cyrilzakka/clinical-trials huggingface dataset:
Acupuncture for Migraine Prophylaxis

Hypothesis: Acupuncture obtains an abiding effect on migraine prophylaxis Design: A open-label randomized controlled trial. 249 participants will be included. Three arms: acupuncture in acupoint-meridian， non-acupoint-meridian group, and waiting list.

Aim: to attest the abiding efficacy and safety of acupuncture for migraine prophylaxis Design: A open-label randomized controlled trial will be performed in Chengdu, Hunan and Chongqing province. Two hundred and forty-three participants will be randomly assign to acupoint-meridian group, non-acupoint-meridian group, and wait-and-see group. Each participants will receive 20 sessions of acupuncture in 4 weeks, with a duration of 30 minutes in a session. After all the treatments was accomplished, there will be 5 times follow-ups in the impending every 4 weeks. The primary outcome is frequency of migraine attacks 16 weeks after inclusion. Secondary outcomes include frequency of migraine attacks at the 4th and 24th week, headache severity, MSQ(Migraine Specific Quality of Life Questionnaire MSQ Version2.1), etc.

Eligibility Criteria:
Inclusion Criteria:

* Age of a subject is between 18 and 65 years old(initially occured beneath the age of 50), male or female;
* in accordance with diagnosis of migraine without aura in International Classification of Headache Disorders, ICHD-2, by IHS;
* 2 to 8 times attack per month in recent 3 months, with each period beyond 15 days;
* with migraine history for over 1 year;
* be able and willing to finish the headache diary in baseline ;
* informed consent form must be signed by patient or lineal relative;

Exclusion Criteria：

* Patients who are unconscious, psychotic.
* Patients with aggravating tumor and other serious consumptive disease, and who are subject to infection and bleeding.
* With serious primary illness or disease of cardiovascular, liver, renal, gastrointestinal, hematological systems and so on.
* Pregnant women or women in lactation.
Retrospective Record Review of Adults and Children Advised for Allergen Immunotherapy (MK-7243-022)

The purpose of this study is to determine the proportion of participants that initiate allergen immunotherapy (AIT) upon the recommendation of their physician and the proportion of participants that persist with their AIT throughout the recommended course.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AR with or without allergic conjunctivitis (AC)
* Documented provider-to-patient or parent discussion of AIT as a treatment option

Exclusion Criteria:

* Participants receiving AIT as an AR treatment without documented provider-to-patient or parent discussion of AIT as a treatment option
* Participants receiving immunotherapy for insect sensitivities only
* AIT started before 2005
A Single-arm Trial of Roxadustat Combined With Retinoic Acid in the Treatment of Refractory Low-risk MDS

Roxadustat has been approved for low-risk MDS clinical trials, but the trial results are not available. For refractory low-risk MDS, the effective rate of roxadustat treatment is about 20-30%, and roxadustat combined with retinoic acid may have better efficacy in the treatment of refractory low-risk MDS.

Patients with low-risk myelodysplastic syndrome who are refractory to the regular treatments have to live on transfusions which lead to poor quality of life (QoL) and survival. Roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, which increases both endogenous EPO and iron metabolism, has shown promising results in several phase 3 clinical trials for chronic kidney disease.

Roxadustat comprehensively improves iron metabolism by upregulating DCYTB and DMT1 through the HIF pathway, which can promote the iron absorption and utilization. Detail mechanisms include upregulating transferrin receptors to increase iron uptake, upregulating transferrin to promote iron transport and downregulating ferritin levels to indirectly improve iron absorption and transportation.

Patients with refractory low-risk MDS were selected and given roxadustat 150mg po qod combined with retinoic acid 20mg po bid.

Eligibility Criteria:
Inclusion Criteria:

* Low-risk MDS unresponsive to first-line therapy

Exclusion Criteria:

* myelofibrosis
* Severe heart and kidney function bu'quan
Phase II Study Evaluating Strategies of Lung Surveillance of Patients Operated of High Grade Soft Tissue Sarcoma

Cancer surveillance has a significant cost and generate anxiety for the patient.

It is important to avoid exams that will not modify health support or whose results wont allow to decide.

