cyrilzakka/clinical-trials huggingface dataset:
Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder

This study is investigating a new indication of Transcranial Magnetic Stimulation (TMS) by conducting a pilot randomized-controlled trial (RCT) comparing structural neuronavigation-directed TMS to Sham-TMS Placebo therapy for treatment of Generalized Anxiety Disorder (GAD).

Participants will complete structural MRI for neuronavigation. Participants will be randomly assigned to treatment condition. TMS or Sham-TMS sessions will occur daily 5 days/week for 6 weeks. Assessments will occur at pretreatment, weekly during treatment, post-treatment, and 3 month.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with GAD as the principal or co-principal disorder
* Clinical Global Impression Score ≥ 4
* Hamilton Anxiety Rating Scale ≥ 18
* Hamilton Rating Scale for Depression ≤ 17
* Fluency in English
* Capacity to understand the nature of the study and willingness to sign informed consent form.

Exclusion Criteria:

* History of epilepsy or head trauma (LOC \> 5 minutes) within the past 6 months.
* Lifetime history of increased intracranial pressure, seizure disorder, stroke, brain tumor, multiple sclerosis, or brain surgery.
* A review of patient medications by the study physician indicates an increased risk of seizure.
* An active autoimmune, endocrine, viral, or vascular disorder affecting the brain; any unstable cardiac disease; hypertension; or severe renal or liver insufficiency.
* Substance use disorder or PTSD within the past 6 months.
* Lifetime bipolar disorder, obsessive-compulsive disorder (OCD), psychotic disorder, mental retardation, or pervasive developmental disorder.
* Any psychotic features, including dementia or delirium. Concurrent psychotherapy and unwillingness to discontinue
* Medication change within past 3 months.
* Current serious suicidal or homicidal ideation, and/or serious suicidal attempt within past 6 months.
* Serious, unstable, or terminal medical condition or clinically judged too psychiatrically unstable to participate in the study.
* Any contraindication for participation in MRI scan
Brain Stimulation for Epilepsy Long Term Follow-up

The purpose of this study is to collect subject data to evaluate the rate of sudden unexplained death in epilepsy (SUDEP) with bilateral neurostimulation of the anterior nucleus of the thalamus in people diagnosed with refractory epilepsy. The data obtained from the physician initiated studies will be pooled with data collected in Medtronic-sponsored studies to assess SUDEP risk.

Medtronic is conducting a pivotal clinical trial entitled Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy (SANTÉ). One of the requirements of the SANTÉ study is to evaluate the rate of sudden unexplained death in epilepsy (SUDEP). Medtronic is aware of approximately 18 subjects with various types of epilepsy that have been treated with neurostimulation of the anterior nucleus of the thalamus outside the SANTÉ trial under five physician-sponsored studies. This protocol will initially collect information regarding the physician-sponsored study subjects' status. The goal of this study is to pool these data with the SANTÉ data for the purpose of estimating the SUDEP rate.

This is a multi-center, retrospective and prospective clinical study in patients previously implanted with devices that provide bilateral neurostimulation of the anterior nucleus of the thalamus during non-Medtronic-sponsored studies.

Eligibility Criteria:
Inclusion Criteria:

* Have received bilateral AN stimulation of the anterior nucleus of the thalamus (AN) for epilepsy or are receiving it at the time of enrollment
* For patients with therapy active at the time of enrollment, ability of the patient or legal representative to understand and provide signed consent for participating in the study
* For patients with therapy permanently discontinued or died at time of enrollment, the IRB/REB has approved a waiver allowing collection of the data OR the ability of the patient or legal representative to understand and provide signed consent/medical authorization

Exclusion Criteria:

* None
Deep Transcranial Magnetic Stimulation for Stimulants Use Disorder

The purpose of the study is to explore the Feasibility, Tolerability and Safety of the H7-Coil deep Transcranial Magnetic Stimulation for Subjects with Stimulants Use Disorder (SUD).

