cyrilzakka/clinical-trials huggingface dataset:
Co-Axial Micro-Incision Versus Co-Axial Small Incision Cataract Surgery Using the Stellaris Enhancement System

The objective of this study is to test the hypothesis that the time to reach a stable refraction is significantly shorter in eyes operated with the 1.8 mm coaxial microincision compared to eyes operated with the 2.75 mm standard incision using the Stellaris Vision Enhancement System.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be undergoing bilateral primary in-the-bag intraocular lens (IOL) implantation for the correction of aphakia.
* Subject's ocular media must be clear except for the presence of the cataract in both eyes.

Exclusion Criteria:

* Subject with any disease, which, in the Investigator's opinion, might interfere with the conduct of the study.
Prevention of Esophageal Variceal Rebleeding

BACKGROUND: Previous studies showed that the combination of endoscopic therapy with vasoconstrictor is better than either vasoconstrictor or endoscopic therapy alone in achieving the successful hemostatsis of acute variceal bleeding. The rationale of using vasoconstrictor is to enhance the efficacy of hemostasis by endoscopic therapy. Nowadays, endoscopic variceal ligation (EVL) has replaced endoscopic injection sclerotherapy (EIS) as the endoscopic treatment of choice in the arresting of acute esophageal variceal hemorrhage. EVL alone can achieve hemotasis up to 97% even in cases of active variceal hemorrhage. However, early rebleeding due to ligation-induced ulcer may be encountered. It appears that prevention of esophageal ulcers and bleeding by a proton pump inhibitor may be more logical than using a vasoconstrictor after cessation of bleeding by EVL.

Thus, the investigators designed a controlled trial to compare the initial hemostasis, early rebleeding rate in cirrhotic patients presenting with acute variceal bleeding receiving either emergency EVL plus vasoconstrictor infusion or losec infusion for 5 days.

Methods of treatment:

Group 1: Somatostatin 250μg slow bolus IV infusion followed by 250μg per hour (6mg/ 24 hours) or Terlipressin 2mg bolus was instituted on enrollment followed by 1mg per 6 hours for 5 days. The use of either somatostatin or glypressin was at the discretion of doctors in charge. Group 2: Pantoloc 20 mg intravenously per day was instituted on enrollment and continued for 5 days.

Definition of initial hemostasis:

Initial hemostasis was defined as achieving a 24h bleeding-free period within the first 48h after treatment together with stable vital signs based on Baveno consensus criteria.

Very early rebleeding was defined as: UGI bleeding occurred after initial hemostasis and within 5 days after enrollment. UGI bleeding was proven to be from esophageal varices.

Treatment failure is defined as failure to control acute bleeding episodes or very early rebleeding.

Eligibility Criteria:
Inclusion Criteria:

1. The etiology of portal hypertension is cirrhosis.
2. Age ranges between 18-80 y/o.
3. Patients presenting with acute esophageal variceal bleeding proven by emergency endoscopy within 12 hours. (Acute esophageal variceal bleeding was defined as:

   * when blood was directly seen by endoscopy to issue from an esophageal varix (active bleeding) OR
   * when patients presented with red color signs on their esophageal varices with blood in esophagus or stomach and no other potential site of bleeding identified (inactive bleeding).
4. EVL is performed after confirmation of acute esophageal variceal bleeding. Enrollment time: Immediately after EVL is completed and variceal bleeding is arrested.

Exclusion criteria:

1. association with severe systemic illness, such as sepsis, COPD, uremia
2. association with gastric variceal bleeding
3. failure in the control of bleeding by emergency EVL
4. moribund patients, died within 12 hours of enrollment
5. Uncooperative
6. Ever received EIS, EVL within one month prior to index bleeding
7. Child-Pugh's scores \> 10
Monoamine Transporter Function and Autonomic Regulation During Psychodynamic Psychotherapy

Outcome of psychodynamic psychotherapy measured by \[123I\] nor-B-CIT SPET imaging

Background Psychodynamic psychotherapy is a widely practised form of psychotherapy in the treatment of depression. There is evidence that serotonin transporter (SERT) densities are altered in depression. Preliminary observations have suggested that SERT function may recover in connection with dynamic psychotherapy.

The objective was to determine whether SERT densities change in relation to clinical recovery during psychodynamic psychotherapy.

N=26

Method Twenty six drug-naïve currently depressed (moderate/severe) patients with no previous treatment were recruited for the study. The baseline study included a group of 18 healthy controls. The patients were randomised into psychotherapy and waiting-list control groups. For controls, psychotherapy was started after a 6-month waiting period. \[123I\] nor-B-CIT SPET imaging was performed at baseline and after 12 months of psychotherapy. For the controls, additional imaging was performed after the 6-month waiting period.

