cyrilzakka/clinical-trials huggingface dataset:
Social Media-based Electronic Bibliotherapy for Dementia Caregivers

This study aims to assess the efficacy of social media-based electronic bibliotherapy in improving the well-being of informal caregivers of people with dementia compared to a control group.

This randomized controlled trial aims to assess the efficacy of social media-based electronic bibliotherapy in improving the well-being of informal caregivers. Sixty informal caregivers of people with dementia were recruited and randomly allocated to the social media-based electronic bibliotherapy group or usual care group. Participants in the social media-based electronic bibliotherapy group received eight weekly e-bibliotherapy sessions. The control group only accepted the usual care provided by community services, but they received the same intervention materials as the intervention group after project completion. Mental health, caregiving appraisal, health-related quality of life, and psychological well-being were measured to test the intervention's effects immediately after completion. Individual interviews were conducted to explore caregivers' experiences participating in this study within two weeks after completing the intervention.

Eligibility Criteria:
Inclusion Criteria:

* caregivers providing regular care to individuals with mild to moderately severe dementia (Global Deterioration Scale=4\~6 of any type), requiring at least five hours per week for a minimum duration of six months;
* aged 18 or above;
* not receiving payment for caregiving services rendered;
* assisting with at least one daily activity of the care recipient;
* possessing reading ability;
* utilized social media platforms such as WhatsApp, Facebook, Twitter, Instagram, and WeChat for over six months.

Exclusion Criteria:

* caregivers with unstable physical or mental conditions;
* caregivers unable to communicate logically;
* involvement in another interventional study
Biomarkers of CVD Dysfunction in Hypertensive Disorders of Pregnancy

Profound and concomitant cardiovascular hemodynamic changes, necessary to support fetoplacental development and its increasing supply demands, occur during a physiological pregnancy characterized by an increase in cardiac output, heart rate and plasma volume, and fall in vascular resistance and blood pressure. The result of these changes is a volume overload that will lead to a compensatory transient left ventricular eccentric hypertrophy. This, together with the pro-inflammatory state typical of pregnancy, represents the pregnancy as a stress-test for the maternal cardiovascular system. Pregnancies complicated by hypertensive disorders of pregnancy (HDP), particularly those with early onset and/or complicated by intrauterine fetal growth restriction (FGR), are characterized by a cardiovascular maladaptation. Women who experienced HDP in pregnancy, especially pre-eclampsia (PE), more often develop later in life ischemic heart disease, hypertension and stroke, obesity, dyslipidemia, and end-stage renal disease.

Regardless its clinical impact, very little knowledge is available on the mechanisms by which PE could lead to cardiovascular disease (CVD), and, especially, to heart failure after pregnancy. Preliminary results suggest a cross-talk between pregnancy-induced biomarkers and cardio-vascular system. Particularly, cultures of neonatal rat cardiomyocytes and fibroblasts were used to investigate the role of the serum of women with HDP in regulating their proliferation. 5-ethynyl-2'-deoxyuridine (EdU) was administered to label DNA synthesis in proliferating cells. After 3 days of in vitro culture, EdU incorporation was analyzed upon immunofluorescence staining using specific antibodies by high content microscopy. A possible protective effect exerted by the selected sera against apoptosis was evaluated, as well, by Caspase activation. Moreover, the effect of cardiomyocytes and fibroblasts proliferation and apoptosis on maternal hemodynamic parameters was evaluated using median regression models. These data show that the serum of women with HDP triggers a net increase in the percentage of proliferating cardiomyocytes compared to controls. Moreover, there were relationship between cardiomyocytes and fibroblasts proliferation and maternal hemodynamics parameters thus, supporting the hypothesis that the serum of women with HDP may contain factors capable of stimulating cardiac cells in response to the cardiovascular stress-test


Eligibility Criteria:
Inclusion Criteria:

CASES:

1. Pregnant women affected by HDP
2. Women ≥18 years old
3. Women able to give an informed consent

CONTROLS

1. Uneventful pregnancy of women ≥18 years old
2. Women able to give an informed consent

Exclusion Criteria:

1. No informed consent
2. Women \<18 years old
3. Presence of other maternal pathologies as viral disease, diabetes
4. Fetal chromosomal/structural anomalies
DMSO Efficacy in IC/PBS Patients During and After Treatment

The purpose of this study is to examine the efficacy of dimethylsulphoxide (DMSO) cocktail in patients with interstitial cystitis during the treatment period (12 weeks) and after it (at 6 weeks, 3, 6 and 12 month).

