cyrilzakka/clinical-trials huggingface dataset:
Accuracy of Accuhaler Tester, Ellipta Tester and Turbutester in Patients with Chronic Obstructive Pulmonary Disease

The goal of this observational study is to investigate the accuracy of Accuhaler tester, Ellipta tester and Turbutester in patients with chronic obstructive pulmonary disease (COPD). The main question it aims to answer is:

• Do Accuhaler tester, Ellipta tester, and Turbutester demonstrate comparable accuracy to the In-check DIAL for assessing inspiratory inhalation force in COPD patients?

This study is a cross-sectional study. COPD patients aged 40 years or older will be included. Peak inspiratory flow rate (PIFR) will be assessed using In-check DIAL as the standard tool. PIFR will be tested in each patient using Accuhaler tester, Ellipta tester and Turbutester.

Eligibility Criteria:
Inclusion Criteria:

* COPD diagnosis with confirmed by post-bronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) \<0.7
* Age 40 years or older
* Smoking history 10 pack-years or more

Exclusion Criteria:

* COPD exacerbation within 3 months
* Oral or intravenous corticosteroid treatment within 6 weeks
* Inability to perform assessment of peak inspiratory flow rate
* Asthma
* Tracheostomy, invasive or noninvasive mechanical ventilation
Effects of Low Dose Buprenorphine on Recovery After Hip or Knee Arthroplasty

Buprenorphine is a highly lipophilic thebaine derivative that appears to have high affinity for mu-, kappa-, and delta-opioid receptors and low affinity for opioid receptors like 1 -receptors. It acts as a partial agonist at the mu-opioid and as a partial agonist/antagonist at the kappa-opioid, and as an antagonist at the delta opioid receptors. Buprenorphine has up to two-fold duration of action and it is approximately 30-fold more potent when compared to morphine.

Pain is a common problem in patients coming to joint arthroplastic surgery. Buprenorphine low dose patches are recommended for treatment of moderate pain for example osteoarthritis pain. It is known that well treated pain even preoperatively may prevent prolonged postsurgical pain.

In the present study the effects of low dose buprenorphine on postoperative pain and recovery were assessed.


Eligibility Criteria:
Inclusion Criteria:

* no pregnancy/lactation, reliable contraception before menopause
* elective knee or hip arthroplasty surgery
* BMI (=body mass index) 18-35 kg/m2
* obtained informed consent

Exclusion Criteria:

* buprenorphine medication
* allergy to study drugs• ikä \< 18 tai \>75 years

  * BMI \<18 tai\>35 kg/m2
  * weight below 50 kg
  * Other contraindication for the study drug
Effect of the Postoperative Trendelenburg Position on Chronic Subdural Hematoma Recurrence

Objective: Determine the effect of the postoperative trendelenburg position on the recurrence of chronic subdural hematoma (CSH) in patients undergoing surgery.

Materials and Methods: An open-label, randomized, controlled clinical trial was conducted in three hospitals in Medellín. Patients with CSH were enrolled and assigned to the trendelenburg position (30° leg elevation and 10° head tilt) or a flat bed for 24 hours postoperatively. CSH recurrence was measured at 3 months, along with functional outcome (modified Rankin scale), adverse events, and comfort (Likert scale).

Objective: Determine the effect of the postoperative trendelenburg position on the recurrence of chronic subdural hematoma (CSH) in patients undergoing surgery.

Materials and Methods: An open-label, randomized, controlled clinical trial was conducted in three hospitals in Medellín. Patients with CSH were enrolled and assigned to the trendelenburg position (30° leg elevation and 10° head tilt) or a flat bed for 24 hours postoperatively. CSH recurrence was measured at 3 months, along with functional outcome (modified Rankin scale), adverse events, and comfort (Likert scale).

