cyrilzakka/clinical-trials huggingface dataset:
Virus Early Transcription Factor (VETF) Multicenter Phototherapy Protocol

Background

Phototherapy UVB TL01 currently represents the first choice in treatment to induce the repigmentation of vitiligo spots. The problem though is that there are no systems or scales which enable an objective evaluation of the therapy, commonly known as percentage of repigmentation.

Recently, a European Task Force (VETF, Vitiligo European Task Force) of experts on vitiligo, within the European Society of Pigmentation, has proposed a gravity classification on the basis of three parameters/standards - extension, progression and the level of depigmentation - and used to classify patients in ten European centres. The aim of the trial is to validate the VETF scoring system set up in relation with the therapeutic answer to the standard treatment for vitiligo and phototherapy.

Leaving aside short term side effects, such as sunrush/erythema and sunburn, which are reversible and infrequent, the main problem with phototherapy is represented by the cumulative long term effects of ultraviolet rays. These can cause premature ageing of the skin (photoaging) and the appearance of skin cancer/neoplasia. Therefore the aim is to get the best results from phototherapy whilst limiting its length.

Aims of the trial:

1. To validate the VETF scoring system. As phototherapy is currently the only universally accepted treatment for vitiligo, it seems logical to test the VETF scoring system first to evaluate the effectiveness of phototherapy.
2. Secondly, the target of this multicentric trial is to compare the effectiveness of two different phototherapy protocols; a first protocol foresees non-stop treatment for 6 months; a second protocol foresees periods of interruption during the treatment. This will help to verify whether interrupting a cycle of phototherapy is useful or not.

This interruption might make the ultraviolet rays more effective 'stimulus on the melanocytes', and may also reduce long term damage caused by phototherapy.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 60 years old

Exclusion Criteria:

* Phototype I
* Previous treatment with any kind of phototherapy in the last 6 months.
* Patients with counter indications for PUVA or phototherapy (history of skin cancer, pregnancy, etc.).
* Acral vitiligo (only hands and feet are affected).
Early Diagnosis of Pulmonary Hypertension in Patients With Inflammatory Rheumatic Connective Tissue Diseases

The purposes of this study are (I), to evaluate various screening methods for their ability to predict and to confirm Pulmonary Hypertension (PH) in scleroderma patients, and (II) to evaluate the incidence of PH (i.e. the number of new cases per year) in scleroderma patients.


Eligibility Criteria:
Inclusion Criteria:

* consent form
* men and women\> 18 years
* fulfill the current definition of a collagen vascular disease according to the actual guidelines of the American College of Rheumatology (ACR)

Exclusion Criteria:

* all contraindications for exercise testing
* significant restriction of the left ventricle, unstable coronary artery disease and myocardial infarction in the last 6 months
* patients with other lung diseases (as the pulmonary infestations as part of systemic disease) or related musculoskeletal disorders influencing baseline exercise capacity
* pregnancy
Dose Ranging Study of Ba 679 BR Inhalation Powder in Chronic Obstructive Pulmonary Disease (COPD) Patients

To investigate the dose response following single inhalation of Ba 679 BR inhalation powder in COPD patients using pulmonary functions as indicators, and to compare data obtained with overseas study findings


Eligibility Criteria:
Inclusion Criteria:

1. In a pulmonary function test of Screening Test II, FEV1.0 was less than 70% of predict normal and FEV1.0 was less than 70% of FVC.
2. In the reversibility test of Screening Test II, FEV1.0 was improved by 10% or more at 1 hour after inhalation of 2 puffs of an anticholinergic agent (Tersigan ® Aerozol)
3. History of smoking (\< no. of cigarettes a day x no. of years of smoking \> = 200 or more)
4. 40 years of age or older
5. Regardless of sex and the length of disease period

Exclusion Criteria:

1. A history of bronchial asthma
2. A history of atopic disease, such as allergic rhinitis
3. Blood eosinophil of 440/µl or more
4. Continuous use of steroid drugs (oral administration, inhalation or injection) at a dose equivalent to over 5 mg daily of prednisolone
5. A history of respiratory infection, including virus infection within 1 month before study initiation
6. Tuberculosis, lung cancer or a history of pneumonectomy
7. Glaucoma
8. Under treatment of benign prostatic hypertrophy
9. Hypersensitivity to anticholinergic agents or sympathomimetics
10. Difficulty in expectoration of sputum
11. Serious heart disease, renal disease, hepatic disease, endocrine disease or metabolic disease
12. Use of any β blockers
13. A history of myocardial infarction within the past 1 year
14. A history of heart failure, cor pulmonale or arrhythmia requiring medication within the past 3 years
15. A history of drug abuse or alcoholism
16. Treatment of psychotic disease
17. Pregnancy, possible pregnancy or lactation
18. A history of participation in any other clinical studies within the past 6 months
19. Judgment by the investigator that the patient is ineligible for inclusion in the present study
PGI2 Induced Headache and Cerebral Haemodynamics in Healthy Volunteers

Before , during and after intravenous administration of PGI2 we score/measure headache, rCBF, blood flow in middle cerebral artery and diameter of superficial temporal artery/radial artery and correlate that to known patophysiology of headache to see if PGI2 is involved in headache pathophysiology.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers,

Exclusion Criteria:

* Primary headache,
* headache on the day of investigation,
* Hypertension,
* hypotension,
* pregnant/nursing
* Daily intake of medication (except oral contraceptives)
* Cardiovascular or CNS disease
* Drug/Alcohol abuse
* Psychiatric disease
Phase 2 Safety and Efficacy Evaluation of AL8326 in ≥2nd Line SCLC

This trial is a Phase II trial designed to evaluate the safety and efficacy of using oral AL8326 , a multi-targeted receptor Tyrosine Kinase Inhibitor( TKI) , to recurrent, advanced, or metastatic small cell lung cancer (SCLC) patients who need ≥2nd line treatment .

This study is designed for two steps: Phase 2 Optimal Biological Dose (OBD) finding and Phase 2 expansion cohort study after OBD determination.

The Phase 2 study aims to find optimal biological dose (OBD) initially. Patients will be randomized to 3 different dosing groups in OBD finding cohorts. Each cohort will enroll 6-12 SCLC patients who need ≥2nd line treatment without or with brain metastasis which is controlled with no active hemorrhage. This OBD finding cohort will also evaluate the pharmacokinetic profile of AL8326.

A phase 2 expansion cohort will be continued if a positive clinical result would have been observed after OBD determination for 40-60 patients. Upon FDA's approval the Phase 2 expansion cohort clinical study will be further expanded to evaluate the safety and efficacy of AL8326 in patients individually with SCLC who need = or \>2nd line treatment without or with brain metastasis which is controlled with no active hemorrhage.

Eligibility Criteria:
Major Inclusion Criteria:

1. Male or female, 18 years of age or older
2. ECOG performance status of 0 or 1
3. Histologically or cytologically confirmed SCLC
4. Have at least 1 lesion that meets the criteria for being measurable, as defined by RECIST 1.1
5. Have a life expectancy of at least 3 months

Major Exclusion Criteria:

1. Serious, non-healing wound, ulcer or bone fracture
2. Major surgical procedure within 28 days or minor surgical procedure performed within 7 days prior to treatment
3. Active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels
4. Clinically significant cardiovascular disease including uncontrolled hypertension; myocardial infarction or unstable angina within 6 months prior to enrollment; New York Heart Association (NYHA) Grade II or greater congestive heart failure serious cardiac arrhythmia requiring medication; and Grade II or greater peripheral vascular disease
5. Hemoptysis within 3 months prior to enrollment
6. Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9 and CYP2C19 within 14 days prior to enrollment and during the study unless there is an emergent or life-threatening medical condition that required it.

More information available upon request
A Study of Oral Oteseconazole (VT-1161) for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)

Recurrent vulvovaginal candidiasis (RVVC), also known as recurrent yeast infections, is defined as at least 3 episodes of acute VVC in the past 12 months. Several properties of oteseconazole (VT-1161) suggest that it might be a safer and more effective treatment for RVVC than other oral antifungal medicines.

