cyrilzakka/clinical-trials huggingface dataset:
Effect of Food on Peposertib PK

The study will investigate the effect of food on the Pharmacokinetic (PK) of a single dose of peposertib administered as film-coated tablet under fed and fasted conditions. Furthermore, the PK profile of peposertib administered as an oral suspension of disintegrated tablets and as film-coated tablets will be compared under fasted conditions to evaluate the relative bioavailability in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Participants are overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring
* Participants are nonsmoker for at least 6 months prior to Screening
* Participants have a body weight greater than 50 kilogram (kg) and a body mass index within the range 18.5 to 30.0 kilogram per meter square (inclusive) at Screening
* Male participants are refrain from donating sperm plus either abstain from any activity that allows for exposure to ejaculate
* Female participants are not pregnant or breastfeeding
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* History of clinically relevant renal, cardiovascular, pulmonary disease, or endocrinology disorder at Screening
* History of clinically relevant gastrointestinal disease, in particular pancreatic disease, cholecystitis, liver diseases or hepatic dysfunction at Screening
* History of psychiatric or relevant neurological disorders (example, depression, epilepsy) at Screening
* History of relevant skin and mucosal diseases (rash, mucositis) at Screening
* Presence or history of any serious allergy (requiring hospitalization or prolonged systemic treatment) at Screening
* Any planned radiologic assessments during the study conduct phase
* Participants who are not able or willing to eat the entire study meals.
* Other protocol defined exclusion criteria could apply
A Study on the Safety and Efficacy of Topiramate in the Treatment of Patients With Bipolar I Disorder

The primary purpose of this study is to evaluate the safety and efficacy of topiramate compared with placebo in the treatment of acute manic or mixed episodes in patients with Bipolar I Disorder.

This is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of topiramate (400 milligrams/day) compared with placebo in the treatment of acute manic or mixed episodes in patients with Biplar I Disorder. In addition, a third group of patients will be treated with lithium (1500milligrams/day) as a comparator drug. The trial consists of 3 phases: a screening period; double-blind treatment for 12 weeks; and an optional open-label period of at least 6 months. Efficacy assessments include the change from baseline to Day 21 in the Young Mania Rating Scale (YMRS) score. Also included as efficacy assessments during the 12 week study are the Clinical Global Impressions (CGI) scale, Global Assessment Scale (GAS), Montgomery-Åsberg Depression Rating Scale (MADRS), Brief Psychiatric Rating Scale (BPRS), and health-related quality of life measures at specified time intervals. Safety assessments include evaluation of adverse events throughout the study, rate of withdrawal from the study due to adverse events, and vital signs (blood pressure and pulse) througout the study, as well as changes in clinical laboratory tests (hematology, chemistry, urinalysis), electrocardiograms (ECGs), and physical examinations at specified times. The study hypothesis is that the change from baseline in the total Young Mania Rating Scale (YMSR) score at Day 21 will be significantly better for the topiramate groups than for the placebo group and that the study drug will be well tolerated by the patients. Topiramate oral capsule will be increased from once daily (50mg) to 3 times daily up to target total daily dose 400mg, maintained through Week 12. Lithium oral capsules will be increased from once daily (300mg) to 3 times daily up to target total daily dose of 1500mg, maintained through Week 12.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Bipolar I Disorder by criteria of Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV) confirmed by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I
* )
* Currently in a manic or mixed episode and at least one previous manic or mixed episode
* meet minimum severity criteria (a Young Mania Rating Scale \[YMRS\] score of \>=20 at screening and baseline visits) for the current acute manic or mixed episode
* Females must be postmenopausal, surgically sterile, or using adequate contraceptive measures, and have a negative pregnancy test

Exclusion Criteria:

* DSM-IV diagnosis of alcohol or substance dependence (with the exception of nicotine or caffeine dependence)
* DSM-IV Axis I diagnosis of schizoaffective disorder or impulse control disorder
* Experienced a manic episode while taking an antidepressant or psychostimulant drug
* known hypersensitivity to topiramate or previously participated in a topiramate study
Investigation of the Effect of Oral Treatment With 100 mg AZD2423 in Subjects With Mild Chronic Obstructive Pulmonary Disease (COPD)

The purpose of the study is to find out if AZD2423 can reduce inflammation in the lungs of patients with mild COPD.