Eligibility Criteria:
Inclusion Criteria:

* The study included patients aged 18 years or older who required surgical management of symptomatic CSH confirmed by CT scan and whose informed consent was given by the patient or responsible family member to participate in the study

Exclusion Criteria:

* Pregnant or breastfeeding
* Conditions in which the trendelenburg position might not be safe, such as intracranial hypertension without a drain to allow evacuation of the hematoma, cardiovascular instability (severe heart failure, unstable angina, cardiogenic pulmonary edema), acute respiratory distress syndrome without a secure airway, glaucoma, spinal cord trauma not stabilized with surgery, peripheral vascular disease,
* History of ipsilateral chronic subdural hematoma drainage, intracranial hypotension syndrome, ventriculoperitoneal shunting
* Simultaneous participation in any other clinical trial.
A Study to Assess the Safety, Tolerability, and Interactions of ABBV-CLS-616 Oral Tablets in Healthy Adult Participants

This is a Phase 1, first in human, randomized, four-part study to investigate the safety, tolerability, and pharmacokinetics of ABBV-CLS-616 after oral dosing in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Part 2 only: Participant must have normal platelet count at screening and upon initial confinement.
* Part 2 only: Participant must not have known or suspected coagulopathy, or prothrombin time (PT)/activated partial thromboplastin time (aPTT)/international normalized ratio (INR) values outside of normal range at screening.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, neurological examination, ophthalmic examination (Part 2 only) laboratory profile and a 12-lead Electrocardiogram.

Exclusion Criteria:

* Part 2 only: Clinically significant active or recurrent ocular disease.
* History of lumbar puncture and/or collection of cerebrospinal fluid within 30 days prior to Screening.
* History of current condition of chronic lower back pain.
* Evidence of conditions that might preclude the subject from undergoing a lumbar puncture.
* History: of clinically significant neurological epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, coagulopathy, or any uncontrolled medical illness.
* History of suicidal ideation within one year prior to study drug administration as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia Suicide Severity Rating Scale completed at Screening, or any history of suicide attempts within the last two years.
Nursing Intervention for HIV Regime Adherence Among People With Serious Mental Illness (SMI)

The purpose of this research study is to investigate how nurses can best help people with serious mental illnesses (SMI) follow their HIV treatment plans.

There is concern that HIV positive SMI persons may be a greater risk for poor treatment adherence, increasing risk for poorer outcomes and development of treatment resistance virus, and also placing others at greater risk. Involvement of advance practice nurses has been previously shown to improve outcomes for persons with HIV/AIDS.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of serious mental illness; HIV positive

Exclusion Criteria:

* None
Effect of a Higher Than Maximum 450IU Gonadotropin Dose in an In-vitro Fertilization Cycle

This goal of this study is to evaluate the outcomes from in vitro fertilization cycles where a 450 IU daily dose of gonadotropins is administered compared to those where a 600 IU daily dose is administered for women who are at risk of a poor ovarian response in order to determine if one dose or the other results in improved cycle outcomes.


Eligibility Criteria:
Inclusion Criteria:

* RESIDENT OF CANADA
* Premenopausal
* Age 40 years or less at the time of enrollment
* At risk of a poor ovarian response defined as: either \<5 oocytes or \<8 follicles in a previous cycle, FSH \> 10 IU/L, AMH \< 1 pg/ml , antral follicle count less or equal to 8 or previous IVF cancellation
* Primary infertility or secondary
* Not previously undertaken a cycle that was included in this study

Exclusion Criteria:

* Simultaneous participation in another clinical trial
* Body mass index (BMI) \> 38 kg/m2
* Early follicular phase (day 2-4) serum FSH level \> 20 mIU/ml
* Any contraindication to being pregnant and carrying a pregnancy to term
* Contraindication for the use of Estrace® , Suprefact®, Menopur®, Bravelle®, hCG, and luteal phase support medication
* Any ovarian or abdominal abnormality that may interfere with adequate transvaginal ultrasound evaluation
* Administration of any investigational drugs within three months prior to study enrollment
* Patient not able to communicate adequately with the investigators and to comply with the requirements of the entire study
* Positive results of screening of either partner for HIV antibodies, Hepatitis B (other than for surface antibodies present after vaccination) or Hepatitis C
* Unwillingness to give written informed consent
Efficacy of Olanzapine on Weight Gain in Advanced Gynecologic Cancer with Paclitaxel and Carboplatin: a Double Blind, Placebo-controlled Randomized Trial

* Efficacy of olanzapine on weight gain in advanced stage gynecologic cancer
* Proprotion of pateints in advanced stage gynecologic cancer who recieving paclitaxel and carboplatin chemotherapy gain weight on olanzapine or placebo

-Proprotion of pateints in advanced stage gynecologic cancer who recieving paclitaxel and carboplatin chemotherapy gain weight on olanzapine or placebo