The modern treatment of IC is a multi-modal treatment which includes behavioural treatment, physiotherapy of the pelvic floor musculature, oral medication (e.g. Amitryptiline) and intra-vesical instillation (e.g. DMSO, steroids, heparin). These treatments were found to be effective in a number of studies and are approved by the FDA. However, the optimal duration of intra-vesical instilation is not known.

All patients with IC (according to the international continence society criteria) will receive 12 weekly intra-vesical instillation of DMSO. All patients will fill an O'leary-Sant questionaire and a urination diary before treatment, after 3, 6, 9 and 12 treatments and at 6 weeks, 3, 6 and 12 month after the end to the treatment.

Eligibility Criteria:
Inclusion Criteria:

* patients with IC according to International Continence Society:

  * more than 6 month of pelvic pain
  * urinary frequency, urgency, dyspareunia

Exclusion Criteria:

* genitourinary tract infection
* known genitourinary malformation
A Study of a Comprehensive Prevention Program to Reduce Lymphedema After Axillary Lymph Node Dissection in People With Breast Cancer

The purpose of this study to test whether a comprehensive program may help the lymph fluid to drain out of the arm and prevent lymphedema in participants with breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Female sex
* Diagnosis of breast cancer
* Ages 18 to 75 years
* Consented for unilateral ALND or for unilateral SLNB with possible ALND

Exclusion Criteria:

* Male sex
* Does not speak English
* Does not fit into study garment
* Axillary recurrence
* History of ALND
* Requirement of bilateral ALND for the treatment of breast cancer
* Treatment with SLNB only
* Known anaphylactic allergy to ICG dye used in ILR
* Impaired decision-making capacity
The Effect of Probiotics on Non Alcoholic Fatty Liver Disease

Nonalcoholic Fatty Liver Disease (NAFLD) has been suggested to be the most common cause of chronic liver disease in the general population in the Western World. In advanced stages of NAFLD, steatohepatitis (NASH) develops characterized by: steatosis, inflammation, and fibrosis progressing to cirrhosis in some patients. The knowledge of the role of small intestinal bacterial overgrowth (SIBO) in the pathogenesis of NASH has led to the proposal of probiotics as a therapeutic strategy for this disorder.

Probiotics may interfere with the development of NASH by several mechanisms. Data from an uncontrolled clinical trial in NASH patients show promising results, with improvement of liver enzymes in treated patients.

RESEARCH GOALS:

A. To assess the degree of SIBO in NAFLD patients vs. healthy controls. B. To evaluate the effect of probiotics vs. placebo on SIBO in NAFLD patients. C. To evaluate the effect of probiotics vs. placebo on disease severity (inflammation, steatosis, and fibrosis) in NAFLD patients.

Eligibility Criteria:
Inclusion Criteria:

* Controls- healthy volunteers, male and female, above 18 years.
* NAFLD group - patients with histological proven NAFLD, male and female, above 18 years.

Exclusion Criteria:

* Controls

  * those who will be found to have fatty liver in abdominal ultra sound
  * any participant who will take antibiotics for any indication for more than 1 week during the study period or before recruitment to the study
  * any participant who had lost more than 10% of baseline body weight during the study period.
* NAFLD group

  * those who will be found to have any concomitant liver disease (i.e., HBV/HCV/HIV/EBV/CMV infection
  * autoimmune hepatitis
  * metabolic liver disease: Wilson's disease, cholestatic liver disease: PBC/PSC, etc.)
  * any participant who will take antibiotics for any indication for more than 1 week during the study period or before recruitment to the study
  * any participant who had lost more than 10% of baseline body weight during the study period
Combining MRI Steatosis Assessment and Transient Elastography to Improve Liver Fibrosis Diagnosis in Non Alcoholic Fatty Liver Disease

The main objective is to compare the accuracy of transient elastography taking into account liver steatosis determined by MRI, to liver biopsy for the diagnosis of liver fibrosis ≥F2 in patient with NAFLD.

No alcoholic fatty liver disease (NAFLD) is induced by an abnormal build up of fat in the liver. It can induce liver damage, namely fibrosis, which leads to cirrhosis and an increased risk of liver cancer. The diagnosis of liver fibrosis is thus critical to identify patients at risk.

