cyrilzakka/clinical-trials huggingface dataset:
Effects of Hydration to Prevent Contrast Induced Nephropathy in PCI for ST-elevation Myocardial Infarction.

The aim of the study is to test the efficacy of low versus high volume hydration and two different solutions (sodium chloride versus sodium bicarbonate) in preventing contrast induced nephropathy (CIN) in ST elevation myocardial infarction (STEMI) patients undergoing primary PCI.

Contrast-induced nephropathy (CIN) is associated with increased morbidity and mortality after percutaneous coronary interventions (PCI). Patients with ST elevation myocardial infarction (STEMI) are at high risk for CIN because of hemodynamic instability of the patient, inability to prevent the phenomenon (hydration) and the possible exposure to high volume of contrast media. Recent reports have shown incidence of CIN up to 19% in this population and a related increase of in-hospital mortality.

Merten e coll. (JAMA 2004) reported that sodium bicarbonate infusion before and after contrast exposure in patients with chronic renal failure and without myocardial infarction (AMI) is more effective than sodium chloride in preventing CIN.

Up to date there is no evidence of any effective prophylactic measures in patients with STEMI undergoing primary PCI.

The aim of the study is to test the efficacy of low versus high volume hydration and the efficacy of two different solutions (sodium chloride versus sodium bicarbonate) in preventing CIN in STEMI patients undergoing primary PCI.

The infusion of the randomized solution will start just after randomization and after determination of baseline serum creatinine.

Determination of serum creatinine will be repeated at 24, 48 and 72 hours after randomization. Creatinine clearance will be calculated with Cockroft-Gault formula and MDRD.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years of years
* Chest pain lasting at least 30 minutes, non responsive to nitrates, associated to ST elevation of at least 0.2 mV on surface ECG in two or more contiguous leads or to new left bundle branch block.
* Informed consent

Exclusion Criteria:

* Chronic hemodialytic or peritoneal treatment
* Coronary anatomy unsuitable for PCI
* Need of emergency coronary artery by-pass grafting
* Post-anoxic coma
* Pregnancy
A Study Comparing Exenatide With Basal Insulin in Achieving a Target HbA1c With Minimum Weight Gain in Type 2 Diabetes Patients

This is a phase 3 trial designed to compare the effects of twice daily exenatide plus oral antidiabetic agents (OADs) and once-daily insulin glargine plus OADs with respect to glycemic control, as measured by hemoglobin A1c, with minimum weight gain, in patients with uncontrolled type 2 diabetes on OADs.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes
* Currently being treated with the following: Dual or triple oral therapy - on a stable combination and dose for at least 3 months.
* HbA1c between 7.5% and 10.0%.
* BMI \>27.

Exclusion Criteria:

* Receive chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to study.
* Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which a medical or surgical treatment was given) within 30 days prior to entry into the study.
* Treatment with the following medications: \*Insulin as outpatient therapy within last 3 months; \*Meglitinides, or acarbose within the last 3 months; \*Regular use of any drugs that directly affect gastrointestinal motility; \*Any previous (study) therapy with exenatide or glucagon-like peptide-1 (GLP-1) analogue; \*Anti-obesity agent use within the last 3 months.
* Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
Online Cognitive Behavioral Intervention Program for Hong Kong University Students

Brief summary:

The objective of this study is to develop an internet-based cognitive behavioral intervention program (including an online platform and a smartphone application) for Chinese university students in Hong Kong, and examine its effectiveness in reducing psychological distress, anxiety/depression symptoms, and improving emotions and automatic thoughts. The 3-month maintenance effect will also be tested.

Previous research has provided evidence for the effectiveness of internet-based cognitive behavioral intervention in improving mental health, but most studies were done in Western countries. This study is intended to design a culturally appropriate online program especially for Chinese university students in Hong Kong. The program will include 8 weekly sessions and one face-to-face session and one telephone follow-up with a with certified CBT therapist. The effects on psychological distress, anxiety/depression, emotions, and automatic thoughts will be tested.

