cyrilzakka/clinical-trials huggingface dataset:
Selecting the SSV-1 as LIV in Scheuermann's Kyphosis

The proper selection of the lowest instrumented vertebra (LIV) remains controversial in the surgical treatment of Scheuermann's disease and there is a paucity of studies investigating the clinical outcomes of fusion surgery when selecting the vertebra one level proximal to the sagittal stable vertebra (SSV-1) as LIV. The purpose of this study is to investigate whether SSV-1 could be a valid LIV for Scheuermann kyphosis (SK) patients with different curve patterns.

The proper selection of the lowest instrumented vertebra (LIV) remains controversial in the surgical treatment of Scheuermann's disease and there is a paucity of studies investigating the clinical outcomes of fusion surgery when selecting the vertebra one level proximal to the sagittal stable vertebra (SSV-1) as LIV. The purpose of this study is to investigate whether SSV-1 could be a valid LIV for Scheuermann kyphosis (SK) patients with different curve patterns.

This was a prospective study on consecutive SK patients treated with posterior surgery between January 2018 and September 2020, in which the distal fusion level ended at SSV-1. The LIV was selected at SSV-1 only in patients with Risser \> 2 and with LIV translation less than 40mm. All of the patients had a minimum of 2-year follow-up. Patients were further grouped based on the sagittal curve pattern as thoracic kyphosis (TK) and thoracolumbar kyphosis (TLK). Radiographic parameters including global kyphosis (GK), lumbar lordosis (LL), sagittal vertical axis (SVA), LIV translation, pelvic incidence (PI), pelvic tilt (PT), sacral slope (SS) were measured preoperatively, postoperatively and at the latest follow-up. The intraoperative and postoperative complications were recorded. The Scoliosis Research Society (SRS)-22 scores were performed to evaluate clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of SK patients;
* underwent one-stage posterior spinal fusion (PSF) with multi-level Ponte osteotomies;
* selecting SSV-1 as LIV;
* with a minimum follow-up of 2 years.

Exclusion Criteria:

* with previous spinal surgical history;
* with any other spinal deformities;
* without complete follow-up data.
Catheter Ablation Using a Novel Navigation and Imaging System

The objective of the ENVIsIoN study is to collect data on the use of the VERAFEYE navigation and imaging system in patients indicated to undergo a catheter ablation procedure for the treatment of Paroxysmal Atrial Fibrillation (PAF).


Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 years of age at the time of consent, or of legal age to give informed consent specific to state and national law
* Subjects is eligible for a catheter ablation procedure with the VERAFEYE System as navigation and imaging system in the treatment of PAF (according to VERAFEYE System IFUs, current international and local guidelines and per physician discretion)
* Subject is able to understand and willing to provide written informed consent
* Subject is able to and willing to complete all study assessments associated with this clinical study at an approved clinical investigational center

Exclusion Criteria:
Retrospective Cervical Cancer Oligo States (Recurrence, Metastasis) Multicentre Outcomes Study

This multi centric international retrospective study aims to register patients with oligo metastatic and oligo recurrent cervical cancer. The study will register patients in planned period with an aim to analyse clinical outcomes with or without use of radiation in this setting.

Detailed clinical protocol can be obtained by contacting the principal investigator.

Eligibility Criteria:
Inclusion Criteria:

1. Cervical cancer with (induced) oligo-metastatic and/or oligo-recurrent cervix cancer whether treated or not treated with radiation. These patients may have received previous treatment within or outside approved clinical trials/studies.
2. Patients with poly-metastatic disease with good response to systemic chemotherapy and treated with radiation to recurrence or metastatic site.
3. Patients treated with radical doses at the time of first diagnosis of oligo-metastasis/oligo-recurrence and present with further oligo-progression.
4. Patients with oligo-metastasis or oligo-recurrence treated with other locally directed therapies (like surgery, ablation, etc.) are also permitted.

