cyrilzakka/clinical-trials huggingface dataset:
Ultra-high-field Brain MRI in Multiple Sclerosis

The MRI scan is one of the most important tools for diagnosing multiple sclerosis (MS) and for monitoring disease progression and medication effects. Increasingly strong MRI magnets (higher field strength) enable us to see abnormalities in the brain in greater detail. On the other hand, it poses challenges because these higher field strength MRIs are more sensitive to disturbances, for example due to motion, including physiological motion such as breathing and swallowing. In current practice, field strengths of up to 3 Tesla are common. The aim of this study is to compare scanning at field strengths of 3 Tesla in 10 MS patients at two different moments (baseline and 6 months) with scanning at field strengths that are higher, namely 7 and 9.4 Tesla, in order to identify the advantages and disadvantages. With the further development of this technique, the investigators may be able to make a better diagnosis in the future and detect subtle changes in the course of the disease more quickly in order to optimize treatments.

Multiple sclerosis (MS) is the most common demyelinating disease of the central nervous system. MRI has a prominent role in diagnosing and monitoring disease and treatment and is most suitable tool to study MS pathology in vivo. In recent years there has been research has been much research on the use of 7 tesla MRI in MS. There is a better signal and contrast allowing for higher resolutions. This may contribute to, among other things, higher sensitivity for detecting MS abnormalities, not only in the white matter but also in the gray matter. Furthermore, there is probably also a better specificity. This is due to the improved visualization of MS specific pathological features such as the presence of a central vein in a lesion and paramagnetic rings.

In this pilot study, the investigators study whether going beyond the field strength of 7 Tesla (7T) has additional benefits in characterizing MS lesions and to also map the limitations and challenges of scanning above 7T. More specifically, first, whether scanning above 7T might improve sensitivity to white and gray matter abnormalities in MS. Second, whether MS specific pathology, such as the central veins and the paramagnetic rings, are better visualized at the higher compared to lower field strengths. To this end, the investigators want to scan 10 relapsing-remitting MS patients for clinical field strength (3T) and also ultra-high field strengths (7T and 9.4T) at two time points (baseline and after 6 months).

If it can demonstrate through this pilot study that scanning at field strengths above 7T can benefit detection of lesions or certain pathological features, the use of this research tool can help us in future studies to better understand MS.

Eligibility Criteria:
Inclusion Criteria:

* Relapsing remitting MS patients (according to the 2017 McDonald criteria)
* Age 18-65 years
* New brain MRI lesion in the past 15 months.

Exclusion Criteria:

* Non-compatible implanted material/devices
* Not being able to lie flat long enough (for the MRI) because of another medical condition
Socket Preservation After Surgical Extraction of Impacted Lower Third Molar

The aim of this study will be to evaluate socket preservation using autogenous particulate dentin in combination with liquid platelet-rich fibrin versus bone allografts and collagen cone after surgical extraction of the horizontally impacted lower third molar

The aim of this study will be to evaluate socket preservation using autogenous particulate dentin in combination with liquid platelet-rich fibrin (sticky tooth) versus bone allografts and collagen cone after surgical extraction of the horizontally impacted lower third molar

Eligibility Criteria:
Inclusion Criteria:

1. Fresh extracted socket of horizontally impacted mandibular third molar
2. Co-operative patients willing to complete the follow-up periods.
3. Patients age from 18-35 years.
4. Good oral hygiene.

Exclusion Criteria:

1. Any pathological condition at the site of surgery.
2. Patients with systemic diseases that contra-indicate the surgical procedure such as uncontrolled diabetes mellitus, bleeding disorders, serious osseous disorders and mental disorders.
3. Smokers .
4. Pregnancy.

   -
Virtually Augmented Self Hypnosis in Peripheral Vascular Interventions

The aim of our study is to compare patients anxiety and pain during percutaneous vascular interventions with and without virtual reality autohypnosis.

The participants in the control group will be treated under local anesthesia, following the usual care protocols.

The participants in the experimental group will be treated under the same conditions, except that they will experience virtual reality autohypnosis during the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent as documented by signature
* \> 18 years
* Any indication for a percutaneous vascular interventional with a single vascular access (angiography, phlebography, arterial intervention, venous intervention) planned to be done under local anesthesia

Exclusion Criteria:

* No French language comprehension, deaf or visually impaired patient
* Inability to sign informed consent
* Need of sedative medication
* History of motion sickness
* History of psychiatric disease such as paranoia, schizophrenia, deep water phobia and dementia
* Patient does not tolerate the virtual reality mask during the pre operative visit at Day 1
A Retrospective Analysis of Raltegravir Use in Minority HIV Infected Women in Houston, Texas

Raltegravir is the first marketed strand-transfer inhibitor of HIV-1 that was FDA approved in 2007. It is currently one of the preferred treatment regimens for HIV by the Department of Health and Human Services. It has become a widely used antiretroviral therapy option for HIV infected patients. It provides good tolerability and a favorable lipid profile for patients when compared to some other antiretroviral treatment options. Little data is reported about efficacy in a minority patient population. Moreover, data in an indigent minority population in the United States has not been aggregated before. Therefore this study will investigate the efficacy of raltegravir in minority women residing in Houston, TX who are HIV infected.


