cyrilzakka/clinical-trials huggingface dataset:
Family Strengthening Intervention for Early Childhood Development (ECD)

Study activities were carried out to adapt and test a family-strengthening intervention to improve child development outcomes among families facing adversity in Rwanda.

Qualitative research from past studies was used to adapt an existing family-strengthening intervention for HIV-AIDS affected families to extremely vulnerable families with children 0-3 in order to improve early childhood development outcomes. This small scale pilot was carried out to test the feasibility and acceptability of the intervention for extremely vulnerable families with young children in Rwanda.

In the first 10 families the intervention consisted of 21 modules, in the second iteration of the study with an additional 10 families, the curriculum was summarized into 15 modules. Modules were delivered by trained bachelor-level interventionists/home-visiting coaches and were delivered to families one on one in their respective homes. Modules were delivered on a weekly to biweekly basis and were flexible to the families needs and other responsibilities.

Eligibility Criteria:
Inclusion Criteria:

* Potential participants must live in the study catchment area
* Caregiver(s) raising a child between 6 and 3 years old and Ubudehe 1 or 2 (Rwanda's poverty classification system)
* We will enroll both single and dual caregiver families to reflect population dynamics.
* Legal guardians may be aunts, uncles, grandparents, or foster parents

Exclusion Criteria:

* Potential participants that do not live in the study catchment area
* Do not have at least one child between the ages of 0 and 3 living in their household for whom they are the primary caregiver
* Are not classified as Ubudehe 1 or 2
* Have severe cognitive impairments which preclude their ability to speak to the research questions under study
Caelyx in Ovarian Cancer: Prevention and Treatment of Infusion Reactions and Palmar-plantar Erythrodysesthesia (Study P04085)(COMPLETED)

The purpose of this study is to evaluate the safety and tolerability of Caelyx in women with advanced ovarian cancer, focusing on infusion reactions and palmar-plantar erythrodysesthesia.

This observational program is aimed at gaining tolerability and safety data with the routine use of Caelyx in its labelled indication in ovarian cancer, focusing on infusion reaction and PPE.

Data will be raised about the premedication routinely used for the prevention of side effects caused by Caelyx. Premedications for infusion reactions include corticosteroids, serotonin 3 (5HT3) antagonists, histamine 1 (H1) blockers, and histamine 2 (H2) blockers. Premedications for PPE include oral dexamethasone and vitamin B6.

The management of infusion reactions and PPE will be recorded. A detailed record of the medical history may reveal patient groups at a higher risk of experiencing these side effects.

Eligibility Criteria:
Inclusion Criteria:

* Women with advanced ovarian cancer with:

  * previous platin/taxane therapy and documented measureable and/or evaluable advanced or metastatic cancer by radiological imaging or increase of serum cancer antigen 125 (CA 125) according to Rustin et al.

Exclusion Criteria:

* Patients that are not treated according to the Austrian Summary of Product Characteristics (SPC)
Learning Through Play (LTP) Plus Group Cognitive Behaviour Therapy for Mothers of Young Children (ROSHNI-2)

The study has both quantitative and qualitative components.

The objective of the quantitative study is to:

Determine if supported implementation of the LTP plus programme improves infant development compared to standard implementation of the LTP plus programme.

The objective of the qualitative study is:

Process evaluation and finding out about implementation challenges (from the perspective of the mothers and the people delivering both the LTP plus and the supported implementation intervention).

In Pakistan, the Learning through Play parenting program was tested initially through a cluster randomized study in a rural area of Pakistan. The results of this recently completed cluster RCT funded by the Grand Challenges Canada (GCC) showed that LTP Plus works and benefits both the mother and the child. More specifically, the results indicate a significant reduction in maternal depression.

Purpose of this cluster RCT is to determine if supported implementation of the LTP plus programme improves infant development compared to standard implementation of the LTP plus programme. This is an implementation trial comparing two ways of introducing LTP plus. A Cluster RCT of culturally adapted intervention LTP Plus will be conducted in the villages of Gadap town, Karachi, Pakistan. Total 60 villages will be randomized in two groups LTP plus and LTP plus supported implementation. Each cluster will be made of up to 15 mothers. Participants will be screened using eligibility checklist. Assessments will be done at baseline and after completion of intervention (3-month). All follow ups will be done by independent RAs, not involved in delivering intervention sessions.