Exclusion Criteria:

1. Gynecological cancer other than cervical cancer
2. Persistent Poly-metastatic disease post systemic treatment
3. Receiving investigational new drugs at the time of relapse as part of other ongoing trials
4. No clinical follow up after treatment
Brilinta DaYu Study

A multicenter, single arm, open label, Phase IV study to evaluate safety and to describe the incidence of major cardiovascular events of ticagrelor in Chinese patients with acute coronary syndrome


Eligibility Criteria:
Inclusion Criteria:

* 1. Female or male aged at least 18 years 2.Index event of non-ST or ST segment elevation ACS 3.A patient who is considered as ethnic Chinese

Exclusion Criteria:

* 1. With coagulation disorder 2.Index event is an acute complication of PCI 3.Patient has planned for an urgent coronary artery bypass graft (CABG) within 7days from the enrolment 4.Oral anticoagulation therapy within 30 days prior to enrolment or cannot be stopped 5.Increased risk of bradycardic events 6. Concomitant oral or intravenous therapy (see examples below) with strong CYP3A inhibitors, CYP3A substrates with narrow therapeutic indices, or strong CYP3A inducers 7.Increased risk of bradycardic events (eg, no pacemaker and known sick sinus syndrome, second degree A-V block, third degree A-V block or previous documented syncope suspected to be due to bradycardia unless treated with a pacemaker). 8.Known clinically important thrombocytopenia 9.Known clinically important anaemia
The Effect and Safety of Plum-blossom Needle for Tourette Syndrome

To evaluate the effect and safety of plum-blossom needle for Tourette syndrome.

This is a randomized, controlled trial with two parallel arms. A total of 60 patients will be randomly allocated into the plum-blossom needle group (n=30) and the habit reversal training (HRT) group (n=30). 12-week treatment will be given to all patients of each group, follow-up will be made at the 12th week after treatment. The primary outcome measure will be the mean change from baseline in the total tic score on the Yale Global Tic Severity Scale (YGTSS) at the 12th week. Secondary outcome measures will include the mean changes in score of YGTSS, TS Clinical Global Impression Scale (CGI) and the Children and Adolescents' Quality of Life Scale from baseline at other time. Safety will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Meeting the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association (DSM-IV) for TS.
2. Aged 7 to 18.
3. Agree to participate in the trial and sign written informed consent by both guardians and subjects.

Exclusion Criteria:

1. Having severe problem in heart, liver or kidney, or having hyperthyroidism.
2. After evaluated by psychiatrists based on the Kiddie-Sads-Present and Lifetime Version, those who are associated with co-morbid conditions such as mental retardation, pervasive developmental disorder, schizophrenia, mania episode, bipolar disorder, anxiety and depression and specific learning disorder will be excluded.
3. Tics symptoms caused by some drugs.
4. Currently receiving any other form of pharmacological or non-pharmacological treatment for their Tourette syndrome.
5. Patients with a history of psychotropic substance or alcohol use during the 3 months preceding screening.
6. Patients with a history of nonresponsiveness to HRT or participating in another clinical trial.
Comparison of Laboratory Test Results of Minimal-Residual Disease in Samples From Patients With Acute Myeloid Leukemia

RATIONALE: Diagnostic procedures that find residual disease may help predict if the disease will come back in patients diagnosed with acute myeloid leukemia.

PURPOSE: This research trial studies the comparison of laboratory test results for minimal residual disease in samples from patients with acute myeloid leukemia.

OBJECTIVES:

* To promote harmonization between Cooperative Group Reference Laboratories conducting minimal-residual disease (MRD) evaluation of acute myeloid leukemia by flow cytometry.

