cyrilzakka/clinical-trials huggingface dataset:
A Multimodal Intervention Program for Children With Attention Deficits (Child ViReal Support Program)

The main aim of this study is the development and implementation of a multimodal intervention program consisting of parent training and child training which utilizes the potentials of immersive virtual reality technology (iVR) in order to test its effectiveness for children with attention deficits.

Attention deficits are commonly observed in children and attention deficit hyperactivity disorder (ADHD) is one of the most commonly diagnosed childhood neurodevelopmental disorders. It is evidently known that attention deficits affect children's school, social and family life making it essential for them and their parents to receive specialized supportive services. Behavioral parent training (BPT) and cognitive-behavioral treatment (CBT) are considered evidence-based interventions for children with ADHD. In fact, they have positive effects on the management of children's behaviors, organization, reduction of parental stress and enhancement of parental self-efficacy. In addition to these traditional evidence-based interventions, immersive virtual reality (iVR) technology has been applied lately as part of intervention programs for children with attention deficits / ADHD diagnosis specifically for cognitive training.

In line with the above, investigators have designed and developed a multimodal intervention program named Child ViReal Support program. This program is comprised of parent training and child training and utilizes the potentials of iVR technology. In order to assess the efficacy of Child ViReal Support program, the investigators will conduct a randomized controlled trial, which consists of a pre-training phase, a training phase, a post-training phase and a follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Participants 9-12 years old and their parents
* ADHD diagnosis (by the approved body of Ministry of Health)
* Greek speaking participants (child and parents)
* Full Scale IQ \> 80 (WISC-V) for child
* Naïve drug treatment for ADHD
* Participants able to comply with all testing and study requirements

Exclusion Criteria:

* Treatment with psychostimulants or other psychotropic drugs
* Children who received intervention based on CBT or parents who attended other behavior parent training programs
* History of comorbid neurological disorders, seizure disorder, autism spectrum disorders, psychosis, or severe dysregulation disorders that may interfere with study participation or use of virtual reality equipment
* Participants presenting a hearing or vision impairment that does not allow the tasks to be performed with the use virtual reality equipment
* Intellectual disability or WISC-V full scale IQ \< 78 (1.5 standard deviations (SD) below mean)
* Non-Greek speaking child or parent
* Parents or children who refuse to give written consent for their participation in the study
Impact of a Bridge Device on the Loop Ileostomy

During the creation of an ileostomy, a bridge device is systematically placed in an aim to reduce wound and peritoneal contamination by stools. Nevertheless no evidence was reported to justify this issue.

Moreover the placement of a bridge device increases the difficulty of nurse cares and is associated with its own morbidity.


Eligibility Criteria:
Inclusion Criteria:

* colorectal disease (cancer; diverticulitis; Crohn disease; inflammatory bowel disease)
* requiring elective surgery with an ileostomy
* patient having given his consent before the enrollment

Exclusion Criteria:

* patient with early closure of the stoma (within 10 days after the colorectal surgery)
* long term corticoids
* emergency surgery
* history of stoma in the side of the stoma placement planned for the study
* BMI \>50
* No signature of the consent to participate in the study
* Physical or mental state not allowing participation in the study
* Contraindication to surgery
* ASA classification (American Society of Anesthesiologists) IV-V or life expectancy \<48h
* Pregnancy or breastfeeding
* Patient under guardianship or guardianship or patient deprived of liberty by a judicial or administrative decision (in accordance with articles L1121-6 and L1121-8 of the Public Health Code)
* Minor patient
* Patient without social protection

Peroperative exclusion criteria:

* no anastomosis
* no ileostomy
* Spontaneous stomal retraction
Exploratory Trial to Evaluate the Efficacy and Safety of D565H Twice Daily Versus D565 Once Daily

Exploratory trial to evaluate the efficacy and safety of D565H twice daily versus D565 once daily.

A Multi center, Randomized, Double-blind, Parallel design, Exploratory trial to evaluate the efficacy and safety of D565H twice daily versus D565 once daily in primary open angle glaucoma or ocular hypertension patients.

