cyrilzakka/clinical-trials huggingface dataset:
Comparative Study of Ologen Collagen Matrix Versus Mitomycin-C in Glaucoma Filtering Surgery

The objective of this prospective randomised study is to compare the efficacy and safety of ologen CM (Collagen matrix) and Mitomycin-C (MMC) as adjuncts to filtration surgery in uncontrolled treated glaucoma cases, the efficacy being the primary objective and the safety being the secondary.

"ologen ® CM" is a biodegradable collagen matrix. To prevent episcleral fibrosis and subconjunctival scarring thay may result in the surgical failure in trabeculectomy, its sporous matrix modulates the migrations and proliferations of fibroblasts to create a vascular and long-lasting bleb without the adverse effects, such as avascular thin bleb wall, bleb leak, hypotony, and inflammations, potentially caused by the regeneration suppression effects upon the use of cytotoxic agents as anti-fibrotic agents, such as MMC (Mitomycin-C)in the study.

Results of ologen CM studies have been published at conferences and published in peer-reviewed journals; ologen CM is approved in Europe as an aid for tissue repair, and by the FDA in the US as an adjunct in wound management(K080868). In general, over 6,000 ologen CM have been implanted worldwide during the past two years with good results and excellent safety profile.

The clinical trial is a phase-IV post-marketing FDA approved device study designed as open-label, randomised, parallel, and comparative. 128 patients at 8 sites are anticipated to be recruited according to the enrollment criteria, while randomisation will be assigned by a sealed envelope system after the patient has signed consent. Trabeculectomy is performed thereafter with either MMC or ologen CM applications as described in the protocol with postoperative parameters to be measured and analysed with non-parametric tests(Chi-square, Fisher's exact, Wilcoxon, and Mann-Whitney tests) as well as Kaplan-Meier survival models.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 30 years (inclusive)
* Uncontrolled treated glaucoma requiring trabeculectomy
* Subject must be able and willing to cooperate with investigation plan
* Subject must be able and willing to complete postoperative follow-up requirements
* subject must be willing to sign informed consent form

Exclusion Criteria:

* Known allergic reaction to MMC or porcine collagen
* Neovascular, uveitic, aphakic glaucoma, previous incisional glaucoma surgery
* Prior cataract unless clear corneal incision
* Previous conjunctival or strabismus surgery
* Participation in an investigational study during 30 days prior to trabeculectomy
* Ocular infection within 14 days prior to trabeculectomy
* Pregnant or breast-feeding women
The Use of Biorepair Peribioma Toothpaste and Mousse for Home Oral Care in Patients Undergoing Periodontal Therapy

This is a split-mouth randomized clinical trial in which a new domiciliary oral care protocol with Biorepair Peribioma Toothpaste and Mousse is evaluated in periodontal patients.

This is a split-mouth randomized clinical trial that aims to suggest an innovative protocol for domiciliary oral care of periodontal patients. In details, home use of Biorepair Peribioma Toothpaste and Mousse is proposed as a support of professional hygiene sessions.

Patients that respond to the eligibility criteria and that sign the informed consent are recruited for periodontal therapy.The first professional hygiene session is performed at the baseline (T0); the following ones will be performed after 3 (T1) and 6 months (T2) from the baseline. In each session, periodontal indices of inflammation are detected; then, subgingival removal of plaque and tartar is performed, followed by glycine air-flow application in periodontal pockets. A microbiological test is perfomed in order to detect red and orange complex bacteria. At this time, patients are randomly allocated into two groups:

* Trial Group: domiciliary oral hygiene with Biorepair Peribioma Toothpaste and Mousse twice a day until T2 session.
* Control Group: home oral hygiene with Curasept Toothpaste (0,2% Chlorhexidine) twice a day until T2 session.

At the end of T1 and T2 professional session, a satisfaction survey about Peribioma Toothpaste and Mousse will ben given to the patients.

