cyrilzakka/clinical-trials huggingface dataset:
Interpersonal Therapy-Based Treatment to Prevent Postpartum Depression in Adolescent Mothers

The Specific Aim of this study is to conduct a randomized controlled trial to evaluate whether Project REACH (an interpersonal psychotherapy-based intervention) compared with a didactic attention-control program reduces the risk of PPD in adolescent mothers.

Primary Hypothesis:

1. The intervention (Project REACH) will be significantly more efficacious than the control program in reducing the risk of PPD up to six months postpartum in adolescent mothers.

   Secondary Hypotheses:
2. The decreased rate of major depression in the Project REACH group compared to the control program group will be sustained through one year postpartum.
3. Adolescent mothers in Project REACH compared to the control program group will have higher levels of maternal-child bonding.

Each year, more than 400,000 births in the United States are to mothers less than 20 years old. Alarmingly, approximately 25-36% of teen mothers experience postpartum depression (PPD), a condition associated with significant social and health morbidity. PPD places teen mothers and their children at great risk during an already challenging time in their lives. Preventing PPD in this vulnerable population is essential to improving overall health.

Project REACH is a randomized controlled trial, to evaluate whether our novel preventive intervention compared to a didactic attention control reduces the risk of PPD in adolescent mothers. The intervention, REACH (Relax, Encourage, Appreciate, Communicate, Help), is based on Interpersonal Psychotherapy (IPT) and targets those factors that may play a significant role in the development of PPD in adolescent mothers (i.e., poor social support, role transitions and life stressors). The control condition includes didactic prenatal education sessions.

Project REACH builds on the foundation of our NIMH-funded treatment development project and pilot study (R34 MH077588). The pilot study demonstrated feasibility, acceptability and initial efficacy in a small sample. The current R01 proposal aims to evaluate the efficacy of the Project REACH intervention in reducing the risk of PPD.

Eligibility Criteria:
Inclusion Criteria:

* Less than 24 weeks pregnant
* Not currently being treated for depression
* Speaks and reads English fluently

Exclusion Criteria:

* Currently receiving mental health services from a health care provider
* Meets DSM-IV criteria for an affective disorder, substance use disorder, or psychosis
Effects of Different Modes of Ventilation and Head Position on Size of Vena Jugular Interna

It is widely known that positive mechanical ventilation increases the positive intrathoracic pressure which affects the pressure in the RIJV, resulting in an increase of the CSA. Currently, there appears to be a lack of studies in the literature that assess the effects of different modes of ventilation of this increase.

The aim of our study is to evaluate the changes in cross-sectional area and diameters of RIJV under two different mechanical ventilation modes (PCV and VCV) and spontaneous ventilation in head neutral and 30 degree rotated lateral position by using ultrasonography and to determine the ventilation mode that is most suitable for catheterization.


Eligibility Criteria:
Inclusion Criteria:

* 30 ASA status I-II patients between 18-80 years old undergoing elective abdominal surgery

Exclusion Criteria:

* Patients with a history of congestive heart failure, pulmonary hypertension, chronic renal failure, diabetes mellitus, rheumatological diseases, neck surgery, valvular disease, obesity or RIJV catheterization will be excluded from the study
Premenstrual Dysphoric Disorder and Antiepileptic Drugs

This study is being done to determine if there are differences in mood during the menstrual cycle among women with epilepsy who take various different antiepileptic drugs and women without epilepsy.

Participants will be given informed consent during the initial study visit. We will gather information about their seizure disorder and medications and provide them with instructions and a form that they will complete daily for two months (two menstrual cycles). During the third week of each menstrual cycle, they will be asked to return once to provide a blood sample.

Eligibility Criteria:
Inclusion Criteria:

* Women with epilepsy, 18-45 years of age. Women will be on one of 4 established (≥ 3 months) AED monotherapies: LTG, CBZ, PHT or LEV and with documented therapeutic range serum AED level during the year prior to enrollment.
* Normal Control women, 18-45 years of age, in good general health by history

Exclusion Criteria:

* Concomitant use of prescribed or OTC reproductive hormones
* Concomitant use of antidepressant and anxiolytic medications such as SSRIs, bupropion, tricyclics, benzodiazepines
Lifestyle Program for Obstructive Sleep Apnea with Severe Obesity

The purpose of this study is to develop a data driven system for persons with severe obesity sleep apnea that utilizes remote monitoring with health coaching to create behavior changes aimed at improving health and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, 18 years of age or older.
* Newly diagnosed with severe Obstructive Sleep Apnea (OSA) and severe obesity (BMI \> 35).

