cyrilzakka/clinical-trials huggingface dataset:
Expanded Access Protocol for PV-10 for Cutaneous or Subcutaneous Tumors

This compassionate use protocol provides expanded access for investigational use of PV-10 in cancer patients who are not eligible for an existing PV-10 clinical trial, for whom there is no comparable or satisfactory approved alternative therapy and whom, in the opinion of the investigator, may benefit from PV-10 administration.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older, male or female.
2. Histologically or cytologically confirmed cancer where there is no comparable or satisfactory approved alternative therapy specific to cutaneous or subcutaneous tumors.
3. Performance Status: ECOG 0-2.
4. Life Expectancy: At least 6 months.
5. Blood Chemistry:

   * Creatinine ≤ 3 times the upper limit of normal (ULN).
   * Total bilirubin ≤ 3 times the upper limit of normal (ULN).
   * AST/ALT/ALP ≤ 5 times the upper limit of normal (ULN).
6. Thyroid Function

   * Total T3 or free T3 (serum triiodothyronine), total T4 or free T4 (serum thyroxine) and THS (serum thyrotropin) ≤ grade 2 abnormality.
7. Renal Function

   * Subjects must have adequate renal function in the opinion of the Investigator with no clinically significant renal impairment or uncontrolled renal disease.

Exclusion Criteria:

1. Cancer patients who are eligible for an existing PV-10 clinical trial.
2. Certain photosensitizing agents within 5 half-lives prior to PV-10 administration.
3. Concurrent or Intercurrent Illness:

   * Subjects with uncontrolled diabetes or extremity complications due to diabetes.
   * Subjects with severe peripheral vascular disease.
   * Subjects with significant concurrent or intercurrent illness, psychiatric disorders, or alcohol or chemical dependence that would, in the opinion of the Investigator, compromise their safety or compliance or interfere with interpretation of study results.
   * Subjects with uncontrolled thyroid disease, goiter, partial thyroidectomy, radioiodine- or surgically-treated Graves' hyperthyroidism or cystic fibrosis.
   * Subjects with clinically significant acute or unstable cardiovascular, (stroke), renal, gastrointestinal, pulmonary, immunological (with the exception of the presence of hepatitis B virus (HBV), viral hepatitis, or cirrhosis), endocrine, or central nervous system disorders.
4. Pregnancy:

   * Female subjects who are pregnant or lactating.
   * Female subjects who have positive serum ßHCG pregnancy test taken within 7 days of PV-10 administration.
   * Fertile subjects who are not using effective contraception.
5. Investigational Agents:

   * Subjects who have received investigational agents within 4 weeks (or 5 half-lives) of study administration.
Characterizing the Synergistic Effects of Physical and Cognitive Training on Attention and Working Memory

The primary goal of this project is to evidence potential synergistic benefits on cognitive control processes using a video game ("Body-Brain Trainer", or BBT) that integrates cognitive and physical challenges in a complimentary fashion. Healthy adults will be recruited for a longitudinal experiment and randomly assigned to one of four study groups to mechanistically tease apart the possible presence of any synergistic effects on cognitive abilities through the combination of cognitive \& physical challenges.

Cognitive control functions (e.g. attention, working memory, goal-management) dictate our ability to learn and accomplish selected behavioral goals, with deficiencies in these processes found in a range of mental illnesses. The primary goal of this project is to evidence potential synergistic benefits on cognitive control processes using a video game ("Body-Brain Trainer", or BBT) that integrates cognitive and physical challenges in a complimentary fashion. Healthy adults will be recruited for a longitudinal experiment and randomly assigned to one of four study groups: 1) BBT, 2) "Brain Training" (BBT played with a gamepad controller), 3) "Body Training" (BBT without any cognitive demands), and 4) an expectancy matched placebo control group. Individuals will engage in eight weeks of training within our Neuroscape Laboratory, with pre- and post-training assessments evaluating physical, cognitive, and neural measures. The completion of this project will result in a more sophisticated understanding of how the integration of cognitive and physical training potentially impacts cognitive control processes, setting the stage for more effective interventions for mental illness and learning-related impairments.