Eligibility Criteria:
Inclusion Criteria:

* Only women of non-child bearing potential are included in the study i.e. women who are permanently or surgically sterilised or post menopausal.
* ≥ 40 years of age at Visit 1
* Clinical diagnosis of COPD (GOLD stage 1)
* FEV1 ≥ 80% of the predicted normal post-bronchodilator at Visit 1 (GOLD stage 1)
* FEV1/FVC \<70% post-bronchodilator at Visit 1 (GOLD stage 1)

Exclusion Criteria:

* Any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk or influence the way the drug works
* Any clinically relevant abnormal findings in physical examination, blood or urine test results, vital signs or ECG at Visit 1 that may put the subject at risk during the study, affect their ability or take part or influence the results of the study
* A past history or current indication of renal (kidney) failure
* Subjects at risk of active tuberculosis or of disease reactivation
* Subjects who have had any clinically significant illness within 4 weeks before Visit 2 (start of treatment)
Feasibility of Lymphocyte Reinfusion in Newly Diagnosed High Grade Gliomas

This research study is being done to see if lymphocytes can be collected from patients with high grade gliomas before they start standard radiation and chemotherapy. (Lymphocytes are cells that normally circulate in the blood and are an essential part of the immune system). The investigators goal is to store these and give them back to the patient after radiation is completed. This is part of a larger effort that will attempt to preserve the immune system from the effects of radiation and chemotherapy.

The patients blood will be collected (apheresis) before starting the patients planned standard of care radiation therapy and chemotherapy:

* An IV will be inserted into the vein in the patients arm.
* The blood will be sent to a machine that removes the lymphocytes and returns the rest to the patient.
* This procedure will last from 1 hour and 15 minutes to 4 hours.
* During this time the patient will also be treated with a blood thinner to prevent the blood from clotting in the machine.
* The lymphocytes will be counted and stored. If an insufficient number were collected, we will ask for another similar collection in about 1 week.
* After the patient has completed the full 6 weeks of radiation, all of the lymphocytes will be returned to the patient through a simple intravenous infusion. A larger intravenous access (i.e. midline) might be needed. Any cells that are not reinfused will be stored for 1 year and then discarded.
* Study bloods (10 ml) will be collected at the time of lymphocyte collection, prior lymphocyte reinfusion, and then every 2 weeks until week 20th. These blood samples will be stored and used for future analysis.

Blood counts are obtained weekly as part of standard care for patients with this kind of brain tumor. For the first 14 weeks after the lymphocyte reinfusion we will be doing some extra tests on the routinely collected blood to see how the effective the reinfused lymphocytes are in raising the patients lymphocyte counts. These results will be available to the patients treating physician.

At no time will this study interfere with the patients planned standard of care radiation and chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* • Age≥18 year

  * New diagnosed high grade glioma
  * Post-operative treatment with standard RT/TMZ
  * Karnofsky performance status ≥ 60%
  * Normal bone marrow function with Hematocrit ≥ 30%, platelet ≥ 100K, ANC ≥ 1000, and absolute lymphocyte count ≥ 1000 prior entry to this study. Blood product transfusions are allowed.

