cyrilzakka/clinical-trials huggingface dataset:
Seaweed-Derived Mineral-Rich Nutraceuticals in Cognition

The aim of the overall project is to investigate the potential of a combination of commercially available nutraceuticals produced by Marigot Ltd (natural seawater derived mineral-rich AquaminMG and seaweed-derived mineral-rich food supplement AquaminTM (FDA GRAS 000028) isolated from Lithothamnion species), as safe and effective supplements to promote cognition in the aged brain.


Eligibility Criteria:
Inclusion Criteria:

To be considered eligible for enrolment into the study, subjects must;

1. Be able to give written informed consent.
2. Be between 65 and 85 years of age (elderly cohort).
3. If female, must be non-pregnant.
4. Be in generally good health as determined by the investigator.

Exclusion Criteria:

Subjects will be excluded from the study if they meet any of the below criteria;

1. Are less than 65 and greater than 85 years of age (elderly cohort).
2. Are pregnant females.
3. Are currently taking calcium/magnesium supplements, or have taken them in the past 14 days.
4. Have a significant acute or chronic co-existing illness (cardiovascular, gastrointestinal, endocrinological, immunological, metabolic or any condition which contraindicates, in the investigators judgement, entry to the study).
5. Have a score of \<22 in the Montreal Cognitive Assessment (MoCA) (elderly cohort) and have no subjective memory impairment.
6. Have a history of renal failure or renal disease, or eGFR creatinine levels below 30ml/min.
7. Have diagnosis of significant low or high calcium or magnesium levels.
8. Have a condition or are taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results; to include misoprostrol, polystyrene sulfonate, Riociguat and vitamin/mineral supplements, probiotics or herbal remedies.
9. Are individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial.
10. Are receiving treatment involving experimental drugs.
11. Have been in a recent experimental trial, these must have been completed not less than 30 days prior to this study.
12. Have a malignant disease or any concomitant end-stage organ disease.
13. Have a psychiatric illness which contraindicates entry to the study.
Study of OSI-211 vs. Topotecan in Patients With Relapsed Epithelial Ovarian Cancer

The purpose of this study is to estimate the efficacy and safety of OSI-211 and topotecan in patients with relapsed epithelial ovarian cancer.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed relapsed ovarian cancer.
* Measurable disease greater than or equal to 20 mm (or greater than or equal to 10 mm on spiral CT scan).
* One or two prior regimens of chemotherapy. At least one regimen must have contained cisplatin or carboplatin.
* At least three weeks since prior chemotherapy and recovery from any related toxicities.
* At least four weeks since prior radiotherapy and recovery from any related toxicities.
Impact of Antiobesity Medications on Appetite and Appetite-related Hormones and Metabolites.

This study aims to explore how anti-obesity medications (AOMs) like semaglutide and tirzepatide affect appetite and energy intake. Researchers will examine two groups: one just starting AOMs and another that has already achieved significant weight loss and maintained it. By conducting meal challenges at different stages of medication use, the study will assess feasibility of the methods and gather preliminary data to design a larger, future study.


Eligibility Criteria:
Inclusion Criteria:

* Adult males and females with a BMI of 30-45 kg/m2 (early group), or a BMI of 30-45 kg/m2 prior to weight loss achieved through medication (late group)
* Age, 25-60 years old
* Passing medical and physical screening, and analysis of blood and urine screening samples
* Anticipated to start or are already prescribed AOMs (semaglutide or tirzepatide)
* 6-months weight stable (early group) or 3 months weight stable at current weight (late group)
* Women of reproductive age must be using an effective form of contraception

Exclusion Criteria:

* Diagnosed with type 1 or 2 diabetes
* Smoker
* Previous surgical treatment or device-based therapy for obesity
* Chronic or acute pancreatitis
* Clinically significant gastric emptying abnormality
* Uncontrolled hypertension or hypo/hyperthyroidism
* Cardiovascular event 3 months within screening
* Acute or chronic hepatitis
* Inability to tolerate beef, eggs, and cheese
* Women who are pregnant
* Women who are nursing
Sildenafil in Single Ventricle Patients

Patients with single ventricle anatomy undergo staged surgical palliation. The result is an "in series" circulation with pulmonary blood flow and cardiac output directly related to pulmonary vascular resistance. While surgical outcomes have improved, the physiology of the single ventricle palliation results in continued long term attrition. Elevated pulmonary vascular resistance and impaired systemic ventricular function are important risk factors for failure of single ventricle palliation.

