cyrilzakka/clinical-trials huggingface dataset:
Behavioral Exercise Therapy and Multidisciplinary Rehabilitation for Chronic Non-specific Low Back Pain

Multidisciplinary behavioral-orthopedic rehabilitation in the treatment of chronic back pain has proven its short-term effectiveness. Exercise therapy plays a major role in such a combination of treatments. There is a considerable need to develop theory-based exercise interventions which foster a long-term adherence to physical activity. Furthermore, an integration of behavioral elements such as coping competencies regarding back pain is needed. It is not yet clear, which specific part of multidisciplinary rehabilitation causes its effects. The role of exercise therapy has yet to be investigated. Aim of this study is the implementation of a standardized behavioral exercise therapy into an existing behavioral-medical rehabilitation for patients with chronic back pain. The main hypothesis is that the participation in the behavioral exercise therapy leads to greater short- and long-term improvements in functional capacity compared to the usual care.


Eligibility Criteria:
Inclusion Criteria (ICD-10):

* F45.4 Persistent somatoform pain disorder
* F45.41 Chronic pain disorder with somatic and psychological factors
* F54 Psychological and behavioural factors associated with disorders or diseases classified elsewhere
* M51.2 Other specified intervertebral disc displacement
* M51.3 Other specified intervertebral disc degeneration
* M51.4 Schmorl's nodes
* M51.8 Other specified intervertebral disc disorders
* M51.9 Intervertebral disc disorder, unspecified
* M53.8 Other specified dorsopathies
* M53.9 dorsophathy, unspecified
* M54.4 Lumbago with sciatica
* M54.5 Low back pain
* M54.6 Pain in thoracic spine
* M54.8 Other dorsalgia
* M54.9 Dorsalgia, unspecified
* R52.2 Other chronic pain

Exclusion Criteria:

* distinct specific diagnosis for back pain (e.g. radicular symptoms, myelopathy)
* severely limited health status (comorbidity)
* serious impairment of vision and hearing (not corrected)
* serious psychiatric codiagnosis (exkl. see inclusion criteria)
* inability to speak german
* pension claim (§51 SGB V - german law)
Deep Neuromuscular Block on Cytokines Release and Postoperative Delirium

The purpose of the study is to determine the relationship between the degree of neuromuscular block, the release of cytokines and clinical outcomes in elderly patients undergoing orthopedic surgery. Investigators hypothesize that deep neuromuscular blockade decreases the release of cytokine and the incidence of postoperative delirium in elderly patients undergoing orthopedic surgery, compared with moderate neuromuscular blockade.

* Study design

  - This is a prospective, randomized, single blinded study.
* Measurement values

  * Neuromuscular monitoring by post-tetanic count (PTC) during operation
  * Regional cerebral oxygen saturation monitoring
  * Mean systemic blood pressure (MBP), heart rate (HR)
  * Cardiac index (CI), using non-invasive cardiac output monitor
  * IL-1ß, IL-6, TNF-α, IL-10 and CRP
  * Arterial blood gas analysis (ABGA)
  * Laboratory values \[Hemoglobin, Hematocrit, serum albumin, creatinine, CPK, LDH\]
  * Postoperative pain, using visual analogue scale (VAS)
  * Postoperative nausea and vomiting (PONV)
  * Total infused amounts of drugs
  * Total anesthesia duration, intubation duration and operation duration
  * Intubation duration, operation duration
  * Incidence of postoperative intensive care unit (ICU) admission
  * Total ICU staying duration, if patients admit to ICU
  * Preoperative and postoperative left ventricular ejection fraction change
  * Incidence of hypotension (mean blood pressure lesser than 60 mmHg)
  * Incidence of postoperative delirium using confusion assessment method (CAM) intensive care unit (ICU)
  * Total amount of blood products transfusion (paced red blood cells, fresh frozen plasma, platelet concentration, cryoprecipitate)
  * Total amount of crystalloids and colloids infusion
  * Total amount urine output

Eligibility Criteria:
Inclusion Criteria:

* All adult (more than 50 years old) patients scheduled for total hip arthroplasty and total knee arthroplasty who have signed the written informed consent.

Exclusion Criteria:

* Inability to give informed consent
* Preexisting cognitive dysfunction or delirium
* Known allergy to rocuronium sugammadex
* Underlying liver dysfunction (AST and ALT more than 100 IU/l)
* Underlying kidney dysfunction (Serum Creatinine more than 1.5 mg/dl)
* Underlying neuromuscular disease
* Patients taking any medication with potential interference with neuromuscular transmission
Daily Activity and Gait Analysis After Viscosupplement Injection Among Hip Osteoarthritis Patients

The objective of this study is to assess the changes in daily physical activity and gait pattern, following a viscosupplement injection among a population who is suffering from hip osteoarthritis. A kinetic and kinematic gait analysis, an Actigraph activity monitor, a functional Timed-Stair-Test and two questionnaires (Medical Outcome Study Short-Form36 (MOS-SF36), Hip disability and Osteoarthritis Outcome Score (HOOS)) about how the pathology affects the quality of life, will be use.


