cyrilzakka/clinical-trials huggingface dataset:
Combined Transcranial Magnetic Stimulation and Therapy for MTBI Related Headaches

This study will assess the combined effectiveness of repetitive transcranial magnetic stimulation (rTMS) and telehealth based therapy in helping manage mild traumatic brain injury (mTBI) related headaches. The investigators hypothesize that active rTMS combined with telehealth therapy will provide marked reduction in mTBI related headaches and symptoms in comparison to their placebo counterparts.

This study will be enrolling a total of 240 veterans or active military over a 4 year period at the VA San Diego Healthcare System (VASDHS). Participants will be randomized into one of four groups:

Group A: active rTMS with telehealth headache management therapy Group B: active rTMS with telehealth headache education control Group C: sham rTMS with telehealth headache management therapy Group D: sham rTMS with telehealth headache education control

Individual participation will consist of 19 visits to the VASDHS and 11 telehealth sessions over the course of 6-7 months. The in person visits will be divided into the following phases:

1. PRE-TREATMENT ASSESSMENTS PHASE (weeks 1-2) which consists of Visit 1 (Screening Visit) and Visit 2 (Baseline Assessments with MRI scan);
2. INDUCTION TREATMENT PHASE (weeks 3-4) consists of Visits 3-12 (10 weekday neuronavigation guided rTMS sessions at \>24 and \<72 hours apart); and
3. POST-TREATMENT ASSESSMENTS AND MAINTENANCE TREATMENT PHASE (weeks 5-24) consists of 4 initial biweekly post-induction treatment assessments and maintenance treatments (Visits 13-16)) and two additional monthly post-induction assessments and maintenance treatments (Visits 17-18) and one final study visit (Visit 19).

Eight weekly telehealth therapy/education sessions will be conducted from week 3 to 10 with additional three bolster sessions at 4 weeks apart. During the baseline and follow up visits, assessments will be conducted to evaluate headaches, neurobehavioral symptoms, depressive symptoms, post-concussion symptoms, and quality of life.

Eligibility Criteria:
Inclusion Criteria:

1. Mild Traumatic Brain Injury (mTBI)
2. Chronic headaches \> 3 months after injury
3. Aged 18-65
4. No prior TMS treatment
5. Persistent Headaches with an intensity \> 30 / 100
6. No history of daily headache prior to mTBI

Exclusion Criteria:

1. Pregnant
2. Pacemaker or any metal in body that would prevent MRI
3. History of dementia or major psychiatric disease, such as bipolar disorder or schizophrenia
4. Presence of any other chronic neuropathic pain states
5. History of seizure
6. Pending litigation
7. Can't understand English
8. History of chronic headache like migraine prior to mTBI
9. Evidence in chart of exacerbation of depressive/anxiety symptoms, active substance dependence, suicidal intent or attempt within previous month
IL-11 in Women With Von Willebrand Disease and Refractory Menorrhagia

The purpose of this study is to determine the efficacy and safety of rhIL-11, when given subcutaneously for six consecutive months, in reducing menstrual blood loss in women with type 1 von Willebrand disease and refractory menorrhagia. Efficacy will be measured by subjective bleeding severity scale and pictorial bleeding chart. Safety will be measured by the frequency of adverse events, including fever, headache, fatigue, myalgias, arthralgias, fluid retention, or edema.

This study is a prospective, single-center Phase II trial of Neumega (rhIL-11) in women with type 1 VWD and menorrhagia refractory to estrogen, hormones, or hemostatic agents. It is anticipated that 10 subjects who meet eligibility criteria will enroll and complete this study. All aspects of this study, including the rhIL-11 injections and the screening, hemostatic and safety monitoring, and coagulation testing, are considered experimental. The specific objectives are to determine the efficacy and safety of rhIL-11 in reducing menstrual blood loss in adult women with type 1 VWD during six consecutive menstrual cycles, and to determine the mechanism of the hemostatic response of rhIL-11.