Sildenafil is a pulmonary vasodilator and has been shown to improve cardiac contractility in the pressure overloaded right ventricle.

The investigators will assess the safety, pharmacokinetics and hemodynamic efficacy of sildenafil in single ventricle patients following stage II and III surgical palliation.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 3 months; ≤120 months.
2. History of congenital heart disease with severe hypoplasia of a right or left ventricle.
3. Undergoing cardiac catheterization as part of standard clinical care.
4. Availability and willingness of the parent/legally authorized representative to provide written informed consent.

Exclusion Criteria:

1. History of serious adverse event related to sildenafil administration.
2. History of sildenafil exposure within 48 hours of the study.
3. Presence of pulmonary venous obstruction.
4. Treatment with organic nitrates or alpha blockade therapy.
5. Contraindication to cardiac catheterization as determined by the attending cardiologist and including:

   1. Significant hemodynamic instability.
   2. Sepsis.
   3. Need for Extra-Corporeal Membrane Oxygenation (ECMO) support.
   4. Venous occlusion precluding adequate access.
   5. Recent systemic illness.
6. Renal failure defined as serum creatinine \> 2 times higher than the upper limit of normal.
7. Liver dysfunction defined as alanine aminotransferase or aspartate aminotransferase \> 3 times higher than the upper limit of normal.
8. Thrombocytopenia defined as a platelet count \< 50 000 cells/µL.
9. Leukopenia defined as white blood cells \< 2500 cells/µL.
Effects of Transcutaneous Perineal Stimulation Versus Anal Stimulation

This study evaluates whether surface perineal stimulation is as effective as anal stimulation in reducing urinary incontinence secondary to radical prostatectomy.

Half of participants will receive a treatment with surface perineal stimulation, while the other half will receive a treatment with anal stimulation.

Pelvic floor muscle training is the most common non-invasive intervention for urinary incontinence secondary to radical prostatectomy. Perineal stimulation has a significant positive impact on the early recovery of urinary continence after this intervention.

The perineal stimulation can be applied with surface electrodes or with an intra-cavitary probe placed in the anus. The two techniques are commonly used. Each techniques stimulates different anatomical points of perineum, and it is a question if both have the same effectiveness or, one of the two techniques has greater effect than the other.

Eligibility Criteria:
Inclusion Criteria:

* Having undergone a radical prostatectomy surgical procedure.
* Presenting involuntary urine losses after radical prostatectomy intervention. (IU grade I, II or III)
* Do not exceed the year since the surgical intervention.
* Accept to participate in the study and grant signed informed consent.

Exclusion Criteria:

* Follow a pharmacological treatment for the UI.
* Presenting anatomical malformations of the pelvic floor musculature.
* Carry pacemaker.
* Present anal fistulas.
* suffer from serious psychic disorders.
* Presenting lower urinary tract infections.
Characterization of Inclusion Body Myopathy Associated With Paget's Disease of Bone and Frontotemporal Dementia (IBMPFD)

The investigators are researching families with inherited inclusion body myopathy (IBM) and/or Paget disease of bone (PDB) and/or dementia (FTD) which is also called IBMPFD. IBMPFD is caused by mutations in the VCP gene. Our main goal is to understand how changes in the VCP gene cause the muscle, bone and cognitive problems associated with the disease.

The investigators are collecting biological specimen such as blood and urine samples, family and medical histories, questionnaire data of patients with a personal or family history of VCP associated disease. Participants do not need to have all symptoms listed above in order to qualify. A select group of participants may be invited to travel to University of California, Irvine for a two day program of local procedures such as an MRI and bone scan.

