cyrilzakka/clinical-trials huggingface dataset:
Collection of Specimens and Clinical Data for Patients With Recurrent or Metastatic Breast Cancer or Male Breast Cancer

This study is being done to create a resource of samples and information that can be used to improve our understanding of the development, progression and treatment of recurrent or metastatic breast cancer or male breast cancer.

PRIMARY OBJECTIVE:

I. To collect blood samples and fresh tissue from biopsies of metastatic lesions from Mayo Clinic patients with metastatic breast cancer.

OUTLINE: This is an observational study.

Patients undergo blood sample collection, tumor biopsy and have their medical records reviewed on study.

Eligibility Criteria:
Inclusion Criteria:

* Female participants must have histologically or cytologically confirmed invasive breast cancer.
* Male participants must have biopsy proven breast cancer.
* Age must be \>= 18 years, and all must be able to understand and willing to sign an informed consent document.

Exclusion Criteria:

* Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent; a history of serious or life-threatening allergic reaction to local anesthetics (i.e. lidocaine, xylocaine).
* Any other condition, which in the opinion of the patient's treating oncologist, or the physician performing the biopsy procedure, would make participation in this protocol unreasonably hazardous for the patient.
Effects of a NeuroAD System, for the Treatment of Alzheimer Disease

To evaluate the long-term efficacy of the NeuroAD system

To evaluate the long-term efficacy of the NeuroAD system in improvement of mild- to moderate Alzheimer patients' cognitive function

Eligibility Criteria:
Main Inclusion Criteria:

1. Male or female age 60-90 years
2. Patients diagnosed with mild or moderate stage of Alzheimer's Disease, according to the DSM-IV criteria
3. MMSE score 18 to 26
4. Physical clearance for study participation as evaluated by the clinician
5. Spouse, family member or professional caregiver agree and capable of taking care for the participation of the patient in the study (answering questions regarding the patient's condition and assuming responsibility for medication)
6. Informed consent by the patient or by legally authorized person if appointed

Main Exclusion Criteria:

1. CDR 0, 0.5 or 3
2. Severe agitation
3. Mental retardation
4. History of Epileptic Seizures or Epilepsy
5. Contraindication for performing MRI scanning
6. Contraindication for receiving TMS treatment according to a TMS questionnaire
7. Patients with metal implants in the head, (i.e. cochlear implants, implanted brain stimulators and neurostimulators, aneurysm clips) with the exception of metal implants in mouth
8. Cardiac pacemakers
9. Implanted medication pumps
10. Intracardiac lines
11. Significant heart disease
12. Currently taking medication that lower the seizure threshold
Feasibility Study of a Vaginal Ring for Delivery of TMC120 (Dapivirine)

The purpose of this trial was to evaluate the safety and feasibility of using a vaginal ring to deliver the candidate microbicide TMC120 (dapivirine). Twelve women initially underwent 7-day exposure to a placebo ring containing no investigational agent. They then underwent 7-day exposure to a ring containing 120 mg of TMC120 (dapivirine). Feasibility was assessed in terms of safety and tolerability as well as drug delivery.


Eligibility Criteria:
Inclusion Criteria:

* Female, 18-50 years, inclusive
* Willing and able to provide written informed consent
* HIV-uninfected and otherwise healthy
* Willing to abstain from sexual activity and use of vaginal products while participating in the trial
* Currently using oral contraceptives for pregnancy prevention
* Willing to use oral contraceptives as needed to avoid menstruation while taking part in this trial

Exclusion Criteria:

* History of alcoholism, drug abuse, psychosis, antagonistic personality, poor motivation, or other emotional or intellectual problems that are likely to invalidate the informed consent process or adversely impact compliance with protocol requirements.
* History of allergy to TMC120 or to the constituents of the vaginal ring.
* History of hypersensitivity to propofol, or other contraindication to general anesthesia or sedation
* History of diagnosis of and/or treatment for a sexually transmitted disease within the last three months.
* History of genital tract surgery within the last month
* Currently pregnant or breastfeeding, or within two months of last pregnancy outcome
* Currently or within one month of participating in any other clinical research trial
* Current (during screening) diagnosis of any genital infection
* Current vulvar of vaginal symptoms
* Current non-iatrogenic pelvic/colposcopic exam findings involving deep epithelial disruption
Assessing Online Interventions for Men's' Mental Health and Wellbeing

