cyrilzakka/clinical-trials huggingface dataset:
Stellate Ganglion Block in Obstructive Sleep Apnea

The goal of this clinical trial is to test the efficacy of stellate ganglion block in Obstructive Sleep Apnea. The main question it aims to answer are:

• Can stellate ganglion block improve Obstructive Sleep Apnea? Patients were randomly divided into two groups, all provided with routine therapy. Based on this, the experimental group was given stellate ganglion block. The video fluoroscopic swallowing study was done to test the swallowing function before and after the study.

Obstructive Sleep Apnea is of increasingly high prevalence.

The goal of this clinical trial is to test the efficacy of stellate ganglion block in Obstructive Sleep Apnea. The main question it aims to answer are:

• Can stellate ganglion block improve Obstructive Sleep Apnea? Patients were randomly divided into two groups, all provided with routine therapy. Based on this, the experimental group was given stellate ganglion block. The video fluoroscopic swallowing study was done to test the swallowing function before and after the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18 years diagnosed with Obstructive Sleep Apnea by polysomnography
* Patients with moderate to severe Obstructive Sleep Apnea
* Patients who have undergone continuous positive airway pressure treatment for at least 3 months but have not achieved satisfactory therapeutic effects
* Patients who voluntarily agree to receive stellate ganglion block treatment and sign the informed consent form

Exclusion Criteria:

* Patients with a history of allergy or contraindications to local anesthetics or corticosteroids
* Patients with severe cardiovascular, cerebrovascular, respiratory, hepatic, or renal diseases
* Patients with a history of neck surgery or cervical spine disease
* Patients with psychiatric disorders or other medical conditions that may affect the safety or effectiveness of Stellate Ganglion Block treatment
* Pregnant or lactating women
* Patients who have participated in other clinical trials within the past 3 months
Non Interventional Clinical Investigation of Ectoin Ear Spray in Skin Treatment of Outer Ear Canal Irritations

In this observational study, insights regarding the tolerability and influence on the quality of life of the topical treatment with Ectoin Ear Spray compared to Normison ear spray shall be gained under real life conditions in patients with chronic eczematous irritations and pruritus of the outer ear canal.


Eligibility Criteria:
Inclusion Criteria:

* according to instructions for use

Exclusion Criteria:

* otitis media, acute otitis media
* acute otitis externa
* earache
* perforation of the ear-drum (membrana tympani)
* infections at the ear
* systemic corticosteroid treatment or local at the ear
Safety of Topical Tranexamic Acid in Total Joint Arthroplasty in High Risk Patients

To evaluate whether there is a difference in symptomatic thromboembolism events in the subset of patients with a history of, or risk factors for thromboembolic disease for topically applied tranexamic acid in total joint arthroplasty.

Tranexamic acid (TXA) has been used successfully to stop bleeding after dental procedures, removal of tonsils, prostate surgery, heavy menstrual bleeding, and eye injuries, as well as in patients with hemophilia. Intravenous TXA has also been shown to reduce blood loss, reduce transfusion requirements, and decrease length of stay for patients undergoing total knee arthroplasty and total hip arthroplasty. These benefits occur without increasing risks of thromboembolism events such as pulmonary embolism, deep venous thrombosis, myocardial infarctions, and cerebrovascular events in patients without history of, or risk factors for thromboembolic disease. Topical TXA in TJA has also been demonstrated to show the above benefits without any increase risks, as well as systemic absorption of the medication that is below the effective therapeutic plasma concentration.

Preliminary retrospective studies has demonstrated that IV TXA to be safe and effective in patients with risk factors for thromboembolic events and patients with American Society of Anesthesiologists score III or IV.

Currently, there are no prospective studies on the use of either IV or topical TXA in these higher risk patients. The goal of this study is to evaluate whether there is a difference in symptomatic thromboembolism events in the subset of patients with a history of, or risk factors for thromboembolic disease for topically applied TXA in total joint arthroplasty (TJA).

