cyrilzakka/clinical-trials huggingface dataset:
ACT-based EMI in College Students

This study aims to evaluate the acceptability and effectiveness of a transdiagnostic, Acceptance and Commitment Therapy (ACT)-based ecological momentary intervention (EMI) among college students. A mixed-methods pilot randomized controlled trial (RCT) will be conducted to assess its impact on psychological flexibility, well-being and mental health outcomes.

Mental health issues are prevalent among college students, yet traditional interventions often face barriers related to accessibility and engagement. This study explores the feasibility, acceptability, and preliminary effectiveness of a transdiagnostic ACT-based EMI designed to deliver in-the-moment psychological support via digital platforms. A mixed-methods pilot RCT will be conducted, with participants randomly assigned to either the ACT-based EMI group or a mood monitoring group. Quantitative measures will assess changes in psychological flexibility, stress, anxiety, depression, and well-being, while qualitative interviews will provide insights into user experience, engagement, and perceived benefits or barriers. Findings from this study will inform the optimization of ACT-based digital interventions for college students and contribute to the growing field of personalized, technology-assisted mental health care.

Eligibility Criteria:
Inclusion Criteria:

* Participants in our study are healthy college students
* have smartphone, and have access to the internet

Exclusion Criteria:

* currently participating in another research
* have significant cognitive impairment that prevents participation in the research
Evaluate the Impact of Drawtex in Venous Leg Ulcers

This is a clinical study to comparatively evaluate the impact of Drawtex wound dressing against wound bioburden in moderately to highly exuding venous leg ulcers.

Each subject is expected to participate in this study for a period of four weeks or until reepithelialization, whichever occurs first. Subjects may participate for an additional period of four weeks or until reepithelialization, whichever occurs first: this it to be decided by the investigator and will be determined by the accessibility of the patient (physical location) and the suitability of the wound to further treatment. The maximum time period for the study is 8 weeks. The minimum time frame is at least 4 week, or until reepithelialization occurs.

Eligibility Criteria:
Inclusion Criteria:

* Subject \> 18 years.
* Subject is attending weekly office visits at SW Wound Care Center as an out-patient.
* Subject has a moderately to highly exudative venous leg ulcer that would be indicated for treatment with Drawtex
* Subject or is informed about the trial, understands its nature of the study and provides written informed consent prior to study enrollment.
* Subject is willing and able to comply with all specified care and visit requirements

Exclusion Criteria:

* Subject has a lesion that does not meet the inclusion criteria.
* Subject refuses to participate in the study.
* Subject already participates in the this study with one wound (only one wound per subject is allowed)
* Subject has known sensitivity to the trial product or any of its compounds.
* Subject is expected to be non-compliant.
* Subject's lesion is a primary skin cancer.
* Subject's lesion is the manifestation of a metastasis.
* Subject is pregnant.
Fractal Analysis of the Pulmonary Arterial Tree in Pulmonary Hypertension

The investigators propose to confirm that normotensive and hypertensive pulmonary arteries are fractal, as well as define if the FD correlates to disease severity when compared to available data such as six-minute walk and right heart catheterization measurements.

Pulmonary hypertension (PH) is an insidious disorder that can occur in isolation or as a result of various other pulmonary and systemic conditions. If left untreated PH may progress to right heart failure and death. Numerous tests are suggestive but not diagnostic of PH including cardiac echo, pulmonary function testing and chest x-ray. Definitive diagnosis requires right heart catheterization that is invasive, costly and time consuming. The fractal dimension (FD) is an index of the space-filling properties of an object so that the closer the dimension is to the topological dimension in which the object is embedded, the greater the space filling properties. No investigations have been performed to analyze the fractal dimension of pulmonary arteries in patients with PH. We propose to confirm that normotensive and hypertensive pulmonary arteries are fractal, as well as define if the FD correlates to disease severity when compared to available data such as six-minute walk and right heart catheterization measurements.

Eligibility Criteria:
Inclusion Criteria:

* Patients having a right heart catheterization and CT pulmonary angiogram

Exclusion Criteria:

* None
Cell Therapy for Immunomodulation in Kidney Transplantation

This study investigates treatment with recipient regulatory T cells and donor bone marrow together with tocilizumab for immunomodulation in living donor kidney transplant recipients.