Eligibility Criteria:
Inclusion Criteria:

* depression

Exclusion Criteria:

* antidepressive medication
Norwegian Laparoscopic Aortic Surgery Trial

Patients with severe atherosclerotic occlusive disease can be operated on with an aortobifemoral bypass(ABFB)through a median laparotomy. Since 1993, this operation has also been performed laparoscopically. The laparoscopic ABFB operation claims to be minimally invasive as compared to the open ABFB. The cohort studies published so far have shown that although a longer operation time with the laparoscopic procedure as compared to the open surgery, the patients have a shorter hospital stay, lesser perioperative bleeding, fewer systemic complications, and earlier convalescence.

However, no randomized control trial has yet been published to compare the two procedures.

In the NLAST-study, which is a multicenter randomized control trial, the patients with TASC type D atherosclerotic lesions shall be randomized to either totally laparoscopic aortobifemoral bypass operation (LABFB)or an open ABFB operation.

The primary endpoint of the study is post-operative complications defined as systemic and local complications, including vascular complications e.g., graft infection, thrombosis, etc.

Secondary endpoints are as follows,

* health-related quality of life, examined and evaluated with the help of pre and post-operative surveys performed with the help of SF36v2 questionnaire and EQ5D5L.
* perioperative stress response (during operation) measured/analyzed with the help of stress hormones changes
* perioperative inflammatory response
* cost-utility analysis
* cost differences

Eligibility Criteria:
Inclusion Criteria:

* Aortoiliac occlusive disease (TASC Type D lesions)

Exclusion Criteria:

* Active cancer disease
* Acute critical limb ischemia
* Prior major abdominal surgery
* Heart failure (Ejection fraction \<40%
Diuretic Response in Advanced Heart Failure: Bolus Intermittent vs Continuous INfusion

Loop diuretics are the main therapy for decongestion of patients with advanced acute heart failure. However, these patients often develop diuretic-resistance or even diuretic-refractoriness. In order to overcome such resistance to diuretic, the clinician can increase the dose of furosemide, or change the way of administration (continuous infusion versus boluses) or associate a different class of diuretics (thiazide diuretics, K+-sparing diuretics) up to the addition of low doses of inotropic agents to improve renal perfusion. At the present time there is no evidence in literature in advanced acute heart failure patients about the superiority of the treatment with furosemide in continuous infusion or in intermittent boluses. The aim of the study was to evaluate the efficacy of furosemide in boluses versus continuous infusion in advanced acute heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Advanced heart failure
* WET ≥ 12
* Systolic blood pressure ≤ 110 mmHg
* Serum sodium ≤ 135 mEq/L
* Left systolic ventricular insufficiency (FE \< 35%) note for at least 6 months
* Class NYHA III-IV despite medical treatment maximal

Exclusion Criteria:

* Acute coronary syndrome
* Shock cardiogenic
* Chronic renal failure stage V
Bryostatin 1 in Treating Patients With Recurrent or Refractory Hodgkin's Disease

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 in treating patients who have recurrent or refractory Hodgkin's disease.

OBJECTIVES: I. Determine the response rate in patients with recurrent or refractory Hodgkin's disease treated with bryostatin 1. II. Determine qualitative and quantitative toxicities of bryostatin 1 in these patients. III. Determine duration of response and survival in these patients.

OUTLINE: Patients receive bryostatin 1 by continuous IV infusion over 72 hours. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity for at least 4 courses. Patients who achieve complete response (CR) are treated with 4 additional courses beyond CR.

PROJECTED ACCRUAL: A total of 14-27 patients will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Diagnosis of recurrent or refractory Hodgkin's disease Measurable disease Must have failed the following regimens: Mechlorethamine, vincristine, procarbazine, and prednisone (MOPP) AND Doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) May have undergone either bone marrow or peripheral blood stem cell transplant Must not be eligible for standard treatment (high intensity therapy with peripheral blood stem cell or bone marrow transplant) or higher priority protocol

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count (ANC) at least 1,000/mm3 (at least 500/mm3 if extensive bone marrow involvement) Platelets at least 75,000/mm3 (at least 50,000/mm3 if extensive bone marrow involvement) Hepatic: Bilirubin less than 1.5 mg/dL ALT and AST less than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Other: Not pregnant or nursing Fertile patients must use effective contraception during and for 2 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (8 weeks since mitomycin or nitrosoureas) and recovered Endocrine therapy: No concurrent steroids Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: Not specified
Multicentric Study VATS Major Introperative Complications

This study investigates the most common major complications that result in unplanned additional surgery in patients undergoing vats anatomical resections. Several high-volume European centres participate. The purpose is to quantify these major complications, discuss the steps that can be taken to prevent these events, how they can be dealt with, be it by vats or conversion

Vats lobectomy is becoming the standard of care for early stage lung cancer. Several studies have shown feasibility and safety in dedicated centres. Compared to thoracotomy the procedure results in at least equal oncologic results and survival, perhaps better.

