cyrilzakka/clinical-trials huggingface dataset:
Lithium Effects on the Brain's Functional and Structural Connectome in the Treatment of Bipolar Disorder

Lithium is highly effective in the treatment of bipolar disorder. This study aims to investigate, for the first time, the impact of lithium monotherapy on the structural and functional connectivity of the brain using MRI imaging.

The premise of this proposal is that the clinical efficacy of lithium in bipolar disorder, and its complex effects on multiple brain physiological functions, may be best deciphered using a network properties-metric approach. This approach is critical because it provides insight into the function of brain networks (e.g., resilience to disruption, central hubs), which is likely to be more closely linked to behavioral outcomes. Furthermore, we will conduct an exploratory investigation of the in vivo molecular effects of lithium by measuring peripheral gene expression. To bring these together, we will also explore whether connectome changes serve as mediator between molecular changes (i.e., gene expression) induced by lithium treatment and behavioral changes (e.g., depression, mood stability, suicidality).

Eligibility Criteria:
Inclusion criteria for BD subjects:

* ages 18-60 years (inclusive) and able to give voluntary informed consent;
* Satisfy criteria for Diagnostic and Statistical Manual 5th edition (DSM-V) for BD I or II, current Depressive Episode;
* 17-item Hamilton Depression Rating Scale (HAM-D) score \>15 and \<25;
* Young Mania Rating Scale (YMRS) \< 8;
* no psychotropics in the last 2 weeks (if previously on fluoxetine then medication free for 5 weeks) OR on stable psychotropic medications for 12 weeks
* no lithium treatment for past 6 months;
* satisfy criteria to undergo an MRI scan based on MRI screening questionnaire;
* able to be managed as outpatients during the study as ascertained by Clinical Global Severity Scale \< 5 (i.e., moderately ill) and no significant suicidal or homicidal ideation or gross disability.

Exclusion criteria for BD subjects are:

* meeting DSM-IV criteria for schizophrenia, schizoaffective disorder, or an anxiety disorder as
* a primary diagnosis;
* requiring inpatient treatment;
* meeting DSM-V criteria for substance dependence within the past 3 months, except caffeine or nicotine;
* positive urinary toxicology screening at screening visit;
* use of alcohol in the past 1 week;
* serious medical or neurological illness;
* current pregnancy or breast feeding;
* metallic implants or other contraindications to MRI.

Inclusion criteria for healthy subjects:

* ages 18-60 years and ability to give voluntary informed consent;
* no history of psychiatric illness or substance abuse or dependence;
* no significant family history of psychiatric or neurological illness in first degree relative;
* not currently taking any prescription or centrally acting medications;
* no use of alcohol in the past 1 week;
* and no serious medical or neurological illness.

Exclusion criteria for healthy subjects are:

* under 18 years of age;
* pregnant or breast-feeding;
* metallic implants or other contraindication to MRI.
Study Comparing One Versus Two Cortisone Injections for Trigger Finger

Trigger finger, also known as stenosing tenosynovitis, is a painful condition that can cause discomfort and disability. Many physicians choose to locally inject cortisone into the infected finger although there is no current consensus as to how many injections are needed to achieve maximum relief. This study will be a prospective, randomized study to compare one versus two injections for the treatment of trigger finger.


Eligibility Criteria:
Inclusion Criteria:

* Subject is greater than 18 years of age, presenting with stenosing tenosynovitis.
* Subject is willing and able to provide informed consent.