Eligibility Criteria:
Inclusion Criteria:

Participants will be included in the study if they are:

18 to 44 years old mothers with children aged between 0-33 months, resident in the trial site catchments area, who are able to complete assessments

Exclusion Criteria:

Participants will be excluded from the study if they have:

A medical disorder that would prevent participation in clinical trial. Temporary resident unlikely to be available for follow up. Active suicidal ideation or any other severe or physical mental disorder.
Translation and Validation of MPCOSQ in Urdu Language

To translate and validate modifies polycystic ovary syndrome quality of life (MPCOQ) questionnaire into Urdu. To evaluate the reliability, validity and of Urdu version of modified polycystic ovary syndrome quality of life questionnaire (MPCOQ).

* All statistical analyses will be conducted using the Statistical Product and Service Solution version 21 software.
* Continuous variables will be shown by mean and standard deviation and the categories will be demonstrated in frequency and percentage.
* In this study, factor structure of the (MPCOQ) will be analyzed using the principal component factor analysis with varimax rotation.
* Intraclass Correlation Coefficient (ICC) (95% confidence interval) will be used for test-retest value and Cronbach's Alpha will be used for internal consistency analysis.
* Measurement error will be determined by calculating the standard error of measurement (SEM) and the Smallest Detectable Change (SDC). Independent t-test will be used to determine the differences between groups

Eligibility Criteria:
Inclusion Criteria:

* • Age 18 - 30

  * Married
  * Female patients diagnosed with PCOS, having 2 of the following Rotterdam diagnostic criteria:

I. Polycystic ovaries visualized on ultrasound scan (presence of 12 follicles or more in one or both ovaries and/or increased ovarian volume \>10ml II. Clinical signs of hyperandrogenism (the hirsutism score based on the Ferriman-Gallwey score \>7 or obvious acne) III. Having an interval between menstrual periods \>35 days and/or amenorrhea as the absence of vaginal bleeding for at least 6 months, i.e. 199 days Patients who are willing to participate

Exclusion Criteria:

* • Non-adrenal hyperplasia, thyroid dysfunction, and hyperprolactinemia

  * Female undergoing Hormone Replacement Therapy
  * Female with malignancies
  * Any recent fractures, surgeries
  * Patient with nephrological and neurological conditions
  * Dementia or cognitive impairments
Effects of Relaxation Training and Stimulus Control in Chronic Insomnia Patients

The study aims to validate the effect of relaxation training and stimulus control on reducing hyperarousal states and improving maladaptive sleep behaviors.

Relaxation training typically includes techniques such as breathing exercises, muscle relaxation, and mindfulness meditation to help patients reduce levels of physical and psychological tension, promote relaxation, and create favorable conditions for sleep onset. Stimulus control aims to break the negative association between the bed and insomnia, and rebuild a positive association between the bed and sleep.

Eligibility Criteria:
Inclusion Criteria:

1. Meet the diagnostic criteria for insomnia disorder according to DSM-5.
2. Pittsburgh Sleep Quality Index (PSQI) total score \> 5.
3. Age ≥ 18 years, with at least a middle school education level.
4. Anxiety symptoms meeting HAMA ≥ 14.
5. "Self-developed 8-item questionnaire on maladaptive sleep behaviors" used to assess "maladaptive sleep behaviors."
6. Voluntarily participate in this study and sign an informed consent form.

Exclusion Criteria:

1. Individuals with severe physical illnesses or severe mental disorders, at risk of suicide.
2. Clinically diagnosed or suspected sleep-related breathing disorders, restless leg syndrome, and sleep-wake rhythm disorders, as well as shift workers.
3. Pregnant or lactating women.
4. Currently undergoing any psychological therapy.
Microspheres in Preventing Lymphatic Fluid Collection After Surgery in Patients With Prostate Cancer

This study is being performed to investigate if the application of Arista absorbable hemostat (AH)®, a product approved to stop surgical bleeding, can prevent lymphoceles. Lymphoceles are collections of lymphatic fluid which can occur after a lymph node dissection for cancer. These fluid collections can become symptomatic in some patients. Arista would be applied to one side of the pelvis after a pelvic lymph node dissection, to see if this decreases the number of postoperative lymph fluid collections seen on a computed tomography (CT) scan after surgery

PRIMARY OBJECTIVES:

I. To determine whether, if applied to the lymph node basins after pelvic lymph node dissection, Arista could potentially reduce the formation of lymphoceles and consequently the need for secondary interventions.

OUTLINE:

Patients undergo standard robotic assisted laparoscopic prostatectomy with pelvic lymph node dissection. After lymph node dissection, patients undergo microsphere-mediated lymphocele prevention to the lymph node basin on one side of the pelvis.

After completion of study treatment, patients are followed up at 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Male patients
* Patients with prostate cancer who are electing to undergo robotic radical prostatectomy with pelvic lymph node dissection at The Arthur G. James Cancer Hospital and Solove Research Institute, The Ohio State University Medical Center by Dr. Ronney Abaza
Effect of Hemodialysis on Toe Pressure- and Finger Pressure and Skin Autofluorescence in Hemodialysis Patients

The aim of this study is to determine the vascular condition of hemodialysis patients with toe pressure measurement, finger pressure measurement and measuring glycated and oxidated proteins by skin autofluorescence.

