cyrilzakka/clinical-trials huggingface dataset:
Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2066 in Young and Elderly Healthy Subjects

The purpose of this study is to investigate the safety and tolerability of AZD2066 using multiple escalating dose panels. There will be separate panels for young healthy volunteers and elderly healthy volunteers. Each panel will contain 10 volunteers who will randomly receive AZD2066 or placebo. One panel will be run at a time with a fixed dose given. After the completion of each panel, a Safety Review Committee will decide if the study can proceed to the next dose panel.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed informed consent
* Clinically normal physical findings and laboratory values as judged by the investigator and a normal resting ECG.

Exclusion Criteria:

* History of somatic disease/condition, which may interfere with the objectives of the study, as judged by the investigator.
* History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder.
* Intake of medicine (except occasional paracetamol or nasal spray) within first 2 weeks before first administration of study drug.
Use of Dental Age Determination Methods in Children With Type Diabetes

The aim of this study was to determine the estimated dental age of children with type 1 diabetes by using Cameriere, Willems and Demirjian methods.

The different metabolic activities of children with type 1 diabetes cause significant differences between them and healthy children. Especially from a forensic point of view, special methods defined for these children are needed and dental age estimation is one of them. The aim of this study was to determine the estimated dental age of children with type 1 diabetes by using Cameriere, Willems and Demirjian methods.

Methods: Between 2017 and 2024, 58 patients with type 1 diabetes and healthy children were included in the study. Dental ages were calculated on panoramic radiographic images by 2 different dentists using Cameriere, Willems and Demirjian methods. Dental ages and their differences with chronological ages were compared by group and gender. Analyses were performed in IBM SPSS 25 program.

Eligibility Criteria:
Inclusion Criteria:

* 4-15 years old
* No chronic disease in addition to the diagnosis of type 1 diabetes
* Children with controlled type 1 diabetes mellitus
* No congenital tooth deficiency
* Pediatric patients with good quality panoramic radiographs were included.

Exclusion Criteria:

* Blurred or distorted radiographs,
* Missing any of the left seven permanent mandibular teeth (genesis or extraction),
* With dental abnormalities (dilaceration, supernumerary teeth) and developmental disorders (cleft lip and palate),
* Patients with incomplete medical or dental history were excluded.
Obesity and Liver Function in Oesophageal Cancer

There is an established link between sarcopenia and outcomes in oesophageal cancer. There is scant reports in the literature regarding the influences of different obesity in different compartments.

Oesophageal cancer rates are increasing as a result of obesity in Western society. Thr investigators are evaluating the influence of viscerala dn subcutaneous obesity on overall outcomes of the participants. In addition the investigators are evaluating if there is a correlation with Liver Function Tests and liver histopathology such as steatosis on survival in participants and post operative sequele.

Eligibility Criteria:
Inclusion Criteria:

* Those undergoing oesophagectomy

Exclusion Criteria:

* patients who only had chemotherapy/chemoradiotherapy without surgery
Anticoagulation After RFCA

The anticoagulation therapy is needed when rhythm control strategy is applied in atrial fibrillation patients but adverse events such as major bleeding exist. This study aims to examine the prognostic inpact of the duration of anticoagulation after radiofrequency ablation of paroxismal atrial fibrillation in patients with low thromboembolic risk. Paroxismal atrial fibrillation patients with 0 or 1 CHADS2-Vasc score undergoing radiofrequency ablation is randomized into one month anticoagulation group and two months anticoagulation group after the procedure. Thromboembolic event and adverse event including major or minor bleeding would be compared.

