cyrilzakka/clinical-trials huggingface dataset:
Phase 3 Study to Evaluate Anecortave Acetate vs. Visudyne for the Treatment of the Wet Form of AMD

The purpose of this study is to demonstrate that Anecortave Acetate is as effective after twelve months of treatment as photodynamic therapy (PDT) with Visudyne in patients eligible for initial PDT treatment for wet age-related macular degeneration.


Eligibility Criteria:
Patients of any race, either gender, aged 50 years and above, diagnosed with subfoveal CNV due to AMD with best corrected logMAR visual acuity of 20/40 (snellen equivalent) to 20/400 (Snellen equivalent) in the study eye. Clinically relevant concomitant diseases will be excluded.
ACT for Healthy Living: a Brief Acceptance and Commitment Therapy Intervention for Women with Obesity

The goal of this clinical trial is to investigate if a 4-hour acceptance and commitment therapy workshop can help the adoption and maintenance of healthy lifestyle behaviors in women with obesity. The objectives are as follows:

1. To assess changes in ACT-related constructs before and after the workshop
2. To assess changes in other psychological constructs that have been shown to hinder successful weight management before and after the workshop
3. To assess changes in dietary and physical activity behaviors before and after the workshop. Participants will complete baseline questionnaires and anthropometric measures at three time points: baseline, 1 week after the workshop, and 1 month after the workshop. Researchers will compare an active intervention group to a waitlist control group to investigate the efficacy of the workshop.

Acceptance and commitment therapy interventions demonstrate efficacy for weight loss. ACT-based workshops represent an innovative and potentially scalable application of this approach to obesity treatment. 70 women will be recruited to participate. Half of the participants (n = 35) will receive a brief ( approximately 4-hour) workshop that aims to facilitate the development and maintenance of healthy lifestyle behaviors using ACT principles such as valued living and committed action. Outcomes will be assessed at baseline, 1-week, and 1-month post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria will be individuals who self-identify as women, have a BMI of \>30.0 kg/m2 based on self-reported height and weight, are able to read and understand written and spoken English, and have a primary residence within 50 miles driving distance of the University of Alabama at Birmingham campus.

Exclusion Criteria:

* Exclusion criteria will include presence of eating disorder symptoms (assessed by participant self-report for a former or current diagnosis) presence of a major mood disorder (assessed by participant self-report of a current or former diagnosis), recent weight change of +/-10 pounds, recent use of prescription medication for weight loss, and current participation in another weight management program.
3E Extension Study

The purpose of this study is to evaluate the long-term efficacy and safety of entecavir 0.5 mg/d + adefovir 10 mg/d for treatment experienced chronic hepatitis B patients.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who completed the EXPLORE or EXCEL studies, or subjects with hepatitis flare after treatment withdrawal in EFFORT study.
* Subjects who are willing to participate the extension study.

Exclusion Criteria:

* Subjects who could not compliance with the protocol judged by investigators
Remineralizing Potential of Biomimetic Scaffolds on Enamel White Spot Lesions

The modern concept in caries treatment focuses on the non-invasive approach and on the biomimetic remineralization of early non-cavitated white spot carious lesions. Recently developed biomimetic scaffolds attempt to remineralize the dental tissues and are more regenerative than reparative.


Eligibility Criteria:
Inclusion Criteria:

* Patients who at least have 1 white spot lesion.
* No systemic diseases or taking any medication affecting salivary flow.
* Patients with good oral hygiene measures.
* Patients with moderate caries risk assessment.
* Post orthodontic WSLs with International Caries Detection and Assessment System (ICDAS II) scoring criteria (1-2).

Exclusion Criteria:

* Participant in another trial.
* Developmental non carious lesion (enamel hypoplasia and dental fluorosis).
* Presence of abnormal oral disease, or medically compromised patients.
* Participants who had evidence of reduced salivary flow or significant tooth wear.
* Allergy to milk products or other drug allergies.
Are Paraspinous Intramuscular Injections of Botulinum Toxin A (BoNT-A) Efficient in the Treatment of Chronic Low-back Pain (LBP)?