Liver biopsy is the gold standard for the diagnosis of liver fibrosis. However this invasive test is expensive and has a significant morbidity.

To avoid this others non invasive test have been developed to assess steatosis and fibrosis of the liver :

* Magnetic Resonance Imaging can quantify liver steatosis accurately.
* Transient elastography (Fibroscan®) is approved for the diagnosis of fibrosis in chronic hepatitis C. However results in NAFLD were disappointing. Further, steatosis by heightening liver elasticity is thought to be the cause of these poor results.
* Several biological tests or score are also approved in chronic hepatitis C, but not in NAFLD.

The hypothesis driving this study is that by accounting for liver steatosis through the mean of MRI, we could more accurately interpret transient elastography value to accurately diagnose the severity of liver fibrosis.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years old
* For which a liver biopsy is indicated for NAFLD according to current guidelines
* Presenting with at least one of the metabolic syndrome criteria:

  * BMI \> 25 kg/m² and/or Waist circumference ≥ à 94cm for men / ≥ à 80cm for women
  * Fasting glucose \> or = to 5,6 mmol/L or diabetes / or lowering glucose treatment
  * Blood pressure ≥ 130/85 mmHg / or treatment
  * Triglycerides ≥ than 1,7 mmol/L
  * HDL-C ≤ than 1 mmol/L (men), ≤ 1,3 mmol/L (women) /or lipid lowering treatment
* Affiliated to medical care insurance
* Having signed informed consent for participating in the study

Exclusion Criteria:

* Associated other chronic liver disease : infectious, auto immune, genetic
* Alcohol consumption higher than 21 standard unit per week for men, or 14 standard unit for women;
* Steatosis inducing treatment: steroids, amiodarone, methotrexate, tamoxifen
* History of bariatric surgery
* Contra indication to MRI (pace maker, metallic foreign body, claustrophobia)
* Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty.
DAO DEFICIENCY SCREENING AMONG PATIENTS with INSOMNIA SYMPTOMS

Insomnia is prevalent in the global population. Diamino oxidase (DAO) is an enzyme that degrades histamine. When there is not enough DAO enzyme activity in the body, histamine accumulates and it can lead to symptoms in the nervous system, among others. In this study we wanted to study the prevalence of DAO deficiency in pacients with insomnia symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years old
* With one or more symptoms of insomnia
* Explicit acceptance to participate to the study through informed consent

Exclusion Criteria:

* Insomnia symptoms that could be justified by the existance of another sleep pathology (e.g., narcolepsy)
Study of Aripiprazole in the Treatment of Patients With Acute Symptoms in Bipolar Disorder

The purpose of this study is to learn if aripiprazole is effective for the treatment of patients with acute symptoms of Bipolar disorder.


Eligibility Criteria:
Inclusion Criteria:

Patients with acute symptoms of Bipolar Disorder
Pharmacokinetics of Ceftaroline in Normal and Obese Subjects

The purpose of this study is to characterize plasma and urinary concentrations of ceftaroline following intravenous administration of a single dose of ceftaroline 600 mg in healthy subjects who are normal weight, overweight, and obese.

This study is planned to be a Phase I, open-label, single period, single-dose pharmacokinetic study conducted in 32 healthy adult male and female subjects. Adult subjects will be recruited and assigned to one of four groups based on their body mass index and total body weight. Subject will receive a single dose of ceftaroline fosamil 600 mg as a 1-hour continuous intravenous infusion. Serial blood and urine samples will be collected over the next 12 hours to determine serum and urinary pharmacokinetics of ceftaroline. Safety evaluations will be assessed throughout the study and will include physical examination, vital sign monitoring, clinical laboratory tests (serum chemistry and hematology), pregnancy testing (female subjects only), monitoring of adverse events, and recording of concomitant medications.

Eligibility Criteria:
Inclusion Criteria:

* healthy adult subjects
* nonsmokers within the last 1 year
* body mass index and total body weight within specific categories

Exclusion Criteria:

* history of significant hypersensitivity reaction or intolerance to ceftaroline or beta-lactam agents or heparin
* aspartate or alanine aminotransferase \>3 times the upper limit of normal
* estimated creatinine clearance \<60 mL/minute and serum creatinine \>1.5 mg/dL
* female subjects who are pregnant or breast feeding
* history of alcohol or substance abuse or dependence within the last 1 year
* use of prescription or nonprescription drugs within last 7 to 14 days
* participations in a clinical trials within last 30 days
* donated blood (\>500 mL) within the last 56 days
Cervical Length in Cases of Placenta Previa

This study establishes the relationship between cervical length and whether it can be used to predict haemorrhage and preterm delivery in cases of placenta previa.

