cyrilzakka/clinical-trials huggingface dataset:
A Phase II Study of Pulse Reduced Dose Rate Radiation Therapy With Bevacizumab

To determine the efficacy of Pulse Reduced Dose Rate (PRDR) radiation when given in 27 fraction over 5.5 weeks with concurrent bevacizumab followed by adjuvant bevacizumab until time of progression in patients with recurrent high grade gliomas (grade III and grade IV). Patients will be placed in 1 of 4 groups based on their histologic diagnosis and prior exposure to bevacizumab.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or molecularly confirmed Grade 3 or 4 glioma, IDH mutant or wildtype, as defined by the 2021 WHO guidelines
* Recurrent disease based on combination of clinical, imaging or histologic confirmation
* Must have previously received radiation and temozolomide to treat their glioma
* Bevacizumab naive patients must be \> 5 months post completion of initial radiation therapy
* Bevacizumab exposed patients must be \> 3 months post completion of initial radiation therapy
* Age must be \>18years, KPS must be greater than 60
* Hematology, chemistry and a urinalysis must meet protocol specified criteria

Exclusion Criteria:

* Pregnant or breastfeeding
* Uncontrolled hypertension (\>160/90mmHg)
* Prior malignancy unless treated \>1 year prior to study and have been without treatment and disease free for 1 yr
* active second malignancy unless non-melanoma skin cancer or cervical cancer in situ
Intervention to Assist MSM Disclose HIV Status to Casual Sex Partners

Men who have sex with men (MSM) remain disproportionately represented in the national HIV/AIDS statistics. Little progress has been made in understanding the nuances of MSM sexual behavior or communication that may be perpetuating the spread of HIV. Non-disclosure of an HIV-positive status may be a key factor responsible for male-male HIV transmission. There are no known intervention programs whose primary focus is to help MSM develop requisite skills to disclose their status to casual sexual partners. The development of such interventions is essential because of the numerous repercussions for not disclosing when one is HIV-positive such as legal prosecution and the transmission of HIV. In a previous intervention development study (R21MH067494) the research team created and tested a 4 session intervention found to be promising for increasing disclosure to casual sexual partners. The purpose of the proposed research is to further refine and enhance our HIV disclosure intervention (DI) designed to increase disclosure to casual sexual partners and reduce sexual risk taking behaviors among HIV-positive MSM; assess the relative effectiveness of a disclosure intervention to an attention control case management group (ACCM) for HIV-positive MSM; examine the effects of the intervention over time; explore differential treatment responses to the disclosure intervention and ACCM on the basis of ethnicity, age, and education level as well as examine the mediating effect of baseline frequency of sexual activity, severity of substance abuse at baseline, and stigmatized fear on the relationship between intervention type and the outcome. Finally, the investigators will test how treatment engagement, retention and expectations predict subsequent disclosure and risky sexual outcomes.


Eligibility Criteria:
Inclusion Criteria:

* HIV-positive
* Male
* Have sex with other men
* Over the age of 18
* Sexually active in the past 90 days
* 2 or more partners in last 12 months
* Indicate an interest in learning more about disclosing serostatus to casual sex partners
* Speak and understand English
* Plan on living in Tampa area for at least 1 year

Exclusion Criteria:

* Women
* HIV-negative
* Children under the age of 18
* Men who exclusively have sex with women
* Those who cannot speak and understand English
* Those who have not been sexually active or are behaviorally monogamous
Music Intervention in the Treatment of Sleep Disorders for Depressed Patients

The purpose of this study is to determine whether music hearing in the evening before going to sleep can improve sleep quality, depressive symptoms and quality of life in patients with affective disorders.

Disrupted sleep including Problems of initiating and maintaining sleep are most often symptoms in patients with depressive Syndromes and often persist after successful treatment of affective symptoms. Normally disrupted sleep in the context of affective disorder is treated with sleep medication, which can lead to severe and sometimes intolerable side effects.

A non-pharmacological approach for improving sleep Quality is Hearing Music before going to sleep. Classical indian Music can improve sleep Quality in depressed patients. In a danish study protocol Western Music improved sleep quality in patients with disturbed sleep and posttraumatic stress disorder.

The investigators want to use western Music to improve sleep . In a three week Intervention time, patients shall hear before going to sleep every night for one hour relaxing Music. The control group receives Treatment as usual. After the end of Intervention, every participant has the possibility to use the sleep inducing Music.

The aim of the study is to prove whether Hearing Music before going to sleep over three weeks improves subjective sleep quality, self rated depressive symptoms and Quality of life and objective Parameters such as sleep duration and sleep latency, measured by actigraphy. In a follow-up interview four weeks after the Intervention the investigators want to prove if the effects continue after end of Intervention.