Studying the therapeutic effect of paravertebral injections of BoNT-A (botulinum toxin A) requires further studies to confirm the reported short-term therapeutic effect and to determine potential predictive factors of efficacy.

This study was a randomized, double-blinded, placebo-controlled phase 3 trial comparing BoNT-A Type A injections to a placebo in patients with chronic Low-back Pain (LBP). This superiority trial obtained support from the French Hospital Clinical Research Project (PHRC) and the approval of a French ethics committee (2003/02) ("Comité Sud-Ouest et Outre-Mer III", consent obtained in February 2003).

The number of participants included in the study was chosen to be similar as those included in previous studies, that showed a strong positive effect of BoNT-A injections on LBP. Furthermore, the design of our study (i.e. a crossover) increased the power of the statistical analysis. A scientific committee has been solicited at this step, after including 19 patients, to assess the results.

Eligibility Criteria:
Inclusion Criteria:

* LBP defined as a pain located between the thoracic lumbar hinge and the gluteal sulcus, where pain had evolved over a period of 6 months despite well conducted medical treatment, self-assessed lumbar pain intensity over 50 millimeters long on a visual analogue scale of 100 millimeters (0=no pain; 100=maximal pain),
* having been on sick leave for 60 or more days in the year preceding the inclusion (in order to include patients with high consequences of chronic low-back pain on their work),
* same long-term chronic pain treatment for at least 6 weeks

Exclusion Criteria:

* age under 18 or over 55 years (to avoid secondary causes of low back pain, like spinal tumor),
* ongoing pregnancy or breast-feeding,
* a neuromuscular pathology (myasthenia gravis, amyotrophic lateral sclerosis, myopathy, polymyositis), aminoglycoside treatment at the time of inclusion,
* skin infection at injection points,
* diabetes and alcoholism (in order to avoid other etiologies of chronic pain),
* a history of injecting BoNT-A A,
* anticoagulation treatment, sciatica,
* suspected spinal inflammatory disorder (spondylitis, inflammatory rheumatism, tumoral pathology),
* a failed back surgery syndrome (when surgery failed to relieve low-back pain), - incapacity to stand, cardiorespiratory deficiency which does not allow the isokinetic exploration of the spinal muscles,
* cognitive disorders limiting patient participation,
* conflicts of interest owing to existing pain (unconsolidated work accident, ongoing damage compensation).
* Spine infection, tumour or trauma had been specifically excluded by an MRI done by all patients before the inclusion in the present study.
* No patient was allowed to take opiates during the time of the study,
* facet joint injections were also not permitted during the study period.
Trans-Nasal Maxillary Multi-Sinus Balloon Dilation Study

The purpose of this study is to show clinically meaningful improvement in symptom severity after transnasal balloon dilation of the maxillary sinus outflow tract with or without balloon dilation of the frontal or sphenoid sinuses.

This is a prospective, non-randomized, single arm, post-approval study conducted under a common protocol designed to evaluate outcomes following trans-nasal balloon dilation of the maxillary sinus outflow tract with or without concurrent balloon dilation of the frontal or sphenoid sinuses and without any concomitant conventional sinus surgery (ie, uncinectomy, complete or partial ethmoidectomy).

Eligibility Criteria:
Inclusion Criteria:

1. Be at least age 18 years old or older.
2. Be a candidate for transnasal balloon dilation of the maxillary sinus(es) with or without balloon dilation of the frontal or sphenoid sinus(es) using XprESS consistent with the device's Indication for Use.
3. Have a sinus CT scan within 12 months of the procedure date.
4. Be able and willing to provide consent.
5. Be willing to comply with the protocol requirements.