This study will evaluate the effectiveness and safety of oteseconazole (VT-1161) for the treatment of RVVC and consists of 2 parts. The first part of the study is a 2-week period for the treatment of the patient's current VVC episode with 3 150mg doses of fluconazole. The 2nd part consists of 12 weeks, when the patient will take either oteseconazole (VT-1161) 150 mg or a placebo (according to a random assignment), and then a 36-week follow-up period.

In addition, at participating sites, an amendment to the study allows US patients who complete the initial 48 weeks without experiencing a confirmed RVVC episode to continue in a 48-week observational extension period designed to evaluate the continued effectiveness of oteseconazole (VT-1161).

This study is identical to VMT-VT-1161-CL-011.


Eligibility Criteria:
Key Inclusion Criteria:

* 3 or more episodes of acute VVC in the past 12 months
* Positive KOH or Gram stain test
* Total vulvovaginal signs and symptoms score of ≥3 at screening visit
* Total vulvovaginal signs and symptoms score of \<3 at baseline visit
* Must be able to swallow pills

Key Exclusion Criteria:

* Presence or a history of another vaginal or vulvar condition(s)
* Evidence of major organ system disease
* History of cervical cancer
* Poorly controlled diabetes mellitus
* Pregnant
* Recent use of topical or systemic antifungal or antibacterial drugs
* Recent use of immunosuppressive or systemic corticosteroid therapies
Hypnosis for Symptom Management in Elective Orthopedic Surgery

The purpose of the study is to determine if teaching self-hypnosis techniques to patients prior to knee replacement surgery will decrease their pain medication requirements, pain medication side-effects, length of stay in the hospital, readmission rates, pain, anxiety, physical function, satisfaction scores, and cost of admission.

Patients will be recruited by through orthopedic surgery clinics or contacted by after pre-screening via chart review and given an information brochure. If they are interested in the trial will be emailed or given a paper copy of the consent form and scheduled for a single additional visit in the Integrative Medicine Center at Hoover Pavilion approximately 1 week before surgery. At the single study visit, participants would be consented, then a mini-mental state test would be performed to determine if participants are eligible by a score of 25 or above. If eligible, participants would be asked to fill out surveys relating to demographics, attitudes and experience with hypnosis, and detailed pain medication usage. Then, participants would be randomized to hypnosis vs. no hypnosis. The hypnosis group will undergo a Hypnotic Induction Profile to score hypnotizability, then be lead through a hypnosis induction and read a perioperative symptom management script, then re-alerted from hypnosis. Patients in this group would then be asked to listen to the same hypnosis script on a telephone recording twice per day until after the surgery when participants feel they don't need it anymore.

The control group will fill out the surveys and the study visit will end. Participants will be asked not to use any hypnosis until the trial period is over. Data regarding pain, activity, and satisfaction is already collected by email survey or by Ipad in orthopedic clinic at or before the pre-op visit, and 3 months post-op.

Patients in the knee study will be asked to fill out the same surveys around the two week and six week post-op orthopedic clinic visits as well. One additional survey will be added at the 2 week post-op visit to reassess attitudes and experience with hypnosis, and detailed pain medication usage. Those participants who do not fill out the survey will be called and/or emailed to remind them to fill it out.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old.
* scheduled for a primary, unilateral, total knee replacement surgery within the study period
* able to commit to a single study clinic visit at least one week prior to their scheduled surgery and use of phone recordings
* able to read and understand English
* Score at least 25 on mini-mental state exam

Exclusion Criteria:

* severe psychiatric or structural brain disease (ie. psychosis, stroke with functional impairment, dementia)
* current use of hypnosis/self-hypnosis
* enrolled in other clinical trials related to pain management or length of stay
* hearing impairment that would impede ability to listen to a phone recording
Pre-etching of Dentin Before Restorations With High Viscosity Glass Ionomer Cement