Stimulants Use Disorder (SUD) is a major public health issue, with potentially severe psychosocial and medical consequences. Even though psychosocial therapies exist, an important proportion of patients do not respond to these approaches, and no approved biological approaches are currently available. deep TMS (dTMS) has been shown effective for Major Depressive Disorder, Obsessive Compulsive Disorder and Nicotine Use Disorder and could also prove available for SUD. Several pilot studies have shown preliminary effectiveness in SUD, but are limited by the length of their protocol, which could result in limited real-world effectiveness secondary to high dropout rates. Given that aTMS protocols have been applied successfully in MDD, we propose to implement this approach for SUD, in order to reduce treatment length and therefore increase retention rates. We will also gather preliminary data on various biomarkers that could help predict response and better understand biological mechanisms behind SUD.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with SUD (moderate or severe) based on DSM-5 criteria
* Current stimulants use with last use in the two weeks prior to admission to the study as confirmed by the Timeline Followback Questionnaire
* Wanting to stop the intake of stimulants
* Being able and willing to adhere to the treatment schedule
* Filling the criteria of the TMS adult safety screening (TASS) questionnaire
* Being voluntary and competent to consent to treatment
* Ability to speak and read French or English

Exclusion Criteria:

* Severe psychiatric condition (history of schizophrenia, schizoaffective disorder or bipolar disorder); current acute psychosis, mania or active suicidality (unipolar major depression, anxiety disorders and personality disorders will be allowed as long as they are not primary and causing greater impairment than SUD)
* Severe and/or unstable medical illness, including but not limited to any neurologic, cardiac, renal or hepatic condition
* Implanted medical device (including but not limited to intracranial implants, cardiac pacemaker, medication pump, etc.) or intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed
* Clinically significant laboratory abnormality, in the opinion of the principal investigator
* Pregnancy or breastfeeding
* Another current severe substance use disorder (except nicotine)
* Anti-craving medication and other psychotropic medications are allowed, but need to have been stable for four (4) weeks before screening
* Currently taking more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit TMS efficacy.
* Non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with the interview)
Accurate Screening Tools for Dysphagia in Amyotrophic Lateral Sclerosis (ALS)

Individuals with th Amyotrophic Lateral Sclerosis are at high risk for swallowing impairment (dysphagia) which leads to malnutrition, decreased pulmonary health, aspiration and aspiration pneumonia. These sequelae necessitate timely identification of at risk individuals to ensure optimal management of oral intake and pulmonary function. The purpose of this study is to evaluate the discriminant ability of several non-invasive screening tools at detecting swallowing impairment in individuals with ALS.

This research study is being performed to determine how accurate different screening tools or tests are at identifying swallowing problems associated with Amyotrophic Lateral Sclerosis (ALS).

As a participant one evaluation will be performed at the University of Florida Swallowing Systems Core laboratory located at Shands Hospital, Gainesville will take place. This will take approximately two-hours. During this evaluation an videofluoroscopy (X-ray of swallowing), cough tests, tongue function test and questionnaires will be completed.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of probable or definite ALS

Exclusion Criteria:

* allergies to barium or capsaicin
* tracheotomy or mechanical ventilation
* absence of diaphragmatic pacer
* respiratory disease (COPD).
Managing Stress and Social Ties for Health Aging

There has been a dramatic rise from 46% to 59% in the percentage of households with only 1-2 people from 1970 to 2000. A 40% increase in the number of people living alone is projected for 2010. Social isolation is consistently one of the strongest predictors mortality in older adults. Recent research is demonstrating that stress plays an important role linking social isolation with poor health. Socially isolated older adults are more likely to feel chronically stressed and overwhelmed with everyday life demands. Furthermore, isolated adults respond to stress differently, both psychologically and physiologically. Socially isolated and lonely older adults show long-term elevations in "inflammatory cytokines", which are signaling molecules related by immune cells. These Inflammatory cytokines play a role in a number of age-related diseases including cardiovascular disease, type-2 diabetes and arthritis. Novel, readily useable interventions aimed at decreasing isolation and "re-calibrating" stress responses might be helpful to older adults.

