cyrilzakka/clinical-trials huggingface dataset:
Acetylic Salicylic Acid for the Treatment of Chronic Obstructive Pulmonary Disease

The pathomechanisms of COPD are still not fully understood, and up to now there is no satisfying causal treatment inhibiting the progress of the disease. Available therapy is in most cases symptomatic. Experimental and clinical observations suggest that treatment with ASA might be beneficial in the treatment of COPD in terms of respiratory and lung-functional improvement.

To evaluate the efficacy of ASA as add-on therapy in COPD in comparison to placebo a prospective, randomized, double-blind, placebo controlled study will be conducted. Adult male and female patients (n=74) with proven COPD GOLD grade II-III will be randomized to 2 groups (i.e. 37 patients per group, stratification according to smoking status and gender). They will receive either 500 mg ASA per day or matching placebo over 12 weeks. Primary efficacy endpoints are changes in the lung-functional parameter FEV1 (forced expiratory 1-second volume) after 12 weeks of treatment. Secondary endpoints are the health score of the St. Georges respiratory questionnaire (SGRQ) and Peak-flow (PEF).


Eligibility Criteria:
Inclusion Criteria:

* COPD GOLD II or III

Exclusion Criteria:

* Long term NSAIDS, pregnancy et al.
Efficacy of Footbaths With Ginger Powder on Subjectively Perceived Quality of Sleep

A randomized, controlled trial to explore whether warm footbaths with added ginger powder can improve the sleep quality of adults with self-perceived insomnia symptoms. Participants receive daily footbaths either with warm water alone or with added ginger powder over a period of 2 weeks.

This is a randomized controlled trial with parallel group design to explore the effects of warm water footbaths with added ginger powder (experimental) compared to footbaths with warm water alone (active comparator) on sleep quality in adults with self-perceived insomnia symptoms. Participants receive daily footbaths 1-3 hours before bedtime over a period of two weeks. The footbaths are prepared by the participants themselves and carried out at their homes. Outcome measures are assessed at baseline (pre intervention) and two weeks after baseline (post intervention). The main focus is on change in subjective quality of sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI). The statistical analysis comprises analyses of variance based on linear mixed effects models.

Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* age between 18 and 70 years
* self-reported insomnia symptoms

Exclusion Criteria:

* known organic insomnia (e.g. periodic leg movements during sleep, restless legs syndrome, sleep apnea syndrome, narcolepsy)
* current intake of allopathic hypnotics
* shift work
* skin lesions at the lower legs or feet
* known intolerance or hypersensitivity to ginger preparations
* acute mental disorder
* varicose vein (degree 3 or 4, classification according to Marshall), chronic venous insufficiency
* pregnancy
* participation in other studies
* insufficient knowledge of the german language
Evaluation of Online Video Counselling

The objective of the study is to establish whether online video counselling is at least equally acceptable and equally as effective to clients and clinicians of the Veterans and Veterans Families Counselling Service (VVCS) as in-person counselling. If this is confirmed by the evaluation then online video counselling can be made more widely available to support the veteran and ex-service community, especially for those who may otherwise be unable to attend therapy and for clients who would prefer such web-based services over in-person sessions.


Eligibility Criteria:
Inclusion Criteria:

* Currently residing in Australia
* Eligible to receive support from the Veterans and Veterans Families Counselling Service (VVCS)
* Aged between 18 and 65
* Home access to broadband internet
* Own a device (e.g., computer, laptop, or tablet) that has a webcam and can support videoconferencing
* Be able to reasonably travel to a VVCS centre to access counselling
* Referred for one-to-one counselling or therapy
* Be willing and able to receive either modality of treatment (i.e., online or in-person counselling).

Exclusion Criteria:

* Not currently residing in Australia
* Not eligible to receive support from VVCS
* Significant current risk issues or levels of acute distress requiring crisis management
* Current serving member of the Australian Defence Force with a high security clearance (above Baseline Vetting)
* Referred for couple or family counselling.
* Have received a psychiatric diagnosis of post-traumatic stress disorder.
To Evaluate if the Medication Gabapentin Lessens Vulvar Pain

The purpose of this research study is to evaluate if the medication gabapentin lessens the vulvar pain some women experience.