OUTLINE: Archived bone marrow and blood samples, distributed to the Eastern Cooperative Oncology Group, Southwest Oncology Group, and Cancer and Leukemia Group B laboratories, are analyzed for leukemia-associated immunophenotype (LAIP) assays and minimal residual disease studies by flow cytometry. Results are then provided to the National Cancer Institute for assessment and comparability of test results.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Non-identified cryopreserved samples of bone marrow and/or peripheral blood from patients with acute myeloid leukemia (AML) from the Children Oncology Group (COG) studies

  * Baseline/diagnostic AML samples
  * Samples collected after initial treatment and representing varying levels of residual blast counts

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy

The purpose of this study is to determine whether once-nightly FT218 is safe and effective for the treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects 16 years of age or older
2. Willing and able to give written informed consent for study participation. For young adults (16 and 17 years old) who have not reached the age of majority they must be capable of giving assent and consent from a legally authorized guardian must be obtained, as required by local laws and regulations
3. Documented evidence of a diagnosis of NT1 (type 1 narcolepsy) or NT2 (type 2 narcolepsy) as, in part, determined by an overnight PSG (polysomnography) and next-day MSLT (maintenance of sleep latency test) with 2 or more SOREMPs (sleep onset REM) with mean sleep latency in the pathological range i.e. \< 8 minutes and meeting the NT1 and NT2 as defined by the International Classification of Sleep Disorders -3 criteria.
4. Current continuing presence of EDS (excessive daytime sleepiness) as defined by subject report for the last 3 months and an ESS (Epworth sleepiness scale) \> 10
5. For NT1 only, current continuing presence of cataplexy as defined by subject report for the last 3 months
6. Subjects may use concomitant stimulants, but must comply with the following:

   1. They must be on a stable dose of stimulants for at least 3 weeks prior to starting the screening process for this study; AND
   2. They must use the same stimulant regimen throughout the entire study period, including during screening and posttreatment periods
   3. They must discontinue all anti cataplexy drugs
7. Addition inclusion criteria per protocol

Exclusion criteria

1. Any prior use of sodium oxybate is allowed in the study but within the following exclusions:

   1. Previous dosing must have been limited to no more than 4.5g per night
   2. Patient should not have taken sodium oxybate for more than 2 weeks.
   3. All previous dosing must not have occurred within the last year prior to entry to the study.
2. Current use of sodium valproate
3. Any use of the following prohibited medications for the duration of the clinical study:

   1. Anticonvulsants
   2. Clonidine
   3. SSRIs (selective serotonin re-uptake inhibitors) and serotonin and norepinephrine re-uptake inhibitors (SNRIs)
   4. MAOIs (monoamine oxidase inhibitors)
   5. TCAs (tricyclic antidepressants)
   6. Hypnotics
   7. Anxiolytics
   8. Sedating antihistamines
   9. Antipsychotics
   10. Other experimental medications designed to treat narcolepsy, cataplexy or any other condition
4. Treatment with any investigational products within 3 months before study enrollment
5. Any drug known to affect sleep-wake function. Concomitant stimulant use is permitted
6. Additional exclusion criteria per protocol
Evaluating the Efficacy and Safety of Vardenafil in Patients Erectile Dysfunction Solely Secondary to Spinal Cord Injury

Investigate efficacy and safety of Vardenafil in patients with spinal cord injury


Eligibility Criteria:
Inclusion Criteria:

* Males ≥18 years with erectile dysfunction (ED) solely as a result of traumatic spinal cord injury (SCI) for ≥6 months with demonstrated 50% failure in intercourse attempts during the 4-week run-in period.
* Stable heterosexual relationship for at least 1 month.

Exclusion Criteria:

* Subjects with unstable medical or psychiatric conditions or using prohibited concomitant medications
* Primary hypoactive sexual desire
* History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
* Nitrate therapy
* Other exclusion criteria apply according to US Product Information or Summary of Product Characteristics
Parallel Group Trial to Evaluate the Efficacy and Safety of Loion® Compared to 10% Salicylic Acid in Patients With Chronic Psoriasis Capitis

The study will be conducted to evaluate the efficacy and safety of a topical dimeticone formulation (Loion®) compared to 10% salicylic acid in octyl-dodecanol with 15% Macrogol-4-laurylether for the removal of scaling in patients with chronic psoriasis capitis (scalp psoriasis).