Exclusion Criteria:

* Patients who have previously undergone surgery for the treatment of trigger finger.
Evaluation of Efficacy and Safety of SDN-037

The efficacy and safety of SDN-037 twice daily will be evaluated and compared with vehicle for the treatment of inflammation and pain associated with ocular surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Be at least 2 years of age on the date of assent or 18 years of age at the date of consent
2. Be able and willing to follow study instructions and complete all required visits
3. Females of childbearing potential must not be pregnant (as confirmed by a negative urine pregnancy test
4. Able to self-instill the IP or have a caregiver available to instil all doses of the IP

Exclusion Criteria:

1. Any known allergy or hypersensitivity to difluprednate therapy
2. An acute ocular infection (bacterial, viral or fungal) or active ocular inflammation in the study eye
3. Any active corneal pathology noted in the study eye
4. Currently suffering from alcohol and/or drug abuse
Cell Samples From Patients With Leukemia

RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about cancer and the development of drug resistance in patients. It may also help doctors find better ways to treat cancer.

PURPOSE: This research trial is studying samples from patients with leukemia.

OBJECTIVES:

* Demonstrate the capability of primary human leukemia samples to survive and proliferate in the zebrafish embryo.
* Confirm the anti-proliferative or toxic effects of known chemotherapeutics on the transplanted cells in vivo.
* Evaluate the effect of novel anticancer drugs and/or their combinations on individual samples.

OUTLINE: This is a multicenter study.

Cryopreserved specimens are injected into the yolk sac of zebrafish embryos under anesthesia. After 1 hour of recovery at 28° C, embryos are maintained at 38° C and screened for fluorescence at the injection site. Within 48 hours post-injection, some embryos are treated with various chemotherapeutic drugs or dimethyl sulfoxide and incubated in protease solution. Proliferation of leukemia cells are monitored by live-cell microscopy. Cells with or without drug treatment are then extracted at 24 and 72 hours post-injection. Leukemia cells are counted and tested with imatinib mesylate, all-trans retinoic acid (tretinoin), cytosine arabinose, and known bioactive chemical compounds from promising drug families, such as tyrosine kinase inhibitors, antiapoptotic agents, channel modulators, and prostaglandin agonists.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Samples of blood and tissue cells from patients diagnosed with myeloid disease including the following subtypes:

  * Chronic phase chronic myeloid leukemia (CML), to complement initial studies in the K562 CML cell line
  * Acute promyelocytic leukemia (APL), to complement initial studies in the NB4 APL cell line
  * Acute myeloid leukemia (AML) expressing the t(8;21)(q22;q22) translocation, which occurs in approximately 12% of pediatric AML and is associated with good prognosis
  * AML expressing 5q- or monosomy 7, associated with a poor prognosis
  * AML expressing the fms-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD), associated with a poor prognosis

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Spanish Meaning-Centered Psychotherapy for Cancer

The aim of this study is to verify the efficacy of the Spanish adaptation of Meaning-Centered Psychotherapy for Spanish participants with cancer in a randomized control trial.

Meaning-Centered Psychotherapy (MCP) is effective in improving meaning in life, hope, optimism, self-efficacy, well-being, and quality of life, and in reducing stress in people with cancer. However, all the studies on the application of MCP in cancer patients have been carried out in Anglo-Saxon samples. Therefore, it is necessary to adapt and verify the efficacy of MCP in populations that speak languages other than English, such as Spanish. Moreover, to expand the data supporting the efficacy of MCP for cancer patients, it would be necessary to compare MCP to other active therapies such as Cognitive Behavioral Therapy (CBT). The study has several aims: The first objective is to verify the efficacy of the MCP intervention for Spanish participants with cancer in a randomized control trial (RCT) comparing it to CBT. The second objective is to analyze the feasibility and acceptance of MCP in Spanish participants with cancer. The third objective is to analyze whether the changes produced in the Meaning in Life dimensions (presence, search, comprehension, purpose, and mattering) will predict changes in anxiety, depression, quality of life, etc.