Eligibility Criteria:
Inclusion Criteria:

1. More than the age of 19 years old
2. Subjects who has primary Open-Angle Glaucoma or Ocular Hypertension
3. Subjects who sign on an informed consent form willingly

Exclusion Criteria:

1. Subjects with IOP(Intraocular Pressure) measured at Visit 1 and Visit 2(AM 09:00) above 35 mmHg at more than one eye
2. Subjects with a maximum corrected visual acuity of less or than 0.3 in the selected evaluation eye at visit 2
3. Subjects who were diagnosed as below with monocular or both eye

   * Acute or Chronic Closed-Angle Glaucoma
   * Secondary Glaucoma
   * Pseudoexfoliation Glaucoma
   * Neovascular Glaucoma
   * aphakia
   * phacocyst capsular torn intraocular lens
4. Subjects with significant eye symptoms/signs(Abscesses, diplopia) or severe visual field impairment(Mean Deviation -25dB or more)
5. Subjects with severe dry eye syndrome or progressive retinal disease(Retinal degeneration, Diabetic retinopathy, Retinal detachment, Macular edema)
6. Subjects with inflammatory/infectious eye disease and active eye disease within the last 3 months
7. Subjects who have medical history following

   * Glaucoma surgery
   * Subjects with significant history of ocular trauma during the last 6 months, or who underwent surgical ophthalmic surgery
   * Subjects who received topical or systemic steroids within the last 6 months
8. Subjects who wore need to wear contact lenses during the study
9. Subjects who have drug interaction with the investigational product, have a significant effect on the intraocular pressure, or who may have an effect on the clinical trial results
10. Subjects with known hypersensitivity to investigational product
11. Women who are nursing, pregnant or planning pregnancy during the study
12. Subjects with bronchial asthma or history
13. Subjects who have received any other investigational product within 1 month prior to the first dosing
14. Impossible subjects who participate in clinical trial by investigator's decision
TF-CBT for Adjudicated Youth in Residential Treatment

Adjudicated youth often have traumatic stress responses but rarely receive treatment for these problems. This study is a randomized controlled trial to evaluate two alternative implementation strategies for providing an evidence-based trauma treatment, Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), to therapist who treat adjudicated youth in 18 residential treatment facilities (RTF) in New Hampshire, Vermont, and Connecticut: 1) web-based TF-CBT implementation strategy ("W"), consisting on only web-based training and consultation; versus 2) W plus live TF-CBT implementation strategy, consisting of W plus face-to face training and phone consultation with TF-CBT experts ("W+L").

Therapists in each of 18 participating RTFprograms that serve adjudicated youth are randomized to receive either:

1. W TF-CBT implementation strategy, provided via the free distance learning resources TF-CBTWeb, (www.musc/edu/tfcbt) and TF-CBTConsult (www.musc.edu/tfcbtconsult); or
2. W+L implementation strategy, provided through W + 2 day TF-CBT training plus one year of twice monthly TF-CBT consultation calls with a TF-CBT expert trainer.

All RTF staff receive one day training in trauma-informed care. All therapists in both conditions receive training in screening youth for trauma exposure and symptoms. Data are collected regarding primary outcomes of: 1) number of youth therapists in each condition screen for trauma symptoms, 2) number of youth consent to TF-CBT treatment; 3) number of youth complete TF-CBT, 4) TF-CBT fidelity during treatment. Secondary outcomes include 1)changes in therapist knowledge and satisfaction regarding TF-CBT treatment and 2) youth outcomes including PTSD symptoms, depression and satisfaction with treatment.

Eligibility Criteria:
Inclusion Criteria: Consenting mental health therapists in participating residential treatment facilities (RTF)in New Hampshire, Vermont and Connecticut; and the adjudicated youth ages 12-17 years old who are residents in these RTF programs being treated by the participating therapists who 1) are screened positive for having at least one past trauma experience with UCLA PTSD Reaction Index score of \>22; 2) assent with legal guardian consent to participate in the project; and 3) are anticipated to remain in the RTF program at least 3 months (long enough to receive TF-CBT treatment).

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Exclusion Criteria: Guardian or youth refuses;youth does not endorse trauma exposure or symptoms; youth is being discharged too soon to participate; Therapist may use clinical judgment to exclude youth from study based on clinical presentation.