Eligibility Criteria:
Inclusion Criteria:

* Chinese nationality
* Has mild to moderate level of psychological distress
* Receive no face-to-face counselling since program commencement

Exclusion Criteria:

* Has low/high level of psychological distress
* Has one or more psychosis
* Has suicidal risk in the past 3 months
Use of Virtual Reality in the Treatment of Flying Phobia

The project aims to explore the potential of Virtual Reality Exposure Therapy (VRET) for the treatment of the fear of driving, the fear of flying and the fear of public speaking.

The study is a randomized controlled trial (RCT) designed to compare the efficiency of cognitive behavioural therapy with exposures in imagination to behavioural therapy with exposures in virtual reality. Anxiety levels are measured using specific questionnaires, SUD ratings and physiological measures (heart rate, skin conductance, skin temperature, breathing frequency, heart rate variability).

Hypothesis: Treatments with exposures in virtual reality are more efficient than treatments with exposures in imagination.

In the past, several studies have demonstrated the effectiveness of virtual reality exposure therapy in the treatment of flying phobia and driving phobia. As an objective tool, psychophysiological recordings help demonstrate the decrease of physiological aspects of anxiety reactions (heart rate, skin conductance, skin temperature, heart rate variability and breathing pattern).

The aim of the present study is to examine the effects of cognitive behavioural therapy with exposures in imagination to behavioural therapy with exposures in virtual reality in the treatment of patients with flying phobia. Thirty patients will be randomized into either an imagination exposure group or a virtual reality exposure group after having received four sessions of cognitive behavioural therapy for coping with panic attacks. Respective exposure therapies consist in four sessions.

Anxiety levels will be measured before and after the cognitive behavioural therapy for coping with panic attacks as well as before and after the exposure therapy sessions and after 3 months using specific questionnaires, SUD ratings and psychophysiological measures (heart rate, skin conductance, skin temperature, breathing frequency and heart rate variability). The exposure stimuli will consist in a 10min movie of a flight with an insight-cabin viewing perspective.

The investigators hypothesize that virtual reality exposure therapies will be more effective than imagination exposure therapy in terms of decrease of anxiety self-ratings and psychophysiological fear reactions.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of a specific phobia (DSM-IV-TR)

Exclusion Criteria:

* Pregnant women
* Subjects with severe pulmonary / cardiovascular problems; Asthma, epilepsy, vertigo
* Drug abuse
* Subjects under on-stabilized anti-depressant treatment
* Psychotic subjects
* Subjects with suicidal ideas
* Subjects presenting insufficient intellectual capabilities
A Study of Evolocumab on Carotid Artery Atherosclerotic Plaque Morphology Prior to Carotid EndArterectomy

This is a multicenter, randomized, open label study with blinded outcome assessment to evaluate the impact of additional/intensive LDL-cholesterol reduction with evolocumab on carotid artery atherosclerotic plaques in higher risk subjects with severe asymptomatic but vulnerable plaques.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 40 years old
2. Significant (70-99%) carotid artery stenosis on one side, as measured by duplex ultrasound or angiogram
3. Asymptomatic carotid stenosis (no history of ipsilateral stroke or TIA within 180 days)
4. Deemed to be fit for carotid endarterectomy
5. At least one of the following high-risk features: (a) prior stroke \>6months prior to randomization; (b) peripheral artery disease; (c) current smoker; (d) type 2 diabetes; (e) eGFR ≥ 30 mL/min/1.73m2 and \<60 ml/min/1.73m2; (f) hsCRP \> 2mg/L in the absence of alternative known causes of hsCRP elevations including autoimmune diseases or active infections.
6. On a moderate to high intensity statin therapy (defined as atorvastatin 40-80mg daily, rosuvastatin 20-40mg or simvastatin 40mg daily) unless a lower dose, or another statin or non-statin therapy is clinically justified

Exclusion Criteria:

1. Contraindications for MRI (pacemaker; neurostimulator; non-removable metal fragments in the eye; etc.)
2. Patients in whom additional lowering of LDL-C with evolocumab is deemed to be clinically inappropriate
3. Currently taking simvastatin \>40mg/day
4. High risk comorbidities such as severe heart failure, severe COPD, severe renal disease, known severe hepatic impairment, unstable coronary syndrome, and/or advanced dementia
5. eGFR \<30 mL/min/1.73m2
6. Current, prior within past year, or known planned use of PCSK9 inhibition treatment
7. Known intolerance or allergy to evolocumab or other PCSK9 inhibitors
8. Known latex allergy
9. Women who are pregnant or breastfeeding
10. Women of child bearing potential who are unwilling to use proper family planning or birth control methods to avoid pregnancy. Women are considered post-menopausal and not of childbearing potential after 12 months of natural (spontaneous) amenorrhea or have had a surgical procedure such as hysterectomy which makes pregnancy impossible
11. Inability to comply with protocol-required study visits or procedures, including administration of study drug
12. Severe concomitant disease that is expected to reduce life expectancy to less than 5 years
13. Participation in another investigational device or drug study which is likely to affect the primary outcome, within 30 days of planned initiation of study drug

Additional Inclusion Criteria

If all eligibility criteria listed above are met, participants with only one high risk feature will undergo a time-of-flight MR angiogram, where one additional inclusion criteria will be assessed to confirm eligibility:

1. Evidence of IPH on MRI
Bioequivalence and Safety Study of Bevacizumab-biosimilar (RPH-001) Compared to Bevacizumab-innovator

The purpose of this to assess pharmacokinetic bioequivalence between two bevacizumab products, RPH-001 (TRPHARM) and EU sourced Avastin® (Roche), after single IV administration at 5 mg/kg fixed dose.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects aged 18 to 55 years inclusive.
* Adult healthy male subjects between 18.0 and 30.0 kg/m2 body mass index (inclusive) and body weight ≥ 60 kg and ≤ 100 kg (inclusive).

Exclusion Criteria:

* Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.
* Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab).
* Positive result on urine drug screen (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
* Positive alcohol test at screening or baseline visits
Perineural Versus Systemic Dexamethasone to Prolong Regional Anesthesia in Front Foot Surgery

Both perineural and systemic dexamethasone administration allows an increase in analgesic duration of regional anesthesia.

There is a lack of data to determine wich route allows a longer analgesic effect.

This study aims to determine wether perineural dexamethasone allows a longer analgesic duration than systemic route in combination with regional anesthesia (Ropivacaine 0.375%) for front foot surgery.

This is a prospective, randomized, double-blind controlled trial.

All Patients undergoing front foot surgery with metacarpal osteotomy will be screened for inclusion in the protocol. All patients without exclusion criteria will be included in the study.

All patients will receive 30cc mixure of Ropivacaine 0,375% in perineural injection and surgery will be performed under regional anesthesia only. If needed, a sedation with midazolam (1mg) will be performed.

The patients will be randomized over 2 groups:

* "Perineural group":

  * 1cc (4mg) of dexamethasone will be administrated in perineural injection
  * 2.5cc of isotonic saline solution will be administrated in systemic injection
* "Systemic group":

  * 1cc of isotonic saline will be administrated in perineural injection
  * 2.5cc (10mg) of dexamethasone will be administrated in systemic injection

For both groups perineural injection will be performed at the ankle and the following nerves will be targeted: the tibial nerve, saphenous nerve, the deep fibular nerve, the superficial fibular nerve and the sural nerve.

Post-operative analgesia will be reached with paracetamol (1gr each 6 hours) and Ketoprofen (100mg each 12 hours).

After surgery, patients will be asked to write down the time to the first opioids request during the first 48 hours, maximal pain during the first 48H using a visual analog scale, occurrence of nausea or vomiting, overall satisfaction regarding pain relief management and any significant side effects during the first 7 days.