Eligibility Criteria:
Inclusion Criteria:

* Can walk briskly for at least 15 minutes continuously without stopping
* Can stand up from a chair without using your hands
* Available to come 3x/week to our UCSF Mission Bay laboratory for 8 weeks
* Willing and able to undergo MRI, EEG procedures
* English fluency

Exclusion Criteria:

* cardiac problems
* bypass surgery
* pacemaker or heart valve replacement
* stroke
* respiratory conditions
* head trauma with loss of consciousness for less than a few minutes
* severe head trauma with loss of consciousness for more than a few minutes
* high/low blood pressure
* kidney failure
* electroconvulsive therapy (ECT)
* seizures
* implanted electrodes
* cancer/chemotherapy/radiation
* diabetes
* irritable bowel syndrome
* back problems
* claustrophobia
* Having been diagnosed with a psychiatric or neurological disorder
* Use of an assistive device (e.g., cane or walker) at any time to assist with ambulation
* Joint problems causing significant pain upon movement
* Heart Disease or Cardiovascular Disease
* Respiratory Disease (Lung Disease)
Multimodal Geriatric Pre-authorization Before Scheduled Orthopedic Surgery

The main objective of this multicentric, prospective and interventional study is to assess the feasibility of multimodal prehabilitation in patients aged 75 years or older with surgical indication for coxarthrosis or severe gonarthrosis

This study consists of a pre-established surgical preparation program in cooperation with physiotherapists or physical activity instructors, dieticians, psychologists, physical therapists and nurses.

This innovative program improves muscle strength, balance and walking of the study patients. It also allows for faster and better recovery of their physical fitness and intellectual abilities after surgery.

These interventions will be performed in day admission (DA) and at home and will consist of training, a diet program to strengthen the muscles and balance of the patients participating in the study.

Patients who agree to participate in the study will receive interventions for 6 weeks prior to surgery, partly in a day hospital and partly at home, including:

* Muscle rehabilitation developed with a physiotherapist or physical activity instructor
* Nutritional support (dietician at 1st, 3rd, and 6th day admission (DA), referring geriatrician)
* Cognitive and physical stimulation "Exergame" (Genious Healthcare); with only cognitive exercises at home
* Psychological support by a psychologist
* Information in the form of videos on the main risks and important points to know and prepare before and after surgery
* 1 follow-up call per week made by the PRE4OS referent between each day admission (DA) to assess patient satisfaction, any limitations encountered, possible exercises at home, the occurrence of possible adverse effects
* 1 hour per week home adapted physical activity session by the Siel Bleu association

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 75 years
* Surgical indication for total hip or knee replacement for hip or knee osteoarthritis.
* Minimum time of 6 weeks between inclusion visit and date of surgery
* Physical (excluding coxarthrosis or knee osteoarthritis) and cognitive capacities to follow a prehabilitation program (assessment by the geriatrician)
* Proximity between place of life and hospital to go to the center for pre-rehabilitation
* Good understanding of the French language
* Benefiting from social coverage
* Have read the information notice and have consented to participate in the study by signing a written consent

Exclusion Criteria:

* Urgent surgery (trauma, acute dislocation)
* Neurocognitive disorders at a moderate or severe stage (Mini Mental State Examination (M.M.S.E) ≤20), or not evaluable and not allowing to participate in the prehabilitation program
* Lack of social coverage (beneficiary or beneficiary)
* Adult persons subject to a legal protection measure (curatorship, guardianship and safeguard of justice)
* Refusal to participate
* Hospitalized patients ( the living space can be the home or thelon term care).
Analgesic Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Knee

To study the efficacy and safety of naproxcinod vs. placebo and naproxen in the treatment of signs and symptoms of Osteoarthritis.

This is a 13-week double-blind study followed by a 52-week, open-label, roll-over on active treatment study. These are randomized, parallel group, multicenter studies comparing efficacy and safety of naproxcinod, placebo and naproxen.

