cyrilzakka/clinical-trials huggingface dataset:
Drug Utilization Study for Olodaterol

This study aims to characterise the use of single-agent olodaterol and single-agent indacaterol, the only marketed long-acting beta2-agonist (LABA)s authorised for chronic obstructive pulmonary disease (COPD), but not for asthma, in clinical practice.

Boehringer Ingelheim GmbH (BI) developed olodaterol, an inhaled long-acting beta2-agonist (LABA), for the indication of chronic obstructive pulmonary disease (COPD). Because the use of LABAs has been associated with increased morbidity and mortality in patients with asthma, the health authorities requested the conduct of a post-approval drug utilisation study to assess potential off-label use of olodaterol in asthma and to characterise the use of olodaterol in clinical practice. The single agent indacaterol, the only other marketed LABA authorised in clinical practice for COPD but not for asthma, will also be assessed. Study objectives include the following: (1) Quantify the frequency of off-label use of olodaterol and indacaterol among new users of these medications; and (2) Describe the baseline characteristics of new users of olodaterol and indacaterol. This cross-sectional study will use information among new users of olodaterol or indacaterol collected in the following healthcare databases: the PHARMO Database Network in the Netherlands, the National Registers in Denmark, and the IMS Health Information Solutions (IMS) Real-World Evidence (RWE) Longitudinal Patient Database (LPD) in France. The source population is all patients enrolled in the selected study databases at the date olodaterol became available in each database's country. The study groups are those patients from the source population who receive a first dispensing for single-agent formulations of olodaterol for the primary objective or indacaterol for the secondary objective and have at least 12 months of continuous enrolment in the study databases. The study will describe the number and proportion of new users by indication and potential off-label use and according to medical history and use of co-medications.

Eligibility Criteria:
Inclusion criteria:

* receive a first prescription/dispensing for single-agent formulations of olodaterol or indacaterol during the study period (no prescriptions/dispensings ever before)
* patients must have at least 12 consecutive months of enrolment in the database before the index date

Exclusion criteria:

- Individuals with missing or implausible values for age or sex will be excluded.
A Phase I Study of TAS-102 in Solid Tumors

The primary objective of this study is to evaluate the pharmacokinetics of TAS-102 after single and multiple dose in Chinese patients with solid tumor.

This is an open-label, non-randomized, single group Phase 1 study of TAS-102, evaluating the pharmacokinetics, safety, and antitumor activity. Blood sampling will be performed during the first cycle (Day1 and Day 12) of therapy in all consenting patients.

Eligibility Criteria:
Inclusion Criteria:

* 1. Has provided written informed consent prior to performance of any study procedure.
* 2. Has definitive histologically or cytologically confirmed advanced or metastatic solid tumor.
* 3. Is able to take medications orally.
* 4. Has adequate organ function (bone marrow, kidney and liver).
* 5. Has Eastern Cooperative Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

* 1. Has received TAS-102.
* 2. Has suffered serious complications.
* 3. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies.
* 4. Has had prior gastrectomy.
* 5. Is a pregnant or lactating female or male who refused using birth control during the clinical trial period and within 6 months after discontinuation of study treatment.
Incorporating Acupuncture Into ERAS for Ambulatory Total Hip Replacement (THR) Surgery

At this time, no formal ERAS (enhanced recovery after surgery) protocol exists for THR that incorporates perioperative acupuncture. Developing, and more importantly, validating a preliminary fast-track protocol for THR can have a significant impact on reducing recovery time and improving the rate at which this subgroup of surgeries is done on an outpatient basis. Furthermore, previous studies of acupuncture as an adjunctive therapy for postoperative analgesia have primarily investigated patient satisfaction rather than the impact on postoperative opioid consumption.

The majority of studies also place acupuncture needles preoperatively, rather than following induction of anesthesia (intra-operatively). This study hopes to show that placing auricular therapy needles intraoperatively is a feasible part of a protocol for motivated patients to minimize opioids after total knee arthroplasty. The prospect of incorporating intraoperative acupuncture as an adjunct into said protocol is very attractive given its low cost, its safety profile, its ease of administration, and the growing evidence supporting its efficacy. This study would provide further clarity on whether perioperative acupuncture can effectively reduce hospital length of stay and post-operative opioid consumption, in addition to evaluating the role of perioperative acupuncture in improving recovery after THR as part of a multimodal fast-track protocol.


