cyrilzakka/clinical-trials huggingface dataset:
Bevacizumab for the Treatment of Corneal Neovascularization

The purpose of the current study is to assess the efficacy and safety of the inhibitory effect of bevacizumab (Avastin) with different routes including topical and subconjunctival application on corneal neovascularization in the human eyes.

The compassionate off-label use of bevacizumab as well as the potential risks, benefits, and adverse effects of this medication are discussed extensively with each patient. To further minimize systemic absorption, silicone punctual plugs are placed in the lower eyelids. One group of patients apply topical bevacizumab, 1.0%(10mg/ml), 4 times of day. The other group of patients received subconjunctival injection of bevacizumab(2.5mg/0.1ml) once. The patients are examined at 1day, 1week, 2weeks, 3weeks, and 1month, then monthly till the corneal neovascularization are gone or reduced to some degrees. Best-corrected visual acuity, slip-lamp examination, tonometry, external photography, pachymetry, specular microscopy (if possible), and systemic blood pressure are completed at all visits.

Eligibility Criteria:
Inclusion Criteria:

* Significant unilateral or bilateral corneal neovascularization that extending over the limbus at least 2mm.
* The underlying etiologies that caused corneal neovascularization included post penetrating keratoplasty (PKP), ocular surface reconstruction , trauma, infectious or non-infectious corneal ulcer.
* Corneal neovascularization induced lipid keratopathy, corneal edema, or irregular corneal surface. The best-corrected visual acuity was less than 20/25.
* Post-PSP or ocular surface reconstruction corneal neovascularization that had no associated lipid keratopathy, no corneal edema, or corneal irregularity. But the neovascularization was highly possible to cause graft rejection.
* The corneal neovascularization was refractory to other medical treatment.
* The patient had received PKP or other corneal surgeries mort than half a year ago and was not in the acute post-operation phase.
* The patient had no active endophthalmitis, glaucoma with uncontrolled intraocular pressure, or vitreoretinal diseases.
* The patient signed inform consent to have regular follow up and treatment.

Exclusion Criteria:

* The neovascularization had clinical improvement three months before the first injection.
* The lipid keratopathy had clinical improvement three months before the first injection.
* The patient that suspected to have poor visual outcome or had already been light sense negative Glaucoma patient that had uncontrolled intraocular pressure.
* Poor corneal epithelialization.
* Patient that had systemic disease which was not suitable for bevacizumab use.
* Pregnant patient.
Photobiomodulation in Dry Age Related Macular Degeneration

The goal of this clinical trial is to evaluate effects of consecutive Yellow and Red Light Emitting Diode photobiomodulation in dry age-related macular degeneration (AMD). The main questions it aims to answer are:

* Is Yellow and Red Light Emitting Diode photobiomodulation effective in decreasing drusen volume in patients affected by dry AMD?
* Does Yellow and Red Light Emitting Diode photobiomodulation increase visual acuity and contrast sensitivity in patients affected by dry AMD? Participants will be randomly assigned to a treatment or a sham group.

Treatment consists in two cycles with two phases each:

* 1st phase: 300 seconds of continuous Yellow light with eyes closed + 60 seconds of pulsed Yellow light with eyes opened;
* 2d phase: 300 seconds of continuous Red light with eyes closed + 60 seconds of pulsed Red light with eyes opened.

Cycle 1 consists of 8 sessions (two PBM per week for 4 weeks) and cycle 2 consists of 6 sessions (two PBM per week for 3 weeks).

Researchers will compare patients in the treatment group to those in the sham group to evaluate differences in objective signs and subjective symptoms of dry AMD.


Eligibility Criteria:
Inclusion Criteria:

* BCVA ETDRS \> 40 L ETDRS at 4 meters
* Diagnosis of DRY AMD AREDS grade 2-3
* Ability to communicate well with the investigator and able to understand and comply with the requirements of the study

Exclusion Criteria:

* Concomitant epilepsy
* Neurological diseases
* Psychiatric pathologies
* Herpes virus infections
* Dense cataract
* Pregnancy
* Other significant ocular and/or retinal diseases
The Russian Multicenter Observational Study "Evaluation of the HDQ for the Diagnosis of Hemorrhoidal Disease ( HDQ )

Currently in Russia there is no available self-evaluating tools with appropriate diagnostic accuracy for screening of patients with haemorrhoids. Therefore, the primary objective of this study is to evaluate a new patient specific questionnaire (HDQ) with appropriate sensitivity and specificity to use for screening of patients with haemorrhoids in Russia. Once evaluated, the HDQ will be used in clinical practice for wider screening of haemorrhoids in population and for increasing patients' awareness of the disease and prompting them to seek professional advice.