Eligibility Criteria:
Inclusion Criteria:

* Men and women (40 or older) with a diagnosis of primary OA of the knee
* Must be a current chronic user of NSAIDS or acetaminophen
* Must discontinue all analgesic therapy at screening

Exclusion Criteria:

* Uncontrolled hypertension or diabetes
* Hepatic or renal impairment
* Current or expected use of anticoagulant
* A history of alcohol or drug abuse
* Candidates for imminent joint replacement
* Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding, within the last 6 months
* Current medical disease that could confound or interfere with the evaluation of efficacy
* Participation within 30 days prior to screening in another investigational study
Brief Alcohol Intervention for HIV-Infected Men Who Have Sex With Men (MSM) in a Primary Care Setting

This is a randomized clinical trial to examine the effects of a brief counseling intervention for heavy drinking HIV-infected men who have sex with men compared to HIV care as usual. The study tests the hypothesis that brief counseling will lower drinking in these patients and that reductions in drinking will be associated with better HIV-related outcomes.

This study is a randomized clinical trial in which 224 heavy drinking men who have sex with men (MSM), who receive their HIV primary care at Fenway Health in Boston, are randomly assigned to treatment as usual (TAU) or TAU plus a brief intervention to reduce alcohol use (TAU-BI). TAU-BI will be based in Motivational Interviewing and include personalized feedback tailored to an HIV-infected MSM population. Follow-ups will occur at 3, 6, and 12 months. The first primary aim of the study is to test the hypothesis that TAU-BI, compared to TAU, will result in reduced alcohol consumption over a 12-month follow-up period as indicated by: (1) a lower number of alcoholic drinks consumed per week; (2) a lower number of drinking days within each follow-up period; and (3) a lower number of heavy drinking days within each follow-up period. The second primary aim is to test the hypothesis that greater reductions in alcohol use will be associated with (1) greater adherence to HIV medication regimens; (2) less engagement in high-risk sexual behavior that could result in HIV transmission; (3) lower plasma HIV RNA levels (viral load) (CD4 cell counts will be a secondary outcome in this sub-aim); (4) improved liver function tests; and (5) improved neurocognitive function.

Eligibility Criteria:
Inclusion Criteria:

* be at least 18 years of age
* drink heavily at least once per month on average (≥5 drinks) or drink more than 14 drinks per week
* have a confirmed diagnosis of HIV/AIDS
* be a male who has had sex (oral or anal) with a male partner in the past 3 months.

Exclusion Criteria:

* current intravenous drug use
* currently psychotic, suicidal, or manic
* are currently being treated or have been treated in the past 3 months for an HIV-related opportunistic infection
* currently receiving treatment for an alcohol or drug problem
ANET Electrosurgery Applicator Pilot Evaluation Study

Evaluate the preliminary safety and performance of the Electrosurgery Applicator (ANET device) during and after bronchoscopic ablation of a target pulmonary nodule/tumor.

This study is a prospective, single arm, single center study that will evaluate the effectiveness of the ANET Electrosurgery Applicator in up to 10 subjects.

Subjects who consent to participate in this study will have a lung tumor that is scheduled to be removed surgically as part of their normal treatment. During the surgical procedure, just prior to resection the subject's tumor will be treated with the ANET device. The ANET device uses a bronchoscope to reach the tumor. Ultrasound on the bronchoscope, CT, and X-rays are used to make sure the ANET device is in the tumor. Once in the tumor, the ANET device uses radio-frequency (RF) ablation to treat the tumor. After standard surgical resection the tumor and surrounding tissue is evaluated to characterize the effect of the ANET.