Catheter based radiofrequency ablation has been used in more than a decade as a rhythm control therapy. Recently, superior outcome to medical therapy has been constantly reported and the radiofrequency catheter ablation (RFCA) became popular globally. It is recommended to anticoagulate patients who received RFCA for atrial fibrillation at least two months after the procedure. However, a few reports suggest anticoagulation in selective patients according to CHADS2-Vasc score. Anticoagulants prevent thromboembolic event in atrial fibrillation but the risk of bleeding is increased in company. There is controversy in the duration of anticoagulation after RFCA of atrial fibrillation. The investigators aimed to investigate the association with thromboembolic and bleeding event of anticoagulation duration after RFCA of atrial fibrillation in patients with low thromboembolic risk. Paroxismal atrial fibrillation patients with 0 or 1 CHADS2-Vasc score who are undergoing RFCA are included and randomized by 1:1 ratio to one month anticoagulation group and two months anticoagulation group after RFCA. Any patient with an evidence of intracardiac thrombus is excluded. The primary endpoint is thromboembolic event in 6 months after RFCA and the secondary endpoint is bleeding event in 6 months after RFCA.

Eligibility Criteria:
Inclusion Criteria:

* Under 75 years old Patients undergoing RFCA for paroxismal atrial fibrillation CHADS-Vasc score 0-1

Exclusion Criteria:

* Presence of intracardiac thrombus
Study to Evaluate Neuromodulation Subject Experience With Contemporary Spinal Cord Stimulation (SCS) Modalities for Chronic Pain

Medtronic, Inc. is sponsoring the SENSE SCS clinical study, a prospective, multi-center, post-market, non-randomized, observational study with a hybrid decentralized model of execution, utilizing a mobile application for the collection of patient reported outcomes (PROs). The purpose of the study is to evaluate workflow of a mobile application for collection of PROs and to gather data on patient experience with spinal cord stimulation therapy.


Eligibility Criteria:
Pilot Phase Inclusion Criteria:

1. 18 years of age or older
2. A clinical decision was made for the patient to receive a commercial Medtronic SCS system (trial and implant) limited to the components for an on-label indication prior to enrollment in the study. NOTE: Vectris™ SureScan™ MRI 1x8 subcompact and Specify™SureScan™ MRI 2x8 leads are not eligible system components
3. Able to differentiate between pain associated with the indication for SCS implant and other types of pain, as determined by the Investigator or designee
4. Willing and able to use a personal smart phone for study surveys. NOTE: All subjects participating in the study must be willing to download the InsightPro™ clinical trial app and maintain current software updates on their own smart phone.
5. Willing and able to provide signed and dated informed consent in English
6. Willing and able to comply with all study procedures and visits

Pilot Phase Exclusion Criteria:

1. Any active implantable neuromodulation device or system (e.g., Peripheral Nerve Stimulation, Sacral Neuromodulation)
2. Currently participating, or plans to participate, in another investigational study or has a planned major medical procedure that may interfere with study procedures or confound study results, as determined by the Investigator or designee, unless documented pre-approval is provided by the sponsor
3. Major untreated or refractory psychiatric comorbidity or other progressive disease (e.g., neurodegenerative disease, heart failure, cancer) that may confound study results, as determined by the Investigator or designee
4. Serious drug-related behavioral issues (e.g., alcohol dependency, illegal substance abuse), as determined by the Investigator or designee
5. Pregnant or planning on becoming pregnant
6. Involved in an injury claim under current litigation, beneficiary of an injury claim, or receiving worker's compensation
7. Patients with buried lead trials/implants will be excluded from this study
Pilot Study of Preoperative Intestinal Training Using Antegrade Ileostomy Infusion

This research study is being conducted to study the effect of infusing your contents from your ostomy bag back into your intestine to re-train them prior to the ostomy takedown operation, which is a surgery to reverse your ostomy to put your intestine back together. Because your intestine past the ostomy hasn't seen any intestinal content for several weeks to months before the takedown operation, it is no longer used to handling the daily work of processing intestinal content and will take time to recover its normal function after surgery. We hope to speed up this process by training them before your planned surgery.


Eligibility Criteria:
Inclusion Criteria:

* Has a diverting loop ileostomy
* undergoing evaluation for stoma takedown

Exclusion Criteria:

* unable to perform consent
* unable to perform stoma infusion
Effect of Ibuprofen on Postoperative Opiate Medication Use and Shoulder Functional Outcomes

This will be a randomized controlled trial to determine if postoperative ibuprofen after arthroscopic rotator cuff repair impacts postoperative opiate medication use, Visual Analog Scale (VAS) pain scores, shoulder range of motion (ROM), and repair integrity.

