cyrilzakka/clinical-trials huggingface dataset:
Effects of Intravascular Laser Irradiation of Blood for Mitochondral Dysfunction in Cerebral Ischemic Stroke

Background : This research is designed through randomization, control, and double-blind trial to explore the clinical effectiveness of intravenous laser irradiation of blood for ischemic stroke patient; The research will further explore the changes of mitochondria function after treatment. The light accelerates blood and cells circulation in the human body, so that protein molecular structure would promote changes. Pain control is indicated in such treatment, but still lacking evidence of neurological symptoms and functional improvement.

Purpose:This research is designed through randomization, control, and double-blind trial to therapeutic effect and platelet activity after intravenous laser irradiation of blood for ischemic stroke patient. Furthermore, to establish a new way of clinical therapy.

Method: The investigators plan to recruit 20 patients who are between the ages of 20 to 80 years old. The participants are required to have clear conscious and be able to communicate. The patient with mild to moderate stroke ( NIHSS=1-15), which onset between one month to 2 years will be included. The treatment group will receive an intravenous helium-neon laser phototherapy. A vein indwelling needle will be placed in their veins located in the upper elbow, and the laser fiber catheter will be introduced through the indwelling cannula. The power is set between 5Mw, 30 minutes each time, once everyother day for 3 days each week, for 2 weeks (total 6 times in one course). The steps for the control group are the same, except that the output power is adjusted to zero intensity. This plan will be explained to the patient in detail during the outpatient visit and patients will sign the consent form upon agreement. Before intravenous laser irradiation,three days, one month, and three months after the therapy, 20 ml of autologous peripheralvenous blood need to be drawn for basic blood tests and platelet activity tests. At the same time, the clinical functions of patients will be evaluated, including NIHSS, mRS.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 20 to 80 years old
* Able to speak and understand Mandarin/Taiwanese
* No cognitive impairment
* Residual motor function impairment (mRS\>1)
* Mild stroke (NIHSS=1-4) or Moderate stroke(NIHSS=5-15)
* No psychological disease

Exclusion Criteria:

* Severe stroke (NIHSS=16-42)
* History of intracerebral hemorrhage and other major surgery
* History of malignancy, chronic kidney disease
* Active infection
* Chronic hepatitis B or Chronic hepatitis C
* Unstable angina or acute myocardial infarction within 6 months
* Severe cognition impairment
* Pregnancy
Breast Cancer Biomarker Sample Collection for the dtectDx v2 Assay Proof of Concept Protocol

The major purpose of this study is to evaluate a laboratory developed test that measures multiple breast cancer-specific biomarker proteins and multiple antibodies in your blood samples. The biomarker and antibody results along with your personal medical profile will be evaluated to determine your risk for the presence of a malignancy in the breast as compared to your breast evaluation assessment conducted by your physician.


Eligibility Criteria:
Inclusion Criteria:

* Adult women from 25 years of age to below 75 years of age
* Breast evaluation results of ACR BI-RADS® Category 3 or 4 by imaging and physicians clinical and radiological evaluation
* Study visit and blood collection within 4 weeks (28 days) of ACR BI-RADS assessment
* Patient agrees to with additional health data being gathered at 6 months post assessment for diagnostic follow-up
* Samples collected under IRB approval and Informed Consent
* Testing performed under IRB approval or waiver (as applicable)
* Previous approved procedures to enroll patients: breast augmentation \& cyst aspiration

Exclusion Criteria:

* Adults from 76 years of age or older and below 25 years of age
* Final breast evaluation results other than a ACR BI-RADS Category 3 or 4
* Subjects that have had a breast biopsy performed during the 6 months prior to the study visit
* Samples not collected under IRB approval and Informed Consent
* Testing not performed under IRB approval or waiver (as applicable)
* Prior breast cancer diagnosis.
Thyroid Lobectomy With or Without Levothyroxine Treatment Postoperatively