Eligibility Criteria:
Inclusion Criteria:

1. Subject with Stage I or Stage II primary lung cancer or metastatic lung tumor
2. Pathological proof of target nodule/tumor type and malignancy
3. Target nodule/tumor which can be accessed via EBUS bronchoscopy
4. Resection/surgical candidate
5. Participants must be at least 18 years old and able to provide consent

Exclusion criteria:

1. Subjects in whom flexible bronchoscopy is contraindicated
2. Target nodule \< 1.0 cm
3. Prior radiation or neo adjuvant chemotherapy of the target nodule/tumor
4. Any comorbidity that the investigator feels would interfere with the safety of the subject or the evaluation of study objectives
5. Pacemaker, implantable cardioverter, or other electronic implantable device
HealthyWeightHub.fi: Web-based Management of Obesity in a Real-life Clinical Setting

This study evaluates the effectiveness of a web-based obesity management program HealthyWeightCoaching (HWC), within a HealthyWeightHub.fi (HWH) platform. HWC is a 12-month intervention within a real-life clinical setting. The program includes a combination of nutrition, physical activity, and cognitive behavioral approaches, with a strong basis in acceptance and commitment therapy.

In addition to the automated, interactive program, HWC includes a personal coach allocated to each patient. The patients are enrolled through referrals from primary care, occupational health, other hospitals, or from private health care units nationwide in Finland.

Obesity is one of the major public health problems globally and it increases the risk of many obesity-associated diseases. Treatment of obesity requires long-term interventions, but nevertheless, it is challenging to provide long-term treatment when resources in real-life health care systems are limited. New cost-effective and accessible intervention methods are needed.

The modern treatment of obesity is based on behavioral changes that modify one´s daily lifestyle, which, according to recent research, are effective especially in the prevention of diabetes. However, little is known about the utilization and effectiveness of online programs using novel interactive technologies.

The aim of this study is to evaluate the effectiveness of a real-life web-based obesity management program (HealthyWeightCoaching, HWC) on weight loss, health, quality of life, and factors predicting long term success in treating overweight adult patients.

Healthy Weight Coaching is a novel 12-month intervention within a real-life clinical setting. The program includes a combination of nutrition, physical activity, and cognitive behavioral approaches, with a strong basis in acceptance and commitment therapy. The program is structured around weekly exercise modules.

In addition to the automated, interactive program, HWC includes a personal coach allocated to each patient. The patients are enrolled through referrals from primary care, occupational health, other hospitals, or from private health care units nationwide in Finland. The program is free for the patient to use.

The 12-month intervention is followed by a 5-year monitoring period. Questionnaires on health, quality of life, and lifestyle are collected at 0, 3, 6, 9, and 12-month time points. Body weight is collected by weekly logs. The recruitment is ongoing as the program is currently used in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* age over 18 years
* body mass index (BMI) ≥ 25 kg/ m²
* the possibility to use a computer and /or a smartphone with access to the internet
* willingness to participate in the digital treatment program

Exclusion Criteria:

* diagnosed severe illness requiring assessment from the specialty care obesity center
* pregnancy or breastfeeding
Adaptive Androgen Deprivation and Docetaxel in Metastatic Castration Sensitive Prostate Cancer

This is a prospective single center phase IIa open label nonrandomized study, which aims to test the hypothesis that the duration of castration sensitive phase of stage IV prostate cancer can be prolonged with adaptive androgen deprivation therapy (ADT) and Docetaxel.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven prostate cancer and the diagnosis can be established through either prostate biopsy or biopsy of a metastatic lesion.
* No androgen deprivation therapy (ADT) with LHRH analog for more than 4 weeks after the diagnosis of metastatic prostate cancer. Prior ADT in the non-metastatic setting is allowed if it was given \> 2 years prior to the diagnosis of metastatic prostate cancer.
* Achieved \>50% PSA decline and \<4 ng/ml PSA after the run-in period.
* Adequate organ function with absolute neutrophil count \> 1000/l, Hb \> 10 g/dl, Platelet \> 100,000/l, Creatinine and liver enzymes within 1.5 folds of upper limits of normal.
* No uncontrolled arrhythmia; patients with h/o myocardia infarction or history of congestive heart failure, need to have estimated left ventricle ejection fraction above 40% either on echocardiogram or MUGA scan within 6 months of study enrollment.
* ECOG performance status 0-1.
* Non-sterilized men who are sexually active with a female partner of childbearing potential treated or enrolled on this protocol must agree to use adequate contraception prior to the study, for the duration of study participation, and for 6 weeks after last dose of ARSI or docetaxel administration.
* Ability to understand and the willingness to sign a written informed consent document or have a legally authorized representative sign on the subject's behalf. Stated willingness to comply with all study procedures and availability for the duration of the study.

