cyrilzakka/clinical-trials huggingface dataset:
Mother and Late Preterm Lactation Study

Breastfeeding has various benefits for the mother and infant. It has the capability of reducing the risk of short term and long term problems for the infant, such as gastroenteritis, respiratory infections, type II diabetes and obesity, and of providing benefits for neurodevelopment. Breast milk offers even greater benefits for preterm infants. Some of the advantages of breastfeeding are related to the constituents of breast milk such as the macronutrients and bioactive factors, the hormones associated with breastfeeding such as oxytocin, and the behavioural aspects of breastfeeding (maternal sensitivity to infant cues). Despite these advantages, breastfeeding rates are below target levels mainly due to the challenges that women face that hinder breastfeeding success. Interventions aimed at improving policies, practices, and maternal support have been developed. However, other interventions that target specific modifiable barriers to breastfeeding can be useful.

The aim of this study is to investigate a simple support intervention for breastfeeding mothers of late preterm and early term infants on maternal stress reduction and infant weight gain. The investigators also aim to study the potential mechanisms by which this effect could be achieved (breast milk composition and volume, mother and infant behaviour).


Eligibility Criteria:
Inclusion Criteria:

* Mothers of late preterm infants (34 to \<37 weeks) or early term infants (37 to 38 weeks)
* Intending to breastfeed for at least 6 weeks
* Free from serious illness
* Fluent in English

Exclusion Criteria:

* Currently smoking or intending to smoke while breastfeeding
* Not based in London
* Prior breast surgery
Study of Chemotherapy Side Effects in Cancer Patients: Non-invasive Optical Measurements of the Brain

Currently there is no methodology that can assign a risk of development of chemo brain and thus, studies to understand how and why only some patients develop chemo brain along with studies of potential treatments face major hurdles. This study will define hemodynamic/optical parameters in normal individuals and cancer patients undergoing chemotherapy potentially identifying optical parameters that are associated with the development of chemo brain, leading to new insights into the origin of the chemo brain condition, and importantly potentially identifying parameters that may predict who will develop "chemo brain" in order to directing investigations of therapies.

The researcher can use Non-invasive optical imaging, diffuse optical spectroscopic imaging, measure various tissues and can determine chemo brain symptoms. Near infrared diffuse optical imaging is a real-time, non-invasive technique that measures hemodynamic variations based on changes in hemoglobin oxygenation. Tissue in general and the cerebral cortex surface in particular, are transparent to near infrared light.

Direct optical measurement of cerebral hemodynamic parameters is superior to systemic approaches that infer brain levels of hemoglobin. Optical imaging in conjunction with physiologic maneuvers measures vascular tone and reactivity and may permit early detection of changes in physiology that precede the onset of chemo brain symptoms. Since chemo brain specifically impacts working memory and executive function the optical imaging can measure the frontal cortical areas behind the forehead.

Eligibility Criteria:
Inclusion Criteria:

* have a histologically proven cancer.
* Planned initiation of chemotherapy
* age range between 18-70 years

Exclusion Criteria:

* have NO a histologically proven cancer.
* NO planned chemotherapy
* age less than 18 years
Treatment of Erectile Dysfunction - Long Term Safety and Efficacy

Open-Label Phase 3 study to evaluate the long-term safety and efficacy of udenafil, an orally administered selective inhibitor of PDE-5 for the treatment of subjects with erectile dysfunction (ED).

Patients completing the double-blind phase will be entered into Study 01409 at the intermediate dose. Up and down dose adjustments will be allowed.

