cyrilzakka/clinical-trials huggingface dataset:
Inspiratory Muscle Training for Patients With Chronic Obstructive Pulmonary Disorder

This study is a randomized controlled trial with the aim of evaluating the effect of homebased inspiratory muscle training (IMT) for patients with COPD in Norway. The intervention group will train with threshold IMT for 6 weeks. The control group will not participate in any other training method or sham. Evaluation parameters are maximal inspiratory pressure, six minute walk test, COPD assessment test, modified Medical research council dyspnea scale and spirometry.


Eligibility Criteria:
Inclusion Criteria:

* COPD grade III-IV,
* Inhabitant of Hedmark (Løten, Våler, Åsnes, Hamar, Elverum)

Exclusion Criteria:

* Undergoing exercise based physical therapy treatment,
* not able to do IMT physically or mentally
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia (FETO)

The purpose of this research is to gather information on the safety and effectiveness of a new procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO).


Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Normal fetal karyotype with confirmation by culture results. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is \> 26 weeks.
* Isolated Left CDH with liver up
* Gestation age at enrollment prior to 29 wks plus 6 days severe pulmonary hypoplasia with ultrasound (US) O/E lung area to head circumference ratio (LHR) \< 25% (measured at 180 to 296 weeks) at the time of surgery; O/E LHR 25% to \<30% (measured at 300 to 316 weeks) at time of surgery.
* Gestational age at FETO procedure with O/E LHR \<25% at 27 weeks 0 days to 29 weeks 6 days; with O/E LHR 25% to \<30% at 30 weeks 0 days to 31 weeks 6 days as determined by clinical information (LMP) and evaluation of first ultrasound
* Patient meets psychosocial criteria

Exclusion Criteria:

* Multi-fetal pregnancy
* History of natural rubber latex allergy
* Preterm labor, cervix shortened (\<15 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa
* Psychosocial ineligibility, precluding consent:
* Inability to reside within 30 minute drive of our hospital, and inability to comply with the travel for the follow-up requirements of the trial
* Patient does not have a support person (e.g. spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at our institution.
* Right sided CDH or bilateral CDH, isolated left sided with O/E LHR ≥30% (measured at 180 to 295 weeks) as determined by ultrasound
* Additional fetal anomaly and chromosomal abnormalities by ultrasound, MRI, or echocardiogram at the fetal treatment center. No cases will be removed post hoc if abnormalities are discovered in the course of postoperative monitoring
* Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
* History of incompetent cervix with or without cerclage
* Placental abnormalities (previa, abruption, accrete) known at time of enrollment
* Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy
* Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality
* Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy
Effect of BNP (Brain Natriuretic Peptides) on Endothelial Dysfunction Induced by Coronary Angioplasty

Patients receiving BNP or nitroglycerin (IV) during the angioplasty procedure. 24 h after the procedure, vascular reactivity will be re-examined using the brachial artery flow-mediated dilatation study. Blood assays for ET-1, pro-BNP, and various inflammatory markers will be checked before and 24 h after the procedure. It is our hypothesis that endothelial function will be better in the BNP treated patients compared to the NTG treated patients


Eligibility Criteria:
Inclusion Criteria:coronary artery disease -

Exclusion Criteria:CHF and/or reduced LV function, or renal failure with Creatinine \>2mg%

-
Delirium Screening 3 Methods Study

Observational study comparing three different methods of delirium detection in critically ill patients.

The DELIS-3 study aims to compare three different approaches to detection of ICU (intensive care unit) delirium in critically ill patients. The CAM-ICU (Confusion Assessment Method for the ICU) and the ICDSC (Intensive Care Delirium Screening Checklist) have both been developed in the early 1990. The CAM-ICU is either positive or negative, whereas the ICDSC is a score between 0-8. A score above 3 is delirium positive. Neither scale has been validated as severity scales. The novel CAM-ICU-7 is developed from the original CAM-ICU and has been validated as a severity scale.

Detection of delirium in critically ill patients is highly necessary as delirium can be very painful to the patient. Moreover, certain subtypes of delirium is associated with increased mortality and poorer cognitive outcome when patients are followed up on long term.