Exclusion Criteria:

* Individuals \< 18 years of age.
* Patients with an inability to provide good data or follow commands (patients who are disoriented, have a severe neurologic or psychiatric condition).
The Role of Extracorporeal Shock Wave Therapy in the Treatment of Trapezial-Metacarpal Osteoarthritis. A Double Blind Randomized Controlled Study.

Evaluate if extracorporeal shock wave therapy is more effective than sham treatment in patients with trapezial-metacarpal osteoarthritis in pain relief and functional improvement.


Eligibility Criteria:
Inclusion Criteria:

* according to the Eaton et al. classification the inclusion criteria involved those patients with stage III, participants had to have a history 6 months of pain and they were 18 years of age or older. Exclusion criteria were also the presence of degenerative or non-degenerative neurologic conditions, in which pain perception is altered, a history of coagulopathy, cancer, cardiac pacemaker, calcaneal fracture, and pregnancy.

Exclusion Criteria:

* Exclusion criteria were also the presence of degenerative or non-degenerative neurologic conditions, in which pain perception is altered, a history of coagulopathy, cancer, cardiac pacemaker, calcaneal fracture, and pregnancy.
A Factorial Approach to Improve Treatment Adherence and Systolic Blood Pressure

In Pakistan, poor medication adherence is a key operational factor in the prevalence of uncontrolled hypertension. Mobile phone treatments based on technology are at the forefront and are a reasonably low-cost strategy for combating the latest health concerns associated with poor adherence. On the other hand, conservative approaches to counseling are also found effective. This study will look at how a mHealth-based strategy and an educational-led peer counseling intervention can help hypertensive patients with coronary artery disease lower their systolic blood pressure.

In Pakistan, hypertension is a serious public health concern. Hypertension affects 18.9% of teenagers over the age of 15 and 33% of adults over the age of 45; however, only around 3% of hypertensive individuals have their blood pressure regulated to 140/90 mm Hg or lower. The majority of hypertensive patients are found to have blood pressure that is out of control. The majority of those undergoing therapies were judged to be non-compliant. According to the study, adherence to cardiac medications ranged from 27 to 77 percent, while adherence to stroke medications was around 68 percent. According to a recent study, 37.7% of patients did not take their antihypertensive medication as advised.

Interventions to help hypertensive patients in controlling blood pressure show potential to alter their behavior and lead to better outcomes, but delivering them at a cheap cost is difficult. Although evidence is scarce, several trials examining clinical interventions utilizing conventional health education support while others employing a mobile health strategy, both showed significant results. For a low-resource country, we built cost-effective models that are integrated with clinical care for patients with hypertension. The goal of this trial is to assess the effectiveness of mHealth intervention with clinical educational support and educational support with peer counseling to improve blood pressure control in hypertensive patients when compared to standard care.

Eligibility Criteria:
Inclusion Criteria:

* Participants with age 21 to 70 years
* Participants who have been registered as hypertensive with comorbidity of coronary artery disease in the Outpatient Departments (OPDs) of one of the three public teaching hospitals in Lahore, for at least last one month
* Participants on antihypertensive drugs
* The participants with stable coronary artery disease who are treated in an outpatient setting
* Participants who are willing to sign a written informed consent form, must have a smartphone with the WhatsApp application installed and be able to read Urdu/English.
* Participants with smartphones and have internet access

Exclusion Criteria:

Participants who suffer from some type of malignancy and require adjustment of drugs

* Participants with any biological condition that makes it difficult for them to read write, communicate or hear phone calls
* Participants in hypertensive emergency blood pressure \>220/120 mmHg
* Participants with pregnancy(self-reporting)
* Participants in their period of lactation
Influencing Factors of Cerebrovascular Disease and Cognition in Hemodialysis Patients

In this observational study, the investigators evaluate the influencing factors of cerebrovascular disease and cognition in hemodialysis patients.