The aim of this study was to compare the prevalence of recurrent nodular goiter in the contralateral thyroid lobe among patients after unilateral thyroid lobectomy for unilateral multinodular goiter receiving versus not receiving prophylactic levothyroxine treatment postoperatively in a five-year follow-up of a randomized study

It is commonly accepted that in patients with benign nodular thyroid disease who undergo operative therapy, surgical resection consists of lobectomy for patients with disease limited to one lobe. Contralateral disease is excluded in such cases by preoperative palpation, ultrasonography of the neck, and intraoperative palpation. On the other hand, the preferred operative procedure for bilateral nodular thyroid disease is total thyroidectomy. Such a treatment strategy minimizes the risk of development of recurrent disease and diminishes the risk of complications when reoperation for recurrent nodular thyroid disease becomes necessary. The recurrence rate for unilateral thyroidectomy of benign nodular goiter performed by expert surgeons has been reported to vary from 10% to 26%. Potential risk factors for recurrence of nodular goiter have been evaluated in many studies and include: young age at presentation, female gender, positive family history of goiter, long duration of symptoms, mutinodularity of thyroid disease, high volume of left thyroid tissue. However, most studies evaluating the incidence of recurrent nodular disease are retrospective, and it is difficult to determine whether the recurrence represents de novo nodule formation in a previously normal thyroid remnant or progression of residual disease left at initial operation.

It is well known fact, that most patients after thyroid lobectomy are euthyroid (60%-90%) and do not require thyroid hormone replacement therapy. However, it is an important question whether thyroid hormone administration postoperatively can prevent recurrent nodular thyroid disease in euthyroid hemithyroidectomized patients? The aim of the present randomized study was to compare the prevalence of recurrent nodular goiter in the contralateral thyroid lobe among patients after unilateral thyroid lobectomy for unilateral multinodular goiter (MNG) receiving versus not receiving prophylactic levothyroxine (LT4) treatment postoperatively in a five-year follow-up.

Eligibility Criteria:
Inclusion Criteria:

* unilateral multinodular goiter with normal appearing on ultrasound of the neck contralateral thyroid lobe, in a patient in euthyroid state

Exclusion Criteria:

* bilateral multinodular goiter, enlargement of contralateral thyroid lobe (volume on ultrasound \>10 ml), suspicion of thyroid cancer, previous thyroid surgery, thyroiditis, subclinical or clinically overt hypothyroidism or hyperthyroidism, pregnancy or lactation, age \< 18 years or \> 65 years, ASA 4 grade (American Society of Anesthesiology), and inability to comply with the follow-up protocol
SARS-CoV-2 in Stools Compared to Respiratory Viral Strains.

The aim of the study is to characterize and to quantify SARS-CoV-2 strains in stools, in comparison with the viral strains in respiratory samples, from patients hospitalized for COVID-19. The methods will be standard ddPCR quantifying SARS-CoV-2 RNA and next generation sequencing-whole genome sequencing. The expected results will allow us to better understand SARS-CoV-2 dynamics and compartmentalization, both in the respiratory tract and in digestive-related tissues, according to the evolution of SARS-CoV-2 variants.


Eligibility Criteria:
Inclusion Criteria:

* Age: men or women of 18 years-old or more
* Clinical signs: hospitalised patient for SARS-CoV-2 infection, nasopharyngeal PCR-confirmed (or any other sample) (in: Infectious diseases department, Intensive care unit), whatever the severity of the clinical form.
* The subject gave his/her informed and writen consent, after complete explanations on the research schedule.
* Compulsory affiliation to a social security scheme.
* Previous medical examination, when a patient is admitted to the hospital, according to good clinical practices.

Exclusion Criteria:

* Subject corresponding to articles L. 1121-5, L. 1121-7 and L1121-8 of the French Public health code:

  * pregnant woman, parturient or breastfeeding woman
  * Minor person
  * Person of full age under guardianship, curatorship, safeguard of justice
* Woman who wants to be pregnant during the study period
* Person in psychiatric care - articles L. 3212-1 and L. 3213-1 who do not fall under the article L. 1121-8 (without consent hospitalisation)
Treatment of Chronic Hand Eczema With Oral Roflumilast (HERO)

This study is a multicentre, double-blinded, randomized, placebo-controlled, clinical trial with open-label extension.