Most series do not publish their early experience. They are retrospective and report on lobectomies and segmentectomies, excluding the live-saving pneumonectomies. They are potentially ignoring the intention-to-treat principle, excluding conversions.

Based on scarce existing literature and conference worst-case presentations a pattern of the most common intraoperative major complications can be drawn In Europe, a large percentage of high-volume-centres have now successfully implemented a vats lobectomy program. In this era with low-volume-centres switching into vats anatomical resections, it is important to focus on potentially life-threatening complications. To be aware of potential hazards is the best way to avoid them.

Eligibility Criteria:
Inclusion Criteria:

* Patients that did undergo resection for oncologic reasons

Exclusion Criteria:

* Patients that did not undergo resection for oncologic reasons, such as pleural metastasis, irresectable disease.
Randomised Controlled Trial of Condoms Plus Additional Lubrication

This RCT compares the clinical and non clinical condom failure rate among condom using heterosexual couples with and without externally applied additional spermicidal lubricant. The hypothesis is that breakage and slippage rates will be reduced.

A recent retrospective cohort study of 1006 subjects reported a marked reduction in condom failure amongst users applying additional lubrication. Improving the reliability of condoms would reduce the incidence of unwanted pregnancies and STI's (and hence health and social costs). This trial investigates the relative risk reduction amongst couples applying additional spermicidal lubrication to condoms, other factors associated with condom failure, the acceptability and side effects of additional spermicide and its cost effectiveness.

200 regular condom users will be recruited from family planning clinics and other community sources. A randomised, controlled investigator blinded, crossover design is being used. Participants will be reviewed at 3 and 6 months. Couples will be randomised to start either with latex condoms alone (Durex Extra Safe) or with additional Duragel (nonoxynol-9 contracceptive gel) applied to the outside of the condom prior to initial penetration. Participants are heterosexual couples using condoms for vaginal non-commercial intercourse in stable relationships of at least 3 months duration. Those under 18, or unable to provide data due to communication difficulties will be excluded from the trial.

Data will be collected by questionnaires for all subjects on their contraceptive and STI history, key demographic, social and behavioural factors relevant to condom failure risk at baseline. At crossover and trial end the rate and types of condom failure, side effects and acceptability of additional spermicide, and health service and subject costs are collected. A random sample of subjects also participate in a detailed semi-structured interview at the end of the study, covering their recent experiences of condom failure, and opinions about condoms in general, including the use of additional spermicide. These qualitative findings will then be discussed in patient and professional focus groups as a proxy for respondent checking and data triangulation.

The research will provide valuable, detailed information on factors associated with condom failure. Confirmation of the previous finding of the protective effects of additional spermicide would have a potentially major international impact in the fields of family planning and infectious diseases.

Eligibility Criteria:
Inclusion Criteria:

* Condom using heterosexual couples in stable relationships

Exclusion Criteria:

* Allergy to latex and or nonoxynol-9, communication difficulties precluding data collection
The Modulatory Effect of Low-intensity Priming Intermittent Theta Burst Stimulation on Motor Cortex Poststroke: a Concurrent TMS-EEG Study

Background: The optimization of the intensity of priming theta burst stimulation increases the probability of success in a randomized controlled trial. We hypothesize that priming intermittent theta burst stimulation (iTBS) with a low-intensity continuous theta burst stimulation (cTBS) will yield superior effects than our original priming protocol in healthy adults and patients after stroke.

Methods: 15 healthy adults and 15 stroke patients will undergo three separate experimental conditions: a low-intensity priming stimulation (55% resting motor threshold \[RMT\] cTBS+70% RMT iTBS), a conventional-intensity priming stimulation (70% RMT cTBS+70% RMT iTBS), and a nonpriming control. The alterations in cortical excitation/inhibition and its impacts on motor behaviors will be evaluated following stimulation.

Significance: The findings will inform future clinical trials investigating the optimized priming iTBS in promoting poststroke recovery.

Background: The optimization of the intensity of priming theta burst stimulation increases the probability of success in a randomized controlled trial. We hypothesize that priming intermittent theta burst stimulation (iTBS) with a low-intensity continuous theta burst stimulation (cTBS) will yield superior effects than our original priming protocol in healthy adults and patients after stroke.

Methods: 15 healthy adults and 15 stroke patients will undergo three separate experimental conditions: a low-intensity priming stimulation (55% resting motor threshold \[RMT\] cTBS+70% RMT iTBS), a conventional-intensity priming stimulation (70% RMT cTBS+70% RMT iTBS), and a nonpriming control. The alterations in cortical excitation/inhibition and its impacts on motor behaviors will be evaluated following stimulation.