Patients will be randomized into two cohorts:

1. Ibuprofen 400mg by mouth three times daily. Patients will also receive the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control.
2. Placebo tablet by mouth three times daily. Patients will also received the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control.

Patients will be screened for the study at the preoperative clinic vist and randomized on the day of surgery if they meet our inclusion criteria.

Postoperatively, they will be seen at 1 week, 6 weeks, 3 months, 6 months, 1 year, and 2 years. Pill counting will be done at the 1 week postoperative visit. VAS pain scores will be assessed at every visit. Functional shoulder outcomes including shoulder range of motion and the American Shoulder and Elbow Society (ASES) survey will be completed at these visits as well. The SF-12 health and Disabilities of Arm, Shoulder, and Hand (DASH) survey will be completed at the preoperative visit and final follow-up visit only. We will assess rotator cuff repair integrity with ultrasound study at 1 year after surgery

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years or older
* Patients that undergo arthroscopic rotator cuff repair only

Exclusion Criteria:

* Patients less than 18 years of age, pregnant, are incarcerated. Women who are not post-menopause are screened for pregnancy preoperatively with a urine test per our UCSF Orthopaedic Institute preoperative guidelines.
* Patients who are unable to and not willing to comply with the study protocol and follow-up visits
* Patients with a history of prior rotator cuff repair
* Patients with rotator cuff tears that require open repair
* Patients with an allergy to ibuprofen or anti-inflammatory medications
* Patients with a medical chart record or those who report a history of upper gastroenterology bleed or gastric ulcers
* Patients who are currently on warfarin, enoxaparin, heparin, or a factor Xa inhibiting anti-coagulation medication
* Patients with a known past medical history of chronic kidney disease, history of kidney transplant, or eGFR \< 60 mL/min per 1.73m2.
Wearable Device for Motivating Hand Use After Stroke

The goal of this study is to determine the effectiveness of interactive feedback from a wearable device that senses hand function, the Manumeter, in improving upper extremity function in a pilot, randomized controlled trial with chronic stroke patients

In this randomized controlled trial, the investigators will compare two groups of chronic stroke participants Group 1 of study participants will use the Manumeter with interactive functions to monitor and motivate upper extremity functional activity. Group 2 of study participants will use the Manumeter but receive no feedback and will be given the current standard-of-care, a booklet describing a home exercise program for increasing upper extremity exercise. The investigators hypothesize that study participants who interactively monitor functional activity with the Manumeter will improve their upper extremity function significantly more.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 80 years of age
* Experienced one or multiple strokes at least six months previously
* Upper Extremity Fugl-Meyer Score \< 60 out of 66
* Absence of moderate to severe upper limb pain (\< 3 on the a 10 point visual-analog pain scale)
* Ability to understand the instructions to operate the device

Exclusion Criteria:

* 80 years of age and above
* Implanted pacemaker
* moderate to severe pain in affected arm
* severe tone in affected arm as measured on a standard clinical scale
* language problem that would prevent from properly understanding instructions
* currently pregnant
* difficulty in understanding or complying with the instructions given by the experimenter
* inability to perform the experimental task that will be studied
TheraPAP Equivalence Crossover Study

The present study, TheraEquivalence, is a Phase 2 crossover study designed to examine the efficacy and safety of TheraPAP (TPAP) vs. CPAP alone in the treatment of OSA.

