cyrilzakka/clinical-trials huggingface dataset:
Telmisartan Compared With Enalapril in Elderly Patients With Blood Hypertension

Study to assess the efficacy and tolerability of Telmisartan 40-80 mg once daily compared with enalapril 10-20 mg once daily in elderly patients with arterial hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 65 years
* Sitting systolic blood pressure (SBP) ≥ 160 mmHg and any diastolic blood pressure (DBP) (safety maximum of sitting DBP 110 mmHg), measured by manual cuff sphygmomanometer at the end of the wash-out period
* Written informed consent

Exclusion Criteria:

* Secondary hypertension
* Malignant hypertension (retinal haemorrhage, exudates or papillary oedema)
* Clinically significant sodium depletion as defined by serum sodium level \< 130 mEq/L, clinically significant hyperkaliemia as defined by serum potassium level \> 5.5 mEq/L, clinically significant hypokaliemia as defined by serum potassium level \< 3.0 mEq/L
* Atrial fibrillation or frequent ventricular ectopic beats or other arrhythmias which could interfere with the cardiac rhythm
* Heart rate \< 50 bpm
* Congestive heart failure (CHF) (NYHA (New York Heart Association) functional class CHF III-IV)
* Angina pectoris or myocardial infarction
* Cardiac surgery within the past 3 months prior to start the wash-out period
* Stroke within the past 6 months prior to start the wash-out period
* Renal insufficiency defined as creatininaemia \> 2mg/dl
* Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post renal transplant
* Liver insufficiency, defined as bilirubinaemia \> 2mg/dl and AST (aspartate aminotransferase) or ALT (alanine-aminotransferase) \> twice the upper normal range
* Clinically significant metabolic and endocrine disease
* Autoimmune disease
* Previous history of angioedema
* Body mass index \> 30kg/m2
* Arm circumference \> 32 cm
* Any condition that may be likely to compromise the trial (alcohol or drug abuse, disability illness, etc.)
* Concomitant therapy with antihypertensive drugs non-permitted by protocol, or present use of tricyclic antidepressant, corticosteroids or drugs known to affect blood pressure
* Investigational drug treatment within the past 30 days before the enrolment or concurrent participation to any other trial
* Sensitivity, significant adverse reaction or contraindications to the study drugs (telmisartan, enalapril, clonidine TTS)
* Predictable lack of patient co-operation
Better Evaluation of Acute Chest Pain With Computed Tomography Angiography

The purpose of this study is to determine whether cardiac CT can improve triage of acute chest pain patients in the emergency department.

Myocardial infarction remains one of the most important causes of death and disability. Therefore it is important that individuals with acute chest pain are accurately assessed without delaying appropriate treatment. Acute coronary syndrome is only one cause for sudden chest pain, which is a very common complaint in the ER. Other life threatening causes such as pulmonary embolism and aortic dissection may also be the cause, although most chest discomfort has a benign reason (musculoskeletal, hyperventilation, oesophageal reflux, etc).

The current work-up of suspected acute coronary syndrome, based on presentation, symptoms, ECG and biomarkers, is not efficient and results in unnecessary diagnostics and hospital admissions, as well as errors or delayed diagnoses, in a substantial number of patients. Computed tomography angiography (CTA) images atherosclerosis, coronary obstruction as well as myocardial hypoperfusion. We hypothesize that early use of CTA is of incremental value and allows for accurate and immediate triage of patients with acute chest pain.

Eligibility Criteria:
Inclusion Criteria:

* Acute chest pain or equivalent
* Patients older than 30 years
* Males \< 75 years and Females \< 80 years

Exclusion Criteria:

* STEMI
* Troponin \> 0.1
* History of known myocardial infarction, PCI or CABG
* Pregnancy
* Contrast allergy
* Renal disfunction
* No informed consent possible
* No follow-up possible
A Prospective Randomized Controlled Study of Natural Orifice Medium-low Rectal Endometriosis Resection

To evaluate the postoperative outcome of low medium-low rectal endometriosis: Natural orifice surgery VS transabdominal surgery.

