cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of 'Supportive Parenting App' on Parental and Newborn Outcomes

The Supportive Parenting App is a theory-based perinatal educational intervention for couples administered through a mobile application. The intervention comprise of knowledge-based content, informational videos and audio, discussion forum, peer volunteer chat group, and a frequently asked questions (FAQ) expert advice section.

The aims of the study are to:

1. develop theory-based supportive parenting App (SPA) intervention for both first-time and experienced parents across perinatal period
2. examine its effectiveness on parental outcomes: including maternal depression at 12 months postpartum (primary outcome), paternal depression, parental anxiety, parenting self-efficacy, help - seeking behavior (social support), parental bonding and parenting satisfaction (secondary outcomes); and new-born outcomes: physical, social and emotional developments (secondary outcomes)
3. evaluate SPA's cost-effectiveness as compared to standard perinatal care across major restructured hospitals, and
4. examine the perceptions of parents in receiving this intervention.

When compared with those in the control group receiving standard care:

1. parents receiving SPA intervention will have better- emotional well-being (reduced depression and anxiety);parenting self-efficacy; social support; bonding and satisfaction.
2. new-borns of parents receiving SPA will have better physical, social and emotional development
3. It will be more cost-effective to provide SPA than the standard care


Eligibility Criteria:
Inclusion Criteria:

* able to read and speak English
* have low-risk singleton pregnancy with more than 24 weeks of gestation (age of viability)
* have smartphone with internet access

Exclusion Criteria:

* have physical or mental disorders which would interfere with their ability to participate in the study
* have high-risk pregnancy including placenta-previa major, pre-eclampsia, pregnancy induced hypertension etc.
* have complicated assisted delivery such as vacuum or forceps with 4th degree perineal tear of the mother; and /or
* give birth to a newborn at still-birth or a newborn with congenital anomalies and/or medical complications including pathological jaundice, that required special care in hospital.
Contribution of Residual Tumour DNA Testing on the Surgical Bed

The aim of this study is to evaluate the interest of residual tumour DNA research in the operating bed after squamous cell carcinoma excision.

Squamous cell carcinomas of the oral cavity have a poor prognosis. The 5-year loco-regional recurrence rate is 45%. Surgery remains the standard treatment. The presence of invasive or insufficient surgical margins is an important histopronostic factor.

Current tools for intraoperative detection of insufficient margins have a very low sensitivity of around 10%. The aim here is to develop a more sensitive tool by looking for the presence of residual tumour DNA in the entire operating bed after squamous cell carcinoma excision

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Patient with T1 to T4 squamous cell carcinoma of the oral cavity, regardless of lymph node status (all N) M0, operable
* 18 years of age or older
* Member or beneficiary of a social security scheme.

Exclusion Criteria:

* Absence of signed informed consent
* Patient of protected age
* Psychosocial problems
* Not affiliated to or benefiting from a social security scheme
* Previous cervical irradiation
* Pregnant or breast-feeding women
* Patient unable to understand the study for any reason or to comply with the constraints of the trial (language, psychological, geographical problems, etc.).
Appendicitis During the National Lockdown During the COVID-19 Pandemic

The study aims to examine whether a nationwide lock-down with an entire population subjugated to social distancing reduces the incidence of appendicitis. If a reduction is detected it supports the hypothesis that infectious disease may play a role in the etiology of appendicitis.


Eligibility Criteria:
Inclusion Criteria:

Registered in the Danish National Patient Register during the study period

Exclusion Criteria:

None
TEA vs. PVB vs. PCA in Liver Resection Surgery

This study aims to compare the efficacy and safety of three alternative methods of analgesia in patients undergoing complex liver resection surgery: 1) thoracic epidural analgesia (TEA), 2) continuous paravertebral block (PVB) with patient-controlled analgesia (PCA) and 3) patient-controlled analgesia (PCA) alone. Regional anesthesia techniques such as TEA and PVB may improve recovery and decrease postoperative pain scores in addition to other benefits such earlier return of bowel function and shortened length of hospital stay, although some practitioners have voiced concerns about the safety and efficacy of these techniques in patients after liver resection who may develop postoperative coagulation abnormalities. The investigators plan to enroll a total of 150 patients (adults \>/= 18 years of age who meet study criteria) scheduled for complex liver resection surgery in this study, who will then be randomized into 50 patients per arm of the study (3 total arms). Postoperative pain scores will be collected in PACU and throughout the patient's hospital stay as well as routine blood tests including complete blood count, coagulation labs (PT/INR, aPTT) and serum creatinine to measure renal function. The study team will also collect additional data prospectively on all patients enrolled in the study; these parameters will include age, sex, type of operation performed, length of operation, volume of intraoperative blood loss, volume of intraoperative fluid administration including blood products, daily postoperative intravenous fluid administration, length of time to first feeding, day of epidural catheter removal, length of hospital stay and incidence of major postoperative complications (surgical, respiratory, cardiac, renal, etc.). Once primary and secondary data points are obtained, the data will undergo rigorous statistical analysis using the appropriate statistical techniques to determine the outcomes. The investigators propose that epidural and/or paravertebral analgesia may improve recovery times and decrease hospital length of stay, which would be beneficial for the patient as well as decrease hospital costs. In addition, if better postoperative pain management scores can be achieved with epidural or paravertebral analgesia, and no significant prolonged postoperative coagulopathy is associated with patients undergoing major hepatic resection surgical procedures, these regional analgesia strategies can be considered a safe option for pain management in this patient population.


Eligibility Criteria:
Inclusion Criteria:

* Age \>/= 18 years and \</= 80 years
* Scheduled for elective hepatic resection surgery

Exclusion Criteria:

* Preexisting coagulopathy (INR \>1.5)
* Spinal stenosis
* Local infection in area where catheter will be inserted
* Severe cardiovascular disease (NYHA Class III/IV)
* Severe pulmonary disease (FEV1 \<50% of predicted value)
* Allergy or sensitivity to narcotics or local anesthetics
* BMI \>45
* Inability to give informed consent
The Safety Outcomes of 27 Gauge Vitrectomy for Posterior Segment Disease in High Myopia

In recent decade, a major improvement in vitreoretinal surgery was the use of small gauge surgical systems that improved the safety of vitrectomy and also reduced the surgical time. However, there were still some concerns regarding small gauge vitrectomy system, especially 27-gauge system, in the stability of its instruments and the efficacy of removing vitreous during surgery. Although there were some studies that had reported the surgical outcomes of 27G vitrectomy system, none had focused on patients with high myopia. The highly myopic patients usually had thinner sclera, which was a risk factor for wound leakage after sutureless vitrectomy, they also had longer axial length which would make the surgical procedure more difficult especially in macular surgery.

Based on previous clinical finding, gas leakage was 36.4% in 25G , while 27G sclerotomy showing less leakage comparing to larger gauge sclerotomy, the investigators believe 27G may have its clinical advantages in overcoming the thinner sclera of high myopia, and show the superiority of leakage control.

Hypothesis:

The 27G vitrectomy system has lower sclerotomy wound leakage rate compared with 25G system


Eligibility Criteria:
Inclusion criteria:

1. Highly myopic patients (axial length 26\~31mm)
2. Diagnosed with vitreoretinal pathology that require vitrectomy
3. Never received vitrectomy before

Exclusion criteria:

1. Surgical planning including scleral buckling during operation
2. Surgical planning including combined phacoemulsification
3. Surgical planning including the use of silicone oil and/or perfluorocarbon liquid
4. Previous ocular surgery involving conjunctival manipulation and scarring such as pterygium removal/trabeculectomy
5. Previous vitrectomy
6. Previous ocular trauma involving corneal/corneoscleral/scleral/conjunctival full thickness laceration
7. Medical history with known connective tissue disease(s)
8. Age younger than 20 years old
Assessment of Cognitive Function and Exercise Capacity in Cystic Fibrosis

No studies in the literature have investigated the simultaneous effects of cognitive function, exercise capacity and arterial stiffness in adult patients with CF. The study aims to compare the cognitive function, exercise capacity, exercise muscle oxygenation, and arterial stiffness of adult patients with CF and healthy subjects.