Exclusion Criteria:

* Prior radiation therapy, chemotherapy, immunotherapy or therapy with biologic agents or hormonal therapy for their brain tumor are excluded. Glucocorticoid therapy is allowed.
* Fresh CNS bleed, current anticoagulation use; and anti-VEGF therapy in past 6 weeks are excluded.
* Patients must not have taken an ACE inhibitor within last 24 hours prior to apheresis.
Lung Dispersing, Turbid Descending and Gut Clearing Decoction for Bronchiectasis

Bronchiectasis is a chronic airway disease which confers significant healthcare burden, with limited therapeutic approaches. From the perspective of traditional Chinese medicine, congenital insufficiency of the lung, spleen and kidney, when coupled with external injury or mood impairment, may collectively contribute to bronchiectasis pathogenesis due to heat trapping in the phlems, congestion of wind evils and stagnation of blood. Here, the investigators will explore the Lung Dispersing, Turbid Descending and Gut Clearing Decoction (LTGD) which targets at expelling the wind evil in patients with bronchiectasis. The investigators sought to conduct a multicenter, randomized cross-over trial which investigates the efficacy and safety of LTGD on clinically stable bronchiectasis.

Bronchiectasis is a chronic airway disease which confers significant healthcare burden, with limited therapeutic approaches. From the perspective of traditional Chinese medicine, congenital insufficiency of the lung, spleen and kidney, when coupled with external injury or mood impairment, may collectively contribute to bronchiectasis pathogenesis due to heat trapping in the phlems, congestion of wind evils and stagnation of blood. Symptomatic treatment may be effective and safe for ameliorating respiratory symptoms and hindering disease progression of bronchiectasis. Here, the investigators have explored the Lung Dispersing, Turbid Descending and Gut Clearing Decoction (LTGD) which targets at expelling the wind evil in patients with bronchiectasis. The investigators sought to conduct a multicenter, randomized cross-over trial which investigates the efficacy and safety of LTGD on clinically stable bronchiectasis.

Eligibility Criteria:
Inclusion Criteria:

* aged between 18 and 75 years;
* remained clinically stable (respiratory symptoms and lung function parameters not exceeding normal daily variations) for 4 consecutive weeks;
* no acute upper respiratory tract infections within 4 weeks;
* 1 or more BEs within the previous 2 years

Exclusion Criteria:

* Other unstable concomitant systemic illnesses (i.e. coronary heart disease, recent cerebral stroke, severe uncontrolled hypertension, active gastric or duodenal ulcer, uncontrolled diabetes, malignancy, hepatic or renal dysfunction);
* Concomitant asthma, allergic bronchopulmonary aspergillosis, or active tuberculosis;
* Concomitant chronic obstructive pulmonary disease as the predominant diagnosis;
* Treatment with inhaled, oral or systemic antibiotics within 4 weeks;
* Type 2 respiratory failure needing oxygen therapy or non-invasive mechanical ventilation;
* Females during lactation or pregnancy;
* Poor understanding or failure to properly operate the instrument;
* Participation in other clinical trials within 3 months.
Study of ADG206 in Subjects With Advanced/Metastatic Solid Tumors

ADG206 is an activatable prodrug form of a fully human monoclonal antibody (mAb) of the immunoglobulin G1 (IgG1) subclass that specifically targets cluster of differentiation 137 (CD137) (also known as 4-1BB) as a co-stimulatory receptor agonist for the treatment of advanced malignancies.

This is a FIH, Phase 1, open-label, multicenter, sequential dose escalation study to evaluate the safety, tolerability, Pharmacokinetics (PK), and preliminary efficacy of ADG206 in subjects with advanced/metastatic malignancies.

Primary Objective of the study: To assess safety and tolerability at increasing dose levels of ADG206 in subjects with advanced/metastatic solid tumors who have exhausted their treatment alternatives.

Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
* Subjects with advanced or metastatic solid tumors (except thymic tumors), which have progressed after all standard therapies, or no further standard therapies exists.
* At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
* Adequate organ function.
* Woman of childbearing potential must agree to use 2 methods of acceptable contraception from screening until 6 months after the last dose of study drug.
* Male subjects who are sexually active with a female partner of childbearing potential must agree to use a barrier contraception.