Cancer surveillance has a significant cost and generate anxiety for the patient.

It is important to avoid exams that will not modify health support or whose results wont allow to decide.

Our study will help rationalise surveillance of soft tissue sarcoma and standardize medical practices.

Eligibility Criteria:
Inclusion Criteria:

* soft tissue sarcoma, histologically proven
* tumor size \> 5 cm (SBR grade 2) or whatever size (SBR grade 3)
* complete excision (R0 or R1)
* no metastasis (checked by spiral chest CT)
* social security covered
* informed signed consent

Exclusion Criteria:

* bone, visceral, uterine, retroperitoneal sarcoma
* GIST
* other malignant tumor
* patients over 70, or for whom thoracic surgery is excluded
* pneumoconiosis or known system disease
* breast feeding or pregnant woman
* patient unable to undergo trail medical follow up for geographic, social or psychological reasons
Biomarkers in Patients With Advanced Rhabdomyosarcoma

This research trial studies tumor tissue to identify important proteins and biomarkers from patients with rhabdomyosarcoma that has spread to other places in the body and usually cannot be cured or controlled with treatment. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer.

PRIMARY OBJECTIVES:

I. To investigate whether the expression of a subset of proteins (by immunohistochemistry), known to be Involved in the paired box (Pax)3, Pax7, and Patched-1 neuromuscular development pathways, are dysregulated in advanced and relapsed alveolar and embryonal rhabdomyosarcomas.

OUTLINE:

Immunohistochemistry is performed for each candidate target (Pax3, Pax7, and Patched-1) in each disease (alveolar, embryonal, and anaplastic rhabdomyosarcoma) for tissue microarray analysis.

Eligibility Criteria:
Inclusion Criteria:

* 8 tissue microarrays (TMA) slides of the following diseases available:

  * Alveolar rhabdomyosarcoma
  * Embryonal rhabdomyosarcoma
  * Anaplastic rhabdomyosarcoma
Study of the Efficacy and Safety of Alirocumab (REGN727/SAR236553) in Combination With Other Lipid-modifying Treatment (LMT) (ODYSSEY OPTIONS I)

This is a randomized, double-blind, active-comparator, parallel-group study in patients at high cardiovascular risk with nonfamilial hypercholesterolemia or heterozygous familial hypercholesterolemia (heFH).


Eligibility Criteria:
Inclusion Criteria:

1. Patients with screening (visit 1) LDL-C greater than or equal to 70 mg/dL with documented CVD, not adequately controlled with a daily dose of atorvastatin. OR
2. Patients with screening (visit 1) LDL-C greater than or equal to 100 mg/dL at high risk for CVD who are not adequately controlled with a daily dose of atorvastatin.

Exclusion Criteria:

1. LDL-C greater than 250 mg/dL
2. LDL-C less than 70 mg/dL at the screening visit in patients with history of documented CVD
3. LDL-C less than 100 mg/dL at the screening visit in patients without history of documented CHD or non-CHD CVD, but with other risk factors
4. TG greater than 400 mg/dL
5. Homozygous FH (clinically or previous genotyping)
6. Currently taking a statin that is not atorvastatin
7. Currently taking Ezetimibe (EZE)
8. Not on a stable dose of allowable lipid modifying treatments (LMT)

(The inclusion/ exclusion criteria provided above is not intended to contain all considerations relevant to a patient's potential participation in this clinical trial).
Contrast Sensitivity Assessment in Pediatric Cataract Surgery With IOL Implantation

The study evaluates contrast sensitivity in older children following surgery for lamellar and posterior subcapsular cataracts. Often, pediatric surgeons tend to delay surgery in these children who present beyond the amblyogenic age group. These cataracts are often compatible with reasonable visual acuity and therefore some surgeons prefer to wait for surgery, whereas others tend to operate.

The study evaluates improvement in contrast sensitivity at different spatial frequencies following cataract surgery for lamellar and posterior subcapsular cataracts in older children.