The objective of this randomized clinical trial is to evaluate the survival of restoration with high viscosity glass ionomer cement (HVGIC) with pre-etching with polyacrilic acid compared with no pre-etching in order to treat occlusoproximais caries lesion in primary molars, as well as the impact of those treatments in the caries lesion progression, the cost-efficacy of the procedures and the discomfort reported by the patient. Children of 4 to 8 years will be selected in the Pediatric Dentistry Clinic of Universidade Ibirapuera. 192 teeth will be randomized in 2 experimental groups: (1) HVGIC restoration with pre-etching and (2) HVGIC restoration with no pre-etching. Will be considered as primary outcome the survival of the restoration evaluated after 6, 12, and 24 months by two trained examiners. The carious lesions progression will be evaluated after 24 months of follow-up. The time of the treatments and the cost of the materials will be considered to estimate the cost-efficacy of each treatment. The discomfort reported by the participant will be measured after each procedure following the Wong-Baker scale. For the primary outcome, Kaplan-Meier survival and the Long-Rank test will be used in order to compare the two groups. Cox regression will be performed in order to evaluate thee influence of explanatory variables on the outcome.


Eligibility Criteria:
Inclusion Criteria:

* Patients with carious lesion of occlusoproximais in primary molars

Exclusion Criteria:

* Patients will be excluded with special needs, using orthodontics devices and/or systemic diseases which may affect the oral cavity.
* Also, teeth with pulp exposure, spontaneous pain, mobility, presence of abscess or fistula next to the tooth, teeth with restorations, sealants or enamel formation defects will also be excluded.
Early Diagnosis of PPD Through Self-portraits

the target of the research is development of a predictive tool for early identification of women which are at higher risk for development of postpartum depression.

the evaluating tools include self portraits and questionnaire during the third trimester of pregnancy.

The suggested research aims to evaluate if and how it would be possible to predict the potential for postpartum mood swing disorders in pregnant women while in the third trimester. The later to prevent the mother from enduring such a detrimental experience, which influences the child development, the family as well as the mother's intimate relationship.

The aim is to identify indicators to predict such potential, using questionnaires and self-portraits during pregnancy, to allow early intervention and treatment. Early diagnosis and quick treatment of pregnant women or post-partum mothers will allow them a higher level of functioning and may even prevent eventually infant neurological and developmental delays and hardships.

the target of the research is to evaluate a method based on self portraits and targeted questionnaire done in the third trimester and three months later in order to identify pregnant women in higher risk to develop PPD.

the minimal number of objectives participating in the research would be 100 pregnant women during the third trimester of pregnancy.

the Draw A Person (DAP) test was described by Machover in 1949. it is still considered a reliable and well recognized test for evaluation of mental stress and disorders (Gilory, 2012).

in the research approximately 100 pregnant women in the third trimester would be asked to draw a self portrait in two different time points (during the third trimester and three to six months postpartum). in addition to the self portraits the participants would be asked to fill a set of questionnaires to evaluate the degree of depression, self esteem, personal history of traumatic events, and demographic data.

the self portraits would be evaluated by three judges. the reliability between judges would be tested using KAPPA test.

Eligibility Criteria:
Inclusion Criteria:

* third trimester pregnant women

Exclusion Criteria:

* pregnant women with established diagnosis of mental disorders
* still birth or intra uterine disorders
Biodex Training in Hemodialysis Females With Osteopenia

imbalance is a common problem in hemodialysis patients with osteopneia, biodex training is a good device that treat imbalance

58 women with osteopenia problem and dialysis will be divided to trained women group with a number of 29 women receiving 3-time biodex training per week, every time will be 10 minutes for 12 weeks or nontrained women group that will act as a control group (n = 29 women)

Eligibility Criteria:
Inclusion Criteria:

* osteopneia women
* hemodialysis women

Exclusion Criteria:

* pregnancy
* autoimmune disorders
* lower limb orthopedic problems
* psychological manifestaion
Prospective Registry of Patients With Isolated Severe Tricuspid Regurgitation

Prospective registry for patients with severe isolated tricuspid regurgitation (TR) without significant left-sided valvular or myocardial diseases.

Aim: To evaluate clinical course and prognostic factors of patients with severe isolated TR.