Eligibility Criteria:
Inclusion Criteria:

* ASA status of 1 or 2
* Ages 18-80
* Undergoing a total hip replacement
* Ability to follow study protocol
* English-speaking

Exclusion Criteria:

* Non-English speaking
* Chronic opioids use (6 weeks or more)
* Contraindication to neuraxial anesthesia or peripheral nerve block
* Intending to receive general anesthesia
* Contraindication to intra-op protocol
* Implanted cardiac device (i.e. pacemaker)
* Active ear infection
* Non-native ear, previous scarring or surgery
* Ear gauges or other deforming ear piercing
* Allergy to Nickel
Evaluation of Post Operative Pain After Using Two Different Types of Sealers

conventional endodontic treatment is done using two different types of sealers in the obturation to evaluate the post operative pain between the two sealers

STUDY WILL BE PERFORMED ON PATIENTS DIAGNOSED WITH SYMPTOMATIC IRREVERSABE PULPITIS.

TREATMENT PROTOCOL FOR ALL PATIENTS IS CONVENTIONAL ROOT CANAL TREATMENT

ACCESS CAVITY AND CLEANING AND SHAPING PROCEDURES WILL BE EXECUTED FOR ALL PATIENTS WITH THE SAME PROTOCOL

SELECTED PATIENTS WILL THEN BE DIVIDED INTO TWO GROUPS,

GROUP1: ALL CANALS WILL BE OBTURATED USING RESIN STANDARD SEALERS.

GROUP2: ALL CANALS WILL BE OBTURATED USING HIGH FLOW BIOCERAMIC SEALERS THAT ACCEPT WARM VERTICAL COMPACTION

POST OPERATIVE PAIN IN THE TWO GROUPS WILL BE EVALUATED USING THE VISUAL ANALOUG SCALE AND COMPARED AT DIFFERENT TIME PERIODS (12H, 24H, 48H, 72H)

Eligibility Criteria:
Inclusion Criteria:

* • Patients age ranges from 18-50 years old.

  * Patients with teeth diagnosed with symptomatic irreversible pulpitis.
  * Normal periapical condition confirmed by normal periapical radiograph or that with minimal widening of the PDL space
  * The teeth are restorable
  * Teeth are periodontally free.

Exclusion Criteria:

* • Teeth with immature roots

  * Non restorable teeth
  * Medically compromised patients with systemic complication that would alter the treatment.
  * Necrotic teeth
  * Teeth with apical periodontitis or periapical lesions
  * Teeth that need multiple visits treatment
Evaluation Of The Portal Pressure By Doppler Ultrasound In Cirrhotic Patients Before And After Simvastatin

Portal hypertension is not a disease in itself. Rather, it is an indication of an illness, caused mostly by chronic lesions of the liver because of distinct causes, such as viral infection, chronic alcoholism, or metabolic disorders. Other reasons include splanchnic vascular diseases (for example, obstruction of the portal or the hepatic veins). Portal hypertension is defined as a pressure in the portal vein exceeding the vena cava pressure by more than 5 mm Hg.

Indeed, use of simvastatin might attenuate liver fibrosis in patients with chronic C infection, it may also reduce hepatic vascular resistance and portal pressure by improving liver generation of nitric oxide and hepatic endothelial dysfunction in patients with cirrhosis, so it could be an effective therapy for portal hypertension. It might even improve survival of patients with cirrhosis after variceal bleeding.

Eligibility Criteria:
Inclusion Criteria:

* Positive diagnosis of cirrhosis by US (coarse echogenic pattern, bulky caudate lobe, attenuated hepatic veins)
* Clinical manifestations of portal hypertension (as esophageal varices ,splenomegaly, ascites and encephalopathy grade I-II)

Exclusion Criteria:

* Pregnancy
* Hepatic encephalopathy grade III-IV
* Hepatocellular carcinoma
* Treatment with statins in the previous 3 months
* Hypersensitivity to statins
* Previous surgical shunt or TIPS
* Treatment with calcium channel blockers
BPA vs. PEA in CTEPH

Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare and potentially life-threatening progressive disease that evolves from unresolved pulmonary embolism. Gold standard treatment for CTEPH is pulmonary endarterectomy (PEA) performed by skilled cardio-thoracic surgeons.