Eligibility Criteria:
Inclusion Criteria:

* Patient has provided written informed consent.
* Patient is 18 years or older.
* Patient is a planned recipient of a living donor kidney transplant.
* Patient is a planned recipient of an ABO blood group-compatible kidney graft.
* Patient is a planned recipient of a kidney graft from a donor that is not HLA (human leukocyte antigen)-identical.
* Patient is negative for DSA (donor-specific antibodies).
* WOCBP (women of child-bearing potential) must have a negative pregnancy test at inclusion.
* WOCBP must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the study in such a manner that the risk of pregnancy is minimized.

Exclusion Criteria:

* Patient is EBV (epstein barr virus)-negative on serology.
* Patient is HIV-positive or suffering from chronic viral hepatitis.
* Patient is CMV (cytomegalo virus)-negative and receiving a kidney from a CMV-positive donor.
* Positive T-cell lymphocytotoxic cross match.
* Patient with prior kidney transplant or non-renal solid organ transplant.
* Patient has a known contraindication to any of the protocol-specified treatments.
* Patient had been diagnosed with a malignancy within 5 years prior to study entry, excluding non-metastatic basal or squamous cell carcinoma of the skin.
* Female patients who are breast-feeding.
* Female patients with a positive pregnancy test.
A Study to Investigate Intravenous Tocilizumab in Participants With Moderate to Severe COVID-19 Pneumonia

This study will assess the pharmacodynamics, pharmacokinetics, safety and efficacy of two different doses of tocilizumab (TCZ) in combination with standard-of-care (SOC) in hospitalized adult participants with moderate to severe COVID-19 pneumonia.


Eligibility Criteria:
Inclusion Criteria

* Hospitalization with COVID-19 pneumonia confirmed by a positive polymerase chain reaction (PCR) of any specimen \[e.g., respiratory, blood, urine, stool, and other bodily fluids\]) and evidence of pneumonia on chest X-ray or computed tomography scan
* For severe patients, SpO2 \</= 93% or PaO2/FiO2 \< 300 mmHg. If a participant is on supplemental oxygen with SpO2 \> 93%, but desaturation \</= to 93% on lower supplemental oxygen or ambient air is documented during screening, the inclusion criterion is met
* For moderate patients (those who do not qualify as severe based oxygen requirements), CRP \> 2 x upper limit of normal (ULN) is required
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, as defined by the protocol
* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined by the protocol

Exclusion Criteria

* Known severe allergic reactions to TCZ or other monoclonal antibodies
* Active tuberculosis (TB) infection
* Suspected active bacterial, fungal, viral, or other infection (besides SARS-CoV-2)
* Participants who are on a mechanical ventilator \> 24 hours or extracorporeal membrane oxygenation (ECMO), in shock, or combination thereof with other organ failure requiring treatment in an ICU
* In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
* Receipt of oral anti-rejection or immunomodulatory drugs (including TCZ) within the past 3 months
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 10 x ULN detected within 24 hours at screening or at baseline (according to local laboratory reference ranges)
* Absolute neutrophil count (ANC) \< 1000/uL at screening and baseline (according to local laboratory reference ranges)
* Platelet count \< 50,000/uL at screening and baseline (according to local laboratory reference ranges)
* Pregnancy or breastfeeding, or positive pregnancy test at a predose examination
* Treatment with an investigational drug within 5 drug-elimination half-lives or 30 days (whichever is longer) of randomization
Comparison of Postoperative Analgesic Effect of Intrathecal Clonidine and Fentanyl Added to Bupivacaine in Patients Undergoing Cesarean Section

Objective :To compare the analgesic effect of intrathecal clonidine and fentanyl as an additive to bupivacaine in patients undergoing cesarean section .

