cyrilzakka/clinical-trials huggingface dataset:
Brief Internet Intervention for Hazardous Alcohol Use to People Seeking Online Help for Depression

Hazardous alcohol consumption is common among people suffering from depression. There are effective Internet interventions that target hazardous alcohol consumption or depression separately but none that combine these online interventions without the involvement of a therapist. This study aims to evaluate the effects of combining an Internet intervention targeting hazardous alcohol consumption with one for depression on drinking and depressive symptoms.

A double-blinded, parallel group randomized controlled trial will be used. Participants with current depression who also drink in a hazardous fashion (N=986) will be recruited for a study to 'help improve an online intervention for depression.' Participants will be assigned, by chance, to receive MoodGYM or to receive MoodGYM plus a brief Internet intervention for hazardous alcohol consumption - Check Your Drinking (CYD). Participants will be contacted 3- and 6-months after receiving the interventions to assess changes in drinking and depression status. It is predicted that participants receiving the CYD intervention in addition to MoodGYM will reduce their alcohol consumption to a greater extent than those who just received MoodGYM. Further predictions include the impact of receiving Check Your Drinking on improvements in depressive symptoms.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or over
* score 10 or more on the Patient Health Questionnaire (PHQ-9)
* score 8 or more on the Alcohol Use Disorder Identification Test (AUDIT)

Exclusion Criteria:

* current suicidal ideation on the PHQ-9
A Bioequivalence Study of Pegylated Interferon Alfa-2a (PEG-IFN Alfa-2a) Benzyl Alcohol (BA)-Free Formulation Versus PEG-IFN Alfa-2a (Pegasys) Following Subcutaneous Administration

This is an open-label, randomized, multi-center, single dose, two-period, two-sequence crossover study to investigate the bioequivalence of PEG-IFN alfa-2a BA-free formulation versus the reference market formulation (PEG-IFN alfa-2a \[Pegasys®\]) following subcutaneous administration via prefilled syringe in healthy Chinese participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female and male Chinese participants
* Body mass index between 19 and 28 kilograms per square meter (kg/m\^2), inclusive
* Participants determined as healthy by their medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory measurements performed at the Screening visit
* Female participants of childbearing potential: willing to use highly effective methods of contraception throughout the study and for 90 days after the last dosing
* Male participants: agreement to remain abstinent or use spermicide and barrier method contraception throughout the study and for 90 days after the last dosing
* Able to participate and willing to give written informed consent and to comply with the study restrictions

Exclusion Criteria:

* Any clinically relevant condition or history of cardiovascular, psychiatric, gastrointestinal, respiratory, renal, hepatic, hematological, lymphatic, neurological (including seizure history), musculoskeletal, genitourinary, immunological, metabolic, malignant, or dermatological disorder
* Participants who are positive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti HCV) or human immunodeficiency virus I and II antibody (anti-HIV I, anti-HIV II) tests at Screening
* Participants with alanine aminotransferase (ALT) above the upper limit of normal at Screening or on Day -1 of Period 1
* Any other condition or disease (other than those already stated) which, in the judgment of the Investigator, would place the participant at undue risk, interfere with the absorption, distribution, metabolism, and excretion of PEG-IFN alfa-2a, or interfere with the ability of the participant to complete the study
* History of drug or alcohol abuse within the last year before screening
* Treatment with interferon or PEG-IFN alfa-2a within 3 months prior to the first dosing
* Female participants who are pregnant, currently lactating, or have a positive serum pregnancy test at screening or have a positive urine pregnancy test on Day -1 of Period 1
* Use of any prescribed or over the counter medication or herbal medicine taken within 14 days prior to the first dosing or within 5 times the elimination half-life of the medication prior to the first dosing (whichever is longer). Exceptions are paracetamol, the contraceptive pill, hormone replacement therapy and commonly used vitamin supplements, which are permitted
* Regular smoking with consumption of more than 10 cigarettes per day or an equivalent amount of tobacco
* Participation in an investigational drug or device study within 3 months prior to the first dosing
Aripiprazole Augmentation of Antidepressants in PTSD

The proposed investigation will determine the therapeutic potential of aripiprazole augmentation to a stable antidepressant regimen for reducing posttraumatic stress disorder (PTSD) symptoms, cognitive symptoms, psychotic symptoms, and depressive symptoms in veterans with PTSD.


