cyrilzakka/clinical-trials huggingface dataset:
Safety and Pharmacokinetics of ODM-204 in Patients With Metastatic Castration-Resistant Prostate Cancer

The purpose of this first-in-man study is to evaluate safety, tolerability and pharmacokinetics of ODM-204 in patients with metastatic castration-resistant prostate cancer.

The safety profile of ODM-204 will be explored together with the pharmacokinetics, pharmacodynamics and tumour response to treatment with ODM-204 to recommend the dosing regimen for further clinical studies. The pharmacokinetic properties of ODM-204 will be evaluated after single and multiple dose administrations at different dose levels.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent (IC) obtained.
* Male aged ≥ 18 years.
* Histologically or cytologically confirmed adenocarcinoma of prostate.
* Ongoing GnRH agonist or antagonist therapy, or after bilateral orchiectomy.
* Progressive metastatic disease
* Adequate bone marrow, hepatic, and renal function
* Acceptable and regular bowel movements without any GI disorder or procedure which may interfere with absorption of study treatment
* Ability to swallow study treatments

Exclusion Criteria:

* History of pituitary or adrenal dysfunction.
* Known brain metastases.
* Active infection or other medical condition that would make prednisone (corticosteroid) contraindicated.
* Uncontrolled hypertension
* Clinically significant heart disease
* Prolonged QTc interval
Assessing the Effectiveness of Digital Wellness Modules on Perceived Quality of Life

The study will examine the role of digital wellness modules (brief mindfulness and light to moderate physical exercise) delivered through a smartphone wellness application and their short-term effects on health behavior motivation and change, and longer-term quality of life and non-pathological affective states.

Primary Objective: The primary objective of this parallel-assignment longitudinal study is to determine whether the digital wellness modules (e.g., mindfulness and light to moderate physical activity) increase quality of life and decrease stress, anxiety, and depression, as mediated by health behavior motivation and change in a healthy population of adults. Secondary Objective(s): The secondary objective is to ascertain qualitatively through deductive thematic analysis specific themes of a) key drivers of health behavior change; b) types of motivations that drive health behavior change, and c) implementation of sustained health behavior change.

The study will be conducted virtually by Yale University researchers.

Eligibility Criteria:
Inclusion Criteria:

* Resides in United States

Exclusion Criteria:

* Any individual who endorses any of the following criteria will be excluded from participation in this study:
* Positive Health Screening Questions, as measured by the Health Screening Questionnaire (HSQ):

  * Pain, discomfort or pressure in the chest, difficulty breathing or shortness of breath, dizziness, fainting, or blackout, blood pressure with systolic greater than 140 or diastolic greater than 90, diagnosed or treated for any heart disease, heart murmur, chest pain (angina), palpitations (irregular beat), or heart attack, heart surgery, angioplasty, or a pacemaker, valve replacement, or heart transplant, resting pulse greater than 100 beats per minute, any arthritis, back trouble, hip /knee/joint /pain, or any other bone or joint condition, personal experience or doctor's advice of any other medical or physical reason that would prohibit the participant from doing light to moderate physical exercise, personal physician's recommendation against participating in light to moderate physical exercise because of asthma, diabetes, epilepsy or elevated cholesterol or a hernia.
* Positive Psychiatric Disorders Screening Questions:

  * Positive screen for depression, excluding suicide (PHQ-8) cutoff score \> 6
  * Positive screen for panic (SMPD) cutoff score \> 2
  * Positive screen for generalized anxiety (GAD-7) cutoff score \> 10
  * Positive screen psychosis (PDSQ) via psychosis section, cutoff score \> 3
  * Positive screen mania via the Altman Self-Rating Mania Scale (ASRM) cutoff score \> 6
The Safety and Efficacy of Naltrexone and Scopolamine Utilized in the Treatment of Major Depression

The purpose of this clinical trial is to determine the safety and efficacy of scopolamine utilized in conjunction with naltrexone for the treatment of major depression.

The study will be a double blinded, randomized controlled trial. The medications will be administered orally. The sample size will be 40 participants, 20 in the treatment group and 20 in the control group. The study period will be 4 weeks. Eligible participants will have major depression by history for at least 8 weeks, between 18-65 years old, and in generally good health other than depression. The MADRS questionaire will be utilized to determine the response to the medications.

Eligibility Criteria:
Inclusion Criteria:

* male or female, aged 18-65
* in good health other than major depression for 8 weeks or more
* negative pregnancy test
* able to comply with instructions
* able to provide informed consent

Exclusion Criteria:

* pregnant or lactating
* danger to self or others
* severe kidney or liver disease
* schizophrenia
* allergy to scopolamine or naltrexone
* glaucoma
* Monoamine oxidase (MAO) inhibitor use
Development and Validation of a Tool for Patient-reported Assessment of Cancer-related Financial Toxicity in Italy

The aim of this study is to develop and validate a patient-reported-outcome instrument (PROFTC-I: Patient Reported Outcome Financial Toxicity in Cancer - Italy) able to describe and measure financial problems of Italian patients receiving cancer treatment.