Eligibility Criteria:
Inclusion Criteria:

1. maintenance hemodialysis patients who are younger than 85 years old and older than 50 years old, regardless of gender
2. dialysis vintage is greater than 3 months;

Exclusion Criteria:

1. Those with severe infection and anemia (Hb \<60g / L);
2. Those with severe mental illness, metabolic diseases and immune system diseases;
3. Patients with abnormal liver function
Feasibility and Efficacy of a Home-based, Computerized Cognitive Training Program in Pediatric Sickle Cell Disease

Disease-related neurocognitive deficits are common in pediatric sickle cell disease (SCD). These deficits can significantly disrupt otherwise normal trajectories toward academic and vocational achievement and negatively impact psychosocial outcomes. Despite widespread recognition of neurocognitive deficits, there are no treatments shown to maintain or recover functioning once a child with SCD endures neuronal damage. Cognitive training (CT) has been a standard intervention used to stabilize and recover functioning in individuals with accidental or disease-related brain injury. Recent advances in technology have led to the development of computerized CT programs. This study seeks to assess the feasibility and efficacy of using computerized CT with pediatric patients with SCD. Children and adolescents with SCD between the ages of 7 and 16 years old (n = 80) will be recruited to complete a randomized (intervention or waitlist-control) home-based computerized CT program (Cogmed). Feasibility will be assessed by examining participation, retention, and program completion rates, as well as feedback from a feasibility and acceptability questionnaire and a brief qualitative interview. Participants will also complete assessments of attention, working memory, and academic fluency at baseline and immediately following the intervention. A final assessment will be conducted 6 months after the conclusion of the intervention to evaluate the stability of treatment effects.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with sickle cell disease (HbSS, HbSC, or HbS-beta thalassemia).
* 7 to 16 years old.
* An absolute or relative working memory deficit.
* IQ of 70 or greater, as measured via the WISC-V.
* Presence of a caregiver who is willing and capable of providing consistent support and supervision during Cogmed training.

Exclusion Criteria:

* Visual, motor, or auditory impairment that prevents computer use.
* Insufficient English fluency.
* Started taking or adjusted dose of medication to treat symptoms of ADHD in the last 30 days.
* Unreliable access to a source of electricity to charge an iPad battery.
Perfusion Analysis Using Rubidium in Cardiac Sarcoidosis

The study aims at assessing diagnostic and therapeutic impact of Rubidium-82 PET in cardiac sarcoidosis.

The presence of cardiac involvement is a serious complication of sarcoidosis. Early diagnosis is challenging since it relies on an array of clinical, biological and imaging abnormalities. Myocardial perfusion imaging with sestamibi is currently a major feature of the diagnosis, since it allows to evidence both microcirculatory impairments and scar. However, some technical limitations are inherent to SPECT, mainly poor spatial resolution and lack of attenuation correction, resulting in the absence of flow quantification. Rubidium-82 (Rb) PET proved to be more sensitive and specific than sestamibi SPECT in the diagnosis of coronary artery disease. Furthermore, it allows noninvasive measurement of coronary flow reserve. Finally, it exposes patients to lower radiation dose than SPECT. Therefore, Rb PET may help to better identify cardiac involvement of sarcoidosis, and hence to better select those patients who require high-dose steroids.

Eligibility Criteria:
Inclusion Criteria:

* (1) histologically proven sarcoidosis;
* (2) suspicion of cardiac involvement on symptoms, and/or ECG and/or echocardiogram.

Exclusion Criteria:

* patient \< 18 years old
Targeted Next Generation Sequencing for the Efficacy of Trastuzumab Neoadjuvant Chemotherapy in Breast Cancer

To explore the genetic background of patients with HER2 positive breast cancer that benefit from trastuzumab combined with neoadjuvant chemotherapy, identify clinically actionable mutations that associated with trastuzumab resistance or drug efficacy, we designed this Observational phase II trial. The primary endpoint is genetic profile of HER2+ breast cancer patients treated with trastuzumab combined neoadjuvant chemotherapy. Secondary endpoints included pathological complete response (pCR) rate and safety.