Eligibility Criteria:
Inclusion Criteria:

* Advanced stage gynecologic cancer receiving Paclitaxel and carboplatin chemotherapy
* ECOG 0-1
* Normal CBC,Liver, renal function
* Communication in Thai language or Thai caregiver
* Inform consent

Exclusion Criteria:

* Pregnancy
* Active infection
* Bowel obstruction or history of bowel surgery
* On dopamine receptor antagonists or psychiatric or anticonvulsant medication
* Olanzapine allery
* Abnormal function of liver and renal
* Diabetic melitus or morbid obesity
* patient can't selfcare
L-Cysteine in Peritoneal Dialysis

Over the last decades, peritoneal dialysis has grown worldwide to become one of the most common modalities of renal replacement therapy, particularly in developing or newly industrialized countries, such as India, China, Korea, Turkey, Malaysia, Mexico and Brazil. Peritoneal dialysis has been associated with an initial survival benefit compared to hemodialysis, although this advantage becomes less apparent over time, likely due to the progressive loss of residual renal function and the development of pathological alterations of peritoneum . Recent results suggest that an antioxidant therapy by N-acetyl-cysteine oral supplementation may improve residual renal function in peritoneal dialysis patients. This finding may have major clinical relevance, as preserving residual renal function in peritoneal dialysis patients has been associated with improved survival . Aim of the present randomized, double-blind, crossover study is to confirm the preliminary evidence of the beneficial effects of antioxidant agents on residual renal function by using the L-enantiomeric form of cysteine in 10 prevalent peritoneal dialysis patients with residual diuresis.


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged ≥ 18 years;
* Chronic automated peritoneal dialysis;
* Residual 24-hour diuresis ≥ 100 ml with less than 30% changes over the three months preceding randomization;
* Written informed consent.

Exclusion Criteria:

* Chronic automated peritoneal dialysis therapy since less than three months;
* Diabetes mellitus;
* Acute peritonitis during the three months before enrollment;
* Concomitant treatment with other antioxidant agents (including N-acetyl-cysteine and vitamin C);
* Cystinuria;
* Pregnancy or breastfeeding;
* Childbearing potential without reliable contraceptive methods during the whole study period;
* Alcohol or drug (excluding tobacco) abuse;
* Inability to comply with the study procedures during the whole study period, legal incapacity;
* Cancer and any severe systemic disease or clinical condition that may jeopardize data interpretation or completion of the study.
Registry of Coronary Lithotripsy in Spain.

The REPLICA TRIAL tries to assess the intracoronary lithotripsy safety and efficacy profiles in real-world patients with calcified coronary artery disease.

The REPLICA TRIAL tries to assess the intracoronary lithotripsy safety and efficacy profiles in real-world patients with calcified coronary artery disease requiring percutaneous revascularization with stent implantation.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age.
* Patients with calcified coronary artery disease requiring percutaneous revascularization with stent implantation who, at the operator's discretion and according to the hospital routine clinical practice, require an ICL with the Shockwave catheter.
* The patients have been informed of the study characteristics and have given their written informed consent.

Exclusion Criteria:

* Refusal to participate in this study.
* Patients whose life expectancy is \< 1 year.
* Patients with hemodynamic instability with Killip class III or IV.
Telephone Care Coordination for Smokers in VA Mental Health Clinics

The purpose of this study is to evaluate whether a smoking cessation telephone care coordination program is effective and feasible in VA Mental Health Clinics.

Smoking is the leading preventable cause of death in the United States and is a particular problem among VA users and among persons with a diagnosed mental illness. The prevalence of smoking among VA mental health patients has remained high, in part because smoking cessation treatment rates have remained low. Telephone-based counseling represents the most feasible approach to increasing smoking cessation treatment among VA patients. The approach used in this study has been used very effectively in a primary care-based population that includes a large percentage of mental health patients. This project would target the program specifically at patients seen in VA Mental Health Clinics.

Eligibility Criteria:
Inclusion Criteria:

* Smokers who are referred from Mental Health Clinics in VA VISNs 1 and 3.
* Patients must have access to a telephone and a regular mailing address.