The project will be conducted according to the methodology delineated by the International Society for Pharmacoeconomics and Outcome Research (ISPOR) Patient Reported Outcomes Content Validity Good Research Practices Task Force in the following phases: concept elicitation and coding, item generation and analysis, instrument refinement and internal validation, and external validation.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years)
* Histologically or cytologically confirmed diagnosis of any type of solid cancer or haematological malignancy
* Written Informed Consent provided
* Medical treatment (chemotherapy, target agents, immunotherapy, hormonal treatment, radiotherapy or combinations of such therapies) ongoing or terminated within the previous 3 months.
* Caregivers of patients who meet the above criteria

Exclusion Criteria:

* Patients with major cognitive dysfunction or psychiatric disorders
* Patients who have never received anticancer medical or radiation treatment
Trial of IC351 in Female Scleroderma Patients With Raynaud's and Sexual Dysfunction

Purpose of the study is to evaluate the effectiveness and safety of a new investigational dur, IC351. Study is designed to gather information regarding the possible usefulness of IC351 as a treatment of several blood vessel features of scleroderma. This includes Raynaud phenomenon as well as the vaginal dryness and discomfort associated with scleroderma


Eligibility Criteria:
Inclusion Criteria:

* Female with diagnosis of scleroderma
* Stable sexual relationship with male partner or be sexually active
* Raynaud phenomenon at least 6 times per week
* Willing to attempt sexual activity 1/month during study period

Exclusion Criteria:

* Severe internal organ problems related to scleroderma
* Other gynecologic problems
* Serious depression
* Receiving other experimental and Raynaud treatments
The $Ensible Weight Program: An Intervention Tailored for Low Income Women

The purpose of this study is to learn if a weight loss program especially designed to address food insecurity is more effective compared to a standard weight loss program.

Low income women are at greater risk of both obesity and food insecurity (not having consistent access to nutritious and adequate amounts of food). Most weight loss programs targeted at low income women do not focus on gaining skills and knowledge to reduce food insecurity.

Eligible participants will be randomized into one of two groups. The two groups will follow different weight management programs. One group will follow a standard weight management program. The other group with follow the investigations program, the $ensible Weigh Program. Participation in the study will last about 9 months.

Eligibility Criteria:
Inclusion Criteria:

* Documented low income
* Body Mass Index (BMI) \>25.0 kg/m2
* Must speak and understand English
* Able to attend intervention sessions and have access to telephone

Exclusion Criteria:

* Report serious medical risk such as insulin-dependent diabetes, cancer, recent cardiac event
* Currently or planning to become pregnant during the intervention
* Have no control over food purchases or choices
* Report participation in a weight reduction program involving diet or PA within past 6 months
* Report symptomology of an eating disorder
* Report adherence to specialized diet regimes, i.e., multiple food allergies, vegetarian, Atkins, macrobiotic, etc.
Correlation Between Dental Arch and Articular Eminence

the aim of the study is to assess the correlation between the dental arch morphology and the articular eminence height and inclination by using CBCT scans of a sample of the Egyptian population.


Eligibility Criteria:
Inclusion Criteria:

* • CBCT scans of adult Egyptian patients, males and females with ages starting from 18 till 45.

  * Scans of patients who have complete set of permanent dentitions (third molars are not considered), or at least not more than one tooth is missed in each arch.
  * CBCT scans with field of view that shows the full view of TMJ.

Exclusion Criteria:

* • CBCT scans of patients with fractures in the articular bone surfaces.

  * CBCT scans of patients with pathological lesions in the TMJ or articular eminence.
  * CBCT scans with artifacts that could interfere with the assessment of the articular eminence and dental arches.
Assessment of the Effects on Barrier Impairment, Clinical Features and Bacterial Colonization of Topical Formulations in Patients With Atopic Eczema; a Phase IIa, Single-center, Randomized, Observer-blind Study

The purpose of the study is the assessment of the barrier impairment, clinical skin condition and bacterial colonization status in patients with atopic eczema following topical treatment with K201 cream and a comparator twice daily over a 4-week treatment period.