Eligibility Criteria:
Inclusion Criteria:

* Subject has completed Study PR-01209 or PR-01309
* Continues in a stable monogamous relationship with a consenting female partner who is at least 19 years of age.
* Partner is not pregnant or lactating

Exclusion Criteria:

* Symptomatic coronary artery disease, myocardial infarction or cardiac surgical procedure.
* Cardiac arrhythmias requiring antiarrhythmic treatment
* Symptomatic congestive heart failure
* Taking nitrate medication in any form
* Uncontrolled diabetes (HbA1c ≥ 13%)
* Hypersensitivity to phosphodiesterase type 5 (PDE-5) inhibitors
18-week add-on to Metformin Comparison of Saxagliptin and Sitagliptin in Adult Patients With Type 2 Diabetes (T2D)

Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to assess the efficacy and tolerability of saxagliptin in addition to metformin and compare to sitagliptin in addition with metformin.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes
* Treatment with metformin alone on stable doses of 1500 mg or higher per day for at least 8 weeks

Exclusion Criteria:

* Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketotic coma
* Insulin therapy within one year
* Previous treatment with DPP-4 inhibitor
Continuous Glucose Monitoring in Pregnant Women Undergoing Betamethasone Therapy

We hope to clarify how betamethasone affects glucose levels in the mother in the days after receiving the drug. This understanding will hopefully allow us to better anticipate the risk of maternal hyperglycemia and therefore establish more appropriate monitoring of maternal glucose to prevent maternal and neonatal complications of hyperglycemia.

Pregnant patients who are undergoing inpatient betamethasone therapy as part of their clinical care will be eligible for the study. Once the clinical team and patients have agreed to pursue betamethasone therapy, the patients' treating physician or nurse will inquire if the patient is interested in participating in our study protocol. Those patients who are interested in participation will be consented by either a member of the treatment team or the study team. Prior to receiving the first betamethasone dose, a soft sensor for continuous glucose monitoring system (CGMS) will be inserted superficially under the skin. For those patients who will be receiving a scheduled course of betamethasone, the sensor may be inserted up to 24 hours prior to the betamethasone administration. The patient will be instructed on how to wear and care for the device. She will wear the CGMS for the duration of her hospitalization or for up to 7 days total, whichever time period is shorter. For those patients who are diabetic, they will receive normal finger stick blood glucose (FSBG) monitoring and insulin therapy as determined by their treating physicians. Those patients who are not diabetic will need to have 2 FSBG checks each day to correlate with the device. Abnormal values will be reported to the patients' treating physician and addressed by the treating physician. Prior to being discharged from the hospital, the patient will have the device removed. The patient will otherwise be treated routinely. We will record baseline demographic information and medical history from each of the women. We will also record information from the neonates' newborn medical records.

Eligibility Criteria:
Inclusion Criteria:- 18 years of age or older

* Receiving betamethasone as part of routine clinical care.
* Pregnancy between 23+5 and 35+0 weeks Exclusion Criteria:- Less than 18 years old.
* Major fetal anomalies
* Use of steroid medications in the past 2 weeks.
THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation CONTINUED ACCESS

This is a prospective, multicenter, non-randomized continued access clinical evaluation utilizing the THERMOCOOL® SMARTTOUCH™ catheter.

The device is currently under investigation with IDE #G110030. This continued access study will enroll subjects that have participated in the Smart-AF IDE study. Subjects with drug refractory symptomatic paroxysmal atrial fibrillation (PAF) will be considered for this study. Effectiveness and safety endpoints have been defined and will be evaluated post treatment.

Eligibility Criteria:
Inclusion Criteria:

* Have had at least 3 atrial fibrillation episodes within 6 months of this study
* Have failed at least one antiarrhythmic drug shown by repeated atrial fibrillation episodes
* 18 years of age or older

Exclusion Criteria including, but not limited to:

* Have had previous ablation for atrial fibrillation
* Have take amiodarone within 6 months of this study
* Have had any heart surgery within the last 60 days
* Have had a heart attack within the last 60 days
* Females who are pregnant or breast feeding
Registry of MIUS for Urolithiasis (ReMIUS-U)

The purpose of this registry is to collect data on patients who have undergone minimally invasive treatments for urinary system stone disease, including percutaneous nephrolithotomy (PCNL), shock wave lithotripsy (SWL), semi-rigid ureterorenoscopy (URS), and flexible ureterorenoscopy (F-URS).