Tai Chi is an ancient Chinese form of calisthenics that promotes relaxation and decreases feelings of stress and as such, it may be a useful intervention for socially isolated, stressed older adults. However, its effects on stress responses are unknown. Tai Chi Chih (TCC) is a simplified, manualized, readily exportable form of Tai Chi particularly well-suited for older adults. This proposed study will test the effects of a TCC intervention with socially isolated older adults on loneliness, stress and health outcomes, including inflammatory assessment. Tai Chi-naïve participants who perceive themselves as socially isolated, as measured by the UCLA Loneliness Scale will be randomized to receive either Tai Chi or education control for a 12-week period. Subjects will undergo pre- and post-intervention stress assessment, including exposure to a psychological stress task, to assess whether Tai Chi affects how subjects physiologically and psychologically respond to stress.


Eligibility Criteria:
Inclusion Criteria:

* Adults \> 60 years old
* Have not done Tai Chi before
* Live in Los Angeles area
* Socially isolated
* Women must be post menopausal

Exclusion Criteria:

* Any physical debility that limits Tai Chi performance;
* Cognitive impairment (\< 23 on the Mini-Mental State Exam);
* Current or recent history of smoking
* Immune suppression resulting from neoplastic disease
* Corticosteroid use or other therapy
* Significant underlying illness that would interfere or prevent completion of the study
* Acute conditions (e.g. viral infection w/in 2 weeks) that might confound interpretation of inflammatory data
* Current or recent (within 1 month) use of illicit drugs.
Practice Analysis of Care, Paraclinical Exams and Treatments Received by Geriatric Patients Both During the Last Week and the Last 24 Hours of Their Lives.

End-of-life care is a core topic for geriatricians. One of the key aspects of end-of-life management is deciding when to discontinue active care measures (for example blood pressure monitoring, blood tests and X-rays) in favor of exclusive comfort care. In this retrospective observational study, the investigators looked at the care measures, treatments and paraclinical exams received by geriatric patients both one week and 24 hours before their death.

This analysis provides information on the differences in geriatric physicians' practices regarding the anticipation of the end of life, by showing on average when active care measures were stopped before death. Secondly, the investigators looked at patient criteria that could explain a prolongation of active care and a delay in the implementation of exclusive comfort care.

Eligibility Criteria:
Inclusion Criteria:

* All patients over 75 years old who died in a geriatric short-stay department at Saint-Etienne University Hospital.

Exclusion Criteria:

- Patients under 75 years old
Improving Colon Cancer Screening for Diverse Populations

This study is a multi-site randomized, controlled trial testing the effect of a combined intervention that includes a colorectal cancer (CRC) screening decision aid plus patient navigation in a diverse, primary care patient population in clinical sites in North Carolina and New Mexico.

Our primary aim is to determine the effect of the intervention on CRC screening completion six months after the index visit among all enrolled participants and among Latinos. Secondarily, we will determine how this intervention affects screening-related knowledge, self-efficacy, intent, and clinical communication, and examine whether these factors mediate the effect of the intervention on screening test completion. Lastly, we will explore whether insurance status, ethnicity, and patient language preference moderate the effect of the intervention on screening.