To evaluate the postoperative outcome of low medium-low rectal endometriosis: Natural orifice surgery VS transabdominal surgery.Both of the two kinds of surgery is conventional,but the comparison is still unclear.The investigators divide the patients into two groups, and compare the differences of postoperative outcomes by statistics.

Eligibility Criteria:
Inclusion Criteria:

Childbearing age women,

older than 18 years,

diagnosed with intestinal endometriosis,

rectum clinical symptoms for invalid medical treatment,

dysmenorrhea, dyspareunia dyschezia, infertility, defecate carries blood,

endometriosis in the lower rectum by intraoperative judgment

Exclusion Criteria:

without endometriosis rectum,

history of colorectal surgery,

intolerance to laparoscopic surgery
A Pilot Cohort Study of Surgical and Non-surgical Management of Rotator Cuff Tears

This project will involve planning and implementing a two-arm prospective pragmatic cohort clinical trial in patients with known rotator cuff tears.

This project will involve planning and implementing a two-arm prospective pragmatic cohort clinical trial in patients with known rotator cuff tears. Pragmatic or effectiveness clinical trials reflect real world settings and thus have greater external generalizability than efficacy trials. The evaluation component in this trial will be three-fold: first, the study team will compare the success of patients undergoing operative versus non-operative management and identify which variables predict success in each group; second, investigators will attempt to predict which patients end up choosing, along with their care giver(s), operative versus non-operative management by examining the predictive capability of a selection of variables; third, investigators will evaluate the clinical research site(s), personnel, and implementation processes for their capability to implement clinical trials with the intent of planning for a future large multi-site clinical trial building on the results of the present study.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age with full-thickness rotator cuff tears eligible for operative repair

Exclusion Criteria:

* less than 18 years old,
* non-operative rotator cuff tears,
* calcific tendonitis, fracture, adhesive capsulitis,
* severe osteoarthritis of the shoulder,
* no prior shoulder surgery
Argon Plasma Coagulation vs Hemoclipping for Bleeding Peptic Ulcers

Endoscopic treatment is recommended for initial hemostasis in nonvariceal upper gastrointestinal bleeding. However, the additional hemostatic efficacy of argon plasma coagulation (APC) has not been widely investigated. We designed a randomized trial comparing APC plus injection therapy vs hemoclipping plus injection therapy for peptic ulcer bleeding.

【Goals and Background 】 Endoscopic treatment is recommended for initial hemostasis in nonvariceal upper gastrointestinal bleeding. Many endoscopic devices have been demonstrated to be effective in the hemostasis of bleeding ulcers. However, the additional hemostatic efficacy of argon plasma coagulation (APC) after endoscopic injection therapy has not been widely investigated.

【Study】 From Feb. 2012 to April 2016, consecutive patients with high-risk bleeding ulcers, characterized by active bleeding, non-bleeding visible vessels and adherent clots, were admitted to our hospital. They prospectively randomly underwent either APC therapy plus distilled water injection or Hemoclipping plus distilled water injection. Pantoprazole infusion was conducted during the fasting period after endoscopy and orally for 8 weeks to encourage ulcer healing. Episodes of rebleeding were retreated with endoscopic combination therapy. Patients who did not benefit from retreatment underwent emergency surgery or arterial embolization.

Eligibility Criteria:
Inclusion Criteria:

． high-risk peptic ulcer bleeding. High-risk bleeding ulcers were defined as participants with stigmata of a bleeding visible vessels (eg, spurting, oozing), a non-bleeding visible vessels (NBVV) or adherent clot.4 A NBVV at endoscopy was defined as a raised red, red-blue or pale hemispheric vessel protruding from the ulcer bed, without active bleeding. An adherent clot was defined as an overlying blood clot that was resistant to vigorous irrigation.