Some patients may not be surgical candidates due to co-morbidities or because the vascular lesions are too distal making them technically inoperable. In these patients, balloon pulmonary angioplasty (BPA) has emerged as an effective treatment. In a subgroup of patients, the distribution of vascular lesions makes it possible to perform either BPA or PEA. There has never been a head-to head comparison of BPA with PEA. The aim of this study is therefore, to evaluate if BPA is non-inferior to PEA in patients with (CTEPH) who are eligible for both treatments.

An investigator-initiated multicenter, prospective, randomized, controlled, open label, non-inferiority trial. The study will randomize (1:1) 152 patients with CTEPH who are eligible for both PEA and BPA. Patients will be screened for study inclusion at the local CTEPH multidisciplinary team conference and eligibility for both PEA and BPA will be confirmed by a central adjudication committee.

PEA or BPA will be completed within 6 months from randomization. Follow-up visit with right heart catheterization will be completed at 4 months and 12 months after PEA or last BPA session.

Primary end-point is change in pulmonary vascular resistance from baseline to 4 months and 12 months after PEA or the last BPA session.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with chronic thromboembolic pulmonary hypertension according to current European society of cardiology/European Respiratory Society guidelines and eligible for both pulmonary endarterectomy and ballon pulmonary angioplasty by decision at the local multidisciplinary team conference and central adjudication committee
* Written informed consent from the patient
* Patient age \>17 and \<80 years
* Able to understand and follow instructions and to participate in the entire study period

Exclusion Criteria:

* Life expectancy \<12 months
* Co morbidities evaluated at the multidisciplinary team conference, that contributes significantly to the patients pulmonary hypertension
* Not possible to perform balloon pulmonary angioplasty or pulmonary endarterectomy within 4 months after randomization.
* Evaluated at multidisciplinary team conference that changes in pulmonary artery hypertension targeted therapy between baseline and 4 months follow-up is inevitable\*
* Known pregnancy or positive urine Human chorionic gonadotropin screening test in fertile women
* Previous balloon pulmonary angioplasty or pulmonary endarterectomy
Exploring the Complex Links Between Menstrual Irregularity and Cellular Markers

A cross-sectional study design was employed, involving 56 premenopausal participants with ages ranging from 20 to 49 years. Serum samples were collected during the early follicular phase, and levels of some biochemicals parameters analyzed.

A cross-sectional study was conducted to investigate the potential relationship between menstrual regularity and the apoptosis marker caspase-cleaved cytokeratin 18 fragment (M30), Asymmetric dimethylarginine (ADMA), and Malondialdehyde (MDA) levels. The investigators screened 80 participants who applied for menstrual irregularity between 2023 February and 2024 March and, in addition to menstrual irregularities, 24 individuals with additional gynecological conditions such as polycystic ovary syndrome (PCOS) and endometriosis were excluded from the study. In the overall study population of 56 subjects aged 20-49 were recruited from, Sivas Cumhuriyet University Faculty of Medicine Research and Practice Hospital, Gynecology and Obstetrics Clinic. Participants were divided into two groups: irregular menstrual cycle (28 participants) and regular menstrual cycle control group (28 participants). While those who met the criteria for menstrual irregularity were included, those with another gynecological disease (PCOS, endometriosis, etc.) and additional diseases (diabetes, insulin resistance, cancer, heart disease, etc.) were excluded from the study. All participants provided written informed consent before participating in the study. The study protocol was approved by the Sivas Cumhuriyet University, Clinical Research Ethics Committee Chairman, 2023-02/06. All procedures were performed in accordance with the ethical standards laid down in the Declaration of Helsinki.

Eligibility Criteria:
Inclusion Criteria:

* Menstrual Irregularity
* Being over 18 years of age and not distinguished by age.

Exclusion Criteria:

* Another gynecological disease (PCOS, endometriosis, etc.) and additional diseases (diabetes, insulin resistance, cancer, heart disease, etc.)
Assessment of Subarachnoid Anesthesia With Low Dose of Pethidine and Combination of Ropivacaine With Fentanyl for Urologic Surgical Operations.

