cyrilzakka/clinical-trials huggingface dataset:
Refractory Chronic Cough Improvement Via NAL ER (RIVER)

The main purpose of this study is to evaluate the effect of NAL ER on 24-hour cough frequency and to assess safety and tolerability of NAL-ER for treatment of refractory chronic cough.


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of refractory chronic cough (RCC) for at least one year
* Chest radiograph or CT of thorax within 24 months or during screening not demonstrating any significant abnormalities contributing to RCC

Exclusion Criteria:

* Diagnosis of sleep apnea
* Respiratory tract infection within 6 weeks of Baseline
* History of bronchiectasis, COPD, or IPF
* History of uncontrolled asthma
* Current smokers/vapers, quit smoking with \<=12 months, using nicotine supplements, or history of \>=20 pack years
* History of major psychiatric disorder
* History of substance abuse
* Pregnant or lactating females
* Known intolerance to opioids
* Abnormal kidney or liver functions based on Screening lab results.
* Known hypersensitivity to nalbuphine or to NAL ER excipients
* Previous participation in a nalbuphine ER clinical study
* Use of opiates, benzodiazepines, or MAOIs within 14 days of Baseline
* Use of pregabalin, gabapentin, thalidomide for treatment of cough within 14 days of Baseline
* Use of ACE inhibitors within 12 weeks of Baseline
* Use of a medication having a "known risk" of Torsade de Pointes (categorized as "KR" on the Credible Meds® website.) 4 weeks prior to Baseline
* Use of unstable doses of medications associated with a potential risk of QT prolongation but not clearly associated with Torsade de Pointes within 4 weeks of screening.
* Use of unstable doses of cough suppressants within 14 days of Baseline
* Use of unstable doses of medications that affect serotonergic neurotransmission that may cause serotonin syndrome with opioids within14 days of Baseline
* Use of unstable doses of P450 isozyme inhibitors/inducers within 14 days of Baseline

Other protocol defined inclusion/exclusion criteria may apply.
Investigation of Upper Extremity Functions in Patients With Rheumatoid Arthritis

There are limited studies in the literature evaluating upper extremity functional exercise capacity, muscle functions and daily living activities in rheumatoid arthritis patients. In this context, the aim of this study was to investigate upper extremity exercise capacity, hand grip strength and daily living activities in rheumatoid arthritis patients.

Rheumatoid arthritis is an inflammatory autoimmune chronic and systemic disease of unknown etiology. In addition to musculoskeletal involvement, lung involvement can also be observed in patients. Lung involvement and accompanying symptoms cause deterioration of physical function, quality of life and functional capacity. In rheumatoid arthritis, dyspnea can be observed during exertion due to disease progression, drug toxicity and respiratory/cardiovascular morbidities. In patients, decreased respiratory muscle strength, respiratory functions, carbon monoxide diffusion capacity and oxygen consumption also cause decreased physical functions. It has been reported that upper extremity exercise capacity and functional performance are reduced in patients with interstitial lung disease. It is known that peripheral muscle strength is an independent determinant of exercise capacity in interstitial lung disease. Rheumatoid cachexia, characterized by decreased muscle mass and increased fat mass, is observed in rheumatoid arthritis patients. Since the patients' accessory respiratory muscles are also affected, it can negatively affect their daily life activities, especially those that use the upper extremities.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for patients with rheumatoid arthritis

* Patients diagnosed with rheumatoid arthritis,
* Between the ages of 18-75 years,
* Patients who volunteer to participate in the study will be included in the study.

Inclusion criteria for the healthy control group

* Between the ages of 18-75 years,
* Volunteer to participate in the study will be included in the study.

Exclusion Criteria:

Exclusion criteria for patients with rheumatoid arthritis

* Those with serious cardiopulmonary, neurological, neuromuscular, orthopedic and other systemic diseases or other diseases affecting physical functions,
* Those who have participated in a planned exercise program in the last three months
* Those with cognitive impairment that will cause difficulty in understanding and following exercise test instructions
* Patients with contraindications for exercise testing or exercise training according to the American Sports Medicine Association will not be included in the study.