Eligibility Criteria:
Inclusion Criteria:

* Females 18-45 years of age
* Confirmed type 1 VWD, as defined by low VWF:RCoF or low VWF:Ag and qualitatively normal VWF multimers
* Menorrhagia refractory to estrogens, hormones, hemostatic agents
* Willingness to have blood drawn

Exclusion Criteria:

* Use of immunomodulatory or experimental drugs, or diuretics
* Pregnant or lactating women or those unwilling to use contraception during study
* Previous cardiac disease, congestive failure, arrhythmia (e.g., atrial fibrillation, atrial flutter), hypertension, MI, stroke, or thrombosis
* Past allergic reaction to Neumega or DDAVP
* Surgery within the past 8 weeks
* Inability to comply with study protocol requirements
* Concomitant use of antiplatelet drugs, anticoagulants, dextran, aspirin or NSAIDs
* Treatment with DDAVP, cryoprecipitate, whole blood, plasma and plasma derivatives containing substantial quantities of FVIII and/or VWF within five days of study
Conditioned Pain Modulation Using Painful Cutaneous Electrical Stimulation or Simply Habituation?

Painful cutaneous electrical stimulation (PCES) and corresponding evoked potentials led to a significant pain relief and decrease of evoked potentials and has been used to analyze conditioned pain modulation (CPM). However, it is unknown whether the pain relief results from habituation to the repeated painful electric stimulation. We compared the effects of CPM and habituation on PCES-induced pain and PCES-evoked potentials and analyzed whether increased attention by a random change of electric intensities amplifies the habituation effects.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* any kind of disease
A Single-arm, Open-label Clinical Study to Evaluate the Efficacy and Safety of VRT106 in Combination with Chemotherapy for Resectable Pancreatic Cancer

This is a single-center, single-arm, open investigator-initiated clinical study to evaluate the efficacy and safety of VRT106 in combination with chemotherapy in the treatment of resectable pancreatic cancer.

This is a single-center, single-arm, open investigator-initiated clinical study to evaluate the efficacy and safety of VRT106 in combination with chemotherapy in the treatment of resectable pancreatic cancer.

The study is planned to enroll 18 subjects. The entire study consists of a screening period of up to 28 days, treatment period, and a follow-up period (safety follow-up 28 days after the final study dose and survival follow-up once every 3 months).

Eligibility Criteria:
Inclusion Criteria:

1. Subject voluntarily agrees to participate in this study and signs an Institutional Review Board -approved informed consent prior to performing any of the Screening Visit procedures.
2. Males and females at 18-75 years of age, inclusive, at the Screening Visit.
3. Have a clinical diagnosis of pancreatic cancer.
4. An Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
5. Expected survival time of≥6 months.
6. No serious hematologic and cardiac abnormalities of the liver, kidneys, or coagulation functions.

Exclusion Criteria:

1. Prior treatment with other oncolytic virus or systemic therapy for pancreatic cancer.
2. Previous allogeneic hematopoietic stem cell transplantation or organ transplantation.
3. Immunocompromised patients.
4. Known alcohol or drug dependency.
5. Women who are pregnant or breastfeeding.
A Study of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease

The purpose of this study is to determine if PRT-201 when applied to a limited segment of your blood vessel (about 2 inches) immediately after surgery to create an arteriovenous fistula is safe and improves the patency of your fistula. PRT-201 is a protein that has been shown to help keep vessels open ("patent") when applied to the outside surface of the blood vessels (arteries and veins) in AVF patients in a previous study.


Eligibility Criteria:
Inclusion Criteria:

1. Age of at least 18 years.
2. Life expectancy of at least 6 months.
3. Chronic kidney disease on hemodialysis, or with anticipated start of hemodialysis within 6 months.
4. Planned creation of a new radiocephalic or brachiocephalic AVF. Revisions of an existing AVF and transposed AVF are not acceptable.

Exclusion Criteria:

1. History or presence of an arterial aneurysm.
2. Malignancy or treatment for malignancy within the previous 12 months with the exception of the following cancers if they have been resected: localized basal cell cancer, squamous cell skin cancer, or any cancer in situ.
3. Hepatic dysfunction defined as bilirubin, ALT \[SGPT\] or AST \[SGOT\] \>2.5 times the upper limit of normal, decompensated cirrhosis, ascites, or known esophageal or gastric varices.
4. Treatment with any investigational drug within the previous 30 days or investigational antibody therapy within 90 days prior to signing informed consent.
The Hope App Study

This research study will test how a computer program (called the Hope App) teaches diabetes care skills for older adults with diabetes. The study will compare those who receive diabetes education (10 educational modules and monthly health coaching) through the research program with those who receive care as usual.