Eligibility Criteria:
Inclusion Criteria:

* inpatient and outpatient treatment in Sanatorium Kilchberg
* one of the following diagnoses according to ICD 10: F32, F33, F34.1, F34.21, F34.8,
* Age between 18 and 65 years
* completed Primary education Level
* good command of the german language
* able to understand Patient information,
* given informed consent,

Exclusion Criteria:

* no informed consent
* one or more of the following diagnoses according to ICD 10: F32.3, F33.2, F31.3, F31.4, F60.31, F10, F13, F00, F01, F02, F03, G47.3, G25.8, H90, H91
* patients with acute suicidal tendency
* pregnant or breastfeeding women
A Study to Assess FLX-787 in Subjects With Motor Neuron Disease Experiencing Muscle Cramps.

The COMMEND Study will assess the safety and effectiveness of FLX-787 in men and women with Motor Neuron Disease \[including Amyotrophic Lateral Sclerosis (ALS), Primary Lateral Sclerosis (PLS) or Progressive Muscular Atrophy (PMA)\] experiencing muscle cramps. Participants will be asked to take two study products during the course of the study. One of these study products will be a placebo.

Approximately 120 participants in approximately 30 study centers across the United States are expected to take part. Participants will be in the study for approximately 3 months and visit the study clinic 3 times.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of Motor Neuron Disease (MND) \[including Amyotrophic Lateral Sclerosis (ALS), Primary Lateral Sclerosis (PLS) or Progressive Muscular Atrophy (PMA)\]
* Expected survival \> 6 months
* Weekly muscle cramping (defined as: a sustained muscle contraction that's most often painful and lasts seconds to minutes)

Exclusion Criteria:

* Presence of major gastrointestinal disorders, such as inflammatory bowel disease, diverticulitis, active peptic ulcer disease, or significant gastroesophageal reflux disease (i.e., not well-controlled on antacids or proton pump inhibitors), or oral or esophageal lesions/ulcers
* Presence of laryngospasm or significant swallowing problems
* Presence of percutaneous endoscopic gastrostomy, esophagogastroduodenoscopy, or G-tube
* Unable or unwilling to discontinue medications for cramps and/or opiates
* Inability to tolerate a spicy sensation in the mouth or stomach
* Actively using illicit drugs or history of chronic substance abuse within the past year prior to screening, including abuse of alcohol
* Intention to change the current level of tobacco use or use of nicotine-containing products (i.e., new smokers or those actively trying to quit may not enrolled)
* Participated in a clinical study (except natural history studies without administration of an investigational product) within 30 days prior to screening
Effects of Nucleus Basalis of Meynert Stimulation on Cognitive Disorders in Dementia With Lewy Bodies

Deep brain stimulation has been developed as a substitute for the classical lesioning methods previously used in stereotactic and functional neurosurgery. Recent, anecdotal cases reports suggested that electrical stimulation of the cholinergic output of the Nucleus Basalis of Meynert (NBM) may improve cognitive performances, especially the memory tasks.

The present study aims to assess the effect of bilateral electrical stimulation of the NBM on the mnesic performance \[assessed by the sum of the three free recalls of the Free and Cued Selective Recall Reminding Test (FCSRT)\] in patients diagnosed with probable, moderate, Dementia with Lewy Bodies.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of probable Lewy-body dementia according to the internationally accepted consensus criteria (McKeith, 2005)
* Outpatients, male or female, aged between 18 to 75 years
* Moderate dementia defined by a mini-mental state examination (MMSE) score between 16 and 26
* Stable dose of cholinesterase inhibitors (maximal dose tolerated) for a minimum of 1 months
* Patients receiving antiparkinsonian treatment unmodified for 3 months, if treated
* French as native language
* Written informed consent of the patient
* Written informed consent of the caregiver

Exclusion Criteria:

* Other causes of dementia (Alzheimer dementia, vascular dementia, dementia associated with Parkinson's disease)
* Other causes of extrapyramidal symptoms (Parkinson's disease)
* Patients with a history of severe psychiatric disorders, such as psychosis. Earlier episodes of depression and/or anxiety without hospitalization are not exclusion criteria
* Contraindications for MR imaging (claustrophobia, metallic foreign bodies, pacemakers, etc)
* MRI evidence of cerebral microbleeds
* Surgical contraindications: especially, hemostatic disorders, severe cortical atrophy
* Patients receiving treatments that may interfere with the cholinergic system: anticholinergics, cholinomimetics.
* Patients receiving neuroleptics
* Patients with a history of alcohol or drug abuse
* Pre-existing structural brain abnormalities (such as tumor, infarction, or intracranial hematoma)
* Previous neurosurgical intervention
* Patients with a progressively fatal disease, or life expectancy £ one year
* Asthma
* Severe visual deficit of ophthalmic origin (such as glaucoma, age related macular degeneration, cataract)
* Fertile women not using adequate contraceptive methods
* Women who are pregnant or breast feeding
Interindividual Variation in Excretion of Curcumin

The objective of this project is to elucidate the interindividual variations in excretion of curcumin and its metabolites.


