of several days or weeks. It could therefore provide a valuable tool to study muscle protein synthesis during ICU admission and the impact of different anabolic interventions. Although multiple studies using the deuterated water methodology have been performed in both healthy volunteers and patients, it has not yet been performed in critically ill patients.

In this prospective study the investigators aim to assess fractional rates of muscle protein synthesis over a period of (maximal) 7 days in critically ill patients admitted to the intensive care unit. Secondly, the investigators aim to assess mechanisms of acute muscle wasting on an microscopic, ultrastructural and molecular level. Furthermore, the investigators aim to investigate to what extent muscle fibre size is recovered 3 months after ICU discharge.


Eligibility Criteria:
Inclusion Criteria:

* age \>18y
* admitted to ICU
* enteral nutrition line in situ
* arterial line (any location) in situ
* expected stay ICU \>7d

Exclusion Criteria:

* spinal cord injury
* chronic use of corticosteroids before hospital admission
* Contraindication to enteral infusion (e.g. due to GI-tract perforation)
* Kidney or liver failure
* therapeutic anti coagulation
GnRH Agonist Plus Hormone Replacement Therapy vs Hormone Replacement Therapy on IVF Outcomes

The study is conducted at Arash Women's Hospital on all women undergoing the frozen embryo transfer cycle. Patients who signed informed consent will be randomly divided into two groups. The first group will receive GnRH agonist plus hormone replacement therapy for endometrial preparation. Group 2 will receive hormone replacement therapy. The random allocation and final outcome of the study will be assessed by a person who is unaware of the study process. Also, the statistician will be unaware of the study process


Eligibility Criteria:
Inclusion Criteria:

The first or second cycle of embryo transfer Normal uterine cavity PCO diagnosis based on Rotterdam criteria and correction (2018) Age 20 to 40 years

Exclusion Criteria:

Infertility with severe male factor endometriosis immunological disease FSH higher than 10 BMI greater than or equal to 30 Endometrial thickness on the day of transfer is less than 7 mm History of recurrent miscarriage
Phase II Trial of Allovectin-7® for Metastatic Melanoma

The purpose of this clinical trial is to determine if Allovectin-7®, an experimental gene-based immunotherapy, can shrink melanoma tumors. The trial will also examine if this treatment can improve the time to disease progression.

Treatment - If you take part in this trial you will be treated for about 10 weeks. You will receive an injection of Allovectin-7® by needle, directly into one or more selected tumors once a week for the first six weeks. The injections may be given in a doctor's office. During a four-week observation period, your disease will be measured to see if the treatment is working. This will be done by general physical exams and scans (such as X-ray scans). Patients who show no sign of disease progression may be offered an option to repeat this treatment course.

Eligibility Criteria:
In order to be in this trial, you must meet the enrollment criteria. Below is a list of some of the enrollment criteria.

* You have been diagnosed with Stage III or Stage IV melanoma
* Your cancer has returned after a prior treatment (e.g. radiation or chemotherapy) or you refused therapy with standard treatment
* You are able to carry out your normal daily activities
* Your melanoma has not spread to your brain
Evaluation of Changes in Pancreatic Fat Content Using Advanced MR Sequences in Diabetics on Dapagliflozin Therapy

The study aimed to assess changes in pancreatic fat content in people with diabetes on dapagliflozin (SGLT2 inhibitor) and beta cell function.

The study assessed and estimated the difference in pancreatic fat content in the patients of Type 2 Diabetes Mellitus at baseline and after taking dapagliflozin for 24 weeks.

The investigators even estimated the correlation between two advanced MR techniques commonly used for quantification of pancreatic fat (PDFF and MR Spectroscopy)

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years,
2. Hba1c 7-11%,
3. Renal function (MDRD) \> 30 ml/min, on glucose-lowering therapy {metformin, sulfonylureas, glinides, dipeptidyl peptidase-4 (DPP-4) inhibitors, or basal insulin} at a stable dose for at least 3 months.

Exclusion Criteria:

1. Uncontrolled hyperglycemia at screening (fasting blood glucose FBG ≥ 240 mg/dL).
2. Diabetes other than type 2 diabetes
3. Age younger than 18 years.
4. Pregnant patients or lactating.
5. Patients who refuse to give consent to be enrolled in the study.
6. Any contraindication to magnetic resonance imaging.
7. More than 5% total body weight loss within the last month.
8. Patients with moderate or severe renal impairment
9. Any contraindication to SGLT2i
10. Prior SGLT2i within the past 3 months
Reducing Older Adults' Sedentary Behavior by Self-monitoring

The first aim of this study is to gain insight into older adults' perceptions towards a self-monitoring tool aimed at the reduction of sedentary behavior. Secondly, this study aimed to investigate the preliminary efficacy of a self-monitoring tool aimed at the reduction of sedentary behavior.