The investigators adapted MCP for Spanish participants with cancer. The Spanish MCP is an adaptation of the MCP developed by Breitbart as an eight-session group therapy for patients with advanced cancer. This paper presents the study protocol. The study design consists of a two-arm RCT with two conditions: MCP and CBT, where participants will be randomized to one of the two groups. Participants will be adults with stage I, II, and III cancer who have completed their medical treatment (surgery, radiotherapy, or chemotherapy). Participants will be assessed at pretreatment, post-treatment, and 6-month follow-up. The intention-to-treat principle will be used when analyzing data, using mixed-effects models with full information and maximum likelihood estimation

Eligibility Criteria:
Inclusion Criteria:

* Participants will be adults with stage I, II, and III cancer who have completed their medical treatment (surgery, radiotherapy, or chemotherapy).
* Participants will have to express a need for psychological care.
* Participants will have low meaning in life.

Exclusion Criteria:

* Participants who are currently receiving another psychological or psychiatric treatment.
* Diagnosis of a serious mental disorder (schizophrenia, substance dependence, dementia, or cognitive impairment).
Efficacy and Safety of Bifidobacterium Combined With High-frequency Transcranial Magnetic Stimulation in the Treatment of Adolescent Depression

A total of 100 patients with adolescent depression who were admitted to our hospital between March 2022 and October 2022 were selected. On the basis of double blinding, these patients were randomly divided into the observation group(n=50) and the control group(n=50) using a random number table. 5S management method was used in the whole process of treatment to improve the hospital environment, increase the work efficiency and reduce the occurrence of cross infection through the effective implementation of the five steps of sort(Seiri), set in order(Seiton), shine (Seiso), standardize(Seiketsu) and sustain(Shitsuke).


Eligibility Criteria:
Inclusion Criteria:

* aged 13-18 years old;
* met the diagnostic criteria for depression in the International Classification of Disease-10 (ICD-10);
* with a total score of the Hamilton Rating Scale for Depression (HAMD-24) ≥20 in the initial assessment;
* who were right-handed

Exclusion Criteria:

* with a definite diagnosis of other mental disorders in the past;
* with a past or current history of manic episodes;
* with a past or current history of severe physical diseases;
* who used antidepressants, mood stabilizers, steroids, anti-inflammatory drugs, antibiotics, and immunomodulators in the past 1 month;
* who used lactic acid bacteria products for ≥7 days in the past 1 month;
* with a history of alcohol or psychoactive substance abuse within the last 3 months;
* with contraindications for rTMS, including but not limited to intracranial metal foreign bodies, cardiac pacemakers, and ear hearing aids;
* complicated with organic brain diseases, epileptic diseases, and severe physical diseases
Comparison of Ro 31-8959 Plus Zidovudine (AZT) Versus AZT Plus Zalcitabine (ddC) Versus Ro 31-8959 Plus AZT Plus ddC

PRIMARY: To determine the efficacy and toxicity of three treatment regimens: saquinavir mesylate (Ro 31-8959) plus zidovudine (AZT) vs. AZT plus zalcitabine (dideoxycytidine; ddC) vs. Ro 31-8959 plus AZT plus ddC.

SECONDARY: To investigate the pharmacokinetics and effects on various clinical parameters of the three regimens.


Eligibility Criteria:
Inclusion Criteria

Prior Medication: Required:

* At least 4 months total of AZT at some point in the past, alone or in combination with other antiretroviral therapy.

Patients must have:

* HIV seropositivity.
* Diagnosis of AIDS, ARC, PGL, or asymptomatic infection.
* CD4 count \> 50 to \<= 300 cells/mm3.
* Life expectancy of at least 6 months.
* Prior AZT therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Acute serious opportunistic infections requiring immediate treatment, including (but not limited to) tuberculosis, CMV, cryptococcal meningitis, disseminated MAC, cerebral toxoplasmosis, and Pneumocystis carinii pneumonia.
* Known intolerance to Ro 31-8959, AZT, or ddC.
* Symptoms suggestive of pancreatitis.
* Moderate or severe peripheral neuropathy as evidenced by discomfort from numbness, tingling, burning or pain of the extremities or any related symptoms that are accompanied by an objective finding.
* Visceral Kaposi's sarcoma.
* Lymphoma that will require therapy within the next 6 months.
* Transfusion dependence.

