cyrilzakka/clinical-trials huggingface dataset:
Effect of 'Parentbot - a Digital Healthcare Assistant (PDA)' in Improving Parenting Outcomes During the Perinatal Period

The Parentbot - a Digital healthcare Assistant (PDA) is a mobile application-based psychosocial parenting intervention with integrated chatbot features, intended for couples to use during the perinatal period. It provides parents with multimedia educational materials (text files, audio files and videos), discussion forum, guided mindfulness-based meditation videos, guided reflection and gratitude journals and a chatbot to answer their queries related to perinatal care in real-time.

This study aims to:

1. Develop a theory-based perinatal intervention with integrated chatbot features for both first-time and experienced parents
2. Examine the effectiveness of the PDA intervention in improving parenting self-efficacy (primary outcome), stress, depression, anxiety, social support, parent-child bonding and parenting satisfaction (secondary outcomes) among parents during the perinatal period
3. Examine the perceptions of parents from both the intervention and control group after the intervention
4. Collate suggestions for further improvement from the participants and members of the research team

The hypotheses of this study are:

The PDA intervention group will have significantly higher scores for parenting self-efficacy, social support, parent-child bonding and parenting satisfaction, as well as lower scores for stress, depression and anxiety compared to the control group receiving standard care after the intervention at one-month postpartum (post-test 1) and three-months postpartum (post-test 2).


Eligibility Criteria:
Inclusion Criteria:

Heterosexual married couples who are first-time parents or experienced parents are included if they:

* Are at least 21 years old
* Are fluent in English
* Own a smartphone with internet access
* Intend to stay in Singapore until three months postpartum
* Are having a low-risk singleton or multiple pregnancy at \> 24 gestational weeks (age of viability).

Exclusion Criteria:

Couples will be excluded if either parent has:

* Any self-reported psychiatric disorders, visual, auditory, cognitive impairment and/or any major medical condition that can affect their abilities to participate in the trial
* High-risk pregnancy including placenta previa major, pre-eclampsia, intrauterine growth restriction etc
* Suffer from a miscarriage or made the decision to abort their child
* Give birth to still-birth newborn
* Give birth to a newborn with congenital anomalies or medical complications (require intensive care, severe jaundice, Down's syndrome)

Single parents will also be excluded. If either the mother or father declines to participate in the study while their partner agrees, the couple will not be allowed to participate in the study.
Safety and Pharmacokinetic Study of Sublingual Flumazenil (CRLS035) in Healthy Adults

This study compare the pharmacokinetic (PK) profile of sublingual CRLS035 (two doses) to I.V flumazenil administration.

Selection of study drug dosage: CRLS035 - sublingual Flumazenil will be administrated at a final dosage of 1.1 mg per 100 µl and 2.2 mg (200 µl) in a sublingual spray administration.

Currently, Flumazenil is given as an IV drug with a repetitive administration of doses of 0.2 mg up to 3 mg per hour. As the bioavailability of Flumazenil is expected to be lower than the IV administration, 1.1 mg and 2.2 mg will be tested in sublingual delivery. The suggested doses in this study are very safe according to the following data: first, sublingual and buccal administration of Flumazenil have been detailed previously with similar and higher doses with no side effects, secondly, IV dose may reach 3 mg and thirdly, oral administration has been reported as up to 600 mg/dose.

The purpose of this study is to determine the single dose PK profile of SL CRLS035. This study is designed to collect short-term safety data and to monitor the PK profile of CRLS035.

Primary Objective The primary objective is to determine the single dose safety and PK profile of SL CRLS035 using the marketed IV flumazenil formulation as the comparator.

Secondary Objectives The secondary objectives are to (1) characterize the concentration time course of two dose levels of SL CRLS035 to support dose selection for Phase 2 and 3 studies and to evaluate the safety and tolerability of flumazenil formulations; (2)To evaluate the effect of high fat diet and water consumption on the PK profile.