The Hope App offers a simple, high-impact, engaging, and immersive telehealth experience with the potential to become a ubiquitous diabetes management tool to transform diabetes patients into high performing drivers of their own care.

The research team aims to scale the platform, develop features that are important to aging adults, and run a clinical trial to validate the Hope App's health benefits.

* Specific Aim 1: Develop the Hope App's state-of-the-art immersive patient engagement experience with automated onboarding, social networking and gamified DSME/S features to support long-term patient retention. In doing so, usability testing will be performed to ensure patient-facing features on the platform and patient-facing content and curriculum materials are functioning and well received by participants.
* Specific Aim 2: Develop the Hope App's predictive analytic capabilities for population health management.
* Specific Aim 3: Conduct a clinical validation trial of the Hope App intervention on six-month clinical outcomes (Hemoglobin A1c), patient reported outcomes (diabetes distress) and engagement outcomes (patient retention, adherence to self-care behaviors).

The research team intends to deliver a scalable Hope App platform with a usable patient engagement portal designed for older adults and achieve decreases in blood glucose levels (HbA1c) and depressive burden, and sustained patient engagement.

Eligibility Criteria:
Inclusion Criteria:

* aged 65 years and above
* diagnosis of type 2 diabetes
* English-speaking
* baseline blood sugar value (HbA1c) of 7.5%
* Internet access

Exclusion Criteria:

* aged less than 65 years
* non English-speaking
* unable to provide informed consent
* diagnosis of type 1 diabetes
* unable to use a computer or mobile device
* medical condition for which participation is contraindicated (dialysis, pregnancy, use of insulin pump)
Acupuncture to Treat Cancer-Related Fatigue in Breast Cancer Patients

This study will evaluate if acupuncture is helpful in treating cancer-related fatigue in breast cancer patients undergoing radiation therapy.

Each participant will have a baseline visit before her radiation therapy begins to complete questionnaires. Participants will receive either true acupuncture or sham acupuncture twice per week for the six weeks of radiation therapy. She will have a short questionnaire at three weeks into her radiation, and she will complete questionnaires again at the end of her radiation and four weeks later.

Eligibility Criteria:
Inclusion Criteria:

* Localized breast cancer
* Average to above average fatigue
* Planning radiation therapy

Exclusion Criteria:

* History of acupuncture treatment
* Allergy to stainless steel
* Pacemaker
* Anticoagulant therapy
* Known bleeding disorder
* Metastatic breast cancer
* Seizure disorder
Intense Pulsed Light Study for Dry Eye Disease

This study will evaluate the efficacy of intense pulsed light (IPL) therapy for the treatment of dry eye disease. One eye of the participant will be randomized to receive the IPL treatment.

Dry eye disease (DED) affects tears and the front surface of the eye. Patients who have DED can experience symptoms of discomfort, blurry vision, redness, and pain. DED can also cause tears to become unstable which could result in damage to the front surface of the eye.

There are two types of DED. The one the investigators are studying is called evaporative dry eye disease. This type of DED occurs because the pores on the eyelids are not functioning properly. In preliminary studies, a new treatment called Intense Pulsed Light (IPL) has shown promise to reduce signs and symptoms of evaporative DED. IPL is a non-invasive and non-laser light treatment that was approved in 1995 by the FDA for dermatology. It is commonly used for treatment of facial rosacea, acne, and hair, wrinkle and lesion removal. It is not currently approved for the treatment of dry eye disease. This treatment is thought to provide relief of evaporative DED symptoms and improve the expression of the pores on the edge of the eyelid.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide informed consent;
* Diagnosed with evaporative dry eye disease with symptoms for 6 months or more;
* Able and willing to comply with follow-up visits, phone calls and intense pulsed light treatments;
* Agree to using an effective method of birth control during the course of the study;
* Agree to continue current dry eye treatments during the course of the study;
* Fitzpatrick skin scale of 1 (very fair) to 4 (olive) as determined by an investigator.