Some studies have reported an association between ultrasonographic decreased cervical length and the likelihood of complications as antepartum or post-partum haemorrhage requiring an emergency caesarean section (CS) .

The safety of trans-vaginal scanning is not in doubt, and the technique now has widespread acceptance. As a consequence, the clinical presentation of placenta previa has changed and most low lying placentas are diagnosed during the second trimester anomaly scan.

The objective of this study was to establish if there is a relation between transvaginal ultrasonographic measurement of cervical length in cases of placenta previa and whether it can be used as a predictor for antepartum haemorrhage or not.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 20-45 years old
2. Single Pregnancy
3. Fetal gestational age 28 to \< 36 weeks
4. Normal amniotic fluid index (AFI)
5. Diagnosis of placenta previa by pelvic ultrasound that was confirmed when the lower placental edge overlies the internal cervical os on transvaginal ultrasound (TVS).

Exclusion Criteria:

1. Threatened preterm labor and maternal use of vaginal progesterone.
2. Preterm premature rupture of membranes;
3. Polyhydramnios;
4. Presence of cercelage and history of cervical cone biopsy which both affect cervical length.
5. Diagnosis of multiple fetal anomalies;
6. Women with other risk factors for intra-partum hemorrhage
Chemotherapy With DNA Damaging Agents In Colorectal Cancer

Chemotherapy Treatment alone with DNA damaging drugs might be as effective as chemotherapy combined with surgery in colorectal cancer (CRC) avoiding surgery complications.


Eligibility Criteria:
Inclusion Criteria:

- patients that did not underwent surgery

Exclusion Criteria:

- patients that underwent surgery
Treating Co-Occurring Substance Use and Mental Disorders Among Jail Inmates

Treatment adaptation and implementation study for adult jail inmates with co-occurring substance use disorders.

We will adapt dual-diagnosis motivational interviewing and integrated group therapy for jail inmates with co-occurring substance use and mental health disorders and to evaluate the feasibility of implementing the adapted interventions and associated research and communication protocols.

Eligibility Criteria:
Inclusion Criteria:

* (1) drug or alcohol abuse or dependence and SMI (major depressive disorder; depressive disorder not otherwise specified \[NOS\]; bipolar disorder I, II, or NOS; schizophrenia spectrum disorder; schizoaffective disorder; schizophreniform disorder; brief psychotic disorder; delusional disorder; or psychotic disorder NOS);
* (2) resident of Wake County and detained in The Jail;
* (3) \>18 years of age; (4) able to speak/read English; and (5) able to provide informed consent.

Exclusion Criteria:

-
A Study of Fluzoparib±Apatinib Versus Placebo Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on First-Line Platinum-Based Chemotherapy

This is a multicenter, randomized, blinded, 3-arm Phase 3 study to evaluate the efficacy and safety of Fluzoparib alone or with Apatinib versus Placebo, as maintenance treatment, in patients with Stage III or IV ovarian cancer. Patients must have completed first-line platinum based regimen with Complete Response (CR) or Partial Response (PR). The study contains a Safety Lead-in Phase in which the safety and tolerability of Fluzoparib+Apatinib will be assessed prior to the Phase 3 portion of the study.


Eligibility Criteria:
Inclusion Criteria:

* （phase 3）Histologically new diagnosed, advanced (FIGO Stage III or IV) high-grade serous or endometrioid ovarian cancer (including primary peritoneal and fallopian tube cancer)
* （phase 3）Complete response (CR) or partial response (PR) achieved with front-line platinum-based chemotherapy regimen as determined by investigator
* （phase 3）Ability to be randomized ≤8 weeks after last dose of platinum
* （Saftey Lead-in）Received 2\~4 prior chemotherapy regimens. Platimun sensitive relapsed; Have at least one measurable disease as defined by RECIST v1.1.

