cyrilzakka/clinical-trials huggingface dataset:
Exercise, Heart Failure, and Type 2 Diabetes

The purpose of this study is to understand the differences in how patients with heart failure respond to exercise training compared to patients with heart failure and type 2 diabetes.

The investigators will measure exercise capacity in patients with heart failure or heart failure plus type 2 diabetes prior to and following a 12-week exercise training program (5d/wk, 30 min/d, 60-75% VO2max) to determine whether improvements in exercise capacity in response to exercise training are mitigated in patients with combined heart failure plus type 2 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* ≥50 yr of age
* New York Heart Association class II-III CHF and ejection fraction ≤35%
* receiving optimal medical therapy
* sedentary (≤ 30 min/wk structured physical activity).
* Half of volunteers (n=30) will have a diagnosis of type 2 diabetes (CHF+T2D).

Exclusion Criteria:

* smoking
* changes in medication ≤6 wk prior to enrollment
* major cardiovascular event or procedure ≤6 wk prior to enrollment
* foot ulcers
* advanced neuropathy
* co-morbidities or other limitations that may interfere with or prevent volunteers from safely completing the exercise training
* fixed rate pacemaker
* type 1 diabetes mellitus
Hydroxylated Polymethoxy Flavones Solid Dispersion in Treatment of Periodontitis

Periodontitis is a serious gum infection that damages the soft tissue and, without treatment, can destroy the bone that supports your teeth.

Hydroxylated poly methoxy flavones are a combination of naturally occurring flavonoids extracted from the orange peel and exert anti-inflammatory, antibacterial, and antifungal activity however, this extract is poorly soluble and poorly absorbable. In this work, this extract was formulated as a solid dispersion formulation to enhance its biological activity and then incorporated into a gel base and used in the treatment of periodontitis after clinical debridement.

In the study, there are 3 groups; the first one first one received plain sodium carboxymethylcellulose. Group II received chlorhexidine gel. GroupIII received Hydroxylated poly methoxy flavones solid dispersion incorporated into sodium carboxymethylcellulose gel.

In all groups, there is clinical debridement before injection of gels.

Eligibility Criteria:
Inclusion Criteria:

* Patients with periodontitis stage I-II
* free from any systemic disorders.
* no mobility - non-smokers - no parafunctional habits.
* Each patient with minimum three periodontitis sites ( split-mouth study)

Exclusion Criteria:

* Smokers.
* patients with diabetes, and hypertension.
Study of Bavituximab Plus Docetaxel in Patients With Locally Advanced or Metastatic Non-Squamous Non Small-Cell Lung Cancer

The primary purpose of this research study is to see whether adding bavituximab (an investigational drug) to the standard chemotherapy drug docetaxel, will improve the results of the treatment for non-small-cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Adults over age 18 years of age with a life expectancy of at least 3 months.
* Histologically or cytologically confirmed stage IIIB or stage IV non squamous non-small-cell lung cancer (NSCLC) who have progressed after 1 chemotherapy regimen.
* Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST, Version 1.1) on cross-sectional imaging that is at least 2 cm in longest diameter.
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
* Adequate hematologic, renal, and hepatic function.
* PT/INR ≤ 1.5 × ULN; aPTT time ≤ 1.5 × ULN.
* New York Heart Association classification I or II

Exclusion Criteria:

* Squamous, small cell, or mixed histology.
* Known history of bleeding diathesis or coagulopathy.
* Cavitary tumors or tumors invading or abutting large blood vessels.
* Bleeding: Clinically significant bleeding such as gross hematuria, GI bleeding and hemoptysis within 12 months of Screening.
* Venous thromboembolic events within 6 months of screening.
* Ongoing therapy with oral or parenteral anticoagulants.
* Concurrent estrogens, anti-estrogens or progesterone compounds.
* Radiotherapy within 2 weeks or major surgery within 4 weeks preceding Study Day 1.
* Symptomatic or clinically active brain metastases.
* Symptomatic coronary artery disease, cerebrovascular accident, transient ischemic attack, myocardial infarction or unstable angina pectoris within 6 months of screening.
* Grade 2 or higher peripheral neuropathy
Cross-over Comparison of Gabapentin and Memantine as Treatment for Acquired Nystagmus

