cyrilzakka/clinical-trials huggingface dataset:
Brain Imaging and Pain: Analysis of Placebo Analgesia

This study examines the brain activation associated with placebo pain reduction.

This study is a basic science study of the mechanisms of placebo analgesia in asymptomatic healthy individuals. Each participant receives a baseline pain testing session, followed by a conditioning paradigm that results in expectation of pain relief and conditioning. They then undergo functional magnetic resonance imaging during either placebo (conditioned analgesia) or baseline. To examine order effects and habituation, the participants also either undergo a repeated placebo or a repeated baseline. The primary dependent measures in the study are the fMRI determined regions of interest, in a network of brain areas associated with pain processing. The anticipated outcome of the study is the alteration of network connectivity between sensory, affective, evaluative areas of the brain associated with placebo.

Because this is not a traditional clinical trial, there are not traditional efficacy criteria, rather the outcomes are changes in brain function from manipulations of patient expectation and classical conditioning.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age
* english speaking

Exclusion Criteria:

* pain condition
* pregnant
Robotic Rehabilitation of Upper Limb in PD

It has been shown that robot-assisted therapy may be considered an effective and reliable method for the delivery of highly repetitive training useful to boost neuroplasticity. Thus, an early, intensive, repetitive and task oriented training could be an ideal strategy to facilitate relearning of motor function and to improve motor function. The ARMEO-S® is a specific upper limb electromedical device mainly used to reduce spasticity and improve muscle force. To date robotic upper limb training has been applied only in patiebts with brain injury and spinal cord lesions.

Aim of the study is to evaluate the efficacy of ARMEO-S in improving upper limb agility in a sample of PD patients, as compared to traditional physiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic PD diagnosed according to the UK BRAIN BANK criteria
* Hoehn-Yahr stage 2- 3
* MMSE score ≥ 23

Exclusion Criteria:

* Severe Dyskinesia

  * On-Off Motor fluctuations
  * History of stereotaxic brain surgery for PD;
  * Changes in dopamine therapy dose in any time within 3 months prior to baseline;
  * Any other medical that may compromise the patient's participation in this study such as history of ostheoarthritis or neuropathies.
Project MIX: Behavioral Intervention to Reduce Risk Among Substance-Using MSM

The purpose of this project is to test the efficacy of an HIV prevention behavioral intervention to reduce sexual risk for HIV infection among non-injection, substance-using men who have sex with men (SUMSM). The primary goal of the intervention is to reduce HIV transmission by reducing the incidence of unprotected anal sex while under the influence of alcohol and other drugs (AOD).

Men who have sex with men (MSM) continue to be the largest risk category for incident and prevalent cases of HIV and AIDS in the U.S. Studies of MSM have established an association between alcohol and other drug (AOD) use and risky sexual behaviors. Although studies have assessed and confirmed the association of AOD use and unsafe sex, few have focused specifically on reducing sexual risk of SUMSM.

Sexual risk reduction interventions for MSM identified in the published scientific literature have demonstrated that they are generally effective at reducing sexual risk behaviors among MSM. However, none of these interventions specifically targeted non-injecting SUMSM. Thus, a gap exists in prevention efforts to reduce HIV transmission among SUMSM.

The primary aim of the Project Mix overall is to develop and evaluate a practical intervention strategy that is specifically tailored to the needs of non-injecting SUMSM. The intent of the intervention is to decrease the number of unprotected anal sex partners (and acts) while under the influence of AOD and in general.