The purpose and aim of this study is to investigate the efficacy and safety of roflumilast (PDE4-inhibitor) in adult patients with chronic hand eczema (CHE).

Patients will receive 16-week treatment with either roflumilast or placebo tablets. Hereafter, both groups continue in open-label treatment for 12 weeks where both groups will receive treatment with roflumilast.

This study will investigate the efficacy and safety of roflumilast in adult patients with CHE and it is hypothesized that patients treated with oral roflumilast (500 microgram once daily) will experience an improvement in their moderate-to-severe CHE (measured by hand eczema severity index (HECSI)) and alter the skin microbiome. Secondly, it is hypothesized that patients treated with oral roflumilast will experience improved lung function and weight loss.

This study includes two phases:

Phase 1: 20 patients will receive 500 microgram tablet of roflumilast once daily for 16 weeks while 20 patients will receive placebo once daily for 16 weeks.

Phase 2: All 40 patients from phase 1 will receive 500 microgram tablet of roflumilast once daily for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Age ≤ 75 years
* HECSI ≥ 18 (moderate to severe hand eczema)
* IGA-CHE ≥ 3
* Body mass index (BMI) ≥ 20 kg/m2
* Negative pregnancy test (only women of child-bearing potential (see section 2.8))
* Willing to use safe anticonception during entire study and at least 1 week after end of treatment (-5 times plasma half-life of Roflumilast). This only account for women child-bearing potential
* Speaks, understands, and reads danish.

Exclusion Criteria:

* Severe immunological disease, e.g. HIV, systemic lupus, and systemic sclerosis
* Diagnosis of current tuberculosis
* Current viral hepatitis
* History of heart failure (NYHA III-IV)
* History of moderate or severe liver failure (Child-Pugh B-C)
* Current or former depression with suicidal ideation
* Topical therapy (anti-inflammatory) for chronic hand eczema 14 days before randomization
* Topical therapy (anti-inflammatory) for chronic hand eczema during study
* Systemic therapy for chronic hand eczema 28 days before randomization
* Systemic therapy for chronic hand eczema during study
* Current treatment with oral dicloxacillin or macrolide
* Current treatment with topical antibiotics
* Diagnosis of contact eczema of clinical significance 3 months before randomization
* Previous treatment with apremilast (Otezla®) or roflumilast (Daxas®)
* Confirmed pregnancy
* Breast feeding
* Blood donation during study
* Allergy to roflumilast or any other PDE-4 inhibitor
A Study Evaluating the Long Term Safety and Efficacy of VX-659 Combination Therapy

This study will evaluate the long-term safety and tolerability of VX-659 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del mutation.


Eligibility Criteria:
Inclusion Criteria:

* Completed study drug treatment in a parent study; or had study drug interruption(s) in a parent study but completed study visits up to the last scheduled visit of the Treatment Period in the parent study.

Exclusion Criteria:

* History of drug intolerance in a parent study that would pose an additional risk to the subject in the opinion of the investigator.
* Current participation in an investigational drug trial (other than a parent study)

Other protocol defined Inclusion/Exclusion criteria may apply.
Treatment of Vasopressor-induced Ischemia With Botulinum Toxin A

The goal of this project is to determine if performing a "chemical sympathectomy" by injecting botulinum toxin A in critically ill patients on vasopressors can treat digital ischemia. This is a prospective, non-randomized pilot study designed to demonstrate proof of concept. We propose to study patients in the intensive care units of Duke Hospital who, secondary to exposure to vasoactive medications used to maintain acceptable blood pressures, have developed signs and symptoms of digital ischemia. A paired T-test will be used to compare pre- and post-injection Laser Doppler measurements for the experimental hand. We will again use a paired t-test to compare the experimental hand against the contralateral control hand. There were no major adverse events reported by the product information sheet or in other related studies of Botox for digital ischemia.


