cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Treatment With Klacid®SR in Patients With Lower Respiratory Tract Infection

The aim of this post-marketing observational study (PMOS) is to describe the relief of symptoms, tolerability and compliance of treatment with Klacid®SR in a dose 1000 mg once daily in patients with lower respiratory tract infection or in patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP).

This PMOS will be conducted in a prospective, open-label, single-country, multicenter format. The investigational sites will be consulting rooms of GPs (general practitioner), pneumologists and centers with experience in the treatment of patients with lower respiratory tract infection, AECB (acute exacerbation of chronic bronchitis) and CAP (mild community-acquired pneumonia). Since this will be a PMOS, Klacid®SR will be prescribed in usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not prescribe Klacid®SR would be taken prior to entry of a subject in the study.

Follow-up of patients should enable two patient visits during this period. Screening/Inclusion Visit will be performed when the decision to start the treatment with Klacid®SR is made. Inclusion of patient in the study will succeed at day 0 (S/I Visit). The Second Visit will follow 10 - 16 days after the Screening/Inclusion Visit.

Eligibility Criteria:
Inclusion Criteria:

* Men, women at least 18 years old

  * with acute tracheitis,
  * acute tracheobronchitis,
  * acute bronchitis,
  * mild community-acquired pneumonia or
  * acute exacerbation of chronic bronchitis

Exclusion Criteria:

* Patients with known hypersensitivity to macrolide antibiotics
* Patients with documented renal impairment (creatinine clearance under 30 ml/min).
* Patients with documented liver parenchyma impairment (AST, ALT and GMT \> 3x higher level in comparison with the norm)
* Concomitant therapy with the following drugs: astemizole, cisapride, colchicine, pimozide, terfenadine and ergotamine or dihydroergotamine
* Pregnancy
* Breast feeding
Effects of Specified Work Site Physical Activity Intervention Among Employees With Physical Heavy Work

The purpose of this study is to evaluate the effect of specified worksite physical-activity interventions on musculoskeletal disorders in an industry with physical heavy workload.

Studies regarding company adjusted intervention have shown positive effects regarding work related neck and shoulder symptoms among workers with monotonous repetitive work. However, limited research is available on physical exercise intervention among workers with physically heavy work. This study introduces a new intervention concept to treat and prevent musculoskeletal disorders including individually and health check based exercise intervention.

The aim of this randomized controlled intervention project is

1. Through Health check to outline the extent musculoskeletal disability in workers with heavy work load in relation to physical and metabolic fitness. Includes is also assessment of physical general activity and working conditions.
2. To evaluate the effect of individual adjusted exercise programs on muscle strength, aerobic capacity, musculoskeletal disability, pain, work ability and sick absenteeism

Eligibility Criteria:
Inclusion Criteria:

* Constructions workers, working for more than 20 hours pr week, Physical heavy work tasks (in Danish: brolæggere, rørlæggere, mekanikere)

Exclusion Criteria:

* Workers with flexible job i.e. for people with a reduced ability to work
Effect of Virtual Reality Glasses on Anxiety During Cystoscopy: A Randomised Controlled Trial

The aim of this study was to investigate the effect of using virtual reality glasses as a distraction method on anxiety in men undergoing cystoscopy under local anaesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the research
* 18 years of age or older
* Male gender
* undergoing a rigid cystoscopy procedure for the first time
* Application of local anaesthesia

Exclusion Criteria:

* Cognitive or physical disabilities that may prevent the use of virtual reality glasses.
* Premedication before the procedure
The Effectiveness of a Virtual Reality-based Multisensory Intervention

This study explores the effectiveness of a virtual reality-based multisensory intervention for postoperative recovery in patients receiving gynecological surgery.

This study explores the effectiveness of a virtual reality-based multisensory intervention for postoperative recovery in patients receiving gynecological surgery. The results of the study included postoperative pain response, comfort, and anxiety of the patients.

Eligibility Criteria:
Inclusion Criteria: 1) significant postoperative pain response (VAS score over 4); 2) age greater than 18 years and volunteered to participate in this study.