Exclusion criteria for the healthy control group

* Those with any diagnosed chronic or systemic disease,
* Those who smoke 10 packs x years or more,
* Those who have pneumonia or any acute infection,
* Healthy individuals with any psychiatric disorder will not be included in the study.
The Management of Neuroendocrine Tumours: A Nutritional Viewpoint.

Nutritional status in patients with neuroendocrine tumours (NETs), especially of gastroenteropancreatic origin, can be deeply affected by excessive production of gastrointestinal hormones, peptides, and amines, which can lead to malabsorption, diarrhoea, steatorrhea, and altered gastrointestinal motility. Besides, the surgical and/or medical management of NETs can lead to alteration of gastrointestinal secretory, motor, and absorptive functions, with both dietary and nutritional consequences. Indeed, disease-related malnutrition is a frequently encountered yet both underrecognized and understudied clinical phenomenon in patients with NETs, with substantial prognostic and socioeconomic consequences. Most of these conditions can be alleviated by a tailored nutritional approach, also with the aim of improving the efficacy of cancer treatments. In this setting, skilled nutritionists can play a fundamental role in the multidisciplinary health care team in NETs management and their presence should be recommended.


Eligibility Criteria:
Inclusion Criteria:

* patients with neuroendocrine tumours (NETs)

Exclusion Criteria:

* age\>65 years
* \< BMI 19 kg/m2
* vegetarians
Evaluation of the Reliability and Validity of a Diagnostic Sleep Disorders Questionnaire

The study aims to develop and test a user-friendly, accessible approach to sleep assessment which can function as an initial "triage" of targeted sleep conditions, such as insomnia, insufficient sleep syndrome, sleep apnea syndromes/snoring, and circadian sleep/wake disorders, within the clinical and community population. Specifically, this study will test the validity and reliability of a self-rated, digitized, and cost-effective diagnostic measure with sufficient sensitivity to accurately assess/diagnose common sleep conditions and/or risk for these conditions. Such an approach, would allow for faster assessment of common sleep conditions and disorders, and provide clinical knowledge to the individual, the physician, and if required insurance companies, as to those persons who need more immediate attention or treatment for their sleep condition.


Eligibility Criteria:
Inclusion Criteria:

Patients aged 21-65 years who are referred to the sleep clinic at Carmel Medical Center and who are capable of filling out an electronic questionnaire in Hebrew.

Exclusion Criteria:

1. Patient age \<21 years or \>65 years.
2. Women who are pregnant or breastfeeding.
3. Nighttime shift-workers.
4. Persons who are unable to provide consent due to mental incapacity.
5. Persons referred for evaluation by Ministry of Transportation (for licensing purposes).
Treatment of Tendon Injury Using Allogenic Adipose-derived Mesenchymal Stem Cells (Rotator Cuff Tear)

Main purpose of this study is to evaluate efficacy of allogenic adipose-derived mesenchymal stem cells in treatment of tendon injury. ALLO-ASC will be administrated to the patients with supraspinatus partial thickness tear by ultrasonographic guided injection.

Injection volume depends on the size of lesion on ultrasound examination. And all injection will be done under ultrasound guidance. Double blind Randomized placebo controlled study will be done with following 3 groups. Each group will have 8 people, so, the total patients will be 24 people.

1. Stem cell treatment group : stem cell 0.5cc (Total: 10 million cells) + Fibrin glue 0.5cc + range of motion exercise
2. Active control (fibrin glue) group : Normal saline 0.5cc + Fibrin glue 0.5cc + range of motion exercise
3. Control (normal saline) group : Normal saline 0.5cc + Normal saline 0.5cc + range of motion exercise

The investigators will compare the efficacy difference with VAS(visual analog scale, primary outcome), ASES(American Shoulder and Elbow Surgeons) Score, UCLA(University of California, Los Angles) Shoulder Score, DASH(The Disabilities of the Arm, Shoulder and Hand) Score and change of tear size compared to the baseline image assessed by MRI. These measurement will be done at 6 and 12 weeks after injections and long-term follow-up will be also planned to 6 months, 12months and 24 months except for the evaluation of the tear size which will be done at baseline, 3 months and 24 months after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* clinically diagnosed as rotator cuff tear (supraspinatus partial thickness tear)
* recurrent pain in spite of conservative treatment such as physical therapy, medication, steroid injection
* symptom duration is over 3 months
* supraspinatus partial thickness tear proven ultrasonography and magnetic resonance image(MRI)
* patient that can understand the clinical trials