Eligibility Criteria:
Inclusion Criteria:

* Be admitted to the ICU
* Have digital ischemia and
* Be on a vasopressor infusion

Exclusion Criteria:

* Patients with a history of systemic sclerosis
* Patients actively receiving aminoglycoside antibiotics - aminoglycosides may potentiate the effect of Botox
* Patients who have previously received botulinum toxin (A or B) injections
* Patients with a history of disorders of neuromuscular transmission (e.g myasthenia gravis, Lambert-Eaton, etc.) - Botox may have a lasting effect in these patients given their disorder
* Patients with clinical evidence of an infection in either forearm or hand
* Patients with a history of sensitivity to albumin - Botox is sold in powder form and there is albumin in the formulation
* Pregnancy - Botox is a class C medication
* Rheumatoid Arthritis
* Upper extremity arterio-venous graft or fistula
* Digital necrosis
* History of hand amputation
* Patients whom the intensive care attending physician deems will expire within 48 hours
A Study to Evaluate the Efficacy and Safety of Tegoprazan in GERD Patients With Nighttime Heartburn

This study aims to compare the nighttime heartburn improvement effect of Tegoprazan 50mg and Esomeprazole 40mg(or 20mg) in patients with GERD.

This is a multi-center, double-blind, randomized, active-controlled phase 4 study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 50mg, esomeprazole 40mg or 20mg).

Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged between 19 and 75 years
2. Subjects who have erosive reflux disease or non-erosive reflux disease

Exclusion Criteria:

1. Unable to undergo upper GI endoscopy
2. Symptoms of primary or secondary esophageal movement disorders
3. Subjects who have undergone or are scheduled to undergo surgery that can affect gastric acid secretion(e.g. upper gastrectomy, vagotomy, etc)
Effects of Multilac Baby on Fecal Calprotectin Levels of Colicky Babies

Open trial with two parallel arms, assessing the effects of Simethicone and Multilac Baby on crying behavior and fecal calprotectin levels in babies diagnosed for infantile colic.

Babies aged 3 to 6 weeks will be diagnosed for infantile colic using the Wessel's criteria. Study design will be open label with two parallel arms (Simethicone and Multilac Baby). Multilac Baby is a synbiotic product containing probiotic bacteria (six lactobacilli and 3 bifidobacteria). Effects of treatments on crying behavior will be assessed by using parental 24h paper diaries. Fecal calprotectin values at the beginning and at the end of the study will be evaluated using BÜHLMANN Quantum Blue® Calprotectin High Range (Schönenbuch, Switzerland), a quantitative immunoassay.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed for infantile colic according to Wessel's criteria

Exclusion Criteria:

* previous treatment with probiotic or synbiotic
* previous treatment with antibiotics
Transfusion in Sickle Cell Disease: Risk Factors for Alloimmunization

Sickle cell patients have a high prevalence of alloimmunization. This high rate of alloimmunization can be partially explained by the existence of an antigenic difference between the predominantly Caucasian donor population and the sickle cell patients of African origin. Genetic and environmental risk factors have also been described.

The main risk factors that have been shown in retrospective or cross-sectional studies are some HLA alleles, the age of the patient, the number of leukocyte-depleted erythrocyte concentrates (CED) transfused, the number of transfusion episodes, the age of the CEDs, the existence of an inflammatory event at the time of transfusion and the presence of anti-erythrocyte autoantibodies.There is also evidence of an impaired TH response but the underlying immunological mechanism is not fully understood.

The aim of this study is to study the prevalence and the risk factors for anti-erythrocyte alloimmunization and to try to understand the immunological mechanisms.


