cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Effect of Multiple Doses of Gemfribozil on a Single Dose of ASP3652, and to Assess the Effects of Multiple Doses of ASP3652 on a Single Dose of Repaglinide in the Body of Healthy Subjects

ASP3652 is being investigated as a novel treatment for chronic pelvic pain. This is a two-part study to investigate the drug-drug potential of ASP3652.

Part I of the study evaluates the effect of gemfibrozil twice daily on the single dose of ASP3652.

Part 2 evaluates the effect of multiple doses of ASP3652 twice daily on the single dose of repaglinide.

Subjects participating in one part of the study may not participate in the other part.

Part 1:

On Day 1, a single dose of ASP3652 is administered. After a wash-out period of 3 days, bid (twice daily) dosing of gemfibrozil starts on Day 4 and continues for 7 days until Day 10. On Day 8 (the 5th day of gemfibrozil administration), a single dose of ASP3652 is administered one hour after the morning dose of gemfibrozil.

Part 2:

On Day 1, a single dose of repaglinide is administered. After a wash-out period of 3 days, bid dosing of ASP3652 starts on Day 4 and continues for 7 days until Day 10. On Day 8 (the 5th day of ASP3652 administration), a single dose of repaglinide is administered one hour after the morning dose of ASP3652.

Eligibility Criteria:
Inclusion Criteria:

* Subject is white and of Caucasian origin.
* Body Mass Index more than or equal to 18.5 and less than 30.0 kg/m2.
* Male subjects must agree to practice an effective contraceptive method with female sexual partners to prevent pregnancy.

Exclusion Criteria:

* Known or suspected hypersensitivity to ASP3652, repaglinide and/or gemfibrozil, or any components of the formulation used.
* Any of the liver function tests (ALT, AST, γ-GT, TBL and ALP) above the upper limit of normal. In such case the sample may be repeated once.
* Regular use of any inducer of metabolism (e.g. barbiturates, Rifampicin) in the 3 months prior to admission to the Clinical Unit.
Observational Study in CLL Patients Receiving BR

The purpose of this observational study is to provide additional data to confirm the safety profile and efficacy of bendamustine and rituximab (BR) chemotherapy for chronic lymphocytic leukemia patients with significant comorbidities treated in routine clinical practice.

BR (bendamustine, rituximab) combination is currently accepted as a first-line treatment of chronic lymphocytic leukemia (CLL) in patients for whom fludarabine combination chemotherapy is not appropriate.

The objective of this observational study is to provide additional data to confirm the safety profile and efficacy of BR for CLL patients treated in routine clinical practice.

Specific data of interest are: comorbid conditions, CLL characteristics, adverse events, reasons for discontinuation BR, overall response rates, complete response rate, progression-free survival, overall survival.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of chronic lymphocytic leukemia
* Patients treated with first-line BR for active disease requiring treatment
* Cumulative Illness Rating Scale (CIRS) \> 6
* Informed consent to data collection

Exclusion Criteria:

* Patients treated with BR within prospective clinical trials
Creating Opportunities Through Mentoring, Parental Involvement and Safe Spaces - Ethiopia

The study is a randomized controlled trial of COMPASS, an intervention for adolescent girls in three refugee camps in Ethiopia. The study design will employ a two group wait-list cluster randomized controlled trial where girls will be invited to participate in the COMPASS program, assigned to groups of approximately 20 for the purposes of the program, complete a pre-test baseline assessment, and will then be randomized by group to the intervention or control condition. In addition, qualitative research will address additional questions of acceptability, processes of change and best practice.

Groups in three refugee camps - Sherkole, Bambasi, and Tongo - will be randomized to determine whether the participants receive the intervention or are placed on the wait-list immediately following the baseline. Those that do not get the curriculum during the study will receive it following the endline phase of the study so as to not create tensions or jealousies.

The intervention, the COMPASS program, will involve a structured intervention for girls between the ages of 13-19 that is intended to engage adolescent girls, those who are influential in their lives, service providers and other stakeholders, with the ultimate goal of co-creating environments in which girls are valued and safe. The program is centered on establishing or supporting community-supported safe spaces for girls where they can come and gather among themselves and participate in a structured life-skills curriculum.

The study assessment will employ a mixed methods approach with most data collection occurring at pre-test/baseline and post-intervention. Quantitative survey methods will be used to evaluate attitudes towards a host of topics related to physical and financial assets and health-related behaviors. Survey questions will be administered using Audio Computer Assisted Self-Interviewing (ACASI). Quantitative methods will be used to yield statistical measures of the scale of changes in attitudes, skills, and behaviors due to the intervention.