In this project, the Minimally Invasive Urology Association urolithiasis study group aimed to collect the data of adult and pediatric urinary system stone patients treated with PCNL, SWL, URS, and F-URS in a non-randomized, observational, and prospective manner. The registry was to be conducted multi-center in Turkey.

In this project, Excel files were created and shared via Google Drive with the responsible physicians at the centers to be included in the study. Each parameter was prepared in an explanatory manner and can be readily filled out by physicians familiar with these methods. The ability to examine and modify existing data will be restricted to the worker and the database administrator. Patients' identities will not be revealed in the registry.

The collected data are summarized in three sections under the major headings below;

1. Demographics and preoperative information; Patient, disease, and treatment method demographic data, such as age, gender, height, weight, previous diseases, medications used, location, size, and hardness of urinary tract stones, the side of the stone, and the methods used for diagnosis, will be prospectively recorded for patients whose consent was obtained.
2. Data during the operation; The duration of the operation as well as the devices and methods utilized will be recorded.
3. In the postoperative period, post-treatment findings, such as stone-free status and post-treatment complications, will be documented.

A separate application to the ethics committee will be submitted for each study on the subject that will be created in the future from the multi-center, prospectively recorded data pool and on the subject that will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* To have a medical indication for urolithiasis
* Complete data of treatment and follow-up course
* Patients with consent
* Patients \> 18 years-old
* Patients \< 18 years-old

Exclusion Criteria:

* Missing data
* Patients without consent
* Not to have a medical indication for urolithiasis treatment
* To have a contraindication for urolithiasis treatment
Comparison of Erector Spina Plane Block and Lumbar Plexus Block in Femoral Fracture Surgery

The aim is to clinical trials compare the lumbar plexus block method with the erector spinae plan block method in terms of analgesic efficacy and possible complications. İn patients for femur fracture surgery. The main questions it aims to answer are: 1. is erector spinae plane block as effective as lumbar plexus block for postoperative analgesia in femur fractures? 2. Is erector spinae plane block effective for reducing opioid consumption compared to lumbar plexus block?


Eligibility Criteria:
Inclusion Criteria:

* Proximal femoral surgery
* All patients who can respond to pain assessment questions

Exclusion Criteria:

* Regional block contraindications,
* Severe cardiac and respiratory disease,
* Severe coagulopathy,
* Body mass index greater than 35
Active Older Adult Program on Health and Well-being

The purpose of this study is to determine whether a structured 12-week program designed for older adults will improve physical function and, in parallel, circulating biomarkers of aging


Eligibility Criteria:
Inclusion Criteria:

* Men and women age 55 years or older.
* Membership at the DAHLC.
* New to AOA (Active Older Adult) Program and commitment to full participation in the twelve-week program.
* Must be able to get down and off the floor with little assistance.

Exclusion Criteria:

* Inability to provide informed consent.
* Previous participation in the AOA Program at the DAHLC.
Comparative Evaluation of Melatonin Versus MTA on Vital Pulp Therapy in Young Permanent First Molars: An in Vivo Study

The process of dental caries is dynamic and can be either reversible or irreversible depending on the balance between protective and pathologic factors in the oral cavity. Untreated dental caries causes pulpal injury, inflammation, and necrosis. Melatonin plays an essential role in the regulation of bone growth. The actions that melatonin exerts on odontoblasts may be similar to its action on osteoblasts.

The aim of this study is to evaluate and compare the pulp response of young permanent first molars after apexogenesis procedure, using melatonin versus MTA clinically and radiographically. This study will be performed on 45 young permanent first molars that will be divided equally into three groups according to the material used following apexogenesis; GroupI: MTA, GroupII: Melatonin and GroupIII: MTA and Melatonin. apexogenesis procedures will be carried out in children aged 6 to 8 years old. This will be followed by placement of MTA or/and Melatonin material as a sub base in the pulp chamber according to the group. Then, placement of a conventional glass ionomer cement (FUGI IX) as a permanent restoration will be conducted. Then, an immediate postoperative periapical digital x-ray film will be taken for the patients. The patient follow-up will be assigned 1,3,6,9 and 12 months after treatment.