All patients undergoes temporal clear corneal incision, manual anterior continuous curvilinear capsulorhexis, bimanual irrigation/aspiration for lens removal and residual cortex, posterior capsule management based on the age of the patient either manual posterior capsulorhexis (PCCC) upto 6 years or leaving intact posterior capsule and implantation of single-piece AcrySof SN60WF (Alcon Laboratories, Forth Worth, Texas) hydrophobic acrylic IOL in-the-bag. Postoperatively, all the patients are examined first for high contrast sensitivity and then for low contrast at 1 week, 1 and 3 months respectively.

The results are analyzed for corrected distance visual acuity (CDVA) which is recorded in LogMAR units at preoperative and 1 and 3 months postoperatively. Monocular high-contrast Snellen visual assessment for distance is done with the Early Treatment Diabetic Retinopathy Study chart (Vector Vision acuity chart at 100% contrast) with Corrected distance visual acuity CDVA at 4 m under photopic condition.

Similarly at preoperative and 1 and 3 months postoperatively contrast sensitivity testing is also performed using the CSV 1000E sine wave grating test face (Vector Vision, USA) with the patient seated at a distance of 2.5 m from the chart. The test is performed after the patient is adapted to the room luminance for 5 minutes. The non viewing eye was occluded for each measurement, and the best spectacle refractive correction is placed in front of the viewing eye. Testing is being tested under two lighting conditions: photopic (85cd/m2) and mesopic (2.7cd/m2). The contrast sensitivity values are documented in log units. Sensitivity levels at each frequency range from 0.7 to 2.08 (3 cpd), 0.91 to 2.29 (6 cpd), 0.61 to 1.99 (12 cpd), and 0.17 to 1.55 (18 cpd) log units. This testing is performed with the patient wearing their refractive correction in form of spectacles.

Eligibility Criteria:
Inclusion Criteria:

* Children older than 4 years and lamellar and posterior subcapsular cataracts undergoing cataract surgery with IOL implantation

Exclusion Criteria:

* eyes with traumatic or subluxated cataract,
A Study to Assess Real-World Use, Safety, and Effectiveness of Oral Upadacitinib in Adult and Adolescent (>=12 Years Old) Participants With Atopic Dermatitis

Atopic dermatitis (AD; also known as atopic eczema) is an inflammatory skin disease. The safety and effectiveness of upadacitinib for AD has been well-documented in previous studies, however, important information is missing on the use patterns and outcomes with upadacitinib in a real-world setting. Therefore, the purpose of this observational study is to help inform real-world usage patterns regarding the safety and effectiveness and duration of response of upadacitinib in adolescent and adult AD participants \>=12 years old in the real-world setting.

Upadacitinib is an approved drug being developed for the treatment of AD. Around 975 adolescent and adult participants who are prescribed upadacitinib for the treatment of AD in routine clinical practice will be enrolled worldwide.

Participants will receive oral upadacitinib as prescribed by their physician. Data from these participants will be collected for approximately 2 years.

There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic and will be asked to provide additional information by questionnaire at each visit.


Eligibility Criteria:
Inclusion Criteria:

* Physician confirmed diagnosis of atopic dermatitis (AD) or atopic eczema at baseline.
* Symptom onset \>=1-year prior to baseline.
* Initiation of upadacitinib treatment for AD is indicated and prescribed per local label.
* The decision to prescribe UPA is made prior to and independently of study participation.
* Medical and medication history available for previous 6 months.
* Participants who can understand the questionnaires, with parental support as required for adolescents.
* Participants who are able to understand and communicate with the investigator and comply with the requirements of the study.
* Participants who are willing and able to participate in the collection of patient-reported data via cloud-based mobile application using a smart device (i.e., tablet).
* Participants who are willing and able to complete the patient-reported questionnaires.

Exclusion Criteria:

- Participants who are currently participating in interventional research (not including non-interventional study, post-marketing observational study, or registry participation).
Extension Study of PRX-102 for up to 60 Months

To evaluate the ongoing safety, tolerability, and efficacy parameters of PRX-102 in adult Fabry patients who have successfully completed treatment with PRX-102 in studies PB-102-F01 and PB-102-F02.

An open-label study to evaluate the ongoing safety, tolerability and efficacy parameters of PRX-102 in adult Fabry patients (≥18 years of age). Patients enrolled received 1.0 mg/kg of PRX-102 as an intravenous infusion every 2 weeks (+/- 3 days) for up to 60 months and no less than 36 months.