Eligibility Criteria:
Inclusion Criteria:

Presence of one or more of seven risk factors for thromboembolic events - Prior DVT, PE, MI, CVA, coronary artery stent placement, CABG, or prothrombotic condition (Factor V Leiden deficiency, protein C deficiency, antiphospholipid syndrome, etc).

Exclusion Criteria:

Simultaneous bilateral, hip resurfacing, partial knee, and revision arthroplasties
Effects of the Elastic Taping on the Chronic Ankle Instability

This study will analyze the effects of an elastic taping application protocol in individuals with chronic ankle instability. One group will perform a protocol with increased tape tension for five weeks while the other group will receive the same tape without tension during the same period.

Elastic taping is a method widely used in clinical practice for the treatment of ankle instability and shows increasing interest in research to verify its effectiveness. The literature presents several studies with short-term effects, largely in healthy individuals and with several application techniques, with the incremental tensioning of the proposed tape subjectively.

The literature presents several studies with short-term effects, largely in healthy individuals and with several application techniques, with the incremental tensioning of the proposed tape subjectively.

Eligibility Criteria:
Inclusion Criteria:

* young adults with chronic ankle instability (unilateral or bilateral);
* the first sprain episode occurred for at least 1 year pre-study associated with inflammatory symptoms (pain, edema, etc.);
* having discontinued for at least 1 day physical activity;
* the most recent sprain occurred more than 3 months prior study;
* self-reported instability feeling to be confirmed by specific questionnaires.

Exclusion Criteria:

* lower limb surgical procedure;
* lower limb fracture history;
* acute injury (last 3 months) of other lower limb joints resulting in at least 1 day in the interruption of physical activity;
* wounds in the ankle region or foot;
* own skin disease;
* have allergy to bandage;
* be in physiotherapeutic treatment.
mHealth for Breast Cancer Survivors With Insomnia

The aim of this study is to determine the impact of the voice-activated smart speaker CBT-I components on insomnia symptoms among breast cancer survivors using a randomized clinical trial.

This study is a Phase II SBIR to further test efficacy of a voice-activated technology to deliver components of cognitive behavioral therapy for insomnia (CBT-I) to breast cancer survivors (BCS) compared to a web-based control. Participants will be randomly assigned to the voice-activated or web-based treatment arms and will complete a 6-week intervention.

Eligibility Criteria:
Inclusion Criteria:

* Willingness to maintain a consistent dosing pattern if currently taking sleep medications or using cannabis for sleep
* Females; Age 18+
* Self-reported or documented diagnosis of breast cancer stage I-III or stage IV ECOG 0-1
* Completed curative treatment (surgery, radiation, chemotherapy) \> 3 months prior to enrollment \[ongoing adjuvant therapy permitted\]
* Has not undergone other behavioral sleep treatment within the prior 12 months
* Score greater than or equal to 8 on the Insomnia Severity Index
* Able to understand and speak English

Exclusion Criteria:

* Diagnosed, untreated obstructive sleep apnea syndrome, narcolepsy, restless leg syndrome, periodic limb movement disorder, delayed sleep phase syndrome, central apnea
* Bi-polar disorder, schizophrenia, initiation of psychological treatment within three months, alcohol or drug abuse in the prior year (Alcohol \>2 drinks/day or consuming 5+ drinks in a single day in the prior month). (Moderate ADHD, depression and anxiety will not be exclusion criteria.)
* Shift-work in the prior three months or anticipated during the study time
* Planned regular travel out of time zone (\>1 hour) during the study period.
* Currently or planning to become pregnant during the study period
PT003 MDI Cardiovascular Safety Study

This study is primarily a safety study. The primary and secondary endpoints are based on 24-hour Holter monitor assessments obtained on Day 14 relative to baseline.