Eligibility Criteria:
Inclusion Criteria:

* be 18 years of age or older;
* self-identify as male;
* understand and read English;
* live within the metropolitan area;
* report being drunk or "buzzed" on alcohol 2 or more times or high on non-injection drugs at least once during (or two hours before) anal sex in the past six months;
* have had at least one unprotected anal sex episode in the past six months with a male partner of unknown or different HIV-status than their own (i.e., DUA)

Exclusion Criteria:

* report only marijuana, only Viagra or only marijuana and Viagra use during anal sex (current research shows that marijuana use is not associated with sexual risk behavior);
* report injecting drugs (eligible if only methamphetamine, steroids, hormones and/or prescribed medications) in the past six months;
* have known their HIV-positive status for less than six months (this is done to allow for psychological and behavioral adjustment following an initial HIV diagnosis and this time frame coincides with our screening window); these men (if they so desire) will be put on a wait list and contacted after 6 months have passed since their first HIV-positive test result;
* are currently involved in another HIV behavioral intervention study for MSM \[local study site identifies a list of such studies in their community at the time of the trial\];
* have a specific plan to move from the metropolitan area within the next 15 months;
* participated in the pilot phase of the project;
* other reasons that the investigators deem would make participation either detrimental to the participant or to the study.
Study of ATI-2138 in Adult Participants With Moderate to Severe Atopic Dermatitis

This is a Phase 2 open label study of ATI-2138 in participants with moderate to severe atopic dermatitis.

This open-label, single-arm study of ATI-2138 in moderate to severe AD participants between the ages of 18 and 60 years (inclusive) will investigate the safety, tolerability, pharmacokinetics, efficacy and pharmacodynamics of ATI-2138 administered over 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Able to comprehend and willing to sign the IRB approved ICF/assent prior to administration of study-related procedures.
* Male patients or non-pregnant, non-nursing female patients 18 to 60 years old, inclusive, at the time of informed consent/assent.
* Have at least a 1-year history of moderate or severe AD prior to the Screening Visit, and no significant AD flares for the 4 weeks prior to the Screening Visit as determined by the Investigator upon review of participant medical history.

Exclusion Criteria:

* Any prior exposure to systemic (oral) JAK inhibitors or TYK inhibitors at any time prior to Screening.
* Unstable course of AD (spontaneously improving or rapidly deteriorating) based on the patient history or as determined by the investigator during the Screening Period.
* Refractory AD (ie, AD that required frequent hospitalizations and/or frequent intravenous treatment for skin infections within the year before the Screening Visit).
* Concomitant skin disease or clinically infected AD or presence of other skin disease in the area to be dosed that may interfere with study assessments.
* Female patients who are pregnant, nursing, or planning to become pregnant during the study.
Changes in the Upper Airway Volume After Rapid Maxillary Expansion in Adults Using Pure Skeletal Anchorage

The objective of this study is to evaluate the effect of bone-anchored rapid maxillary expansion (RME) in the volume of the right maxillary sinus, left maxillary sinus and nasal and maxillary sinus airway complex, through bone anchored maxillary expansion devices (BAME); in addition, the influence of gender and age in the volume changes will be also analyzed. Material and method: 18 patients between undergone RME treatment with a jackscrew based on 4 miniscrews which will be placed in the palate on both sides of the midpalatal suture. Cone-beam computed tomography (CBCT) scans will be taken before and after suture palatine expansion and datasets will be uploaded into therapeutic digital planning software to measure the volume (mm3) of the right maxillary sinus, left maxillary sinus (mm3) and nasal and maxillary sinus airway complex (mm3). The airway volumes will be isolated after selecting the anatomical area in the axial, coronal and sagittal space plane and ensuring the air density measurement by reference points placement inside the selected area. Statistical analysis between preoperative and postoperative measurements will be performed using the statistical analysis of the t-test.


Eligibility Criteria:
Inclusion Criteria:

* adult patients
* no history of systemic conditions that could interfere in bone metabolism and in the surgical process of orthodontic mini-implant placement
* radiographic imaging (CBCT KAVO OP3D Pro FOV 13X15cm) of maxillary discrepancy of more than 3mm compared with the ideal dimensions according to their mandible

Exclusion Criteria:

* Age more than 31 years old
* Systematic conditions that interfere in bone metabolism
Laser Therapy for the Prevention of Radiodermatitis in Head and Neck Patients

Up to 90% of the radiotherapy patients will develop a certain degree of skin reaction at the treated area, also known as radiodermatitis (RD).