Eligibility Criteria:
Inclusion Criteria:

* Completion of study PB-102-F02
* The patient signs informed consent
* Female patients and male patients whose co-partners were of child-bearing potential agree to use a medically acceptable method of contraception, not including the rhythm method. Acceptable methods of contraception include hormonal products, intrauterine device, or male or female condoms. Contraception should be used throughout the duration of the study and for 3 months after termination of treatment.

Exclusion Criteria:

* Presence of any medical, emotional, behavioral or psychological condition that, in the judgment of the Investigator and/or Medical Director, would interfere with the patient's compliance with the requirements of the study
Intravenous Versus Perineural Effect Dexamethasone in Interscalene Nerve Block With Levobupivacaine

Interscalene brachial plexus block can be used as an additive to general anaesthesia or as the primary anaesthetic for shoulder surgeries for pain management.

The investigators compared the effect of perineural versus intravenous dexamethasone on the prolongation of the action of levobupivacaine in ultrasound guided interscalene block for shoulder and upper arm surgeries.

Dexamethasone had been shown to prolong the duration of postoperative analgesia when given as an adjuvant for peripheral nerve blocks.

The investigators compared the effect of perineural versus intravenous dexamethasone on the prolongation of the action of levobupivacaine in ultrasound guided interscalene block for shoulder and upper arm surgeries.

The study hypothesized that adding perineural dexamethasone to levobupivacaine in ultrasound guided interscalene block may be more superior to adding intravenous dexamethasone to levobupivacaine and levobupivacaine alone in shoulder and upper arm surgeries as regard analgesic effect, duration of analgesia and hemodynamic stability.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status grade I and grade II.

Exclusion Criteria:

* Patient refusal.
* Neuromuscular diseases (as myopathies, myasthenia gravies, ......)
* Hematological diseases, bleeding or coagulation abnormality.
* Psychiatric diseases.
* Local skin infection
* Sepsis at site of the block.
* Known intolerance to the study drugs.
* Body Mass Index \> 40 Kg/m2
* contralateral phrenic palsy
* pneumothorax
* pneumectomy
* severe COPD
What is the Perceived Role of Risk in DOC Healthcare.

Critical ethnography exploring how decisions are made on behalf of people in disorder of consciousness (DOC).

Prospective longitudinal case study design including observation, field interview and video reflexive ethnography.


Eligibility Criteria:
Inclusion Criteria:

* People in a DOC:
* Working diagnosis of being in a DOC.
* Have an appropriate family member able to act as a consultee.
* Over 18 years of age.

Family members and healthcare workers:

* conversational English.
* able to give consent.
* over 18 years of age.
* Involved in decision making on behalf of a person in a DOC

Exclusion Criteria:

Person in a Disorder of Consciousness

* Not in a DOC, diagnosis uncertain, or appears to be emerging.
* Clinically unstable or approaching the end of their life.
Study Comparing 2 Different Strategies For Management of Subjects With Plaque Psoriasis Who Have Responded to Etanercept

This study proposes to compare 2 different methods for managing a subject with psoriasis who has achieved good disease control, as defined by a clinical response with a Physician Global Assessment (PGA) inferior or equal to 1 at the screening visit, on etanercept treatment.

The first method involves stopping etanercept treatment on entry into the study, with the option to reinitiate etanercept at 50 mg once weekly after medical review and agreement between the subject and the investigator. The second method involves continuing on etanercept at 25 mg once weekly, with the option to increase the dose to 50 mg once weekly after medical review and agreement between the subject and the investigator. Subjects will be randomized into one of these two study arms.


Eligibility Criteria:
Inclusion Criteria:

* Eighteen (18) years of age or older at the time of consent.
* Previously treated with etanercept for chronic plaque psoriasis for at least 12 weeks prior to the screening visit and received a total weekly dose of 50 mg per week for at least the 6 weeks preceding the day of the screening visit
* Having shown clinical response with a PGA inferior or equal to 1 at the screening visit.
* PGA inferior or equal to 1 at the baseline visit.