Exclusion Criteria:

* Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor or Apatinib
* Patients who have received other study drug treatment within 4 weeks prior to the first administration(\< 5 elimination half-lives of the study drug molecular targeted anti-cancer drugs).
* Patients with clinical symptoms of cancer ascites, pleural effusion, who need to drainage, or who have undergone ascites drainage within 2 months prior to the first administration.
Immediate Loading Of Dental Implants: A Pilot Clinical Study

Objective: To provide 2-year clinical- and patient-oriented data with regard to mandibular overdenture assisted by 2 immediately loaded unsplinted implants.

In this pre-post design, Phase-I clinical trial, 18 edentate individuals received a new set of complete denture. Then, following standard procedures, 3 threaded implants (OsseoSpeed TXTM, Dentsply Implants, Mölndal, Sweden) were placed in the mandible in each patient, and locator abutments (Zest Anchors LLC, Escondido, U.S.A.) were inserted on the right and left side implants. The midline implant served as a control for within-patient comparison. The immediate loading was conducted within 24 h of surgery. Data were collected at baseline (T0), 12 (T1) and 24 (T2) months after immediate loading. The clinical outcomes included implant survival rate, crestal bone level changes and implant stability. These criteria were assessed through clinical and radiographic examinations as well as resonance frequency analysis. Patient-centered outcomes included patient satisfaction and oral health-related quality of life measured using validated questionnaires. Brunner-Langer approach was used for statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Minimal age of 18 years
* Complete edentulism for more than 1 year
* Wear of total conventional prosthesis for more than 1 year
* Bone morphology in the anterior mandibular region amendable for the placement of 3 regular diameter implants without any additional procedure (graft or membrane).

Exclusion Criteria:

* Any absolute or relative contra-indication to implant therapy
* Physical incapacity to render oral or prosthetic hygiene
* Incapacity to obtain a free and informed consent
* Incapacity to assist to planned follow up appointments
* Incapacity to understand and complete questionnaires

Exclusion Criteria to Immediate Loading Protocol Found on One or Both of Un-splinted Implants During Surgery:

* Inadequate bone quality: IT\<35 Ncm
* Inadequate primary stability: ISQ\<60
Assessing the Time-Course of Dexmedetomidine-Induced Analgesia Via EEG

Objective: To investigate the temporal dynamics of dexmedetomidine's analgesic effects in the brain using EEG.

Methods: Eligible patients scheduled for total hip arthroplasty under intrathecal anesthesia received a continuous infusion of DEX at 1.5 μg/(kg·h) for 15 minutes before neuraxial puncture, followed by an additional 15-minute infusion. The study was divided into three phases:

Phase 1: Non-dosing phase (Baseline). Phase 2: DEX preemptive analgesia phase (DEX infusion). Phase 3: DEX cessation phase (Post-infusion).

Outcomes:

Primary safety outcome: EEG spectral analysis at different phases. Secondary outcomes: NRS scores, postoperative nausea and vomiting (PONV), dizziness, agitation, and time to intestinal exhaust within 48 hours. Intraoperative hemodynamics were also monitored.

Objective: To investigate the temporal dynamics of dexmedetomidine's analgesic effects in the brain using EEG.

Methods: Eligible patients scheduled for total hip arthroplasty under intrathecal anesthesia received a continuous infusion of DEX at 1.5 μg/(kg·h) for 15 minutes before neuraxial puncture, followed by an additional 15-minute infusion. The study was divided into three phases:

Phase 1: Non-dosing phase (Baseline). Phase 2: DEX preemptive analgesia phase (DEX infusion). Phase 3: DEX cessation phase (Post-infusion).

Outcomes:

Primary safety outcome: EEG spectral analysis at different phases. Secondary outcomes: NRS scores, postoperative nausea and vomiting (PONV), dizziness, agitation, and time to intestinal exhaust within 48 hours. Intraoperative hemodynamic monitoring was performed.

EEG/ERP monitoring: The 64-site EEG and ERP were recorded at different phases

Eligibility Criteria:
Inclusion Criteria:

Patients with hip osteoarthritis scheduled for total hip arthroplasty under intrathecal anesthesia; Age 18-70 years; American Society of Anesthesiologists (ASA) physical status classification I-III; Body mass index (BMI) 22-30 kg/m².

Exclusion Criteria:

Pre-existing peripheral or central nervous system disorders; Mental disorders; Cognitive impairment; Emergency surgery; or Hearing impairment.