Exclusion Criteria:

* patient that underwent other injection treatment within 6 weeks
* some associated diseases (adhesive capsulitis, full thickness supraspinatus tear,. arthritis of related joint to the target lesion, muscle weakness or atrophy, innervated by suprascapular nerve, paralysis of related joint to target lesion, proximal humeral fracture, infectious disease, bilateral rotator cuff tear, generalized pain syndrome, radiculopathy, rheumatoid arthritis, impaired sensibility, dementia, history of allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue and contraindication to MRI
* patient that enrolled other clinical trials within 30 days
* history of drug/alcohol addiction, habitual smoker, operation, allergic reaction to fibrin glue, local anesthetics and bovine-derived proteins and severe medical disease.
Efficacy of the Brand-name Latanoprost and One of Its Generic Version in Primary Open Angle Glaucoma and Ocular Hypertension

The purpose of this study is to evaluate and compare efficacy and tolerability of the brand-name latanoprost and one of its generic version in subjects with primary open angle glaucoma or ocular hypertension.

This randomized, double-blinded, cross-over design study has a 4 months follow-up. There are two periods of 8 weeks. During the first period, subjects put brand-name latanoprost in one eye and the generic version in the other one. In the second period, drops are switched from one eye to the other. There are intraocular pressure measurements (diurnal curves) on day 0 (before treatment), at 8 weeks (at the end of first period) and at 16 weeks (at the end of second period). Variations of intraocular pressure in each eye will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

1. \>18 years old
2. Primary open angle glaucoma, glaucoma suspect or ocular hypertension
3. Bilateral
4. Without any treatment or treated with latanoprost or another prostaglandin analog
5. Intraocular pressure \>21mmHg (without treatment or after a washout period)

Exclusion Criteria:

1. Intraocular pressure \>30mmHg
2. Secondary glaucoma (uveitic, neovascular, traumatic ) or congenital glaucoma
3. Pseudoexfoliation syndrome
4. Pigmentary dispersion syndrome or Pigmentary glaucoma
5. Severe glaucoma; Cup-to-disc ratio ≥9/10 OU Loss of central visual field (central 10°)
6. Use of other topical medication to lower intraocular pressure
7. Pregnancy and breast-feeding
8. Being allergic to latanoprost or benzalkonium chloride (BAK)
9. Current use of acetazolamide (Diamox)
10. Changes of systemic doses of beta-blockers during study
11. Recent use of topical corticosteroids (\<1 month)
12. Contact lens wearer
13. Closed angle at gonioscopy or past angle closure glaucoma
14. Filtration surgery (example. : trabeculectomy)
15. Selective Laser Trabeculoplasty (SLT) or Argon Laser Trabeculoplasty(ALT)
16. Recent Intraocular surgery (\<3 months)
17. Refractive surgery
18. Recent iridotomy or capsulotomy (\<3 months)
19. Past medical history of ocular trauma (example : angle recession)
20. Past or active uveitis
21. Herpetic keratitis
22. Monocular vision
To Investigate Safety, Tolerability and Pharmacokinetics of TC-5214 in Healthy Male Japanese Subjects

The purpose of this study is to assess safety, tolerability and pharmacokinetics after a single and repeated oral doses of TC-5214 (S-mecamylamine) in healthy male Japanese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Japanese Healthy male ≥20 and ≤55 years old inclusive with suitable veins for cannulation or repeated venipuncture
* Have a body mass index (BMI) of ≥18 and ≤27 kg/m2 and weigh at least 50 kg

Exclusion Criteria:

* History of any clinically significant medical or neurologic disease or disorder which, in the opinion of the investigator and sponsor, may either put the subject at risk because of participation in the study, or influence the results of the subject's
* History of psychiatric disorders
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product.
A Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects With Crohn's Disease

The purpose of this study is to demonstrate the efficacy and safety of adalimumab for the induction of clinical remission in Japanese subjects with Crohn's disease.


