cyrilzakka/clinical-trials huggingface dataset:
Reducing Shoulder Complaints in Employees With High Occupational Shoulder Exposures

Aim: To evaluate the effectiveness of Shoulder-Café (intervention) compared to Shoulder-Guidance (control intervention) with respect to shoulder exposures and shoulder complaints.

Hypothesis: The Shoulder-Café, which unifies education, diagnostic clarification, supervised and home-based shoulder exercises, and advice from a health and safety consultant on workplace interventions, will reduce shoulder exposures and shoulder complaints more effectively than an individual-oriented control intervention with home-based shoulder exercises and written general advice on workplace interventions.

Introduction:

Shoulder complaints prevail in the working age population and constitute a common cause of contacts with general practitioners. In occupations with high mechanical shoulder exposures, these complaints are especially frequent. Persons with high occupational mechanical shoulder exposures and shoulder complaints seem an obvious target group for secondary prevention efforts, and more research on interventions targeting shoulder complaints in occupations with high shoulder exposures is needed.

The aim is to develop and evaluate a Shoulder-Café intervention to reduce high occupational mechanical shoulder exposures and prolonged shoulder complaints.

The specific objectives are:

I. To evaluate the effectiveness of the Shoulder-Café as compared to the control-intervention, the Shoulder-Guidance, measured on reductions in shoulder complaints.

II. To evaluate the effectiveness of the Shoulder-Café as compared to the Shoulder-Guidance measured on reductions in occupational mechanical shoulder exposures.

III. To identify the influence of shoulder exercises and reduced occupational mechanical shoulder exposures, respectively, on shoulder complaints.

The hypothesis is that the Shoulder-Café will reduce shoulder exposures and shoulder complaints more effectively than the Shoulder-Guidance. Furthermore, a hypothesis is that fear avoidance beliefs is reduced and the degree to which the participants feel informed about the nature of their complaints and their remedies is increased more effectively with the Shoulder-Café compared to the control intervention.

Method:

The project consists of a two-armed, cluster-randomised controlled trial with randomisation at company level (objectives I and II) and a prospective cohort study based on the cluster-randomised study (objective III).

Follow-up: A questionnaire 3 and 9 months after end of intervention with e.g. OSS.

Eligibility Criteria:
Inclusion Criteria:

* Adults
* Employed in occupations with expected high mechanical shoulder exposures (industry, construction and service)
* Shoulder complaints
* Able to read and understand Danish

Exclusion Criteria:

* Previous shoulder surgery
* Breast cancer operation
* Pregnancy
* Sickness absence expected to continue into the intervention period
Methods Study to Characterize Early Indicators of Weight Loss in People

Methods study to characterize early indicators of weight loss in people.


Eligibility Criteria:
Inclusion Criteria:

* Subjects \>=18 years of age with BMI \>= 30 and \< 40 kg/m2

Exclusion Criteria:

* Females, those with illnesses expected to cause weight loss, those without stable body weight within 3 months of screening.
Virtual Reality Education Module in Reducing Anxiety and Increasing Knowledge in Patients With Prostate Cancer Undergoing Radiation Therapy

This pilot clinical trial studies a virtual reality education module in reducing anxiety and increasing knowledge in patients with prostate cancer undergoing radiation therapy. A virtual reality education module may be useful in helping patients understand what they can expect to happen during their radiation treatments and help reduce stress relating to the radiation treatments.

PRIMARY OBJECTIVES:

I. To determine if a virtual reality education module for prostate cancer patients is effective in increasing patient comprehension and decreasing patient anxiety related to radiation treatments.

SECONDARY OBJECTIVES:

I. This pilot study could have implications for a broader patient base undergoing radiation therapy.

Eligibility Criteria:
Inclusion Criteria:

* English speaking males capable of giving informed consent
* Must be able to read English language
* Receiving pre-treatment cone beam and volumetric modulated arc therapy (VMAT) for prostate cancer on the "A" or "B" treatment machines at the Bodine Center
* Must be able to walk two city blocks
* Must not have any auditory or visual deficits

Exclusion Criteria:

* If inclusion criteria are not met
* Previous radiation therapy treatment
* Employment in radiation oncology
The Feasibility and Safety of Avoiding Chest Tube Placement After Video-assisted Thoracoscopic Surgery (VATS）of the Lung

This is a prospective randomized controlled trial.The main study content is the feasibility and safety of avoiding chest tube placement after Video-Assisted Thoracoscopic Surgery lung disease,participants were randomly divided into experimental group and control group.Avoiding chest tube placement after VATS of the lung in the experimental group.Indwelling thoracic drainage tube after VATS of the lung in the control group.