Therefore, delirium screening of all patients is standard care in most intensive care units.

However, there is also a need to assess severity of delirium. The recently published CAM-ICU-7 has now been translated to Danish and this study will explore its performance compared to the CAM-ICU and the ICDSC.

In 17 Danish ICU's 10 nurses will be trained in using all three instruments. Each nurse will subsequently screen 10 patients each with all three instruments as part of their normal practice. The sequence of the instruments will be randomized to avoid that one instrument is favored by always being used first, second or last.

For each patient the following data will be collected: sex, age, reason for hospitalization (medical, neurological, surgical/ acute, planned), ventilator treatment, ability to verbalize, RASS score (sedation and agitation score) severity of disease (SMS score) and time of admission.

After all screenings has been collected, nurses will fill in a questionnaire on their perceptions of each scales' ability to reliably detect delirium, userfriendliness and how time consuming each scale were to use.

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to critical care units.

Exclusion Criteria:

* Patients with RASS score of -3, -4, -5
MHealth Incentivized Adherence Plus Patient Navigation

Polysubstance use involving opioids and methamphetamine is emerging as a new public health crisis. Patients with opioids and methamphetamine use often experience serious medical complications requiring hospitalization, which provides an opportunity to offer addiction treatment. Yet linkage to outpatient treatment post-discharge is suboptimal and methamphetamine exacerbates outcomes. The investigators propose to pilot test "MHealth Incentivized Adherence Plus Patient Navigation" (MIAPP) to promote treatment linkage and retention for patients with opioid use disorder (OUD) and methamphetamine use who initiate buprenorphine in the hospital. The investigators Aim is to perform a two-arm, pilot randomized clinical trial (n=40) comparing MIAPP + treatment-as-usual (TAU) versus TAU alone on outpatient medication for opioid use disorder (MOUD) linkage within 30 days (primary) and 90-day retention on medications (secondary) among hospitalized patients with OUD and methamphetamine use.


Eligibility Criteria:
Inclusion Criteria:

* Adult greater than or equal to 18 years of age
* Admitted to Harborview Medical Center (HMC) on any inpatient service
* Initiated on buprenorphine for OUD while in the hospital or at the time of discharge and planning to continue outpatient
* Used methamphetamine within the past 30 days (any route of administration or frequency)
* Willing to be randomized to video-DOT
* Willing and able to use a smartphone (study can provide) and work with patient navigator
* Discharge setting does not preclude the use of video-DOT (i.e., nursing home, inpatient psychiatry, etc.)

Exclusion Criteria:

* Unable or unwilling to use smartphone (phones to be provided when needed)
* Cognitive impairment (acute or chronic) resulting in inability to provide informed consent
* Currently incarcerated and will discharge to jail or prison
* Plans to discontinue buprenorphine in the near future (\<3 months)
* Lives far away such that cannot keep study visit at 30 days post-discharge
* Not English speaking
* Behavioral risk per discretion of research staff
Percutaneous Peripheral Nerve Stimulation and Performance

Percutaneous Peripheral Nerve Stimulation is a relative new intervention applied by physical therapists. Although it has been hypothesized that this technique could improve pain and function, no studies have investigated changes in physical performance in soccer players. This study will evaluate changes in physical performance after the application of Percutaneous Peripheral Nerve Stimulation in a sample of healthy soccer players.


Eligibility Criteria:
Inclusion Criteria:

* Semiprofessional soccer player
* No symptoms or injury in the lower extremity previous 6 months
* Training frequency of at least 3 days a week plus soccer game

Exclusion Criteria:

* fear to needles
* presence of pain or any musculoskeletal disease
* previous surgery in the lower extremity
* underlying medical conditions, e.g., diabetes, hypertension
DIMINI - Diabetes Mellitus? - Not me!

