cyrilzakka/clinical-trials huggingface dataset:
Aminolaevulinic Acid Photodynamic Therapy of Cervical Persistent HPV Infection and Cervical Neoplasia

The study will examine the effect of aminolaevulinic acid (ALA) photodynamic therapy (PDT) of cervical precancerous lesions in women.


Eligibility Criteria:
Inclusion Criteria:

1. Premenopausal women, 25-50 years of age
2. Meet one of the 3 following conditions:

   high-risk HPV-DNA persistently positive for at least 6 months, without CIN or higher grade lesions as verified by cervical biopsy within the last 3 months; CIN1 as verified by cervical biopsy within the last 3 months and high-risk HPV-DNA positive; CIN2/3 as verified by cervical biopsy within the last 3 months, with intense desire to retain the cervical structure or function
3. Satisfactory colposcopy examination (visibility of entire transformation zone and entire lesion margin ) and endocervical curettage negative
4. In good health condition as confirmed by past medical history, physical examination, electrocardiogram, laboratory tests and urinalysis on the screening and baseline evaluation within the last 4 weeks of the onset of the study
5. Meet the following conditions: pregnancy test negative; no pregnancy plan during the trial;no sexuality or reliable contraceptive measures taken since last menstruation to the onset of the study, agreeing to adopt reliable contraceptive measures during the study
6. Written informed consent signed

Exclusion Criteria:

1. Atypical glandular cells of undetermined significance (AGUS) or adenocarcinoma in situ (AIS) on cytology ,or malignant cells on cytology or histology, or other suspicion of either micro-invasive or invasive disease
2. Invasive carcinoma possibility or positive endocervical curettage on colposcopy
3. Severe pelvic inflammatory disease, severe cervicitis, or other severe gynaecological infection as per clinical examination
4. Undiagnosed vaginal bleeding
5. With allergic disease at present; known or suspected porphyria; known allergy to ALA or similar compounds
6. Evidence or history of clinically significant cardiovascular, endocrine, neurologic, pulmonary, hematological, immunological, psychiatric, metabolic disease or other serious diseases
7. Pregnancy or nursing
8. Therapeutic drug or other therapeutic measures applied on cervix or rectum within the last 2 weeks of the onset of the study
9. Participation in any clinical studies within the last 30 days
10. Subjects that the investigators judged to be not suitable to participate the study besides above
Open-Label Prospective Study Comparing Long-Term Outcome With or Without HFNC in Patients With Stable Hypercapnic COPD

The aims of the study are to compare long-term one-year outcome with or without AirvoTM in stabile hypercapnic COPD patients, who are non-compliant to NIV after an acute exacerbation of COPD.

When compared to NIV, much less experience is available from clinical studies on HFNC therapy. Until now, few studies have investigated the effect of HFNC therapy on hypercapnic COPD patients and the number of patients recruited in these studies is limited. AirvoTM therapy could be good choice of treatment for those COPD patients that are not compliant to NIV but need treatment for hypercapnia in order to reduce COPD exacerbations and enhance QOL.The aims of the study are to compare long-term one-year outcome with or without AirvoTM in stabile hypercapnic COPD patients, who are non-compliant to NIV after an acute exacerbation of COPD.

Eligibility Criteria:
Inclusion Criteria:COPD patients 1) with at least two acute moderate or severe exacerbations during past 12 months, 2) who at the follow-up visit one month after an acute severe exacerbation of COPD are hypercapnic (capillary pCO2 \>6.5 kPa) and not willing to use NIV or have used it less than 4 h/d during the last month despite optimal settings prescribed by an experienced pulmonologist, or if a patient at the follow-up one month after a severe exacerbation is hypercapnic and is willing to try NIV (initiated at the follow-up visit, not at the ward), but then uses it less than 4h/d during the following month. Acute moderate (treated with short acting bronchodilators plus antibiotics and/or oral corticosteroids) and severe (patient requires hospitalization or visits the emergency room) exacerbations of COPD are defined according to the GINA Guidelines (GOLD 2019).