Eligibility Criteria:
Inclusion Criteria:

* Outpatient veterans with posttraumatic stress disorder (PTSD)
* Receiving treatment with an antidepressant at a stable dose for 4 weeks
* Male or female
* Ages 18-65 years old
Study for Subjects With Chronic Kidney Disease(CKD) Not Receiving Dialysis

The proposed study is designed to test a novel dosing paradigm that would facilitate the treatment of anemia in CKD patients not on dialysis. Anemic patients who are not currently receiving ESA therapy will be dosed with darbepoetin alfa Q2W for 18 weeks.


Eligibility Criteria:
Inclusion Criteria: - Diagnosis of CKD and not expected to initiate dialysis for the duration of the study - Estimated glomerular filtration rate (eGFR): greater than or equal to 15 mL/min and less than or equal to 60 mL/min measured by the following modified MDRD (Modification of Diet in Renal Disease) equation: eGFR = 186 x \[serum creatinine\]-1.154 x \[Age\]-0.203 x \[0.742 if subject is female\] x \[1.212 if subject is black\] - Clinically stable, in the judgment of the investigator - Mean Hb greater than or equal to 11.0 g/dL to less than or equal to 13.0 g/dL (mean of 2 values drawn at least 3 days apart during the screening period) - Transferrin saturation (Tsat) greater than or equal to 15.0% - Serum vitamin B12 and folate levels above the lower limit of the normal range - Receiving stable Q2W subcutaneous (SC) doses of Aranesp® (darbepoetin alfa). A stable dose is defined as less than or equal to a 25% change in dose over the 6-week period immediately prior to enrollment and with no missed doses in this period Exclusion Criteria: - Prior recipient or scheduled to receive a kidney transplant - Diastolic blood pressure (BP) greater than 110 mm Hg or systolic BP greater than 180 mm Hg during screening - Acute myocardial ischemia - Hospitalization for congestive heart failure or myocardial infarction within 12 weeks before enrollment - Parathyroid hormone level greater than 1500 pg/mL - Major surgery within 12 weeks before enrollment (excluding vascular access surgery) - Currently receiving antibiotic therapy for systemic infection - Known positive HIV antibody or positive hepatitis B surface antigen - Clinical evidence of current malignancy and/or receiving systemic chemotherapy/radiotherapy with the exception of basal cell or squamous cell carcinoma of the skin and cervical intraepithelial neoplasia - Red blood cell (RBC) transfusions within 8 weeks before enrollment - Androgen therapy within 8 weeks before enrollment - Systemic hematologic disease (e.g., sickle cell anemia, myelodysplastic syndromes, hematologic malignancy, myeloma, hemolytic anemia) - Any disorder that may impact (in the judgment of the investigator) the ability to give informed consent for participation in this study - Pregnant or breast-feeding women - All subjects must practice adequate contraception (in the judgment of the investigator) throughout this trial - Treatment with an investigational agent or device within 30 days before enrollment or scheduled to receive an investigational agent other than those specified by this protocol during the course of this study
Physical Inactivity and Appetite Regulation

The goal of this parallel-group, two-arm, assessor-blinded, randomised clinical trial is to investigate the effects of reducing physical activity on food intake and satiety in physically active and healthy males, 40-55 years of age.

The main questions it aims to answer are:

* Does physical inactivity affect GLP-1 stimulated food intake?
* Does physical inactivity affect food preferences, satiety and other mechanisms supporting appetite regulation?

Participants will be randomised (1:1) to two weeks of either no intervention (control group) or inactivity. Inactivity will be implemented as cessation of active commuting and all other structured exercise. Furthermore, steps will be reduced to a maximum of 1500 steps/day.

Researchers will compare the inactivity group to the control group to see if physical inactivity impairs appetite regulation.