Secondary objectives of the study are to describe a prevalence of haemorrhoids among patients in the study and to describe a prevalence of the symptoms of haemorrhoids among patients in the study

Main parameters (primary outcomes) to be evaluated in the study are:

1. sensitivity of the HDQ for screening of patients with haemorrhoids;
2. specificity of the HDQ for screening of patients with haemorrhoids;

Additional parameters (secondary outcomes) in the study are:

1. Prevalence rate of haemorrhoids among study population established by physicians basing on the results of the objective examination;
2. Prevalence of the symptoms of haemorrhoids among patients in the study

Eligibility Criteria:
Inclusion Criteria:

* The patient came to visit a coloproctologist
* Male or female aged over 18 years
* Signed informed consent form to participate in the study has been obtained
* Absence of conditions requiring emergency medical care.
* The patient is not taking VAD for at least 1 month before the date on inclusion to the study

Exclusion Criteria:

* Confirmed or suspected malignant tumor
* Diagnosed coloproctological disease at the time of inclusion
* Severe somatic disorders (of heart and blood vessels, lungs, kidneys, pancreas, or liver), associated with decompensation of organ functions
* Mental disorders
* Presence of contraindications for examination
Effects of Nalmefene After Single Dose on the Blood Oxygen Level Dependent (BOLD) fMRI Signal in the Ventral Striatum to Reward Responding in the Monetary Incentive Delay Task (MIDT), in Non-treatment Seeking Subjects With Alcohol Dependence Following Alcohol Challenge

To contribute to the understanding of the underlying neurobiological mechanism behind the interaction of alcohol and nalmefene


Eligibility Criteria:
Inclusion Criteria:

* The subject has alcohol dependence, diagnosed according to DSM-IV-TR™.

Exclusion Criteria:

* The subject is seeking treatment for alcohol dependence.
* The subject has had \<6 heavy drinking days (HDDs) in the 4 weeks prior to the Screening Visit.
* The subject has had an average alcohol consumption below high risk levels (that is, 60 grams of alcohol/day for men) \<4 weeks prior to the Screening Visit.
* The subject has \>5 consecutive abstinence days in the 4 weeks prior to the Screening Visit.
* The subject has a Revised Clinical Institute Withdrawal Assessment of Alcohol Scale, (CIWA-Ar), score ≥10.
* The subject is, in the opinion of the investigator, at significant risk of suicide or meets the exclusion criteria based on C-SSRS.

Other inclusion and exclusion criteria may apply.
Assessment and Treatment of Social Skills Deficits in Individuals With Social Phobia

This study will determine whether people with social phobia are deficient in certain social skills.

Social phobia is a debilitating condition that can cause severe social, emotional, educational, and occupational functioning problems. Evidence suggests that individuals with social phobia are deficient in social skills, but the exact skills deficits have not been elucidated. This study will comprise two substudies: one will examine social skills deficits in social phobics and determine how they differ from those of people without social phobia; the other will determine if skills deficits in social phobics can be improved and whether improvements will affect overall social functioning.

Participants in this study will be randomly assigned to one of three groups for 16 weeks: an exposure group, a social skills training and exposure (SET) group, or a wait-list control group. Interviews, self-reports, and simulated role plays will be used to assess the social skills of participants.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Social Phobia

Exclusion Criteria:

* Axis II diagnosis of schizoid or schizotypal personality disorder or paranoia
* Axis II diagnosis of mental retardation, obsessive-compulsive disorder, and personality disorders, except for avoidant personality disorder
* Instability on any antidepressants
* Psychotic disorder
HBOT for Patients With IC/FM (Interstitial Cystitis/Fibromyalgia)

The investigators observed 12 fibromyalgia and interstitial cystitis patients undergoing hyperbaric oxygen oxygen treatment in a multiplace pressure chamber for 90 minutes, 40 treatment each, using an oro-nasal mask.