Eligibility Criteria:
Inclusion Criteria:

1. The subject understood and voluntarily signed an informed consent form prior to any study-mandated procedure.
2. Male or female aged ≥18-at screening.
3. Body mass index ≥ 18.5 and \< 32 kg/m2.
4. Subject is in good health as determined by a medical history, physical examination and ECG.
5. Negative any use of illicit drug, alcohol (ethanol), stimulants.

Exclusion Criteria:

1. Any use of medications within 1 month prior to screening visit, except for contraceptive pills.
2. Previous exposure to Benzodiazepines and/or non-Benzodiazepine hypnotic drugs within 3 months prior to study initiation.
3. History of Epilepsy and or anti-epileptic drugs.
4. Pregnancy or breast feeding.
5. Clinically relevant ECG abnormalities.
6. History of alcohol or drug abuse within 3 years prior to the screening visit.
7. Known hypersensitivity to drugs of the same class as the study treatment, or any excipients of the drug formulation.
8. Treatment with another investigational drug within 1 month prior to the screening visit.
9. History of severe head injury.
10. Any acute or chronic illness
11. Xerostomia (endogenic or drug induced).
Long-Term Follow-up of Radiofrequency to Articular Branches of the Femoral and Obturator Nerve in Chronic Hip Pain

It has been observed that the deterioration in the physical performance of the hip, the medical need before the specialist consultation and the deterioration in the health status can progress treatment\[3\]. When conservative treatment methods such as physical therapy and weight change, the use of walking aids (such as a cane) and analgesic agents are used, these interruptions usually provide short-term and partial benefits. After the application of medical treatment procedures, hip prostheses are usually separated. However, the additional diseases of the patients, the fact that the surgery is a major surgery and the mortality rate is high, and the life of the prostheses used are limited have led to the search for alternative pain palliation.

Hip joint radiofrequency thermocoagulation is a procedure performed in our clinic. In this study, we aimed to examine the long-term effects of hip RFT on pain and functional capacity changes in patients.

After obtaining hospital ethics committee approval, it was planned to retrospectively examine adult patients over the age of 18 who applied to the outpatient clinic of the Department of Algology, ADÜTF, between May 2021 and September 2023 and who underwent elective conventional radiofrequency thermocoagulation (RFT) procedure to the articular branches of the femoral and obturator nerves due to chronic hip pain. The prospective studies conducted in our clinic titled "Treatment of chronic hip pain with conventional radiofrequency thermocoagulation to the articular branches of the femoral and obturator nerve" and "Comparison of Conventional Radiofrequency Thermocoagulation to the Articular Branches of the Femoral and Obturator Nerve in Chronic Hip Pain with Intra-Articular Steroid Injection and Pericapsular Nerve Group (PENG) Block" (theses of assistants Sevilay Şimşek Karaoğlu and Bilge Ergün, respectively) will include patients who underwent conventional RF. In the studies, patients who underwent elective conventional radiofrequency thermocoagulation (RFT) to the articular branches of the femoral and obturator nerve were followed up for up to 6 months. The follow-up of the patients in our clinic is ongoing. In our study, the long-term follow-up of these patients will be evaluated retrospectively at 12 months and 24 months.

Eligibility Criteria:
Inclusion Criteria:

1. Being over 18 years of age
2. Having received written consent
3. Those with chronic hip pain lasting longer than 3 weeks

Exclusion Criteria:

1. Major psychiatric disease
2. Patients with lumbar pressure pain or referred pain
3. Patients using anticoagulant agents
4. Patients with infection in the area to be treated
5. Those with local anesthetic allergy
6. Those with betamethasone allergy
7. Pregnant women
An Intervention Targeting Fruit and Vegetable Intake Among Rural Youth

The investigators implemented a theory-based randomized controlled trial in ten rural Virginia middle schools in 2008-2010 and assessed the impact on health behaviors including fruit/vegetable intake as a primary outcome. Schools were randomized to intervention or control groups. Goal setting, peer leaders, and in-class workshops were intervention features. Seventh graders filled out surveys on health behaviors, psycho-social variables, and demographic characteristics. The investigators expected schools receiving the intervention to report a higher fruit-vegetable intake compared to control schools where students received standard health information. Sample (n=1,119) was 48.5% female, 50% White, with a mean age of 12.6 years. Fruit/vegetable intake was significantly higher in intervention schools at immediate post and at 1-year follow-up compared to controls.