Hypothesis: Lowering of finger pressure/toe pressure during hemodialysis, especially in whom with a arteriovenous fistula, may contribute to critical limb ischemia in the extremities.

1. To determine the macrovascular status of hemodialysis patients by measuring toe pressure, finger pressure and skin autofluorescence.
2. Measuring toe- and finger pressure before and during hemodialysis to determine the chance of developing critical limb ischemia in the extremities.
3. To assess the differences in finger pressure in hemodialysis patients before and during hemodialysis in patients with either arteriovenous fistula in the upper extremity or not.
4. To predict mortality and cardiovascular disease by determine the fastness of accumulation of Advanced-Glycation-Endproducts (this concerns follow-up measurements of skin autofluorescence; another study has collected data of skin autofluorescence in hemodialysis patients in our centre in 2003)

Eligibility Criteria:
Inclusion Criteria:

* Patients with End Stage Renal Disease with hemodialysis therapy

Exclusion Criteria:

* Hemodialysis during the night
* Dark coloured skin towards unreliable skin autofluorescence measurements
Registry of Patients Treated With Systemic Mold-Active Triazoles

The purpose of this study is to describe representative real-world patterns of care for the management of invasive fungal infections (IFIs), including invasive mold infection (IMI). Specifically, the study goals are to examine real world patient characteristics and treatment patterns, associated healthcare resource utilization, and outcomes associated with use of mold-active triazoles (MATs) to treat invasive fungal infections (IFIs).


Eligibility Criteria:
Inclusion Criteria:

* Patients taking one of the following target drugs at the time of enrollment: isavuconazonium sulfate (ISAV), voriconazole (VORI), posaconazole (POSA).

Exclusion Criteria:

* Currently enrolled in any clinical trial with an investigational antifungal agent. Individuals who subsequently enroll in an investigational antifungal study will be discontinued and data collected up to the time of investigational product will be evaluable.
* Patients who died before entering the study.
* Patients who previously participated in this registry.
Long-Term Follow-up Study for Patients Previously Treated With JCAR015

This study will provide long-term follow-up for patients who have received treatment with JCAR015 in a previous clinical trial. In this study, patients will be followed for up to 15 years after their last dose of JCAR015 for evaluation of delayed adverse events, presence of persisting JCAR015 vector sequences, and survival.


Eligibility Criteria:
Inclusion criteria:

* Patients who have received at least one dose of JCAR015 in a previous treatment protocol.
* Patients who have provided informed consent for the long-term follow-up study prior to study participation.

Exclusion criteria:

* None. All patients who have previously received JCAR015 treatment are eligible for this long-term follow-up study.
Next-Day Residual Effects of Gabapentin, Diphenhydramine and Triazolam on Simulated Driving Performance in Normal Volunteers

This study will examine the next-day residual effects of a nighttime dose of gabapentin 250 mg, diphenhydramine citrate 76 mg and triazolam 0.5 mg compared to placebo and each other on simulated driving performance in normal volunteer subjects. It will also examine other measures of next-day performance and next-day sleepiness.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females of non-childbearing potential, 25-55 years of age
* Valid driver's license

Exclusion Criteria:

* Psychiatric disorder
* Recent history of clinically significant neurological disorder, such as seizures, stroke, multiple sclerosis, or head trauma
* Recent histroy or current treatment for sleep disorder
Evaluation of a Web-Based Fall Prevention Program on People With Multiple Sclerosis

This study evaluates the effectiveness of a web-based fall prevention program called Free From Falls Online (FFFO) on people with multiple sclerosis.

The overarching goal of this study is to evaluate the effectiveness and impact of an online self-management program for preventing falls among people with multiple sclerosis (PwMS). To accomplish this objective, the investigators have designed a web-based fall prevention program called Free From Falls Online (FFFO), based on the traditionally in-person program developed by the National Multiple Sclerosis Society. The specific aims of this study are three-fold: (1) to evaluate the effectiveness of an online fall prevention self-education program by comparing fall frequency between participants and controls; (2) evaluate the impact of FFFO by comparing patient reported measures of physical function, fatigue, self-efficacy, psychosocial illness impact, social participation and satisfaction, and perception of global health between participants and controls; (3) and to determine usability of and satisfaction with FFFO.