Methods:Following Ethics Committee approval and informed patients consent, Ninety patients 18-45 yr old ASA physical status I or II, scheduled for cesarean section under spinal anesthesia, were studied in a prospective, double-blinded, randomized way. The patients were randomly allocated to one of three groups of 30 each. The clonidine group (groupC) received bupivacaine 10mg combined with 75microgram clonidine preservative free ,the fentanyl group (group F) received bupivacaine 10mg combined with25microgram fentanyl and the placebo group (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally . Time to first requirement of analgesic supplement, Sensory block onset time, maximum sensory level , onset of motor block, duration of blockade, hemodynamics variables, the incidence of hypotension, ephedrine requirements, bradycardia ,hypoxemia \[Saturation of peripheral oxygen (SpO2)\<90\], postoperative analgesic requirements and Adverse events, such as sedation, dizziness , Pruritus and postoperative nausea and vomiting were recorded. Patients were instructed preoperatively in the use of the verbal rating scale (VRS) from 0 to 10 (0no pain, 10maximum imaginable pain) for pain assessment. If the VRS exceeded four and the patient requested a supplement analgesic, diclofenac Na supp 100 mg was to be given for post-operative pain relief as needed . For breakthrough pain(VRS \>4) if time of administration of diclofenac Na less than 8h,Pethidine 25 mg IV was given.


Eligibility Criteria:
Inclusion Criteria:

* Patients with American Society of Anesthesiologists(ASA) physical status I and II, undergoing elective cesarean section

Exclusion Criteria:

* Significant coexisting disease such as hepato-renal and cardiovascular disease
* Any contraindication to regional anesthesia such as local infection or bleeding disorders
* Allergy to ketamine or midazolam
* Long-term opioid use or a history of chronic pain. -
A Prospective Study on Incidence and Prevention of Contrast-induced Nephropathy in Croatia

The study is analysis of the incidence of contrast-induced nephropathy (CIN) in patients with previously normal renal function undergoing angiography and comparison between the three different treatment protocols on renal function.

Patients are randomly assigned to the three groups: 1) peroral hydration, 2) Na bicarbonate (NaHCO3), and 3) NaHCO3 plus N-acetylcysteine (NAC) infusion.

Serum creatinine (SCr), blood urea nitrogen (BUN), and neutrophil gelatinase-associated lipocalin (NGAL) are measured before and 48 hours after the angiography. CIN was defined as an absolute increase of 0.5 mg/dL or a relative increase of \>25% in creatinine levels 48-72 hours after the procedure

Patients are randomly assigned to the three groups: 1) peroral hydration, 2) Na bicarbonate (NaHCO3), and 3) NaHCO3 plus N-acetylcysteine (NAC) infusion The first group of patients receives standard peroral hydration of 1500 ml water on the day of the procedure.

The second group receives 3 mL/kg/hour of Na bicarbonate, an hour prior to angiography and 1 mL/kg/hour, within six hours after angiography.

The third group receives parenteral NAC (1200 mg twice a day) one day before angiography, on the day of the angiography, and one day after the diagnostic procedure in addition to Na bicarbonate solution on the day of the angiography.

The low-osmolar iodinated contrast agent was used.

Eligibility Criteria:
Inclusion Criteria:

* angina (stable, unstable)
* coronary artery disease
* cardiomyopathy
* valvular disease
* vasculitis
* peripheral arterial disease

Exclusion Criteria:

* kidney dysfunction
* uncontrolled hypertension (systolic blood pressure \>160 mm Hg and/or diastolic blood pressure \>100 mm Hg)
* pregnancy
* lactation
* history of allergic reaction to contrast agents
* cardiogenic shock
* pulmonary edema
* multiple myeloma
* urgent coronary angiography
* receiving contrast agents two days prior to the study and 48 hours within the study
A Phase 2 Study of Panitumumab in Patients With Cetuximab-refractory Metastatic Colorectal Cancer

The purpose of this study is to assess if panitumumab is active enough to warrant comparative studies in patients with metastatic colorectal cancer that has progressed after treatment with cetuximab.

The study was amended with modification of inclusion criteria (from wild-type tumor KRAS gene to wild-type RAS gene, including KRAS and NRAS exons 2, 3 and 4)

RAS mutational status of tumors of patients enrolled before amendment 1 approval will be centrally revised. Patients whose tumors will result RAS mutated at the biomarkers central revision, will be replaced. Therefore, the overall sample size at both the stages may be higher than the one initially planned.