The investigators structured a prospective observational pilot experimental design in consenting patients with IC and FM, with repeated subjective and urological measures conducted before and after a therapeutic protocol. The study duration was set to 3 months. Patients were exposed to breathing 100% oxygen at 2 atmospheres absolute (ATA) in a multiplace pressure chamber for 90 minutes using an oro-nasal mask. Patients undertook a cycle of 20 sessions for 5 days per week for four weeks. After one week of suspension, a second cycle of 20 sessions was completed.

Eligibility Criteria:
Inclusion Criteria:

* Presence of absence of Hunner's ulcers
* Pain in bladder that improves with urination
* pain(supra-pubic, pelvic, urethral, vaginal, or perineal)
* presence of glomerulation or bleeding +/- at the cystodistension
* reduced capacity
* increased proprioceptive sensitivity
* normal or reduced compliance
* number of tender points that establish that diagnosis

Exclusion Criteria:

* Pregnancy (diagnosed or within a year)
* age less than 18 years
* benign or malignant bladder tumors
* radiation cystitis
* symptomatic bladder diversions
* herpes in active phase
* bladder and urethral stones
* urinary frequency less than 10 times a day
* presence of symptoms less than 12 months
* bladder capacity\>400ml with no sensitive urgency
Long-Term Follow-Up Safety Monitoring of Patients Dosed in the First-in-Man Phase I/II Study of TT-034.

This is a long-term safety follow-up protocol for subjects who received TT-034 under the B2801001 protocol and consists of monitoring for at least 4.5 years.

The main purpose of this follow-up study is to detect events suggestive of delayed adverse effects of the study drug by review of clinical histories and discussion with subjects to identify/elicit significant medical events, including but not limited to hematologic, malignant, autoimmune, neurologic, and hepatic events.

Eligibility Criteria:
Inclusion Criteria:

* Prior enrollment in Study B2801001 and dosing with TT-034
* An informed consent form for this study signed and dated by the subject or a legally acceptable representative

Exclusion Criteria:

* There are no specific exclusion criteria for this follow-up study
Center for the Study of Vascular Disease in Hispanic and Native Americans

This is a working registry of a longitudinal cohort of Hispanics, Native Americans, and non-Hispanic whites (as controls) for tracking of vascular disease endpoints. Blood samples collected for ongoing pilot projects as well as specimen banking. Pilot studies are observational and involve risk measures for stroke, atherosclerosis, and vascular inflammatory responses. Questionnaires on demographics, risk factors, and vascular disease history are performed. No interventions proposed as yet.


Eligibility Criteria:
Hispanics and Native Americans are oversampled, but non-Hispanic whites will be included for comparison purposes. No other exclusion criteria.
Phase 1b Study of Tizanidine in Pediatric Patients With Cerebral Palsy

A Single-Dose, Phase 1b, Multicenter, Open-Label Study to Assess the Pharmacokinetics, Safety and Tolerability, and Pharmacodynamics of Tizanidine at 4 Different Oral Dose Levels in Pediatric Subjects 2 to 16 Years Old With Mild to Moderate Spasticity Due to Cerebral Palsy.

Evaluation of the study's progress after the amendment remained challenging with continued pre-screen failures noted in areas of Botox injection inclusion; family participation refusal / disinterest and gastric or jejunostomy tube placement. A third protocol amendment to improve enrollment was discussed with the Investigators who did not believe further amendment would overcome the barriers expressed by parents that would subject their children to an intense study time commitment without direct benefit. The investigative sites were notified that the study was closed to enrollment March 27, 2012.

Eligibility Criteria:
Inclusion Criteria:

* Have clinically diagnosed spasticity resulting from cerebral palsy
* Have a motor disability resulting from a static, nonprogressive brain injury or malformation occurring prenatally or before the age of 2 years
* Have mild to moderate spasticity at screening
* Have a parent or legally accepted representative able to understand and comply with study requirements who voluntarily provides informed consent and agrees to be primarily responsible for adhering to the requirements of the study

Exclusion Criteria:

* Have a history of hypersensitivity or allergic reaction to tizanidine or any of the capsule components
* Have dietary restrictions or food allergies that conflict with a standardized meal
* Have clinically significant psychiatric, gastrointestinal, pulmonary, hematologic, endocrine, cardiovascular, renal, or hepatic disease that requires pharmacologic intervention
* Have an ongoing seizure disorder that requires medical therapy
ImmeDiate Versus EArLy Invasive Approach in Non-ST-Elevation Myocardial Infarction (IDEAL NSTEMI)