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age
* Having a diagnosis of chronic psoriasis capitis (scalp psoriasis) with or without the involvement of other body areas and with or without psoriatic arthritis.
* PSSI ≥5 (range 0-72)
* Scaling ≥2 (on an scale from 0 to 4)
* At least 10% of scalp area affected
* If a women:
* Postmenopausal
* Premenopausal and using an established oral, injected or implanted hormonal method of contraception, intrauterine device (IUD) or intrauterine system (IUS)
* Negative pregnancy test at inclusion
* Patients with no concomitant systemic psoriasis medication.
* Willingness and adherence to the prohibitions and restrictions specified in the study protocol.
* Willingness to self-administer the drug.
* Signed informed consent document indicating that the patient to be included understands the purpose of and the procedures for the study and is willing to participate.

Exclusion Criteria:

* Patients having a solely non- plaque form of psoriasis (e.g. erythrodermic, guttate, pustular).
* Patients with uncontrolled psoriasis under the current treatment.
* Patients having received topical keratolytic agents for the scalp within the past 2 weeks and topical steroids for the scalp within the past week (prior to inclusion).
* Patients receiving systemic antipsoriatic drugs, immunosuppressants or systemic corticosteroids (within 4 weeks prior to inclusion).
* Women who are pregnant or breastfeeding or planning to become pregnant during the observational period.
* Patients participating in another study using an investigational agent or procedure during participation in the study observation period.
* Known hypersensitivity to any ingredient in the investigational products' formulations.
* Having any condition that in the opinion of the investigator makes the participation not be in the best interest of the subject.
* Employees and staff of the investigator or study site with direct involvement in the study as well as family members of the employee or the investigator.
Protocol for Evaluating Physiological and Psychological Adaptation Mechanisms in Tibetan Plateau Environments

This study is a single-center prospective observational study. It plans to use a series of physiological and medical instruments and international common physiological and psychological questionnaires. To dynamically detect the changes of physiological and psychological adaptability of doctors in Peking Union Medical College Hospital before leaving Beijing, 1-7 days after arriving at the plateau in Tibet during the acute phase of plateau hypoxic stress, 2 weeks, 3 months, 6 months, 12 months after staying in Tibet during the chronic phase of plateau hypoxic stress, and after returning to Beijing.


Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals aged 20-65 years
* They can sign a written informed consent and is willing to cooperate
* They have the qualification to aid Tibet and meet the basic requirements of physical examination for aid to Tibet

Exclusion Criteria:

* Age less than 20 years or more than 65 years
* Unable to sign a written informed consent or unwilling to cooperate
* They do not have the qualification for supporting Tibet or do not meet the basic requirements of medical examination for supporting Tibet
Comparison of Cefdinir and Cefdinir/Clavulanic Acid Combination in Adults

It is planned to compare the efficacy and safety of cefdinir and cefdinir/clavulanic acide treatments in acute exacerbation of chronic bronchitis (AECB) and community-acquired pneumoniae (CAP) patients.


Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of chronic bronchitis
* The diagnosis of community-acquired pneumoniae
* FEV1 value = 30-80%
* The diagnosis of mild-severe acute exacerbation of chronic bronchitis (AECB)
* Oxygen saturation \< 90%

Exclusion Criteria:

* Pregnancy or breastfeeding
* Allergy against to penicillin or cephalosporins
* Renal impairment
* Active hepatic disease
* Antibiotic use except study drugs
* Immunosuppressive therapy before 6 months of study initiation
* Use of probenecid like drugs
The Influence of a Stabilization Splint on the Body Posture

The study was designed to investigate a possible influence of an occlusal stabilization splint on the body posture in TMD cases and controls. Interocclusal appliances or occlusal splints are therapeutic devices that are most frequently used in the treatment of TMD. Changes of the mandibular position and occlusal equilibrations are assumed to have an impact on the general body posture.