Involuntary oscillations of the eyes (nystagmus) impairs vision so that affected patients, who have neurological disorders such as Multiple Sclerosis (MS) , cannot read or watch TV. Two medicines have been reported to suppress nystagmus and improve vision in such patients: gabapentin and memantine. The investigators set out to test which of these two drug was more effective by carrying out a double-blind cross-over study. In this way, we could determine which drug worked best in each patient.

The study entails careful measurements of visual acuity and precise measurements of eye movements, using a contact lens device (magnetic search coil method). In this way, it is possible to make objective and reliable measurements of the effect of each drug, which are unbiased by the investigator or the patient.

Eligibility Criteria:
Inclusion Criteria:

* Adult (18 years or older) males or females with acquired nystagmus that is degrading their vision

Exclusion Criteria:

* Pregnant women
* Individuals who cannot describe their visual symptoms, cooperate with testing, or give informed consent
* Individuals with intolerance of gabapentin or memantine
Long-Term Study of OnabotulinumtoxinA Treatment in Adult Patients With Upper Limb Spasticity

This is a long-term safety and efficacy study of onabotulinumtoxinA in poststroke patients with upper limb spasticity.


Eligibility Criteria:
Inclusion Criteria:

* For patients entering from the 191622-127 study, successful completion of study 191622-127
* For patients entering directly into study 191622-129, upper limb spasticity in the elbow and shoulder due to stroke, with the most recent stroke at least 3 months ago

Exclusion Criteria:

* Spasticity in the non-study upper limb that requires treatment
* Presence of fixed contractures in of the study muscles in elbow or shoulder
* Profound atrophy of muscles to be injected
* Previous surgical intervention, nerve block, or muscle block for the treatment of spasticity in the study limb in the last 12 months
* Injection of corticosteroids or anesthetics, use of casting or dynamic splinting or constraint-induced movement therapy (CIMT) for the study limb within 3 months
* Ultrasound therapy, electrical stimulation, or acupuncture in the study limb within 1 month
* Condition other than stroke contributing to upper limb spasticity
* Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, and/or amyotrophic lateral sclerosis
The Effects of SAFE Early Intervention Approach in Premature Infants in Turkey

In this study, it was aimed to develop the SAFE treatment approach, which is a family collaborative early intervention approach based on sensory strategies, activity-based motor training and environmental enrichment, and to examine the effects of this approach on sensory, motor, cognitive and language development in premature infants.

Early intervention practices in Turkey is widely based on the principle of neuro-developmental therapy (NDT). It has been reported in recent years that the NDT approach has minimal effect on the development of risky premature infants. For these reasons, it was necessary to develop an early intervention program that does not include passive interventions and includes sensory and motor strategies in our country.

Within the scope of this study, a new early intervention approach that can be applied to infants between 0-24 months has been developed based on the shortcomings in the literature. Sensory strategies, activity-based motor training, family collaboration and environmental enrichment constitute the basic principles of this early intervention program. The name of the early intervention program was formed from the English initials of these basic principles and was determined as SAFE early intervention approach (S: Sensory Strategies, A: Activity Based Motor Training, F: Family Collaboration, E: Environmental Enrichment).

In this study, it was planned to establish the theoretical and practical foundations of the SAFE early intervention approach developed by the Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation. Also we aimed to examine the effects of this approach on sensory, motor, cognitive and language development in preterm infants with corrected ages of 9-10 months.