Samples are coded to maintain confidentiality. Travel is not necessary except for families invited for additional testing.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria include all individuals with a combination of medical problems including muscle and bone disease and their family members. Because historically VCP related muscle disease has been erroneously diagnosed with the following diagnoses, therefore if these patients also have a personal or family history of bone disease they will be considered eligible for the study:

Muscle disorders considered include:

* Limb Girdle Muscular Dystrophy
* Myopathy
* Inclusion body myopathy
* FSH (Facioscapular muscular dystrophy) without the mutation
* Scapuloperoneal muscular dystrophy
* Amyotrophic Lateral Sclerosis
* Non specific muscular dystrophy

AND

* Bone disorders including:

  * Paget disease of bone
  * Fibrous dysplasia
  * Diaphyseal medullary stenosis with malignant fibrous histiocytoma (DMS-MFH)
  * Non-specific bone disease

Eligible participants must also be:

* Subjects must to 18 years or older
* Subjects must to able to give consent
* Adult family members or spouses over the age of 18 of the affected individuals

Exclusion Criteria:

* Under the age of 18.

Individuals who report a different unrelated diagnosis will be excluded from the study. Testing to confirm different diagnoses will not be performed, instead patient will be questioned for this information and records will be obtained for confirmation of appropriate testing.

Those who are unable to provide consent for themselves will be excluded from participating in the study.
Nivolumab or Nivolumab Plus Cisplatin, in Combination With Radiotherapy in Patients With Cisplatin-ineligible or Eligible Locally Advanced Squamous Cell Head and Neck Cancer

This study has two, independent, cohorts, both in locally advanced squamous cell head and neck cancer. The purpose of the first cohort is to determine whether nivolumab in combination with radiotherapy is more effective than cetuximab in combination with radiotherapy, in subjects who are ineligible for cisplatin. The purpose of the second cohort is to determine whether nivolumab, cisplatin, and radiotherapy is more effective than cisplatin and radiotherapy in subjects who are eligible to receive cisplatin


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Histologically proven squamous cell carcinoma of the head and neck (SCCHN) from one of the following primary sites: oral cavity, oropharynx, hypopharynx, and larynx
* Locally advanced disease which is unresectable, or resectable but suitable for an organ sparing approach
* No previous radiotherapy or systemic treatment for SCCHN

Exclusion Criteria:

* Carcinoma originating in the nasopharynx or paranasal sinus, squamous cell carcinoma that originated from the skin and salivary gland or non-squamous histology (e.g., mucosal melanoma), squamous cell carcinoma of unknown primary
* Clinical or radiological evidence of metastatic disease
* Prior radiotherapy that overlaps with radiation fields

Other protocol defined inclusion/exclusion criteria could apply
Gonadal Function in Young to Middle Aged HIV-infected Men

HIV infection is associated to premature decline of serum testosterone. However, prevalence and biochemical characterization of hypogonadism in HIV-infected men are still to be well defined. HIV-infection is strongly associated to erectile dysfunction in men, but preliminary data suggest that it is poorly associated with serum testosterone in this context.

The aim of this study is to evaluate the gonadal function of young to middle aged HIV-infected men in order to characterize hypogonadism by assessing circulating total testosterone with either Liquid Chromatography tandem Mass Spectrometry (LC-MS/MS) or chemiluminescent immunoassay. Furthermore, secondary aim is to assess the erectile function through the use of validated questionnaires (International Index of Erectile Function (IIEF) 15 and 5).

Eligibility Criteria:
Inclusion Criteria:

* Male gender
* Age 18-50 years
* HIV-infection
* Ongoing Highly Active Antiretroviral Therapy

Exclusion Criteria:

* Previous treatment with androgens, anti-androgens
* Severe liver insufficiency
* Severe renal insufficiency
Massage Therapy and Port-a-Catheter Insertion

The purpose of this study is to assess the feasibility and efficacy of massage therapy for reducing pre-operative anxiety and post-operative pain among predominantly low income minority cancer patients undergoing surgical placement of a Port-a-Catheter.