Exclusion Criteria: 1) patients with psychosomatic disorders such as delirium, schizophrenia, and bipolar disorder; 2) patients with epilepsy, motion sickness, lightsensitivity, or other neurological diseases may have difficulty wearing the VR headset; 3) patients have severe heart, liver, kidney, blood, digestive, and nervous diseases.
Effects of a Vestibular Rehabilitation Maneuver

Rotational maneuver is a vestibular rehabilitation method, performed in a supervised manner. Using a rotating chair, subjects are rotated towards the opposite direction of dominant side in order to inhibit this side and simultaneously, stimulate the subordinate side. We propose that the rehabilitative effect is the result of a decrease in the vestibular imbalance, mainly due to a decrease in the response of the dominant vestibular side. Previously, we have shown the short-term effects of this maneuver on patients with recent onset vestibular imbalance. In the present study, we investigated the long-term effects of the rotational maneuver in patients with a history of peripheral vestibular vertigo for at least one year, originally confirmed by clinical tests. Our results show a significant improvement which lasted for \>4 weeks after the end of rehabilitation (i.e., the last time tested). Moreover, there seems to be a relationship between the decrease in DP values and a decrease in subjective symptoms. We propose that this maneuver can be used as an effective method for both short- and long-term rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* History of vertigo for at least one year
* Not under drug therapy for vertigo
* directional preponderance \>10% measured by electronystagmography during rotation test

Exclusion Criteria:

* severe vertigo
* intolerance to rotation
* previously diagnosed for a central pathology (e.g., neuroma)
* previously diagnosed with a fluctuating vestibular disorder (e.g., Menier's)
The Impact of 3D Patch One-Suture Fixation vs No Fixation on Chronic Pain and Recurrence in Ⅲ Inguinal Hernia

This study aims to compare the effects of one-stitch fixation and non-fixation of 3D patches on chronic pain and recurrence in type III inguinal hernia. The primary outcome measures include hernia recurrence, chronic pain, etc.


Eligibility Criteria:
Inclusion Criteria:

1. primary inguinal hernia
2. Type III inguinal hernia (internal annulus \>3cm)

Exclusion Criteria:

1. Age below 18 years or older than 80. recurrent hernia, incarcerated hernia,strangulated hernia, and other types of hernias.
2. Patients not suitable for general anesthesia.
3. Patients requiring open surgery.
4. patients requiring emergency surgery Loss to follow-up or communication difficulties, or poor compliance.
Intermittent Oro-esophageal Tube on Rehabilitation Therapy Compliance for Stroke

The aim of this clinical trial is to compare Rehabilitation Therapy Compliance of ischemic stroke patients who receive enteral nutrition support through either Intermittent Oro-esophageal Tube or Nasogastric Tube. Patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. The observation group will receive enteral nutrition support through Intermittent Oro-esophageal Tube, while the control group will receive it through Nasogastric Tube. Researchers will then compare Rehabilitation Therapy Compliance of the two groups.

The study will last 15 days for each participant. The aim of this clinical trial is to compare Rehabilitation Therapy Compliance of ischemic stroke patients who receive enteral nutrition support through either Intermittent Oro-esophageal Tube or Nasogastric Tube. Patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. The observation group will receive enteral nutrition support through Intermittent Oro-esophageal Tube, while the control group will receive it through Nasogastric Tube. Researchers will then compare Rehabilitation Therapy Compliance of the two groups.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years;
* meeting the diagnostic criteria of stroke;
* any degree of dysphagia at admission;
* steady vital signs, without severe cognitive impairment or sensory aphasia, able to cooperate with the assessment.
* transferred out within three weeks of hospitalization in the neurology department.

Exclusion Criteria:

* complicated with other neurological diseases;
* damaged mucosa or incomplete structure in nasopharynx;
* tracheostomy tube plugged;
* unfeasible to the support of parenteral nutrition;
* simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.
Minocycline in Primary Sclerosing Cholangitis (PSC)

The purpose of the study is to see how safe and effective minocycline is in the treatment of Primary Sclerosing Cholangitis (PSC).

The purpose of the study is to determine the safety profile of minocycline in patients with PSC and to compare the effects of minocycline on the baseline values of the following parameters: symptoms of pruritus and fatigue, liver biochemistries, Mayo Risk Score, the development of clinical progression and complications of liver disease.