Eligibility Criteria:
Inclusion Criteria:

* Pathologic diagnosis of metastatic colorectal adenocarcinoma
* a wild-type RAS tumor (mutational status has to be determined by an experienced laboratory using validated test methods for detection of KRAS exons 2, 3, and 4, and NRAS exons 2, 3, and 4
* Failure from previous treatment with fluoropyrimidine, oxaliplatin and irinotecan. Patients may or may not have been treated with bevacizumab.
* Documented disease progression following a treatment with cetuximab in patients who showed either an objective response after 8 weeks or stable disease after 16 weeks of cetuximab treatment.
* Age at least 18 years
* ECOG Performance Status 0-2
* Neutrophils at least 1,500 mm3, platelets at least 100,000 mm3, and hemoglobin at least 9 g/dL
* Bilirubin level less than 1.5 times ULN
* AST (SGOT) and ALT (SGPT) not greater than 2.5 times ULN (or 5 times ULN in presence of liver metastasis)
* Serum creatinine less than 1.5 times ULN
* Effective contraception, if the risk of conception exists
* Life expectancy at least 3 months
* Written informed consent

Exclusion Criteria:

* Symptomatic brain metastasis
* Interstitial pneumonitis or pulmonary fibrosis
* Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or non melanoma skin cancer)
* Chemotherapy, radiotherapy or immunotherapy within the past 4 weeks
* Any unstable systemic disease (including active infections, any significant hepatic, renal or metabolic disease), metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of study drugs or render the patient at high risk from treatment complications
* Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment
Identification and Clinical Relevance of an Oxytocin Deficient State (Melatonin Study)

Oxytocin (OT) is a hypothalamic peptide that enters the peripheral circulation via the posterior pituitary gland. OT plays a key role in regulating appetite, psychopathology, prosocial behavior and sexual function. Hypopituitarism is associated with increased obesity, increased psychopathology, sexual and prosocial dysfunction despite appropriate hormone replacement. A few studies suggest the existence of a possible OT deficient state in hypopituitarism. In animal models, melatonin has shown to increase OT release.

This study is designed to evaluate oxytocin values after administration of melatonin in adults (healthy volunteers and patients with hypopituitarism).

The investigators hypothesize that OT response will be blunted following melatonin in patients with hypopituitarism compared to healthy controls.


Eligibility Criteria:
Inclusion Criteria:

* Patients with hypopituitarism (HYPO) (\>1 pituitary hormone deficiency) and stable hormone replacement for the prior three months
* At least one clinical sign of hypothalamic damage

Exclusion Criteria:

* uncorrected hormone deficiency
* creatinine \>1.5mg/dL
* alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5x upper limit of normal
* hematocrit less than 30%
* suicidality or active psychosis
* participation in a trial with investigational drugs within 30 days
* using a high glucocorticoid dose
* vigorous physical exercise
* alcohol intake within 24 hours before the study participation
* evidence of any acute illness or any illness that the Investigator determines could interfere with study participation or safety
* pregnancy or breastfeeding for last 8 weeks
* known allergies towards melatonin
* patients refusing or unable to give written informed consent
* patients receiving fluvoxamine and/or impossibility to stop hypnotics 48 hours prior to the study visit.
* Additionally for healthy controls: the presence of brain or pituitary tumor, radiation involving the hypothalamus or pituitary, history of hypopituitarism or receiving testosterone or glucocorticoids esters.
The Effects of Oxytocin Treatment on Social Touch

The main aim of the study is to investigate the modulatory effects of oxytocin (24IU) administration on the affective processing of touch manipulated differently in gentle caress-like stroke vs. social massage with a moderate pressure.