There is not a "best" treatment plan for vulvar pain including vulvodynia (chronic vulvar pain) and vulvar vestibulitis syndrome (VVS, chronic vulvar pain localized to the vaginal opening). We propose that vulvodynia is a neuropathic pain (pain that effects the nervous system) as characterized by pain from stimuli that is not usually painful, stimuli that would not usually be painful causing significant pain, and burning pain. Gabapentin has been shown to be effective in treating chronic pain.

Eligibility Criteria:
Inclusion Criteria:

* All women, ages 18 years and older with the diagnosis of vulvodynia or VVS (by Friedrich's criteria), who present to the University of Iowa Vulvar Vaginal Disease Clinic.

Exclusion Criteria:

* Vulvar Vaginal Disease clinic patients who are pregnant, less than 3 months postpartum, breast-feeding, non-English speaking, or have contraindication to use of gabapentin due to allergy or renal disease (serum creatinine level greater than 1.4).
Phase II Trial of Sorafenib Combined With Concurrent HAIC for Hepatocellular Carcinoma

To evaluate safety and efficacy of combined hepatic arterial infusion (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin and sorafenib in patients with advanced hepatocellular carcinoma (HCC).

In most current guidelines, unresectable HCC with major PVTT are considered not generally suitable for transarterial chemoembolization, and sorafenib is recommended as standard care.3-5 However, for patients with major PVTT, the median overall survival of those treated with sorafenib monotherapy was only 3.1 to 6.0 months.

Whether combining sorafenib with hepatic arterial infusion (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin is safe, well tolerated, and efficacious remains unknown, with no prospective clinical data currently available.The investigators therefore conducted a prospective single center, single-arm phase II trial to evaluate the safety and efficacy of sorafenib combined with HAIC in patients with unresectable advanced HCC.

Eligibility Criteria:
Criteria:

Inclusion Criteria:

* The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
* Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.
* diagnosed with major or main portal vein invasion (Vp3 or Vp4)
* KPS≥70；
* with no previous treatment
* No Cirrhosis or cirrhotic status of Child-Pugh class A only
* Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
* The following laboratory parameters:

  * Platelet count ≥ 75,000/µL
  * Hemoglobin ≥ 8.5 g/dL
  * Total bilirubin ≤ 30mmol/L
  * Serum albumin ≥ 30 g/L
  * ASL and AST ≤ 5 x upper limit of normal
  * Serum creatinine ≤ 1.5 x upper limit of normal
  * INR ≤ 1.5 or PT/APTT within normal limits
  * Absolute neutrophil count (ANC) \>1,500/mm3
* Ability to understand the protocol and to agree to and sign a written informed consent document

Exclusion Criteria:

* Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
* Known history of HIV
* History of organ allograft
* Known or suspected allergy to the investigational agents or any agent given in association with this trial.
* Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
* Evidence of bleeding diathesis.
* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
* Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug
* Serious non-healing wound, ulcer, or bone fracture
* Known central nervous system tumors including metastatic brain disease
Treatment of Cocaine Dependence With Lisdexamfetamine

This protocol is a 2-group double-blind placebo-controlled outpatient study investigating lisdexamfetamine for treatment of cocaine dependence. The investigators plan to enroll 100 subjects in a 14-week trial. The primary objectives will determine changes in cocaine use and secondary objectives will be cocaine craving and impulsivity.

This 2-group, double-blind, placebo-controlled, 14-week study (N=100) will investigate the efficacy of cognitive behavioral therapy plus lisdexamfetamine vs. placebo to treat cocaine dependence. We hypothesize that lisdexamfetamine will reduce cocaine use (primary outcome), as well as cocaine craving and impulsivity (secondary outcomes) vs. placebo.

Eligibility Criteria:
Inclusion Criteria:

* Eligible participants must:

  1. Be treatment-seeking males or females between 18 and 65 years-of-age;
  2. Understand the study procedures and provide written informed consent;
  3. Be judged by the examining physician to be in generally good health with the exception of health problems related to acute drug use;
  4. Meet DSM-IV criteria for cocaine-dependence.