Eligibility Criteria:
Inclusion Criteria:

* Crohn's Disease Activity Index (CDAI) score of \>= 220 and \<= 450
* If subjects have previously been administered infliximab, subjects who discontinued use due to a loss of response or intolerance to infliximab therapy

Exclusion Criteria:

* Ulcerative colitis or indeterminate colitis
* History of cancer, lymphoma, leukemia or lymphoproliferative disease, active tuberculosis (TB), or Human immunodeficiency virus (HIV)
* Body weight is below 30 kg
* Surgical bowel resections within the past 6 months
* Females who are pregnant or breast-feeding or considering becoming pregnant during the study
Safety and Efficacy of AGN 203818 for Pain Associated With Painful Bladder Syndrome/Interstitial Cystitis

This study will explore the safety and effectiveness of different doses of AGN 203818 in treating the pain associated with painful bladder syndrome/interstitial cystitis


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of painful bladder syndrome/interstitial cystitis
* Moderate or severe bladder pain

Exclusion Criteria:

* Any other uncontrolled disease
* Pregnant or nursing females
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HMS5552 in Patients With Type 2 Diabetes

The objectives of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of HMS5552 following multiple ascending doses in patients with type 2 diabetes mellitus.

This will be a randomized, double-blind and placebo-controlled study with multiple oral doses of HMS5552 given to patients with type 2 diabetes mellitus who never accepted anti-diabetic drug for treatment before.

The primary objective is to characterize the safety and tolerability of HMS5552 following multiple ascending doses in patients with type 2 diabetes mellitus after BID dosing for 8 days.

The secondary objectives include:

1. To determine the single dose and steady state pharmacokinetics of HMS5552 in patients with type 2 diabetes
2. To evaluate the single dose and steady state pharmacodynamics of HMS5552 in patients with type 2 diabetes
3. To further explore food-effect on HMS5552 pharmacokinetics and pharmacodynamics

A maximum total of 80 patients (10 in each dose group and assuming a maximum of 5\~8 dose levels). There will be 8 active and 2 placebo patients in each dose group. The safety, tolerability, pharmacokinetics and pharmacodynamics data after each dose cohort will be reviewed in blinded fashion before escalation to the next dose cohort.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects with type 2 diabetes
* Age: 18 to 65 years
* BMI: 20 to 29 kg/m2
* Mentally, physically and legally eligible to give informed consent.
* Willingness to adhere to the protocol requirement.

Exclusion Criteria:

* Subjects with type 1 diabetes
* Episodes of hypoglycemia
* Unstable cardiovascular diseases
* Hepatic diseases
* Kidney disease
* Mental or central nervous system diseases
* Clinical abnormal findings in ECG, labs and physical exams
Variability of the Autonomic Nervous System (ANS) During Cluster Headache (CH).

Cluster Headache (CH) is associated with ipsilateral vegetative signs, related to parasympathetic system hyperactivity and/or signs of sympathetic hypoactivity. The precise mechanism of Cluster Headache (CH) is still unknown. The question is whether these dysautonomic disorders are simply secondary to the Cluster Headache (CH) process or whether they are the triggering factor.

This study cares about the evolution of the Autonomic Nervous System (ANS) in Cluster Headache (CH) seizures. Patients will be offered Holter ECG to study the temporal relationships between changes in Autonomic Nervous System (ANS) activity during Headache (CH) seizures and changes in Autonomic Nervous System (ANS) activity before and after seizure treatment, using heart rate variability measurement.