Eligibility Criteria:
Inclusion Criteria:

* Patients 50 to 75 years old who are not current with colorectal cancer (CRC) screening, defined as not having completed a home fecal occult blood test (FOBT) within the past year; a flexible sigmoidoscopy within the past five years; or a colonoscopy within the past ten years.
* Have an appointment at one of the clinic sites

Exclusion Criteria:

* Will include: inability to speak either English or Spanish, severe illness at the time of the clinic visit, co-morbidity that is estimated to limit life-expectancy to less than 5 years as estimated by the treating nurse or provider, severe cognitive, visual, or hearing impairment that would preclude Decision Aid (DA) viewing. We will also exclude patients who are at elevated risk for CRC, defined as having ever been diagnosed with CRC, a precancerous (adenomatous) polyp, or inflammatory bowel disease.
A Biomarker Study of ATH434 in Participants With MSA

This study will assess the safety and efficacy of ATH434 in participants with a clinical diagnosis of Multiple System Atrophy


Eligibility Criteria:
Inclusion Criteria:

1. Participant has clinical features of parkinsonism.
2. Participant has evidence of orthostatic hypotension and/or bladder dysfunction.
3. Participant has ataxia and/or pyramidal signs on neurological examination.
4. Participant has biomarker evidence of MSA in biologic fluid and on MRI.

Exclusion Criteria:

1. Participant is unable to swallow study drug.
2. Participant is unable to attend study visits or complete study procedures.
3. Participant has structural brain abnormality on MRI.
4. Participant has any significant neurological disorder other than MSA.
5. Participant has an unstable medical or psychiatric illness.
6. Participant has a contraindication to, or is unable to tolerate, MRI or lumbar puncture.
A Phase I Study of TQ-B3139 on Tolerance and Pharmacokinetics

A study of TQ-B3139, inhibitor of ALK/C-Met tyrosine kinase, in patient with advanced cancer

phase I of safety, pharmacokinetic and pharmacodynamic study of TQ-B3139. To recommend a reasonable dose and indication for subsequent research.

Eligibility Criteria:
Inclusion Criteria:

* Histological documentation of Advanced solid tumors
* Lack of the standard treatment or treatment failure
* 18-65years,ECOG PS:0-1,Life expectancy of more than 3 months
* Patients with anti-treatment or surgery within 4 weeks
* Main organs function is normal
* Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped
* Patients should participate in the study voluntarily and sign informed consent

Exclusion Criteria:

* Patients participated in other anticancer drug clinical trials within 4 weeks
* Blood pressure unable to be controlled(systolic pressure\>140 mmHg，diastolic pressure\>90 mmHg).

Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QT≥470ms)

* Patients with non-healing wounds or fractures
* Patients with drug abuse history and unable to get rid of or Patients with mental disorders
* History of immunodeficiency
* Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment
Analysis of Circulating Epithelial Tumor Cells in Peripheral Blood in Patients With Primary Non-metastatic Breast Cancer Under Adjuvant Radiotherapy

The aim of this study was to investigate the systemic effect of radiotherapy on patients with primary non-metastatic breast cancer using CETC and to analyze possible changes in CETC quantity under adjuvant radiotherapy.

In cooperation with the Women's Hospital of the Friedrich Schiller University in Jena, a total of 161 patients with clinically proven, primarily non-metastatic breast cancer were sampled and examined before and after radiotherapy over a period from 09/2002 to 09/2012. The MAINTRAC method was used to quantitatively determine the amount of CETC in the blood and to observe its peritherapeutic course.

Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed invasive breast carcinoma
* age \>= 18 years
* exclusive treatment at the Jena University Hospital
* complete curative-intended adjuvant or definite radiotherapy
* at least 2 blood collections (before the start of therapy, after the end of the RT)

Exclusion Criteria:

* presence of metastases
* recurrence
* DCIS, inflammatory breast cancer
* second malignancy \<10 years before diagnosis of breast cancer
* radiotherapeutic pretreatment
Temporal Artery Temperature Measurement in Neonates

The aim of this study was to evaluate the temporal artery thermometer by comparing temporal artery and axillary thermometer temperature measurements with rectal thermometer temperature measurements in neonatal patients. The investigators measured temporal artery, axillary, and rectal temperatures of 49 infants. Temporal artery temperature was measured using an infrared temporal artery thermometer, and the results with this device were compared with axillary temperature (clinical standard) and rectal temperature (gold standard). The difference between rectal and temporal artery temperatures was compared with the difference between rectal and axillary temperatures for each infant, and the data were analyzed based on weight, postmenstrual age and bed type - open crib or incubator.