Eligibility Criteria:
Inclusion Criteria:

* Presence of periodontal disease according to the recent 2017 classification (2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions): severity grade II-III and complexity grade I-II.
* Presence of bilateral periodontal probes, for at least one tooth per side up to 20 elements with pathologic probes).
* Patients' good compliance

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients suffering from neurological disorders
* Patients suffering from psychological disorders
* Pregnant women
Preventing Injuries in Young Football Players

Football is the most popular sport in the world, with 260 million male and female active participants, including \~113,000 FIFA registered professional players. Playing football is fun and can provide many health benefits, however, it also presents a high injury risk. Studies on elite and non-elite footballers have reported similar injury rates in both genders. The most common football-related injuries are the knee and ankle ligament and thigh muscle strains, Over the past two decades, significant advancement has been made in the field of injury prevention in football. There are used trials to prevent specific injuries, as ankle sprain, ACL injuries, hamstring strains, etc. On the other hand, there are created programs designed to prevent a wider spectrum of injuries like FIFA11+.

Therefore, the aim of this study is to investigate the effect of a new injury prevention program on the overall injury incidence in young football players.


Eligibility Criteria:
Inclusion Criteria:

officially registered football club in the football federation of Kosovo players must be between 13-19 years old regular training must take place at least three times per week

Exclusion Criteria:

teams already using an injury prevention program injured players
Exercise Therapy for Femoroacetabular Impingement Syndrome

The aim of the clinical trial is to investigate the characteristics of patients, who respond vs. not respond to exercise therapy for the nonsurgical management of femoroacetabular impingement syndrome (FAIS).

Patients with a diagnosis of FAIS will be recruited from 2 clinical centers and will receive exercise therapy (study intervention). Exercise therapy is a semi-standardized intervention and will last 12 weeks (3 months). Hip pain, function and quality of life will be assessed using a patient-reported questionnaire at baseline, 3, 6 and 12 months' follow-up. Hip joint contact pressure will be evaluated using motion analysis and modelling at baseline, 3 and 12 months' follow-up. Hip morphology will be evaluated using imaging at baseline and hip surgery rate will be evaluated at 6 and 12 months' follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 to 50 years;
* Diagnosis of FAIS;
* Availability of magnetic resonance arthrography and anteroposterior pelvic radiography of the involved hip;
* Signed informed consent form.

Exclusion Criteria:

* Previous hip surgery;
* Any surgery on the lower extremities in the last 6 months;
* Hip dysplasia: lateral center edge angle \<25°;
* Hip osteoarthritis: Tönnis grade \>1;
* BMI: \>35 kg/m2;
* Significant cardiopulmonary diseases.
Effects of Mindfulness on PTSD

The purpose of this randomized control trial is to examine the effects of a Mindfulness-Based Stress Reduction (MBSR) program on women with posttraumatic stress disorder related to intimate partner violence.

Posttraumatic stress disorder is a prevalent, chronic, and debilitating disorder characterized by a reduced capacity to adapt to stressors, marked by poor regulation in the following domains: emotion, attentional function, and physiological stress. Mindfulness-based stress reduction (MBSR) holds promise for treating symptoms of trauma and PTSD as evidence suggests it targets these domains. The central hypothesis is that MBSR, which teaches non-judgmental awareness, can improve emotion regulation and attentional function, and diminish physiological stress dysregulation, which in turn will improve PTSD symptoms. We will examine changes in stress capacity and PTSD symptom severity among women survivors of intimate partner violence with PTSD after participation in an MBSR program.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* Women
* 18-64 years of age
* Victim of IPV
* Meet diagnostic criteria for PTSD
* No or stable use of medications (including, for example, beta blockers).

Exclusion Criteria:

* There is suspicion or evidence of dementia or cognitive impairment (Mini-Mental State Examination score \< 24) or inability to provide informed consent
* They have ever been a perpetrator of IPV
* History of schizophrenia or bipolar I disorder; current suicidality with either plan, intent, or a suicide attempt in the past 6 months
* Active substance dependence or in remission \< 3 months
* Cardiovascular conditions (e.g., congestive heart failure, pacemaker, prior myocardial infarction)
* The age range was chosen to reduce heterogeneity in this pilot study, as aging is associated with changes in emotion regulation, attention, and PNS tone.
NET in Iranian Women Suffering From Post Traumatic Stress Symptoms

The proposed study seeks to investigate to what extent Narrative Exposure Therapy (NET) is an effective treatment for the reduction of symptoms of Post-Traumatic Stress Disorder (PTSD) and depression and for the improvement of daily functioning in Iranian women who have experienced intimate partner violence (IPV). In addition, the study seeks to investigate whether NET therapy could lead to the reduction of Intimate Partner Violence (IPV) within their marriage.