Exclusion Criteria:

1. Have any prior maxillary sinus surgery (eg, antrostomy, uncinectomy).
2. Require any concomitant endoscopic sinus surgery (ESS) or nasal surgery (exception: turbinate reduction) at the time of the study procedure.
3. Have any nasal surgery (eg, septoplasty) or nonmaxillary sinus surgery (eg, frontal sinusotomy, sphenoidotomy, full/partial ethmoidectomy) performed within 3 months prior to enrollment.
4. Have presence of features consistent with sinus fungal disease.
5. Be allergic to nickel or barium sulfate.
6. Be currently participating in any other drug or device clinical studies excluding postapproval or marketing registry studies.
Kinesio Taping and Manual Therapy Efficacity on Lumbar Pain During Pregnancy

Pregnant women often suffer from lumbar pain , specially during the last semester . Usually physiotherapy and manual therapy on TRIGGER point help them .

But there is also another type of support , the Kinesio-Taping using the pose of a strip which aims to mobilize the muscle without any restriction.

The purpose is to reduce the pain with the combo therapy (TRIGGER point plus Kinesi Taping)


Eligibility Criteria:
Inclusion Criteria:

* age \> 18
* french speaking
* single pregnancy
* lumbar pain
* EIFEL score\>6
* medical insurance

Exclusion Criteria:

* twins pregnancy
* rachial arthrodesis
* Probable Acrylique allergy
* Psoriasis or other cutaneous problems
* circulatory disorder
Carboplatin and Paclitaxel in Treating Older Patients With Metastatic or Recurrent Unresectable Non-small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of carboplatin and paclitaxel in treating patients who have metastatic or recurrent unresectable non-small cell lung cancer.

OBJECTIVES: I. Determine the response rate to carboplatin and paclitaxel in elderly patients with metastatic or recurrent unresectable non-small cell lung cancer. II. Determine the toxicity of this regimen in these patients. III. Determine if the hypothesized lack of social support impacts the recruitment of elderly patients into clinical trials. IV. Determine if a previously validated tool of functional status in the elderly predicts treatment related toxicity superior to that predicted by the ECOG performance status in this patient population.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer Stage IV disease OR Recurrent unresectable disease No other conventional curative or significant palliative therapies available Measurable disease At least one lesion a minimum of one dimension in diameter of at least 20 mm No symptomatic and/or untreated CNS metastases

PATIENT CHARACTERISTICS: Age: 65 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: AST no greater than 3 times upper limit of normal Renal: Creatinine clearance at least 40 mL/min Other: No uncontrolled infection No uncontrolled seizure disorder No uncontrolled diabetes mellitus No other malignancies within the past 3 years except adequately treated basal or squamous cell skin cancer or noninvasive carcinomas

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic or immunotherapy for recurrent or metastatic disease No concurrent biologic therapy Chemotherapy: No prior chemotherapy for recurrent or metastatic disease except as radiosensitizer No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for recurrent or metastatic disease except as adjuvant therapy At least 4 weeks since prior radiotherapy to greater than 25% of bone marrow No concurrent radiotherapy except for CNS therapy Surgery: See Disease Characteristics At least 3 weeks since prior major surgery
Post-COVID-19 Outpatient Care and Biomarkers

The aims of this case-control, non-randomized study including patients with post-COVID-19 persisting symptoms are 1) to establish the large blood biobank, 2) to examine levels of circulating inflammatory biomarkers and different classes of non-coding RNAs (ncRNA), such as selected circRNAs and miRNAs, in plasma and serum samples collected from patients with post- COVID-19, 3) to test the levels of cfDNA in plasma and serum, 4) to define correlation between ncRNAs and cf-DNA with persistent clinical symptoms, and type of symptoms, and 5) to investigate diagnostic and prognostic performances of these circulating biomarkers.

Study design. This is a prospective registry including biobank.

Currently, several studies are ongoing to investigate different treatment modalities of post-COVID-19 symptoms, but there is a complete lack of investigations on biomarkers predicting type, duration or severity of post-COVID-19 symptoms. The aim of this study is to investigate circulatory biomarkers diagnostic or predictive for long/post-COVID-19 syndrome.

Study patients. Patients with at least 3 weeks after proven infection by SARS-CoV-2, reflected by at least one positive PCR-test in nose throat swabs, who visits at the Post-COVID-19 outpatient clinic of the Medical University of Vienna, will be consequently recruited into the presented registry. Additionally, 100 vaccinated patients with HFrEF and 100 healthy vaccinated volunteers will be recruited to serve as comparison groups.