Exclusion Criteria:

* Subjects within washout period of other anti-tumor therapies. .
* History of prior malignancy other than the cancer under treatment in the study.
* Major trauma or major surgery within 4 weeks before the first dose of study drug.
* Serious nonhealing wound, ulcer, or bone fracture.
* History of significant immune-mediated AE.
* Central nervous system (CNS) disease involvement.
* Any evidence of underlying severe liver dysfunction.
* Prior organ allograft transplantations or allogeneic bone marrow, cord blood or peripheral blood stem cell transplantation.
* Clinically significant cardiac disease with insufficient cardiac function.
* Evidence of active uncontrolled viral, bacterial, or systemic fungal infection.
* Known positive test result for human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS).
* Infection of hepatitis B virus (HBV), or hepatitis C virus (HCV) (unless the disease is clinically controlled) .
* History or risk of autoimmune disease.
* Subjects with active severe lung infection or with a history of interstitial lung diseases, noninfectious pneumonitis, active pulmonary tuberculosis, or evidence of active pneumonitis. Clinically significant and unmanageable ascites defined as requiring constant therapeutic paracentesis.
* Any serious underlying issue that would limit compliance with study requirements, impair the ability of the subject to understand informed consent.
* Known hypersensitivity, allergies, or intolerance to immunoglobulins or to any excipient contained in ADG206.
* Pregnant, lactating, or breastfeeding.
Postoperative Analgesia After Low Frequency Electroacupuncture

The purpose of this study is to determine whether electroacupuncture is a effective tool to the postoperative analgesia

The electroacupuncture is a known therapeutic modality with particular application to pain. In this study the investigators investigate the effect of electroacupuncture in condition of surgery, which is a particularly painful situation. The investigators will verify the postoperative analgesia, as patients will receive either electroacupuncture or placebo electroacupuncture.

Eligibility Criteria:
inclusion criteria:

* healthy male volunteers
* 18-75 years old

Exclusion Criteria:

* bilateral or recurrent hernia
* significant cardiovascular, pulmonary, renal, hepatic, neurological disease
* psychiatric history
* use of opioids until the last month
* body mass index greater than 30
* treatment with beta-blockers
* aged over 75
* previous experience with acupuncture
* hypersensitivity to opioids
* pacemaker patient
* patients being treated with monoamine oxidase inhibitors and selective serotonin reuptake inhibitors.
Prevalence of Mental Health Issues in Endurance Athletes.

Participation in endurance sports has been increasing over the last few decades and our aim of our exploratory descriptive survey study is therefore to examine mental health issues in endurance athletes (marathon runners, ultra endurance runners, triathletes), employing the IOC assessment tool, to provide information on mental health issues in this population. Secondary objects are to evaluate risk factors for mental health issues in endurance athletes (like exercise behaviour, competition behaviour, age, gender, medical issues)

This study is an exploratory descriptive survey study.

The study protocol will be largely replicated from the IOC consensus paper and the questionnaires based according to SMHAT 1 with an athlete-specific screening tool (APSQ) and further eleven subsequent disorder-specific screening tools:

Eleven disorder specific screening tools:

1. General Anxiety Disorder-7 (GAD-7): assesses the presence of symptoms of anxiety.
2. Patient Health Questionnaire-9 (PHQ-9): assesses the presence of symptoms of depression.
3. Athlete Sleep Screening Questionnaire (ASSQ): assesses the presence of sleep disturbance.
4. Alcohol Use Disorders Identification Test Consumption (AUDIT-C): assesses the presence of alcohol misuse.
5. Cutting Down, Annoyance by Criticism, Guilty Feeling, and Eye-openers Adapted to Include Drugs (CAGE-AID): assesses the presence of substance misuse, being slightly adapted for the SMHAT (no focus on alcohol use as already explored with the AUDIT-C; additional question to explore which substance was used).
6. Brief Eating Disorder in Athletes Questionnaire (BEDA-Q): assesses the presence of disordered eating.
7. ADHD
8. Bipolar disorder
9. PTSD
10. Gambling
11. Psychosis

Additionally questions to assess exercise addiction will be used as it has been shown that exercise addiction may be particularly prevalent in endurance athletes.