Eligibility Criteria:
Inclusion Criteria:

* 7 grade youth
* attending participating middle schools

Exclusion Criteria:

* In grades other than 7th grade
Kinect Sensor in Cerebral Palsy Children: Phase 2.1

There are 3 phases of the study. This registration is phase 2.1.This registration will conduct a pilot study in the cerebral palsy children.


Eligibility Criteria:
Inclusion Criteria:

* Spastic cerebral palsy aged 10-15 years
* Sufficient cognitive/attention capacity to understand basic instructions
* Can cooperate with the therapist for short period of time during training
* Manual Ability Classification System (MACS) 2-3
* Zancolli classification of the affected upper extremity was grade I-II.
* Give the informed consent

Exclusion Criteria:

* Inability to understand the instruction and follow the task
* Severe comorbidities, visual or auditory impairment
* Had history of Botulinum toxin injection on the affected upper extremity for last 6 months or receive the injection during the study time
* Other treatment options planned on the affected upper extremity during the study time
* Wear daytime orthosis on the affected limb
* Zancolli classification of the affected hand was grade III.
* Got an epilepsy or convulsive condition
* Denied to give the informed consent or continue the study
Natural History Study of Azathioprine Adherence

This study began in 1993 as a prospective, natural history study of renal transplant patients' medication compliance measured by using an electronic monitor on the cap of medication vials. Hypothesis: Poor medication compliance predicts adverse outcomes. Enrollment is closed.

* The study is complete. Patient recruitment is closed and active patient involvement in the study has ended.
* Statistical analysis of monitor records and new patient outcome data continues

Eligibility Criteria:
Inclusion Criteria:

* Kidney transplant recipient
* Discharged from hospital with functioning graft,not on dialysis
* Prescribed azathioprine

Exclusion Criteria:

* Unable to give informed consent
* Non English speaking
* Previous or concurrent organ transplant other than kidney
* Taking liquid form of azathioprine
* Followed outside of the United states
Bilateral Cochlear Implantation in Children With the MED-EL Cochlear Implant

The purpose of this study is to evaluate and document longitudinal efficacy in young children implanted bilaterally with MED-EL COMBI 40+ / PULSARCI100/SONATATI100 cochlear implant systems.


Eligibility Criteria:
Inclusion Criteria:

* Between 12 and 36 months of age at time of implantation
* Profound bilateral sensorineural hearing loss
* English as the primary language in the home
* Realistic expectations of guardians
* Child must be enrolled in a post-operative rehabilitative/educational program that supports the use of cochlear implants and the development of auditory-based skills
* Willing and available to comply with all scheduled procedures as defined in the protocol

Audiological:

* Profound bilateral sensorineural hearing loss with average thresholds between ears of 90 dB HL or greater at 1000 Hz and above, and must demonstrate minimal functional benefit from conventional amplification
* Behavioral test measures must include unaided threshold measures for the right and left ears using insert earphones; left-alone and right-alone aided sound field threshold measurements; and aided and unaided speech-awareness / detection thresholds (for each ear individually)
* Children accepted into the study must be able to demonstrate a consistent response to sound. If a child has no measurable hearing, he/she must be able to demonstrate a consistent response to vibrotactile stimuli.
* All children must have completed an appropriate trial period with optimally fit amplification prior to inclusion in the study.