Eligibility Criteria:
Inclusion Criteria:

* Being born before 37 weeks
* A history of Neonatal Intensive Care Unit (NICU) for 15 days or more
* Adjusted age to be between 9-10 months
* Family's willingness to participate in the study

Exclusion Criteria:

* Having a congenital anomaly or systemic disease
* Having a high risk for the diagnosis of Cerebral Palsy (Intraventriculer hemorrhage (IVH) Stage 4 or periventricular leukomalacia (PVL) Stage 3-4, such as the absence of fidgety movements).
Study to Evaluate the Safety and Tolerability of a Nasal Spray in Patients With Chronic Allergic or Nonallergic Rhinitis

The purpose of this study is to determine if Astepro Nasal Spray (0.1% azelastine hydrochloride) is as safe as Astelin Nasal Spray (0.1% azelastine hydrochloride)


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients 12 years of age and older with an established history (\> 1 year) of rhinitis due to perennial allergies, non-allergic triggers or vasomotor rhinitis (VMR).
2. Provide written informed consent/pediatric assent. If the patient is a minor, a parent or legal guardian must give written informed consent
3. Willing and able to comply with the study requirements, including daily use of medication for a one year period, even if symptoms are not bothersome.
4. General good health and free of any disease or concomitant treatment that could interfere with the interpretation of the study results as determined by the investigator or the sponsor's medical officer
5. Patients receiving immunotherapy (antigen desensitization) must be on a stable maintenance regimen for at least 30 days before the first study visit (adjustments to regimen following a brief period of missed injections does not preclude participation)

Exclusion Criteria:

1. The use of any investigational drug within 30 days prior to screening. No other investigational products are permitted for use during the conduct of this study
2. Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose (Splenda® brand sweetener)
3. Women who are pregnant or nursing
4. Women of childbearing potential who are not abstinent and not practicing a medically acceptable method of contraception. Female patients must practice an acceptable contraceptive technique for 30 days before randomization and agree to continue its use during treatment and for 30 days after the last dose of study drug. Oral, intrauterine, implantable, injectable contraceptives, or a double barrier form of contraception are acceptable and the medication including dose, device or method must have been stable for at least 30 days before the first dose of study drug.
5. Nasal disease(s) likely to affect deposition of intranasal medication, such as sinusitis,rhinitis medicamentosa or clinically significant nasal polyposis or nasal structural abnormalities
6. Patients with asthma (with the exception of mild, intermittent asthma) or other significant pulmonary disease such as Chronic Obstructive Pulmonary Disease
7. Patients with a known history of alcohol or drug abuse
8. Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor, might significantly alter the evaluation of study
9. Clinically relevant abnormal history and/or physical findings which, in the opinion of the investigator or sponsor, would interfere with the objectives of the study or that may preclude compliance with the study procedures
10. Study site staff, immediate relatives of study site staff, or other individuals who would have access to the clinical study protocol
A Prospective, Mono-center, Interventional Study Evaluating the Effect of One Year Initial Care by Hygieno-dietary Advices With or Without Phlebotomy on Glycemia After at Least 5 Years in Patients With Dysmetabolic Iron Overload Syndrome

A prospective, mono-center, interventional study evaluating the effect of one year initial care by hygieno-dietary advices with or without Phlebotomy on glycemia after at least 5 years in Patients with dysmetabolic iron overload syndrome

Dysmetabolic iron overload syndrome (DIOS) is defined by a slight iron overload associated to features of the metabolic syndrome. This is a frequent condition that parallels the increasing prevalence of non alcoholic steato hepatitis. The role of iron overload on insulin sensitivity is described in large cohorts study, with an increased risk of type 2 diabetes in patients with increased serum ferritin, and in vitro where iron load alters key regulators of lipid and glucose metabolism.

In patient with DIOS, improving diet and lifestyle is a major goal, albeit it does not allow to lower body iron stores. Therefore the role of bloodletting in this setting was raised. Several low quality studies suggested a beneficial effect of bloodletting on insulin resistance. Our group demonstrated in a large multicenter randomized trial, the lack of beneficial effect of bloodletting over one year. Because this may be a too short period of time to demonstrate a positive effect we would like to assess the long term effect of iron depletion on insulin resistance and its clinical consequence.

