cyrilzakka/clinical-trials huggingface dataset:
Perceptions and Experiences of (Family Members of) People With Mental Illness About the Chance for Mental Illness in (Future) Children, and Needs for Care and Research

Despite consistent evidence that mental illness runs in families, intergenerational transmission of risk of mental illness is rarely considered in clinical practice. Neither preventive programs for children of parents with mental illness are usually implemented in care, nor supportive programs for parenting. Furthermore, parents with mental illness are not always aware of how their disorder may impact the well-being of their children. To date, the needs for counseling, care and research in parents with mental illness and family members of people with mental illness are unclear. Therefore, this prospective qualitative interview study aims to gain insights into the perceptions and experiences of (future) parents with mental illness, partners and family members of people with mental illness about risk for and resilience against mental illness in (future) children, as well as their needs for counseling, care and research.


Eligibility Criteria:
Inclusion Criteria:

* Having (a partner or relative with) a diagnosis of a mental illness in the mood-psychosis spectrum, i.e., psychotic disorder, bipolar disorder, or severe depression
* At least 18 years old

Exclusion Criteria:

* Insufficient proficiency of the Dutch language
* No demonstration of adequate understanding of the purpose, procedures, risks, benefits, emergency contacts, and payment issues (in accordance with criteria to assess capacities to consent from Appelbaum \& Grisso, 1988).
* Unable to give consent to all aspects of the study.
Resilient HIV Implementation Science With SGM Youths Using Evidence

The Resilient HIV Implementation Science with SGM Youths using Evidence (RISE) Clinical Research Center will use a Type 2 hybrid-effectiveness-implementation study to evaluate the effectiveness and implementation of HMP, a youth-tailored digital health platform. It is hypothesized that SGM youths in the HMP intervention group will demonstrate improved PrEP initiation and viral load suppression over 12 months compared to the delayed HMP group.

RISE is a randomized control trial where participants are randomized (1:1) to either healthMPower (HMP) exposure for a 12 month period or delayed access to the HMP within 8 strata based on the serostatus group. HIV seropositive and HIV seronegative at risk, age group 15 to 17 or 18 to 24 years of age and country either Nigeria, Kenya, Malawi, or Zambia. Within the strata of serostatus, age, and country, participants will be randomly assigned to the next treatment allocation from a randomly permuted block sequencing using block size of four.

750 Participants will be randomly assigned to the HMP exposure while the other 750 participants will have delayed access to HMP. The HMP is a culturally adapted status neutral mobile app that works to address HIV prevention to care continuum (PHCC) for SGM youth at each of the CBSPs.

Participants who are delayed access for 12 months will be granted "Open access" for 12 months thereafter, when compared to participants who were provided access for 12 months then provided 12 months of access called "continued access" without other external support. Therefore, participants will either be provided access for 12 or 24 months depending on the randomization.

Primary outcome, clinical effectiveness endpoint for HIV seronegative at risk young will be the uptake of PrEP and for HIV seropositive viral load suppression. Secondary outcome, PHCC pathway characterized for HIV seronegative at risk youth such as PrEP education and continuation and for HIV seropositive HIV testing, linkage, and ART initiation.

Eligibility Criteria:
Inclusion Criteria:

* Male sex at birth
* Age 15-24 years
* Own an Android or iOS smartphone
* Had receptive or insertive sex with another man in the past 12 months
* Receiving care or prevention services at the CBSP-associated with the CRPS at the time of study.

Exclusion Criteria:

* Less than 15 years old
* Greater than 24 years old
* Inability or cognitively impaired to provide consent
* Does not own an Android or iOS smartphone.
Biomarkers in Tissue Samples From Patients With Ductal Breast Carcinoma in Situ

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in tissue samples from patients with ductal breast carcinoma in situ.

OBJECTIVES:

* To validate the prognostic utility of a new ductal breast carcinoma in situ (DCIS) genomic score and the Oncotype DX Recurrence Score® assay in tissue samples from patients with DCIS enrolled on clinical trial ECOG-E5194.