A randomized double-blind placebo-controlled mixed experimental design with three arms (intranasal oxytocin administration vs. oral oxytocin administration vs. placebo administration, each with 60 subjects) will be employed in the current study. 35 minutes after treatment subjects will be applied two different types of pleasant touch (social massage vs. caress-like stroking) to their calf. After each applied touch stimulation session, the subjects will be asked to rate their subjective experience of the touch including the perceived pleasantness, arousal, intensity and payment. The neural basis of touch processing will be measured via simultaneously acquired fNIRS together with skin conductance responses and the electrocardiogram recording. Blood samples will be taken before and after the treatment as well as after each run session to measure plasma oxytocin levels to explore the associations with primary outcome measure (the behavioral and neural measures of touch processing). Mixed-measure analysis of variance (ANOVA) with treatment as between-subject factor and condition as within-subject factor will be used to investigate oxytocin effects on social touch processing.

To control potential confounding effects across groups, before the experiment all participants will be asked to complete a range of Chinese versions of validated questionnaires on personality, traits, attitude towards interpersonal touch and sensitivity to reward: Autism Spectrum Quotient (ASQ), Beck Depression Inventory II (BDI), State-Trait Anxiety Inventory (STAI), the Cheek and Buss Shyness Scale (CBSS), the Adult Attachment Scale (AAS), the Childhood Trauma Questionnaire (CTQ), social touch questionnaire (STQ), Sensitivity to Punishment and Sensitivity to Reward Questionnaire (SPSRQ), Sensory Over-Responsivity (SensOR) Scales and the Interpersonal Reactivity Index (C-IRI). And associations between questionnaire scores (especially the ASQ and STQ scores) with primary outcome measure will be explored to investigate modulatory effects of autistic traits. Additionally, to control for potential confounding effects of treatment on mood across the experiment, the Positive and Negative Affect Schedule (PANAS) will be administered immediately before and 30 minutes after the treatment. Participants will also complete the PANAS after each type of touch condition to further measure the modulatory effects of stroking touch and massage on mood.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects without any past or present psychiatric or neurological disorders and without any current psychotherapeutic medication.

Exclusion Criteria:

* Any history of brain injury, psychiatric/physical illness, alcohol/substance abuse, or other major health concern.
Effect of Guanfacine Extended-Release on Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia

This study seeks to determine, using special sleep tests (polysomnography and actigraphy) if guanfacine extended release is able to improve nighttime sleep in children with ADHD - associated insomnia while improving daytime ADHD symptoms. Male and female children with diagnosed or suspected ADHD with sleep problems (difficulty falling asleep, difficulty staying asleep, or less than expected hours of sleep) will be recruited. After obtaining informed consent and assent (when appropriate) and after discontinuation of excluded medications, children will have evaluations of his or her sleep and evaluations confirming the ADHD diagnosis. Children who successfully pass screening will be enrolled into the double-blind, placebo-controlled, randomized investigation with 50% of participants receiving guanfacine extended release and 50% of participants receiving matching placebo. Using a flexible-dose optimization design based on ADHD symptom improvement and medication tolerability, the dose will be adjusted between 1 to 4 mg over the course of four weeks. At the end of medication adjustment (week 4 or 5), ADHD questionnaires, sleep questionnaires, and sleep tests will be repeated and analyzed. The medication will be weaned over the course of the following 3-10 days.


Eligibility Criteria:
Inclusion Criteria:

1. Subject must be male or female, aged 6 - 12 years with ADHD.
2. Subject must (a) be taking methylphenidate, amphetamine, or atomoxetine for treatment of ADHD with parent or subject concerns of inadequate efficacy or intolerable side effects, or (b) free of any other medication used to treat ADHD for at least 30 days at the time of the initial sleep study.
3. Subject must have repeated difficulty with sleep initiation or persistence despite attempts at adequate sleep hygiene.
4. Subject must be able to swallow tablets.

Exclusion Criteria:

1. Subject or parent/LAR is unable or unwilling to discontinue present medications used to treat ADHD.
2. Subject has a body mass index \< 5th percentile for age, using the Centers for Disease Control standards reported in 2000.
3. Subject has a body weight \> 176 pounds.
4. Subject has a diagnosis of Autism or Autism Spectrum Disorder.
5. Subject has other serious psychiatric diagnoses.
6. Subject has a medical condition that may require treatment with an unapproved medication, that may cause a safety concern, or that may confound outcome results
7. Subject has an excessive caffeine intake (greater than 2.5 mg/kg/d).
8. Subject has a prior problem with clonidine or guanfacine.