Further questions about age, gender, country of origin, training data, past medical history and medication will be asked as well as a few specific questions about there thoughts on mental health issues as per IOC consensus paper

Eligibility Criteria:
Inclusion Criteria:

* endurance athletes (marathon runners, ultramarathon runners and triathletes)
* over the age of 16
* all genders
* recreational athletes (non- elite)
* elite athletes (professional, international, college level)

Exclusion Criteria:

* athletes that that are not competing or have not competed in an official endurance race
* athletes that are younger than 16 years of age.
Geriatric Assessment (GA) for Elderly Patients Undergoing Allo-HSCT

This comprehensive, multidimensional evaluation assesses patient-related factors, disease-related factors, donor-related factors, and treatment-related factors. The study aims to identify potential risk factors influencing transplant outcomes in elderly patients and enhance the outcomes of allo-HSCT.

This comprehensive, multidimensional evaluation assesses patient-related factors (e.g., age, physical function, and comorbidity index), disease-related factors (e.g., primary diagnosis and blast count), donor-related factors (e.g., donor age, sex, ABO, and type), and treatment-related factors (e.g., conditioning regimen, graft source, and GVHD prophylaxis). The study aims to identify potential risk factors influencing transplant outcomes in elderly patients, establish a comprehensive geriatric assessment model, and guide personalized pre-transplant treatment strategies to reduce transplant-related mortality (TRM). Ultimately, we hope this study could help enhance the outcomes of allogenic hematopoietic stem cell transplantation (allo-HSCT).

Eligibility Criteria:
Inclusion Criteria:

* (a)Age ≥55 years.
* (b)Hematologic disorders with established indications for transplantation, including malignant and non-malignant hematologic diseases. (c)Willingness to provide informed consent.

Exclusion Criteria: (a)Pregnancy. (b) Uncontrolled active infection. (c) Lack of informed consent. (d)Deemed ineligible for transplantation after investigator assessment
Piano Training, Caregivers, and Parkinson's Disease

The purpose of this study is to investigate the impact of group piano training on psychosocial outcomes in caregivers of adults with Parkinson's disease (PD). As well, the study is investigating the impact of group piano training on psychosocial outcomes in the care-recipient with PD.


Eligibility Criteria:
Inclusion Criteria:

* Caregiver:

  * Are currently a primary caregiver to an adult with PD
  * Are between the age of 40-80 years
  * Have less than 5 years of music training
  * Speak and read English fluently

Adult with PD:

* Stage 1-3 Parkinson's disease
* Are between the age of 40-80
* Have less than 5 years of music training
* Speak and read English fluently

Exclusion Criteria:

* Doesn't meet all the inclusion criteria
Induction of Labour at Term With Low Dose Oral Misoprostol Versus a Foley Catheter

Comparison of efficacy and safety of low-dose oral Misoprostol versus folley catheter for preinduction in women with an immature cervix at term.

Open-label randomised trial in 2 hospitals in the Almaty,Kazakhstan. Women with a term singleton pregnancy in cephalic presentation, an unfavourable cervix, intact membranes, and without a previous caesarean section will be randomly allocated to 2 groups: 1 group -cervical ripening with 25 μg oral misoprostol once every 2 hour, 2 nd group- a 30 mL transcervical Foley catheter. The primary outcome will be vaginal delivery within 24 hours(to evaluate effectiveness) and secondary outcoms 1-5-min Apgar score and hospitalization in ICU, hyperstimulation frequency and hemorrage (for evaluating safety)

Eligibility Criteria:
Inclusion Criteria:

* women with an unfavourable cervix who will scheduled for induction of labour

Exclusion Criteria:

* Women with previous caesarean sections unable to give informed consent Multiple pregnancy History of allergy to misoprostol Ruptured membranes Chorioamnionitis All cases when physiological childbirth is impossible (placenta previa,transverse position of the fetus )