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Observational Study of NovoPen® 4 on Treatment Satisfaction of Insulin Therapy in Type 1 or Type 2 Subjects With Diabetes Mellitus

This study is conducted in Asia. The aim of this observational study is to evaluate subjects' treatment satisfaction and to evaluate subjects' preference of pen device and the incidence of clinical technical complains while using NovoPen® 4 under normal clinical practice conditions.


Eligibility Criteria:
Inclusion Criteria:

* Any subject with Type 1 or Type 2 diabetes and accepting to use NovoPen® 4. The selection will be at the discretion of the individual physician.
* A study specific signed informed consent must be signed by each subject before any study-related activities or information is collected, if required by local regulations

Exclusion Criteria:

* Subjects who are unlikely to comply with the protocol, e.g., unwillingness to cooperate, inability to return for the final visit
* Subjects with known or suspected allergy to any insulin or any of its excipients
Physical Exercise Program in Chronic Chagas Heart Disease

The aim of this investigation is to evaluate the impact of exercise in a cardiac rehabilitation program on functional capacity, clinical markers, quality of life and biomarkers in patients with chronic chagasic cardiomyopathy.

The present study consisted in a randomized clinical study conducted at the Evandro Chagas National Institute of Infectious Disease (INI), located on Rio de Janeiro, Brazil. INI is a national reference center for treatment and research in infectious diseases and tropical medicine in Brazil, which follows a large cohort of patients with Chagas disease, all of them diagnosed by two simultaneously positive serological tests (enzyme-linked immunosorbent assay and indirect immunofluorescence). Patients included in the study are randomly divided in two groups: intervention and control groups. Safety analysis will be performed by monitoring any symptoms presented during data collection and follow-up study.

One of the potential risks that the patient may experience during the study is a noninvasive test that will be performed on a treadmill in a controlled environment, with the possibility of the appearance of symptoms such as fatigue, dyspnea, chest pain, dizziness, with minimal chances of occurring complications of difficult clinical control. Except for the blood test and the cardiopulmonary exercise test, the other tests to be performed are non-invasive and do not bring any risk to the participant's health. Will be collect 10 ml of blood which will be stored for up to five years for biomarker assessments.

During the exercise sessions, patients will be clinically monitored for decompensation, need for hospitalization and suspend or end the participation on the study. All cases will be individually assessed to determine the reversibility of the clinical status. Those cases will continue to be followed by the assistant staff, offering all the clinical support available in INI.

Eligibility Criteria:
Inclusion Criteria: (1) Chagas disease diagnosis by serology; (2) chronic chagasic cardiomyopathy, with left ventricular ejection fraction \<45% or compensated heart failure (3) clinical stability in the last three months, (4) adherence to the ambulatory clinical treatment and (5) age above 18 years.

Exclusion Criteria: (1) pregnancy, (2) neuromuscular limitations, (3) tobacco use, (4) evidence of nonchagasic heart disease, (5) systemic conditions that limits exercise practice or hemodynamic stress tests (6) unavailability to attend three times a week for a minimum of six months, (7) practitioners of regular exercise and (8) claustrophobia.
A Study to Evaluate the Efficacy and Safety of ALS-L1023 in Subjects With NASH

The main objective of this study is to evaluate safety and efficacy of ALS-L1023 in patients with Non-alcoholic steatohepatitis

Besides the main objectives, there are other objectives as follows:

1. To evaluate efficacy of ALS-L1023 for liver fibrosis and steatosis by noninvasive imaging biomarker MRI-PDFF and MRE
2. To determine optimized dose of ALS-L1023 in NASH disease

Eligibility Criteria:
Inclusion Criteria:

* Men or women ages 19 and over, under 75 years of age
* Patients diagnosed with NAFLD on abdominal ultrasonography and MRI
* Patients show presence of hepatic fat fraction as defined by ≥ 8% on MRI-PDFF and liver stiffness as defined by ≥ 2.5 kPa on MRE at Screening

Exclusion Criteria:

* Any subject with current, significant alcohol consumption or a history of significant alcohol consumption for a period of more than 3 consecutive months any time within 2 year prior to screening will be excluded
* Chronic liver disease (including hemochromatosis, liver cancer, autoimmune liver disease, viral hepatitis A, B, alcoholic liver disease
* Uncontrolled diabetes mellitus as defined by a HbA1c ≥ 9.0％ at Screening
* Patients who are allergic or hypersensitive to the drug or its constituents
* Pregnant or lactating women
Inovium Ovarian Rejuvenation Trials

The Inovium Ovarian Rejuvenation Treatment is a PRP-based autologous treatment used in combination with a stimulated IVF sequence and Pre-Implantation Genetic Screening to treat infertility in women experiencing menopause, perimenopause, and premature ovarian failure.