Eligibility Criteria:
Inclusion Criteria:

* being victims of Intimate Partner Violence and seeking help at target clinics in order to reduce their psychological symptoms, currently living together with their partner/husband, meeting the set cut-off point on the PTSD scale according to DSM-IV.

Exclusion Criteria:

* schizophrenia, epilepsy, mental retardation, drug abuse and mal-nourishment
Oral Lactoferrin Supplementation for Prevention of Sepsis in Preterm Neonate

Hypothesis:

Orally ingested lactoferrin has effects on promotion of growth and differentiation of the immature gut; also it has immunomodulatory properties, so it will prevent serious infections in preterm infants.

The aim of the study is to:

* Evaluate the effectiveness of oral lactoferrin in prevention of neonatal sepsis.
* Compare two dose regiment of lactoferrin supplementation.
* Study effect of lactoferrin supplementation on serum iron stores.

It is a prospective, randomized, double blind, placebo-controlled study, it will include 180 preterm neonates admitted to the Neonatal Intensive Care Units of of Ain Shams University Hospitals and Manshiet El Bakry Hospital.

•Group A: Who will receive oral lactoferrin supplementation in a dose of 100 mg/day.

•Group B: Who will receive oral lactoferrin supplementation in a dose of 150 mg/kg/ twice daily.

•Group C (Controls): Who match the subjected neonates, will receive placebo in form of distilled water.


Eligibility Criteria:
Inclusion Criteria:

1. Neonates with a birth weight between 500g and 2500g.
2. Neonates with a ≤ 36 weeks of gestation counting from the first day of the Last Menstrual Period.
3. Preterm neonates born in, or referred to the Neonatal Intensive Care Units of one of the participating hospitals in the first 48 hours of life.

Exclusion Criteria:

1. Neonates with underlying gastrointestinal problems that prevent oral intake.
2. Neonates with predisposing conditions that profoundly affect growth and development (chromosomal abnormalities, structural brain anomalies, severe congenital abnormalities).
3. Neonates with a family background of cow milk allergy.
4. Neonates who will not have the chance to complete the study time (who will be referred to another hospitals).
5. Neonates whose parents decline to participate.
6. Neonates with early onset sepsis.
Iloperidone Augmentation of SSRIs for Patients With Major Depressive Disorder With Residual Anger and Irritability

Iloperidone is an atypical antipsychotic drug, FDA-approved for the acute treatment of schizophrenia in adults in 2009 (Marino et al., 2010); moreover, some of its pharmacological features seem to be very promising in treating symptoms like anger and anxiety (Fava et al., 1997; Wang et al., 2010). The investigators therefore feel that an adequately sized, well powered, double-blind, placebo-controlled, randomized, cross-over study of iloperidone augmentation of SSRIs among MDD outpatients in partial remission with residual anger and irritability is warranted at this point to evaluate its efficacy, safety and tolerability on residual anger, irritability and depressive symptoms.

Main hypothesis: Adults with MDD in partial remission, who are experiencing residual symptoms of anger and irritability, assigned to treatment with iloperidone will demonstrate a significantly greater reduction in the total score of the Anger/Hostility Scale of the Symptom Questionnaire from baseline to endpoint than those assigned to placebo using the cross-over design.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent.
* Men or women ages 18-65 years old.
* Current Major Depressive Episode in partial remission based on the Structured Clinical Interview for DSM IV-Axis I Disorders (SCID I/P) and a HAM-D-17 score between 9 and 15.
* Current treatment with a selective serotonin reuptake inhibitor (SSRI) other than paroxetine or fluoxetine for at least three months, at a stable dose for the past 4 weeks, and more than 50% but less than 75% improvement on the current antidepressant, as determined by the MGH Antidepressant Treatment Response Questionnaire (ATRQ).
* Score \> 8 on the Anger/Hostility Scale of the Symptom Questionnaire both at screen and baseline.