A mixed-method study will be conducted to assess participants' perceptions and preliminary efficacy of a self-monitoring based intervention aimed at the reduction of sedentary behavior in older adults (\> 60 years).

A convenience sample of 40 older adults will be recruited using Facebook advertisements, as well as from an existing database of older adults willing to participate in research studies.

Older adults who agree to participate will be contacted by phone to make an appointment for a visit. During this first visit, participants will receive an informed consent. After signing the informed consent, a structured interview will be conducted to assess the participants' socio-demographic characteristics, domain-specific sedentary behavior and health status. A semi-structured interview will be conducted to examine participants' perceptions towards (reducing) sedentary behavior. Moreover, an inclinometer will be attached to the participants' thigh. Participants will be instructed to wear the inclinometer for one week. After one week, a researcher will visit the participants once again to collect the inclinometers. During this second visit, participants will receive a self-monitoring tool (i.e. the Activator) aimed at the reduction of sedentary behavior. Participants will be able to use the self-monitoring tool for four weeks. Apart from that, participants will receive a booklet with general sedentary behavior information and an explanation on how to use the self-monitoring tool. By the end of the intervention, the self-monitoring tools will be collected, and participants will be instructed to answer another structured interview and to wear the inclinometer for another week. At the end of this week, inclinometers will collected, and a semi-structured interview will be conducted with the older adults of the intervention group to gain insight into their experiences with self-monitoring as a behavior change technique to reduce sedentary behavior, as well as with the Activator.

Eligibility Criteria:
Inclusion Criteria:

* be at least 60 years old
* be Dutch-speaking
* be able to walk 100 meters without severe difficulties
* have a smartphone

Exclusion Criteria:

- having functional limitations to stand up
The Effect of Clindamycin and a Live Biotherapeutic on the Reproductive Outcomes of IVF Patients With Abnormal Vaginal Microbiota

Study question: Does antibiotic alone or in combination with live biotherapeutic treatment of an abnormal vaginal microbiota improve the reproductive outcomes of IVF couples?

Study hypothesis:

The investigator hypothesize that treatment of the reproductive tract pathogens and restoration of vaginal Lactobacillus will improve the reproductive outcomes of IVF patients.

What is known already? Ultra-deep sequencing methods enable the refinement of reproductive tract microbiology in infertile patients. A recent meta-analysis reported that 19% of infertile patients had abnormal vaginal microbiota Moreover, someone have detected the presence of a Gardnerella (G.) vaginalis dominated endometrial biofilm in 50% of non-infertile patients with abnormal vaginal microbiota undergoing curettage; thus the treatment of such an endometrial biofilm might play an important role for the endometrial receptivity and subsequently the clinical pregnancy rate.

Pilot study: In a recent pilot study it was observed that an abnormal vaginal microbiota negatively affects the clinical pregnancy rate in IVF patients. In this study the prevalence of abnormal vaginal microbiota was 28% (36/130) and only 9% of patients with qPCR defined abnormal vaginal microbiota obtained a clinical pregnancy (p=0.004). This association remained significant in an adjusted analysis. Furthermore, the invetigators have preliminary results demonstrating that vaginal bacteria such as G. vaginalis can be found in the endometrium of IVF patients, which is also supported by recent publications

What is the novelty of this study? To the investigators knowledge, no previous treatment study of abnormal reproductive tract microbiota has been performed in IVF patients; this relatively small intervention holds the potential to increase the baby-take-home rate after IVF treatment.


Eligibility Criteria:
Inclusion Criteria:

* Abnormal vaginal microbiota.
* The screening swab should be repeated if more than 3 months old.
* HIV, Hepatitis B or C positivity.
* First, second or third IVF stimulation cycle or embryo transfer therefrom.
* BMI\<35
* Written informed consent.

Exclusion Criteria:

* Known or suspected hypersensitivity to clindamycin.
* HPV CIN 2 or higher.
* Former or current inflammatory bowel disease
* Severe concomitant disease, including diabetes.
* MAX 2 embryos may be transferred
* Artificial heart valve
* Intrauterine malformations with operation indication as determined by treating physician (Polyps, Septum, fibroma)
Metastases of Cutaneous Squamous Cell Carcinoma in Organ Transplant Recipients. The "SCOPE-ITSCC Metastases Study"

The investigators hypothesize that a low number of SCC in OTR will metastasize.