Currently, there is a wide variety of strategies to manage RD, including creams, gels, ointments, wound dressings. However, up to now, there is still no comprehensive, evidence-based consensus for the treatment of RD. Low-level laser therapy (LLLT) is a promising, non-invasive technique for treating RD. In a recent study conducted in our research group, LLLT prevented the aggravation of RD and provided symptomatic relief in patients undergoing radiotherapy for breast cancer after breast-sparing surgery. This was the first prospective study investigating the potential of LLLT for RD. In the current study, we want to investigate the efficacy of LLLT as a tool for the prevention of radiodermatitis in head and neck cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of head and neck squamous cell carcinomas (HNSCC) starting in the lip, salivary gland, oral cavity (mouth), nasal cavity (inside the nose), paranasal sinuses, pharynx, or larynx
* Scheduled for radiotherapy (\>60 Gy), chemo-irradiation or bio-radiation either as primary or as post-operative treatment to the head and neck region
* Age ≥ 18 years
* Able to comply to the study protocol
* Able to sign written informed consent
* Signed written informed consent

Exclusion Criteria:

* Previous irradiation to the head and/or neck region
* Metastatic disease
* Patients with pre-existing skin rash, ulceration or open wound in the treatment area
* Patients with known allergic and other systemic skin diseases even when not directly affecting irradiated fields
* Substance abuse patients or patients with medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results as judged by the investigator
* Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator
* Patients using high doses of non-steroidal anti-inflammatory drugs
A Study to Evaluate the Safety, Tolerability and Efficacy of RZ-001 with Valganciclovir (VGCV) in Subjects with Hepatocellular Carcinoma

This is first in human study to evaluate the safety, tolerability, immunogenicity, and preliminary clinical activity of RZ-001 when given to subjects with human telomerase reverse transcriptase (hTERT)-positive HCC.

The study will be conducted in 2 parts.

Part 1 is a dose escalation study which aims to explore the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) after the single escalating dose of the intratumoral (IT) injection given through 4 different cohorts.

Part 2 will consist of dose expansion, exploring clinical activity for the optimal fixed dose based on the results of Part 1.

Eligibility Criteria:
Inclusion Criteria:

* Adult males and females
* Hepatocellular carcinoma diagnosis (BCLC stage B or C)
* hTERT positive expression confirmed during the screening period
* ECOG score of 0 or 1
* Child-Pugh score of A to B7
* Life expectancy \>= 3 months

Exclusion Criteria:

* Moderate or severe ascites
* History of hepatic encephalopathy
* Carcinomas other than HCC
* Current or history of HIV positive
* Not suitable for inclusion judged by the investigator
Comparison of the Result of TVT Performed at the Time of Prolapse Surgery or 3 Months After

It is unknown whether it is best to do the TVT( procedure for urinary stress incontinence in women) at the time of prolapse surgery or at a later date. Women with both conditions were randomized to both procedures together or the TVT 3 months after the prolapse surgery. Any or no leakage when couching was the main end-point, evaluated 1 year after the last surgery

All women were evaluated by the POP-Q (pelvic Organ Prolapse Quantification) prior to surgery and 1 year after.

Examination for urinary leakage was done prior to surgery and 1 year after. Group 2 was also examined after prolapse surgery to see if TVT was still needed.

Eligibility Criteria:
Inclusion Criteria: Pelvic Organ Prolapse that needs surgical repair and objectively proven urinary stress incontinence -

Exclusion Criteria: Not agreed to participate in randomization

-
Laryngeal Mask Airway Facilitates a Safe and Smooth Emergence From Anesthesia in Patients Undergoing Craniotomy

Stabilizing hemodynamic and reducing pulmonary complications during extubation with switching endotracheal tube to laryngeal mask in craniotomies

recruit ASA: 1-3, 20-65 years old undergoing neurosurgery under general anesthesia Excluded 1.Decline to participated 2.Difficult airway 3.Body Mass Index \>30 4. Pregnant woman 5.Nothing Per Os \<8hrs(case number:80).