Inclusion criteria Severe isolated TR for more than 6 months

Exclusion criteria

1. Severe mitral and aortic valvular heart disease
2. Age equals to or more than 75 years
3. Malignancy or serious comorbidity with life expectancy \< 5years
4. Acute or subacute infective endocarditis requiring antibiotics therapy
5. Untreated hyperthyroidism
6. Constrictive pericarditis
7. Unclosed significant atrial septal defect
8. Previous tricuspid valve surgery
9. Significant coronary artery disease
10. Cardiomyopathy
11. Pregnancy
12. Severe resting pulmonary hypertension(TR Vmax \>4.0 m/s)

Eligibility Criteria:
Inclusion criteria

* Severe isolated TR for more than 6 months

Exclusion criteria

1. Severe mitral and aortic valvular heart disease
2. Age equals to or more than 75 years
3. Malignancy or serious comorbidity with life expectancy \< 5years
4. Acute or subacute infective endocarditis requiring antibiotics therapy
5. Untreated hyperthyroidism
6. Constrictive pericarditis
7. Unclosed significant atrial septal defect
8. Previous tricuspid valve surgery
9. Significant coronary artery disease
10. Cardiomyopathy
11. Pregnancy
12. Severe resting pulmonary hypertension(TR Vmax \>4.0 m/s)
NobleStitch EL STITCH Trial is a PFO Comparative Trial

STITCH - Prospective Multi-Center Comparative Parallel Concurrent Study of the NobleStitch™ EL versus FDA-approved Amplatzer Occluder device for closure of Patent Foramen Ovale to prevent recurrent Ischemic stroke.

To demonstrate the non-inferiority of the NobleStitch™ EL with medical management in both safety and effectiveness compared to the FDA-approved Amplatzer Occluder with medical management for PFO Closure.

To demonstrate that the NobleStitch EL does not increase the incidence of ischemic stroke compared to published medical management data.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female ages 18 - 60 years old
* A PFO and a Cryptogenic Stroke verified by a neurologist
* Stroke is defined as an acute focal neurological deficit, presumed to be due to focal ischemia, and either:

  * Symptoms persisting ≥24 hours, or
  * Symptoms persisting \<24 hours with Magnetic Resonance or CT findings of a new, neuroanatomical relevant infarct
* Cryptogenic stroke was defined as a stroke of unknown cause
* Prolonged cardiac rhythm monitoring (recommended 30 days and not less than 24 hours required)
* Intra and extracranial artery imaging: Magnetic Resonance Angiography, CT angiography, or contrast angiography, or contrast angiography or echocardiography of the carotid arteries to rule out ischemic stroke associated with atherosclerotic plaque, arterial dissection, or other vascular diseases. (The aortic arch may also be evaluated by TEE).
* Hypercoagulable state assessment to rule out an underlying hypercoagulable state

Exclusion Criteria:

* Female participant who is pregnant, lactating or planning a pregnancy during the course of the study
* Age \<18 or \> 60 years of age
* Previous myocardial infarction or unstable angina within 6 months
* Clinically significant mitral or aortic valve stenosis or severe regurgitation
* Left Ventricular Ejection Fraction \<50 percent
* Progressive neurological dysfunction or reduced life expectancy
* Contrast allergy
* Atrial Septal Defect (baseline left to right shunt assessed by TEE or other congenital heart diseases
* Active Endocarditis
* Perspective participants with known causes of Ischemic Stroke
* Arterial dissection
* Contraindicated or unsuitable for antiplatelet agents or oral anticoagulants
* Perspective participants with prosthetic heart valves
* Uncontrolled diabetes Mellitus
* Pulmonary hypertension
* Uncontrolled systemic hypertension
* Intracranial pathology
* Neurological deficits not due to stroke that may affect neurologic assessments
* Active autoimmune disease
* Active infection
* Alcohol and/or drug abuse
* A requirement for chronic anticoagulation therapy that cannot be discontinued
* Anatomic features (inability to achieve vascular access)
Compassionate Use Study of 125 mg Per Day of Azimilide Dihydrochloride in One Patient

This is an open-label, long term compassionate use study of 125 mg per day of azimilide 2HCl in a patient who completed two other protocols (2000098 and 2001060.


Eligibility Criteria:
Inclusion Criteria:

* No inclusion criteria as the patient to be included is this compassionate use protocol is currently receiving azimilide therapy

Exclusion Criteria:

* Currently taking Class I or other Class III antiarrhythmic drug or other drugs that may prolong QT interval.
* Is unwilling or unable to give or understand informed consent.