This is a prospective randomized controlled trial.The main study content is the feasibility and safety of avoiding chest tube placement after VATS of the lung,divided into experiment group and control group.Communicating with surgeon and patients who met the inclusion criteria,decided whether to enter the experimental group or control group. Experimental group avoid chest tube placement after VATS of the lung and control group indwell thoracic drainage tube after VATS of the lung.By collecting personal information of two groups of patients and the corresponding observation indicators to analyze whether the treatment of avoiding chest tube placement after VATS of the lung is more beneficial than the conventional indwell thoracic drainage tube after VATS of the lung,and it's safe and feasible.

Eligibility Criteria:
Inclusion Criteria:

- 1.Age ranges from 18 to 75 years old,do the examination of chest CT showed pulmonary disease,no invasion of peripheral blood vessels and viscera,no pleural effusion and pericardial effusion.

2.Electrocardiogram, pulmonary function,color doppler ultrasound of the heart,arteries and veins of both lower limbs are normal,no potential infection was confirmed before surgery, no serious organic disease of the heart and lung,and no obvious operation contrain.

Exclusion Criteria:

* 1.The lungs continue to leak air preoperation more than six days. 2.The appearment of the hemothorax,empyema and chylothorax preoperative. 3.The appearment of the preoperative chest X-ray pulmonary atelectasis and pulmonary infection.

  4.The lungs leak air appears in the surgery. 5.Patients with severe cardiovascular and cerebrovascular accident after operation were terminated.

  6.Impaired lung function (forced expiratory volume in 1 second \[FEV1\]\<60% predicted).
Darunavir Levels, Virological Efficacy, Proviral ADN and Resistances in Patients on Darunavir/Ritonavir Monotherapy

To evaluate the relationship between plasma and intracellular darunavir (DRV) concentrations and virological efficacy in HIV-infected patients on DRV/rtv monotherapy.

To be enrolled, subjects had a plasma HIV-RNA \<50 copies/mL for at least 6 months based, virologic failure while on a PI-containing regimen was allowed if the genotypic resistance tests showed no major resistance mutation associated to reduced susceptibility to DRV/rtv according to the International AIDS Society. Patients with transitory episodes of detectable plasma HIV-RNA viral load ("blip") preceded and followed by a plasma viral load \<50 copies/mL without changes in antiretroviral treatment could also been included. The only exclusion criteria were pregnancy, hepatitis B coinfection and the concomitant use of drugs with potential major interactions with DRV/rtv pharmacokinetics.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years, starting an antiretroviral regimen based on darunavir-ritonavir (800/100 mg) once daily monotherapy between June 2010 and September 2010
* Plasma RNA-VIH \< 50 copies/ml on stable antiretroviral treatment for ≥ 6 months
* Absence of resistance mutations in the protease gene, based on treatment history and/or genotypic resistance testing. that would decrease darunavir susceptibility

Exclusion Criteria:

* Pregnancy
* Chronic B hepatitis
* Genotypic resistance tests with evidence of resistance mutations in the protease gene that would decrease darunavir susceptibility
* Concomitant use of drugs with potentially adverse interactions with darunavir-ritonavir pharmacokinetics, such as rifampin
Study of Different Doses of Irinotecan and Cisplatin for First-line Extensive-stage Small-cell Lung Cancer Treatment

The purpose of this study is to identify the appropriate dose of irinotecan by dose escalation(dose climbing) test. The study would provide rationale for regimen decision in a future phase III clinical trial, in which irinotecan combined with cisplatin(IP) will be selected as therapeutic drugs.