The TheraEquivalence Study is a randomized, controlled, crossover study in participants with OSA. A split-night polysomnogram (PSG) will be conducted on CPAP and TPAP (3.5 h each treatment arm) in previously diagnosed OSA patients, to test the effectiveness of TPAP vs. CPAP. The sequence of periods for each participant are assigned in random order. Therapeutic CPAP level will be defined based on each individual's pressure levels from their currently used APAP device deemed to eliminate breathing obstructions for at least 90/95% of the sleep period (P90/P95) + 1 cmH2O (cm of water pressure). P90/P95 will be defined based on the previous 2 months of adherent Auto-adjusted Positive Airway Pressure (APAP) usage (defined as averaging \> 5 hrs/night). On TPAP Tthe pressure drop during inspiration is generally done in two steps and varies, as outlined in table 1, based on the set pressure level, with larger drops occurring when the set pressure is higher. However, the pressure never goes below 5 cm H20. This lower pressure is returned to the set pressure level about halfway through expiration. These pressure drops are designed to make TPAP considerably more comfortable than CPAP.

Eligibility Criteria:
Inclusion Criteria:

1. AHI \> 10 on a previous PSG.
2. CPAP adherence for an average of 5 h/night in the 2 months before the study
3. BMI above 18 kg/m2, inclusive.

Exclusion Criteria:

1. Current clinically significant sleep disorder other than OSA of a severity that would interfere with study participation or interpretability of data (including central sleep apnea, per central AHI \> 5 events/h).
2. Current clinically unstable cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or poorly controlled hypertension (\>140/90mmHg).
3. Current clinically significant neurological disorder, including epilepsy/convulsions.
4. Other serious major organ system disease including renal failure, lung disease, neuromuscular disease, or liver disease.
5. Schizophrenia, schizoaffective disorder or bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders-5 (DSM 5) or International Classification of Disease tenth edition criteria.
6. Attempted suicide within 1 year prior to screening, or current suicidal ideation.
7. History of substance use disorder as defined in DSM-V within 24 months prior to Screening Visit.
8. A serious illness or infection in the past 30 days as determined by investigator.
9. Clinically significant cognitive dysfunction as determined by investigator.
10. Chronic oxygen therapy.
11. Patients with hypoglossal nerve stimulation implant.
12. Any non-previously mentioned vulnerable population.
13. Any condition that in the investigator's opinion would present an unreasonable risk to the participant, or which would interfere with their participation in the study or confound study interpretation.
VNP40101M in Treating Patients With Relapsed or Refractory Leukemia or Myelodysplastic Syndrome

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of VNP40101M in treating patients who have relapsed or refractory leukemia or myelodysplastic syndrome.

OBJECTIVES:

* Determine the toxic effects of VNP40101M in patients with relapsed or refractory leukemia or poor-risk myelodysplastic syndromes.
* Determine the maximum tolerated dose of this drug in these patients.
* Determine the pharmacokinetics of this drug in these patients.
* Determine the antitumor effects of this drug in these patients.

OUTLINE: Patients receive VNP40101M IV over 15 minutes once every 4 weeks.

PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Relapsed or refractory leukemia for which no standard therapy is anticipated to result in a durable remission OR
* Poor-risk myelodysplastic syndromes

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* ECOG 0-1

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST and ALT no greater than 3 times ULN

Renal

* Creatinine no greater than 2.0 mg/dL

Cardiovascular

* No myocardial infarction within the past 3 months
* No symptomatic coronary artery disease
* No uncontrolled arrhythmia
* No uncontrolled congestive heart failure

Other

* No uncontrolled active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Prior biologic therapy allowed

Chemotherapy

* At least 2 weeks since prior myelosuppressive cytotoxic chemotherapy in the absence of rapidly progressing disease
* At least 48 hours since prior hydroxyurea

Endocrine therapy

* Not specified

Radiotherapy

* Prior radiotherapy allowed

Surgery

* Not specified

Other

* No other concurrent standard or investigational treatment for leukemia
* No concurrent disulfiram
A Study to Detect Progression of Mass Effect from Unilateral Brain Lesions

The purpose of this research is to gather information on the safety and effectiveness of the Brain4Care device for measuring intracranial pressure without invasive procedures.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with non-traumatic hemispheric brain lesions deemed at risk for progression of mass effect and possible subfalcine and/or uncal herniation.
* Patients admitted the Neuroscience ICU for serial neurological monitoring.
* Patients whose care is not expected to include immediate surgical decompression.