In a large international multicenter prospective observational study a total number of 1000 OTR (organ transplant recipients) with a histologically proven cutaneous SCC (squamous cell carcinoma) will be included in 10 centers and followed during 2 years to establish the cumulative incidence of metastases in OTR with cutaneous SCC.

Eligibility Criteria:
Inclusion criteria:

* Organ-transplant recipients (OTR).
* Histologically proven cutaneous invasive SCC at time of inclusion

Exclusion criteria:

* Lack of consent.
* History of metastases of cutaneous SCC
CONNECT Trial of eSupport Online Health-coach Moderated Support Groups for Multiple Sclerosis

Within-subject waitlist-control group design trial of eSupport health-coach moderated online support group participation to address mental health needs in persons with multiple sclerosis (PwMS) from historically underrepresented groups (i.e., Black and Latinx patients).

The purpose of this research is to see how well a new online eSupport Health Weekly Group Sessions program addresses the needs and improves the mood of adults with MS. This study is focusing on improving the online eSupport Weekly Group Session program for people with MS while assessing the impact of the program, particularly for Black and Latinx individuals as clinical research has often not included their experience.

The entire study is done remotely by computer, tablet, or smartphone with a web camera and with a stable internet connection. Subjects will be enrolled into closed, private, health-coach facilitated online support groups called eSupport Health Weekly Group Sessions. These sessions are hosted on eSupport Health's proprietary Zoom-based secure HIPAA-compliant telehealth platform. Each group is expected to have 10 participants and will meet weekly for 12 weeks. A licensed therapist ("Study Coach") leads the group sessions. The company's Mutual Respect \& Trust (MRT)-based coaching method is utilized.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form (ICF)
* Able to speak, read and understand English
* Reside in the U.S.
* Willingness to enroll as a member in eSupport Health
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Willingness to adhere to the schedule of weekly online meetings with a minimum of 50% attendance (i.e., 6 of 12 meetings)
* Males and females; Age 18+
* Self-reported diagnosis of multiple sclerosis including the date of the diagnosis (month and year) and the name of the diagnosing physician
* Access to necessary resources for participating in a technology-based intervention (i.e., computer or tablet with a web camera and with a stable internet connection in a private setting) and demonstrated basic ability to use a computer by completing the electronic ICF completion process and meeting with the Study Coach via Zoom Telehealth secured platform at the Enrollment Session.
* Provide identification to verify name, date of birth, and address.

Exclusion Criteria:

1. Current participation in another treatment or intervention study
2. Presence of a condition(s) or diagnosis, either physical or psychological that precludes participation such as significant brain injury and developmental disability
3. Current suicidal intent
4. Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
Causes and Patterns of Anterior Cruciate Ligament Injuries Among Egyptian Population

The aim of work is to detect the patterns and the causes of ACL injury among Egyptian population and to identify its risk factors. Identify the male to female ratio of injuries in our community. To document the patterns and frequencies of associated injuries

The ACL (Anterior Cruciate ligament) is one of the most frequently injured ligaments of the knee, with a prevalence estimated to be 1 in 3000 in the US (greater than 120000 cases annually). ACL injury frequently affects young, active individuals. It is also frequently associated with other structural injuries in the Knee joint like meniscal tears and multi-ligamentous injuries. ACL injury leads to increased laxity in the knee, predispose the knee to subsequent injuries and early onset osteoarthritis of the knee.

Sports related trauma is the commonest cause of ACL rupture. Females are reported to have 2 to 10-fold higher risk of injury than males playing the same sport. According to previous studies at Assuit University Hospital the impression was that the ACL injuries are more common in males than females. Additionally, non-sports injuries like motor cycle accidents and domestic injuries are expected to be a major cause of ACL rupture, besides sports injuries, among Egyptian population.

Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed ACL injury

Exclusion Criteria:

* Patients with ACL injury associated with fracture at the same limb
Phase I Study to Assess the Absorption, Metabolism, and Excretion of [14C] Labeled SPN-810M

An Open-Label, Single-Dose, Mass-Balance Study to Assess the Absorption, Metabolism, and Excretion of Radio Labeled SPN-810M in Healthy Adult Male Volunteers


Eligibility Criteria:
Key Entry:

1. Healthy males.
2. Aged 30 to 55 years.
3. Considered medically healthy by the Investigator via assessment of physical examination, medical history, clinical laboratory tests, urinalysis, vital signs, and electrocardiogram.
4. Able to voluntarily provide written informed consent to participate in the study.