OUTLINE: RNA extracted from archived tissue samples are analyzed for gene expression profile by Oncotype DX Recurrence Score® assay (a reverse transcriptase-PCR-based assay).

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of ductal breast carcinoma in situ
* Enrolled on clinical trial ECOG-E5194

  * Local surgery without radiotherapy
  * Treated or not treated with tamoxifen
* Available tissue samples
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Menopausal status not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
A Novel Device for the Management of ADHD

This is a 2-months study, where eligible ADHD adult participants will be provided with personalized VIZO glasses.

This study was designed as a pilot single-center, open-label study of 2 months treatment. Following the enrollment, the participants will go through an adjustment process where they will be fitted with a personalized pair of VIZO Glasses. The participants will be instructed to wear the glasses throughout the day for two months. A follow-up visit at the end of the 2-month treatment will be conducted to assess the efficacy of VIZO Glasses on managing ADHD symptoms, using the Conners Continuous Performance Test-3, the Adult ADHD Self-Report Scale (ASRS), Behavior Rating Inventory of Executive Function Adults (BRIEF-A), and Clinical Global Impression-Improvement (CGI-I) .

Eligibility Criteria:
Inclusion Criteria:

* Documented history of primary ADHD diagnosis by certified clinicians
* Age 18-40 y
* Written informed consent
* Able and willing to complete all required ratings and assessments

Exclusion criteria:

* Any current psychiatric / neurological comorbidity (e.g., epilepsy, Autism, depression, TBI, etc), other than ADHD
* ADHD Medications (stimulants, non-stimulants, other)
* Neurofeedback, cognitive training
Comparison of Two Web-Based Education/Support Programs for Partner Caregivers of People With Spinal Cord Injury

The purpose of this research study is to compare the effect of two different types of education and support programs for partner caregivers of people with spinal cord injury (SCI).

SCI particularly affects partners (spouses or other types of significant others), as they face changes in relationship dynamics and identity as they take on a caregiver role. The purpose of this research study is to compare the effect of two different types of education and support programs for partner caregivers of people with spinal cord injury (SCI).

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Fluent in English (reading and writing)
* Romanic partner of a person with SCI (regardless of martial status) for at least one year prior to injury
* Live in a private residence with their partner with SCI
* Partner is at least 3 months post discharge from inpatient rehabilitation
* At least 6 months since their partner's injury
* Provide care to their partner with SCI on a daily basis
* Have access to the internet in a private location

Exclusion Criteria:

* Participant reports a diagnosis of a schizoaffective disorder, bipolar personality disorder, or severe depression
* History of hospitalization for depression treatment
Comparison of Cervical Traction Versus Snag to Improve Pain and Quality of Life in Cervical Radiculopathy

For the wellness by Comparing of Cervical Traction Versus Snag to reduce Pain and improve Quality of Life in Cervical Radiculopathy


Eligibility Criteria:
Inclusion Criteria:

* Males and females were included. Age group 20-50 years. Patient suffering with neck pain radiating down the arms. Patients with positive Spurling test, cervical distraction and upper limb tension test.

Exclusion Criteria:

* Subject suffering with any systemic diseases of MSK. Patients already suffering with pain in shoulder and upper extremity which is of local origin.

Patient with cardiovascular or respiratory disease. Patients having osteophytes in cervical vertebrae. Hypermobility of cervical region.
Prometra Post-Approval Study

The Prometra Pump is approved by the FDA for use in the United States. The purpose of this study is to collect long-term safety data on the Prometra Pump.

This study is proposed under part of the post-Premarket Approval (PMA) requirements. This study is a prospective, non-randomized, open-label, multicenter study. It will be performed at 10-30 centers in the US and enroll a maximum of 400 subjects. Subjects will be followed for a total of five years.

Eligibility Criteria:
Inclusion Criteria:

1. Patient meets at least one of the following:

   * is suffering from malignant pain (i.e., cancer pain)
   * has chronic, non-malignant pain
   * subject was enrolled in PUMP I or PUMP II study and chooses to participate in this Post-Approval study
   * Patient with an existing implantable pump for pain therapy that requires replacement
2. Patient is at least 22 years of age.
3. Investigator considers the patient to be able and willing to fulfill all study requirements.
4. Patient has provided written informed consent to participate in the study.