Eligibility Criteria:
Key Inclusion Criteria:

* Signed written informed consent
* 40 - 80 years of age
* Clinical history of COPD with airflow limitation that is not fully reversible
* Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods
* Current/former smokers with at least a 10 pack-year history of cigarette smoking
* A measured post- bronchodilator FEV1/FVC ratio of \< or = 0.70
* A measured post- bronchodilator FEV1 \> or = 750ml or 30% predicted and \< or = 80% of predicted normal values
* Able to change COPD treatment as required by protocol
* Acceptable baseline (Visit 2) Holter monitor recording

Key Exclusion Criteria:

* Women who are pregnant or lactating
* Primary diagnosis of asthma
* Alpha-1 antitrypsin deficiency as the cause of COPD
* Active pulmonary diseases
* Prior lung volume reduction surgery
* Abnormal chest X-ray (or CT scan) not due to the presence of COPD
* Hospitalized due to poorly controlled COPD within 3 months of Screening
* Clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ECG, uncontrolled hypertension, glaucoma, symptomatic prostatic hypertrophy)
* Cancer that has not been in complete remission for at least 5 years
* Treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives
* Clinically significant abnormal findings during the baseline Holter recording
* Patients with a pacemaker or ICD/CRT/CRT_D devices

Other inclusion/exclusion criteria as defined by the protocol
Experiences of Pregnant Women Who Use NRT in Pregnancy as Part of a Quit Attempt

This study is largely a qualitative study with a small survey component. The aim of the survey would be to gain a quantitative perspective of how women use NRT after this has been prescribed by stop smoking services (SSS). The aim of the qualitative study would be to enhance knowledge of pregnant smoker's views and attitudes about their experiences of using NRT and in particular to understand why pregnant women who start using NRT often discontinue this early or do not use the medication as it is prescribed. This information is important for a number of reasons; firstly it will help health professionals and researchers gain an in depth understanding about how women experience using NRT, which may be used to help devise strategies for encouraging better adherence and which could be used in future clinical trials to gain a clearer understanding as to whether or not NRT is effective in pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Quantitative survey;

  * Women who are pregnant
  * Aged 16 or over (no upper age limit)
  * Who have been prescribed NRT (patches/dual therapy) to aid a quit attempt.

Qualitative interview study will include the above plus;

* Women will have used NRT for over 24 hours
* Either not be using NRT as prescribed (as deciphered by the survey questions) or have currently quit NRT (and have either stopped smoking or continue to smoke)

Exclusion Criteria:

* Survey and qualitative interviews

  * Women who cannot understand the study procedure sufficiently in order to provide consent e.g. due to cognitive difficulties
  * Women who are unable to read or understand the consent procedure and study procedures in English.
Superiority of VCD Versus CTD in Patients With Newly Diagnose Multiple Myeloma Eligible for Transplantation

This study compared two main different induction protocols used to treat myeloma eligible patients in Brazil. VCD against CTD.

The primary aim was observe response rate after 4 induction cycles.

Eligibility Criteria:
Inclusion Criteria:

* multiple myeloma newly diagnose elegible to autologous transplantation Patients submitted to ctd or vcd Myeloma patients newly diagnose \>18yo

Exclusion Criteria:

* other chemotherapy induction protocol
Safety and Effectiveness of Low Dose Edoxaban in Patients With NVAF

The efficacy and safety of edoxaban has not been adequately studied in Asians versus non-Asians, who are quite different physiologically from each other. Compared with non-East Asian patients, the East Asia patients were twice as likely to have the reasons for requiring dose reduction of edoxaban, such as CrCl 30-50 ml/min (30.0% and 18.2%, respectively), weight ≤60 kg (30.6% and 7.8%, respectively), or concomitant use of verapamil or quinidine (P-gp inhibitors, 6.6% and 3.3%, respectively). This study is aimed to evaluate the safety of the low dose edoxaban therapy in patients with high bleeding risk and non-valvular AF in the real world population of Korea.