Exclusion Criteria:

* Patients under the age of 18.
* Patients who are unable to provide consent due to neurologic deficit and does not have a surrogate decision maker available to provide consent.
Effects of a Clinical Dietary Intervention During Inpatient Treatment

The purpose of the study is a scientific and prospective documentation of the clinical effects of an inpatient treatment at the Immanuel Hospital of Berlin, in the department for complementary and integrative medicine, with the use of a modified fasting regime. A pre- and post- as well as group comparisons are planned. Patients that are admitted to the inpatient department for metabolic syndrome, osteoarthritis of the hip or knee, rheumatoid arthritis and fibromyalgia will be enrolled in the study.

At the beginning, during and at the end of the treatment at the inpatient department routine blood parameters, anthropometric parameters and certain scores and parameters specific to the different conditions will be measured. Questionnaires will be filled out by patients before and after the treatment as well as 3, 6 and 12 months after leaving the inpatient department.

Eligibility Criteria:
Inclusion Criteria:

* The patient is consents to participating in the trial during the first 24h of his or her stay in the inpatient naturopathic department of the Immanuel Hospital.
* Written informed consent is given
* The referral diagnosis is one of the following: diabetes mellitus type 2/metabolic syndrome, osteoarthritis of the hip, osteoarthritis of the knee, rheumatoid arthritis, fibromyalgia.

Exclusion Criteria:

* Language barries to understanding the instructions of the study personnel
* Dementia or other strong cognitive impairment
* Pregnant or lactating women
* Taking part in another study at the same time
Development of Sleep Intervention for Parent and Child

This study aims to develop and test the intervention program to help manage parental thoughts in parents with child sleep problems.

Pediatric sleep problems are common and persistent, which result in negative outcomes without appropriate intervention. Behavioral sleep interventions (BSI) are evidence-based sleep training methods for improving pediatric sleep. However, parental factors (e.g., parental dysfunctional beliefs about child sleep) can interfere with the implementation of BSI. For example, being too worried or having misperceptions about infant sleep may interfere with the parent's ability to successfully and persistently implement BSIs. Therefore, parental thoughts and beliefs should be considered as an important target in the context of pediatric sleep interventions. This study aims to develop a cognitive intervention that identifies and targets parental misperceptions about child's sleep, and test the efficacy of the intervention through a randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Child's primary nighttime caregiver (mothers or fathers) of full-term, healthy, singleton, 6 to 24 months old
* Caregiver participants aged between 19 to 65 years
* The caregiver who is a native speaker of Korean (a person who is able to listen, speak, and write in Korean, and does not have any difficulties in understanding the Korean language)
* Residents of South Korea
* Sleep arrangements without restriction for using an auto-videosomnography device: (1) parent-child sleep separately (one should not change the sleep arrangement only for the participation in the study); (2) if parents and child share a bed, the child's own space should be large enough for the videosomnography camera to capture child body solely.
* Be available on devices with the camera (e.g., tablets, personal computers) for the online intervention/session

Exclusion Criteria:

* Child's gestational age before 37 weeks or after 42 weeks
* Children with developmental disability
* Caregiver participant (or partner) who is currently working the night shift or night duty
* Caregiver participant who has a history of sleep disorders besides insomnia
* Caregiver participant who has lifetime bipolar disorder, schizophrenia spectrum, and other psychotic disorders, alcohol, caffeine, or other substance substance-related disorders, neurocognitive disorders, thyroid-related disorders, or epilepsy
* Caregiver participant who is currently experiencing a major depressive disorder, panic disorder (only if ≥ 4 nocturnal panic attacks in the past month), or post-traumatic stress-related problems
* Caregiver participant who is using medications or substances that directly affect sleep
* Caregiver participant who is currently getting cognitive behavioral therapy for insomnia (CBTi)
* Pregnant women