Despite major advances in the understanding of cancer and its treatment, patients continue to suffer greatly. Massage is now included in the National Comprehensive Cancer Network guidelines for the treatment of refractory cancer pain (1), and many cancer patients are turning to massage and other complementary therapies to help alleviate both their psychological and physical symptoms. However, complementary therapies, such as massage, are often unaffordable or unavailable to predominantly low-income cancer patients at safety net hospitals like Boston Medical Center.

The vast majority of cancer patients receiving chemotherapy undergo implantation of a permanent central venous access device, often referred to as a port implantation or implanted port. Although the implanted port carries multiple benefits for ease of treatment, after the procedure patients often complain of headaches, muscle stiffness and neck and shoulder pain that lasts for several days. Pain medication is the only therapy commonly offered for this and is often inadequate (2). Furthermore, since this is often the first surgical procedure for cancer patients at the beginning of their treatment, they often have significant levels of pre-procedure anxiety (3,4). Safe, efficacious, and cost-effective interventions that can reduce the anxiety and pain related to port implantation are needed.

This pilot study will look at how feasible and effective massage therapy is in reducing pre-operative anxiety and post-operative pain among BMC patients already undergoing surgical placement of an implanted port.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be adults within one month of diagnosis with any form of cancer.
* Patients must be scheduled to undergo, but have not yet received, port implantation.
* Patients must have the ability to understand and sign a written informed consent.

Exclusion Criteria:

* Patients who are unable or unwilling to provide consent.
Rapid Hormonal Cycling as Treatment for Patients With Prostate Cancer: The Men's Cycle

Objective: To determine the response to rapid hormonal cycling in patients with non-castrate prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

-Patients residing in the following clinical states wit! be considered: A. Rising PSA: Patients with a history of localized disease who have undergone definitive radiation or surgery. These patients must demonstrate progression of disease biochemically as outlined below. Patients in this group may not have radiographically evident disease.

B. Non-castrate metastatic: Patients must present with radiographic evidence of metastatic disease at the time of diagnosis or after treatment for localized disease. These patients must show newly detected disease or progressing disease in bone or in soft tissue. Biochemical progression is defined as: minimum no. of determinations: 3 Interval: \>2 weeks Minimal Baseline PSA value (ng/ml): 2 Minimal % increase in range of values: 50%

* Diagnosis of prostate adenocarcinoma histologically confirmed at MSKCC.
* Patient must have level of serum testosterone above the lower limit of normal.
* Karnofskcy performance status (KPS) \>_70%.
* Patients must have adequate organ function as defined by the following laboratory criteria:
* WBC \>_3500/mm3, platelet count \>_100,000/mm3.
* Bilirubin \<2.0 mg/dl or SGOT \<3.0 X the upper limit of normal.
* Creatinine \<_1.6 mg/dl or creatinine clearance \>_60 cc/min.
* Prior hormonal therapy is allowed as:

  1. Neoadjuvant treatment prior to radiation therapy or radical prostatectomy, provided that the total duration of exposure does not exceed 10 months.
  2. One cycle of intermittent therapy up to a maximum exposure of 10 months.
* Patients must be at least 18 years of age.
* Patients must have signed an informed consent document stating that they understand the investigational nature of the proposed treatment

Exclusion Criteria:

* Clinically significant cardiac disease (New York Heart Association Class III/IV),or severe debilitating puhnonary disease.
* Uncontrolled serious active infection.
* Anticipated survival of less than 3 months.
* Active CNS or epiduraltumor
* Inability or unwillingness to comply with the treatment protocol, follow-up, or research tests.
A Study to Evaluate the Ocular Blood Flow Effects of Unoprostone Isopropyl in Adults With Dry Age-related Macular Degeneration

The purpose of this study is to determine the pharmacodynamics of ocular blood flow measurements with multiple drop unoprostone isopropyl administration versus placebo in subjects with dry age-related macular degeneration (AMD).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 50 years at screening
* Ametropy ≤ 3 diopters
* Clear ocular media
* Visual acuity in the study eye \> 20/40

Exclusion Criteria:

* Presence of any ocular condition in the study eye (other than AMD) that may progress during the course of the study and could affect central vision, or other ocular conditions that may be a confounding factor in this study
* Blood donation during the previous 3 weeks
* Current smoker or a history of smoking within 5 years of enrollment
* Treatment with protocol-specified prohibited concomitant medications
* Prior exposure to Rescula (unoprostone isopropyl) and or a known sensitivity to any of the components of the study medication (e.g. benzalkonium chloride)
Predictors of Persistence in Patients With Schizophrenia Treated With Once-monthly Aripiprazole in Spain

This is an observational, retrospective, non-interventional study that will include schizophrenic patients who were initiated on AOM treatment during an schizophrenia-related hospitalisation at least 6 months before data collection and in a real clinical practice setting.