Qualitative methods at baseline will include focus group discussions with caregivers and participatory methods with girls to assess topics such as self-esteem, empowerment, safety, and resilience. Endline qualitative methods include in-depth interviews with caregivers, and small-group warm-up activities with adolescent girls, followed by in-depth interviews.

Eligibility Criteria:
Inclusion Criteria:

* female
* aged 13-19
* speak one of the languages included in the study (Sudanese Arabic, Funj/Berta, Maban, Regarig and Engesena Quickly dialects)
* give informed consent

Exclusion Criteria:

* cognitive impairment
Effect of Thoracic Manual Therapy in Hemiplegic Patients

Neurological problems both lead to many respiratory problems primarily and events secondary to neurological diseases or symptoms can be the cause of respiratory failure. The addition of respiratory failure will adversely affect the course of the neurological picture, making treatment more difficult.

The cardiopulmonary functions of hemiplegia patients decrease due to the decrease in the expansion of the thoracic part on the hemiplegic side and insufficient respiratory muscles. In addition, common symptoms in stroke patients, including limited use of ankylosis and muscle movements, cause oxygen deficiency and increased metabolic demands. After stroke, thoracic expansion is reduced upon paralysis of the diaphragm and respiratory muscles. Continuation of this condition can lead to muscle fibrosis. As a result, the level of thoracic expansion decreases during breathing.

A decrease in thoracic spine mobility correlates with a decrease in forced vital capacity (FVC) and forced expiratory volume in the first second (FEV1). The increase in the rigidity of the chest wall affects the ventilator pumping mechanism, reducing the level of rigidity (increasing the mobility of the chest wall) is recommended as a way to improve lung function.


Eligibility Criteria:
Inclusion Criteria:

* Being between 45-65 years old
* Stage 4-6 according to Brunnstrom
* According to Modified Ashworth, the upper extremity is at most two values
* Sufficient to answer the level of consciousness survey
* No smoking
* No hearing or vision loss

Exclusion Criteria:

* Not being able to read and write
* Having cognitive impairment
* Hearing difficulties and vision loss
* Having any acute pain
* Acute Bronchitis
Uroflow Measurements in Healthy Volunteers

The goal of this study to determine normal values for certain urinary measurements in order to better understand voiding dysfunction in women.

see above

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers/employees
* Normal voiding function.
* Willing to participate.

Exclusion Criteria:

* Subjects currently receiving treatment for any lower urinary tract condition or having any voiding difficulty.
Feasibility of a Developmentally-tailored Mobile App for Tracking Mood and Pain in Children With Migraine

This study aims to inform the continued development of a mobile app intended to support the treatment of CYP with migraine. After extensive public and patient involvement, Happyr Health has developed a mobile app that allows children and young people to track headache attacks and emotional wellbeing and to access coping techniques. With the use of gamification and storytelling elements, the app aims to engage children to be an active part in tracking and coping with their headaches. The outcomes of this study will inform future adaptations and development cycles of the Happyr Health app.

15 participants aged 10-16 will access the Happyr app for 8 weeks (= intervention). Primary outcomes of acceptability and implementation will be measured via surveys following the 8-week intervention in the app.

The Happyr App is a mobile app to support children and young people with primary headaches in tracking their mood and symptoms. The app was developed in close collaboration with patients, their parents, and clinicians (pediatric neurologists, pediatric pain psychologists).

In the 'Happyr Tracking' study, we recruit 15 CYP aged 10-16 from the neurology department at Leeds Teaching Hospitals NHS Trust. Participants experience at least three primary headache attacks per month.

After receiving information on the study via the Principal Investigator (PI), those interested can contact the research team to receive access to the Happyr App.

In the app, participants and their parents/legal caregivers review information on the study and give their assent/consent. A copy of their signed assent/consent document will be sent to them as well as the research team and sponsor via email.

After creating their account, participants receive a survey in the app. As soon as completed, they can access the app's features. Participants are asked to make an entry to their mood diary at least once per day and to their pain diary only on days they experienced a pain attack. Participants are asked to send a PDF of their pain diary data (which they can export in the app) to the PI at the end of the intervention period (8 weeks).

After 8 weeks of using the app, participants will automatically receive another survey in the app to complete their participation. The pain diary export can be discussed with their clinician at their next appointment.

Outcomes of the study will be analyzed from the two in-app survey at beginning and end of the intervention period as well as usage data from the app analytics. The study objective is to understand the acceptability and feasibility of the Happyr App.