The purpose of this study is to test a comprehensive, male-oriented, online screening and referral (Screening for Mental Health; SMH) and male-oriented online information and referral intervention program (Man Therapy; MT) to improve mental health and wellbeing with a focus on prevention of suicide and help-seeking behaviors among middle-aged men. The online programs will be offered together to maximize the effect on reducing suicide behavior and increasing mental health help-seeking behaviors for men. If successful in decreasing suicide behavior and ideation and increasing suicide help-seeking behavior, this intervention could be scaled up to contribute to a reduction in suicide behaviors and deaths across the country.


Eligibility Criteria:
Inclusion Criteria:

1. men living in Michigan;
2. 25-64 years of age at time of enrollment;
3. scoring in the moderate- to high-risk range (or answering positively on Question 9) on the Harvard Department of Psychiatry/NDSD Scale (HANDS), scoring in the moderate- to high-risk range for anger on the DSM-5 Level 1 Cross-Cutting Symptom Measure, or identifying any risk for suicide ideation or behavior on the Columbia-Suicide Severity Rating Sale (C-SSRS); and
4. fluent in reading English

Exclusion Criteria:

1. females
2. scoring in the low risk range on the Harvard Department of Psychiatry/NDSD Scale (HANDS), scoring in the low risk range for anger on the DSM-5 Level 1 Cross-Cutting Symptom Measure, or not identifying any risk for suicide ideation or behavior on the Columbia-Suicide Severity Rating Sale (C-SSRS); and
3. not fluent in reading English
Feasibility of a Physiological Monitoring for Teleassistance to Isolated Workers in Industrial Cleaning

The purpose of the study is to test the feasibility of the monitoring of physiological parameters during operations of industrial cleaning

A letter about TIGER study is sent to employees eligible to participate. For volunteers, a written consent is signed after complete oral and written explanation of the protocol is signed.

On the day of the industrial cleaning task, the employee wears the connected t-shirt and performs the cleaning. Data are retrieved on a 5 min interval basis. Physiological parameters above or beyond pre-defined limits are transmitted as potential alarms to an operational teleassistance center. A missing data (Invalid recording) are considered alarms.

The number and causes of alarms are determined after the end of the cleaning task.

Eligibility Criteria:
Inclusion Criteria:

* Employee involved in industrial cleaning task of non-ATEX sites (EXplosive ATmosphere)
* Affiliation to the French National healthcare system
* French speaking employee

Exclusion Criteria:

* Contraindication to the measures or procedures provided for in the study (physical characteristics do not allow measurements to be taken, wounds, etc.)
* Pregnancy
* Inability to understand the study goal
* Employee protected by decision of law
Safety, Tolerability, and Efficacy Study of Idiopathic Pulmonary Fibrosis

To evaluate the safety and tolerability of FG-3019 in subjects with Idiopathic Pulmonary Fibrosis (IPF) and the efficacy of FG-3019 for attenuating fibrosis in these subjects.

Major Changes: FGCL-3019-049 Protocol Amendment 3 offers long-term extension of treatment with FG-3019 to eligible Cohort 1-EX (approximately 14 subjects) and Cohort 2 (approximately 28 subjects) subjects who complete the Week 48-EX and Week 48 assessments described in Protocol Amendment 2, respectively. A subject is eligible for long-term extension of treatment if the investigator, after discussion with the Fibrogen Medical Monitor, believes that the subject would benefit from continued treatment with FG-3019.

Eligibility Criteria:
Main Inclusion Criteria:

1. Age 35 to 80 years, inclusive.
2. Clinical diagnosis of IPF by high resolution computed tomography (HRCT) scan (and in some cases by surgical lung biopsy) and reduced lung function (forced vital capacity).
3. History of IPF of 5 years duration or less.
4. Evidence of progression of IPF within the last 3-12 months for Cohort 1, or within the last 18 months for Cohort 2 before screening.
5. Women of childbearing potential, and men, must be willing to use a medically acceptable method of contraception during the trial and 3 months after the last dose of study drug.