Exclusion Criteria:

1. Patient meets any of the contraindications for use of the Prometra System
2. Patient has a prior history of granuloma formation, or is receiving treatment for a suspected granuloma.
3. Patient is pregnant or breast-feeding or is of child-bearing potential and not employing effective birth control.
Sunitinib in Metastatic Renal Cancer

Sunitinib is the registered treatment for first-line therapy of metastatic clear-cell carcinoma of the kidney.Data from the Expanded Access Study have shown activity also in non-clear cell renal cancer (NCCRC). The aim of this study is to prospectively evaluate the anti-tumor activity and safety of sunitinib as a first-line therapy in metastatic NCCRC patients.

This is a prospective, open label, multicenter phase II study to evaluate efficacy of Sunitinib (in advanced/metastatic renal cancer with non-clear cell histology (papillary or chromophobe).

Sunitinib will be administered orally at a dose of 50 mg once daily, in six weeks cycles consisting of 4 weeks on treatment followed by 2 weeks off.

Treatment with the study drug will continue until tumor progression or unacceptable toxicity.

The planned total sample size for this study is 55 patients. Approximately 10 study sites will be involved.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven diagnosis of metastatic renal cancer with non-clear cell
* No previous treatment

Exclusion Criteria:

* Prior treatment with an antiangiogenetic compound
* Symptomatic and/or unstable pre-existing brain metastases
* Severe or uncontrolled cardiovascular diseases
Gene Function in Bone Marrow Cells From Patients With Fanconi Anemia and From Healthy Participants

RATIONALE: Studying samples of bone marrow from patients with Fanconi anemia and from healthy participants in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to Fanconi anemia.

PURPOSE: This laboratory study is evaluating gene function in bone marrow cells from patients with Fanconi anemia and from healthy participants.

OBJECTIVES:

* Describe the complete hematopoietic transcriptomes of Fanconi cells of every common complementation group (e.g., A, C, G, and F) as well as transcriptomes of neoplastic cells derived from bone marrow of patients with Fanconi anemia.
* Define large-scale dynamic gene expression data in these patients.

OUTLINE: This is a multicenter study.

Patients and healthy volunteers undergo bone marrow aspiration or biopsy for biological studies. Samples are analyzed for gene expression profiles using microarray assays.

PROJECTED ACCRUAL: A total of 80 patients and 10 healthy volunteers will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

  * Diagnosis of Fanconi anemia

    * Requires bone marrow aspiration or biopsy for clinical purposes
  * Healthy volunteer

    * Over 18 years of age
    * No known blood abnormality

PATIENT CHARACTERISTICS:

* Platelet count \> 150,000/mm\^3
* White Blood Cell(WBC) \> 4,000/mm\^3
* Hemoglobin \> 13 g/dL
* No clinical signs or symptoms of acute or subacute infection (e.g., viral, bacterial, or fungal)
* No allergies to lidocaine or xylocaine

PRIOR CONCURRENT THERAPY:

* Not specified
HAIC in Combination with Immune Checkpoint Inhibitors and Tyrosine Kinase Inhibitors for Advanced HCC

The purpose of this study is to evaluate the safety and efficacy of hepatic arterial infusion chemotherapy (HAIC) in combination with PD-1 inhibitors and Lenvatinib in patients with different tumor burden advanced-stage hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT).


Eligibility Criteria:
Inclusion Criteria:

1. Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
2. Barcelona Clinic Liver Cancer (BCLC) stage C with the presence of portal vein tumor thrombus;
3. Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy);
4. Both TKIs and ICIs patients received only include marketed drugs but are not limited to HCC approval;
5. HAIC was performed after the first TKIs/ ICIs treatment or before treatment;
6. Received at least 2 cycles of HAIC or ICIs treatments；
7. Has repeated measurable intrahepatic lesions;
8. Child-Pugh class A or B.