Concurrent Medication:

Excluded:

* Investigational or antineoplastic agents.

Concurrent Treatment:

Excluded:

* Radiotherapy (other than local skin radiotherapy).
* Transfusions.

Prior Medication:

Excluded:

* Any antiretroviral agent (other than AZT) or immunomodulatory therapy within 14 days prior to study entry.
* Prior treatment with an HIV proteinase inhibitor.
A Dose-escalating Clinical Trial With KH176

Mitochondrial Diseases are rare progressive, multi-system, often early fatal disorders affecting both children and adults. KH176 is a novel chemical entity currently under development for the treatment of inherited mitochondrial diseases, including MELAS (Mitochondrial Encephalomyopathy, Lactic acidosis, and Stroke-like episodes), Leigh's Disease and Leber's Hereditary Optic Neuropathy (LHON). KH176 is a potent intracellular redox modulating agent targeting the reactive oxygen species which are important in the pathogenesis of disorders of mitochondrial oxidative phosphorylation. After demonstrating a favourable safety profile in the pre-clinical testing, the safety, tolerability and pharmacokinetic and pharmacodynamic characteristics of the compound will now be evaluated in healthy male subjects in this trial


Eligibility Criteria:
Inclusion Criteria:

* Healthy as assessed by medical history, physical examination, Vital Signs, Clinical Laboratory, ECG

Exclusion Criteria:

* Allergies,
* Concomitant medication,
* concomitant disease,
* relevant surgery,
* recent blood donation
Expressive Writing for COVID-19 Resilience for Parents

The purpose of this study is to determine the impact of a 4-week, virtually-delivered expressive writing intervention on resilience in a cohort of parents and caregivers currently navigating the COVID-19 pandemic during spring \& summer of 2020.

In 2016, the research team piloted a 6-week intervention on expressive writing for resilience in a population of trauma survivors. Participants self-identified as having had a recent trauma or significant life upheaval, such as a divorce, major illness, job loss, or the death of a loved one. At 6 weeks, the investigators found that participants experienced significantly improved levels of resilience and lower levels of stress, rumination, and depression. These results added to a growing body of research indicating the potential for expressive writing to be a powerful healing modality for both psychological and physical well-being.

The current COVID-19 pandemic presents the potential for trauma or significant life upheaval for nearly all members of the community and the world at large. Parents of children who are at home face unique challenges during this time. Social distancing guidelines, shelter in place protocols, school and business closures, travel restrictions, high levels of job loss, loss of childcare, and the looming threat of illness have disrupted daily routines, family life, and significantly altered life plans for many. Parents and caregivers who have unexpectedly lost childcare, are having to adjust to home schooling arrangements, and/or are having to end to heightened emotional needs in their children may experience this time as particularly difficult.

Resilience is the capacity for individuals to adapt and recover in the face of trauma, adversity, or significant sources of stress. The current collective reality magnifies the need for accessible, low-cost, effective interventions to help people cultivate resilience and other dimensions of psychological well-being.

In this study, the investigators seek to further the work the research team began in 2016 with a 4-week, virtually-delivered expressive writing intervention designed to support parents in cultivating personal resilience and emotional wellness during the COVID-19 pandemic.

Eligibility Criteria:
Inclusion Criteria:

In order to have up to 40 evaluable subjects, we plan to consent up to 45 individuals. Potential subjects will be considered eligible if they are parents or primary caregivers of children aged 0-18 who have been home with them during the COVID-19 experience. Other eligibility criteria include:

* Able to speak, read, write, and understand English
* Cognitively able to provide consent
* Ability to participate in a 4-week intervention delivered via Zoom and email
Intracoronary Transplantation of Bone Marrow Derived Mononuclear Cells in Pediatric Cardiomyopathy

According to the high morbidity and mortality of idiopathic Dilated CardioMyopathy (IDCM) in pediatric, new modality of treatment is emerging. There are some case reports of administration of stem cell therapy. The investigators design the first randomized clinical trial in this setting. The investigators enroll 32 pediatric IDCM patients in two groups (16 pts. in each group including cell therapy and control). The investigators assess the safety and efficacy of intracoronary transplantation of autologous bone marrow derived mononuclear cells in this patients compared to control group.