Cystic fibrosis (CF) affects other body systems as well as the respiratory system. Patients with CF seem to have reduced exercise capacity, which is a major contributor to mortality rates. Changes in lung function, ventilatory dysfunction, and respiratory muscle function potentially contribute to exercise intolerance in CF. Both children and adults with CF exhibit neurocognitive dysfunction. Arterial stiffness is a predictor of cardiovascular events, including myocardial infarction, heart failure, and mortality. Individuals with CF exhibit an increase in arterial stiffness. However, no studies in the literature have investigated cognitive function, exercise capacity, and arterial stiffness coexistence in adult CF patients. The study aims to compare the cognitive function, exercise capacity, exercise muscle oxygenation and arterial stiffness in adult patients with CF and healthy subjects. Additionally, it will determine the relationship between cognitive function and arterial stiffness with exercise capacity and muscle oxygenation during exercise in adult patients with CF.

Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with cystic fibrosis
* Being 18 years old and older
* Clinically stable condition
* Able to cooperate with the tests performed
* Volunteered to participate in the study

For the control group:

* Being 18 years old and older
* Volunteered to participate in the study

Exclusion Criteria:

* History of hospitalization or exacerbation in the last month.
* Chronic respiratory failure and long-term use of oxygen therapy
* Using noninvasive mechanical ventilator therapy
* Indication for lung transplantation
* Who had a lung transplant
* Forced expiratory volume in the first second (FEV1) value 30% and below
* CF-related diabetes
* Chronic liver disease
* Allergic bronchopulmonary aspergillosis
* Systemic steroid use
* History of diagnosed orthopedic or musculoskeletal problems affecting mobility
* Cardiovascular instability
* Serious psychiatric illness

For the control group:

* Known chronic or systemic disease
* Who did not volunteer to participate in the study
T3AI-Pain After Breast Surgery

Current standard of care for post-operative analgesia after breast surgery in CDHA is Tylenol #3® (300 mg acetaminophen, 30 mg codeine, 15 mg caffeine per tablet). We are proposing to test the analgesic efficacy of acetaminophen plus ibuprofen against Tylenol #3® in patients undergoing outpatient breast surgery.

Block randomization will be used to randomize patients to one of two combinations. Group A will receive capsules containing 650 mg Acetaminophen plus 400 mg Ibuprofen. Group B will receive capsules containing 600 mg Acetaminophen, 15 mg caffeine and 60 mg codeine. Capsules are placed in identical dossettes containing a seven day supply. Patients are instructed to start taking their medications post-op and continue until they are pain free. All participants are given a series of blank Visual Analogue scales and Likert scales and instructed to record their level of pain intensity and pain relief four times per day for the entire week. Peri-operative pain management will be standardized. Patients will not receive pre-operative analgesics. Intra-operative analgesia will be intravenous opioids as selected by anaesthesiology. No local/regional anaesthesia will be used. Intravenous ketorolac will not be allowed for trial participants. All patients will receive intravenous opioid and anti-emetic if required in PACU. Any patients with peri-operative complications or other problems requiring admission or alternative analgesics will be excluded.

Eligibility Criteria:
Inclusion Criteria:

* ages 18 to 70 inclusive
* outpatient breast surgery: lumpectomy; mastectomy, simple or modified; with or without sentinel lymph node biopsy, axillary node dissection.

Exclusion Criteria:

* allergies to acetaminophen, NSAIDs, ASA or codeine.
* asthma.
* recent reported history of upper GI bleeding.
* daily analgesic use (OTC or opioid) pre-operatively.
* any opioid use in the week prior to surgery.
* reported history of PUD if not on PPI regularly.
* anticoagulant use (low dose ASA excepted).
* renal disease or impairment.
* reported history of liver disease.
* pregnancy.
* major operative complications.
* patients requiring admission.
* communication barrier.
* cognitive or memory impairment.
* reported history of drug and/or alcohol abuse.
Study of an eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Predisposition in Metastatic Cancer Patients

This study aims to determine if web-based eHealth delivery of pre-test and/or post-test counseling in cancer patients and/or those at risk for cancer can provide equal or improved cognitive and affective outcomes when compared to the standard of care delivery model.