Eligibility Criteria:
Inclusion Criteria:

* 1- Apparently healthy and medically free children. 2- Their age ranges from 6-8 years. 3- Both boys and girls will be included. 4- Children should have mandibular permanent first molars with the following clinical and radiographic criteria. 4.1Restorable young permanent first molars. 4.2Absence of clinical evidence of pulp degeneration:
* No history of spontaneous pain, history of night pain or pain that not relieved by analgesics.
* No pain on percussion.
* No mobility.
* Absence of abscess, purulent sinus or soft tissue edema.
* Bleeding should stop within 5 minutes after the amputated pulp stumps.

Exclusion Criteria:

* Internal root resorption.
* External root resorption.
* Inter radicular or periapical bone destruction (radiolucency)
* A deep carious lesion radiologically that approaches the pulp
Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations

The purpose of this large comparative effectiveness study led by Richard J. Barohn, MD, of the University of Kansas Medical Center, is to learn about the safety and effectiveness of nortriptyline, duloxetine, pregabalin and mexiletine in treating cryptogenic sensory polyneuropathy (CSPN).

The goal of this research project is to find the best drug for the treatment of pain in patients with CSPN. While the pharmaceutical industry has focused attention on drugs for treating diabetic sensory neuropathy (DSPN), and two drugs are now FDA approved, there have not been any prospective trials in CSPN. And, because there are no studies with CSPN patients, insurance carriers often reject authorizing prescriptions for some drugs for patients with CSPN.

There are four drugs that will be tested in this study: nortriptyline, duloxetine, pregabalin and mexiletine. These drugs are not approved by the FDA for the treatment of CSPN and are considered "investigational" in this study.

There are two periods in this study: Screening/Baseline and Study Drug. During the Screening/Baseline period the researchers will determine eligibility for potential subjects. During the second period, eligible patients who consented to participate will take the study drug. Participants will be randomized to receive one of the four drugs in this study. Participants will know which drug they are taking. Participants will not be allowed to switch groups and receive a different drug during the study.

This study uses an adaptive study design. This means the study can enroll less participants and provide better conclusions. The study design allows the researchers the ability to make changes to the approach of the study or to stop the study early if there are strong results.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cryptogenic sensory polyneuropathy.
* Likert Pain Score of greater than or equal to 4.
* Must not currently be on nortriptyline, duloxetine, pregabalin or mexiletine or similar class of medication for at least 7 days from baseline study visit.

Exclusion Criteria:

* Any medical condition or current medication that would prevent them from taking either nortriptyline, duloxetine, pregabalin or mexiletine.
* Unable to give consent.
* Unable or not willing to comply with the study.
* Other causes for polyneuropathy.
A Double Blind Randomized Study Using Placenta Derived Decidual Stromal Cells for Hemorrhagic Cystitis

A prospective double blind randomized study comparing placenta derived decidual stromal cells with placebo for hemorrhagic cystitis after allogeneic hematopoietic cell transplantation. It is hypothesized that the decidual stromal cell therapy will be superior to placebo.

Patients with grade 2-4 hemorrhagic cystitis will be randomized to receive either decidual stromal cell therapy at approximately 1x106 cells/kg or placebo on two occasions at weekly intervals. Patients not responsive within 2 weeks will receive decidual stromal cells at approximately 1x106 cells/kg openly.