General anesthesia Induction: 0.15-0.2 mg/kg cisatracurium or 0.6-1.2mg rocuronium , 1.5-2 mg/kg propofol, 1-2 mcg/kg Fentanyl. Endotracheal tube 6.5-7.5mm. Maintenance with sevoflurane 2- 3% FiO2:100%. Optimal muscle tension monitor. When surgery done, sevoflurane at 2.63-2.97%

Then randomly assigned two group Anesthesia group(control group) : Removed endotracheal tube at sevoflurane at 2-3% Switching group (intervention group): Intervention with endotracheal tube to laryngeal mask, and removing laryngeal mask at sevoflurane: 0.4MAC

Eligibility Criteria:
Inclusion Criteria:

* ASA: 1-3, 20-65 years old undergoing craniotomies under general anesthesia

Exclusion Criteria:

* Decline to participated
* Difficult airway
* Body Mass Index \>30
* Pregnant woman
* Nothing Per Os \<8hrs
Low Level Laser Therapy for Hair Preservation With Chemotherapy for Breast Cancer

The purpose of this study is to see whether low level laser therapy can help maintain normal hair growth on the scalp in people receiving chemotherapy, which is generally associated with hair loss.

Chemotherapy is a common treatment given to patients with breast cancer. Many chemotherapy drugs cause rapid hair loss. While hair loss is temporary, this side effect is a significant concern for patients. Low level laser therapy has been shown to help make hair grow. It is hoped that it may stop hair loss from occurring.

Participants will be receiving 20 to 30 minute laser sessions to their scalp twice a week beginning two weeks before treatment begins until one week past the last chemotherapy session. . Photographs will be taken during each study participant's initial visit, during treatment visits, and one month following the final chemotherapy treatment.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have breast cancer and must be starting chemotherapy with Adriamycin or a taxane-based therapy.
* Participants must be 18 years old or older
* Participants must be female
* Participant must agree to comply with therapeutic and follow-up schedule.
* Patient must signed informed consent form.

Exclusion Criteria:

* Participants cannot have sensitivity to the laser light.
* Participants cannot have used any topical or oral products to grow hair within 3 months of enrollment to this study.
* Participants cannot be pregnant, lactating or planning on pregnancy during therapeutic schedule.
Effects of Sevoflurane and Propofol on Optic Nerve Sheath Diameter During Laparoscopic Gynecologic Surgery

Intracranial pressure（ICP) increases during laparoscopic gynecologic surgery increase (ICP) and may alter optic nerve sheath diameter(ONSD).This study measures ONSD in different team because sevoflurane and propofol have different effects on ICP.Half of participants will receive sevoflurane anesthesia,while the other half undergo propofol anesthesia.

Due to the anatomical and physiological characteristics of optic nerve sheath ,ONSD increases when ICP rises.

Sevoflurane and propofol have different effects on ICP.When sevoflurane concentration \>1.1 minimum alveolar concentration（MAC),ICP increases because of cerebral vasodilatation；on the other hand ,propofol constricts the blood vessels and ICP decreases.

ICP increases during laparoscopic gynecologic surgery because of steep Trendelenburg position and pneumoperitoneum .

Meanwhile,sevoflurane affects self regulation of cerebral blood flow on the way of dose dependent,but propofol has no effects on self regulation of cerebral blood flow.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status diagnosed as I or II

Exclusion Criteria:

* neuromuscular diseases;laboratory abnormalities in electrolytes; liver and kidney dysfunction;allergy to general anesthetics;pregnancy;ocular lesions including ocular trauma, optic neuritis, optic nerve tumor.
Long-term Outcome of Patients With Acute Ulcerative Colitis After First Course of Intravenous Corticosteroids

All episodes of patients with acute UC admitted to Tampere University Hospital and treated with intravenous corticosteroids between January 2007 and January 2016 were identified from patient records and reviewed. The risks for colectomy and for continuous use of corticosteroids were evaluated. Predictive factors were analysed.