Exclusion Criteria:

* the presence of another possible bleeding site (eg, gastroesophageal varix, gastric cancer, reflux esophagitis)
* coexistence of actively severe ill diseases (eg, septic shock, stroke, myocardial infarction, surgical abdomen)
* treatment with an anticoagulant (eg, warfarin)
* pregnancy
* the presence of operated stomach
* refusal to participate in the study
The Effect of Circadian Clock System on Perioperative Cognitive Function of Elderly Patients

Postoperative cognitive dysfunction (POCD) is a common postoperative complication in patients aged 65 and above. It refers to the cognitive function changes such as memory decline and attention loss after anesthesia and surgery. In serious cases, people may also experience personality changes and decline in social behavior ability, which will develop into irreversible cognitive impairment.Some studies reported that 25.8% of elderly patients presented POCD one week after non-cardiac surgery, and the incidence at 3 months after surgery was still 9.9%, which could increase the mortality in the first year after surgery.In recent years, studies have also proved that POCD is associated with patients' inability to perform their original jobs after non-cardiac surgery.Postoperative cognitive dysfunction seriously affects the clinical outcome, in addition to medical costs and other issues will bring an impact on the society and family.With the aging of the population, how to prevent cognitive dysfunction in elderly patients is a major challenge for perioperative management.There is a certain correlation between circadian rhythm and the dosage of general anesthesia, and postoperative sleep disturbance may be related to the effect of anesthesia and surgery on circadian rhythm.Preoperative sleep deprivation is known to be an independent risk factor for postoperative cognitive dysfunction (POCD), but the circadian mechanisms involved after general anesthesia are not yet clear


Eligibility Criteria:
Inclusion Criteria:

* preoperative sleep disorders
* did not receive any preoperative chemoradiotherapy
* the duration of surgery ≧3 hours

Exclusion Criteria:

* History of schizophrenia
* epilepsy
* parkinson's disease or myasthenia gravis
* Critical illness (preoperative American society of anesthesiologists (ASA) ASA \>III)
* severe liver insufficiency (ChildePugh grade C)
* severe renal insufficiency (preoperative dialysis)
* neurosurgery
Effectiveness of Contingency Management in the Treatment of Crack Addiction in Brazil

Crack addiction has become a severe public health problem in Brazil. Crack users present elevated prevalence rates of psychiatric comorbidities, sexual transmitted infections and unemployment with high probability of living or have lived in the streets, history of incarceration and engagement in illegal activities. For the last 20 years a treatment called Contingency Management (CM) have achieved the best results regarding reduction of substance use, promotion of abstinence, treatment attendance and retention in treatment. The first CM study conducted in Brazil advocates for the efficacy of CM on all of these outcomes, suggesting that CM can be effective in a Brazilian population of crack users.

The objective of this study is to evaluate the effectiveness of Contingency Management (CM) for crack users living in the "Crackland" region. To achieve this goal, regular treatment staff from Unidade Recomeço Helvétia treatment service will be capacitated in CM to latter-on apply the CM intervention in their respective services. The design will be a single-blind randomized clinical trial composed of a sample of 100 subjects with current diagnose for crack/cocaine dependence. Participants allocated to the control condition will receive 12 weeks of the usual care treatment provided by these two treatment facilities. Participants allocated to the experimental condition will receive the exact same treatment as control participants associated with CM. CM procedure will occur 2 timer per week (every Monday and Thursday or Tuesday and Friday). Primary outcomes are: (1)retention in treatment; (2) reduction of crack use; (3) promotion of continuous crack cocaine abstinence. Secondary findings are reduction on psychiatric symptomatology. The investigator hypothesis is that participants in the CM condition will have a better treatment response in all studied outcomes.

Eligibility Criteria:
Inclusion Criteria:

* DSM-V diagnose for crack cocaine use disorder

Exclusion Criteria:

* being under 18 years old
Usage Of Artificial Intelligence-Integrated Usg In Application of Pectoral Block In Mastectomies

The investigator's goal in this study is to apply PECS II block, before starting surgery, by either conventional USG or artificial intelligence integrated USG to patients who will undergo mastectomy under general anesthesia to determine the effect of the block on hemodynamics and opioid consumption in the intraoperative period. Besides, the investigatorwanted to investigate the contribution of artificial intelligence integrated USG use in the success of a 4-year anesthesiology resident for imaging the injection site.