Of estimated 140,000 cases of acute myocardial infarction admitted to hospitals in Germany per year, approximately 50% present with Non-ST-elevation myocardial infarction (NSTEMI). The currently available evidence led to current guideline recommendations that a systematic approach of immediate angiography in NSTEMI patients stabilized with contemporary antiplatelet treatment is not mandatory. However, this immediate invasive approach is appealing because it allows treating the underlying cause (the plaque rupture) as early as possible with subsequent reduction of death and recurrent myocardial infarction. In the IDEAL NSTEMI trial we test an immediate invasive approach (\<2 h) with an approach 12-72 h according top guidelines with respect to 6 months death and mortality.


Eligibility Criteria:
Inclusion Criteria:

* NSTEMI with

  * ischemic symptoms \>10 minutes within 24 h
  * elevated troponin or creatine kinase above the upper limit of normal
  * ST-segment depression or transient ST-segment elevation, T-wave inversion
  * informed consent.

Exclusion Criteria:

* Age \< 18 years
* Age \> 90 years
* persistent angina
* hemodynamic instability
* overt congestive heart failure
* life-threatening arrhythmias
* STEMI
* limited life-expectancy \< 6 months
* chronic oral anticoagulation
* fibrinolysis \< 48 hours
* PCI \< 14 days
* contraindication for treatment with glycoprotein IIb/IIIa inhibitors, heparin, aspirin and clopidogrel
* recent major trauma or surgery
Cardiovascular and Cerebrovascular Control in Healthy Subjects

The aim of the study is to evaluate autonomic function and cerebrovascular control in 60 healthy subjects by means of noninvasive analysis of time series variability.

To this extent, heart period, systolic and mean arterial blood pressure, cerebral blood velocity, peripheral resistances, respiration will be recorded from subjects during an orthostatic challenge.

The interactions between autonomic cardiovascular function, cerebrovascular and peripheral control will be evaluated exploiting the most advanced signal processing techniques.


Eligibility Criteria:
Inclusion Criteria:

* age \>18
* sinus rhythm
* informed consent signed

Exclusion Criteria:

* age \<18
* presence of autonomic nervous system diseases or dysfunctions
Investigation Of A New Medication (GW642444) In Asthmatic Patients

This study will evaluate efficacy (FEV1), safety, tolerability, pharmacodynamics and pharmacokinetics of single and repeat inhaled doses of GW642444. This will be a multi-centre, double-blind, placebo controlled, dose ascending, four way cross-over study in approximately 28 mild to moderate asthmatic subjects.

Key assessments: Efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics will be assessed by measurement of FEV1, blood pressure, heart rate, 12-lead ECGs, clinical laboratory tests, collection of adverse events (AE) information and blood samples.


Eligibility Criteria:
Inclusion criteria:

* Female subjects must be non-childbearing (i.e., surgically sterilised or post-menopausal).
* Non-smokers for at least 6 months.
* Stable asthma.

Exclusion criteria:

* Abnormal findings on heart monitoring assessment.
* Lower respiratory tract infection within 4 weeks, upper respiratory tract within 2 weeks of study.
* Currently taking doses of fluticasone propionate over 500mcg/day.
* Unstable asthma medication.
Clinical Evaluation of the SEQureDx T21 Test In High Risk Pregnancies

Whole blood samples will be collected from high-risk pregnant women to validate the clinical performance of the SEQureDx Trisomy 21 Test.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman 18 years of age or older at 10 - 22 weeks gestation inclusive
* Subject has one or more high risk indicator for fetal chromosome 21 aneuploidy
* Subject provides signed and dated informed consent
* Subject agrees to provide a whole blood sample

Exclusion Criteria:

* Fetal demise at the time of the blood draw
* Previous specimen donation under this protocol
Effect of Autogenous Demineralized Dentin as a Bone Graft Substitute in Management of Periodontal Intrabony Defects

one of the ultimate goals in periodontology is to achieve periodontal regeneration and change the prognosis of questionable or hopeless teeth to maintainable.Bone substitutes have been actively used to reconstruct bony defects. Four categories of bone graft materials exist: Autograft, Allograft, Alloplast, and Xenograft.many researchers paid attention to human tooth as one of the intraoral donor sites due to the chemical and structural similarity between dentin and alveolar bone since both demonstrate low crystalline hydroxyl appetite (HA) with comparable calcium-to-phosphorus ratio.