Exclusion Criteria:

* Exclusion criteria include:

  1. DSM-IV diagnoses for current psychotic disorders, mood disorders (except substance-induced depression), anxiety disorders, ADHD, and other current substance dependence (except marijuana and nicotine dependence); subjects may not have physiological dependence upon alcohol requiring medical detoxification;
  2. Current use of any prescription medications;
  3. Females currently pregnant or nursing;
  4. Current elevation of liver enzyme levels above twice normal limits;
  5. Existing cardiovascular disease as determined by physician, EKG evaluation;
  6. History of significant acute or chronic physical illness precluding participation;
  7. History of hyperthyroidism, glaucoma, or seizures.
Comparison Between Conventional and Model-based Infusion Strategy of IV PCA in Patients Undergoing RALP

Comparing postoperative analgesics requirements and complications between conventional and model-based infusion strategy of intravenous patient-controlled analgesia in patients who undergoing robot assisted laparoscopic radical prostatectomy

Group A: conventional intravenous patient-controlled analgesia, Group B: model-based infusion strategy of intravenous patient-controlled analgesia

The investigators compared postoperative analgesics requirements and complications between conventional and model-based infusion strategy of intravenous patient-controlled analgesia (IV PCA) in patients who undergoing robot assisted laparoscopic radical prostatectomy (RALP)

Group A: conventional IV PCA, Group B: model based IV PCA

1. Primary endpoint: comparison of postoperative analgesic requirements in patient undergoing robot assisted laparoscopic radical prostatectomy (RALP) between conventional patient controlled analgesia (PCA) (Group A) and effective-compartment based dosing strategy of PCA (Group B)
2. Secondary endpoint: 1) VAS analysis between two groups, 2) postoperative nausea and vomiting analysis between two groups, 3) complication evaluation between two groups

Eligibility Criteria:
Inclusion Criteria:

* Patient who is scheduled to get a robot assisted laparoscopic radical prostatectomy
* Patient who agree to get a patient controlled analgesia

Exclusion Criteria:

* American Society of Anesthesiologist (ASA) physical status over III
* History of alcohol or drug addiction
* History of acute or chronic pain or pain treatment
* Allergic to opioid analgesics
* BMI over 30 kg/m2
* History of sleep apnea or respiratory complications
Comparison of GW433908 and Nelfinavir in HIV Patients Who Have Not Had Antiretroviral Therapy

The purpose of this study is to compare GW433908 and nelfinavir when each is given with abacavir and lamivudine to HIV patients who have not taken antiretroviral drugs.

Patients are randomized in a 2:1 scheme to 1 of 2 treatment groups. Group 1 receives GW433908 plus abacavir (ABC) plus lamivudine (3TC); Group 2 receives nelfinavir (NFV) plus ABC plus 3TC. Patients undergo safety and efficacy assessments at the Screening Visit, Day 1 (Entry), and Weeks 1, 2, 4, 8, 12, 16, 20, 24, and every 8 weeks thereafter. A follow-up visit is performed 4 weeks after the permanent discontinuation of study drug. Detailed assessments for the development of lipodystrophy/fat redistribution occur at Day 1, Week 24, Week 48, and every 16 weeks thereafter. Patients have examinations and laboratory tests performed at visits.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are at least 13 years old (consent of parent or guardian required if under 18).
* Agree to use a proven barrier method of birth control (e.g., spermicide plus condom) during the study period (hormonal birth control will not be accepted), if able to have children.
* Have received less than 4 weeks treatment with any nucleoside reverse transcriptase inhibitor (NRTI) and have never received any nonnucleoside reverse transcriptase inhibitor (NNRT) or protease inhibitor (PI).
* Have a viral load (amount of HIV in the blood) of 5,000 copies/ml or more, or have a positive result at the screening visit.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Abuse drugs or alcohol in a way that would interfere with the study, in the opinion of the doctor. Patients stable on methadone will be considered for participation.
* Have an active/acute CDC Category C event.
* Are unable to absorb or take medicines by mouth.
* Are pregnant or breast-feeding.
* Have a serious medical condition (such as diabetes, heart problem, hepatitis) that might affect the safety of the patient.
* Have had pancreatitis or hepatitis within the last 6 months.
* Have been treated with radiation or chemotherapy within 28 days before the study drug will be taken, or will have the need for these during the study.
* Have taken drugs that affect the immune system (such as corticosteroids, interleukins, interferons) or that have anti-HIV activity (such as hydroxyurea or foscarnet) within 28 days before the study drug will be taken.
* Have received HIV vaccine within 3 months before the study drug will be taken.
* Have received certain other drugs within 28 days before the study drug will be taken, or think that they will be needed during the study.
* Have received experimental treatments.
* Have allergies which might interfere with the study, in the opinion of the doctor.
Del Nido Versus HTK Cardioplegia in Adult Aortic Valve Replacement