To determine the Maximum Tolerated Dose (MTD) and Limiting Toxicity (DLTs) of irinotecan in patients with extensive stage small cell lung cancer treated with irinotecan plus cisplatin

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 65 years, male and female
2. Histologically or cytologically confirmed extensive stage .small cell lung cancer(SCLC )（except metastases only as pleural effusion）
3. No prior chemotherapy
4. Metastatic lesion had been treated more than 14 days by palliative radiation therapy or surgery
5. With measurable tumor lesions (Non-irradiated parts),(RECIST 1.1: Without radiotherapy ,the longest diameter is more than 10mm by CT or MRI ,except that lymph nodes need short diameter need more then 15mm, and the lesions can be accurately evaluated repeatedly measurable)
6. Eastern Cooperative Oncology Group(ECOG) Performance Status 0-1
7. Expected survival ≥ 3months
8. Marrow,kidney, liver,heart and lung are well -functioning,and absolute count of

   * absolute neutrophil coun(ANC) ≥ 2.0 × 109 / L
   * blood platelet(PLT) ≥ 100 × 109 / L
   * Hb≥ 90g / L
   * conjugative bilirubin(CB)≤ upper limit of normal(ULN) × 1.5
   * Aspartate transaminase(AST )(glutamic oxalacetic transaminase,GOT): ≤ upper limit of normal(ULN )× 2.5
   * Alanine aminotransferase(ALT)(Glutamate Pyruvate Transaminase,GPT): ≤ ULN × 2.5
   * Serum creatinine: ≤ ULN or calculated creatinine clearance≥ 60 ml / min
   * (PT INR) ≤ ULN × 1.5
   * ECG: no abnormalities in need of treatment
9. No pregnancy or no pregnancy demand at the end of the study within six months
10. Must provide written informed consent.

Exclusion Criteria:

1. Patient have platinum compounds allergy history
2. Patient with active ulcer disease or chronic enteritis patients
3. Primary lesion(s) has (have) been treated by Surgery or radiation
4. Patient had received Immune drugs treatment for anti-lung cancer indications or anti-cancer Chinese traditional medicine treatment within two weeks
5. Patients with interstitial pneumonia or pulmonary fibrosis
6. Brain metastasis requiring treatment
7. Patient with bronchus or bronchial stenosis or blockage and superior vena cava syndrome caused by serious invasion
8. Patients with severe infections, severe abnormal secretion of (Anti Diuretic Hormone,ADH) syndrome, poorly controlled diabetes, severe complications requiring treatment vena cava syndrome
9. Severe cardiovascular disease: hypertension that medical treatment can not be controlled , unstable angina, myocardial infarction within the last June a history of congestive heart failure\> 3 (NYHA) and severe arrhythmia
The Effect of Acupuncture Treatment on the Perception of Pain and Coping With Pain

The Purpose of this study is to evaluate whether cognitive and emotional components take part in the positive acupuncture effect on pain.

The effect of acupuncture on pain intensity has been already investigated and confirmed. Recent publication (Pariente J., et a., 2005) indicated that acupuncture may affect midbrain areas, that are associated with cognitive control of pain.

The Pain Self Regulation Model (Levental, 1980)distinguishes between emotional response pain representations and cognitive pain representations. According to this model, emotional and cognitive pain representations leads to a new (cognitive or emotional) evaluation of the pain, that affects its perception and the ability to cope with it (Levental at al., 2001).

This study will try to assess the hypothesis that acupuncture treatment is involved in this process.

The study is designed as pilot study, limited to 45 patients.

Eligibility Criteria:
Inclusion Criteria:

* patients suffering from pain,who are reffered for acupuncture treatment,and consented to participate in this study

Exclusion Criteria:

* children under 18 years of age
Effect of Adjunctive Metformin on Recurrence of Non-DM Colorectal Cancer Stage II High-risk/ III Colorectal Cancer

The aim of this study is to identify the effect of adjunctive metformin on recurrence of non-DM Stage II High-risk/ III colorectal cancer. This study is open-label randomized controlled study.

The primary endpoint is to compare the 3-year disease free survival between metformin group and non-metformin group. The secondary endpoint is to compare the 5-year overall survival and disease specific survival between two group, to identify the safety of metformin, and to compare the recurrence rate of polyps after polypectomy between two groups.