After receiving the approval of the Clinical Research Ethics Committee of Başkent University (KA21/353), 70 patients with ASA I-II, between the ages of 18-75, who were scheduled for mastectomy surgery were included in the study. A 4. year anesthesiology resident under the supervision of two senior anesthesiologists, performed a PECS II block with AI-integrated USG or conventional USG (Group AI-USG and Group USG) after randomization. Although the resident had no experience with pectoral blocks, she had experience with the use of USG and regional anesthesia related to other trunk-area and peripheral blocks. The block was performed after induction of general anesthesia. Patient data in terms of hemodynamic changes in the intraoperative period, opioid (remifentanil) consumption, and postoperatively hemodynamics, pain scores (VAS), postoperative opioid \[tramadol administered with a patient-controlled analgesia pump (PCA)\] and, if necessary, rescue analgesic agent (non-steroidal antiinflammatory agent) consumption were monitored in the post anesthesia care unit (PACU), and at postoperative 6., 12. and 24.hours.

Eligibility Criteria:
Inclusion Criteria:

* 18-70 years
* ASA I and II
* Female
* Underwent mastectomy surgery
* Without local anesthetic allergy

Exclusion Criteria:

* Patients with ASA III and above
* Obesity (body mass index \>30)
* Psychotropic drug use
* Bleeding diathesis
* Local anesthetic allergy
* Chest wall deformity
* Infection at the injection site
* Chronic analgesic usage
Multiple Ascending Doses (MAD) of Anti-A Disintegrin and Metalloproteinase With Thrombospondin Motifs-5 (Anti-ADAMTS-5) Nanobody in Participants With Knee Osteoarthritis (OA)

The study will be conducted in participants with symptomatic knee OA to explore the safety, tolerability, immunogenicity, pharmacokinetics (PK), and pharmacodynamics (PD) of MAD of M6495.


Eligibility Criteria:
Inclusion Criteria:

* Kellgren Lawrence (KL) radiological Grade of 2 to 4 in the target knee
* Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscore of greater than or equal to (\>=) 40 out of 100 in the target knee at screening
* Primary or post-traumatic femorotibial OA according to American College of Rheumatology clinical and radiographic criteria
* Have completed at least 4 days of the participant 7-day diary in the period from Day -8 to Day 1
* Can give signed informed consent
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* History of arthroscopy or intra-articular administration of corticosteroids or hyaluronic acid into the target knee within 6 months before screening
* Intention of having major knee surgeries or total knee replacement during the time frame of this study in either knee
* Secondary OA in target knee joint because of joint dysplasia, aseptic osteonecrosis, acromegaly, Paget disease, Stickler syndrome, hemochromatosis, gout, chondrocalcinosis, or calcium pyrophosphate deposition disease
* Any known active systemic infection, including infection that might compromise the immune system such as human immunodeficiency virus, or hepatitis B or C
* History of myocardial infarction or cerebrovascular event within 6 months prior to screening, or current active angina pectoris, symptomatic heart failure, seizures, untreated hypertension, gastrointestinal bleeding, or any other significant medical condition in the Investigator's opinion
* History of cancer, except adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ/cervical intraepithelial neoplasia of the uterine cervix, unless considered cured \>= 5 years
* Other protocol defined exclusion criteria could apply
When the Alarm Goes Off, You're Already Awake

This is a behavioral observational study aimed at evaluating the impact that anxiety exerts on working people at the moment of awakening in the morning. It consists of a short self-administered questionnaire which will be given to workers to complete. Relationships between workers' answers and anxiety will be evaluated.

This is a behavioral observational study aimed at evaluating the impact that anxiety exerts on working people at the moment of awakening in the morning. Literature found out that anticipatory anxiety plays a key role as for awakening quality (experiencing self). This evaluation could change at the end of the working day due to biased memory effects (remembering self).

In Literature there are not studies which investigate the relationships between time to awakening before the alarm sounds and anxiety.

The study consists of a short self-administered questionnaire which will be given to workers to complete. In more details, the survey is made of five questions collecting information on type of work, people who use an alarm, time of awakening before the alarm goes off, feelings on the moment of awakening, and feelings as for the working day spent. Further, participants will have to complete an anxiety self-administered questionnaire on anxiety, and namely the Zung Self-Rating Anxiety Scale.

Descriptive statistics will be presented by taking into account the characteristics of the sample being investigated. Statistical correlations between workers' answers and anxiety will be also evaluated.