Eligibility Criteria:
Inclusion Criteria:

1. Male
2. Age ≥ 40 years and ≤ 55 years
3. Body mass index (BMI) \> 20 and \< 25 kg/m2
4. Physical activity level should as a minimum include: Active commuting by biking a minimum of 10 km, four days per week or an equivalent amount of other physical activity four days per week.
5. Healthy (based on self-reporting, pre-study medical examination and biochemical screening)
6. Can adhere to two weeks of inactivity (refrain from running, cycling and all other exercise while reducing steps to max. 1500 pr. day)
7. Caucasian
8. No change in body weight \> 5 kg within the last 6 months
9. Eats breakfast and lunch daily
10. Does not follow specific dietary restrictions
11. No disliking of spaghetti bolognese
12. No diagnosis of psychiatric disorder or treatment with anti-depressant or anti-psychotic medication
13. No history of suicidal behavior or ideations.
14. No previous surgical treatment for obesity
15. No cardiovascular disease
16. No rheumatologic disease
17. No metabolic/endocrine disease
18. No liver disease (ASAT or ALAT \>2x upper normal range)
19. No other chronic disease
20. No elite sports
21. No frequent or chronic use of medications affecting bodyweight, physical performance, or inflammation (NSAIDS, DMARDS, corticosteroids)
22. No current infection
23. No history of cancer
24. No anemia (hematocrit \<33%)
25. No smoking
26. No participation in other research intervention studies

Exclusion Criteria:

1. Clinical or biochemical signs of disease
2. HbA1c \> 39 mmol/mol
3. Unable to allocate the needed time to fulfill the intervention
4. Language barrier, mental incapacity, unwillingness, or inability to understand and be able to complete the interventions
Dysferlinopathy Protein in Peripheral Blood Monocytes.

The objective of the study is to answer the following important questions. Deficiency of the dysferlin protein is the cause of a very rare limb-girdle muscular dystrophy (LGMD-2B) that leads to significant disability. This disease is caused by mutations in the dysferlin gene. It is a recessive inherited disease, meaning that both copies of the gene must have mutations for the disease to develop. This study aims to analyze the frequency of carriers of a mutation in the DYSF gene in the Caucasian population. To achieve this, The investigator analyzed the blood of 100 healthy volunteers from their local area, quantifying the dysferlin protein in peripheral blood monocytes.


Eligibility Criteria:
Inclusion Criteria:

* Individuals diagnosed with dysferlinopathies.
* Carriers of a single mutation in the DYSF gene.
* Participants who are willing to undergo treatment with oral vitamin D3.
* Subjects who can provide informed consent for participation in the study.
* Controls and carriers willing to participate in in vitro studies using HL60 cells, monocytes, and myotubes.

Exclusion Criteria:

* Individuals with conditions or medications that could interfere with the study outcomes of dysferlin expression.
* Participants who are unwilling or unable to adhere to the study protocol for the duration of the study period.
* Pregnant or breastfeeding women.
* Individuals with known allergies or adverse reactions to vitamin D3 supplements.
* Subjects with severe concurrent illnesses that may impact the study's objectives or their ability to participate effectively.
BAFF/APRIL in Kidney Transplant Rejection Risk Assessment

Antibody-mediated rejection (AMR) is a significant risk factor for graft loss in kidney transplantation. Soluble B cell-activating factor (sBAFF) and a proliferation-inducing ligand (APRIL) plays a critical role in the activation and differentiation of B cells, making it a potential predictive biomarker for AMR. In this prospective multicenter cohort study, the effectiveness of sBAFF/APRIL in predicting AMR after kidney transplantation is evaluated. Recipient sBAFF/APRIL levels are monitored before transplantation, and at seven days, two weeks, one month, three months, and every three months after transplantation continuously . The primary outcome is the occurrence of AMR, while the status of donor-specific antibodies (DSA), T cell-mediated rejection (TCMR), and other clinical parameters are secondary outcomes. The predictive capacity of sBAFF/APRIL for both the primary and secondary outcomes will be investigated.


Eligibility Criteria:
Inclusion Criteria:

1. Living donor or deceased donor kidney recipients.
2. Patient is willing and capable of giving written informed consent for participation and able to participate in the study for 24 months.

Exclusion Criteria:

1. Preoperative donor specific antibody positive .
2. Combined or multi-organ transplantation.
3. Poor compliance.
4. Unable to continue the follow-up.
5. Patients who are judged by the doctors to be excluded for this trial (Details need to be provided).
Impact of Slowly Digestible Carbohydrates on the Gut-brain Axis

Our laboratory is investigating the physiological outcomes and health benefits of the consumption of high-quality carbohydrates. One important aspect of the high-quality carbohydrate characteristics is a slow and sustained digestion and glucose release to the blood. In the proposed study, the investigators will evaluate the consumption of different types of slowly digestible carbohydrates (SDCs) and their beneficial effects including moderation of the glycemic response profile (postprandial glycemic response, PPGR) and stimulation of the gut-brain axis, which controls appetite and food intake. This stimulation will be evaluated in terms of second-meal food intake and the circulatory level of appetite-suppressing gut hormones (such as glucagon-like peptide-1).