The efficacy and safety of edoxaban has not been adequately studied in Asians versus non-Asians, who are quite different physiologically from each other. Although 1,943 patients from East Asia (1,010 were from Japan, 469 from China, 234 from Taiwan, and 230 from South Korea) were included in ENGAGE AF-TIMI 48, majority of the patient (19,162) were from non-East Asia. Compared with non-East Asian patients, the East Asia patients were twice as likely to have the reasons for requiring dose reduction of edoxaban, such as CrCl 30-50 ml/min (30.0% and 18.2%, respectively), weight ≤60 kg (30.6% and 7.8%, respectively), or concomitant use of verapamil or quinidine (P-gp inhibitors, 6.6% and 3.3%, respectively). Due to the relatively small number of patients in the East Asian group included in the analysis compared with that of the patients in the non-East Asian group, a limitation preventing it from providing sufficient power for such comparison is unavoidable. This study is aimed to evaluate the safety of the low dose edoxaban therapy in patients with high bleeding risk and non-valvular AF in the real world population of Korea.

Eligibility Criteria:
Inclusion Criteria:

* atrial fibrillation low dose edoxaban

Exclusion Criteria:

-
Evaluation and Validation of Novel Diagnostic Tool for Allergists (AbioSCOPE)

In this study, investigators evaluated for the first time the diagnostic efficacy of abioSCOPE® versus Phadia Laboratory System as an aid in the diagnosis of allergic diseases. Investigators targetted the agreement between test results obtained in abioSCOPE® and a laboratory reference method (Phadia Laboratory System, ThermoFisher Scientific, Uppsala, Sweden), considered as a quasi-gold standard in IgE (immunoglobulin E) antibody assays. Investigators also reported the medical decision taken by a panel of allergy experts who had access to patient history, skin tests and IgE antibody assay, but blinded to the method used, i,e, the reference method or the abioSCOPE® .


Eligibility Criteria:
Inclusion Criteria:

* Subjects examined at ambulatory medicine medicine center CHUV / PMU and for wich serum sample is required for the research of specific IgE (allergic patients, allergic group) or for any other reason (immunological) (non-allergic control patients, control group)
* Subjects for which it is expected (allergic group subjects) or who will be asked (non-allergic control group) to perform a panel of standard prick tests as basic allergological investigation, including pollen birch, grasses, mites (D pter, D far), cat dander.
* Obtain informed consent from each subject before any study procedure.

Exclusion Criteria:

* Presence of positive HIV-1 viremia by the ultra-sensitive method in the 12 months preceding the study.
* Use of any investigational or non-registered product (drug or vaccine)
* Chronic administration (more than 14 days) of immunosuppressive or immunomodulatory drugs in the 6 months preceding the study for corticosteroids. This means a dose of Prednisone or equivalent substance greater than or equal to 0.5 mg per kg / day. Inhaled topical steroids are allowed.
* Administration of any immunoglobulin, any immunotherapy or administration of some blood products in the 3 months preceding the study, or planned during the study period.
* Any health condition or patient history, in the opinion of the investigator, could interfere with the evaluation of the study's objectives.
* Participation in another experimental protocol during the period of the study.
* Demonstration, confirmation or suspicion of a condition of immunosuppression or immunodeficiency (including HIV infection) based on medical history and physical examination (no laboratory test).
* A family history of congenital or hereditary immunodeficiency.
* Subjects taking any of the following medications: antihistamines in the week preceding the consultation, systemic steroids (inhaled or nasal steroids are allowed), anti-cytokines or cytokines, systemic interferon (injection local interferon α for the treatment of HPV is allowed) or treated with systemic chemotherapy.
Comparison of Blood Pressure Medications on Metabolism

The purpose of this study is to determine if there are differences, (benefits) between carvedilol and metoprolol in the treatment of HTN in patients with type 2 diabetes. Specifically we will be looking at differences in blood pressure and blood sugar control, endothelial function, inflammation, oxidative stress and coagulation.

Subjects will be randomized to one of the two beta-blockers and followed for 5 months. Each subject will undergo 4 inpatient studies where an oral glucose tolerance test will be done, Inflammatory and oxidative stress markers will be measured. Endothelial function will be measured using brachial artery ultrasound and laser skin Doppler

The purpose of this study is to determine if there are differences, (benefits) between carvedilol and metoprolol in the treatment of HTN in patients with type 2 diabetes. Specifically we will be looking at differences in blood pressure and blood sugar control, endothelial function, inflammation, oxidative stress and coagulation.

