cyrilzakka/clinical-trials huggingface dataset:
Comparison of Ultrasonic Pachymetry With Orbscan in Corneal Haze

This study is planned to compare the results of ultrasonic and Orbscan pachymetry in corneal haze not related to surgery. Corneal haze is graded with slit-lamp by a single examiner. Ultrasonic and Orbscan II pachymetry measurements are obtained. Paired t and Kruskal-Wallis tests are used to evaluate the difference between ultrasonic and Orbscan pachymetry measurements. Correlation of the two methods and haze grade is determined with Kendall's tau-b correlation analysis.

We planned this study to compare the results of ultrasonic and Orbscan pachymetry in corneal haze not related to surgery. In this institutional based, prospective, controlled clinical trial subjects with corneal haze not related to surgery are included. Normal eyes are used as control group to calculate the customized acoustic factor. Corneal haze is graded with slit-lamp by a single examiner. Ultrasonic and Orbscan II pachymetry measurements are obtained by one technician each masked to the other measurement. Paired t and Kruskal-Wallis tests are used to evaluate the difference between ultrasonic and Orbscan pachymetry measurements. Correlation of the two methods and haze grade is determined with Kendall's tau-b correlation analysis. According to the results of the study, we will determine which method is accurate in subjects with corneal haze.

Eligibility Criteria:
Inclusion Criteria:

* Patients with significant corneal haze on slit-lamp are included in the study group. 50 eyes of 50 age-matched patients with normal eye and clear cornea are included in the control group. Only one eye of each subject is included.

Exclusion Criteria:

* Exclusion criteria to participate in the study are previous ocular surgery, history of contact lens use, glaucoma, and topical ocular medication use, excluding artificial tears.
IOP Elevation Study

The purpose of this study is to improve understanding of the pathophysiologic process that leads to the development of glaucamotous damage. The mechanism by which vision loss in glaucoma occurs is still unknown, but it is clear that increased intraocular pressure (IOP) is a major risk factor. It is also thought that the LC is a site of primary damage during pathogenesis of the disease. This prospective study with determine the in-vivo mechanical response to IOP modulation at the level of the ONH and LC.

The present study will briefly increase the pressure in eyes of living subjects and examine the effect of elevated intraocular pressure on optic nerve topography and position during pressure elevation using optical coherence tomography imaging of the posterior eye. Outcome measures will include measurements in microns based on these images quantifying the deformation of the lamina cribrosa.

Eligibility Criteria:
Inclusion Criteria:

Healthy volunteers

* No family history (first degree relative) of glaucoma.
* No history of IOP \>22 mmHg.
* Normal appearing optic discs and RNFL on dilated fundus examination.
* Normal Swedish interactive thresholding algorithm (SITA) standard perimetry tests as defined by glaucoma hemifield test (GHT) within normal limits.

Glaucoma suspects

* Normal visual field as defined above.
* Either IOP between 25 to 30 mmHg with central corneal thickness \< 550µm, or a difference ≥ 0.2 in cup to disc ratio between eyes.

Glaucoma

* Glaucomatous ONH abnormality: rim thinning, notching, undermining (excavation) or diffuse or localized RNFL defects that are characteristic of glaucoma.
* Two consecutive abnormal SITA standard perimetry tests with GHT outside normal limits.

Exclusion Criteria:

* Media opacity (e.g. lens, vitreous, cornea).
* Strabismus, nystagmus or a condition that would prevent fixation.
* Diabetes with evidence of retinopathy.
* Previous intraocular surgery or ocular trauma (with the exception of laser procedures and subjects that have undergone uneventful cataract surgery more than 6 months from enrollment date).
* Neurological and non-glaucomatous causes for visual field damage.
* Any intraocular non-glaucomatous ocular disorders.
Sitagliptin in the Elderly

Diabetes is common in the elderly; by the age of 70, approximately 25% of the population will have diabetes. Unfortunately, currently available medications are often not as effective or not well tolerated in older adults. Sitagliptin is a new medication in a new class of agent called incretins. Incretins have many potential advantages for the treatment of diabetes in the elderly. They stimulate insulin secretion, which is impaired in all older people with diabetes. The incidence of hypoglycemia with currently available medications increases with age, and incretins rarely cause hypoglycemia . They assist with weight loss, whereas many current medications used to manage diabetes result in weight gain in the elderly. They improve insulin action, and insulin resistance is a major problem in older people with diabetes.