Significance: The findings will inform future clinical trials investigating the optimized priming iTBS in promoting poststroke recovery.

Eligibility Criteria:
Inclusion Criteria:

* (1) have a diagnosis of monohemispheric ischemic or hemorrhagic stroke, with time after stroke onset≥6 months;
* (2) aged between 18 and 80 years old;
* (3) with residual upper limb functions from 2-6 levels in the Functional Test for the Hemiplegic Upper Extremity, i.e., moderately impaired overall upper extremity functions.
* (4) able to give informed written consent to participate in the study.

Exclusion Criteria:

* (1) any contraindications to TMS (screened by the safety checklist by Rossi \[12\]); -
* (2) any concomitant neurological disease;
* (3) any sign of moderate-to-severe cognitive problems, i.e., Montreal cognitive assessment (MoCA)\<19/30
* (4) Modified Ashworth score\>2 in hand, wrist or elbow extensor muscle in the hemiparetic upper extremity.

In addition, a group of age-matched, right-hand dominant healthy adults without any known neurological diseases will be enrolled. Healthy adults with any contraindications to TMS will be excluded.
Personalized Treatment for Refractory H Pylori Infection

In this study, the investigators develop a personalized treatment according to culture-guided antibiotics plus high-dose proton-pump inhibitor and bismuth to treat refractory H pylori infection.

They are categorized into three groups: (1) patients who have positive result of culture with equal to or more than three susceptible antibiotics are treated by non-bismuth quadruple therapy (rabeprazole 20 mg q.d.s. and three effective antibiotics), (2) patients who have positive result of culture with one or two susceptible antibiotics are treated by bismuth-containing therapy (rabeprazole 20 mg q.d.s., bismuth subcitrate 120 mg q.d.s. and all the effective antibiotics), and (3) patients who have negative result of culture or whose culture data are unavailable will be treated by (rabeprazole 20 mg q.d.s, amoxicillin 500 mg q.d.s., tetracycline 500 mg q.d.s. and levofloxacin 500 mg o.d.) for 14 days.

Eligibility Criteria:
Inclusion Criteria:

H pylori-infected adult patients with at least two previous failed eradication attempts will be enrolled in this study after giving informed consent.

* positive results of both rapid urease test and histology,
* a positive result of Urea breath test,
* or a positive result of culture

Exclusion Criteria:

* ingestion of antibiotics, bismuth, or proton-pump inhibitor within the prior 4 weeks,
* patients with allergic history to the medications used,
* patients with previous gastric surgery,
* the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia),
* pregnant women.
Retinal Thickness Analysis Using Optical Coherence Tomography

The main objective of this study is to characterize and correlate diabetic macular edema (DME), i.e. increased retinal thickness, measured by Optical Coherence Tomograph (OCT), and retinal visual function.

The secondary objectives of this study are the analysis and characterization of DME progression over time (between two visits), and the comparison of OCT data obtained with different devices.

The results of this study will be used exclusively for scientific purposes.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of DR
* Females or Males
* Age over 18 years
* Signed Informed Consent Form

Exclusion Criteria:

* Cataract or other eye disease that may interfere with fundus examinations
* Vitreous syneresis or posterior vitreous detachment
* Dilatation of the pupil \< 5 mm
The Effects of Cognitive Rehabilitation on Motor Performance, Balance and Fear of Falling in Stroke Patients

One of the most common complications in stroke patients is cognitive impairment. Cognitive impairment affects a large part of the life of stroke patients. However, the relationship between cognitive impairment and fear of falling in stroke patients has not been investigated in any study yet. Various treatment approaches have been developed to improve cognitive function. While some of these approaches focus on improving cognitive function, others aim to reach the maximum functional level with various compensation methods taught to the patient in the current cognitive situation. As a result of cognitive interventions, stroke patients' participation in daily life, adherence to treatment and quality of life increase. The aim of this study is to investigate the effects of cognitive interventions on motor performance, balance and fear of falling. This study will contribute to the literature by investigating these effects of cognitive rehabilitation.

Participants will be randomized into two groups as control and experimental groups. The control group will receive traditional rehabilitation intervention, while the experimental group will receive additional cognitive intervention to traditional rehabilitation. Two groups will be evaluated before and after the study. Participants' motor performance, balance and fear of falling will be determined by evaluation criteria.

Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with stroke
* The duration of the disease is in the range of 1-24 months
* Having a score of 21 or lower on the mini mental state test
* Having received 3 or more according to the Functional Ambulation Scale
* Not having a vision problem that will affect the vision of the materials to be used during the treatment
* Being able to communicate sufficiently to understand the simple orders given

Exclusion Criteria:

* Having been diagnosed with bilateral stroke
* Having a neurological disease other than the diagnosis of stroke
* Development of aphasia after stroke