Extracted tooth will be cleaned from periodontal ligaments, cementum, soft tissue attachment, caries, or restorations (if present), using a high-speed fine finishing stone and saline irrigation. The pulp chamber will be cleaned with sterile endodontic files. Subsequently, teeth will be grounded, using hand bone mill .

ADDG particles prepared by demineralization of tooth particles in 0.6N hydrochloric acid for 30 min to achieve demineralized then washed twice in saline and dried with sterile gauze. The intrabony defect will be debrided using hand and ultrasonic devices and then ADDG particles will fill the defect. Vertical or horizontal mattress sutures and additional interrupted single sutures will be performed to obtain primary closure of the interdental space. The selection of the suturing technique will be based upon the dimension of the interdental space and the thickness and height of the interdental tissues using 5-0 proline suture then follow up period at 3 months and 6 months measuring CAL which is primary outcome and radiographic bone fill , probing depth and recession which are secondary outcome.


Eligibility Criteria:
Inclusion Criteria:

* Patient-related criteria:

Motivated patient 18 years of age or order.

* Patient consulting in the outpatient clinic.
* Patient ready to perform oral hygiene instructions.
* Provide informed consent.
* Accepts the 6 months follow-up period.

Teeth related criteria:

* Tooth with one or two walled intra-bony defect, probing depth ≥ 5mm with intra osseous defect ≥ 3mm.
* Mature permanent tooth.
* Unrestorable tooth or fractured tooth beyond restoration, impacted third molar or Supernumerary tooth to be extracted and used as whole tooth graft inside the defect

Exclusion Criteria:

* Patient-related criteria:

  * Medically compromised patients.
  * Pregnant women.
  * Uncooperative patients.
  * Smokers.
  * Systemic diseases that may compromise healing or bone metabolism (e.g diabetes, hyperthyroidism)

Teeth related criteria:

* Teeth with supra-bony defects.
* Teeth with grade III mobility.
Pioglitazone Therapy for Chronic Granulomatous Disease

The purpose of this proposed research is to investigate the efficacy and safety of the therapy with pioglitazone for chronic granulomatous disease (CGD) patients severe infection.

Chronic granulomatous disease (CGD) is a rare genetic disease caused by defects in genes encoding the subunits of the nicotinamide adenine dinucleotide（NADPH）phosphate oxidase complex. In normal phagocytes peroxisome proliferator-activated receptor gamma (PPARγ) activation links NADPH oxidase activity with enhanced mitochondrial reactive oxygen species (ROS) production. There is deficient mitochondrial ROS production in CGD，due to the lack of this upstream signaling by the NADPH oxidase and PPARγ. These patients are susceptible to bacterial and fungal infections, as well as extensive tissue granuloma formation. X-chromosome-linked CGD (X-CGD) is most frequently. And it generally produces a severe phenotype, with a mortality rate of 3% to 5% per year despite state-of-the-art prophylaxis and intensive multimodal treatment.

At present the most curative treatment for patients with X-CGD is hematopoietic stem cell transplantion (HSCT). But for many patients without an HLA-matched donor and active infections/inflammatory complications still require novel approches.

PPARγ agonist such as pioglitazone, approved for type 2 diabetes, was reported to bypass the need for the NADPH oxidase for enhanced mtROS production and partially restored host defense in CGD. What's more, some animal models and several clinical cases have proved its efficacy. The investigators propose to study the efficacy and safety of the therapy with pioglitazone for children with severe infection of CGD, and its long-term effects.

Through this study the investigators hope to confirm the benefits of pioglitazone in the treatment of this rare disease especially for those patients without a prompt suitable matched donor or for whom the critical disease conditions force to postpone HSCT.

Eligibility Criteria:
Inclusion Criteria:

1. Age：1 months to 18 years
2. Chronic Granulomatous Disease
3. with severe infections

Exclusion Criteria:

1. \> 18 years of age
2. infections are treatable by conventional therapy (antibiotics, antimycotics, allogeneic granulocytes)