Eligibility Criteria:
Inclusion Criteria:

1. HIV-infected women who picked up raltegravir in the year 2013 at Thomas Street Health Center.
2. Minority women -Black/African American, Hispanic/Latino

Exclusion Criteria:

* n/a
Allogene MSCs Transplantation in Liver for Patients With Chronic Liver Diseases Through Portal Vein by Ultrasound Guiding

Allogene MSCs transplantation will be performed in patients with chronic liver diseases through portal vein by ultrasound guiding and therapeutic effects including short-term effects and long-term follow-up will be compared and investigated.


Eligibility Criteria:
Inclusion Criteria:

1. chronic liver diseases including: viral hepatitis, alcoholic liver disease, autoimmune liver disease.
2. age: 15-65 years old.

Exclusion Criteria:

1. pregnant women and women in lactation.
2. other systems and organs disfunction
3. space-occupying lesion were found in liver.
4. concurrent infection with HIV and other immunodeficiency diseases.
5. DIC and active bleeding were confirmed.
Safety and Pharmacokinetic Effects of Oseltamivir Alone or in Combination With Amantadine

This study is designed to assess the safety and pharmacokinetic effects of oseltamivir administration alone or in combination with amantadine in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects aged 18 to 45 years, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests
* Vital signs within the following ranges:

  * oral body temperature 35.0 - 37.5°C
  * systolic blood pressure 90 - 140 mm Hg
  * diastolic blood pressure 50 - 90 mm Hg
  * pulse rate 40 - 90 bpm
* Female subjects of child bearing potential must be using double-barrier local contraception (for example, intra-uterine device plus condom, or spermicidal gel plus condom) or have been surgically sterilized at least 6 months prior before study start, with supportive clinical documentation OR Postmenopausal women must have no regular menstrual bleeding for at least 1 year prior to inclusion.
* Body mass index must be within 18 - 30 kg/m2. Subjects must weigh at least 50 kg.

Exclusion Criteria:

* Smokers (use of tobacco products in the previous 3 months). Smokers will be defined as those who report tobacco use or have a urine cotinine greater than 500 ng/mL
* Female subjects who are pregnant or lactating
* Participation in any clinical investigation involving medical intervention within 4 week prior to study start.
* Donation or loss of ≥ 400 mL of blood within 8 weeks prior to study start, or longer if required by local regulation.
* Significant illness within 2 weeks before study start.
* A past personal or close family medical history of clinically significant ECG abnormalities or of a prolonged QT-interval syndrome.
* History of autonomic dysfunction (for example, history of fainting).
* History of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or untreated),
* History of clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to the study drug or to similar drugs.
* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs, or which may jeopardize the subject in case of participation in the study, including bowel, gastrointestinal, renal, pancreatic, hepatic, hematological, immunological, or neurological disorders.

Other protocol-defined inclusion/exclusion criteria may apply
PMCF (Post-Market Clinical Follow-up) Study on the Tether™ in UK (United Kingdom)

The goal of this observational study is to collect information about The Tether™ device in participants with progressive idiopathic scoliosis, Lenke Type 1 curves. The main purpose is to provide assessment of:

* ongoing safety
* probable benefits Participants who will receive The Tether™ during spine surgery will have to attend follow-up visits which are part of standard-of-care.

This study is designed to be prospective. After the initial visit, followed by the surgery, the participant is expected to take part in the study for a time period of 5 years post-surgery.

Patients will be enrolled during a period of 36 months, and the study will last until complete collection of the 5-year follow-up data. Data will be collected at: first follow-up post discharge, 6, 12, 24, 36, 48 and 60 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of progressive idiopathic scoliosis;
* Skeletally immature, based on both Risser (\<5) and Sanders (\<8) assessments;
* Major Cobb angle ≥30° and ≤65°;
* Osseous structure dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging;
* Failed bracing and/or be intolerant to brace wear;
* Lenke Type 1 curves (i.e., main thoracic);
* Signed Informed Consent Form by legal guardian or by the patient if ≥ 16 years old.
* The decision to treat patients with The Tether™ - VBT System was made by the patient's clinician outside of this research

Exclusion Criteria:

* Presence of any systemic infection, local infection, or skin compromise at the surgical site;
* Prior spinal surgery at the level(s) to be treated;
* Known poor bone quality defined as a T-score -1.5 or less;
* Skeletal maturity;
* Any other medical or surgical condition which would preclude the potential benefit of spinal surgery, such as coagulation disorders, allergies to the implant materials, and patients unwillingness or inability to cooperate with post-operative care instructions;
* Unwillingness, inability, or living situation (e.g., custody arrangements, homelessness, detention) that would preclude ability to return to the study site for follow-up visits as described in protocol and Informed Consent;
* Patients who are pregnant at the time of enrollment.
Neuropsychological Rehabilitation of Spontaneous Confabulation

Confabulators consistently generate false memories without intention to deceive and with great feeling of rightness. However, there is currently no known effective treatment for them. In order to fill this gap, the aim of this trial was to design a neuropsychological treatment based on the current theoretical models and test it experimentally in two groups of confabulators: experimental vs. control. The treatment consisted of some brief material that patients had to learn and recall at both immediate and delayed moments. After both recollections, patients were given feedback about their performance (errors and correct responses). Pre-treatment and post-treatment baselines were administered. Confabulators in the control group performed the baselines without treatment, and were then offered the treatment after the second baseline.


Eligibility Criteria:
Inclusion Criteria:

* The presence of spontaneous confabulations after acute brain injury, for at least three months and without clinical improvement (interfering with the patient's daily life with frequent arguments and exhaustive supervision).
* The presence of momentary confabulations in the Spanish adaptation of Dalla Barba provoked confabulation interview.
* Prior to injury, all patients should be completely independent for daily living.

Exclusion Criteria:

* The presence of impairment in alertness.
* Dementia.
* Acute confusional state.
* A history of alcohol or drug abuse.
* Psychiatric antecedents.
Stryker Triathlon® Cruciate Substituting vs. Posterior Stabilized Outcomes Study

This study compares the clinical and radiographic outcomes obtained with the use of the Stryker Triathalon® Cruciate Substituting (CS) and Posterior Stabilized (PS) tibial inserts.


Eligibility Criteria:
Inclusion Criteria:

* Adults ages 20-80 years old
* Body mass index \<40
* Undergoing primary total knee arthroplasty for osteoarthritis of the knee

Exclusion Criteria:

* Inflammatory arthritis
* Revisions

Other criteria may apply
VEIN Health - CVD Prevalence and Characteristics

Epidemiology Study to learn prevalence and characteristics of CVD at Primary and Specialized healthcare level

Cross sectional study that will evaluate prevalence, characteristics, diagnostic and treatment status of the patients with Chronic Venous Disease at primary or specialized healthcare level during 2 week period. No interventions are made. Information on patient demographic, physical, clinical parameters, medical history data and procedures performed during visit in routine daily practice of physicians is registered and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years
* Patient consented to participate

Exclusion Criteria:

* Patient applying due to emergency situation
Clinical Trial of Sound-Based Versus Behavioral Therapy for Tinnitus

The purpose of this study is to determine if a novel sound-based therapy in comparison to standard of care (cognitive behavioral therapy) results in reducing tinnitus-related effects for people with bothersome tinnitus.

This study is a randomized controlled trial evaluating if a customized sound-therapy device is just as effective or more so, than the standard of care (cognitive behavioral therapy, CBT) for bothersome tinnitus. All eligible participants will be randomly assigned to one of the two groups. Depending on group assignment, participants will attend approximately 7-12 visits over a 7-month period.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Primary and persistent tinnitus (6 months or longer in duration)
* Tonal tinnitus
* Dominant tinnitus frequency measured between 0.2 and 10 kHz
* Tinnitus Questionnaire score
* No current participation in other tinnitus therapy program
* Willing and able to listen to the acoustic prescription for 4-6 hours daily during the trial
* Able to pass the Tone Audibility Assessment with factor of 1.1

Exclusion Criteria:

* Secondary/somatic tinnitus due to a suspected underlying disease
* Atonal, pulsatile, intermittent, or occasional tinnitus
* Any hearing threshold \>70 dB HL from .25-8kHz, unless subject passes the Tone Audibility Assessment screening with a factor of 1.1
* Any health or other problems that may prevent the person from completing the study procedures as determined by investigator
* Participant reports current suicidal ideation and/or homicidal ideation
* Use of medication which may trigger tinnitus \[e.g., quinine derivatives, aminoglycoside antibiotics, daily high dose non-steroidal anti-inflammatory drugs ≥1000 mg, salicylates (when not prescribed as a low dose for cardiac health), loop diuretics and chemotherapy agents like cis-platin\]
* Conductive hearing loss
* Visible congenital or traumatic deformity of the ear
* History of active drainage from the ear within the past 90 days
* History of sudden or rapidly progressive hearing loss within the past 90 days
* Inability to read and respond appropriately to instructions that appear on the computer screen, and/or to perform all of the procedures
* Previous use of Desyncra for Tinnitus Therapy System
A Study of Suizenji in Patients With Unresectable Pancreatic Cancer