Exclusion Criteria:

* Darker skinned individuals defined by the Fitzpatrick scale 5 and 6 as determined by an investigator;
* Neurotrophic keratitis;
* Ectropion, trauma, or any other lid abnormalities;
* Previous diagnosis of Stevens Johnson syndrome or graft versus host disease;
* Ocular burn, active ocular infection, or active ocular inflammation;
* Currently pregnant or trying to become pregnant in the next 5 months;
* Systemic conditions or currently taking medications which makes light therapy contraindicated (the use of doxycycline is allowed);
* Tattoos in the treatment area;
* Patients who have had intense pulsed light therapy, Lipiflow or Meibothermoflo within the past six months;
* Contact lens wear more than one time/week or history of refractive surgery;
* Glaucoma drop use
* Ophthalmic steroid use within the past 30 days;
* Punctal plugs if instilled within 30 days of the start of the study;
* Obvious asymmetry between the two eyes deemed significant by the investigators (such as punctal plugs or cautery in only one eye, etc);
* History of a trabeculectomy or tube surgery;
* Uncontrolled ocular or systemic disease;
* Ocular or eyelid surgery within the last 6 months;
* Any condition which leads the investigator to believe that the patient cannot comply with the study requirements and/or the patient may be placed at risk with participation.
Cross Iron (Comparative Randomized Oral Versus Systemic IRON)

Patients were recruited at the scheduled preoperative visit for hip or knee arthroplasty. If the haemoglobin (Hb) level was below 13 g/dl with no contraindication to iron supplementation the patients were randomized to the oral or intravenous (IV) group. The oral group received 160 mg ferrous glycine sulfate daily during the month prior surgery, associated with 3 epoetin alpha (EPO) injections (40 000 IU subcutaneous on day - 21, day - 14 and day-7). The IV group received ferric carboxymaltose 1000 mg IV in 15 minutes one month before surgery, associated with 3 EPO injections. Primary efficacy endpoint was the change in Hb level from the day of the preoperative visit to the day before surgery (day-1). Secondary endpoints comprised the Hb level on day 3 and 5 after surgery, allogenic transfusion during and after surgery, and the change in iron indices from the day of the preoperative visit to day - 1.


Eligibility Criteria:
Inclusion criteria:

* unilateral prothetic orthopaedic surgery scheduled
* age \> 18
* weight \> 50 kg
* hemoglobin rate: 10 g/dl ≤ Hb \<13 g/dl

Exclusion criteria:

* bilateral arthroplasty
* EPO contraindication
* generalized infection
Access to Chiropractic Care During the COVID-19 Healthcare Emergency in Spain

This is a pragmatic controlled clinical trial taking place in the first phase of COVID-19 lockdown re-opening in Spain. Patients of 52 chiropractic clinics were invited to participate in a pseudo-random order (one out of every three contacted patients) as they were contacted to either schedule an appointment with their current chiropractor or not, depending on the clinic's and the patient's availability. Patients would receive chiropractic in-person care (one or more than one visits) or no care at all, for a two-week period. According to the care received, they were assigned to one of three groups (receiving no care, receiving care once, and more than once). Participants filled an online questionnaire with self-reported outcome-measures at the beginning of the two week period. A follow-up questionnaire was completed 14 days after.


Eligibility Criteria:
Inclusion Criteria:

* chiropractic patients active when lockdown was declared, over the age of 14

Exclusion Criteria:

* new patients in the clinic, patients with no current pain at the time of the trial
Double-blind Comparative Study of E3810 Tablets (10 or 20 mg b.i.d.) to Evaluate Efficacy and Safety in Patients With Refractory Reflux Esophagitis

The purpose of this study is to evaluate the efficacy and safety of E3810 tablets in patients with Proton Pump Inhibitor-resistant reflux esophagitis.

This is a multicenter, randomized, double-blinded study. The efficacy with E3810 20 mg once daily is compared with E3810 20 mg twice daily and 10 mg twice daily using endoscopic recovery. The frequency of adverse event, etc., will be compared among 3 groups for safety assessment.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have mucosal breaks (erosions, ulcers) on endoscopy and are diagnosed with reflux esophagitis.
* Proton Pump Inhibitor standard dose-resistant reflux esophagitis.
* Patients who are 20 years and older when informed consent is obtained.