Currently, patients with stage II-III breast cancer still accounts for a large population in China, and neoadjuvant therapy is considered the standard treatment for them. The pathological complete response (pCR) rate takes for an indicator for regimens efficacy, and the achievement of pCR after neoadjuvant chemotherapy is associated with favorable outcomes including disease-free survival and overall survival.

HER2+ breast cancer represents an invasive and poor prognosis subtype, and the efficacy of neoadjuvant therapy for these patients has been greatly augmented by the addition of trastuzumab. However, more than 50% of HER2+ breast cancer patients treated with trastuzumab combined neoadjuvant chemotherapy cannot achieve pCR, even experience primary drug resistance and rapid disease progression. Therefore, to explore the genomic features of the population that benefited from trastuzumab combined with chemotherapy is of great significance for personalized treatment of HER2+ breast cancer, aiming to avoid overtreatment and identify clinically actionable mutations for future therapy instructions.

Eligibility Criteria:
Inclusion Criteria:

* women aged 18-70 years old at the time of diagnosis of primary breast cancer
* Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1
* Stage III breast cancer according to the 7th Edition of Cancer staging Manual of American Joint Committee on Cancer (AJCC)
* full assessment of ER, PR and HER2 status of primary tumor in accordance with the American Society of Clinical Oncology (ASCO) guidelines
* pathological diagnosis and all courses of treatment confirmed

Exclusion Criteria:

* any known metastatic disease, by physical exam or by imaging studies such as computed tomography (CT)/magnetic resonance imaging (MRI), at the time of study entry
* any previous exposure to chemotherapy, radiotherapy, or endocrine therapy
* left ventricular ejection fraction (LVEF) \< 55% by Echocardiogram (ECHO) or multigated acquisition scan (MUGA) or significant clinical symptoms or signs of heart failure
* major organ dysfunction, inclusive of bone marrow, renal, liver and hepatic function, that would prohibit patients from receiving standard chemotherapy
Comparison of Two Surgical Techniques to Treat Knock Knees in Children

Knock knees or genu valgus necessitates in some children corrective surgery with partial closure of the growth plate at level of the knee.

Background: Genu valgus is a condition with malalignment of the lower extremity. Surgery may be indicated in severe cases and reversible hemiepiphysiodesis is often the treatment of choice in growing children. Partial closure can be obtained by stapling technique or with a new treatment called tension band plating.

Eligibility Criteria:
Inclusion Criteria:

* genu valgus
* remaining growth

Exclusion Criteria:

* systemic disease
* unilateral disease
The Effect of Navy Beans and Yellow Peas on Satiety in Children

The frequent consumption of pulses is associated with multiple cardiometabolic benefits in adults including a lower risk for overweight and obesity. However, it remains unclear whether these effects are mediated through the short-term mechanisms, including enhanced satiety and reduced food intake (FI), or through the long-term metabolic effects triggered by regular consumption of pulses. The objective of this study is to investigate the short-term effect of cooked pulses served in the amount similar to their recommended serving of 175ml (3/4 cup) on food intake in 12-14y children, and gastrointestinal comfort over 2-hours. The secondary objective is to evaluate how children perceive the sensory characteristics of the meals made with the whole pulses.


Eligibility Criteria:
Inclusion Criteria:

* Healthy boys and girls born at full-term
* do not receive any medications

Exclusion Criteria:

* Food sensitivities or allergies
* Dietary restrictions
* Health problems
* Learning, emotional or behavioral problems.
Perioperative Coagulopathy in Patients Undergoing Cytoreductive Surgery and HIPEC Intraperitoneal Chemotherapy (HIPEC)

Cytoreductive surgery (CRC) with intraperitoneal hyperthermal chemotherapy (HIPEC) has been shown to improve survival in selected patients with peritoneal carcinomatosis. 51% of patients are transfused due to the high intraoperative blood loss caused by surgery and the appearance of a perioperative coagulopathy attributed to the loss of proteins into the peritoneal cavity, the high fluid turnover and possibly the action of hyperthermic chemotherapy. So far, the haemostatic changes described consist of a decrease in the levels of antithrombin III and the platelet count, as well as in alterations of the usual coagulation tests. Conventional coagulation tests analyze only the plasmatic phase of coagulation while viscoelastic tests, such as rotational thromboelastometry (ROTEM), reproduce the global coagulation process much more faithfully, keeping good correlation with perioperative bleeding.