Eligibility Criteria:
Inclusion Criteria:

* signed written informed consent obtained;
* male or female patients, 18 years or older;
* manifest atopic eczema diagnosed according to Hanifin and Rajka;
* two comparable lesional areas of 20 - 50 cm2 with a distance of at least 5 cm, clinical condition of atopic eczema mild to moderate (meeting Hanifin and Rajka´s criteria;
* TEWL in the lesional areas at least 12 g/m²h, TEWL value differences ≤ 30 % are allowed between both lesional areas;
* the physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study;
* sexually active females of childbearing potential should either be surgically sterile hysterectomy or tubal ligation), or should use a medically accepted contraceptive regimen:systemic contraceptive (oral, implant, injection), diaphragm or cervical cap with intravaginal spermicide, intrauterine device (IUD), condom with intravaginal spermicide.

Exclusion Criteria:

* acne, eczema other than atopic eczema, hyper- or hypopigmentation or tattoos in the treatment areas;
* suntan which in the opinion of the investigator prevents correct assessments
* dark-skinned persons whose skin color prevents ready assessment of skin reactions;
* evidence of drug or alcohol abuse;
* pregnancy or nursing;
* UV-therapy within 6 weeks before first treatment;
* participation in another clinical study involving pharmaceutical products in the 28 days preceding or during the study;
* symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study;
* known allergic reactions to components of the study preparation and the comparator;
* treatment with systemic or locally acting medications which might counter or influence the study aim (e.g. antihistamines or glucocorticosteroids) within two weeks before the beginning of the study (exception: asthma may be found in patients with atopic eczema,therefore inhalation with corticosteroids in patients with asthma accompanying atopic eczema will be allowed at a dose not exceeding 1 mg/day. The dosage should remain constant throughout the study period);
* in the opinion of the investigator or physician performing the initial examination the patient should not participate in the study, e.g. due to probable noncompliance or inability to understand the study and give adequately informed consent;
* patient is institutionalized because of legal or regulatory order.
Endtidal Carbon Dioxide for Earlier Detection of Pulmonary Hypertension

Measurement of the endtidal carbon dioxide by capnography to exclude or to ensure the diagnosis pulmonary hypertension. The aim of the study is to obtain an endtidal carbon dioxide cut-off value for the diagnostic algorithm for pulmonary hypertension as an easily measurable and cheap diagnostic tool in patients with suspicion of pulmonary hypertension.

The disease pulmonary hypertension is due to a remodeling of the lung vessels which results in a change of the exhaled air. This change is measurable with a so called capnograph. The investigators want to measure the breath from patients with and without pulmonary hypertension to detect a cut-off value for the diagnosis pulmonary hypertension.

Patients which have the probably diagnosis pulmonary hypertension and are older than 18 years are investigated. This patients will get an right heart catheterization and a measurement from their exhaled air.

Eligibility Criteria:
Inclusion Criteria:

Age \> 18 years, suspicion of pulmonary hypertension, planned or accomplished right heart catheterization

Exclusion Criteria:

none
Effects of an Auto-Regulating Oxygen System Compared to Constant-Flow Oxygen During Walking in Hypoxemic COPD Patients

Oxygen therapy is a cornerstone in treating patients with severe chronic obstructive pulmonary disease. Usually, oxygen supplementation is delivered using constant-flow rates. Varying oxygenation levels may occur throughout patients´ changing activity. There is some evidence available that an auto-regulating oxygen flow system (FreeO2), which adjusts the oxygen flow automatically to prevent desoxygenation could be beneficial in comparison to a constant oxygen dose of 2 liter/min during walking. However, these possible benefits are unknown if the FreeO2 is compared to a constant oxygen dose according to the individual prescription. Therefore, the primary aim of this study is to investigate the effects of auto-regulated oxygen flow rates compared to constant oxygen flow rates as prescribed according to international guidelines on walking capacity in patients with COPD.

Rationale:

Hypoxemia is frequently observed in COPD and thus can negatively impact exercise tolerance. Supplemental oxygen or long-term oxygen therapy is recommended to ensure that the patient is still able to manage his daily life. Usually, oxygen supplementation is delivered using constant flow rates during day- and nighttime or as needed. However, studies have shown, that auto-regulated oxygen flow systems (FreeO2) may enhance the patients endurance, lower the time in severe hypoxemia and increase the time spent within the SpO2 target range.

Aim of this study is to investigate the effects off an auto-regulated oxygen flow system in hypoxemic COPD patients on the patient´s endurance, the oxygen saturation, the pCO2 blood level as well as on heart rate and breathing frequency compared to the effects off the prescribed constant flow (according to the British Thoracic Society Guidelines for Home Oxygen Use in Adults) during an endurance shuttle walk test (ESWT). Additionally, patients experience, e.g. comfort and Preference of the Oxygen-delivery System will be documented.

Design:

This study is a randomized, controlled cross-over trial. Following an initial incremental shuttle walk test (ISWT) in order to determine the participants individual maximal walking capacity, the participant will perform 2 endurance shuttle walk tests (ESWT) at 85% of the maximal walking rate. In randomized order, the participants will perform one ESWT with constant flow as prescribed and one ESWT with the auto-regulated oxygen flow system.