Exclusion Criteria:

1. Patients who took systemic anti-tumor treatments before the combination therapy;
2. With other malignant tumors;
3. Unable to meet criteria of combination timeframe described above.
Autologous Bone Marrow Stem Cell Therapy for Autism

The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells in the management of autism.

The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells in the management of autism of 24 patients at Vinmec International Hospital, Hanoi, Vietnam

Eligibility Criteria:
Inclusion Criteria:

- Confirmed diagnosis of autism according to the Diagnostic and Statistical Manual-IV (DSM-IV) diagnostic criteria for autistic disorder

Exclusion Criteria:

* Epilepsy
* Hydrocephalus with ventricular drain
* Coagulation disorders
* Allergy to anesthetic agents
* Severe health conditions such as cancer, failure of heart, lung, liver or kidney
* Active infections
* Severe psychiatric disorders
Intra-nasal Dexmedetomidine for Children Undergoing MRI Imaging

This study aims to assess the use of intranasal dexmedetomidine (IN-dex) as a sole agent in aiding the successful completion of a MRI scans in children. Dexmedetomidine, a routinely used anesthetic agent in our institution, has many benefits including sedation with neuro-protective and respiratory sparing features. We will test its effectiveness in completing MRI scans in children that would otherwise be given a full general anesthetic.

Purpose:

To assess the use of IN-dex as a sole agent in aiding the successful completion of a MRI scan in children.

Hypothesis:

We hypothesize that the optimal dose for IN-dex to produce appropriate sedation for MRI will be between 1 and 3 mcg/kg. We also hypothesize that this dose will be lower in the older age group.

Justification:

The dose required for IN-dex to enable safe sedation for MRI scanning as a sole agent is undetermined at present. This study will enable us to find the optimal dose for effective sedation for MRI scanning in a range of age groups. This will avoid the need for propofol and remifentanil general anesthesia (that is the current standard of care) in this group of patients. Our motivation for avoiding general anesthesia is that there is ongoing concern that general anesthesia causes long term neurocognitive effects in children. Finally, identifying a safe yet effective dose of IN-dex, which can be nurse-administered, will also allow us to improve access to MRI scans that are limited by the access to general anesthesia.

Objectives:

1. To determine the dose of IN-dex that, when used as a sole agent, produces minimal to moderate sedation that is adequate for successful completion of MRI in children with \>90% effectiveness.
2. To explore the logistics of a nurse-administered sedation protocol to increase access to the MRI.

Research Design:

We propose a dose finding study of IN-dex using the biased coin design (BCD) method in three different age groups (3 to \<8 years, 8 to \<12 years, 12 to \<19 years). The study specific interventions will include identification of children appropriate for the study following detailed assessment using a scoring system developed by our Child Life specialists for use at their MRI preparation session.

Statistical Analysis:

The dose of IN-Dex that produces mild to moderate sedation in 90% of subjects will be calculated using the pooled adjacent violators algorithm (PAVA) and bootstrap methods will be used to calculate the 95% confidence limits.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1 or 2
* Scheduled for elective MRI scan on the general anesthesia list
* Child Life MRI simulation score of 6-10 (Figure 1)
* Age 3 - 18

Exclusion Criteria:

* Taking existing opioid, sedative, or cannabinoid medication
* Severe learning disability defined as the inability to follow simple commands
* Severe Cardiac disease
* Chronic hypertension
* Allergy to dexmedetomidine
* Nasal anatomical abnormality
* Known or anticipated difficult airway
A Safety and Efficacy Study to Evaluate Romosozumab (AMG 785) in South Korean Women With Osteoporosis

The primary objective is to evaluate the effect of treatment with romosozumab for 6 months compared with placebo on percent changes in bone mineral density (BMD) at the lumbar spine as assessed by dual-energy X-ray absorptiometry (DXA) in postmenopausal women with osteoporosis.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory postmenopausal Korean women, ≥ 55 to ≤ 90 years of age at enrollment.
* Postmenopause is defined as no spontaneous vaginal bleeding or spotting for 12 or more consecutive months prior to screening.
* BMD T-score \</= -2.50 at the lumbar spine, total hip or femoral neck.
* At least 2 vertebrae in the L1 through L4 region and at least one hip are evaluable by DXA.
* Other inclusion criteria may apply.