Exclusion Criteria:

* No access to a telephone
* no mailing address
* not receiving care from a VISN 1 or VISN 3 Mental Health provider
Rehabilitative Management of Mastication

The purpose of this study is to verify the effectiveness of a systematic rehabilitative program for mastication in patients submitted to orthognathic surgery.

Orthognathic surgery can produce complications during the postoperative period - i.e. situations of acute pain and inflammation - as a consequence of fractures and incisions in the mucosa. The inadequate management of soft tissue and prolonged surgical time could be the causes of acute facial oedema, hematoma and ecchymosis in the face and neck, as well as functional disorders involving swallowing and breathing, which can affect patients' integrity.

Despite the fact that decreased muscular extensibility and strength, increased muscular fatigability, hipomobility, and alteration of the biomechanical efficiency and length of the masticatory muscles are documented clinical consequences, no systematic method of obviating such problems through muscular rehabilitation has yet been published

Eligibility Criteria:
Inclusion Criteria:

* Skeletal Class III orthognathic surgery patients
* adults (age above 18 years)
* agreement to perform orthognathic surgery
* agreement to undergo all of the necessary procedures determined by the multidisciplinary team

Exclusion Criteria:

* previous orthognathic surgery
* previous head and neck surgery
* neurologic and/or systemic diseases
* facial trauma
* syndromes
* cognitive impairment
* communication and hearing deficits
Study of a Drug [DCVax (tm)-Prostate] to Treat Prostate Cancer When Hormone Therapy is no Longer Effective.

The purpose of this clinical research study is to assess the safety and efficacy of an investigational therapy called DCVax(TM)-Prostate.

Patients with hormone refractory prostate cancer are eligible if they have a rising PSA or three or fewer metastatic lesions. The experimental therapy uses a patient's own white blood cells and "teaches" the cells to recognize a "flag" on prostate cancer cells. This may help the immune system destroy prostate cancer cells. Side effects reported from the Phase I/II trial include skin reactions of redness, pain \& swelling at the injection site, and short-lived headache, fever \& fatigue. Full details are available in the informed consent.

Eligibility Criteria:
Inclusion Criteria

* Hormone refractory prostate cancer (HRPC) \&#8211; progressive disease despite androgen deprivation and serum testosterone \<50ng/dL; progression defined as either:

  1. Rising PSA over 6 months with at least a 50% increase between the 1st and 3rd measurement, and the 3rd measurement \>2.0 ng/ml; or
  2. Progression of metastatic lesion on bone scan, or
  3. Progression of lymph node metastasis by CT scan.
* Zubrod or ECOG performance status of 0-1.
* Three or fewer bone metastases on a bone scan with minimal symptoms.
* No lymph node lesions greater than 3.0 cm at longest diameter.
* Adequate hematological, hepatic and renal function.

Exclusion Criteria

* History of other active malignancy.
* Prior chemotherapy, radiation therapy, immunosuppressive or investigational therapy for metastatic disease in previous 12 months.
* Strong opioids, immunosuppressives, megestrol acetate or other estrogenic hormones (e.g., Saw Palmetto, PC-SPES) within 1 month prior to enrollment.
* Brain, liver, or lung metastases; uncontrolled heart, liver, lung, or renal diseases or other serious illness.
* Prior splenectomy.
* History of severe asthma, anaphylaxis, or other serious adverse reactions to vaccines or any of the antigens included in the skin test.
* History of moderate to severe lower limb lymphedema, or recent signs of deep venous thrombosis (DVT) or thrombo-embolic disease, or impending stroke.
* History of immunodeficiency or autoimmune disease; positive HIV, HbsAg or anti-HCV.
* Impending untreated spinal cord compression or urinary outlet obstruction.
* Any medication that might affect immune function. (Exceptions: Nonprescription doses of NSAIDS; acetaminophen or aspirin; low doses of antihistamine therapy; normal range doses of vitamins; and H2 blockers).
Effect of Degenerative Spondylolisthesis on the Clinical Outcome of Unilateral Biportal Endoscopy for Lumbar Spinal Stenosis: Study Protocol

A single-center, prospective cohort trial aims to provide stronger evidence regarding the impact of degenerative spondylolisthesis on the clinical outcome of unilateral biportal endoscopy for lumbar spinal stenosis


Eligibility Criteria:
Inclusion Criteria:

* Age range: 50-80 years
* Diagnosis of LSS affecting 1-2 vertebral levels
* Predominant manifestation of neurogenic intermittent claudication, with ineffective conservative treatment for at least 3 months
* Presence of lumbar DS of less than grade II and absence of spine instability
* Willingness to participate in the study and complete follow-up assessments.