Exclusion Criteria: 1) OSA (diagnosed OSA or high suspicion OSA because of regular snoring, witnessed apneas and daytime sleepiness), 2) neuromuscular or chest wall disease, 3) BMI\>35 kg/m2 or 4) a patient is not able to give his/her informed consent for the study.
The Acetylcysteine for Contrast-Induced Nephropathy Trial

The purpose of this study is to evaluate the efficacy of acetylcysteine compared to placebo for the contrast-induced nephropathy prevention, between 48 and 96 hours after procedures that use contrast.

Contrast-induced nephropathy is defined as an increase of 25% in serum creatinine before the procedure.


Eligibility Criteria:
Inclusion Criteria:

At least one of the following criteria:

* Aged more than 70 years-old
* Chronic renal failure (defined as serum creatinine higher than 1.5mg/dL within the last 3 months)
* Diabetes mellitus
* Congestive heart failure or ventricular disfunction (left ventricular ejection fraction less than 0.45)
* Shock or intra-aortic balloon pump use
* Urgency or emergency procedures

Exclusion Criteria:

* Pregnant women, breastfeeding or aged below 45 years-old and with no efficacious contraceptive methods.
* Patients in dialysis
* Previous inclusion in this trial
* Patient refusal to informed consent
* Pacientes com Infarto Agudo do Miocárdio com supradesnivelamento do segmento S-T nos quais não seja possível administrar o protocolo de hidratação pré e pós-procedimento.
Anti-Estrogen Therapy for Hereditary Hemorrhagic Telangiectasia A Double-Blind Placebo-Controlled Clinical Trial

Hereditary hemorrhagic telangiectasia (HHT) is associated with recurrent epistaxis in 90% of cases. Good response to hormone treatment has been documented, although its use remains controversial. A double-blind placebo-controlled trial with estrogen treatment did not show any benefit over placebo. The aim of this study is to examine the efficacy of an antiestrogenic agent, TAMOXIFEN, in the treatment of HHT-associated epistaxis. The study will include up to 60 patients, over 18 years old.

Patients with HHT-related epistaxis who will attend our center will randomly be assigned to 6 months of treatment with either Tab. tamoxifen 20 mg once daily or placebo. The group will included both men and women over the age of 18 years.

A detailed medical history will be taken at presentation. All patients will be examined by an otolaryngologist before and during the trial to assess the nasal condition and telangiectases and blood clots in the airway, nasal and oral cavity, and body skin. Blood will be collected for blood count and measurement of clotting time and liver function at onset of the trial and once monthly during treatment. Patients will be requested to complete a daily chart describing the course of their epistaxis, and female patients will be referred for gynecologic follow-up, including ultrasound. Evaluations will be conducted once a month throughout the treatment period.

The study was approved by the Ethics Committee of Rabin Medical Center. All patients will sign a consent form.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from HHT with severe epistaxis
* Over 18 years old

Exclusion Criteria:

* Under 18 years old
* Pregnancy
* Treatment with anticoagulance
* Treatment with hormones
Effects of Whey Protein Intervention on Body Composition and Muscle Function in the Elderly With Sacropenia

The purpose of this study is to compare the effects of different dose of whey protein intervention(in a daily dose of 0g, 10g, 20g) on lean body mass,body fat composition and muscular function state in the elderly with sacropenia.


Eligibility Criteria:
Inclusion Criteria:

* People aged over 65 years.
* Usual gait speed less than 0.8m/s.
* Willing to participate in the study, consume the test product and perform all measurements.

Exclusion Criteria:

* nervous system disease.
* Other diseases with movement disorder such as stroke,fracture,arthritis.
* people who unconsciousness and can not complete questionnaire
* long-term regular use of protein and antioxidant.
An Open-Label Study of Naltrexone in Adults With Attention Deficit Hyperactivity Disorder.

The primary aim of this study is to assess whether naltrexone as a monotherapy is effective in treating Attention Deficit Hyperactivity Disorder (ADHD) in adults. Medications that increase dopamine are often effective in treating ADHD in adults. Since naltrexone is a kappa opioid receptor antagonist, it increases dopamine in the brain.