Objetive:

The platelet, coagulation, von Willebrand and Factor XIII levels and function have not been consistently investigate in pre-established (fix) time periods in patients undergoing elective CRC with hyperthermia. This prospective observational study aimed at investigating the variations of the values of estándar coagulation test, ROTEM parameters, platelet function assay (PFA-100), von Willebrand and Factor XIII at baseline (before surgery) and after 4h and 48 after surgery in 40 patients undergoing CRC. A control group (N=40 blood donors) will be also obtained by baseline comparasion and to obtain local reference ranges.

This prospective observational study aimed at investigating the variations of the values of estándar coagulation test, ROTEM parameters, platelet function assay (PFA-100), von Willebrand and Factor XIII at baseline (before surgery) and after 4h and 48 after surgery in 40 patients undergoing CRC. A control group (N=40 blood donors) will be also obtained by baseline comparasion and to obtain local reference ranges.

Eligibility Criteria:
Inclusion Criteria:

1. - Consecutive patients with peritoneal surface malignancy treated with cytoreductive surgery and HIPEC in the Department of Surgery of Virgen del Rocio General Hospital
2. -All patients gave written informed consent.
3. -Age above 18 years and Karnofsky performance status scale 450%

Exclusion Criteria:

1. - Exclusion criteria: were severe cardiovascular or respiratory disease,
2. - Lower hemoglobin than 10,0 g/dL , platelet count 100,000/mm3,
3. - Renal or hepatic failure,
4. - Pregnancy,
5. - Multiple partial intestinal obstruction or extensive involvement of the surface of the small bowel as well as distant and non-resectable metastases.
Diagnostic Performance of Noninvasive Fractional Flow Reserve From Computed Tomography

Fractional Flow Reserve derived from computed tomography(FFRCT) is a novel method for determining the physiologic significance of coronary artery disease (CAD), which will help physicians in clinical decision-making and decrease the medical cost, but its ability to identify patients with ischemia has not been adequately examined to date.

Fractional Flow Reserve derived from computed tomography(FFRCT) is a novel method for determining the physiologic significance of coronary artery disease (CAD), which will help physicians in clinical decision-making and decrease the medical cost, but its ability to identify patients with ischemia has not been adequately examined to date.

Available data from registered clinical trials has testified the diagnostic performance of FFRCT, but the diagnostic accuracy among them are not consistent.

Thus, the investigators designed a collaborative individual patient-data pooled-analysis aimed to assess the diagnostic accuracy of FFRCT and find the possible cause for inconsistency

Eligibility Criteria:
Inclusion Criteria:

* Coronary computed tomographic angiography(CCTA) with over 50 percent stenosis in a major coronary artery over 2mm diameter
* Undergoing clinically indicated invasive coronary angiography with FFR

Exclusion Criteria:

* A history of CABG surgery
* Prior percutaneous coronary intervention with suspected instent restenosis
* Suspicion of or recent acute coronary syndrome
* Complex congenital heart disease
* Prior pacemaker or defibrillator
* Prosthetic heart valve
* Significant arrhythmia
* heart rate \>100 beats/min
* systolic blood pressure≤90 mmHg
* contraindication to beta blockers, nitroglycerin or adenosine
* Serum creatinine level greater than 1.5 mg per dL
* Allergy to iodinated contrast
* Pregnant state
* Body mass index greater than 35
* Evidence of active clinical instability or lifethreatening disease
* Canadian Cardiovascular Society class IV angina
* nonevaluable CCTA as determined by the CCTA core laboratory
* Inability to adhere to study procedures
Personalized Evidence-based Treatment in Patients With Invasive Breast Cancer

A population-based case-cohort study of breast cancer-specific survival among all first invasive breast cancer cases


Eligibility Criteria:
Inclusion Criteria:

All women with stage I-III disease who survived at least 12 months post-diagnosis

Exclusion Criteria:

Unknown cause of death Treatment outside the region (thus precluding the treatment assessment)