Eligibility Criteria:
Inclusion Criteria:

1. patients with stage II high-risk/ III colorectal cancer who were taken an operation for cure, or patients with stage III rectal cancer who were taken an chemoradiation therapy and subsequently operation
2. age 20 - 80 years
3. patients without DM
4. patients who have well performance status for chemotherapy
5. patients who are agreed the study protocol

Exclusion Criteria:

1. patients with DM
2. patients who were diagnosed other cancers (≥ stage II) within 5 years
3. patients who have familial adenomatous polyposis, hereditary non-polyposis colorectal cancer, or inflammatory bowel disease
4. patients who are taken other chemoprevention drugs (ex. NSAIDs, Aspirin)
5. patients who have risk factors to increase lactic acidosis which are renal disease, lung disease, liver disease, or infectious disease
6. Creatinine ≥ 1.5mg/dL (for male), ≥ 1.4mg/dL (for female)
7. patients with congestive heart failure which is needed to treat
8. patients who have allergic history of metformin
9. pregnancy
Microwave Ablation Versus Laparoscopic Hepatectomy for 3-5cm Hepatocellular Carcinoma

As the most common subtype of liver cancer (85% \~ 90%), HCC is highly malignant; thus, one of the crucial issues in HCC management is an effective therapy for tumors at an early stage, which is vital for improving the prognosis of patients. For ≤3cm HCC, ablation has been recommended by international guidelines as a first-line or alternative treatment because of similar survival outcomes and milder liver function injury with liver resection (LR). However, the appropriate treatment options for 3-5cm HCC remain controversial. Thus, none of the international guidelines recommend ablation as a first-line treatment for 3-5cm HCC. In the past few decades, treatment for HCC has tended to be less invasive, have fewer complications, and have higher cost-effectiveness. Compared with LR, laparoscopic Hepatectomy (LH) demonstrates the advancement of minimal invasion. As another minimally invasive technique for HCC, Microwave Ablation (MWA) has the potential to eradicate larger HCCs with larger coagulation areas and is less affected by the heat sink effect caused by vessels around the tumor. Many studies have identified the potential advantages of MWA over other ablation techniques. However, to date, no clinical studies have compared the efficacy of LH and MWA therapies for 3-5cm HCC with periodic progression.


Eligibility Criteria:
Inclusion Criteria:

i) age ≥18 years ii) all patients with an initial diagnosis of 3-5cm HCC(within 3 tumors, at least one 3-5cm) by histopathology iii) Child-Pugh class A or B iv) no vascular invasion or distant metastasis v) no other malignant neoplasms within the last 5 years

Exclusion Criteria:

i) age \<18 years ii) Child-Pugh class ≥B iii) vascular invasion or distant metastasis iv) with other malignant neoplasms within the last 5 years
The Mini-Screw as Orthodontic Anchoring: Survival, Clinical Efficiency and Experience of the Patient

This is a clinical trial to evaluate the mini-screw as orthodontic anchoring. This trial will study implant survival, clinical efficiency and experience of the patient.


Eligibility Criteria:
Inclusion Criteria:

* 10-70 years of age
Reconstruction of 12-Lead Electrogram From Intracardiac Signals From Defibrillators During or After Implantation

The purpose of this study is to reconstruct a 12-lead electrocardiogram (ECG) from intracardiac (IC) electrograms (EGM) obtained from defibrillator devices (ICD). The purpose of such a reconstruction is to allow the use of IC EGM for diagnosis of clinical conditions for which ECG have historically been used, and to test the feasibility of a reconstruction technique for the standard 12-lead or extended electrocardiogram from electrical potentials obtained from inside a patient.

Reconstructing a 12-lead surface ECG from intracardiac EGM vectors of patients implanted with defibrillators can be of great value. It allows implantable devices that have thus far been used exclusively for arrhythmia detection and treatment, to be used for diagnostic purposes in similar ways as the ECG. The advantage of the reconstruction process is that it provides real-time continuous monitoring, which can be used for multiple purposes, including but not limited to:

1. Ischemia detection
2. Myocardial Infarction detection
3. Electrolyte abnormalities detection
4. Assessment of effect of medications
5. Improved rhythm discrimination

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be at least 18 years of age.
2. Subjects must be referred for ICD implantation or already have an ICD implanted..
3. Subjects must be willing to sign informed consent.