Eligibility Criteria:
Inclusion Criteria:

* 18-30 year old healthy adults

Exclusion Criteria:

* Exclusion criteria included those who are \<18 or \>30 years old, have a BMI of \<20 or \>29 kg/m2, have a weight change \>4.5 kg in the past 3 months, exceed exercise activities of a curcumin level over the past 3 months, have any diseases, especially intestinal disorders, had abnormal liver or kidney function tests. Those who smoke, consume more than two alcoholic drinks per day, use medication affecting gut microbiota profile (e.g., antibiotics and probiotics) in past three months will also be excluded.
* Additionally, this study excludes menopausal women, those using hormone-based contraceptives, those with abnormal menstrual cycles, and those who are pregnant, lactating or planning to become pregnant.
Study to Evaluate the Use of RenalGuard to Protect Patients at High Risk of AKI

The Strength study aim to evaluate the use of the RenalGuard device to protect the patients at high risk to develop acute kidney injury following a complex cardiovascular intervention requiring a high volume of contrast.

The Strength Trial is a randomized, international (France and Germany) and multicentre (7) trial.

The patients population targeted is suffering from kidney insufficiency (estimated Glomerular Filtration Rate (eGFR) between 15 to 40 ml/min/m2) need to go through a complex cardiovascular intervention..

This is a population of patients at high risk to develop AKI following contrast media administration and complex cardiovascular interventions require a high amount of contrast.

Standard treatment is hydration but with risk of hyper and hypohydration for this population of patients. RenalGuard insure the replacement of the urine output by infusion of a matched volume of sterile replacement solution to maintain patients' intravascular fluid volume.

The patients are randomized to be protected from contrast-induced nephropathy with the use of RenalGuard or by standard hydration treatment and will be followed-up during 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* 15 ml/min/m2 ≤ eGFR ≤ 40 ml/min/m2
* High volume contrast-requiring cardiovascular procedures (estimated contrast volume \> 3 times eGFR value)
* Patient has agreed to all FU testing

Exclusion Criteria:

* Administration of iodine contrast media within 5 days before index procedure
* Emergency procedure or primary PCI
* Patients with pulmonary edema or cardiogenic shock (Killip 3 or 4)
* Hypoxemia defined as SaO2 ≤ 90% and/or PaO2 ≤ 80 mmHg on room air
* Acute Kidney Injury requiring dialysis before the procedure
* Multiple myeloma or cancer treated with chemotherapy
* Subjet is anuric
* Subject has been hospitalized for any change in renal function or has undergone renal replacement therapy (hemodialysis or hemofiltration) within the past month
* Known hypersensitivity to furosemide active ingredient or excipient
* Renal insufficiency with oligoanuria resistant to furosemide or caused by nephrotoxic or hepatotoxic substances
* Pre-coma or coma induced by an hepatic encephalopathy
* Severe hypokalemia, sever hyponatremia, hypovolemia with or without hypotension or dehydration
* Hypersensitivity to sulfamides
* Enrollment in another study unless the study is a registry or unless primary endpoint is reached
* Expected life expectancy \< 1 year
* Pregnant or breastfeeding patient
* Patient under trusteeship or guardianship
* Patient is unable / unwilling to provide an informed consent
Dietary Phytosterols and Human Aortic Valve

This randomized controlled double-blind intervention study unravels influence of dietary plant sterols and stanols on the structure and the sterol composition of the human aortic valve. The study patients will include 50-60 voluntary patients from the Helsinki Univ. Central Hospital, who will undergo aortic valve surgery. The patients will be randomized into plant sterol (E), plant stanol (A) and control (C) groups. Patients in the E and A groups will be asked to consume daily 2 grams plant sterols or plant stanols, respectively, in a margarine product.

High level of serum cholesterol is a risk factor for atherosclerotic complications, including atherosclerotic aortic valve disease. Over 50 years dietary plant sterols have been used to inhibit intestinal cholesterol absorption and to decrease its levels in serum. Daily human diet contains numerous different plant sterols, of which sitosterol and campesterol are the most abundant ones. Few epidemiologic studies suggest that sitosterol and campesterol may also be involved in formation of atherosclerotic changes in human arteries. The saturated forms of sitosterol and campesterol, i.e., the plant stanols (mainly sitostanol and campestanol) are beneficial with this respect. As part of daily diet, the plant stanols decrease absorption of both cholesterol and plant sterols, and thus, are putatively even more effective in prevention of atherosclerosis than the respective plant sterols.

Our double-blind controlled intervention study unravels influence of dietary plant sterols and stanols on the structure and the sterol composition of the human aortic valve.