Eligibility Criteria:
Inclusion Criteria:

* MS of any type with no relapse in the previous month
* Self-reported history of 2 or more falls in the previous 2 months
* Ability to walk at least 100 meters with intermittent or unilateral constant assistance (Expanded Disability Severity Scale (EDSS) step \<6.0)
* Daily access a computer and willingness to respond to a daily survey

Exclusion Criteria:

* Medical conditions that would preclude reliable participation or increases risk for injury during the program
Fenestrated AAA Endovascular Graft Post-Approval Study

This post-market study is approved by the US FDA to evaluate the long-term safety and performance of the Zenith® Fenestrated AAA Endovascular Graft.


Eligibility Criteria:
Inclusion Criteria:

* abdominal aortic and aortoiliac aneursyms with a diameter greater than or equal to 5 cm
* aortic or aortoiliac aneurysm with a history of growth greater than or equal to 0.5 cm per year, or clinical indication for AAA repair

Exclusion Criteria:

* proximal neck less than 4mm or greater than or equal to 15 mm in length unless otherwise compromised to preclude seal
* renal artery stenosis greater than 50 percent
Adjuvant Chemotherapy Combined With Huaier Granule for Treating High-risk Stage II, Stage III Colorectal Cancer

A randomized, paralleled control clinical study investigating Huaier Granule for prevention of recurrence and metastasis of colorectal cancer after radical surgery, to evaluate the efficacy and safety.


Eligibility Criteria:
Inclusion Criteria:

* The subjects volunteer to sign the informed consent
* Aged: 18 to 75 years old
* Colorectal cancer (AJCC-TNM, high-risk Stage II and Stage III)
* The diagnosis and colorectal cancer has been confirmed by pathological examination after radical surgery
* The liver and kidney function satisfies the following conditions within 15 days after surgery (excluding day 15): aspartate aminotransferase (AST), glutamic-oxalacetic transaminase (ALT), alkaline phosphatase (ALP)\< 2 upper limit of normal (ULN), total bilirubin ≤ 1.5 ULN, serum creatinine \< 1.5 ULN; normal coagulation function
* Other laboratory tests meet the following requirements within 15 days after surgery (excluding day 15): white blood cells count ≥ 3.0×109/L, absolute neutrophil count ≥ 1.5×109/L, platelet count ≥ 100×109/L
* ECOG：0-2 points
* No other previous history of malignancy.

Exclusion Criteria:

* Multiple primary cancer
* Not recover from the colorectal surgery
* Presence of organ, bone, or skin metastases
* Pregnant or lactating women
* Those with active bleeding due to various reasons
* Those with HIV infection or AIDS-associated diseases
* Those with severe acute and chronic diseases
* Those with severe diabetes
* Those with serious infectious diseases
* Those who can not take drugs by oral route
* Drug abusers or those with psychological or mental diseases that may interfere with study compliance
* Conditions that are considered not suitable for this study investigators
Suicide Risk Assessment by Digital Means

This study is an observational study, without intervention. Using a tablet application that developed for this study. In addition, sensors are used to examine the possibility of using the system to assess the risk of suicide. It should be noted that this is a pilot study, only for a wider study involving a larger number of patients.

The system developed for the benefit of this study is based on a smartphone application installed on a standard Smartphone device that will be found in the ED or by the examiner. The system collects data from five channels one by one (the information collected from each channel is collected separately).

The data recorded from the various channels is saved on the tablet device. Then, the information transferred to the database using a cable. A statistical analysis of the data from the various channels is carried out in order to assess suicidal behavior.

After the statistical analysis, correlations will be examining between the results of the measurements and the results of the accepted questionnaires for the assessment of suicidality, which will be performed simultaneously.

Note that the duration of participation is the duration of the measurements, ie a single session that lasts up to two hours The duration of the participants in the study is determined by the time of the measurements, ie a single session lasting up to two hours.


Eligibility Criteria:
Inclusion Criteria:

* Every patient who is examined in the psychiatric ward at the Sheba Medical Center
* Proper ability to give informed consent

Exclusion Criteria:

* A patient who is not independent and without an active therapist / guardian involved in the treatment
A Strategy to Prevent the Recurrence of Dental Disease in Children Receiving Dental Treatment With General Anesthesia

The purpose of this study is to evaluate the effectiveness of a preventive strategy in increasing return to follow up and recall appointments.


Eligibility Criteria:
Inclusion Criteria:

1. parent with child (patient) planned for dental treatment with general anesthesia (GA)
2. parent of a child (patient) age less than six
3. parent of a child (patient) with health status of healthy (American Society of Anesthesiologists (ASA) I or II).

Exclusion Criteria:

1. parents/guardians who chose not to participate in the study
2. parents who spoke a language other than English or Spanish
3. Parents of a child (patient) with special health care needs or patients of ASA III or IV status