Cancer genetic testing has become a standard evidence-based practice, with established risk reduction and cancer screening guidelines for genetic carriers. With FDA approval for PARP inhibitors in patients with advanced breast, ovarian, pancreatic and prostate cancer, there is an additional therapeutic rationale for testing all breast, ovarian, pancreatic and prostate cancer patients for germline genetic mutations. Yet, access to genetic specialists is limited in many area, and the traditional model of pre- and post-test counseling with a genetic professional will not support the rising indications for cancer genetic testing. Thus, there is an urgent need to consider alternative delivery models to increase access and uptake of testing, while maintaining adequate patient outcomes.

This study aims to assess if traditional pre-test (visit 1) and post-test (visit 2: disclosure) counseling delivered by a genetic counselor can be replaced with a self-directed web-based eHealth intervention to provide critical data to inform optimal ways to deliver cancer genetic testing in patients with breast, ovarian, pancreatic and prostate cancer, while maintaining quality of care and favorable cognitive, affective and behavioral outcomes.

Specific Aim 1: To determine if web-based eHealth delivery of pre-test and/or post-test counseling can provide equal or improved cognitive and affective short-term and 6-month outcomes as compared to the two-visit standard of care delivery model with a genetic counselor. The investigator's primary outcomes will be changes in knowledge and anxiety. Secondary outcomes will include uptake of testing, depression, cancer specific distress, uncertainty and health behaviors and provider time.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Speak and understand English
* Male or Female
* A personal history of one or more of the following:

  * metastatic breast cancer
  * advanced ovarian cancer (Stage III-IV)
  * metastatic pancreatic cancer
  * metastatic prostate cancer
* Naive to previous cancer germline genetic testing

Exclusion Criteria:

* Communication difficulties such as:

  * Uncorrected or uncompensated hearing and/or vision impairment
  * Uncorrected or uncompensated speech defects
  * Uncontrolled psychiatric/mental condition or severe physical, neurological or cognitive deficits rendering individual unable to understand study goals and tasks
Clinical Trial To Evaluate ANT-1207 In Subjects With Acne

The purpose of this study is to provide evidence of the safety, tolerance, and efficacy of ANT-1207 in the treatment of acne.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of moderate to severe facial acne
* 15 to 40 papules and pustules, and 5 to 50 open and/or closed comedones
* no presence of nodules
* female subjects must be not pregnant and non-lactating

Exclusion Criteria:

* presence of 1 or more nodules
* use of topical steroids on the face 4 weeks prior and during the study
* use of systemic corticosteroids 6 weeks prior and during the study
* topical or systemic acne treatment in the 4 weeks prior to Baseline
Management of Cisplatin-Ineligible Patients With Metastatic Bladder Cancer and The Role of Geriatric Assessments

The goal of this study is to better understand how to best treat participants with advanced bladder cancer who may not be able to tolerate all of the chemotherapy drugs that have been shown to be effective. In this study, investigators are assessing the role of the survey, the Geriatric-8, and its ability to predict outcomes in older participants undergoing cancer treatments. Additionally, investigators are evaluating the differential impact of treatments on quality of life in an older and at risk population.

In this prospective, observational study, investigators are assessing the optimal approach to treating bladder cancer in older participants with other disease that might put the participants at additional risk from cancer-directed treatments. Investigators are specifically assessing the impact on adverse events, quality of life, and treatment outcomes. Additionally, investigators are assessing the role of the survey, the Geriatric-8, and its ability to predict outcomes in older participants.

The research study procedures include screening for eligibility and completing questionnaires.

Participation in this research study is expected to last for up to 8 months.

It is expected that about 180 people will take part in this research study.