Exclusion Criteria:

1. Subject is unable or unwilling to sign informed consent.
2. Subject is pacemaker dependent.
3. Subject is pregnant as indicated by standard clinical procedures prior to implant.
The Effect of Physostigmine on Cognitive Functioning in the Immediate Period After Sedation for Colonoscopy

The purpose of this study is to determine whether the administration of physostigmine in combination with sedation for colonoscopy can minimize the cognitive decline at the time of hospital discharge

Physostigmine, a tertiary cholinesterase inhibitor, which prevents the breakdown of ACh by inhibiting the enzyme acetylcholinesterase (AChE), crosses the blood-brain barrier (BBB), and elevates brain ACh levels. Physostigmine has been shown to improve attention, and performance in working memory. It has also been shown to produce analgesia following systemic or central administration.

Patients undergoing colonoscopy under sedation of propofol and fentanyl show cognitive decline in the immediate period following the procedure. In this study, half the patients will receive physostigmine in combination with the sedation, and their cognitive functioning at the time of hospital discharge will be assessed by standard neuropsychological tests, and compared to that of patients without physostigmine.

Eligibility Criteria:
Inclusion Criteria:

* Over18 years old
* ASA I-III
* Fluency in Hebrew, Russian, or Arabic
* Absence of serious hearing or vision impairment

Exclusion Criteria:

* History of head trauma, neurological diseases, alcoholism, drug abuse, consumption of psychotropic drugs or antidepressants
* Heart failure (NYHA \> 3)
* Liver failure
* Respiratory problems (asthma, etc.)
The EEG Study Under Remimazolam Anesthesia in Children

The effect of Remimazolam on brain electrical activity. Previous studies have shown that in healthy male volunteers, EEG changes during Remimazolam infusion are characterized by an initial increase in the beta band and a later increase in the delta band. When monitoring the depth of anesthesia, the commonly used Bispectral Index in clinical practice was originally developed for propofol. Therefore, studies have shown that the correlation between the depth of sedation of benzodiazepines such as midazolam and Bispectral Index is weak. In contrast, the beta wave ratio is considered a more suitable EEG indicator for monitoring the sedative effect of Remimazolam. The above indicates that Remimazolam has a specific pattern of influence on EEG activity, especially in the regulation of anesthesia depth, with unique characteristics.

This study is a prospective, observational study.Children undergoing elective general anesthesia with Remimazolam will be divided into three groups (1-3 years old, 4-6 years old, 7-12 years old) based on their age range, with 20 cases in each group.Inform the family of the general research plan and obtain informed consent. Main outcome measure: Time frequency characteristics of electroencephalography (EEG) in children of different age groups under general anesthesia withRemimazolam (including anesthesia induction, maintenance, and recovery periods).

Eligibility Criteria:
Inclusion Criteria:

1. aged 1 years-12 years; 2, with American Society of Anesthesiologists (ASA) physical status I or II; 3, children requiring general anesthesia under remimazolam; 4, parents or legal guardians of children who volunteered to participate in the trial; And signed the informed consent form.

Exclusion Criteria:

1. Congenital malformation or other genetic conditions that are thought to affect brain development ;
2. History of severe heart, brain, liver, kidney and metabolic diseases ;
3. Premature infants (≤32 weeks);
4. Upper respiratory tract infection in the last two weeks. -
Preliminary Effectiveness of Remotely Monitored Blood Alcohol Concentration Device as Treatment Modality

State the scientific aim(s) of the study, or the hypotheses to be tested. The purpose of the current study is to evaluate the usage and acceptability of the Soberlink's blood alcohol concentration (BAC) unit in collaboration with Aware treatment to assess increased sobriety within patients suffering from alcohol use disorder (AUD).

The specific AIMS will be:

1. To determine the effectiveness of Soberlink's ability to increase abstinence
2. To evaluate the impact of Soberlink's device on the participant based on their quality of health and sobriety.
3. To evaluate the extent to which need for higher levels of follow-up care and treatment is reduced for individuals who have had access to the Soberlink device.


Eligibility Criteria:
Inclusion Criteria:

* are at least 21 years old,
* currently enrolled at Aware In home treatment,
* Primary or secondary DSM-5 diagnosis of alcoholism use disorder (AUD).

Exclusion Criteria:

* Current suicide or homicide risk,
* meet criteria for DSM-IV current psychotic disorder, or bipolar disorder,
* does not have phone access with text message capabilities
* Unable to read or understand English,
* Unable to complete the study because of anticipated incarceration or move,
* Life-threatening or unstable medical problems,
* No course of current or pending legal action,
* Soberlink results being used for child custody or legal circumstance.