Exclusion Criteria:

* Prior treatments with TAK-700/Orteronel, abiraterone, apalutamide or enzalutamide.
* Surgical castration.
* Documented liver or brain metastases
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to docetaxel (including any drugs formulated with polysorbate 80), or LHRH analog (e.g., leuprolide, triptorelin, relugolix, degarelix)
* Treatment with any investigational compound within 30 days prior to the first dose of study drugs.
* Diagnosis or treatment for another systemic malignancy within 2 years before the first dose of LHRH analog, or previously diagnosed with another malignancy \& have any evidence of residual disease. Patients with early-stage skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
* Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Subjects with delayed healing of wounds, ulcers, and/or bone fractures.
Identification of the Genetic Variants Responsible for Primary Biliary Cirrhosis (PBC)

Primary biliary cirrhosis (PBC) is a disease of the liver, which predominantly affects women. It causes slowly progressive liver disease, which eventually causes liver failure, requiring a liver transplant. Several different studies of large patient cohorts indicate that the cause of this disease is likely due to a combination of factors including genetic and environmental. PBC is associated with several other "autoimmune diseases" - recently a gene has been identified to be abnormal in individuals with another autoimmune liver disease, namely rheumatoid arthritis. This gene usually tells the body when to switch off an immune response. This study plans to identify whether individuals diagnosed with PBC have a similar abnormality in this gene called protein Tyrosine Phosphatase.

Very recently, a single nucleotide polymorphism (SNP) in the PTPN22 gene encoding the Lyp (lymphoid-specific phosphatase) PTP has been shown to be associated with susceptibility to rheumatoid arthritis (RA) and Type 1 diabetes (T1D)4,5. These data are consistent with the known role for Lyp in suppressing T cell activation and with data showing T cell activation (and potentially autoreactivity) to be increased by the RA and T1D-associated PTPN22 variant. The PTPN22 risk allele has also been recently implicated in Grave's disease and as such appears to represent a susceptibility allele for many autoimmune diseases. As a number of these conditions (RA, T1D etc.) frequently occur within members of PBC families, this PTPN22 variant is very likely to also be involved in PBC, a possibility we will directly investigate in this pilot study. The aim of this study is to analyze the frequency of a specific PTPN22 polymorphism in patients with PBC.

Eligibility Criteria:
Inclusion Criteria:

* patients attending Liver Clinic at Toronto Western Hospital, Toronto, ON, Canada
* AMA positive and liver biopsy proven PBC.

Exclusion Criteria:

- AMA negative PBC
MDA D-Dimer / Recurrent DVT Study

To determine whether treatment and further investigation can be safely withheld in patients who present with suspected recurrent deep vein thrombosis (DVT) and have either a (i) negative D-Dimer or (ii) a positive D-Dimer with normal serial compression ultrasound.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Currently suspected for recurrent DVT
* Has a prior history of objectively documented DVT or PE

Exclusion Criteria:

* Comorbid condition limiting survival to less than 3 months
* History of hypersensitivity to contrast medium
* Renal dysfunction with a creatinine of \> 150 mcmol/L
* Treatment with full-dose therapeutic unfractionated or low molecular weight heparin that was initiated 24 hours or more prior to eligibility assessment
* Pregnancy or lactation
* Symptomatic for pulmonary embolism
* Absence of symptoms within five days prior to presentation
* Participation in another trial precluding the use of the diagnostic algorithm in this study
* Geographically inaccessible for follow-up
* Compression ultrasound, venogram, IPG, or D-dimer performed PRIOR to assessment