The increasing prevalence of type 2 diabetes mellitus is a worldwide problem. In preventing risk factors and unhealthy lifestyle through improved health literacy, chances are seen to delay or even avoid type 2 diabetes mellitus. The aim of the DIMINI-project is to prevent type 2 diabetes mellitus and to strengthen the health literacy of people at increased risk of developing it. For this purpose, people at increased risk are first identified by using the standardized screening tool Finnish Diabetes Risk Score (FINDRISC) adapted for Germany. Identified risk persons then receive a needs-based, modular lifestyle intervention including nutrition tips and physical exercises either paper- or app-based.

DIMINI, a randomised controlled trial, will assess whether the implementation of a lifestyle intervention for people at increased risk of developing type 2 diabetes mellitus will result in an improvement in body weight (primary outcome) and participants health literacy (secondary outcome) or not. A three-month intervention in the intervention group is followed by a one-year follow-up. The control group receives standard care as provided by the German statutory health insurance for three months and a one-year follow-up as well.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* resident in Hesse or Schleswig-Holstein
* statutory health insurance in one out of five participating health insurances
* overweight/obesity
* low physical activity
* known family disposition for type 2 diabetes mellitus
* history of increased glucose levels
* FINDRISC results with scores ≥ 12

Exclusion Criteria:

* age \< 18 years
* resident outside Hesse or Schleswig-Holstein
* statutory or private health insurance with other than the participating health insurances
* clinically manifested diabetes mellitus
* malnutrition
* psychiatric disorders
* pregnancy
* FINDRISC results with scores \<12
* participation in other clinical trials
Absorbable Interface Screw Clinical Trial

Validation of the safety and efficacy of absorbable interface screws for clinical use

Interface screws are divided into metal screws and absorbable screws. Since metal screws cut tendon grafts, absorbable interface screws are now mostly selected. At present, the materials of absorbable screws are mainly polylactic acid and polyglycolide. The test product is composed of two kinds of polylactic acid and bioactive glass fiber, which can reduce the adverse stimulation to the surrounding bone, promote the absorption of the screw and the bone grow into.Estimated enrollment for 4 months, follow-up for 14 months, a total of 18 months.

Eligibility Criteria:
Inclusion Criteria:

* ① Before surgery, subjects or guardians are willing and able to sign the informed consent;

  * Patients aged 18 to 80 (including 18 and 80 years old), regardless of gender;

    * Patients who meet the diagnostic criteria for anterior cruciate ligament rupture of the knee joint and have no contraindications to implantation;

      * The patient's bones are mature;

        * Good compliance, willing and able to conduct follow-up observation as required.

Exclusion Criteria:

* ① Subjects who have participated in other clinical studies of drugs, biological agents or medical devices before being selected and did not reach the primary study endpoint;

  * The patient is known to have a history of allergy to one or more implanted materials;

    * Those who are physically weak or cannot tolerate surgery due to other diseases of the body;

      * Active infection in the knee joint or other parts of the body; ⑤ Those with other ligament injury and/or meniscus injury in the affected knee joint; ⑥ Those who need to perform simultaneous meniscus repair and other surgeries on the ipsilateral knee joint; ⑦ Obese BMI\>35;
Role of Lymphnode Dissection in Men With Prostate Cancer Treated With Radical Prostatectomy

Currently, lymph node dissection is standard of care during prostatectomy of intermediate risk tumors at the Martini Clinic. It allows the assessment of possible but unlikely lymph nodes metastases. In case of lymph node metastasis, depending on the number of affected lymph nodes, an adjuvant radiation with or without additional hormone therapy may be discussed in order to stop or delay further progression of the disease.

Since the procedure carries additional risks, it is controversial. The risks include prolonged surgery duration, injury of vessels and nerves, as well as disorders of lymphatic circulation after surgery. Moreover, formation of lymphoceles (accumulation of lymph fluid in the tissue) are common, which may result in soft tissue swelling, thrombosis, inflammation and additional surgical procedures.

Therefore, the aim of this study is to evaluate whether the removal of the lymph nodes during prostatectomy positively influences the course of the disease in patients with intermediate risk prostate cancer, or if the lymph node dissection does not have any influence on the recurrence of the disease and therefore further therapies.