Methods. Identity of the registry patients will be protected by pseudonymization. During the ambulatory visit, basic clinical examination, electrocardiogram, chest X-ray, routine laboratory tests will be performed. Additionally, venous blood will be collected for biobank.

Expected Outcome This registry will provide further insights regarding pathophysiology, risk stratification and treatment of complex post-COVID-19 symptoms. Specific therapies and search of prognostic factors will enable to select patients with high risk of persistence or worsening of their symptoms thereby improve patient care.

Eligibility Criteria:
Inclusion Criteria:

For post-COVID patient group:

* Age≥18to90years
* Proven infection by SARS-CoV2, at least 3 weeks after recovery from the infection
* Signed informed consent For HFrEF patient group:

For vaccinated healthy volunteer control group:

* Full vaccination against SARS-CoV2 at least 3 weeks before inclusion in the study
* Signed informed consent

Exclusion Criteria:

* non-willingness to participate or withdrawal of informed consent
* Clinically confirmed HFrEF (EF \<40%)
* participation in any SARS-CoV-2 medical treatment trial
* pregnancy
Cross-Sectional Survey on the Use of Tobacco Products - London (UK)

The main purpose of the research study is to estimate the prevalence of tobacco product use and describe the tobacco use patterns in adults in London, United Kingdom.

The study was prematurely terminated after the first annual survey and was not be repeated due to the impossibility to recruit sufficient participants to meet the target sample size in the IQOS user sample.

The aim of the survey is to describe the current and past patterns of use of tobacco products in the general adult population of the Greater London area and in adult IQOS users registered in the IQOS user database of Philip Morris Limited (UK IQOS User Database), and explore their association with key independent variables. More specifically, the objectives are:

1. Estimate the prevalence of current tobacco use status in the study population.
2. Describe the past tobacco use status (cigarette, IQOS and other innovative products, including e-cigarettes) in the study population (i.e. never-use, initiation, product use transition, cessation, re-initiation, and relapse).
3. Explore the association between self-reported health status and use of tobacco products in the study population.
4. Explore the association between patterns of IQOS use including motivation to use, mis-use, satisfaction, and self-reported changes since switching to the product (in a number of domains where IQOS may have potential benefits), and consumer's satisfaction in the population of IQOS users in the Greater London area registered in UK IQOS User Database.

Eligibility Criteria:
Inclusion Criteria (all participants, including IQOS users):

* Legally permitted to buy tobacco products in UK (≥18 years of age).
* Currently residing in the Greater London area.
* Able to read, write and understand English.
* Consent to participate in the survey

Inclusion Criteria (IQOS users only):

* Has used more than 100 HEETS tobacco sticks in his or her lifetime.
* Is currently using IQOS.
* Has access to the internet.
* Is not currently employed by Philip Morris International or any of its affiliates

Exclusion Criteria:

* Not meeting the inclusion criteria
Dose Response Effects of Inhaled Fluticasone on Airway Effects of Hypertonic-saline in Asthma

This study investigates the effect of a inhaled corticosteroid (fluticasone or "Flovent") on airway narrowing induced by hypertonic saline (salty water). The study hypothesis is that fluticasone will be more effective in preventing saline-induced airway narrowing than methacholine-induced narrowing.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of asthma

Exclusion Criteria:

* Habitual cigarette smoking
Clinical Study of Hospital-manufactured CD19 CAR-T in Children and Adolescents With Acute Lymphoblastic Leukemia

Chimeric antigen receptor T cells (CAR-T cells) have been developed to treat relapsed and refractory hematological malignancies with promising outcome in patients with very poor prognosis. The purpose of this clinical study is to produce the CD19\[cluster of differentiation antigen 19\] CAR-T (SNUH-CD19-CAR-T) at the investigational site and to evaluate safety and efficacy of SNUH-CD19-CAR-T in children and adolescent with relapsed/refractory B-cell acute lymphoblastic leukemia.