Eligibility Criteria:
Inclusion Criteria:

* Persons who participated in the " Phlebotomy " protocol: A Prospective, Randomized Study Comparing Effect of Phlebotomy and Hygieno-dietary Advices With Hygieno-dietary Advices Only on Glycemia in Patients With Dysmetabolic Iron Overload Syndrome
* Persons affiliated to French Social Security
* Persons who received an oral and written information on the protocol and signed the informed consent form

Exclusion Criteria:

* Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship) since their enrolment in the "Phlebotomy" protocol
* Persons deprived of liberty
* Pregnant or breastfeeding women
14473 - D9126C00001 Proof of Principle Study - Effect of AZD2066 on Transient Lower Esophageal Sphincter Relaxations

The purpose of the study is to assess the safety and tolerability of AZD2066 and to explore the effect of a single dose of AZD2066 on the function of the cardia (the opening between the stomach and the esophagus) compared to placebo (not containing any medical substance) in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Provision of written consent prior to any study specific procedures.
* Healthy subjects, age 18-45 years inclusive. Females must be of no childbearing potential or must use a highly effective contraceptive method.
* Clinically normal physical findings and laboratory values at the time of pre-entry visit, as judged by the investigator.

Exclusion Criteria:

* Clinically significant illness within the 2 weeks prior to the first dose of the investigational product, including a suspected/manifested infection according to WHO risk categories 2, 3 or 4, as judged by the investigator.
* A measured LES pressure of \< 5mm Hg.
* History of previous or ongoing psychiatric disease/condition.
Specific or Non-Specific Manipulation for Patients With Back Pain

We aim to evaluate the long-term effects of 10 sessions of spinal manipulative therapy applied in a vertebral region-specific or region nonspecific level immediately after treatment and 3 and 6 months after randomization.

To evaluate the long-term effects of 10 sessions of spinal manipulative therapy applied in a vertebral region-specific or region nonspecific level immediately after treatment and 3 and 6 months after randomization.

148 patients with chronic non-specific low back pain will be enrolled for this clinical trial. Patients will undergo to a specific physical examination in order to determine the ideal lumbar spine level to be manipulated. The outcomes of interest are pain intensity, pain pressure threshold, global perceived effect and disability associated with back pain. After the first assessment patients will be randomly assigned to two groups that will receive 10 sessions of spinal manipulation over a period of four weeks, and may receive manipulation according to the findings on physical examination (specific manipulation) or may receive manipulation in the upper thoracic region, disregarding the physical examination findings (nonspecific manipulation).

Eligibility Criteria:
Inclusion Criteria:

- Patients with low back pain duration from 3 to 24 months.

Exclusion criteria:

* Patients with a pain duration lower than 3 months and higher than 24 months.
* Patients with nerve root compromise or with serious spinal pathology,
* Pregnant patients,
* Previous back surgery
* Patients with any contra-indication to spinal manipulation.
A Study of Bevacizumab (Avastin) in Combination With Capecitabine (Xeloda) in Elderly Patients With Metastatic Colorectal Cancer

This 2-arm study assessed the efficacy and safety of bevacizumab (Avastin) in combination with capecitabine (Xeloda), compared with capecitabine alone, in elderly patients with metastatic colorectal cancer. Patients were randomized to receive either bevacizumab (7.5 mg/kg intravenously on Day 1 of each 3-week cycle) in combination with capecitabine (1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle) or capecitabine (1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle) alone.

No notable trends or interactions in laboratory values, electrocardiogram, or vital signs suggesting an effect in either direction for capecitabine/bevacizumab combination therapy or capecitabine monotherapy were observed during the study.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, ≥ 70 years of age.
* Cancer of the colon or rectum.
* Metastatic disease diagnosed ≤ 6 months before enrollment.
* ≥ 1 measurable metastatic lesion.