This study's usefulness relies on detecting on advance mood disorders (like anxiety is) and maladaptive behaviors, in order to build persons' positive routines (i.e. well-being) and improve their productive quality at work.

Eligibility Criteria:
Inclusion Criteria:

* Being workers (any type)
* Adult age
* Ability to understand the Italian language

Exclusion Criteria:

* People who do not use the alarm clock to wake up in the morning
* Refuse to adhere to the study
Evaluation of the Effectiveness of Prophylactic LMWH by Thromboelastography

This study aims to evaluate the necessity and effectiveness of using low molecular weight heparin (LMWH) for prophylaxis in the postoperative period in patients who underwent lobectomy due to malignancy, using thromboelastography.Blood samples taken from the patients before low molecular weight heparin prophylaxis (preoperative), before prophylaxis in the postoperative period (postoperative day 1) and after the start of postoperative prophylaxis (postoperative day 3) will be examined by thromboelastography.

General characteristics of the patients such as age, gender, presence of comorbidities, smoking, type of operation and approach applied, operation duration, TEG measurements and postoperative complication development were recorded with case forms.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent lobectomy with thoracotomy or videothoracoscopy (VATS) due to malignancy (primary or secondary lung cancer)

Exclusion Criteria:

* Patients with a known diagnosis of bleeding or coagulation disorders
* Patients receiving anticoagulant and antiplatelet therapy in the preoperative period
* Patients who developed perioperative bleeding and therefore underwent perioperative blood and blood product replacement
Efficacy of Different Acid Suppressors in Bismuth-containing Quadruple Therapy Against Helicobacter Pylori

Ａretrospective study was conducted to compare the efficacy, safety, and cost-effectiveness of traditional proton pump inhibitors (PPI ) and Potassium-competitive acid blockers ( P-CAB )for clarithromycin-based bismuth-containing quadruple therapy in the management of Helicobacter pylori eradication.

This study retrospectively enrolled participants with H. pylori infection who received bismuth quadruple regimen containing clarithromycin. The basic information, treatment results, adverse reactions and compliance of the patients were collected. According to the type of acid inhibitors, participants were divided into traditional PPI group and P-CAB group. Traditional PPI group which were divided into lansoprazole group and esomeprazole group. The eradication rate, safety, compliance of H. pylori in different treatment regimens was evaluated. Multivariate analysis was performed to identify predictors of eradication failure.

Eligibility Criteria:
Inclusion Criteria:

* Participants aged 18-75 years with persistent H. pylori infection.
* Participants received clarithromycin-based bismuth-containing quadruple therapy.

Exclusion Criteria:

* Patients received rescue therapy
* Patients treated with PPI, P-CAB,bismuth and antibiotics in the previous 4 weeks
* Patients with gastorectomy
* Currently pregnant or lactating or other conditions unable to receive therapy
* Severe concomitant cardiovascular, respiratory, or endocrine diseases, clinically significant renal or hepatic disease, hematologic disorders and any other clinically significant medical condition that could increase risk
* Severe neurologic or psychiatric disorders
* Information incomplete
Two Versus Four Weeks of Antibiotic Treatment in Native Joint Arthritis

The optimal duration of systemic antibiotic administration for native joint septic arthritis is unknown. The investigators perform a randomized study allowing up to 3 surgical lavages and allocating patients into a two-week's and a four week's randomization arm

The optimal duration of systemic antibiotic administration for native joint septic arthritis is unknown. The investigators perform a randomized study allocating patients into a two-week's and a four week's randomization arm.

The adult patients are hospitalized for septic arthritis. A computer program randomizes 1:1 between a two week's and a four week's arm of targeted antibiotic treatment of which at least the first week is intravenously. The randomization may occur until Day 5 of admission. Up to three surgical interventions are allowed. The investigators allow the inclusion of all bacterial arthritis and all joints.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>17 years
2. Microbiologically-confirmed septic arthritis
3. At least one surgical drainage/lavage

Exclusion Criteria:

1. Presence of osteosynthesis material in the vicinity of the articulation
2. Presence of a concomitant infection needing more than 2 week's of antibiotic therapy
3. More than 3 surgical drainages
4. Life expectancy less than 6 months
5. Chronic osteomyelitis in vicinity of the arthritis