Eligibility Criteria:
Inclusion Criteria:

* 1. Relapsed or refractory CD19 Positive Acute Lymphoblastic Leukemia. All subjects must be younger than 26 years old at the time of obtaining informed consent

  a. 2nd or greater BM\[bone marrow\] relapse OR b. Any BM relapse after allogeneic SCT\[stem cell transplant\] and must be ≥ 6 months from SCT at the time of SNUH_CD19_CAR-T infusion OR c .Refractory as defined by not achieving a CR after 2 cycles of a standard chemotherapy regimen or chemorefractory as defined by not achieving a CR after 1 cycle of standard chemotherapy for relapsed leukemia OR d. Ineligible for allogeneic SCT because of:
  * Severe comorbid disease
  * Other contraindications to allogeneic SCT conditioning regimen
  * Lack of suitable donor

    2. Documentation of CD19 tumor expression in bone marrow or peripheral blood by flow cytometry.

    3. Karnofsky (age ≥ 16 years) or Lansky (age \< 16 years) performance status ≥ 50 at screening

Exclusion Criteria:

1. Evidence of uncontrolled hepatitis B virus (HBV) or hepatitis C virus (HCV) based on assessment done by treating physicians.
2. Known human immunodeficiency virus (HIV) infection.
3. Presence of clinically active uncontrolled infection based on assessment done by treating physicians. Infections are considered controlled if appropriate therapy has been instituted and, at the time of screening, no signs of progression are present. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
4. Pregnant or nursing (lactating) women.
Multicenter Subcutaneous ICD Registry

This multicenter registry aims to collect data regarding S-ICD longevity, and battery and lead failure rates. Only clinically collected data is gathered in this registry.


Eligibility Criteria:
Inclusion Criteria:

* S/P S-ICD Implantation

Exclusion Criteria:

* n/a
Effects of Appropriate Technology for Home-based Rehabilitation in Patients With Post-stroke Physical Dysfunction

The goal of this clinical trial is to assess the effect of S-HRAT to improve patients' motor function and activities of daily living.

Limb dysfunction is the primary disability factor among stroke patients. However, due to various factors, most stroke survivors do not receive sufficient rehabilitation training after discharge. Home-based rehabilitation appropriate technology (S-HRAT） training could be a strategy to meet the patients' requirements for rehabilitation after hospital discharge. This study aims to assess the effect of a nursing intervention based on Cox's Interaction Model of Client Health Behavior (IMCHB) with the application of S-HRAT to improve patients' motor function and activities of daily living.

In this pilot trial, 36 stroke survivors with limb dysfunction will be screened for inclusion before hospital discharge and randomly assigned to the experimental or control group with their informed consent. The control group(n=18) will receive the usual care provided by the hospital. The experimental group(n=18) will receive usual care and an 8-week S-HRAT training program. This nursing interventions use Cox's IMCHB as a theoretical framework that consists of rehabilitation exercises and the provision of health information. Baseline assessments will be conducted on the day before hospital discharge, and outcomes will be assessed at 8 weeks and 12 weeks after discharge. The primary outcome is change in motor function 8 weeks after discharge, and the secondary outcomes include the activities of daily living, anxiety, depression, exercise adherence, and patient satisfaction.

This study is the first of its kind conducted in China to use Cox's IMCHB as a framework to guide the development of the S-HRAT training program. Our pilot will determine if such an approach is feasible and effective in enhancing motor function and improving the activities of daily living post-stroke after discharge.

Eligibility Criteria:
Inclusion Criteria:

* Age≥18;
* Patients diagnosed with cerebrovascular disease who have cerebral infarction or cerebral hemorrhage based on cranial CT or MRI and meet the diagnostic criteria;
* Patients are in the non-acute phase, meaning between two weeks and six months after the onset of the disease;
* Patients with limb dysfunction.

Exclusion Criteria:

* Return to a hospital or rehabilitation facility after discharge;
* The patient has a history of mental illness and dyslexia;
* Patients have a combination of serious, life-threatening conditions.