Thirty TMD cases and 10 controls were included in the study. All participants were recruited from the School of Dentistry, University of Greifswald. All subjects gave their written consent to participate in the study. They then completed a TMD history questionnaire and underwent a clinical examination. The examination included palpation of the masticatory muscles and the TMJs, range of mandibular motion measurements, and assessment of joint noises. The TMD cases were required to have a diagnoses of myofascial pain and/or arthralgia. Controls had to be free of pain symptoms in their masticatory muscles and TMJs. Body posture was measured during five minutes of walking using an ultrasound-distance measuring device (sonoSens® Monitor) with small sensors placed on the skin that continually record changes in the distance between them. A static posture evaluation was performed with a contactless, and radiation-free static measurement of the back surface and spine using a 3D measurement system (formetric II). A second measurement was performed after insertion of the occlusal appliance and a third one after 7 days of treatment.

The occlusal appliances were inserted after the first examination and all participants were instructed to use it at night and during examinations.

Eligibility Criteria:
Inclusion Criteria:

* TMD cases: diagnoses of myofascial pain and/or arthralgia

Exclusion Criteria:

* TMD cases: chronic systemic diseases, cardiac pacemakers
Is Hepatitis B Surface Antigen (HB s Ag) Enough Alone as a Screening Test Before Immunosuppressive Therapies?

Hepatitis B virus (HBV) infection is a challenging health problem. According to the World Health Organization, an estimated 240 million individuals (3.7%) suffered from chronic HBV infection worldwide.

After acute hepatitis B virus (HBV) infection, the disappearance of hepatitis B surface antigen (HBsAg) had generally been believed to signify viral elimination. However, it now becomes clear that those subjects may have occult HBV infection which is defined as the presence of HBV DNA in the liver in the absence of HBsAg in the serum. Occult HBV infection usually accompanies antibody against hepatitis B core antigen (anti-HBc) and/or antibody against HBsAg (anti-HBs), but some cases might not have these serological markers (seronegative occult HBV infection) .

In a recent systematic review, nearly 40% of HBsAg carriers and 5% of antiHBc-positive but HBsAg-negative patients developed HBVr during TNF inhibitor therapy.

Considering the lifelong use of multiple antirheumatic drugs, we need more specific guidelines for the management of rheumatic disease patients who are scheduled to receive biological and/or non-biological DMARDs.

Eligibility Criteria:
Inclusion Criteria:

* • Any patients with rheumatic disease with hepatitis B surface antigen negative.

Exclusion Criteria:

* • Overt co-morbid condition.

  * Any malignancy e.g. HCC
Study to Evaluate the Efficacy and Safety of DWP14012 on Maintaining Healing in Subjects With Healed Erosive Esophagitis

This study aims to demonstrate the noninferiority of DWP14012 to Lansoprazole 15 mg in the maintenance effect of treatment and confirm the safety of DWP14012 in patients with healed erosive esophagitis confirmed on EGD after medication treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female adults aged 19 to 75 years, at the date the written informed consent form is signed
2. Subjects with erosive esophagitis (LA Grade A-D) confirmed on EGD within 12 weeks from Visit 2 (randomization day)
3. Subjects with healed erosive esophagitis (no mucosal break observed according to LA classification) confirmed on EGD performed within 10 days before Visit 2 (randomization day) after receiving the standard dose of medicinal products of erosive esophagitis (PPI, P-CAB, etc.) for 4 to 8 weeks for the treatment of erosive esophagitis

Exclusion Criteria:

1. Subjects who have Barrett's esophagus (\> 3 cm), gastroesophageal varix, esophagostenosis, ulcer stenosis, active peptic ulcer, acute gastrointestinal bleeding, or a malignant tumor upon EGD screening
2. Subjects who have inflammatory bowel disease (Crohn disease, ulcerative colitis, etc.), irritable bowel syndrome (IBS), primary esophageal motility, or pancreatitis.
3. Subjects with history of clinically significant disease of hepatic, renal, nervous, pulmonary, endocrine, hemato-oncologic, cardiovascular or urinary system
4. Subjects who have had a malignant tumor in the last 5 years
5. Subjects who must continue to take non-steroidal anti-inflammatory drugs (aspirin, etc.), antithrombotic drugs, etc. during the study period (A low dose of aspirin \[100 mg/day\] which has been administered for prophylactic purpose before study entry is allowed)
6. Subjects who cannot stop the existing erosive esophagitis treatment being taken