The primary objective of the study is to determine if perineural dexamethasone is associated with a longer analgesic duration than systemic route in combination with regional anesthesia (Ropivacaine 0.375%) for front foot surgery.

The primary end-point will be time to the first opioids request during the first 48 hours.

Eligibility Criteria:
Inclusion Criteria:

* front foot surgery with metacarpal osteotomy under regional anesthesia
* \>18 years old
* consent to participate in the study

Exclusion Criteria:

* refusal to participate
* pregnancy
* feeding
* pre existing neuropathy
* ropivacaine allergy
* paracetamol allergy
* liver failure
* cardiac failure
* ketoprofen allergy
* gastric ulcer within the previous year
* tramadol allergy
* history of epilepsy
Acupuncture and Post-Surgical Wound Healing

The purpose of this study is to determine if acupuncture improves wound healing. Since we, the investigators at the University of California, San Francisco (UCSF), know that how much oxygen is delivered to tissue is the best predictor of how well a wound will heal, we are measuring changes in tissue oxygen of wounds before and after acupuncture treatments. We are focusing on the leg wounds of coronary artery bypass graft (CABG) patients who have their saphenous veins harvested in an open fashion since this is a fairly well controlled patient model.

This is a prospective, randomized, controlled pilot study of the effects of acupuncture on surgical site complications in patients undergoing coronary artery bypass grafting. The past forty years of research in the UCSF Wound Healing Laboratory have solidified the following observations:

1. without adequate oxygen delivery, many processes of wound healing cannot proceed normally, particularly resistance to infection, collagen deposition, angiogenesis, and inflammation; and
2. hypoxic conditions, unfortunately, are common in chronic and acute wounds, and often result from subcutaneous vasoconstriction.

Sympathetic nervous system (SNS) activators and other vasoconstrictors have been shown to produce wound hypoxia. Activation of the SNS by any means, including pain and anxiety, causes vasoconstriction and impairs oxygen delivery. Simple means that limit SNS activity have been shown to increase perfusion and oxygen tension, and thereby facilitate wound healing. Many preliminary studies have shown that acupuncture decreases SNS activation, pain, and anxiety. In addition, there is evidence that acupuncture enhances circulation of blood. We therefore hypothesize that acupuncture will facilitate wound healing. We aim to quantify changes in anxiety, pain, stress hormones, and perfusion and oxygenation induced by these interventions, as well as wound healing outcomes, including infection and other wound complications.

Eligibility Criteria:
Inclusion Criteria:

* Adults (age \> 18)
* Males/females
* All races
* Elective/urgent CABG
* Open saphenous vein graft harvest
* University of California, San Francisco, and additional approved hospital sites

Exclusion Criteria:

Pre-operative

* Emergent CABG, valves
* History of peripheral vascular surgery, amputation, severe peripheral neuropathy, immunocompromise, or end-stage renal disease requiring hemodialysis

Post-operative

* Postoperative day 1 (POD1) hemodynamic instability
* ≥ 4u packed red blood cells transfusion (PRBC)/8 hours, CT \> 200cc/hour 3 hours, \> 2 pressors
* Prolonged intubation (\> POD1)
* Altered mental status
Single Versus Double Dose Intra-vaginal Prostaglandin E2 "Misoprostol" Prior Abdominal Myomectomy

Introduction: The study aimed to investigate the effectiveness of a single versus double dose of Prostaglandin E2 "Misoprostol, 400 microgram" during myomectomy for multiple uterine fibroids. This was a prospective randomized controlled trial comprised of 69 patients with multiple myomas undergoing myomectomy. Patients randomly allocated to either an intra-vaginal single dose of 400 microgram Misoprostol 1 hour pre-operatively (group A, 34 cases) or 2 doses, 3 and 1 hours, prior surgery (group B, 35 cases). Operation time, intra and post-operative blood loss, hemoglobin concentration, blood pressure and body's temperature were estimated and compared in both groups.