Eligibility Criteria:
Inclusion Criteria:

* Both genders
* Females of childbearing age must have negative pregnancy test within 48 hours of participation and agreement to practice contraception for the duration of the study.
* Age 18 years old and \< than 75 years old.
* History of chronic cholestatic disease of at least 6 months duration.
* Serum alkaline phosphatase level at least 1.5 times the upper limit of normal.
* Cholangiography demonstrating intrahepatic and/or extrahepatic biliary obstruction, beading, or narrowing consistent with PSC.
* Liver biopsy consistent with the diagnosis of PSC.
* Patient's informed consent for study participation.

Exclusion Criteria:

* Treatment with tetracyclines, ursodeoxycholic acid, corticosteroids, colchicine, methotrexate, azathioprine, cyclosporine, chlorambucil, budesonide, pentoxifylline, pirfenidone, nicotine, tacrolimus, silymarin, vitamin E or prednisone in the preceding three months.
* Findings highly suggestive of hepatobiliary disease of other etiology complicating PSC.
* Anticipated need for liver transplantation in one year determined by the Mayo model with an estimate of \<75% one year survival without transplantation.
* Recurrent variceal bleeding, presence of ascites, or encephalopathy.
* Active drug or alcohol use.
* Pregnancy.
* Breast-feeding.
* Serum creatinine over 1.5 mg/dl.
* Prior history of allergic reactions to antibiotics belonging to the tetracycline family.
* Any condition that, in the opinion of the investigator, would interfere with the patient's ability to complete the study safely or successfully.
* Patients with active inflammatory bowel disease (IBD) requiring specific treatment in the preceding three months, except for maintenance therapy with 5-ASA compounds, or those individuals who have been involved in a trial evaluating any experimental drug for the treatment of IBD in the preceding three months.
* Recurrent ascending cholangitis requiring hospitalization in the past year.
Acute Postthoracotomy Pain - Impact of Gender

Adequate analgesia in thoracic surgery is essential to prevent severe postoperative complications, especially respiratory problems. Current knowledge about gender-related differences in pain states generally more frequent and intense pain and more demand for analgesics in women. Results about postsurgical pain in particular are very inconclusive.

The investigators tried to find out if gender has an influence on postthoracotomy pain and analgesics requirement.


Eligibility Criteria:
Inclusion Criteria:

* open lung surgery between July 2010 and December 2014

Exclusion Criteria:

* redo-thoracotomy
* chest wall or rib resection
* other approach than lateral thoracotomy
* additional incision at other site (e.g. laparotomy)
* chest trauma
* mesothelioma
* hemofiltration or haemodialysis
* longer than one day stay at intensive care unit
* pre-existent chronic pain and/or chronic opioid intake
* short stay in hospital
Program of Rehabilitative Exercise and Education to Avert Vascular Events After Non-disabling Stroke or Transient Ischemic Attack: A Multi-site RCT

The objective of the Program of Rehabilitative Exercise and Education to avert Vascular Events after Non-disabling stroke and Transient ischemic attack (PREVENT) Trial is to determine whether the timely delivery of secondary stroke prevention strategies will reduce modifiable vascular risk factors in two groups of people who have survived NDS or TIA. One group will receive a comprehensive education and exercise program (PREVENT); the other group will receive usual care (USUAL CARE). We will measure modifiable vascular risk factors in both groups. We will also compare the effects of PREVENT vs USUAL CARE on exercise capacity, walking endurance, and daily physical activity. In addition, we will compare thinking ability, depression, achievement of personal goals for healthy behavior, and health-related goal attainment and health-related quality of life. Finally, we will compare outcomes in urban and rural settings as well as costs of the PREVENT program and USUAL CARE in order to assess sustainability of the PREVENT program.


Eligibility Criteria:
Inclusion Criteria:

* Males and females
* Over 17 years of age.
* Diagnosis of first probable or definite TIA or non-disabling stroke (National Institutes of Health Stroke Scale \< 6)
* Post-event interval of \<90 days.
* Residence within 75 km of intervention site.
* Orientation to time, place and person and ability to follow simple 3-step commands.
* Ability and willingness to provide informed consent.