Exclusion Criteria:

* Subjects with a BMD T-score \</= -4.0 at the lumbar spine, total hip, or femoral neck.
* History of hip fracture.
* Bone disease other than osteoporosis/ or evidence of any other clinically significant disorder, condition/ or disease or significant laboratory abnormalities.
* Known sensitivity or intolerance calcium and vitamin D products.
* Other exclusion criteria may apply.
Effect of Taping in the Hemiplegic Patient With a Deficit of the Footbrowers

A majority of people undergoing rehabilitation following a stroke have a deficit of the dorsal flexors of the foot. The implementation of rehabilitation techniques in accordance with the recommendations of learned societies is not sufficient to compensate for this deficit. Also Kinesio Taping's method of Dr. Kenzo Kase has caught our attention by its action on muscle, joint, circulatory and pain functions.

The use of taping would increase the duration of stimulation of the muscles of the dorsiflexors of the foot which would facilitate the motor recovery.

Data from the literature do not support the conclusion that taping is effective, but no studies evaluating the efficacy of this technique in the foot-lift deficiency of the hemiplegic patient have been found.

The investigators hypothesize that the use of taping in conjunction with common rehabilitation for hemiplegic patients following a stroke improves the stimulation of the muscles of the dorsiflexors of the foot with a positive impact on the walking.


Eligibility Criteria:
Inclusion Criteria:

* Patient with a stroke occurring in a period ranging from 15 days to a month before inclusion and presenting left or right hemiplegia.
* Voluntary motricity of the dorsal flexors of the foot greater than or equal to 1 on the scale of Held and Pierrot Deseilligny
* Quadriceps voluntary motor skill greater than or equal to 2 on the scale of Held and Pierrot Deseilligny
* Informed consent of the patient.

Exclusion Criteria:

* - Evolutive neurological disease leading to cognitive impairment (Alzheimer's, Parkinson's, Multiple sclerosis ...)
* Pre-stroke neurological sequelae
* Achilles tendon elongation or tendinous transfer surgery.
* Spasticity of the sural triceps greater than 2 on the modified Ashworth scale
* Injection of botulinum toxin
* Patients under guardianship, curatorships or under safeguard of justice.
* Allergy to glue, skin lesions located on the zone of laying of the bands
* Complex Regional Pain Symptom of the Ankle
5FU/VL Vs LV5FU2 + CPT11 in Stage II-III Resected Rectal Cancer

The main objective of this randomized trial is to compare 5FU/LV (Mayo-Clinic regimen or LV5FU2) to LV5FU2 + irinotécan in patients with resected B2 and C rectal cancer. Preoperative radiotherapy is recommended but not mandatory. Main endpoint is disease free survival. Secondary endpoint are overall survival, time to local recurrence, time to distant metastases, and tolerance. A total of 600 patients will be included in the trial.


Eligibility Criteria:
Inclusion Criteria:

* rectal adenocarcinoma
* R0 surgery
* T3, N0, M0 or T4, N0, M0 or N1,2, M0
* chemotherapy can be started within 8 weeks after surgery
* Age \> 18
* Performance status ECOG \< 3
* preoperative radiotherapy allowed
* preoperative chemotherapy with 5FU +/- LV allowed
* Neutrophiles \> 1 500/mm3; Pl. \> 100 000/mm3
* Transaminases \< 2 x UNL; Alcalines Phosphatases \< 2 x UNL; Bili \< 1.1 UNL
* creatininemia \< 120 µmol/l and/or clearance of creatininemia \> 60 ml/mn
* Written informed consent before inclusion

Exclusion Criteria:

* postoperative radiotherapy
* Distant metastases
* Contraindication to any drug contained in the chemotherapy regimens
* Any serious active disease or co-morbid medical condition including digestive inflammatory disease
* Gilbert disease
* severe toxicity of radiotherapy
* Pregnancy or breast feeding
* Absence of contraception in non menopausal women
* Adult patient unable to give informed consent because of intellectual impairment
* Concomitant participation to another trial