The hypothesis is that there would be an initial temporary sympathetic activation, followed quickly by parasympathetic hyperactivation and a return to a state of equilibrium.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age
* Affiliated or entitled to a Social Security scheme
* Resident in the territories of the hospital grouping of Loire territory (located less than 50 km away)
* Whose diagnosis of episodic or chronic Cluster Headache (CH) has been confirmed according to International Classification of Headache Disorders (ICHD)- 3 criteria
* With a regular sinus rhythm and heart rate

Exclusion Criteria:

* Conditions contraindicating the use of injectable sumatriptan
* Conditions likely to affect the Autonomic Nervous System (ANS): dysautonomic sensory neuropathies, sleep apnea syndrome, etc.
* Cognitive or language disorders that may interfere with pain assessment and seizure follow-up.
* Patients taking treatments that may modify the Autonomic Nervous System (ANS): catecholamine (adrenaline, noradrenaline, dopamine), B-stimulants (isoprenaline, dobutamine, dopexamine, salbutamol, terbutaline, fenoterol, orciprenaline, clenbuterol, salmeterol, formoterol), B-blockers, alpha-stimulants (midodrine, alpha-methyl-dopa, clonidine, rilmenidine, moxonidine), alpha-blockers (phentolamine, prazosin, urapidil), amphetamine, tyramine, ephedrine, selegiline, cocaine, imipramine.
* Impossibility to submit to the medical follow-up of the program for geographical, social or psychological reasons.
* Patient deprived of liberty or under guardianship.
* Patient with preventive background treatment of Cluster Headache (CH).
Microvascular Reactivity of the Gingiva Around Implant Born Crown

Apply LSCI method for follow-up changes in regional blood flow after compression of the gingiva in order to compare the vascular reactivity of the attached gingiva at implant versus at tooth.

This study will examine the effects of implantation and peri-implant soft tissue shaping on the circulation and the regeneration processes of the human gingiva.

The primary aim is to determine the effect of a short term disruption of the blood flow in the gingiva next to an implant and the contralateral tooth, in order to compare the functionally active collateral circulation in the attached gingiva at these respective regions. Using Laser Speckle Contrast Imaging technique (LSCI), which provides blood perfusion data, the investigators will have the possibility to detect functional alterations in gingival microcirculation during and after a short term compression of the gingiva. The secondary aim is to assess and compare the time course of the restoration of the circulation on the affected areas. Further aims are to observe if the compensation capability of the circulation is influenced by gingival thickness (biotype) and patient's gender.

Eligibility Criteria:
Inclusion Criteria:

Patient with single dental implant installed in the front region of the jaw at least 6 months ago. On the contralateral side a natural tooth is located.

Exclusion Criteria:

* systemic disease
* smoking
* alcohol abuse
* pregnancy
* gingivitis
* periodontitis
Myofascial Induction and Eccentric Exercises in Volleyball Players

Introduction. Myofascial therapy aims to improve fascial restrictions through the application of mechanical stimuli. The eccentric exercises involve the recruitment of fast fibers and help increase muscle volume.

Aim. Compare the effectiveness of myofascial induction intervention in the improvement of the range of motion of glenohumeral rotation and the pain perception, with respect to the use of eccentric exercises in volleyball players from 18 to 35 years of age.

Study design. Multicenter and single-blind randomized clinical study with follow-up period.

Methods. A random assignment of the 40 subjects recruited to the different study groups will be carried out: experimental (myofascial induction technique and eccentric exercises) and control (eccentric exercises). The intervention will last 4 weeks, with a weekly session of 17 and 7 minutes (in the experimental and control group, respectively). The dependent variables and measurement instruments will be: internal and external shoulder rotation (goniometry) and pain perception (visual analog scale). The Kolmogorov-Smirnov test will calculate the distribution of the sample, using parametric tests (t-student to calculate the difference of means between the evaluations in each group and ANOVA of repeated measures to calculate the intra- and intersubject effect) in case of normal.

Expected results. To improve the range of motion of glenohumeral joint global rotation and of the perception of pain of the subject.


Eligibility Criteria:
Inclusion Criteria:

* Volleyball players
* Both gender
* Age range of 18 to 35 years
* Compete in a federated team in the Community of Madrid.

Exclusion Criteria:

* Have an injury to the osteoarticular complex of the shoulder at the time of the study or the previous 6 months
* Who are receiving a physiotherapy intervention at the time of the study or receiving analgesic drugs
* Not signed the informed consent document.