Main Exclusion Criteria:

1. Women who are pregnant or nursing.
2. History of any other types of lung or heart disease and any other medical conditions that, in the opinion of the investigator, would preclude the subject's participation in the study.
3. Clinically important abnormal laboratory tests.
4. Upper or lower respiratory tract infection of any type within 4 weeks of the first screening visit.
5. Acute exacerbation of IPF within 3 months of the first screening visit.
6. Use of certain medications within 4 weeks of the first screening visit.
7. Receipt of an investigational drug within 6 weeks of the first screening visit.
8. History of cancer of any type in the 5 years preceding the first screening visit, excluding non-melanomatous skin cancer, localized bladder cancer, or in situ cervical cancer.
9. Trauma or surgical procedures requiring hospitalization within 4 weeks of the first screening visit.
10. Planned elective surgery during the study including 4 weeks following the final dose of study drug.
11. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies.
12. Inability to cooperate with study personnel or history of non-compliance to a medical regimen.
13. Previous treatment with FG-3019.
Post-marketing Surveillance of Administration of Botulinum Toxin Type B(NerBloc)-Investigation of the Clinical Condition and Safety in Patients With Cervical Dystonia

Investigation of the clinical condition and safety in patients with cervical dystonia


Eligibility Criteria:
Inclusion criteria:

Patients with cervical dystonia

Exclusion criteria:

The patients who participated in this surveillance in the past
Third-Generation CAR-T-cell Therapy in Individuals With HIV-1 Infection

To evaluate the safety of autologous CAR-T-cell therapy in individuals lived with HIV-1 infection, CAR T cells are infused after ex vivo expansion and transduction with lentiviral vectors encoding a broadly neutralizing HIV-1 scFv antibody.

This study is a prospective, single-center, single-arm, open-label and phase I clinical trial. Subjects with CD4+T cell counts greater than 350/μl and viral loads of \<50 copies/ml over 1 year by antiviral treatment are enrolled. T cells are stimulated with CD3 and CD28, transduced with lentiviral vectors encoding a broadly neutralizing HIV-1 scFv antibody and expanded for approximately 2 weeks. Then, patients are infused with CAR T cells at a dosage of 1×10\^5 CAR-T cells/kg body weight. If this dose is well tolerated, dosing will be increased to 5×10\^5 CAR T cells/kg body weight. After infusion, adverse events, and HIV-1 latent reservoir size and CAR levels in peripheral blood will be monitored to assess the safety of CAR-T-cell treatment, potential therapeutic efficacy and kinetics of CAR T cells.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 to 70 years
2. HIV-1 infection by confirmed test;
3. Receiving antiviral treatment ≥ 1 years;
4. Current CD4+ T cell count \> 350 cells/μl;
5. HIV-1 RNA levels of \< 50 copies/ml for at least a year;
6. Patients who agrees to use two effective methods of contraception to avoid pregnancy during the study period.
7. Patients who sign the informed consent form prior to inclusion in the study.

Exclusion Criteria:

1. Patients with concomitant HAV, HBV, HCV, HDV, HEV, EBV, CMV or syphilis infection;
2. A history of AIDS-related opportunistic infections and tumors within 1 year prior to enrollment;
3. A History of corticosteroids or immunosuppressive drugs for autoimmune diseases by physicians within the last 2 years;
4. Participants with clinically significant laboratory abnormalities as follows:

   * Hemoglobin ≤ 10 gm/dl (female), \<11g/dl (male)
   * Absolute neutrophil count ≤ 1×10\^9/L
   * Platelet count ≤100×10\^9/L
   * Alanine aminotransferase (ALT)≥ 2.5 x ULN
   * Aspartate aminotransferase (AST) ≥ 2.5 x ULN
   * Total bilirubin \> 1.5 ULN
   * Serum creatinine \>110 μmol/L
   * International normalized ratio (INR) \>1.5 or activated partial thromboplastin time (APTT) \>45 s
5. Patients with severe psychiatric illness, drugs or alcohol abuse;
6. A woman who is in pregnancy or lactation;
7. A history of central nervous system disease, such as cerebral hemorrhage, dementia, epilepsy and autoimmune diseases;
8. Patients with a non-AIDS-related serious underlying disease;
9. Patients who participate in another clinical study currently which may affect the results of this study.
A Study of RoActemra/Actemra (Tocilizumab) With or Without Methotrexate in Patients With Mild to Moderate Rheumatoid Arthritis With an Inadequate Response to Methotrexate