Exclusion Criteria:

* Adjuvant anti-vascular endothelial growth factor (VEGF) treatment.
* Prior chemotherapeutic treatment for metastatic colorectal cancer.
* Past or current history of other malignancies (with the exception of basal and squamous cell cancer of the skin, or in situ cancer of the cervix).
* Clinically significant cardiovascular disease.
* Current or recent daily use of aspirin (\> 325 mg/day) or other non-steroidal anti-inflammatory drug (NSAID), or full dose anticoagulants.
Non-Inferiority Study of the FRESCA Airbox Positive Airway Pressure System

Prospective, open-label, randomized crossover assignment, multi-center non-inferiority study conducted in the United States

This study is designed to demonstrate that the FRESCA Airbox Positive Airway Pressure System is non-inferior to the existing FRESCA Positive Airway Pressure System. Subjects meeting the inclusion and exclusion criteria will be randomized to one sleep night with the existing FRESCA device programmed to fixed pressure and one sleep night with the investigational FRESCA device programmed to auto-adjusting pressure and exhale pressure relief.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged 22 - 75 years old.
2. BMI: ≤ 40 kg/m2.
3. Subjects diagnosed with OSA (either newly diagnosed (naive) OSA subjects or current CPAP subjects).
4. Must be able to be fitted properly with FRESCA mask.
5. Must be able to comply with all study requirements as outlined in the protocol.
6. Subject must complete a valid PSG titration night.

Exclusion Criteria:

1. Subjects with non-OSA sleep disorders (including periodic limb movement (PLM) disorder and chronic insomnia).
2. Subjects with substantial central or mixed apneas (central and mixed apnea ≥ 5/hr.).
3. Subjects with prior surgical intervention for OSA.
4. Subjects with frequent or sustained episodes of O2 saturation ≤75%.
5. Subjects with obesity-related hypoventilation.
6. Subjects currently using a CPAP full face mask.
7. Subjects who are medically unstable.
8. Subjects with unstable or severe cardiovascular abnormalities (e.g., heart failure, valvular heart disease).
9. Subjects with atrial fibrillation or other arrhythmias that are not effectively controlled with medication.
10. Subjects with hypotension or uncontrolled HTN.
11. Subjects with chronic lung disease, including COPD.
12. Subjects with significant cardiopulmonary disease.
13. Subjects with ongoing severe nasal allergies or sinusitis or difficulty breathing through the nose; persistent blockage of one or both nostrils; or any nasal or facial abnormalities that would not allow adequate placement and use of the mask.
14. Subjects with surgery of the upper airway, nose, sinus or middle ear within the previous year.
15. Subjects currently working nights, rotating night shifts or with planned travel during the study period.
16. Subjects on a non-stable dose of medications or other agents that may affect sleep and/or PSG (e.g., sedatives or hypnotics).
17. Subjects who consume \> 500 mg caffeine per day (e.g., \> 8 cola-type beverages, \> 5 cups of coffee).
18. Subjects who consume \> 14 alcoholic drinks/week.
19. Subjects who are pregnant (confirmed verbally).
20. Subjects currently enrolled in any other research study.
Dysfunctional Hemoglobin

The purpose of the study is to determine if a new pulse oximeter accurately detects carboxyhemoglobin and methemoglobin when intentionally increased in the blood.


Eligibility Criteria:
Inclusion Criteria:

* Subjects does not have significant medical problems
* Subject is willing to provide written informed consent
* Subject is between 18 and 45 years of age

Exclusion Criteria:

* Has a BMI greater than 31
* Has had any relevant injury at the sensor location site
* Has deformities or abnormalities that may prevent proper application of the device under test
* Has a known respiratory condition
* Is currently a smoker
* Has a known heart or cardiovascular condition
* Is currently pregnant
* Is female and actively trying to get pregnant
* Has a clotting disorder
* Is known to have a hemoglobinopathy such as (anemia, bilirubinemia, sickle-cell anemia, inherited or congenital methemoglobinemia)
* The subject has a COHb greater than 3% or MetHb greater than 2%
* Has taken blood thinners or medication with aspirin within the last 24 hours
* Has unacceptable collateral circulation from the ulnar artery
* Has donated more than 300 mL of blood within one month prior to start of study
* Is unwilling or unable to provide written informed consent to participate in the study
* Is unwilling or unable to comply with the study procedures
* Has another health condition which in the opinion of the principal investigator makes him/her unsuitable for testing