Eligibility Criteria:
Inclusion Criteria:

* With recurrent headaches (at least 3x per month)
* Access to a device (Android or iOS smartphone)
* Access to internet connection
* English-speaking

Exclusion Criteria:

* Secondary headaches
* Continuous headache
* Severe cognitive impairments
* Major comorbid medical or psychiatric illnesses (e.g. severe anxiety disorder)
Teeth and Jaw Misalignment in Patients Suffering From Congenital Fourth Cranial Nerve Palsy

Patients suffering from congenital fourth cranial nerve palsy may have misalignment of jaws as well as teeth due to head tilt in childhood.

Measurement of teeth and jaw parameters in patients suffering from congenital fourth cranial nerve palsy compared to patients without fourth cranial nerve palsy.

Eligibility Criteria:
Inclusion Criteria:

* unilateral congenital fourth nerve palsy
* natural teeth occlusion
* age \> 18 years

Exclusion Criteria:

* bilateral fourth nerve palsy
* no natural teeth occlusion
Pharmacokinetic Study of Esomeprazole Magnesium in Patients 1 to 11 Years-Old With Endoscopically-Proven Gastroesophageal Reflux Disease (GERD)

The purpose of this study is to determine the area under the plasma concentration-time curve (AUC) of esomeprazole after single oral doses of 5 mg, 10 mg or 20 mg esomeprazole in pediatric patients 1 to 11 years-old inclusive with endoscopically-proven GERD.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be able to take solid or bland food (eg, applesauce).
* Patients must weigh at least 8 kg and at the investigator's discretion be able to undergo extraction of an adequate volume of blood.
* The patient's weight for height percentile should be less than the 90th percentile and/or the BMI must be between the 5th and 85th percentile for age.
* Patients must be diagnosed with endoscopically-proven GERD

Exclusion Criteria:

* Use of any other investigational compound or participation in another clinical trial within 28 days prior to the screening visit.
* History or presence of gastrointestinal, hepatic or renal disease or other conditions that could interfere with absorption, distribution, metabolism or excretion of esomeprazole.
* Unstable diabetes mellitus or history of seizure disorder.
* Any acute or chronic illness or a medical history, which in the opinion of the investigator and/or sponsor, could compromise the patient's safety or successful participation in the study.
Follow-up Study of ICUS and CCUS Patients

The proposed minimal diagnostic criteria for myelodysplastic syndromes (MDS) and potential pre-MDS conditions has been released by an international consensus group. Based on the criteria, patients with persistent cytopenia could be diagnosed with MDS, CCUS and ICUS. However, the process and outcome of pre-MDS conditions (CCUS, ICUS) is still to be characterized in Chinese population. We design this prospective observational study to explore the disease process and outcome in ICUS and CCUS patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with cytopenia of any degree in one or more lineages: erythrocytes, neutrophils, or platelets. And the cytopenia has to be persistent (≥ 4 months) and lacking minimal diagnostic criteria of MDS.

Exclusion Criteria:

* Patients with cytopenia which could be explained by any other hematologic or non-hematologic disease.
TAKing Steps for Incentives

The purpose of this study is to test the overall effects of incentives on physical activity among older taxi drivers, and whether mental accounting exists in this context.

As part of the 4-month Randomized Controlled Trial, participating taxi drivers will be assigned to 1 of 2 groups where they will receive either cash or taxi rental credits for meeting specified monthly step goals measured via a step counter. Subsequently, for an additional 3 months, drivers will be incentivized to wear step counters to test if effects of the rewards are sustained once the reward is no longer in place. Effects will be quantified in terms of step activity; and in terms of changes in Body Mass Index (BMI), Resting Heart Rate (HR), Blood Pressure (BP), self-reported General Health, Health-Related Quality of Life (HR-QOL) and work productivity.

Eligibility Criteria:
Inclusion Criteria:

* Must be a taxi driver who is a hirer, and who drives for at least 8 hours daily over 5 days
* Aged between 50 to 75
* English/Mandarin-speaking

Exclusion Criteria:

* Report difficulty doing 10 minutes of aerobic activities without stopping, walking up 10 stairs without stopping or performing basic activities of daily living
* Have any medical conditions that limit their ability to walk as a means of physical activity
Evaluation of Radiofrequency Neurolysis and Chemical Neurolysis of the Genicular Nerves

Knee osteoarthritis is one of the most common causes of pain and loss of function in the elderly population and is a source of socioeconomic costs. Selective denervation of the superior medial, superior lateral and inferior medial genicular nerves, which provide the sensory innervation of the knee joint, is an effective treatment method used to relieve pain and improve functional capacity. Radiofrequency neurolysis of genicular nerves (RFN) is accepted as an effective technique for the treatment of knee pain. However, due to higher equipment costs, longer procedure times, and procedure-related pain, alternative treatments are needed.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* Coagulation disorders
* Rheumatoid disorders
* Infections
Predictors of Atrial Fibrillation Recurrence After Ablation Using PENTARAY Catheter

CARTO represent a new way of 3D electroanaromic mapping for AF which has improved safety and success rate of AF ablation compared with other conventional methods of AF ablation as it provide accurate visualization of atrial anatomy and identification of atrial substrate properties for catheter ablation of atrial arrythmias which ensure good ablation with decreased incidence of recurrence of AF.