Exclusion Criteria:

* Evidence of intracranial hemorrhage on MRI or CT scan.
* Presence of contraindications to exercise testing and training, in accordance with American College of Sports Medicine Guidelines.
* Participation in another study that could potentially confound the outcomes of this trial.
Clinical Decision-Making and Virtual Reality Exercise

Degenerative lumbar spine disease (DLSD) is common in elderly individuals and can result in pain, muscle weakness, and paresthesia. Numerous studies have reported that patients with DLSD usually have postural balance instability, which may affect the patient's gait, functional activities, and quality of life. The investigators propose to achieve the following aims: (1) to develop a clinical balance diagnostic tool to identify patients with DLSD who may require lumbar surgery (2) to investigate the effects of virtual reality skateboard exercise training on gait and balance in patients with DLSD, as well as to compare them with asymptomatic participants.


Eligibility Criteria:
Inclusion Criteria:

* 1) able to stand and walk for 5 minutes independently
* 2) aged between 50 and 80 years
* 3) received a diagnosis of DLSD based on imaging

Exclusion Criteria:

* 1) previous lumbar surgery
* 2) neurological disorder such as stroke or spinal cord injury
* 3) metabolic disease such as diabetes mellitus
* 4) vestibular disease such as Meniere's disease.
Efficacy of Hylenex in the Treatment of Pain Among Hospice Patients

The overall aim of this study is to find out whether Hylenex recombinant (for short, Hylenex) in subcutaneous (SC) injection improves the speed and effectiveness of SC opioids in hospice patients. Specifically, this study proposes to compare the level of self-reported pain in hospice patients started on SC infusions of morphine and hydromorphone (Dilaudid) over the initial 8 hours of opioid infusion with and without the preceded co-injection of Hylenex. Hospice patients include both home-bound patients as well as those under intensive care in hospice houses.

As of January 2009, 58 patients were recruited to the study as study subjects. Target goals for the study is to recruit 88 subjects with full and accurate information with about 44 patients in the Hylenex group and another group of subjects in the control group.

Eligibility Criteria:
Inclusion Criteria:

1. Non-pregnant, non-lactating adults 18+ years enrolled in inpatient facilities at LifePath or Good Shepherd Hospice
2. Ability to provide informed consent; Patient has decision-making capacity (SPMSQ score 6+)
3. Ability to provide numerical report on pain level on pain scale
4. English-speaking
5. Pain not satisfactorily controlled with current meds -oral, topical, or rectal; Pain level greater than 3 at admission on a 0-10 scale
6. Able to self-administer bolus dose or ask someone to hit bolus button
7. Estimated life expectancy of 3 days or more
8. Patients appropriate for continuous SC infusion with either morphine or hydromorphone.

Exclusion Criteria:

1. History of allergy or hypersensitivity to Hylenex or any components of product
2. Patients on infusion therapy for pain management up to 14 days prior to entering inpatient facilities.
3. Patients who are actively dying identified by any of the following physical signs and symptoms:

   1. non-communicative or unresponsiveness; b) confusion/disorientation about time, place, and people; c) significant chest congestion with gurgling sounds; d) restless and repetitive motions; e) little or no food or fluid intake; f) minimal urine output and g) different breathing pattern, i.e., shallow rapid breaths with period of no breathing.
Safety Study to Assess Opiate Withdrawal Signs and Symptoms in Opioid Dependent Patients

This study will evaluate whether crushed EMBEDA capsules induce clinical opiate withdrawal signs and symptoms in opioid-dependent patients with chronic non-cancer pain who are stabilized on EMBEDA.

The decision to terminate the trial was due to a lack of study drug supply. Decision was not based on any safety concerns. The date of the notification of termination letter was March 11, 2011.

Eligibility Criteria:
Inclusion Criteria:

* Chronic moderate to severe non-cancer pain that has been treated with opioid analgesics for at least three months (with stabilized pain control and stabilized dose for 28 days prior to enrollment).
* Receiving an opioid dose equivalent to 20 mg - 120 mg morphine once or twice daily.
* Patient displays signs and symptoms of withdrawal (i.e., COWS score ≥5) following naloxone administration during the Naloxone Challenge.

If female and able to become pregnant, must use an approved method of birth control.

* Excluding the chronic moderate to severe non-cancer pain, the patient is judged by the Investigator to be in generally good health at screening based upon the results of a medical history, physical examination, laboratory profile, and 12 lead electrocardiogram (ECG).