Medical:

* Good general health status, as judged by Primary Investigator
* Patent cochleae bilaterally, as indicated by radiological evaluation
* No contraindications for surgery, in general, or cochlear implant surgery in particular

Exclusion Criteria:

* Prior experience with any cochlear implant system
* Younger than 12 months or older than 36 months at time of implantation
* Audiological: Presence of otoacoustic emissions and/or cochlear microphonic, indicating possible condition of auditory neuropathy

Medical:

* Evidence of ossification that would prevent full insertion of the standard C40+ / PULSARCI100 /SONATATI100 electrode array in the cochlea(e) to be implanted, as indicated by radiological evaluation
* Abnormal or malformed cochlea(e) to be implanted
* Severed or non-functional auditory nerve in the ear(s) to be implanted
* Central auditory lesion
* Cognitive and/or neurological dysfunction
* Auditory neuropathy
Telemedicine Evaluation for Stem Cell Transplant Patients

Telemedicine is a new area of health care where medical information is transferred through audiovisual media, such as a computer or a video camera, for the purpose of remote doctor's visits or examinations. This new area of health care is important to test because it can potentially provide real-time interactions between the patient and their health care team, including phone conversations, online communication, and/or home visits. Many activities such as a history review or physical examination can be conducted virtually as compared to the traditional face-to face visits.

The purpose of this study is to determine patient and health care team acceptance of a "virtual medical visit" as a substitute for a "face to face" visit for patients either preparing to receive a stem cell transplant or previously received a stem cell transplant.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent or are planning to undergo a hematopoietic progenitor cell transplantation for any disease.
* Participants must be able to read and understand English\*
* Age over 18 years of age since this pilot trial is only being performed in the Adult BMT Service Non-English speaking patients have been excluded in this pilot study because we do not have the support for translation services at this time. Additionally, the telemedicine instruments being used are not yet validated across all languages.

Potential patients will be identified according to their medical condition, type and complexity of stem cell transplant procedure performed, and distance from MSKCC.

The patients should:

1. minimal comorbidities,
2. be less than 75 years of age. These characteristics have been associated with good understanding and acceptance of telemedicine in other pilot trials. These characteristics will be assessed by the clinician.

Please note: Patients on other therapeutic protocols will be eligible for this protocol as well.

Exclusion Criteria:

* Medically unstable patient as deemed by the treating team.
Health Related Quality of Life in Pediatric Central Nervous System (CNS) Tumors: A Feasibility Study Utilizing PROMIS

In this research study the investigators want to learn more about the quality of life before, during and after cancer treatment in patients with central nervous system brain tumors. Often CNS tumors and cancer treatment can cause many physical and emotional problems and side effects. Some of these problems and treatment side effects can cause a change in a patient's qualify of life and overall well-being. Quality of life questionnaires are used to measure well-being and ability to carry out daily activities by asking patients to answer several questions about their physical, emotional, and social well-being.

In this research study we want to find out if patient's answers to these questions change over the course of your treatment. We also want to see if doctors and nurses can use these answers to the questions to help patients feel better and increase their activity during cancer treatment.

Pediatric CNS tumors are the second most common form of pediatric cancer and the leading cause of death related to pediatric malignancies. Over decades of work and through the efforts of collaborative groups, cure rates have increased significantly. However, various types of CNS malignancy outcomes have remained stagnant. Moreover, side effects from treatments of even the most curable CNS tumors may have dramatic short and long-term sequela ranging from cognitive, endocrine malfunction, functional mobility, neurological, and ophthalmologic compromises. As science and protocol directed therapies continue to find cures for these patients, work also must continue in efforts to explore patient reported outcomes (PROs) and health related quality of life (HRQOL) throughout the trajectory of a patient's disease process. Increased efforts in patient reported outcomes will lead to improvements in symptom management, functional status, and overall quality of life (QOL).