Exclusion Criteria:

* The following DSM-IV diagnoses: 1) organic mental disorders; 2) substance use disorders, including alcohol, active within the last 3 months; 3) schizophrenia; 4) delusional disorder; 5) psychotic disorders not elsewhere classified; 6) bipolar disorder; and 9) antisocial personality disorder; 10) dementia.
* Current, serious suicidal or homicidal risk.
* Pregnancy or breast-feeding.
* Serious, unstable medical illness including cardiovascular, kidney, liver, neurological and endocrine disorders.
* Congenital long QT syndrome or a QTc \> 450 ms.
* History of cardiac arrhythmias.
* Electroconvulsive therapy (ECT) within the 6 months preceding baseline.
* Concomitant use of buspirone, fluoxetine, paroxetine, any psychostimulant, modafinil, other antipsychotic drugs, or anticonvulsants (although stable doses of benzodiazepines and hypnotics are allowed) (see Concomitant Therapy).
Continuous Local Anesthetic Infusion Following Hernia Repair

The primary endpoint of this study will determine if subjects receiving a continuous infusion of local anesthetic following laparoscopic ventral hernia repair, with the pain pump installed as described to treat post surgical pain will have a lower incidence of pain than those patients treated with a placebo, saline-filled pain pump.The secondary endpoint of this study will determine if subjects receiving a continuous infusion of local anesthetic following laparoscopic ventral hernia repair, with the pain pump installed as described to treat post surgical pain will have a lower utilization of narcotic analgesic medication than those patients treated with the placebo, saline-filled pain pump.

Patients will be screened to determine study eligibility using inclusion/exclusion criteria. Following the consent process, subjects will be randomly assigned to a treatment arm (anesthetic or placebo group). Baseline data will be collected prior surgical implantation of the pain pump delivery system. Both study and control groups will be able to receive supplemental medication for breakthrough pain as determined by the surgeon. Post-operative data will be collected up to three weeks following surgery.

Eligibility Criteria:
Inclusion Criteria:

\>18 years

* ASA I,II,III
* Scheduled for Laparoscopic Ventral Hernia Repair

Exclusion Criteria:

* ASA IV or greater
* Needing emergency surgery
* Known history of drug abuse
* GI, liver, kidney or other condition which, per the surgeon's opinion, could interfere with the absorption, distribution, metabolism or excretion of any drug used during the duration of the study
* Patients with a prior allergic reaction or dependency to morphine, demerol, dilaudid, fentanyl, marcaine(bupivicaine), lidocaine, or ropivicaine.
β-galactosidase Producing Probiotic Strains to Improve Lactose Digestion

The purpose of this study is to assess that two β-galactosidase Producing Probiotic Strains help improve lactose digestion in subjects with lactose maldigestion.

The trial will be cross over, randomized in incomplete blocks, controlled, double-blind:

each subject will be administered 3 products out of 4 (positive control, probiotic Streptococcus (S.) thermophilus, probiotic Bifidobacterium (B.) longum, negative control) in a random order on 3 different days separated by a washout period of at least one week, and maximum 2 weeks between each challenge.

The total sample size is 42 enrolled subjects/37 completed Patients will be males and females aged between 20 and 65 years with positive hydrogen breath test.

Eligibility Criteria:
Inclusion Criteria:

1. HBT\> delta 20ppm (compared with the baseline value) measured at screening visit before challenge tests
2. Having signed the informed consent or having provide his/her legal representative's informed consent

Exclusion Criteria:

1. Known Food allergy
2. Any obstructive (COPD, asthma...) or restrictive respiratory syndrome that may impact breath test measurements
3. Any medically relevant malabsorption syndrome
4. Any medically relevant chronic gut motility disorder other than Irritable Bowel Syndrome (IBS), assessed with Rome III questionnaire
5. Ongoing therapy with drugs known to affect gut motility
6. Any general antibiotherapy taken during or within 4 weeks of study onset
7. Use of lactase pill (eg. Lacdigest®), as well as yoghurt and probiotics, for at least 2 days prior to Visit 0b
8. Subject who cannot be expected to comply with the study procedures
9. Currently participating or having participated in another clinical trial during last 8 weeks prior to the beginning of this study.
10. To be a close collaborator to the Investigators, either in terms of Family relationship and/or professional relationship
11. Pregnancy, based on anamnesis
Effects of Continuous Positive Airway Pressure (CPAP) Treatment on Glucose Control in Patients With Type 2 Diabetes

The overall goal of the proposed protocol is to rigorously test the hypothesis that CPAP treatment has beneficial effects on glycemic control in patients with both type 2 diabetes (T2DM) and obstructive sleep apnea (OSA). If our hypothesis were to be proven, this would imply that CPAP treatment of OSA in patients with T2DM is an essential component of their glycemic control. The proposed work is thus expected to provide additional preventive and therapeutic approaches in the management of millions of patients with T2DM.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects with type 2 diabetes on a stable medication regimen (no change in diabetic medications in the previous 3 months) will be eligible.