Data collected included epidemiological (gender, age at index flare, smoking status), clinical (UC duration, extent of the disease, prior Cs usage, disease severity, laboratory results at index flare) and treatment data (occurrence of new flares, need for further Cs therapy; CyA, thiopurines, biologics or colectomy during follow-up). The diagnosis of UC was made on basis of clinical history, symptoms, endoscopic and histological features. Disease extent was categorized by the Montreal classification and the severity of the flare was assessed by Mayo scoring system based on clinical and endoscopic characteristics. ASUC was characterized by more than six bloody stools/day along with any of the following: tachycardia, elevated temperature, anemia and/or ESR \>30 mm/h (Truelove and Witt´s criteria)5. Alleviation of UC was defined as clinical response to intravenous corticosteroids with no need for colectomy or rescue therapy at the same hospitalization as the index flare. Relapse was defined as requiring further corticosteroid treatment, rehospitalization, rescue-therapy, or colectomy later in follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Acute severe ulcerative colitis treated first time with iv corticosteroids
* Follow-up for at least six months after hospitalization or until colectomy.

Exlusion:

-Under 16 year of age
QST for Corneal Nerve Function

This study is designed to learn more about the impact different types of stimuli, such as heat, cold and vibration, can have on ocular pain response. This is called quantitative sensory testing (QST). Most procedures being performed in this study, except the QST, are standard of care which means they are performed during the participant's routine eye examination.

Quantitative Sensory Test (QST) is a non-invasive neurophysiological method that refers to a group of procedures that assess the perceptual responses to systematically applied and quantifiable sensory stimuli for the purpose of characterizing somatosensory function or dysfunction.

In this study, we propose to evaluate corneal nerve functions in patients with corneal nerve abnormalities by QST and correlate the nerve functions with symptoms, clinical signs and nerve morphology detected by In-Vivo Confocal Microscopy (IVCM). Identification of corneal nerve functions and correlations with other findings may help us to understand underlying pathological mechanisms of the disease and may guide us toward new treatment targets.

We hypothesize that, QST may provide us detailed information about corneal nerve function alterations and may correlate with morphological nerve changes detected by IVCM.

Eligibility Criteria:
Inclusion Criteria:

Group 1: Stage I Neurotrophic Keratopathy (NK)

1. Clinical findings of Stage I NK
2. Decreased nerve density by IVCM
3. Decreased corneal sensation

Group 2: Stage II NK

1. Clinical findings of Stage II NK
2. Decreased nerve density by IVCM
3. Decreased corneal sensation

Group 3: Dry Eye Disease (DED)

1. Symptoms of DED at least 3 months
2. Presence of at least one of the following DED signs; tear film break-up time lower than 7, ocular surface staining more than +1 based on NIH scale
3. Normal or mildly effected corneal sensation

Group 4: Healthy Individuals

1. Absence of any ocular surface symptoms
2. Absence of ocular surface findings
3. Transparent and clear cornea
4. Normal corneal sensation

Group 5: NCP

1. Presence of neuropathic symptoms AND
2. Symptoms out of proportion to clinical findings AND
3. Nerve abnormalities detected by in vivo confocal microscopy

Exclusion Criteria:

1. History of diabetes
2. History of ocular surgery, corneal infection, or corneal injury within the last 3 months
3. Systemic regular anti-inflammatory and/or steroid and/or immune-modulatory therapy in the last 3 months
4. Active ocular allergies
5. Any major psychiatric illness including bipolar, psychosis, obsessive-compulsive disorder and major depression
6. Pregnancy
7. History of surgery within the last 3 months
8. History of , sarcoidosis, GVHD or collagen vascular disease
9. Allergic to benzalkonium chloride "BAK" (an eye-drop preservative)
10. Concurrent enrollment in other studies that in the opinion of the investigator will interfere with the results of this study
11. Non-English speakers