This is an observational, retrospective, non-interventional study that will include schizophrenic patients who were initiated on AOM treatment during an schizophrenia-related hospitalisation at least 6 months before data collection and in a real clinical practice setting.

Data from each patient will be collected after informed consent is obtained (if possible), and will include retrospective information mainly from the index date (start of AOM treatment, baseline timepoint) until the last information available in the patient file at the time of data collection (minimum of 6 months after the index date). Data will be retrospectively collected from all visits occurring as per clinical practice (usually once-monthly).

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (age ≥ 18 years at the time of AOM initiation).
2. Diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders V available at start of AOM treatment, and confirmed by the current investigator.
3. Having been hospitalized for an acute psychotic relapse and having been initiated with AOM as primary maintenance antipsychotic treatment, in accordance with the terms of the marketing authorisation, during the hospitalisation, at least 6 months before the inclusion and before November 1st 2016 (and up to January 2016 at the earliest).
4. Provision of patient informed consent unless a) not required by local regulations, b) it would take a non-reasonable effort\* or c) if the source patient is deceased or untraceable.

   * A reasonable effort is defined as 3 contact attempts separated by 3 weeks. All efforts to obtain the informed consent, reasonable or not, shall be registered in the medical history of the patient to be used as documental source.

If allowable by Ethics Committees, provision of oral (e.g., by phone) instead of written consent is also possible for patients with retrospective assessment only.

Exclusion Criteria:

1. The patient has a psychiatric disorder other than schizophrenia which is established as the primary diagnosis
2. Chronically hospitalized patients at time of AOM initiation.
3. Patients who receive, after AOM initiation, a concomitant oral antipsychotic treatment for more than 4 weeks (with the exception of low dose quetiapine)\*

   \* Low dose quetiapine is acceptable up to a maximum of 150 mg daily only for sedative purposes, but not for the induction of any psychopharmacological effect on mood and/or psychosis.
4. Participation in an interventional clinical trial during the retrospective follow-up period.
Feasibility and Functionality of fPAM Imaging in Melanoma

Melanoma is a cutaneous malignancy that has the potential for local (skin) and regional (lymph node) recurrence. These recurrences may be difficult to detect in their earliest stages. We are attempting to use novel form of skin imaging that uses ultrasound combined with laser to identify these recurrences early, when they may be most amenable to treatment. This imaging will detect melanoma pigment below the surface of the skin and in the draining lymph nodes, as well as new blood vessel formation that occurs with these loco-regional metastases.

recruiting healthy individuals with pigmented lesions and individuals with melanoma and pigmented lesions

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\> 18 yrs of age) with recently diagnosed or a history of, Stage I - III melanoma who are able to give informed consent.

Exclusion Criteria:

* Patients with melanomas \< 1mm.
* Pregnant females.
* Children and young adults \< 18 yrs of age and patients who are unable to give informed consent.
Effects of Vitamin D Supplement Before and During Pregnancy on Birth Weight

The purpose of this study is to determine whether a daily supplement of vitamin D, taking before and during pregnancy, effects child birth weight, pre- and postpartum complication and bone mineral density during lactation.


Eligibility Criteria:
Inclusion Criteria:

* P-OH25-vitamin D \< 50 nmol/l
* Woman age 30-35 years
* In good general health

Exclusion Criteria:

* Infertility
* Intake of 400 IU or more Vitamin D/day
* Cancer
* Alcohol or drug abuse
* Calciummetabolic disturbances
* Spontaneous abortion within last 6 month