Eligibility Criteria:
Inclusion Criteria:

* GOLD III/ IV
* Hypoxemia (PaO2\<55 mmHg) under roomair conditions (rest or during exercise) or SpO2 \<88% during exercise
* established Long-term oxygen therapy or given indication for a Long-term oxygen therapy
* Age: 40 to 80 years
* Participation in an inpatient pulmonary rehabilitation program (Schoen Klinik BGL, Germany)
* Written informed consent

Exclusion Criteria:

* Acute Exacerbation of COPD
* Clinical signs of any acute cardiac comorbidity
* Not able to walk
Turkish Validity-Reliability of the Outcome Expectations For Yoga Scale

Evaluation of the Turkish validity and reliability of the outcome Expectations for Yoga (OEY) Scale, which was developed to evaluate attitudes and beliefs related to yoga practice

The Turkish version of the Outcome Expectations for Yoga (OEY) scale will be studied. The OEY scale is designed to assess the physical, mental, and spiritual health benefits associated with yoga practice in adults.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years and older

Exclusion Criteria:

* Pregnant women
* Body Mass Index above 40
* Practiced yoga, Tai Chi, Qi Gong, or a mindfulness-based therapy program 2 times or more in the past month or 10 times in the past year
To Find Out Whether Valsartan With or Without Other Blood Pressure Medications Would Improve the Ability of the Heart to Fill and Empty, and the Ability of the Heart Muscle to Relax Adequately in People With High Blood Pressure.

Patients who have had high blood pressure for a long time may have diastolic dysfunction. Diastolic Dysfunction is when your heart has difficulty filling and emptying, and relaxing adequately.

This study is to find out if Valsartan) will improve the ability of the heart to fill, empty, and relax appropriately when given alone or with other medicines to treat high blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis/History of high blood pressure
* Male or Female age 45 years or older

Exclusion Criteria:

* History of stroke, transient ischemic attack or heart attack within the last 6 months
* A hospital admission for congestive heart failure within the last year
* Use of certain high blood pressure medications such as ACE inhibitors, Angiotensin Receptor Blockers or aldosterone antagonists or other agents that may work in the same pathway (RAAS) as valsartan within the past 3 months.

Other protocol-defined exclusion criteria may apply.
Effect of Tirzepatide on Markers of MASLD in Patients With Obesity

Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) is the most common cause of chronic liver disease worldwide and predominately affects individuals with overweight and obesity, as well as those with type 2 diabetes and cardiovascular disease. Tirzepatide is a medication used to treat type 2 diabetes and obesity. It has also been shown to help with MASLD. The purpose of this study is to study how tirzepatide affects the liver in patients with MASLD.

Participants will be asked to:

* Take tirzepatide for 12 months.
* Come in for clinic visits every 3 months.
* Have blood drawn at baseline, 6, and 12 months.
* Complete a liver ultrasound at baseline and at 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Men and women
* Age 18-75
* Diagnosis of MASLD based on the following criteria:

  * Presence of at least 1 out of the 5 following cardiometabolic criteria:
* BMI \>25 kg/m2 OR waist circumference \>94 cm (men) or 80cm (women)
* Fasting serum glucose \>100 mg/dL OR 2-hour post-prandial glucose levels \>140mg/dL OR AbA1c \>5.7% OR type 2 diabetes OR treatment for type 2 diabetes
* Blood pressure \>130/85 mmHg OR specific antihypertensive drug treatment
* Plasma triglycerides \>150mg/dL OR on lipid lowering treatment
* Plasma HDL-cholesterol \<40mg/dL (men) and \<50mg/dL (women) OR on lipid lowering medication

  * No other identified causes of steatosis
  * Evidence of steatotic liver disease (hepatic steatosis identified by imaging or biopsy)
* English speaking

Exclusion Criteria:

* Pregnancy or breast feeding
* Premenopausal women not on any form of contraception
* Reports alcohol intake \>50g/day or 350g/week for women and \>60g/day or 420g/week for men or an AUDIT score \>8
* Other identifiable causes of steatosis
* Documented allergic reaction to tirzepatide or any other GLP1 RA
* Decompensated liver disease
* Decompensated renal disease requiring hemodialysis
* Decompensated heart failure
* Active malignancy
* Prior history of pancreatitis
* Serum triglyceride levels \>500 mg/dL
* Personal or family history of medullary thyroid cancer or MEN2a or MEN2b
* Concurrent use of other ant-obesity medications
* Use of other GLP1 RAs within 3 months of study enrollment
* Unable to obtain the medication due to cost or insurance coverage restrictions.