Exclusion Criteria:

* Patients with a concurrent severe illness, serious heart disease, comorbid severe disease such as hematology, kidney disease, or liver disease.
* Patients with malignancy.
* Patients who are taking another trial drug or the interval between the end of treatment and screening is less than 12 weeks.
S. Aureus, Skin and Soft Tissue Infections

Methicillin-resistant Staphylococcus aureus (MRSA) is reported as one of the main causative pathogen of community acquired SSTIs. In the USA, high prevalence of MRSA among Skin and soft tissue infections (SSTIs) is known to be due to the spread of the USA300 clone \[Moran et al. 2006\]. Among S. aureus SSTIs infections in Europe, data regarding the prevalence of MRSA in SSTIs and the causative genotypes remain scarce. The paucity of literature on the prevalence of MSSA, MRSA and PVL-producing S. aureus strains in SSTI in Europe is probably due to the fact that culture and antimicrobial susceptibility testing is not a routine component of SSTI management.

Setting-up a prospective multi-centre study involving patients presenting to emergency departments with SSTIs in several European countries would allow drawing a picture on the role and the respective contribution of MSSA, MRSA and PVL-producing S. aureus strains as a cause of SSTIs. However, the roles of emergency rooms and local policies with regard to performing microbiological analysis after surgical drainage of SSTIs vary between countries.

In order to evaluate the feasibility of such multicenter European study, we aim at performing a pilot study based on few European clinical laboratories (five to seven) which will: i) evaluate the prevalence of MSSA, MRSA and S. aureus PVL-positive strains in community-acquired SSTIs; and ii) determine molecular characteristics of the isolated strains. The main objectives of this pilot study are to collect some preliminary information on the role of S. aureus in SSTIs and to determine factors that need to be harmonized or taken into consideration for the set-up a larger prospective cross-sectional study involving more European countries with several centers per country to cover different geographical areas per country.


Eligibility Criteria:
Inclusion Criteria:

- All patients (adults and children) presenting to emergency department with purulent skin and soft tissue infections (SSTIs) of less than one week duration are eligible

Exclusion Criteria:

- Patients (adults and children) presenting to emergency department with OTHERS type of infections than SSTIs
Effects of Mother-Sung Lullabies on Infant Pain and Maternal Anxiety

Childhood pain can cause long-term and psychologically harmful effects. Music can reduce pain and anxiety. This study aimed to investigate the effects of the mother-sung lullaby during vaccine administration on vaccine-induced pain in babies and anxiety in mothers.

This study aimed to investigate the effects of the mother-sung lullaby during vaccine administration on vaccine-induced pain in babies and anxiety in mothers. Two family health centers in Turkey between March 4, 2020, and August 28, 2020. A total of 60 babies who received the Bacille Calmette-Guérin vaccine and their mothers.These babies were randomly assigned to one of two groups, including 30 babies in the lullaby group and 30 babies in the control group. Data on descriptive information for all babies and mothers were collected through face-to-face interviews with the mothers before vaccination. Heart rate, oxygen saturation, and crying duration were measured in all babies. Heart rate and oxygen saturation of the babies were recorded using a pulse oximeter during and after vaccine administration. The crying time, measured for up to 30 seconds after vaccination, was recorded as the total cry time (using video seconds). The pain score was evaluated by two observers using the Neonatal Infant Pain Scale, based on video recordings obtained during and after vaccine administration. In addition, mothers' anxiety scores were measured using the "State Anxiety Inventory," both before and after vaccination.

Eligibility Criteria:
Inclusion Criteria:

* gestational age of 37-42 weeks
* postnatal age at full two month
* receiving the Bacille Calmette-Guérin vaccine
* birth weight of 2500 gr or higher
* no congenital anomalies
* stable general condition
* not taking any pain medication before vaccination
* mothers were required to be older than 18 years and agree to participate in the study

Exclusion Criteria:

* taking analgesic medication within 4 hours before the procedure
* parents not willing to participate in research.