This multicenter study with a randomized, double-blind, parallel-group phase will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate versus RoActemra/Actemra monotherapy in patients with mild to moderate rheumatoid arthritis, with an inadequate response to methotrexate. Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks plus oral methotrexate 15-25 mg weekly for 12 weeks. Patients with a good/moderate EULAR response will then be randomized to receive either RoActemra/Actemra plus methotrexate or RoActemra/Actemra plus placebo for the following 12 weeks. Anticipated time on study treatment is 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Rheumatoid arthritis of \>/= 1 year duration
* Mild to moderate disease activity at screening (DAS 28 \</= 4.5 and \>2.6)
* On methotrexate treatment for at least 12 weeks, at stable oral dose of (10)15 mg to 25 mg/week for at least 6 weeks prior to Day 1
* Body weight \</= 150 kg
* Oral corticosteroids must have been at stable dose (maximum 10 mg/day) for at least 25 out of 28 days prior to baseline

Exclusion Criteria:

* Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after baseline
* Rheumatic autoimmune disease other than rheumatoid arthritis
* Functional class IV American College of Rheumatology (ACR) Classification
* Prior history of or current inflammatory joint disease other than rheumatoid arthritis
* Treatment with a biologic agent at any time prior to baseline
* Treatment with traditional DMARDs other than methotrexate within 1 month (for leflunomide 3 months) prior to baseline
* Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
* Previous treatment with tocilizumab
* Pregnant or lactating women
* Uncontrolled disease states, such as asthma, psoriasis or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids
* Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections
* History of or currently active primary or secondary immunodeficiency
* Evidence of active malignant disease, malignancies diagnosed within the previous 5 years
* Active tuberculosis requiring treatment within the previous 3 years
* Positive for HIV infection
Research Study to Investigate How Well Semaglutide Tablets Taken Once Daily Work in People Who Are Overweight or Living With Obesity (OASIS 1)

This study is being conducted to see if semaglutide tablets can be used as a treatment to help people living with overweight or obesity lose weight.

This study will look at the change in participants body weight. Participants will either get semaglutide tablets (new medicine) or placebo tablets ('dummy' medicine that looks like semaglutide but has no effect on the body). For a fair comparison, people are divided into two groups at random by a computer. This process is called randomisation.

Semaglutide tablets are new medicine being tested to treat overweight and obesity. Doctors in many countries can already prescribe semaglutide tablets at lower doses to treat type 2 diabetes.

Participants will get semaglutide or placebo tablets for 68 weeks and will need to take 1 tablet every morning

In addition to taking the medicine, participants will have talks with study staff about:

* healthy food choices
* how to be more physically active
* what participants can do to lose weight The study will last for about 1½ year.Participants will have 14 clinic visits and 7 phone calls with the study doctor. Blood samples will be taken at 10 visits.

Participants will have a test to check their heart done at 3 visits. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period. If participant is a woman and is able to become pregnant, participant will be checked for pregnancy via urine tests.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age greater than or equal to 18 years at the time of signing informed consent
* Body mass index (BMI):

greater than or equal to 27.0 kg/m\^2 with the presence of at least one of the following weight-related complications (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease OR greater than or equal to 30.0 kg/m\^2

* History of at least one self-reported unsuccessful dietary effort to lose body weight

Exclusion Criteria:

* HbA1c greater than or equal to 6.5% (48 mmol/mol) as measured by the central laboratory at screening
* A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
Infusion System for Hepatic Cancer

This is a single-site, open-label continued access study/treatment protocol under a treatment IDE. In addition to treating patients, the primary objective of this study is to assess the safety of using the Medtronic SynchroMed II programmable pump combined with the Intera tapered catheter for hepatic artery infusion (HAI) of a standard chemotherapy (FUDR) drug for adults with a clinical or biopsy-proven diagnosis of colorectal cancer metastatic to the liver or intrahepatic cholangiocarcinoma.