The goal of this clinical trial is to compare del Nido and Bretschneider-HTK (HTK) cardioplegia solutions in patients undergoing elective aortic valve replacement. The main question it aims to answer is:

• Does the del Nido cardioplegia provide better cardioprotection and clinical outcomes than HTK cardioplegia? Participants will receive one of the investigated cardioplegia solutions according to the randomization.

Researchers will compare both groups in terms of cardioprotection (described as levels of CK-MB and hsTnI), in-hospital clinical outcomes, biochemical changes in coronary sinus blood and one-year follow-up.

The idea of using del Nido cardioplegia in adult cardiac surgery appeared after many reports proving its safety and efficacy in the paediatric population. Therefore many adult centres started to apply it in everyday practice. Despite its growing popularity and application in different types of cardiac surgeries, there is still an insufficient number of prospective randomized trials which compare del Nido cardioplegia with the Bretschneider-HTK formula in the adult population.

The described problem will be analyzed at different levels in this prospective, randomised study.

Clinical aspects - del Nido and HTK cardioplegia will be compared in terms of intraoperative and postoperative details such as perfusion details and concentration of cardiac enzymes.

Echocardiographic changes - The next step will be revealing potential echocardiographic changes in cardiac function in short- and long-term observations after cardiac surgery.

Metabolic changes - the metabolic profile of amino acids and nucleotide changes after each cardioplegia solution delivery will be analyzed.

Statistical calculations will be performed by a qualified statistician. In the case of binary variables, Fisher's exact test will be used to assess differences between groups. In the case of quantitative variables, the compliance of the distribution with the normal distribution will be tested using the Shapiro-Wilk test. For quantitative variables with a distribution not significantly different from normal, the Student's t-test will be used for comparison between groups. If the distribution differs significantly from the normal distribution, the Mann-Whitney U test (comparisons of two samples) or the Kruskal-Wallis test (comparisons of many samples) will be used. Correlations between variables will be assessed using the Pearson or Spearman method, depending on the distribution of the variables. Repeated-measures ANOVA will be used to assess the variability of biochemical parameters over time.

In all analyses, p\<0.05 will be considered as the level of statistical significance.

A comparison of the two cardioplegia solutions would allow assessing whether del Nido provides better cardioprotection than HTK.

Eligibility Criteria:
Inclusion Criteria:

* patients aged 18 and over,
* qualified for elective isolated aortic valve replacement (AVR)

Exclusion Criteria:

* patients with significant coronary artery disease,
* urgent cases,
* cases with additional cardiac procedures.
Student Exercise and Sleep Timing Study - Part 2

The purpose of this study is to examine the effects of a morning exercise intervention on sleep (quality and duration), mood (positive affect, anxiety, depression, anger), stress and productivity among undergraduate students (18-23 years) evening-exercisers with poor self-reported sleep quality.

Aim 1. Compared to the control condition, evening-exercisers prescribed morning exercise will exhibit improved sleep quality (increased efficiency, decreased fragmentation) and increased sleep duration.

Aim 2. Compared to the control condition, evening-exercisers prescribed morning exercise will exhibit improved mood (increased positive affect, decreased depression, anxiety and anger).

Aim 3. Compared to the control condition, evening-exercisers prescribed morning exercise will exhibit decreased stress and increased productivity.