Eligibility Criteria:
Inclusion Criteria:

* BMI 18.5 - 25 kg/m2
* Stable weight for the past 3 months (i.e. +/- 2..5 kg)

Exclusion Criteria:

* Pregnant or nursing women
* Diabetic
* Individuals with history of gastrointestinal disease
Safety and Equivalence of a Terconazole Vaginal Suppository (Test Product) Compared to the Reference Terconazole Vaginal Suppository in the Treatment of Vulvovaginal Candidiasis

The objectives of this study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppositories, 80 mg(Test Product) and Terconazole Vaginal Suppositories, 80 mg(Reference Product) in the treatment of subjects with vulvovaginal candidiasis in order to establish bioequivalence.


Eligibility Criteria:
Inclusion Criteria:

* Female at least 18 years of age
* Presented with symptomatic vulvovaginitis consistent with a diagnosis of moniliasis
* Willing and able to read and sign an IRB approved ICF, which included agreement to comply with all study requirements as indicated in the protocol.

Exclusion Criteria:

* History of hypersensitivity or allergy to imidazoles
* Female who was pregnant or lactating
* Was menstruating or expected the onset of menses during the treatment days
* Had evidence of any bacterial, viral or protozoal infection
* Had a history of alcoholism, drug abuse, or problems that would likely have made the subject unreliable for the study
* Had any condition or used any medication that, in the opinion of the Investigator, might have interfered with the conduct or results of the study or placed the prospective subject at increased risk
* Had participated in any investigational study within 30 days prior to study enrollment
Resuscitation Registry - Surrogate Markers of Outcome After Cardiac Arrest

The aim of the study is to determine surrogate markers for prognostication of unfavorable outcome (death or persistent vegetative state) in cardiopulmonary arrest survivors. These patients are comatose. Conscious patients are unsuitable for prognostication.

The aim of the study is to determine surrogate markers for prognostication of unfavorable outcome (death or persistent vegetative state) in cardiopulmonary arrest survivors. These patients are comatose. Conscious patients are unsuitable for prognostication.

This will be a prospective mono-center survey (Department of Intensive Care Medicine, University Hospital Bern), evaluating the survival and neurological outcome after cardiac arrest. The study will be performed in cooperation with the Department of Neurology and Neuroradiology, University Hospital Bern.

Inclusion: all patients surviving resuscitation after cardiac arrest older than 18 years. Detailed medical and neurological examination including 6-lead continuous EEG, 10/20 EEG and somatosensory evoked potentials, standard blood tests including Neuron-specific Enolase (NSE) and cerebral MRI will be assessed during the first 72 hours after cardiac arrest. Structured telephone interviews to determine outcome parameters (Cerebral Performance Category CPC, modified Ranking Scale mRS) will take place at day 30, after 3 and 12 month.

The results of the registry could identify early comatose patients after cardiac arrest with no chance of a good neurological recovery and regain consciousness to avoid unjustified expectations of relatives and prolonged life-sustaining therapies. A good neurological recovery is defined as a CPC of 1 and 2 or a mRS 0-2. An unfavourable neurological outcome will be defined as persistent vegetative state and death (CPC 4 and 5, mRS 5-6).

Eligibility Criteria:
Inclusion Criteria:

* Age at least 18 years
* Down time ≤ 20 minutes (down time = time breakdown to start of professional resuscitation)
* Persistent stable circulation without further need of CPR
* Glasgow Coma Scale \< 8 after return of spontaneous circulation

Exclusion Criteria:

* Cardiac arrest due to neurological causes (stroke, intracerebral hemorrhage, subarachnoid hemorrhage, SUDEP - sudden unexpected death in epilepsy)
* Cardiac arrest due to unobserved asystole
Elastic Band Resistance Exercise on Glycated Haemoglobin and Muscle Strength, Balance, and Physical Function in Patients With Comorbid Type 2 Diabetes Mellitus and Knee Osteoarthritis

Whether elastic band resistance exercise (EBRE) as a home-based rehabilitation routine can control the glycated heamoglobin (HbA1c) level and improve the muscle strength, dynamic balance, and physical function in older patients with comorbid T2DM and knee OA?