Exclusion Criteria:

* Female who is pregnant or breastfeeding.
* Patient has a known allergy or history of significant adverse reaction to morphine, other opioids, naltrexone, acetaminophen, or related compounds.
* Patient is receiving systemic chemotherapy, has an active malignancy of any type, or has been diagnosed with cancer within the 5 years prior to screening (excluding squamous or basal cell carcinoma of the skin).
* History of, or ongoing, alcohol or drug abuse.
* Patient has made a donation of blood or has had a significant blood loss within 30 days prior to screening.
Effect of Chronic Catecholamine Overproduction on Brown Adipose Tissue

* To investigate the effect of catecholamine excess on brown fat.
* To evaluate the effect of brown fat on energy expenditure and lipid and glucose metabolism


Eligibility Criteria:
Inclusion Criteria:

* 10 patients with pheochromocytoma
* 5 patients with incidentaloma without hormone production
* Age \> 18 years

Exclusion Criteria:

- None
Relative Bioavailability Study in Healthy Male Subjects for ZD4054 (Zibotentan) Immediate Release Tablets.

This study is designed to see how different formulations of ZD4054 (Zibotentan) are absorbed by the body. As for all clinical trials, safety and tolerability of the drug will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Normal resting 12-lead ECG with normal QTc interval (\<450 msec)
* Negative screens for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV) at screening

Exclusion Criteria:

* Receipt of another new chemical entity in the 4 months before dosing in this study; participation in another study and participation in a non-invasive methodology study in which no drugs were given within 30 days before dosing in this study
* Risk (in the investigator's opinion) of transmitting, through blood or other body fluids, the agents responsible for acquired immune deficiency syndrome (AIDS), hepatitis B or hepatitis C
* Judgement by the investigator, that the healthy volunteer should not participate in the study
Genome, Proteome and Tissue Microarray in Childhood Acute Leukemia

We will study gene and protein expression in leukemia cells of children diagnosed with acute leukemia. We hope to identify genes or proteins which can help us grade leukemia at diagnosis in order to: (a) develop better means of diagnosis and (b) more accurately choose the best therapy for each patient.


Eligibility Criteria:
Inclusion Criteria:1. All children who present at Packard hospital with a new diagnosis or relapse of acute leukemia will be eligible. There is no bias in regards to age range, gender or ethnic background.

2. Signed informed consent
Density Lowering Effect of "OFS Add on to TMX"(DELFINO Trial)

DELFINO tial is designed to investigate the role of "OFS add on to TMX ", based on MMG density as a surrogate marker in premenopausal women

* Premise - MMG density as a surrogate marker of hormone therapy
* Assumption - "Add on OFS to TMX" would have further decrease of density

  * 3-arm(Observation arm + Randomised 2-arm), phase III, RCT with 1:1 allocation

Enroll : Sep03,2018\~(Planned N= 224)

1. Inclusion criteria

   * Premenopausal
   * ER+
   * Planned tamoxifen(TMX)
   * No planned ovary function suppression(OFS)
   * Regardless of ChemoTx
   * Mammography(MMG) density check via Volpara\*(=Baseline MMG density, BaMD) (\*Volpara= software to check MMG density)
2. Check MMG Density via Volpara After 1yr TMX (At1yrMD) Check menopausal status after 1yr TMX(Menstruation episode or FSH \<30)
3. MMG Density Reduction(MDR =BaMD-AtMD ) at 1yr
4. MDR ≥5% -\> Keep go on TMX MDR \<5% -\> 1:1 randomization -\> Keep go on TMX vs OFS add on to TMX
5. Analysis : 5yr MDR (1'endpoint), 5yr DFS(2'endpoint), 5yr OS
6. Calculation of patients' number In previous study(\<Kim et al. Breast Can Res 2012\>) MDR (Mammography Density Reduction) was found in about 50% of all patients who received endocrine therapy.

Expected

* MDR in "TMX only" cohort -\> 6 ± 7%
* MDR in "OFS add on to TMX" -\> 10 ± 7%

  * after 1yr, Significance level 5%, average MDR 4% difference, 80% power, 10% dropout rate =\> 1:1 randomization Number = 112(56:56) Total number = 224

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women, ER+ breast cancer, stage I\~III, underwent standard treatment including surgery, Planned TMX
* available MMG density check via Volpara

Exclusion Criteria:

* Bilateral breast cancer
* Prior endocrine therapy
* Postmenopausal status
* unavailable MMG density check via volpara before and after TMX