Exclusion Criteria:

* Evidence of skin conditions (eg, eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis.
* Evidence of active or previously known medical history of inflammatory arthritis (eg, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis).
* Any biologics other than etanercept within the 20 weeks prior to the screening visit.
Study of Specimens Obtained During Epilepsy Surgery

This study will collect brain tissue samples for research purposes from patients undergoing surgery to treat epilepsy. The standard surgical procedure for medically intractable epilepsy i.e., epilepsy that cannot be controlled with medicine requires removal of more brain tissue than is needed for diagnostic study. This extra tissue, which would otherwise be discarded, will be used for research purposes. In addition, a blood vessel in the scalp, called the superficial temporal artery, is also normally cut during surgery, and a piece of this vessel will be taken for research use.

Patients 4 years of age or older who undergo surgery for medically intractable epilepsy may be eligible for this study.

Brain tissue collected under this protocol will be used for studies of brain cells in other diseases and of serotonin receptors. Any remaining brain tissue will be frozen for use in future research. The superficial temporal artery will be used for comparison with carotid arteries (a neck artery that supplies the brain) from patients with blockage of this blood vessel.

This is a protocol to perform research studies on tissues that are removed in the operating room during surgical procedures for drug resistant epilepsy. Our aim is to acquire and supply useful tissue specimens for intramural NIH research projects.

The investigators will evaluate participants with medically intractable drug resistant epilepsy who are considered for surgery to determine whether surgical specimen may be available for this protocol. Surgery and standard care for these participants will be performed under a separate protocol, 11-N-0051 Epilepsy Surgery. The intent of this protocol is solely for procuring tissue that is resected for standard clinical care during surgery. This protocol is not designed to test any new treatments.

These are the research aspects of the protocol: 1) Any brain tissue that is removed and is not required for diagnostic studies will be used for laboratory studies, consistent with institutional guidelines. 2) Blood tests to test for immune and inflammatory mediators will be performed. 3) Saliva will be collected to test for immune and inflammatory markers.

Eligibility Criteria:
* INCLUSION CRITERIA:

To be eligible for entry into the study, candidates must meet al the following criteria:

1. Be 4 years of age or older.
2. Able to give informed consent, or, assent if a child.
3. Have agreed to undergo brain surgery to treat drug resistant epilepsy and are enrolled in protocol 11-N-0051 Epilepsy Surgery.

EXCLUSION CRITERIA:

Candidates will be excluded if they:

1. Are not a surgical candidate as specified in appropriate protocols.
The Role of Spreader Grafts in Reduction Rhinoseptoplasty: a Randomized Clinical Trial With Quality of Life Assessment

Nasal obstruction is one of the majors concerns in reduction rhinoseptoplasty, because it affects quality of life and surgical outcomes. Is the association of middle third grafts with reduction rhinoseptoplasty responsible for an increase in quality of life related to nasal obstruction when compared to reduction rhinoseptoplasty without the placement of these grafts?

Reduction rhinoplasty and rhinoseptoplasty are among the most accomplished aesthetic procedures in Plastic Surgery and Otorhinolaryngology. Nasal obstruction is one of the majors concerns in this procedures, because it affects quality of life and surgical outcomes. Nasal surgeons have paid much attention to nasal valve area to prevent nasal obstruction and some assert reconstruction of the middle vault after dorsal reduction with grafts. The gold standard for middle vault reconstruction after dorsal reduction has been the spreader graft, first advocated by Sheen. Studies in surgical techniques for the treatment of nasal valve collapse focus much more in techniques than in evidence of its efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Patients eligible for reduction rhinoseptoplasty who agreed to participate in the study and who did not meet the exclusion criteria

Exclusion Criteria:

* Absence of nasal obstruction;
* Previous nasosinusal surgery;
* Symmetrical or asymmetric insufficiency of the middle third that would justify the placement of middle third grafts for the treatment of these problems;
* Presence of nasal valve insufficiency as the only cause of nasal obstruction;
* Cranio-facial anomalies;
* Presence of nasosinusal tumors;
* Active acute rhinosinusitis;
* Patients undergoing treatment of other entities concomitant to rhinoseptoplasty such as: sinus inflammatory surgery, adenoid hypertrophy removal, septal perforation correction, otoplasty or blepharoplasty.