The aim of this study is to assess the efficacy of subarachnoid anesthesia with low dose of pethidine (0.4mgkg-1) compared to administration of ropivacaine and fentanyl which is nowadays the common practice.


Eligibility Criteria:
Inclusion Criteria:

* All patients about to be subjected to Transurethral resection of the prostate (TURP) and Transurethral resection of urinary bladder tumors (TUR)
* Signed informed consent

Exclusion Criteria:

* When subarachnoid block is contraindicated
* Patient's denial in performing subarachnoid anesthesia
* Failure of subarachnoid block (L1 dermatome in 30 minutes after intrathecal drug administration)
* Mental illness or drug abuse
* Estimated time of operation \>90 minutes
Epigenetics and Metabolic Disorders in Men With the Klinefelter Syndrome

This study will elucidate how the parental origin of the X-chromosome influences health status as well as metabolic fate in Klinefelter patients. Epigenetics and transcriptome-research will be directly linked to the metabolic and inflammatory pattern of actual patients to improve care for them. The Klinefelter Syndrome is one of the most common genetic disorders in men. The patients have one supernumerary X-chromosome, which is partly active and disturbs a normal male development. Testosterone deficiency in form of primary hypogonadism is a common feature in these men. Such a condition promotes clinically relevant metabolic patterns related to a pro-inflammatory status and diabetes mellitus type 2 (insulin resis-tance), cardiovascular disease as well as infertility. However, the variety of pathologies is pro-nounced between patients and low testosterone concentrations cannot fully explain the wide scope of pathologies in these men. Some patients become clinically obvious during puberty and adoles-cence, some in their thirties or later and all exhibit a huge variation in phenotype. Switching on and off of specific genes on the X-chromosome is differential, depending on the origin either from the maternal or paternal side. Hence, an influence on the clinical picture is hypothesised. Thus, key targets are clarification of the parental origin of the supernumerary X chromosome and elucidation of methylation and expression profile of pivotal X-chromosomal genes. These will be related to clinically relevant metabolic and inflammatory patterns as well as fertility to identify individual risks as well as treatment strategies for Klinefelter patients.


Eligibility Criteria:
Inclusion Criteria:

Klinefelter Syndrome

Exclusion Criteria:

Mosaic status
Intravitreal Avastin Versus Intravitreal Avastin and Triamcinolone in Central Retinal Vein Occlusion(CRVO)

In this study we intend to evaluate and compare the outcomes of intravitreal avastin versus avastin and triamcinolone on improving the visual acuity and macular edema and late complications of CRVO like NVI and NVG.

Central retinal vein occlusion (CRVO) is a common retinal vascular disorder with potentially complications like reduced vision resulting from extensive intraretinal hemorrhage, retinal ischemia and persistent macular edema and neovascular glaucoma secondary to iris neovascularization. Macular edema is a common cause of severe visual loss in both branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO). Natural history data indicate that CRVO patients presenting with poor visual acuity (_20/200) have an 80% chance of being left with visual acuity less than 20/200 at final visit, whether the CRVO is ischemic or nonischemic at presentation. Treatments that target the secondary effects of venous occlusion, such as grid laser photocoagulation for macular edema and prophylactic panretinal laser photocoagulation for nonperfused CRVO, were shown to be ineffective in improving visual acuity in the Central Vein Occlusion Study (CVOS). Although panretinal photocoagulation is advocated for reducing the risk of neovascular glaucoma in patients with ischemic CRVO, recent clinical trials have failed to demonstrate any significant benefit with laser photocoagulation in the treatment of macular edema due to CRVO. A number of other treatment options are sometimes used in cases of CRVO, such as oral corticosteroids, intravitreal steroids, vitrectomy, hemodilution, intravitreal tissue plasminogen activator, hyperbaric oxygen, and laser or surgical chorioretinal anastomosis. Studies demonstrating the effectiveness of these treatments are inconclusive, although some benefits have been suggested in recent reports. In recent studies the benefit of antiVEGF agents in improving the macular edema due to CRVO have been shown. In this study we are going to compare the effect of intravitreal antiVEGF (Avastin) with combination of Avastin and Triamcinolon in improving the visual acuity and macular thickness in patients with recent (Less than 6 months) CRVO.