Eligibility Criteria:
Inclusion Criteria:

* All patients had symptomatic multiple uterine fibroids (abnormal vaginal bleeding, lower abdominal dull aching pain and pelvic heaviness, subfertility or recurrent abortion)

Exclusion Criteria:

* hypertension, cardiac and pulmonary disease, chronic endocrine or metabolic diseases such as diabetes, obesity (body mass index \>30 kg/m2), all cases of single myoma and those known to be allergic to prostaglandin preparations.
Safety and Effectiveness of TRIZIVIR (Abacavir/Lamivudine/Zidovudine) With Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

The purpose of this study is to determine the effect of treatment with Trizivir (TZV) plus efavirenz (EFV) or TZV alone on viral load (level of HIV in the blood).

Patients receive TZV plus EFV in the 48-week Induction Phase. Eligible patients, defined as those with plasma HIV-1 RNA under 50 copies/ml, participate in the 48-week Maintenance Phase. Patients are randomized equally to receive either TZV plus EFV or TZV alone.

An immunology substudy will be conducted, including approximately the first 100 patients enrolled who agree to participate.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are at least 13 years old.
* Are HIV-positive.
* Have a viral load of at least 5,000 copies/ml.
* Agree to use adequate and reliable methods of birth control. Note: Hormonal birth control is not considered adequate.
* Provide written consent of a parent or guardian, if under 18 years of age.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have taken nonnucleoside reverse transcriptase inhibitors.
* Have taken other anti-HIV drugs for 2 weeks or more.
* Have an opportunistic (AIDS-related) infection.
* Are pregnant or breast-feeding.
* Have had hepatitis within the past 6 months.
* Are allergic to the study drugs or their ingredients.
* Have a mental, physical, or substance abuse disorder.
* Have a serious medical condition, such as diabetes, congestive heart failure, or other heart disease.
* Have a gastrointestinal disorder that affects drug absorption or makes it difficult to take medication by mouth.
* Have received within 4 weeks before study entry, or may require during the study period, radiation therapy, chemotherapy, or drugs that affect the immune system (such as steroid drugs, interleukins, vaccines, or interferons).
* Have received an HIV vaccine within 3 months before study entry, or are scheduled to receive one during the study period.
* Require foscarnet or other drugs that are shown to be effective against HIV.
* Are taking astemizole, cisapride, midazolam, triazolam, or ergot derivatives.
* Are taking experimental drugs.
* Are unlikely to complete the study or take the drugs.
Open Dose Escalating Trial to Determine the Maximum Tolerated Dose in Paediatric Patients With Advanced Cancers for Whom no Therapy is Known

The present trial will be performed according to an open design to determine the maximum tolerable dose (MTD) by evaluation of dose-limiting toxicity (DLT) of volasertib in paediatric leukaemia and solid tumours in the age group 2 to less than 12 and 12 to less than 18 years. A further objective is to collect data on safety, tolerability, toxicity, efficacy (preliminary activity), pharmacokinetics and pharmacodynamics of volasertib in paediatric cancer patients


Eligibility Criteria:
Inclusion criteria:

* paediatric patients with leukaemia or advanced solid tumours including lymphomas (age 2 - less than 18 years) for whom no further treatment is known
* Lansky score \> 60 for children 2 to less than 12 years
* Karnofsky score \> 60 for children aged 12 or older
* life expectancy of at least 6 weeks as judged by the investigator
* parents or legal guardians have given written informed consent and informed assent suitable for the respective age group obtained

Exclusion criteria:

* patient eligible for other anti-leukaemic therapy with curative intent or effective therapy known for solid tumour therapy
* presence of cardiac disease (LVEF by echocardiography less than 25 %)
* symptomatic Central Nervous System involvement of the malignant disease
* primary CNS tumour
* inadequate lab parameters
* inadequate venous access
* QTc prolongation
* pregnancy, breastfeeding
* other diseases or CTs that might interfere with evaluation of safety