We predict that naltrexone as a monotherapy will be effective for ADHD symptoms in adults with ADHD.


Eligibility Criteria:
Inclusion Criteria

* Male and female outpatients 18-55 years of age.
* Diagnosis of ADHD, by DSM-IV by clinical evaluation by an expert clinician.
* Subjects treated for anxiety disorders and depression who are on a stable medication regimen for at least one month, and who have a disorder-specific CGI-Severity score ≤ 3 (mildly ill) and who have a score on the Hamilton-Depression and Hamilton-Anxiety rating scales below 15 (mild range).

Exclusion Criteria

* Any clinically unstable psychiatric conditions including any history of psychosis or mania, suicidality, sociopathy, criminality, or delinquency.
* Current (last 3 months) substance use disorders (alcohol or drugs),
* Medical condition or treatment that will either jeopardize subject safety or affect the scientific merit of the study including cardiovascular disease, current untreated hypertension, history of renal or hepatic impairment, or a condition that will or may require treatment with opioid analgesics.
* Clinically significant abnormal baseline laboratory LFT's, which is defined as LFT's greater than the ULN.
* Mental retardation (IQ \< 80).
* Organic brain disorders including delirium, dementia, seizures, stroke, neurosurgery, and head trauma with loss of consciousness.
* Pregnant or nursing females.
* Subjects with current adequate treatment for ADHD.
* Current treatment with medication for ADHD.
* Any other concomitant medication with primarily central nervous system activity other than specified in the protocol (a stable and effective treatment regimen of an SSRI or benzodiazepine is permitted per clinical review.)
* A Clinical Global Impression (CGI) of 7 (among the most extremely ill patients) at the screening visit is exclusionary, and any subject who presents a CGI-S of 7 at any point during the study will be removed from participation.
* Subjects presenting with a CGI-Severity score of 6 (severely ill) at two consecutive visits after week 2 will be dropped from the study (i.e. A subject with a CGI of 6 at his/her week 3 visit and at week 4 visit will be dropped from the study at the week 4 visit). Subjects who are dropped for severe or worsening symptoms after exposure to the study medication will receive free follow up care as described in the detailed protocol and protocol summary.
* Non-English speaking subjects
Safety and Efficacy of MILEP Versus Standard EEP

Endoscopic enucleation of the prostate (EEP) is a standard treatment for benign prostatic hyperplasia (BPH), with modifications such as MiLEP that utilizes smaller instruments. The reduced resectoscope diameter in MiLEP may help decrease rates of stress urinary incontinence (SUI) and urethral strictures.

Objective: to compare the efficacy and safety of MiLEP and standard EEP with a thulium fiber laser (TFL).


Eligibility Criteria:
Inclusion Criteria:

LUTS presence, proven by:

1. IPSS questionnaire (Score \>20);
2. OR uroflowmetry result (Qmax \<10 ml/s);

Exclusion Criteria:

* Prostate volume \> 120 cc
* Prostate cancer on pathology;
* Urethral strictures;
* Bladder calculi;
* Prior prostate surgery;
* Neurogenic bladder dysfunction.
Influence of Transcranial Direct Current Stimulation on Cortical Plasticity in Concussed Athletes

Concussed athlethes have discrete decreased abilities in motor learning. Recent research could further show, that cortical plasticity, as measured by transcranial magnetic stimulation (TMS) is reduced. This is possibly due to an increased GABAergic activity, what have been found in concussed athletes by paired pulse protocols in TMS.

GABAergic acitivty can be modulated by transcranial direct current stimulation (tDCS) in a polar-specific manner: anodal tDCS was able to decrease GABA, whereas cathodal tDCS increased tDCS.

Our study aimes to assess the influence of anodal tDCS on cortical plsticity in concussed athlethes. We hypothesize, that anodal tDCS is able to increase cortical plsticity in concussed athlethes.