Eligibility Criteria:
Inclusion Criteria:

* Hemorrhagic cystitis grade 2-4
* Receives Misoprostol therapy

Exclusion Criteria:

* Patients with urinary urge without macroscopic hematuria or clots
Optimizing a Technology-based Body and Mind Intervention

Older adults may feel at risk for falling, but do not have a physical risk of falling. On the other hand, some older adults may not feel at risk for falling, but do have a physical risk of falling. This study is being done to test a preventative, in-home exercise program (called PEER) which may allow older adults to improve balance, align the perceived risk for falling with the physical risk for falling, and prevent falls. Participants will be asked to participate in this study for approximately 9 months. This study has three specific aims:

1. Examine differences in balance, fall risk, and physical activity after program completion, follow-up 3 months and 6 months between older adults (OAs) in the Physio-fEedback Exercise pRogram (PEER) intervention and OAs in attention control (AC) condition.
2. Explore differences in exercise adherence and the proportion of shifting in fall risk appraisal and negative self-perception on aging after program completion, follow-up 3 months and 6 months between OAs in the PEER intervention and OAs in AC condition.
3. Explore participants' experiences with the PEER intervention and potential barriers to access and adoption of the technology-based PEER intervention to inform future research.

Participants will be asked to participate in this study for approximately 9 months. This includes the baseline assessment, 8 weeks of PEER activities or attention control activities, and follow-up assessments at 3 months and 6 months. After the informed consent and completion of the baseline assessments, participants will be randomized to either the PEER intervention or the attention control (AC) group. Participants in the PEER intervention group will be asked to participate in group exercises (60 minutes per week for 8 weeks) and home-based exercises (twice a week for 8 weeks) that focus on balance, strength training with a peer coach. Participants in the AC group will receive an information pamphlet developed by the CDC about falls called Simple Exercises for Improving Balance and Preventing Falls in Older Adults. Topics include information on fall risks, how to prevent falls, how to check for safety, postural hypotension, and chair rise exercises. The control group will be encouraged to discuss fall prevention with a primary care provider and continue normal activities.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 60 years of age,
* No marked cognitive impairment \[Memory Impairment Screen (MIS) score ≥ 5\]
* Live in their own homes or senior/retirement units
* Understand English

Exclusion Criteria:

* A medical condition precluding exercise such as uncontrolled cardiac disease (shortness of breath or feel pressure, squeezing, burning, or tightness when doing a physical activity)
* Currently receiving treatment from a rehabilitation facility
A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease

This is a multicenter, randomized, double-blind, placebo-controlled study that will evaluate the efficacy and safety of intravenous (IV) prasinezumab versus placebo in participants with Early Parkinson's Disease (PD) who are on stable symptomatic PD medication.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic PD based on MDS criteria with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity), without any other known or suspected cause of parkinsonism
* On symptomatic PD medication, with stable doses for at least 3 months prior to baseline
* A diagnosis of PD for at least 3 months to maximum 3 years at screening
* MDS-UPDRS Part IV score of 0 at screening and prior to randomization
* Hoehn and Yahr (H\&Y) Stage I or II in OFF medication state at screening and prior to randomization
* Dopamine transporter imaging with single photon emission computed tomography (DaT-SPECT) imaging consistent with dopamine transporter deficit, as assessed by the central reader
* No anticipated changes in PD medication from baseline throughout the study duration based on clinical status during screening
* Willingness and ability to use a smartphone application to measure PD-related symptoms for the duration of the study
* Willingness and ability to wear a smartwatch to measure PD-related motor signs

Exclusion Criteria:

* Medical history indicating a Parkinsonian syndrome other than idiopathic PD
* Diagnosis of PD dementia
* Diagnosis of a significant neurologic disease other than PD
* Within the last year, unstable or clinically significant cardiovascular disease
* Uncontrolled hypertension
* Drug and/or alcohol abuse within 12 months prior to screening, in the investigator's judgment (Nicotine is allowed, Marijuana use is not allowed)
* Clinically significant abnormalities in laboratory test results at the screening visit, including hepatic and renal panels, complete blood count, chemistry panel and urinalysis
* Allergy to any of the components of prasinezumab, a known hypersensitivity, or a previous IRR following administration of any other monoclonal antibody
* Any contraindications to obtaining a brain magnetic resonance imaging (MRI)
* Any contraindications to DaT-SPECT imaging