This research extends earlier work conducted by Inovium associates in Athens, Greece who demonstrated efficacy of intraovarian injection of autologous PRP for resumption of menses, hormone stabilization, and conception after IVF in multiple women following PRP+natural cycle IVF (i.e., without gonadotropin stimulation). The use of stimulation (gonadotropins) and targeted pre- and posttreatment hormone monitoring during this clinical trial aims to characterize more fully the transition from PRP dosing, embryogenesis, IVF and conception.

The current study seeks to describe how PRP works to rejuvenate immune system and ovarian stem cells, restore menses, provide hormone stability, and generate successful IVF sequences and conceptions. The quality of all embryos generated will be studied via PGS, with the goal of generating euploid embryos. Hormone stability and biomarkers of aging will also be evaluated to understand the extent of any observed benefits, and to estimate how long such effects may be sustained with a single PRP treatment.

Autologous activated PRP used in this clinical study is isolated from patient derived (blood) samples collected on-site, using FDA-approved Regenlab \[Lausanne, Switzerland\] BCT-1 PRP Kit and RegenLab Drucker Centrifuge (FDA 510(k)-Approval #BK110061; ISO#13485).

Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent
* Women over the age of 35
* Primary or secondary amenorrhea at least for 3-6 months
* Presence of at least one ovary
* Agree to report any pregnancy to the research staff immediately.
* Willing and able to comply with study requirements.
* Willing to receive IVF to get pregnant as part of the experimental protocol.

Exclusion Criteria:

* Men will be excluded from the study.
* Current or previous IgA deficiency
* Current or previous premature ovarian failure due to a genetic origin, such as Turner's Syndrome or chromosomal abnormality
* Current or previous great injuries or adhesions to the pelvis or ovaries
* Current and ongoing pregnancy
* Current and ongoing anticoagulant use for which plasma infusion appears contraindicated
* Current and ongoing major Mental health disorder that precludes participation in the study
* Current and ongoing active substance abuse or dependence
* Current and ongoing gynecological or non-gynecological cancer
* Current and ongoing chronic pelvic pain
Comparative Study of Ultrasound-guided Paravertebral Block Versus Intravenous Tramadol in Percutaneous Nephrolithotomy

Paravertebral block has been widely used for analgesia. The aim of this study,comparison of the effect of ultrasound-guided paravertebral block versus intravenous tramadol for postoperative pain control in percutaneous nephrolithotomy.

The study protocol was approved by the Local Ethical Committee. Written informed consent was obtained from all patients, before starting to surgery.

The patients were given no premedication. The demographic data of patients (age, gender, the presence of other diseases) were recorded, preoperatively. All patients were applied standard monitoring in the operating room. After the induction of anesthesia provided intravenously propofol (2-3mg/kg) and rocuronium bromide (0.5 mgkg-1), all patients were intubated with a suitable endotracheal tube. Anesthesia maintenance was provided with 1-2% sevoflurane and a 60% nitrous oxide-40% oxygen gas mixture. 0.9% NaCl (5-10 mLkg-1) was started as fluid resuscitation. Urinary catheter was inserted before placement, and then all patients were placed in the prone position.

Postoperatively, duration of surgery, systolic and diastolic blood pressures, heart rate, peripheral oxygen saturation (SBP, DBP, HR, and SpO2), visual analog scales (VAS), side effects such as vomiting and nausea, complications such as pneumothorax, tramadol consumption and additional analgesic requirements of patients were recorded at 1, 2, 4, 6, 12 and 24 h in the postoperative period. These parameters were evaluated by an anesthesiologist in the first 24 hours postoperatively. If the VAS score was \>4, patients in both groups were administered diclofenac.