The purpose of this study is to evaluate the safety and efficacy of standard chemotherapy with or without a novel High Intensity Focused Ultrasound system (Code: Suizenji) in patients with unresectable pancreatic cancer who are refractory or intolerant to first-line chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Ages 20 years and over.
* Unresectable pancreatic cancer (including metastatic pancreatic cancer) who are refractory or intolerant to first-line chemotherapy. Any first-line chemotherapy is acceptable.
* Target treatment tumor is located in the pancreas, and the target tumor can be visualized with ultrasound echography and can also be treated by high-intensity focused ultrasound.
* Has primary tumor site of measurable lesion according to RECIST guidelines version 1.1
* ECOG performance status of 0 to 2.

Exclusion Criteria:

* Active multiple cancers that require treatment.
* Suspected gastrointestinal invasion of the primary tumor based on CT scan.
* Obstructive jaundice. However, patients who have a bile duct stent placed for obstructive jaundice by the time of allocation may be enrolled.
* Child-Pugh Classification B or C liver failure due to liver metastases.
* Tumor embolization in the veins surrounding the pancreas.
* Cystic component within the pancreatic cancer.
* Peritoneal dissemination.
* Pleural effusion or ascites with poorly controlled
* Contraindications to the use of secondary chemotherapy used in this study.
Unboosted Atazanavir as Initial ART Therapy in China

This is an open-label, Pilot study.The study hypothesis is that the feasibility and efficacy of a non-boosted ATV based HAART will be well as the first line treatment in a Chinese resource-limited setting.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* The subject should have established HIV infection more than 6 month.
* Qualifying plasma HIV RNA ≥ 2,000 c/mL and a CD4 cell count within 100 - 350 cells/mm3
* ≥16 years of age
* Both females of child-bearing potential and males must utilize effective barrier contraception - other contraception in addition to barrier methods are permitted
* Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such a manner that the risk of pregnancy is minimized.

Exclusion Criteria:

* Patients who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study.
* Presence of a newly diagnosed HIV-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment.
* History of hemophilia
* Proven or suspected acute hepatitis in the 30 days prior to study entry. Subjects with chronic hepatitis are eligible provided that their liver function enzymes are \< 3 times the upper limit of normal.
* Presence of cardiomyopathy.
* A history of arrhythmia or clinical symptoms potentially related to heart block or second / third degree heart block.
* Inability to tolerate oral medication
* Presence of a newly diagnosed HIV-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment.
Ultrasound Imaging of Kidney Stones and Lithotripsy

The purpose of this study is to determine whether new software processing of ultrasound images can improve detection and size determination of kidney stones.

The purpose of our research is to improve the ability to see kidney stones with ultrasound imaging. Specifically, we are testing how well new stone specific processing can find stones and show their size. Ultimately, better imaging can improve the care of future patients.

Patients with kidney stones or undergoing surgery for kidney stones will be recruited and consented.

We will image the kidney and ureter stones of consented subjects. We will place a water-based gel and ultrasound probe against the subject's skin on the back, sides, and abdomen. We will save the images and the raw electrical signals received from the probe and used to make the images. The images will be used to estimate the location and size of kidney stones in the kidney or ureter. The size and location will also be determined from x-ray and ultrasound images and reports already in the subject's medical record. And for recruited subjects who are already undergoing surgery in an existing clinical not research procedure, the surgeon will also measure location and size of stones seen in surgery. All these measurements of size and location of kidney stones will be compared to test the accuracy of the new ultrasound image processing.

After the examination, we will not ask anything more of subjects, but we will collect some information from their existing medical records. This information includes existing images of your stones, size of stones, location of stones, number of stones, type of stones, and treatment records. We will also record your weight, height, race, and ethnicity. Not all this information may be available. We will use what information is available. This additional information is used to test how well our ultrasound exam did. It also shows if we do better with certain groups of patients, for example, for certain stone types or body sizes.

Eligibility Criteria:
Inclusion Criteria:

* Patients with kidney stones that are visible on x-ray (i.e., calcium stones)
* Current CT scan within the 90-day pre-operative period
* Able to give informed consent
* Age 21 years or older

Exclusion Criteria:

* Inability to give informed consent
* Age less than 21 years
* Stones not visible on x-ray
* Patients with systemic disease or renal anatomical disorders (RTA, primary hyperparathyroidism, sarcoidosis, enteric hyperoxaluria, medullary sponge kidney)