Eligibility Criteria:
Inclusion Criteria:

* history of at least 2 sports concussion
* age 18 - 50 years

Exclusion Criteria:

* structural deficit on cerebral MRI
* Epilepsy
* neurological disorder
* intake of CNS-active drugs
Robotic-assisted Versus Conventional Total Knee Arthroplasty

This is a multicenter, prospective and randomized controlled pre-market clinical Trial. Study subjects will be randomized into one of two operative groups: 1) TKA assisted with ROSA® Knee System; 2) TKA with conventional surgical instrumentation.

The objective of this clinical trial is to measure the effectiveness and safety of the ROSA® Knee System in assisting surgeons with bone resections and implant positioning optimization through early clinical and radiographic outcomes compared with conventional surgical instrumentation in total knee arthroplasty (TKA).

Eligibility Criteria:
Inclusion Criteria:

1. Patient is age between 18 and 85 years old, inclusive;
2. Patient qualifies for a primary TKA based on the investigator's clinical judgement;
3. Patient is a candidate for commercially available Persona® Knee Joint Prosthese which is compatible with the ROSA® Knee System;
4. Patient is willing and able to provide written Informed Consent.

Exclusion Criteria:

1. Patient planning to receive bilateral TKA surgery within 3 months;
2. Patient who has undergone revision surgery for partial or total knee arthroplasty of the ipsilateral knee；
3. Bone tumor patient who has undergone bilateral TKA;
4. Stable, painless ipsilateral knee arthrodesis within a satisfactory function and position;
5. Patient who has received partial or total knee arthroplasty for the contralateral knee within 6 months prior to scheduled primary TKA;
6. Patient has active, local infection or previous intra-articular infection in the affected joint;
7. Insufficient bone stock on femoral or tibial surfaces;
8. Skeletal immaturity;
9. Osteomalacia or any metabolic disorder which may impair bone formation;
10. Patient has neurologic disorders (e.g. Stroke);
11. Patient hs diseases that could lead to prosthesis instability, failure of prosthesis fixation or postoperative complications (e.g. Arthrodesis, Scoliosis, Lumbar Stenosis)
12. Patient has a hip pathology with significant bone loss (e.g. avascular necrosis of the femoral head with collapse, severe dysplasia of the femoral head or the acetabulum);
13. Patient has hip pathology severely limiting range of motion (e.g. arthrodesis, severe contractures, chronic severe dislocation);
14. Patients with severe knee instability caused by incomplete collateral ligaments, cruciate ligaments, and posterolateral structural injury;
15. Rheumatoid arthritis accompanied by an ulcer of the skin or history of recurrent breakdown of the skin;
16. Patient has severe angular knee deformity of \>20° varus or \>20° valgus;
17. Patient has a known or suspected sensitivity or allergy to one or more of the implant materials;
18. Patient has other contraindications specified by the implant manufacturer;
19. Patient is pregnant or considered a member of a protected population (e.g. prisoner, mentally incompetent);
20. In the past 1 month participated in or is participating in clinical trials related to other drugs and medical devices;
21. Any other conditions that the investigator considers inappropriate for participation in this trial.
Clinical Trial of Sipjeondaebo-tang on Fatigue of Breast Cancer Patients

This is a pilot study that investigate efficacy and safety of Sipjeondaebo-tang on fatigue of patients with breast carcinoma receiving chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* men and women aged over 18 years
* patients who have histologically or cytologically confirmed breast tumor
* patients who applicable AC(doxorubicin + cyclophosphamide)
* ECOG score 0 to 2

Exclusion Criteria:

* patient impossible to orally intake
* patient with dementia, delirium and depression
* patient suffering from diseases like chronic hepatitis B, C or hepatocirrhosis
* severe liver disability (3-fold the normal high range value for ALT, AST)
* patient who has diabetes not controlled by diet, hypertension, hyperthyroidism,
* severe systemic disease
* use of other investigational products within the past 30 days
* hypersensitivity to investigational product
* others who are judged not to be appropriate to study
Postoperative Pain Evaluation Of Novel Bioceramic-Based Root Canal Sealers

Brief Summary: The purpose of this study was to evaluate the effect of MTA-Bioseal, GuttaFlow bioseal, and NeoSealer Flo calcium-silicate based root canal sealers on postobturation pain in teeth with asymptomatic irreversible pulpitis or chronic apical periodontitis undergoing single-visit root canal treatment.