After successful implantation, the combined pump and catheter system will be evaluated using a nuclear scan in the postoperative period, which is standard procedure to confirm that the pump is functioning prior to HAI of FUDR. Monitoring for safety will include a record of residual pump volume when it is emptied (every 2-12 weeks depending on whether the pump is being used for chemotherapy infusion) to determine if the pump is still working and surveillance of routine cross-sectional imaging (usually every 2-6 months) for any sign of a pump or catheter problem. Patients will be monitored for the safety of the pump/catheter combination for up to 5 years or pump removal/study withdrawal.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be greater than or equal to 18 years of age
* Have a clinical or biopsy-proven diagnosis of colorectal cancer metastatic to liver or intrahepatic cholangiocarcinoma
* At the time of pump placement, patients will either have unresectable, chemotherapy-responsive disease or they will be undergoing resection with planned postoperative HAI
* Be deemed appropriate for pump chemotherapy by both a medical oncologist and a surgical oncologist
* Provision of signed and dated informed consent form

Exclusion Criteria:

* Known active infection
* Is pregnant or breastfeeding or expecting to conceive children within the projected duration of the trial
Virtual-reality and Emotion Regulation in Violence-Exposed Youth

The current proposal aims to evaluate a novel virtual-reality-based (VR-B) video game treatment for emotional dysregulation for youth currently under the supervision of the juvenile justice system. 135 participants under the age of 17 will be enrolled and will be asked to complete up to 6 VR-B sessions.

The goal of this proposal is to determine the feasibility of a novel virtual-reality-based biofeedback (VR-B) treatment among youth highly vulnerable to difficulties in emotional regulation. Biofeedback, which involves the provision of real-time information about physiology, is a well-studied approach to enhancing self-regulatory ability, with potential promise for alleviating mental health problems. In children (as well as adults), biofeedback may be ideally facilitated through video game environments, which offer engaging, immersive, yet dynamic environments that can be changed in real-time. Video games are enormously popular with youth, and may represent an important avenue for treatment in adolescent populations. The current proposal aims to evaluate a novel virtual-reality-based video game treatment for emotional dysregulation for youth currently under the supervision of the juvenile justice system. Exposure to risk factors known to promote impaired self-regulation, such as child mal-treatment, is nearly endemic in this population. Indeed, 'delinquent' youth (i.e., youth in contact with the justice system) are considerably more likely to meet diagnostic criteria for a range of disorders centrally involving dysregulation of affect or arousal, such as post-traumatic stress disorder, anxiety, depression, oppositional defiant disorder, and many others.

Specific Aims:

* AIM 1: Evaluate the feasibility of a virtual reality treatment for youth

  * Hypothesis 1: Study youth receiving treatment with the virtual reality-based paradigm will qualitatively report the experience to be tolerable and positive with minimal discomfort.
* AIM 2: Identify potential changes in physiological signaling (e.g., heart rate, skin conductance) across treatment sessions

  * Hypothesis 2: Youth receiving virtual reality biofeedback (VRB) treatment will exhibit physiological changes across sessions (e.g., increased heart rate variability or changes in skin conductance responses).
* AIM 3: Identify potential changes in symptom severity across treatment sessions

  * Hypothesis 3: Youth receiving virtual reality biofeedback (VRB) treatment will show greater improvements in youth emotion regulation and reduced severity of PTSD mental health symptoms.

Eligibility Criteria:
Inclusion Criteria:

1. 13 to 17 years of age at enrollment
2. Availability of a caregiver to provide oral consent
3. Able to provide assent/consent in English
4. Visual acuity adequate to read text on a computer monitor

Exclusion Criteria:

1. Report of previous discomfort with immersive experiences, including virtual reality, 3D films, or similar media
2. Active psychosis or comparably impairing psychiatric condition
Fluid Responsiveness Using TFU (Transfontanel Ultrasound) in Children With Congenital Heart Disease

The purpose of this study was to evaluate the clinical usefulness of TFU (transfontanel ultrasound)for the prediction of fluid responsiveness in children undergoing congenital heart surgery.


Eligibility Criteria:
Inclusion Criteria:

* pediatric patients undergoing cardiac surgery

Exclusion Criteria:

* preterm closure of anterior fontanelle
* anatomical abnormalities on aortic arch (ex, patent ductus arteriosus)
* presence of intracardiac and extracardiac shunt