In this case, the omission of lymph node dissection may avoid an unnecessary expansion of the operation and the potentially associated side effects linked to it. This is particularly of interest considering the rapidly advancing technical possibilities, both in imaging and in the treatment of prostate cancer, since this enables an earlier and more individual intervention in the case of recurrence.

The significance of lymph node dissection in radical prostatectomy has not been conclusively clarified. If a radical prostatectomy is planned, the question occurs if the additional pelvic lymph node dissection (LND) is justified and to what extent it should be performed (limited LND, standard LND or extended LND). On the one hand, the detection of lymph node metastases is associated with a significantly worse course of the tumor disease and requires immediate or delayed hormone-ablative therapy. On the other hand, the lymph node dissection is associated with risks (lymphoceles, thromboses, lymphedema), so that the indication in negative lymph node findings appears questionable. It must be weighed between the diagnostic advantage and the possibility of increased morbidity due to the lymphadenectomy. For localized intermediate risk prostate cancer (PSA\> 10 ng / ml - 20 ng / ml or Gleason score 7 or cT category 2b ), there are currently no recommendations for performing a lymph node dissection during prostatectomy.

Eligibility Criteria:
Inclusion Criteria:

* localized intermediate risk prostate cancer (intermediate risk (PSA\> 10 ng / ml - 20 ng / ml or Gleason score 7 or cT category 2b)
* scheduled for open radical prostatectomie or DaVinci prostatectomie

Exclusion Criteria:

* American Society of Anesthesiology Classification\> 3
* Existing contraindications for performing a lymph node dissection
* Neoadjuvant hormone therapy
Development of Rational Ways of Medical and Non-medical Treatment Methods for Metabolic Syndrome

Metabolic syndrome: aetiology, pathogenesis, diagnosis, clinical management and prognosis

Purpose: To create the complex scientifically proved concept of Metabolic syndrome (МS) development based on elaboration of the new methods of clinical diagnostics of МS components and highly effective МS clinical management in comparative studying of clinical, laboratory and cost effectiveness.

Participants and methods: This clinical study included 351 adults (184 female) in the Scientific research institute of cardiology and internal diseases (Almaty, the Republic of Kazakhstan). Statistical analysis was performed using Microsoft Excel-2008 in updating Lapach, Chubenko et al (2000) and SPSS for Windows v.17.0.

Eligibility Criteria:
Inclusion Criteria:

* written consent form
* age\> 25 years
* skinfold thickness \> 0,7 cm BP\> 130/85 mm Hg or a patient on antihypertensive medications fasting blood glucose \> 6.1 mmole/L, or 2-hour postprandial glucose level \> 11.1 mmole/L / or a patient with type 2 diabetes blood cholesterol \> 5.6 mmole/L possibility of treatment \> 6 months follow-up \> 1 year

Exclusion Criteria:

* complete immobilization of a patient (paresis /paralysis)
* patients with severe concomitant diseases of the kidneys and (or) of the liver
* early post-operative condition
* mental illness
* pregnancy
* persons who are in prison
* persons who are in military Armed Forces
Observational Retrospective Study on Spinal Analgesia in Laparoscopic and Laparotomic Hysterectomy

Perioperative multimodal analgesia, defined by the use of various analgesic medications targeting different drug receptors, provides adequate pain relief with minimal or no opiate consumption. Therefore, it represents one of the cornerstone of Enhanced Recovery After Surgery (ERAS) protocols, as the reduction in opioid use and the associated side effects may eventually reduce length of hospital stay, increase patient satisfaction and minimise the risk of long-term opioid use.

Regional and neuraxial anesthesia techniques are key interventions to provide successful analgesia in the context of a multimodal strategy. Intrathecal morphine, for its effectiveness and potential of reducing the need of intravenous postoperative opioids, seems an attractive option in the case of hysterectomy, one of the most common major surgical procedures performed in women, associated with severe postoperative pain even when performed laparoscopically.

The aim of our observational retrospective study is therefore to compare the analgesic efficacy and the safety of morphine administered by intrathecal route versus intravenous route during the first 48 hours after performance of laparoscopic/laparotomic hysterectomy.