The National Comprehensive Cancer Network and EMD Serono are supporting this research study by providing the necessary funds.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥65-years-old (study will limit total enrollment of patients between ages 65-70 to 20% of the total study population)
* Unresectable or metastatic bladder cancer with histologically proven urothelial carcinoma. Any component of variant histology is allowed
* Cisplatin-ineligible as determined by the subject's primary oncologist
* Receiving treatment with chemotherapy (+/- immunotherapy maintenance), enfortumab vedotin-pembrolizumab combination therapy or immunotherapy alone
* Ability to understand and the willingness to sign a written informed consent document and to complete patient reported outcomes that will be in English or Spanish either alone or with assistance of study researcher or family

Exclusion Criteria:

* Subjects who elect to not undergo cancer-directed therapy
* Subjects obtaining their care outside of DFCI or DFCI affiliate sites
* Advanced cognitive impairment or inability to complete surveys
* Participants who are receiving any other investigational agents for this condition (if appropriate only).
Violence Prevention for Middle School Boys

This study will develop and test a web-based intervention to enhance emotion regulation skills and parent-son relationship communication to decrease adolescent boys' risk for dating violence involvement as well as attitudes supporting relationship aggression.

Over the past ten years dating violence (DV) has been recognized as a significant public health problem affecting adolescents. Emerging data suggest that boys and girls have different developmental trajectories toward violence and therefore prevention programs that target their unique pathways to DV are needed. Despite this need, there is a relative dearth of such gender-informed programs for early adolescent boys. This research project aims to prevent the emergence of DV perpetration/ victimization among boys by developing a web-based intervention that is informed by research on gender-specific pathways to violence and harnesses the influence of parents during the early adolescent years.

Among boys, the perpetration of delinquency-related violence and attitudes supporting violence has been found to predict later perpetration of DV. Thus, gender-informed interventions designed to prevent DV in boys need to target skills that underlie violent behavior and attitudes. The goal of this study is to develop and test a web-based intervention to enhance emotion regulation skills and parent-son relationship communication to prevent DV.

Development and testing will occur in three phases. In the Development Phase, the intervention modules will be developed and iteratively reviewed by both a panel of experts familiar with the research in the field as well as an advisory group of parents and teens from the target population. In the Acceptability Testing Phase, testing will be conducted to assess acceptability and feasibility, and this will be followed by revisions to the intervention program based on feedback and observations. During the Randomized Controlled Trial (RCT) Phase, 120 families will complete the intervention program in an observed setting, to ensure fidelity to intervention dosing. Parents and adolescents will complete the program together and then complete assessments of aggressive and risk behaviors, parent-child communication, and emotion regulation at baseline, 3-,and 9-month follow-ups.

Eligibility Criteria:
Inclusion Criteria:

* 1) adolescent enrolled in the 7th or 8th grade,
* 2) parent/legal guardian and teen are English speaking,
* 3) parent/legal guardian is willing to provide consent for the adolescent to participate in the study,
* 4) adolescent is willing to provide assent for their own participation.

Exclusion Criteria:

* 1) observable cognitive or developmental delays that would preclude participation,
* 2) residing with participating parent/guardian less than half time
Study of Cobalt's Role in Excessive Erythrocytosis Among High Altitude Dwellers in Cerro de Pasco, Peru

Chronic mountain sickness is characterized by excessive red blood cell production which causes sludging of the vascular system. This high viscosity blood causes heart failure, cognitive dysfunction, and strokes. The investigators hypothesize that cobalt which has been previously been shown to be an environmental pollutant worsens the overproduction of red blood cells. The investigators plan to conduct a 6 week trial in which acetazolamide (already shown to improve chronic mountain sickness) and N-acetylcysteine (a drug that removes cobalt from the blood) are evaluated in their potential to improve chronic mountain sickness.


Eligibility Criteria:
Inclusion Criteria:

* Males over 17 years of age
* Hematocrit \> 70%
* Chronic Mountain Sickness score (CMS) \> 6
* Able to give informed consent and follow instructions in written Spanish

Exclusion Criteria:

* CMS \> 15
* Underlying lung disease, smoking, or oxygen therapy
* Asthma (bronchospasm can be caused by N-acetylcysteine)
* Phlebotomy in last 3 months
* h/o adverse reaction to acetazolamide or N-acetylcysteine