Eligibility Criteria:
Inclusion Criteria:

Sickle cell disease patients treated within the CHU Brugmann or Queen Fabiola Children's Hospital

Exclusion Criteria:

None
KN046 (a Humanized PD-L1/CTLA4 Bispecific Single Domain Fc Fusion Protein Antibody) in Subjects With Thymic Carcinoma

This is a Phase 2, open-label, multi-center, single arm study in subjects with advanced thymic carcinoma after failure of platinum-based combination chemotherapy. Subjects should have documented progressive disease while on platinum-based combination chemotherapy. If subjects discontinued platinum-based therapy due to reasons other than progressive disease, subjects should have completed at least 2 cycles of platinum-based combination chemotherapy before the commencement of documented progressive disease. Subjects will be treated with KN046 5 milligram per kilogram every 2 weeks.


Eligibility Criteria:
Inclusion Criteria

* Male or female, ≥18 years
* Pathologically confirmed diagnosis of thymic carcinoma
* Inoperable or metastatic disease
* Had failed at least one regimen containing platinum-based combination chemotherapy for locally advanced unresectable or metastatic disease
* Baseline measurable disease

Exclusion Criteria

* Thymomas, thymolipoma, germ cell tumors, teratomas, seminomas
* Leptomeningeal metastasis or untreated active CNS (central nervous system) metastasis or leptomeningeal metastasis.
* Is currently participating and receiving an investigational drug or has participated in a study of an investigational drug within 4 weeks
* Has received other anti-tumor treatment within 4 weeks
* Major surgery for any reason, except diagnostic biopsy, within 4 weeks of the first administration of trial treatment
* Curative radiation within 3 months of the first dose of trial treatment.
* Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of trial treatment
Ultrasound Assessment of Entheseal Sites in Patients with Seronegative Spondyloarthropathy with or Without Fibromyalgia

Seronegative spondyloarthropathies are a family of joint disorders that classically include ankylosing spondylitis (AS), psoriatic arthritis (PsA), inflammatory bowel disease (IBD) associated arthritis, reactive arthritis (formerly Reiter syndrome; ReA), and undifferentiated SpA. Enthesitis, or inflammation of the sites where the tendons or ligaments insert into the bone, is a key pathological finding in SpA . It is considered the hallmark and characteristic feature of spondyloarthritis (SpA). Entheses could be classified as fibrous entheses and fibrocartilaginous entheses. Regional structural damage, such as tendon injuries and bone erosions, are frequently caused by persistent enthesitis. The healing process that follows may result in the emergence of enthesophytes and, eventually, functional impairment of related anatomic structures. Imaging modalities for evaluating entheseal lesions include conventional radiology, bone scintigraphy, magnetic resonance imaging (MRI) and power Doppler (PD) ultrasound (US). US has its own unique advantage in the diagnosis of enthesitis in AS; it uses a high-frequency or ultra-high-frequency probe that effectively visualizes the internal structure of the tendon and is recognized as the gold standard for tendon involvement.

It is superior to clinical examination in the detection of peripheral enthesitis.

Manifestations of tendon enthesitis in SpA on US include a thickened tendon, hypoechoicity, local calcification and bony erosion. Abnormal blood flow in tendon entheseal sites can be detected by Power Doppler US. Fibromyalgia (FM) is a syndrome characterized by chronic musculoskeletal pain. The main symptoms of which are muscle stiffness, joint stiffness, insomnia, fatigue, mood disorders, cognitive dysfunction, anxiety, depression, general sensitivity and the inability to carry out normal daily activities \[8, 9\]. It can also be associated with specific diseases, such as infections, diabetes, rheumatic diseases and psychiatric or neurological disorders. Smythe and Moldofsky later developed the name "fibromyalgia" after identifying "pain points," which are areas of severe tenderness. These points are defined as areas of hyperalgesia/allodynia when a pressure of about 4 kg causes pain.


Eligibility Criteria:
Inclusion Criteria:

* Patients fulfill the Assessment in Spondyloarthrits International Society (ASAS) classification criteria for Axial Spondyloarthritis.
* Age above 18 years old.
* Patient cooperative and can answer questions.
* Patients who are able and willing to give written informed consent.

Exclusion Criteria:

* Other rheumatologic or collagen diseases.
* Age below 18 years and above 60 years.
* Uncooperative patients.
* Patient not able and willing to give written informed consent.