Eligibility Criteria:
Inclusion Criteria:

* Adult women American Society of Anaesthesiologists (ASA) physical status \<= 3, scheduled for elective hysterectomy under general anesthesia between January 1st 2019 and December 31st 2021.

Exclusion Criteria:

* patients with American Society of Anaesthesiologists (ASA) status \> 3,
* opioid use or history of opioid dependence,
* chronic use of analgesic medications,
* psychiatric disorders,
* surgery including upper abdominal procedures (for example liver mobilization and diaphragm peritonectomy/resection, splenectomy) or xifo-pubic incision
Evaluation of Central Macular Thickness in Femtosecond Laser-assisted Cataract Surgery

The investigational device is an approved femtosecond laser (FSL) device with an integrated imaging system to perform certain steps of the cataract procedure. The FSL will perform anterior capsulotomy and lens fragmentation in individuals suffering from age-related cataract with need of cataract surgery.

Cataract surgery will be performed in subjects who have signed an informed consent form. Macula thickness will be measured with Spectralis OCT on screening date.

Postoperative examinations will be implemented in accordance with the approved investigational plan on subjects and includes: visual acuity, slitlamp examination, retinal oct imaging and quantitative autofluorescence.


Eligibility Criteria:
Inclusion Criteria:

* Bilateral Age-related cataract necessitating lens extraction and posterior IOL implantation
* Age 40 and older (females of childbearing age will be interviewed if pregnancy is possible)

Exclusion Criteria:

* Corneal abnormality
* Preceding ocular surgery or trauma
* Uncontrolled glaucoma
* Proliferative diabetic retinopathy
* Macular degeneration
* Iris neovascularization
* History of uveitis/iritis
* Microphthalmus
* Recurrent intraocular inflammation of unknown etiology
* Blind fellow eye
* Uncontrolled systemic or ocular disease
Comparison of Low GI and High GI Potatoes in Relation to Satiety (POSAT)

The study is a single-blind, randomised crossover study, investigating how a high glycaemic potato affects satiety in humans compared to a low glycaemic potato. This is done to shed further light on the discussion about whether potatoes with a high glycaemic index increases the risk of overweight and obesity and thus indirectly type 2 diabetes and cardiovascular disease.

The POSAT study follows a single-blinded randomized crossover design. Each subject will have two separate intervention days with at least a six-day washout period in between. On the two intervention days the subjects will be randomized into receiving a breakfast containing isocaloric amounts of either low or high GI potatoes. VAS will be measured 5 minutes before the meal, immediately after the meal is consumed and in intervals of 30 minutes thereafter until 2,5 hours after the initial meal. After this the subjects will be served a standardized homogenous ad libitum meal. The amount of food consumed will be registered. The subjects will be asked to fast for 8-10 hours prior to the trial days and abstain from vigorous physical activity and alcohol consumption for 2 days prior to each trial day. The trial will be conducted over a total of 8 days with 5-6 study subjects pr. trial day. The trial days will be spread out over a total of 2 weeks to allow for a 1-week washout period between trial days for each subject.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men
* Body mass index (BMI) 18-27 kg/m2
* Age 18-40 years
* Signed informed consent
* Able to eat 500 grams of potato for breakfast

Exclusion Criteria:

* Chronic diseases as diabetes, cardiovascular diseases or other chronic metabolic diseases, which could affect the results.
* Use of daily prescription medicine (mild analgesics and antihistamines are allowed).
* Use of medicine or dietary supplements that can affect ones appetite one month before the start of the study.
* Smoking or have been smoking or using any nicotine products (gum or e-cigarette) within the last 3 months. Irregular smoking is allowed.
* Elite athletes defined as doing \>10 hours of strenuous physical activity per week.
* Participation in other clinical studies \<1 month before or during the study.
* Inability, physically or psychologically, to comply with the procedures required by the study protocol. Judged by the investigators.
* Any food allergies.
* Weight change of ±3 kg from screening to the trial has been conducted.
* Inability to complete the trial within 3 months after screening.
* Unable to fast 8-10 hours before the trial days.