The study tried to answer whether the type of sealer used altered the incidence and intensity of postobturation endodontic pain, whether pulp status affected the incidence and intensity of postobturation endodontic pain and whether there was no difference in analgesic intake by patients after a single-visit root canal treatment between the experimental groups.

This prospective clinical study was reported pain levels experienced after obturation were similar for the different pulp statuses and root canal sealers tested. The participants with single-rooted teeth were included and divided into four groups according to the root canal sealer used. Then, the patients were divided into two subgroups according to pulp vitality. The postobturation pain scores were recorded after obturation on a visual analog scale (VAS) at 6, 12, 24, and 48 hours, and at 7 and 30 days. The level of pain experienced after obturation was similar for all root canal sealers in different pulp statuses. The results of the study showed that the bioceramic-based sealers tested can be used safely in clinical practice in terms of postobturation pain.

Eligibility Criteria:
Inclusion Criteria:

* Good oral hygiene,
* Not reporting pain before the appointment
* Asymptomatic irreversible pulpitis caused by deep carious lesions (vital cases),
* Asymptomatic primary apical periodontitis (non-vital cases).

Exclusion Criteria:

* Pregnancy,
* Autoimmune diseases,
* Uncontrolled diabetes,
* Smokers,
* Advanced periodontal disease (with 5 mm or more probing depth),
* Patients requiring endodontic treatment for more than one tooth,
* Unrestorable coronal destruction,
* Incomplete root formation, systemic,
* Allergic sensitivity to local anesthetic or NSAIDs.
* ASA II patient
* An analgesic or antibiotic intake the 7 days before the beginning of treatment
Exercise Training in Individuals With Peripheral Arterial Disease

In this controlled trial, patients with peripheral arterial disease will be randomized to either maximal walking, submaximal walking, or usual care groups.

Exercise training (walking) is a recommended therapeutic intervention for patients with peripheral arterial disease (PAD). Studies have shown that exercise training improves walking distance, pain-free walking distance, endothelial function and quality of life in these patients. However, to date the most effective exercise training option in terms of improvement of cardiovascular parameters has not been clearly identified. In this controlled trial, patients with PAD will be randomized to either maximal walking group, submaximal walking group, or usual care. The aim of the study is to compare the effect of maximal vs. submaximal walking training programmes on i) walking ability, ii) vascular function, iii) arrhythmogenic potential, iv) parameters of inflammation, hemostasis and heart failure severity, v) health-related quality of life in individuals with PAD.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed peripheral arterial disease,
* Fontaine stage II,
* not included in a cardiovascular rehabilitation programme for at least 3 months.

Exclusion Criteria:

* contraindications for physical activity,
* uncontrolled dysrhythmias,
* uncontrolled heart failure (New York Heart Association (NYHA) stage IV),
* unstable coronary or other arterial disease,
* intellectual development disorder,
* pregnancy.
Metalloproteinases and Recurrent Corneal Erosion Syndrome

Recurrent corneal erosion (RCE) syndrome can be observed either in the context of a dystrophy of the basement membrane or following corneal trauma. This syndrome is characterized by recurrent episodes of ocular pain more or less associated with localized separations between the outer epithelium and the epithelial basal lamina (basement membrane) because of anchorage abnormalities between these two corneal layers. This could be the result of an increased expression of metalloproteinases cleaving the hemidesmosomes which anchor epithelium to the basement membrane.

The investigators hypothesis is that episodes of RCEs are favored by a hyper- expression of matricial metalloprotease 9 (MMP-9) induced by EMMPRIN and Galectin-3. The identification of such induction could lead to development of therapeutics inhibiting EMMPRIN and Galectin- 3 in the RCE syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Recurrent Corneal Erosion Syndrome, with - failure of medical treatment and therapeutic photokeratectomy scheduled
* Photorefractive surgical keratectomy (control patients)

Exclusion Criteria:

* Opposition to participation in the study
* Known pregnancy or breast-feeding patient
* No medical insurance coverage