Eligibility Criteria:
Inclusion Criteria:

* From 45 years old to 65 years old
* Clinically symptomatic moderate or severe hip osteoarthritis (Tönnis Grade II to III)
* Capacity to keep steady upright position and walking during 15 minutes
* Body mass index \< 40kg/m2

Exclusion Criteria:

* Bilateral hip osteoarthritis
* No broken hip or leg during the last 12 months
* Bone necrosis
* Rheumatoid arthritis, articular chondrocalcinosis, metabolic bone disease, psoriasis, gout, active infection
* Per os corticosteroid treatment
* Corticosteroid injection \< 3 months
* Viscosupplement injection \< 6 months
* Hypersensitivity to hyaluronic acid products
* Planed surgery during study duration
* Physical or mental disability to fill in questionnaires and/or to participate to follow-up
Explore the Clinical Application Value of Ciprofol in Painless Colonoscopy

This study used propofol as a positive control, and adopted a large-sample, multi-center, randomized, double-blind, positive parallel controlled trial design to explore the clinical application value of ciprofol in painless colonoscopy.

Subjects were randomly assigned 1:1 to receive intravenous ciprofol or propofol 1 hour prior to diagnosis and treatment. A centralized random grouping method was used in this study. After screening subjects, the researchers in each test center will log in to the random system after being confirmed by the researchers of the center, fill in the screening information, obtain the random number information, and issue the corresponding study drugs according to the random number. Random shelter number was generated by SAS software, and was used as the total blind base pair drug number and imported into the centralized random grouping system. In this study, evaluation researchers and drug administration researchers were set up. The whole process of the experiment was blind not only to the subjects, but also to the evaluation researchers. Evaluation investigators and administration investigators were set up in this study. The administration investigators were only involved in the process of random grouping, drug dispensing and administration, and the other processes including informed consent of subjects, screening, evaluation of efficacy indicators and safety, and planned visits were all completed by the evaluation investigators.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing painless colonoscopy;
2. Patients aged from 18 to 80 years old, no gender limitation; 3, 18 \< BMI \< 30kg/m2 \[BMI = weight (kg)/ height (m) squared\]

4. American Society of Anesthesiologists (ASA) grades ⅰ \~ ⅲ

Exclusion Criteria:

1. Preoperative blood pressure \>160/100 mmHG or \< 80/50 mmHG.
2. Preoperative ecg suggested heart rate \<50 times/min;
3. Acute respiratory tract infection with no cured history within 2 weeks;
4. People with serious metabolic diseases such as heart, brain, lung, liver, kidney and diabetes;
5. Predict people who may have or have had difficult airway;
6. Patients with obvious electrolyte disorders such as hyperkalemia;
7. Long-term use of immunosuppressants such as hormones or history of adrenocortical inhibition;
8. People who are known to be allergic to emulsions and opioids;
9. Preoperative combined use of other sedative and analgesic drugs
10. Suspected abuse of narcotic analgesics or sedatives; 11, there are neuromuscular system diseases, mental diseases and other people do not cooperate with the communication;
The Impact of Grand Tour Cycling on Sleep and the Hematological and Metabolomic Profile in World-class Cyclists

This project aims to identify the effect of a 3-week Grand Tour (e.g. Tour de France, Giro d'Italia, and Vuelta a España) on sleep, hematological parameters and the serum metabolome in world-class cyclists.


Eligibility Criteria:
Inclusion Criteria:

* Cylist participating in a Grand Tour (e.g. Tour de France, Vuelta a España, Giro d'Italia)

Exclusion Criteria:

* /
Low Power ThULEP for Prostate Size More Than 80 gm

Feasibility and Efficacy of lower power thulium enucleation of prostate more than 80 grams

Intra operative outcome and postoperative follow up of IPSS score and IEFF score at 6 months.

Eligibility Criteria:
Inclusion Criteria:

* BPH patients with failed medical treatment
* Refractory retention
* Hematuria
* Bladder stones
* Renal impairment due to BPH

Exclusion Criteria:

* Neurogenic patients
* stricture urethra
A Study in Healthy Men to Test How Fluconazole Influences the Amount of BI 425809 in the Blood

The main objective of this trial is to investigate the effect of fluconazole, under steady state conditions on the pharmacokinetics of BI 425809 (Reference Treatment R: BI 425809 alone; Test Treatment T: BI 425809 given under steady state conditions of fluconazole).