Eligibility Criteria:
Inclusion Criteria:

* Patients in hospital well-baby nursery or neonatal intensive care unit

Exclusion Criteria:

* Birth weight \<500 grams
* Anal atresia
* Central nervous system malformation
* Hypoxic-ischemic encephalopathy
* Clinical concerns for necrotizing enterocolitis or other bowel injury or discontinuity
Study to Evaluate the Efficacy and Safety of P-3074 Topical Solution in the Treatment of Androgenetic Alopecia

The purpose of this study is to confirm the clinical efficacy and the safety of P-3074 in participants with androgenetic alopecia.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent before starting any study related procedures;
* Men 18 to 40 years of age;
* Men with mild to moderate vertex male pattern hair loss according to a modified Norwood/Hamilton classification scale (III vertex, IV or V);
* Participants willing to have a tattoo in the target area;
* Outpatients;
* Ability to comprehend the full nature and purpose of the study, including possible risks and side effects;
* Ability to co-operate with the Investigator and to comply with the requirements of the entire study.

Exclusion Criteria:

* Clinically relevant abnormal skin scalp findings which could interfere with the aim of the study; in particular, abrasion, actinic keratosis, inflammatory disorders or any other abnormality;
* Participants who had had hair transplant surgery or hair weaving;
* Clinically relevant abnormal laboratory values indicative of physical illness;
* Ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study;
* History of local infections of skin and subcutaneous tissues of the head in the 3-months period before the trial inclusion;
* Relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases, that may interfere with the aim of the study;
* Suspicion of malignancy, including prostate cancer;
* History of infertility or difficulty fathering children;
* Participants who wish to conceive children during the study or whose sexual partner(s) is pregnant;
* Participants with active seborrheic dermatitis;
* History of varicocele;
* Concurrent use of systemic corticosteroids, topical corticosteroids in the balding area studied, anabolic steroids, or over-the-counter "hair restorers";
* Use of the following drugs with antiandrogenic properties within 6 months of study entry: flutamide, cyproterone acetate, estrogen, progesterone, cimetidine, spironolactone or ketoconazole;
* Participants who had been treated with any of the following drugs within the past year: minoxidil (topical or oral), zidovudine, cyclosporine, diazoxide, phenytoin, systemic interferon, psoralens, streptomycin, penicillamine, benoxaprofen, tamoxifen, phenothiazines or cytotoxic agents;
* Use of finasteride or dutasteride within previous 12 months;
* Light or laser treatment of scalp within previous 3 months;
* Participation in the evaluation of any drug for 3 months before this study, calculated from the first day of the month following the last visit of the previous study;
* History of drug, alcohol \[\>2 drinks/day defined according to USDA Dietary Guidelines 2010\], caffeine (\>5 cups coffee/tea/day) or tobacco abuse (10 cigarettes/day).
Rosiglitazone and Insulin in T1DM Adolescents

Type 1 Diabetes is the most common life-long disorder with onset in childhood. Patients need insulin injections, blood sugar monitoring several times each day, and adhere to a strict diet. Adequate control of blood glucose is essential to prevent long term kidney and eye complications that result in kidney failure and blindness. Adolescence is a time when diabetes is difficult to control, due in part to high growth hormone levels causing insulin resistance ( a state where the body does not respond as strongly to insulin). This study will test whether treatment with rosiglitazone (an oral medication used frequently in type 2 diabetes) will reduce the insulin resistance of adolescence and improve the control of type 1 diabetes during puberty.


Eligibility Criteria:
Inclusion Criteria:

* T1DM duration \> 1year
* age 10-18years
* HbA1c \> 8%
* puberty \> Tanner stage 2 breast or testis \>4ml

Exclusion Criteria:

* known non-compliance
* hypo unaware