Subjects will be randomized to one of the two beta-blockers and followed for 5 months. Each subject will undergo 4 inpatient studies where an oral glucose tolerance test will be done, Inflammatory and oxidative stress markers will be measured. Endothelial function will be measured using brachial artery ultrasound and laser skin Doppler. Baseline visit will be done when subjects are off all antihypertension medications except ACEI/ARB. Following the baseline study subjects will be randomized to study drug. The dose will be titrated until goal blood pressure is reached. Add on medication will be used if needed.

Subjects will then undergo a second study. The third study will take place after 5 months on treatment. Stud drug will then be stoppped and subjects will be restudied 2 weeks later

Eligibility Criteria:
Inclusion Criteria:

* not enrolling

Exclusion Criteria:

* not enrolling
Toric Intraocular Lens Implantation in Pediatric Cataract

To evaluate the visual and refractive outcomes after an intraocular lens (IOL) implantation in pediatric eyes with cataract and preexisting corneal astigmatism

This single-center, single-blinded, prospective, randomized controlled trial was performed at two sites of Kazakh Eye Research Institute.

Children with pediatric cataract and corneal astigmatism were included and randomized to two groups for pediatric cataract surgery with toric and non-toric intraocular lens (IOL) implantation. The uncorrected and corrected distance visual acuity, near visual acuity, keratometry data, and residual astigmatism were evaluated.

The purpose of this study is to evaluate the visual and refractive outcomes after a toric IOL implantation in pediatric eyes with cataract and preexisting corneal astigmatism.

Eligibility Criteria:
Inclusion criteria:

1. Visually significant cataract;
2. Corneal astigmatism more than 1.25 diopters;
3. Children aged ≥ 6 years and \< 18 years.

Exclusion criteria:

1. Patients with a corneal diameter less than 9 mm;
2. Presence of corneal scarring;
3. Irregular astigmatism;
4. Intraocular pressure more than 25 mm Hg;
5. Active inflammatory process of the eyeball or signs of a previous episode of inflammation;
6. Traumatic, subluxated, or complicated cataract;
7. Persistent Fetal Vasculature;
8. Diseases of the optic nerve or macula that may limit visual potential;
9. History of previous intraocular surgeries;
10. Performing posterior capsulorhexis intraoperatively.
The Optimal Width of Gastric Conduit for Minimally Invasive Esophagectomy: Wide or Narrow?

The study hypothesized that a narrow gastric conduit(less than 3cm in width) would minimize anastomotic leakage following minimally invasive esophagectomy. Therefore we raise this random-controlled research, and investigate the leakage ratio from different widths of gastric conduit formed during the operation.

Patients underwent minimally invasive esophagectomy in Zhongshan Hospital of Fudan University will be enrolled and be assigned to wide or narrow gastric conduit group randomly. Intra-operative blood supply and vascular SaO2 will be observed during the operation, and the rate of anastomotic leakage, together with its clinical details will be recorded in the two groups.

Eligibility Criteria:
Inclusion Criteria:

1. Patients underwent minimally invasive esophagectomy(three-hole procedure)
2. Clinical Staged T1-3N0M0 esophageal cancer patients or: patients who were restaged as T1-3N0M0 esophageal cancer after neo-adjuvant therapy

Exclusion Criteria:

1. With previous cancer history
2. Severe Co-morbidity
Same-day Cervical Preparation With Misoprostol Before Hysteroscopy

This is a randomized trial, assessing Misoprostol efficacy in cervical preparation several hours prior to hysteroscopy, comparing the different routes of administration (PO/PV/buccal). Initial cervical dilatation will be assessed, as well as surgical ease of dilatation, time required to achieve dilatation and patient preference.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted for elective hysteroscopy (diagnostic/surgical) at Wolfson Medical Center
* Written consent supplied

Exclusion Criteria:

* Contraindications to prostaglandin treatment (severe asthma, glaucoma, severe cardiac disease, renal failure)
* Prostaglandin allergy
* Pregnancy
* Genital infection
* Space-occupying lesion in the endocervical canal
* Prior cervical surgery