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 55 years (inclusive)
* Body mass index (BMI) of 18.5 to 29.9 Kilograms/Square Meter (kg/m2) (inclusive)
* Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion Criteria:

* Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or Electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetres of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.
To Improve Lung Function and Symptoms for Emphysema Patients Using Zephyr Valves

To compare the clinical outcomes of Endoscopic Lung Volume Reduction (ELVR) using Pulmonx Zephyr Valves vs. Standard of Care (SoC) in the treatment of heterogeneous emphysema subjects in a controlled trial design setting.


Eligibility Criteria:
Inclusion Criteria:

1. Obtained informed consent.
2. Diagnosis of heterogeneous emphysema with a heterogeneity index of ≥10 % between target and adjacent lobes.
3. Subjects of both genders of at least 40 years of age.
4. 15 % predicted ≤ FEV1≤ 45% predicted.
5. TLC \> 100% and RV ≥ 180% predicted.
6. 150 meters \< 6MWD \< 450 meters.
7. Non-smoker \>8 weeks prior to signing the Informed Consent.
8. CV negative target lobe.

Additional inclusion criterion French CIP\*:

- If treated in France, Subject must be entitled to French social security

Exclusion Criteria:

1. Any contraindication for bronchoscopic procedure.
2. Evidence of active pulmonary infection.
3. History of 2 or more exacerbations requiring hospitalization over the past 12 months.
4. Known pulmonary hypertension that according to the physician will be unsuitable for EBV treatment.
5. Myocardial infarction or other relevant cardiovascular events in the past 6 months.
6. Significant bronchiectasis seen at CT scan.
7. Greater than two tablespoons of sputum production per day.
8. Prior LVR or LVRS procedure. Criterion 8 French CIP wording\*: Prior lung transplant, median sternotomy, LVR or LVRS procedure (including lobectomy).
9. Pulmonary nodule requiring follow-up within any lobe.
10. Pregnant or nursing women. French CIP wording\*: Subject is pregnant or lactating, or plans to become pregnant within the study timeframe.
11. Hypercapnia (paCO2 \> 7.33 kPa).
12. Current diagnosis of asthma.
13. \> 25mg Prednisolon (or equivalent) use/days.
14. Any other condition that as judged by the investigator may make follow-up or investigations inappropriate.
15. Evidence of pleural adhesions or earlier pulmonary surgery.
16. Severe Bullous Emphysema (\> 1/3 Hemithorax)
17. Any subject that according to the Declaration of Helsinki is unsuitable for enrollment.

Additional exclusion criteria in the French CIP\*:

* History of allergy to silicone and/or nitinol.
* If treated in France, Subject is a "personne vulnerable" as defined by French regulation.
* Simultaneous participation in another drug and/or medical device related clinical.
Effect of Fermented Products and Probiotics on the Condition of the Implant

126 individuals with peri-implant disease and health, aged between 18-70 years, who applied to Bolu University Faculty of Dentistry Periodontology Clinic, participated in the study.The inclusion criteria for patient participation in the study were: age of patients between 18 and 70 years; the presence of at least 20 natural teeth in the oral cavity; systemic health. Peri-implant status was determined by the clinician (T.Ş.) by evaluating dental implants' plaque, gingival index, bleeding on probing, pocket depth measurements, and clinical attachment level. In addition, them systemic illness, pregnancy, breastfeeding status, medication, antibiotic use, and whether they smoked were questioned. Systemically unhealthy patients who did not use antibiotics within a month, were breastfeeding or pregnant, had uncontrolled diabetes, rheumatic fever, a history of lung and kidney disorders, and used drugs that could affect periodontal tissues were not included in the study. After examination, the patients were divided into three groups according to their disease: Peri-implantitis (42 patients), peri-implantitis (42 patients), and peri-implant health (42 patients). Demographic characteristics (age, weight, gender, height, education, and employment status) of the participants were collected with a questionnaire. With this survey, fermented foods and probiotic products such as bacon, soy sauce, pickles, sourdough bread, whole grain, rye, wholemeal bread, ayran, kefir, turnip, vinegar (homemade), pomegranate syrup (homemade), probiotic beverage, the frequency and amount of consumption of cheese, dark chocolate, tablets, capsules, chassis, butter and other (Kimchi, sauerkrauth, miso soup, fermented herring, kombucha, etc.) were determined. It was requested to determine the relationship between the health and disease of the implant and the frequency of consumption of fermented and probiotic products and foods in individuals with implants.


Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy individuals
* Individuals between the ages of 18-70

Exclusion Criteria:

* No use of antibiotics within one month
* Breastfeeding or being pregnant
* Uncontrolled diabetes, rheumatic fever, history of lung and kidney disorders, and drug use that will affect periodontal tissues
The Effect of Dexamethasone on Rebound Pain in Patients Receiving Ilioinguinal and Iliohypogastric Nerve Block

Rebound pain is a newly defined phenomenon, observed within the first 24 hours after the operation. Open inguinal hernia repair is a common surgical procedure that can be associated with pain of the either acute or chronic character. A peripheral nerve block of the ilioinguinal (IIN) and iliohypogastric (IHN) nerves is a relatively well-known method for postoperative pain management. However, rebound pain after IIN/IHN block resolution may reduce its overall benefit. The primary aim is to assess whether intravenous dexamethasone reduces postoperative opioid consumption and the incidence of rebound pain in patients undergoing unilateral hernia repair in adults.

Male patients older than 18 years, of American Society of Anesthesiologists physical status I or II, and scheduled for unilateral primary hernia repair with a Lichtenstein style (open surgery with insertion of mesh) under general anesthesia will be included in the study. The patients will be randomized using a computer-generated randomization technique. After induction of general anesthesia, the patients in the dexamethasone group (Group Dex) will receive 5 mg dexamethasone in a 50 ml syringe containing normal saline. The patients in the saline group (Group S) will receive normal saline in a 50 ml syringe. Ultrasound-guided block of the ilioinguinal (IIN) and iliohypogastric (IHN) nerves will be performed on all patients included in both groups. The primary aim is to assess whether intravenous dexamethasone reduces postoperative opioid consumption and the incidence of rebound pain in patients undergoing unilateral hernia repair in adults.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II
* Having signed a written informed consent form
* Scheduled for unilateral primary hernia repair Lichtenstein style (open surgery with insertion of mesh) under general anesthesia

Exclusion Criteria:

* Chronic opioid use (more than one month of 60 mg of oral morphine equivalents daily)
* Contraindications to peripheral nerve blocks including localized infection, coagulopathy, or allergy to local anesthetics
* Stomach ulcer
* Severe obesity (body mass index \> 35 kg/m2)
* Uncontrolled Diabetes
* Psychiatric disorders
* Systemic steroid use
* Neuropathic disorder
* Can not communicate in Turkish
Study of Interventional Pulmonologic Treatment of Malignant Central Airway Stricture

The purpose of this study is to evaluate the efficacy and safety of four interventional pulmonology techniques for the treatment of malignant central airway stricture.

The four techniques are：

* cryotherapy
* argon plasma coagulation
* stent
* snare


Eligibility Criteria:
Inclusion Criteria:

* malignant neoplasm caused central airway stenosis
* the degree of stenosis is above 50%
* estimated survival duration is longer than 3 months
* received no treatment one month before
* can understand the statement informed consent
* agree to enroll in the study

Exclusion Criteria:

* older than 70 years or younger than 18 years
* not malignant neoplasm caused central airway stenosis
* not central airway stenosis
* existence of lumina collapse or twisting
* severe arrhythmia, myocardial ischemia or hypertensive crisis
* coagulation disorders
* existence of severe organ disfunction
* allergic to anesthesia drugs
* refuse to participate the study
Therapeutic Response of Ultrasound and Muscular Stretching in Temporomandibular Disorder Patients

The combination of ultrasound and muscular stretching may have positive effects on pain relief and on the balance of the masticatory muscles activity.

This study aimed to evaluate the therapeutic response of ultrasound (US) and ultrasound associated with stretching of the masticatory muscles on the pressure pain threshold and the electrical activity of masseter and anterior temporal muscles in Temporomandibular Disorder (TMD) patients . The study included 18 women with TMD diagnosed by the instrument Research Diagnostic Criteria for Temporomandibular Disorders (RDC / TMD). The pressure pain threshold, evaluated through algometry, and the electrical activity of the masticatory muscles were evaluated, by means of surface electromyography, before and immediately after the therapeutic procedures. The volunteers underwent three different interventions: ultrasound, ultrasound associated with stretching and ultrasound placebo, with a 1-week of minimum interval between them.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of myogenic or mixed TMD according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC / TMD)
* women aged 20 to 35 years.

Exclusion Criteria:

* psychomotor impairment ;
* history of orthopedic trauma involving the temporomandibular region , orofacial surgery or poor training ;
* analgesics , anti-inflammatories , muscle relaxants , antidepressants ;
* presence of acute TMJ pain ( last 3 months) ;
* have perform physical therapy or speech therapy for the past 6 months;
* periods of the end of the menstrual cycle (7 days prior to menstruation ) and onset of menstruation ( first 2 days ) were excluded for conducting evaluations of volunteers who did not use oral contraception and those who used it to break.