Eligibility Criteria:
Eligibility Criteria

* Patient must have diagnosis of a CNS tumor (newly diagnosed, relapsed, refractory, or progressed) and scheduled to receive a new therapy including surgery, chemotherapy and/or radiation therapy.
* Age: 5 -35 years of age.
* The planned therapy must include at least one disease evaluation with the first 90 days of therapy. The patient and family must intend to return to Cincinnati Children's Hospital at least once in the next 90 days.
* Each subject may only participate once in this study.
* The subject and/or his /her parent/guardian must be fluent in English. At the time of study enrollment, the medical care of the subject must be managed by an attending oncologist at Cincinnati Children's Hospital.
* The subject must have a minimum performance score of 50% (either Lansky or Karnofsky) as documented in their medical record by clinical provider (MD or nurse practitioner). Appendix I.
* A patient / family must be approached to participate in this study within 28 days of the administration of the first dose of the associated therapy or surgery.
Biomarkers for Predicting Neoadjuvant Chemoradio-resistance for Middle-low Advanced Rectal Cancer

Neoadjuvant therapy has been widely applied to locally advanced rectal cancer. However, about 50% of patients receiving this therapy do not respond well as evidenced by the fact that their T or N stages are not effectively decreased judged by postoperative pathological examination. The purpose of this trail is to identify the biomarkers (from within patients' tumor mass before neoadjuvant therapy) to predict resistance to neoadjuvant therapy. These biomarkers can help stratify neoadjuvant-resistant patients towards surgery while avoiding unnecessary chemoradio-based neoadjuvant therapy.

According to postoperative pathological examination results, all participants will be divided into two groups: complete response (ypT0N0) and poor response (\>ypT1-2N0). Differentially expressed genes between complete response and poor response will be analyzed. A scoring formula will be established based on the results. Tumor tissue samples are collected before neoadjuvant therapy and will be analyzed via RNA sequencing.

Eligibility Criteria:
Inclusion Criteria:

* Histopathology proved to be adenocarcinoma of the rectum.
* The edge of tumor is within 12cm of anus margin.
* According to the eighth edition of AJCC TNM staging standard ,that staging for Ⅱ-Ⅲ period, as T3-T4, N0 or any T, N1-2.
* There is no history of chemotherapy, radiotherapy or immunotherapy before neoadjuvant therapy.
* Understand and agree to sign the informed consent for the study.

Exclusion Criteria:

* With intestinal obstruction or impending obstruction, or perforation.
* With other malignancies occurred within 5 years.
Mechanisms Underlying Peanut Allergic Reactions in TRACE Peanut Study Participants: Extension Study

Food allergy affects up to 10% of the population. The mainstay of management involves dietary avoidance and provision of rescue medication in the event of an accidental reaction. The Integrated approaches to food allergen and allergy management (iFAAM) collaboration is an EU-funded academic/clinical/industry consortium with the aim to improve allergen risk management including food labelling. Much of this work requires the validation of the minimum 'eliciting dose' for the food-allergic population and how this can be translated into risk management.

A number of studies (including iFAAM and the TRACE study - NCT01429896) have assessed the eliciting dose for peanut allergic patients, using food challenges where peanut-allergic individuals are eat incremental doses of peanut under strict medical supervision.

In this extension study, peanut-allergic subjects will have undergone (in a cross-over manner) three double-blind, placebo-controlled food challenges to peanut:

1. incremental doses of peanut in a water-continuous matrix;
2. incremental doses of peanut baked into a cookie biscuit;
3. a single dose of peanut in a water-continuous matrix.

The differences in eliciting dose, symptom pattern and underlying physiological mechanisms will provide essential data on how the presentation and consumption of peanut affects the amount needed to trigger an allergic reaction, to inform industry and food regulators as to how to best protect the food-allergic population.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent.
* Male and female participants in the TRACE study (NCT01429896) who are 18-45 years of age at the time of entry to the TRACE study (Visit 1) and had a positive DBPCFC to peanut at baseline (Visit 1).

Exclusion criteria

* unable to comply with study procedures
Outcomes Following Delta Xtend Reverse Shoulder System

To collect medium to long-term survivorship implant outcomes on the DePuy Delta Xtend Reverse Shoulder Stystem.


Eligibility Criteria:
Inclusion Criteria:

Patients whom were implanted with the DePuy Delta Xtend Reverse Total Shoulder System in the time frame indicated. Patients must be willing to sign the consent form and complete all follow-up visits.