Design: Randomised controlled trial. Participants: Seventy patients diagnosed with T2DM together with knee OA. Intervention: Patients in the experimental and control group were instructed by clinical staff to perform home-based exercises and followed up through phone calls. The experimental group performed exercises using an elastic resistance band with 10 repetitions/set × 5 sets/day × 3 days/week. The control group underwent active joint range-of-motion exercises and isometric contraction exercises. The intervention regimens lasted 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for this study were as follows: age between 60 and 70 years; comorbid T2DM and knee OA diagnosed by a physician; and Kellgren and Lawrence (K\&L) grade \<3 based on the findings of plain radiographs.

Exclusion Criteria:

* Exclusion criteria were as follows: inability to perform any self-activity; DM with complications, such as lower extremity neuropathy, retinopathy, stroke, foot wounds, or amputations; K\&L grade \>3, hip or knee arthroplasty; history of myocardial infarction; uncontrolled liver and kidney disease; and uncontrolled hypertension.
Study of Biotene OralBalance Gel for Oral Care in Critically-Ill Mechanically Ventilated Neonates

The goal of this pilot study is to test the hypothesis that mechanically ventilated infants receiving Biotene OralBalance® gel for oral care would have a reduced intubation time compared to infants receiving oral care placebo. This study is also performed to test the feasibility as well the safety of Biotene OralBalance® gel.

Prolonged mechanical ventilation is a known risk factor strongly associated with ventilator-associated pneumonia (VAP). As the fatality rates for VAP are high, prevention of VAP has focused on the use of "VAP bundles". Oral decontamination, by reducing the microbial burden within a patient's oral cavity, is an essential part of VAP bundle strategy for reducing VAP rates in mechanically ventilated adults and older children. However there are no published studies of oral care products for VAP prevention in mechanically ventilated neonates. Biotene OralBalance® gel contains antibacterial active ingredients, including lactoperoxidase, lysozyme and lactoferrin,all enzymes with bacteriostatic or bactericidal activity on selective oral microflora. We hypothesize that by directly reducing the oral microbial burden, we indirectly reduce the number of VAP. This will be reflected in the reduced time on mechanical ventilation in the group of infants receiving Biotene OralBalance® gel.

This is a prospective, randomized, unmasked, controlled trial with 40 mechanically ventilated infants recruited from level IV nursery at Forsyth Medical Center, Winston-Salem, NC. The participants will be randomized to two equal groups, stratified by gestational age categories: \<28 weeks, and \>=28 weeks as well as multiple births. Twenty infants will receive Biotene OralBalance® gel (Intervention Group) and 20 infants will receive swabs with sterile water (Control Group) for timed oral care. Both study groups will receive the NICU standard ventilator-associated pneumonia (VAP) bundle, a combination of strategies aimed to reduce the rate of VAP.

Eligibility Criteria:
Inclusion Criteria:

* Neonates who are mechanically ventilated between 7 and 10 days old. Signed parental informed consent is required for recruitment into the study.

Exclusion Criteria:

* Neonates with chromosomal anomalies or major congenital anomalies, neonates with terminal conditions, neonates for whom a decision has been made not to provide full medical support, neonates whose parents refused or are unable to provide consent, and/or attending physician refusal.
To Compare the Strategies of Universal Antibiotic Prophylaxis Versus Screen-and-treat in Reducing Infective Complications and Re-infection in Women Who Undergo Termination of Pregnancy

Screen-and-treat approach reduces postabortal pelvic inflammatory disease after induced abortion, and at the same time alters women's sexual behavior and prevents further re-infection by sexually transmitted infections when compared to the universal antibiotic prophylaxis strategy.

While universal antibiotic prophylaxis during induced abortion has been proven to reduce postabortal pelvic inflammatory diseases, screen-and-treat approach has the potential benefit of altering women's sexual behavior and preventing further re-infection by sexually transmitted infections. We conducted a randomized controlled trial to compare the effect of the two approaches in preventing postabortal pelvic inflammatory disease and the women's sexual behavior.

Eligibility Criteria:
Inclusion Criteria:

* women requesting for induced abortion in the gynecology clinic

Exclusion Criteria:

* nil