Exclusion Criteria:

* Subjects on insulin will be excluded.
* Subjects with unstable cardiopulmonary disease, painful neuropathy, significant psychiatric illness, cognitive impairment and pregnancy will be excluded.
* Shift workers
* Subjects having traveled across \>2 time zones less than one month prior to the study
* Diagnosis of a sleep disorder other than OSA by screening polysomnography
* Previous treatment with positive airway pressure or supplemental oxygen
* Requirement of supplemental oxygen or bi-level positive airway pressure for OSA treatment during titration
* Claustrophobia or other conditions of CPAP intolerance,
* Presence of active infection.
A Pharmacokinetic (PK) Study of Nilotinib in Pediatric Patients With Philadelphia Chromosome-positive (Ph+) Chronic Myelogenous Leukemia (CML) or Acute Lymphoblastic Leukemia (ALL)

This study will assess the pharmacokinetics of nilotinib in Ph+ CML pediatric patients that are newly diagnosed or resistant or intolerant to imatinib or dasatinib or refractory or relapsed Ph+ ALL compared to the adult populations. It will also evaluate safety and activity of nilotinib as secondary objectives.


Eligibility Criteria:
Inclusion Criteria:

* Must have one of the following: newly diagnosed CP Ph+CML, CP or AP resistant/ intolerant to imatinib and/or dasatinib, or Ph+ ALL either relapsed after or refractory to standard therapy
* adequate renal, hepatic and pancreatic function

Exclusion Criteria:

* patients receiving therapy with strong CYP3A4 inhibitors and/or inducers and treatments cannot be stopped or changed to a different medication at least 14 days prior to starting study drug
* patients receiving therapy with any medications with a known risk or possible risk to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug.
* gastrointestinal impairment or disease that may interfere with drug absorption
* liver, pancreatic or severe renal disease unrelated to disease under study
* impaired cardiac function
* patients who received dasatinib within 3 days of starting study drug
* patients who received imatinib within 5 days of starting study drug
* patients receiving hydroxyurea or corticosteroids that has not been discontinued at least 1 week after initiation of nilotinib
* patients who received hematopoietic growth factors within 7 days of starting study drug or Pegfilgrastim (Neulasta®) within 14 days of starting study drug
* patients with Stem Cell Transplant (SCT) or Rescue without TBI: Evidence of active graft vs. host disease and \< 3 months since SCT

Other protocol-defined inclusion/exclusion criteria may apply
Pulmonary and Cardiac Effects of E-Cigarette Use in Pulmonary Patients Who Smoke Cigarettes

The purpose of this study is to compare the effects of e-cigarettes and continued smoking on pulmonary and cardiac outcomes in a population with established pulmonary disease.

E-cigarettes with nicotine can affect important cardiopulmonary outcomes and likely pose less risk than cigarettes, but they are not harmless. Given the existing literature, there is a need for controlled trials of e-cigarette use in populations with cardiopulmonary disease to fill the gaps between these existing examinations. Clarifying how the pulmonary and cardiac effects of e-cigarettes compare to use of conventional cigarettes in those with cardiopulmonary disease beyond single acute exposures will provide important new health information that can help inform policy.

Eligibility Criteria:
Inclusion Criteria:

* Men and women 40 years of age or older
* Current, every day smoker (5 or more cigarettes per day for one year or longer) confirmed with intake CO of 8ppm or greater
* Established pulmonary disease (chronic obstructive pulmonary disease \[COPD\], chronic bronchitis, emphysema, or asthma-COPD overlap syndrome) confirmed by physician diagnosis and/or current prescription of medication for treatment (i.e., LABA, LAMA, +/- ICS, or combination)
* Lives and plans to remain in the greater Burlington, VT area for the next month
* No intention to quit smoking within the next month
* Speaks English

Exclusion Criteria:

* Patients who are medically unstable (unstable symptoms, changes in medications or hospitalizations within last 3 months)
* Inability to conduct in-home measurements.