Eligibility Criteria:
Inclusion Criteria:

* 53 patients scheduled for percutaneous nephrolithotomy (PNL),
* 18-70 years of age,
* weight between 50-100 kg,
* American Society of Anesthesiologists (ASA) classification I-II were included

Exclusion Criteria:

* The exclusion criteria were refusals by patients,
* coagulation abnormalities,
* patients with spinal deformity,
* cutaneous infection at the injection site and
* a known allergy to drugs.
Clinical Trial on Ganoderma Spore Lipids Combined With Chemo in Patients With G.I. Cancers

A phase III double-blind randomized clinical trial on the effects of ganoderma spore lipids to the immunological response in patients with G.I. Cancers. The trial is randomized, double-blind. Cancer patients are diagnosed based on pathology or cell biology. Patients are randomized into 2 groups: both groups receive chemotherapy. Either group receives ganoderma spore lipids or placebo capsules 600mg three times a day (TID) in addition to the chemotherapy. Clinical evaluation includes chemotherapy drug toxicities, life quality improvement. Blood biochemistry tests mainly include malondialdehyde (MDA), superoxide dismutase (SOD), glutathione peroxidase (GSH-Px), adrenaline, nor-adrenaline, tumor necrosis factor (TNF)-α, interleukin (IL)-1b, interleukin (IL)-6, cell flow cytometry on Th1, Th2, Th17, Treg cytokines, as well as serum cortisol, estradiol (female), progesterone (female), testosterone (male), etc.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-80, male and female.
* Diagnosis: imaging, cell and pathology report.
* Eastern Cooperative Oncology Group (ECOG) O-2, life expectancy more than 3 months.
* Chemotherapy is not contraindicated.
* No apparent surgical trauma during the previous 2 weeks.
* Past treatment:

  * Biological treatment: at least 4 weeks after previous treatment with immunotherapy or other biological; chemotherapy, at least 6 months after last treatment with chemotherapy and or target therapy.
  * Surgery: had not received transplantation surgery, at least 2 weeks after last major surgery.

Exclusion Criteria:

* A purulent and chronic infection of wound healing delayed.
* Diseases of the blood system.
* Abnormal blood coagulation function.
* Severe brain disease or primary brain tumors without control, and mentally ill person.
* Patients with brain metastases.
* Pregnant or lactating women.
* Patients (male/female) with fertility, But the patients themselves or their spouses do not take effective contraception.
* Allergic constitution.
* In addition, patients taking part in other clinical trials, being treated with other biotherapy or immunotherapy and researchers consider not suitable for clinical subjects for other reasons will be excluded.
Overdose Prevention Centers and Behavioral Health

The aims of this study are: (Aim 1) Identify sources of heterogeneous impacts of opioid prevention center (OPC) use on non-fatal and fatal overdose risk among individuals with histories of polysubstance use (PSU); (Aim 2) Estimate the impact of OPC use on treated psychiatric events among clients with histories of PSU, and; (Aim 3) Assess the barriers and facilitators of integrating mental health services into existing syringe service and OPC delivery models.

Aims 1 and 2 of this study will use secondary data to identify sources of heterogeneous impacts of OPC use on fatal and nonfatal overdose risk (Aim 1) and estimate the impact of OPC use on treated psychiatric events among clients with histories of PSU (Aim 2). Aim 3 of this study will use qualitative interviews with harm reduction staff to assess barriers and facilitators of integrating mental health services into existing syringe service and OPC delivery models.

Eligibility Criteria:
Inclusion Criteria:

Aims 1 and 2:

* are 18 years of age or older;
* engaged in syringe service program and/or overdose prevention center services in New York City in the past 30 days before the date of enrollment;
* are able to complete assessments in English or Spanish;
* are competent to give written informed consent at the time of the interview;
* are able to provide informed consent;
* self-report use of illicit opioids (e.g., heroin, fentanyl), illicit stimulants (e.g., powder cocaine, crack, methamphetamine), counterfeit prescription pills (defined as prescription pills obtained through the illicit drug market) or any injection drug use in the past 30 days, and
* are able to participate for at least 6 months following enrollment.

Aim 3

* are 18 years of age or older;
* are employed by a harm reduction program;
* are able to complete assessments in English; and
* are able to provide informed consent.

Exclusion Criteria:

• Individuals not meeting the criteria detailed above for the respective Aims will not be eligible for participation in this study.