50-60 patients, who will undergo aortic valve surgery, will be asked to volunteer our study. The patients will be randomized into three groups: (A) a group consuming margarine containing daily 2 grams plant stanols, (E) a group consuming margarine containing daily 2 grams of plant sterols, (C) a control group consuming margarine without any plant sterols or stanols. The dietary intervention will last for 4 to 8 weeks from the randomization to the operation.

Serum samples for analyses of serum lipids, lipoproteins and sterols will be collected at the randomization and at the operation. The atherosclerotic aortic valve will be examined with respect to its composition of cholesterol, other sterols and stanols.

The aim of our study is to elucidate the effects of dietary consumption of plant sterols and stanols on the sterol composition and structure of the atherosclerotic disease-affected aortic valve in human patients.

Eligibility Criteria:
Inclusion Criteria:

* Atherosclerotic aortic valve disease needing an aortic valve replacement operation

Exclusion Criteria:

* None
Effect of Thiamphenicol on EAAT2 and Other Biomarkers From Nasal Biopsied Tissue

The purpose of this study is to determine if two-weeks of dosing with thiamphenicol is safe and is able to change the levels of certain pre-specified biomarkers in nervous tissue taken from the nasal passages.

Thiamphenicol has been proposed to increase the levels of the excitatory amino acid transporter 2 (EAAT2) in the nervous tissue. This study evaluated the ability of two weeks of treatment with thiamphenicol to increase EAAT2 in a nasal biopsy as a surrogate of brain nervous tissue.

Eligibility Criteria:
Inclusion Criteria:

* normal volunteers

Exclusion Criteria:

* less than 18 years
* older than 55 years
Fragility Fractures of the Pelvis (FFP)

Prospective data will be collected in approximately 420 patients, above the age of 65, suffering from an FFP type fracture equal to or higher than type II, according to Rommens and Hofmann.

Patients will be followed up according to the standard (routine) for up to 1 year after the treatment. Data collection will include underlying disease, treatment details, functional and patient reported outcomes (PRO)s, radiological outcomes, and anticipated or procedure-related adverse events (i.e. complications).

More in detail this registry has the following objectives:

* To identify the difference in patient related outcome comparing the surgical and conservative treatment in patients suffering from an FFP with different levels of pelvic instability at different time points
* To compare the rate of complications, morbidity and mortality between the different treatment modalities over the whole study period

Eligibility Criteria:
Inclusion Criteria:

* Age 65 years or older at time of injury
* Diagnosis, via CT scan as per standard of care, of FFP grade II or higher according to the Rommens and Hofmann classification (including fractures of the anterior pelvic ring involving the anterior lip of the acetabulum not regarded as the acetabular fractures)
* Informed consent obtained, ie:

  * Ability to understand the content of the patient information/ICF
  * Willingness and ability to participate in the registry according to the standard of care in each clinic
  * Signed and dated Ethics Committee (EC)/ Institutional Review Board (IRB) approved written informed consent OR
  * Written consent provided according to the IRB/EC defined and approved procedures for patients who are not able to provide independent written informed consent

Exclusion Criteria:

* Pelvic fractures that do not meet the criteria of a fragility fracture (ie, high-energy trauma)
* FFP type I fractures
* Concomitant fractures of the acetabulum (except anterior lip of the acetabulum, see above)
* Pathological fractures (ie, patients with malignant or metastatic diseases of the pelvis, infections)
* Concomitant osteoporotic fractures outside of pelvis
* Participation in any other medical device or medicinal product study within the previous month that could influence in opinion of the PI the results of the present registry
Mass Balance Study of MT-3995

The purpose of this study is to investigate the absorption, metabolism and excretion of MT-3995 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Able to provide written informed consent to participate in the study
* Caucasian male aged at least 35 years at Screening
* Healthy and free from clinically significant illness or disease at Screening and Day-1
* A body weight of 60 to 110 kg at Screening and Day-1
* Vital signs within the following ranges at Screening, Day-1 and Pre-dose:

  * Body temperature : 35.0°C to 37.5°C
  * Systolic blood pressure: 90 to 140 mmHg
  * Diastolic blood pressure: 50 to 90 mmHg
* Regular daily bowel movements

Exclusion Criteria:

* Presence or history of severe adverse reaction or allergy to any medicinal product
* Participation in more than three clinical studies of an Investigational Medicinal Product (IMP) in the previous year or participated in a clinical study of any IMP within 12 weeks or five half-lives
* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardise the subject in case of participation in the study. The Investigator should be guided by evidence of any of the following:

  * History of inflammatory bowel syndrome, gastritis, ulcers, gastrointestinal or rectal bleeding considered clinically significant by the Investigator
  * History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy or bowel resection
  * History or clinical evidence of pancreatic injury or pancreatitis