Eligibility Criteria:
Inclusion Criteria:

* CRVO with duration less than 6 months

Exclusion Criteria:

* vision less than 20/320 and vison more than 20/50
* history of galucoma and diabetic retinopathy
* previous laser or intravitreal treatment
* any media opacity that prevents funduscopy
Message Testing in Older Adult Smokers

This study is examining different messages to motivate older smokers to quit smoking. Participants will be current smokers, between the ages of 50-80 years old, who do not have a history of cognitive impairment or dementia. Participants can expect to take part in a one-time 30 minute online survey.


Eligibility Criteria:
Inclusion Criteria:

* Current smoker (smoking at least some days per week)
* Ability to read and write English
* Between the ages of 50 and 80 years old

Exclusion Criteria:

* History of Mild Cognitive Impairment or dementia
Pain and Safety of Restylane With and Without Lidocaine for Correction of Moderate and Severe Nasolabial Folds

The purpose of this study is to evaluate the pain and safety associated with injections of Restylane Lidocaine compared to Restylane using a visual analogue scale.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Men or women aged 18 years or older of Chinese origin
* Subjects willing to abstain from any other facial plastic surgical or cosmetic procedures below the level of the lower orbital rim for the duration of the study
* Intent to undergo correction of both nasolabial folds(NLF) with a wrinkle severity in Wrinkle Severity Rating Scale(WSRS) of either 3 on both sides or 4 on both sides

Exclusion Criteria:

* Previous use of any permanent (non-biodegradable) or semi-permanent facial tissue augmentation therapy or autologous fat below the level of the lower orbital rim
* Previous use of any hyaluronic acid based or collagen based biodegradable facial tissue augmentation therapy below the level of the lower orbital rim within 12 months before treatment
* Previous tissue revitalisation treatment with laser or light, mesotherapy radiofrequency, chemical peeling or dermabrasion in the midface within 6 months before treatment
* Scars or deformities, active skin disease, inflammation or related conditions near or in the area to be treated
* Other condition preventing the subject from entering the study in the Investigator's opinion
Stress and Health Interview for Primary Care Patients With Medically Unexplained Symptoms

The goal of this study is to test the feasibility and acceptability of providing an experiential assessment interview that targets emotional and stressful experiences in primary care. In this randomized, controlled trial, the investigators will compare an interview condition to a wait-list control condition. The investigators hypothesize that helping individuals first identify the links between their stress and symptoms will likely increase their awareness and endorsement of the link between stress and physical symptoms, including a willingness to engage in stress management techniques. It is also expected that helping raise an individual's awareness about their symptoms, followed by an experience and expression of unexpressed emotions is likely to influence their physical symptoms and psychological status.

Emotional stress, particularly when a patients inhibits their experiences and feelings, contributes to physical symptoms. However, primary care patients with medically unexplained symptoms are rarely assessed for the stress and emotions in an comprehensive manner. The goal of this study is to test the feasibility and acceptability of providing an experiential assessment interview that targets emotional and stressful experiences in primary care with medically unexplained physical symptoms. In this randomized, controlled trial, the investigators will compare an interview condition to a wait-list control condition. The interview will review patients health history, psychosocial history, make links between the two, and help patients identify and express emotions related to conflicts or victimization. The investigators hypothesize that helping individuals first identify the links between their stress and symptoms will likely increase their awareness and endorsement of the link between stress and physical symptoms, including a willingness to engage in stress management techniques. It is also expected that helping raise an individual's awareness about their symptoms, followed by an experience and expression of unexpressed emotions is likely to influence their physical symptoms and psychological status.

Eligibility Criteria:
Inclusion Criteria:

* Participants must score above 10 (moderate range) on the Patient Health Questionnaire-15, which is a measure of a range of medical symptoms that are often medically unexplained.

Exclusion Criteria:

1. Conditions that could interfere with the interview:

   * non-English speaking
   * psychosis
   * dementia
   * mental impairment
2. The presence of disease or injury that could account for the physical symptoms. - Examples: autoimmune disease, bodily injury, serious infection, cancer, heart disease, COPD, post-stroke.