Eligibility Criteria:
Inclusion Criteria:

* Healthy undergraduates (18-23 years)
* Frequent evening exercisers (6pm-11pm, 3+ times per week)
* Poor self-reported sleep quality
* Must be willing to wear wrist actigraph 24/7 except when showering/bathing

Exclusion Criteria:

* Sleep/circadian rhythm disorders
* Medications for sleep
* Inability to change schedule to exercise in AM
* Inability to maintain exercise frequency over next 4 weeks
The Effect of Mesotherapy and Intra-articular Steroid Injection in Shoulder Pain

Patients with chronic shoulder pain will be divided randomly into mesotherapy and intra-articular steroid injection groups. Pain severity, range of motion and functional impairment will evaluated before treatment, 30 minutes and 4 weeks after the injections.

The study will include 84 patients aged 18-75 who applied to physical medicine and rehabilitation out-patient clinic with chronic shoulder pain between May and July 2024. Patients will be randomly divided into two groups: a mesotherapy group and steroid injection group, using the closed-envelope method. In the first group, a total of 3 sessions of mesotherapy are applied to the shoulder areas of the patients, 7 days apart. A single-session intra-articular 20 mg triamcinolone hexacetonide injection will be administered for patients in group 2. Pain severity, range of motion and functional impairment will evaluated before treatment, 30 minutes and 4 weeks after the injections.

Eligibility Criteria:
Inclusion Criteria:

1. Ages 18-75
2. Having shoulder pain for 6 months
3. VAS (Visual Analog Scale) \&gt; 4
4. Patients who can receive verbal instructions and do not have cognitive deficits

Exclusion Criteria:

1. Physical therapy applied to the shoulder area in the last 3 months
2. Having had a shoulder joint injection in the last 3 months
3. History of previous upper extremity surgery
4. History of drug allergy
5. Use of anticoagulant drugs (warfarin, low molecular weight heparin), patients with coagulation disorder
6. History of malignancy
7. Psychiatric illness
8. A rheumatological diagnosis such as Polymyalgia Rheumatica, Rheumatoid Arthritis, Ankylosing Spondylitis
9. Kidney failure
10. Liver disease
11. Heart failure
12. Pregnancy
13. Presence of infection, wound, allergy, burn-like lesions in the application area
Neuroendocrine Mechanisms in Behavioral Treatment of Insomnia

The purpose of this study is to evaluate the change in measures of physiological arousal before and after behavioral treatment of insomnia.

There is good evidence that physiological arousal, associated with sustained activation of the hypothalamic-pituitary axis and the sympathetic nervous system, is an underlying cause of chronic insomnia. Accordingly, relaxation-related treatments that address elevated cognitive and somatic arousal have been effective for insomnia. Previous studies have documented the effectiveness of behavioral treatments in reducing activation of the hypothalamic-pituitary axis and the sympathetic nervous system and in the treatment of specific medical disorders including insomnia. The aim of this proposal is to evaluate the hypothesis that improvements in chronic psychophysiological insomnia following a behavioral treatment are tightly associated with reduction of arousal in the hypothalamic-pituitary axis, as measured by plasma cortisol, and in the sympathetic nervous system, as measured by urinary catecholamines. Objective measures of sleep will be derived from polysomnographic recordings from subjects randomized into a 10-week active behavioral treatment or placebo behavioral control treatment group. Continuous 24-hour evaluation of cortisol and catecholamines will be performed under controlled laboratory conditions before and after treatment. We anticipate significant reductions in cortisol and catecholamines in the active treatment group as compared with the control group. We also anticipate that the active treatment will yield reductions in related measures of arousal including heart rate, autonomic arousal (as determined from heart rate variability), and body temperature. Given reported evidence that melatonin levels are chronically low in insomnia we anticipate an increase in the sleep-related hormone melatonin in the yoga treatment group. If achieved, these results will provide a novel demonstration of a reduction of arousal in a behavioral insomnia treatment and a behaviorally enhanced melatonin secretion under controlled laboratory conditions.

Eligibility Criteria:
Inclusion Criteria:

* primary insomnia for 6 months
* average total wake time \>60 minutes and sleep efficiency \<80%
* at least 1 daytime complaint due to insomnia
* adequate opportunity and circumstance for sleep

Exclusion Criteria:

* current psychiatric condition
* medical condition that interferes with sleep
* pregnancy
* rotating shift work, night work or transcontinental travel during study
* anticipated major life stressor over the course of the study
* use of hypnotic or psychoactive medications
* no idiopathic or sleep state misperception insomnia