Dilated cardiomyopathy as the most common form of cardiomyopathy is a rare but life-threatening disorder in children. The primary cause of nearly 37 % of children with DCM was unknown at diagnosis. Despite of the developing in the medical and surgical treatment during the past several decades, standard treatments (including Digitalis, diuretics, inhibitors of ACE, beta blockers, antiplatelet drugs and treatments Antiarrhythmic), may stabilize the condition, but will not restore heart function to its previous condition. Therapy remains complex and expensive. For some not all children the heart transplantation is only option and mortality continues to be high, also. Stem cell and cell-based therapies offer an innovative approach to reverse cardiac structure and function towards normal, possibly reducing the need for aggressive therapies and cardiac transplantation. According to the inclusion and exclusion criteria of trial, 32 patients with left ventricular ejection fraction less than 45% who resistance to the standard medical therapy were randomly allocated in 2 groups including BM-derived mononuclear (n=16) and control (n=16). Only the MNC group underwent the bone marrow aspiration and intracoronary injection. The investigators followed all of patients at 2 weeks, 1, 2, 4 and 6 months after transplantation for cell therapy group or registration for placebo by physical examination, laboratory tests and imaging such as echocardiography, CXR and CMR.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 1-16 year(s)
2. LVEF \<45% (echocardiography)
3. Duration of diagnosis more than 3 months
4. Resistance to Standard therapy more than 2 months
5. Informed consent

Exclusion Criteria:

1. Congenital Heart Disease
2. Active infection less than one month
3. Dysrhythmia
4. Cardiogenic shock
5. Renal failure
6. Immune Deficiency (Documentation)
7. Terminal illness or malignancy(Documentation)
8. TORCH (Documentation)
9. Metabolic disorder (Documentation)
10. Neuromuscular disorder (Documentation)
11. Autoimmune disease (Documentation)
12. Developmental delay
13. Cytotoxic drugs
14. Previous bone marrow transplant
15. Contraindications to CMR such as metallic implants
The Effects of The Products Used In Nazogastric Tube Fixation

The present study was planned to compare the effect of products, used in the fixation of nasogastric tube, on skin integrity of 4-6 weeks infants hospitalized at neonatal and infant units. The hypothesis of the study is "Water-based barrier tape is more effective to protect skin integrity than hydrocolloid barrier tape."

The study was planned as randomized controlled and experimental design to compare the efficiency of three different methods protecting skin deficiencies using adhesive products for 4-6 weeks infants. The universe of the study consisted of 4-6 weeks infants in neonatal and infants clinics of Giresun Women's and Children's Hospital between the dates of October 2020-2021. Power analysis was performed through G\*Power (v3.1.7) programme in order to determine the number of the sample. At the beginning of the study, a pilot study was carried out with 15 participants from each of the groups and the effect size was calculated as d=0.672 regarding the assessment of skin condition scores and 108 participants in total should be included in the study as 36 participants for each groups in order to obtain 80% power in the level of α=0.05. Block randomization technique is applied in the study as a randomization method. "As for data collection "Infant desciption form" and "Neonatal Skin Condition Score Scale" is used. The scale is filled by two independent observer via double-blind method.

Eligibility Criteria:
Inclusion Criteria:

* All the 4-6 weeks infants including interventional process and without any skin diseases

Exclusion Criteria:

* The infants receiving treatment without any interventional process
* Those having a skin disease
* Those infants having PICC and SVK catheters and do not meet the required criteria