Exclusion Criteria:

* Diagnosis of isthmic lumbar spondylolisthesis or lumbar DS of grade ≥II
* Evidence of instability at the affected vertebral level (intervertebral angle change exceeding 15° in standing flexion-extension radiographs of the lumbar spine)
* History of prior surgery at the affected vertebral level
* Presence of scoliosis with a Cobb angle \>20º
* Presence of other conditions affecting the lumbar spine (infection, tumor, fracture, neurological diseases, and others)
* Medical disorders that preclude surgical tolerance
* Participation in other clinical research projects related to the treatment of lumbar spinal stenosis.
Closed-loop in Adults With T2D Not Requiring Dialysis

The main objective of this study is to determine the efficacy, safety and utility of fully automated closed-loop glucose control in the home setting over an 8 week period in adults with type 2 diabetes (T2D). This study builds on previous and on-going studies of closed-loop systems that have been performed in Cambridge in adults with type 1 diabetes in the home setting, and in adults with type 2 diabetes in the inpatient setting.

This is an open-label, single centre, randomised, cross-over study, involving two home study periods during which glucose levels will be controlled either by a fully automated closed-loop system or by participants' usual insulin therapy in random order. Each treatment arm is 8 weeks long with a 2-4 week washout period between treatments. A total of up to 30 participants with T2D will be recruited through outpatient clinics to allow for 24 completed participants available for assessment.

Participants will receive appropriate training by the research team on the safe use of the study devices (insulin pump and continuous glucose monitoring (CGM) and closed-loop insulin delivery system). Participants in the control arm will continue with standard therapy and will wear a blinded CGM system.

The primary outcome is time spent with glucose levels in the target range between 3.9 and 10.0 mmol/L as recorded by CGM. Secondary outcomes are the time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics in addition to insulin requirements. Safety evaluation comprises the tabulation of severe hypoglycaemic episodes.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or over
2. Diagnosis of type 2 diabetes using standard diagnostic practice
3. Current treatment with subcutaneous insulin
4. Screening HbA1c ≤ 11% (97mmol/mol) on analysis from local laboratory
5. Subject is willing to perform regular finger-prick blood glucose monitoring
6. Willingness to wear study devices
7. Literate in English

Exclusion Criteria:

1. Physical or psychological condition likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator
2. Known or suspected allergy to insulin
3. Lack of reliable telephone facility for contact
4. Pregnancy, planned pregnancy, or breast feeding
5. Severe visual impairment
6. Severe hearing impairment
7. Medically documented allergy towards the adhesive (glue) of plasters
8. Serious skin diseases located at places of the body, which potentially are possible to be used for localisation of the glucose sensor
9. Illicit drugs abuse
10. Prescription drugs abuse
11. Alcohol abuse
Compare the Success Rate of T3 Dental Implant (Biomet 3I) With or Without Platform-switch Concept

In patients that received a T3 (Biomet 3I) dental implant, does the use of platform-switch concept compared to the use of platform-matched concept, refrain marginal bone loss during osseointegration phase (t=12 weeks =T1) and from then to final rehabilitation (t= placement of the final restoration = at 18 weeks=T2)

Patients from a private practice who received dental implants (T3 dental implant Biomet 3I) from November 2012 to October 2013 were eligible to enter the study.

Two groups were formed: one group received a T3 dental implant with platform switch concept and the other received an implant with platform matched type of connection.

We evaluate osseointegration at T1 (12 weeks) and marginal bone position in relation to the implant platform at baseline (implant installation) T0 and again at T1 and T2.

From data recorder in T0,T1 and T2, we evaluate changes in marginal bone position.

Eligibility Criteria:
Inclusion Criteria:

* Single unit implant rehabilitation
* Maxilla and mandible
* Biomet 3I T3 dental implant placed
* Final Rehabilitation placed

Exclusion Criteria:

* Immediate implants
* Radiographic impossibility of measure
* Absence of baseline T0 radiograph
* Smoking habits (more 10 cigarets a day)
* Diabetes
* Patients who receive Radio or/and Chemotherapy