Eligibility Criteria:
Inclusion Criteria:

* Patient with paroxismal AF who are eligible for AF ablation
* Patient resistant to medical treatment

Exclusion Criteria:

* Patient with other types of arrythmias
* Patient with prothetic valves
* Patient with valvular AF
A Drug-Drug Interaction Study of GK Activator (2) and Simvastatin in Patients With Type 2 Diabetes.

This study will assess the potential pharmacokinetic interaction between GK Activator (2) and simvastatin, and the potential effect of simvastatin on the glucose-lowering effect of GK Activator (2) in patients with type 2 diabetes. Patients will be randomized to one of 6 treatment sequences to receive single doses of a)GK Activator (2) 100mg po, b)simvastatin 80mg po and c)GK Activator (2) 100mg + simvastatin 80mg po. Dosing will take place on study days 1, 8 and 15, and there will be a 7-14 day follow-up period after the last dose. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients aged 18-75 years;
* type 2 diabetes mellitus;
* untreated, or taken off anti-diabetic or statin therapy \>=2 weeks before study start.

Exclusion Criteria:

* type 1 diabetes mellitus, or latent autoimmune diabetes in adults;
* diabetic neuropathy, retinopathy or nephropathy;
* patients treated with insulin or PPAR gamma agonist within 6 weeks of screening.
Evaluation of the Quality of Life Questionnaire-Bronchiectasis (QOL-B) in Patients With Bronchiectasis

Over the 70-day study period, eligible patients visited the study clinic every 2 weeks (total of 6 visits) and received a 28-day course of aztreonam for inhalation solution (AZLI). The Quality of Life-Bronchiectasis (QOL-B) questionnaire was completed at several time points during the study, in additional to pulmonary function testing and other standard procedures.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent prior to any study-related procedures
* Ability to read and understand the English language
* Bronchiectasis confirmed by CT scan of the chest
* Previous treatment with antibiotics for bronchiectasis
* Documented history of positive sputum culture for a gram-negative organism within 5 years
* Positive sputum culture for a gram-negative organism at first visit (Day -14)

Exclusion Criteria:

* Hospitalization or hemoptysis \> 30 mL within 14 days of first visit (Day -14)
* Antibiotic use for respiratory symptoms within 14 days of first visit (Day -14), excluding chronic, stable azithromycin use
* Change in corticosteroid or bronchodilator regimen within 14 days of first visit (Day -14)
* Forced expiratory volume in 1 second (FEV1) \< 25% predicted approximately 15 minutes following use of a bronchodilator at first visit (Day -14)
* Cigarette smoking within 6 months of first visit (Day -14)
Safety and Efficacy Study of Bimatoprost/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension

The purpose of this study is to assess the safety and efficacy of Bimatoprost/Timolol Fixed Combination in patients with glaucoma or ocular hypertension


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of ocular hypertension or chronic glaucoma in both eyes
* Patient requires IOP-lowering drug in both eyes

Exclusion Criteria:

* Uncontrolled medical condition
* Contraindication to beta-adrenoceptor antagonist therapy
A Study of LY3499446 in Participants With Advanced Solid Tumors With KRAS G12C Mutation

The reason for this study is to see if the study drug LY3499446 is safe and effective in participants with solid tumors with KRAS G12C mutation.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have diagnosis of a solid tumor with KRAS G12C mutation that did not respond to at least 1 line of standard therapy and has spread to other part(s) of the body
* For phase II, participants must be willing to have new tumor tissue biopsies (doctor removes a small amount of tissue) during the study if it does not cause undue risks to health
* Participants must be willing to use highly effective birth control
* Participants must have adequate organ function
* Participants must be able to swallow capsules

Exclusion Criteria:

* Participants must not have certain infections such as hepatitis or tuberculosis or HIV that is not well controlled
* Participants must not have another serious medical condition including a serious heart condition, such as congestive heart failure, unstable angina pectoris, or heart attack within the last three months
* Participants must not have cancer of the central nervous system that is not stable
* Participants must not be pregnant or breastfeeding
* Participants must not use herbal supplements