To date, no clinical trials have been conducted specifically in the elderly, but the data noted above from our laboratory would imply that inhibitors of this enzyme could be more effective in the elderly patient population. In addition, we have convincingly demonstrated that diabetes in the elderly is metabolically distinct from diabetes in middle aged patients (1). Thus, it is clear further studies are warranted to determine the effectiveness of drugs in this class in elderly patients with diabetes. We propose a series of studies with your DP4 inhibitor sitaglipitin to determine its efficacy and safety in an elderly patient population with diabetes.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes managed by diet or metformin only
* A1c \< 8.5%

Exclusion Criteria:

* treated with insulin or oral agents other than metformin in the past 6 months
* evidence of diabetic complications including coronary artery disease, stroke, transient ischemic attacks, peripheral vascular disease, nephropathy, retinopathy, or neuropathy
* type 1 diabetes or a history suggestive of a secondary causes of diabetes
* A1c ≥ 8.5%
* participated in another clinical trial within the past 30 days
Safety and Effectiveness Study for a Needle Guidance System in Lung Biopsies

This study is designed to provide clinical data regarding safety and clinical effectiveness of the ActiSight Needle Guidance System in assisting radiologically guided percutaneous needle biopsy or aspiration of pulmonary lesions, which is a common procedure.

This will be a prospective, single-arm study. At least three centers in Canada will participate in the study and at least 4 different experienced staff radiologists will perform the procedures for the study.

A total of forty eight (48) consecutive subjects meeting the eligibility criteria, scheduled for clinically indicated CT guided lung biopsy or aspiration procedure at the participating centers will be invited to enroll in the study. To ensure diversity in the study population, consecutive patients will be enrolled in the following groups until these groups are fully enrolled:

Lesion size ≥1.0 cm and ≤ 1.5 cm: 10 patients; Lesion size \>1.5 and ≤ 3.0 cm: 19 patients; Lesion size \>3.0 cm: 19 patients.

A maximum of 24 patients will be enrolled at each center.

Informed consent will be signed prior to the procedure. Subject data collection on the day of the procedure will include demographics, relevant medical history and vital signs. Enrolled subjects will undergo CT guided percutaneous lung aspiration and/or biopsy as clinically indicated by a qualified physician, utilizing the ActiSight Needle Guidance System. Subjects will be followed-up as outlined below to assess adverse events related to the procedure. A subject's enrollment in the study will be completed after the follow-up visit or after resolution of any procedure related adverse event.

A procedure difficulty classification is defined for this study, based on existing literature. Difficulty levels for all procedures will be recorded and included in the final report.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, 18 years of age or older at the time of enrollment;
* Subjects scheduled for clinically indicated CT guided percutaneous lung aspiration/biopsy;
* Written informed consent to participate in the study;
* Ability to comply with the requirements of the study procedures;
* Verified home address and phone number to facilitate study follow-up.

Exclusion Criteria:

* Significant coagulopathy that cannot be adequately corrected;
* Subjects who participated in an active stage of any drug, intervention or treatment trial within 30 days of enrollment;
* Subjects with preexisting conditions which, in the opinion of the investigator, interfere with the conduct of the study;
* Subjects who are uncooperative or cannot follow instructions;
* Mental impairment that may preclude completion of the study procedure;
* Pregnant or nursing female subjects.
Effectiveness of Stereotactic RadioTherapy in Solid Primary Inoperable and Oligometastatic Cancer

The purpose of this study is to development of more effective treatment tactics of the stereotactic radiotherapy and radiosurgery alone and together with classic radiation therapy in primary inoperabel solid tumors and oligometastastatic cancer.

Despite the fact that of many investigations in the world clinical researches, the SRT of primary-inoperabel and metastatic solid tumors combined with conventional and conformal radiation therapy methods the possibility of the sequences, the optimal fractions of the regimes and doses which determines normal tissues toxic manifestations, implementation of prevention, have not been solved yet.

The conducted research works to study quality of life for improving the social status of patients with primary-inoperable and metastatic solid tumors, is not fully resolved.

Thus, preparing of highly effective treatment tactics in primary-inoperable and metastatic solid tumors, is one of the most important problems of modern clinical oncology and this fact gives grounds to carry out the planned research work.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed primary-inoperable solid tumors or oligometastatic cancer.
* Acceptance of patient by surgeon as non-operabel or refusing of surgery.
* No more than 4 metastatic foci in irradiated organ.
* Karnofsky scale more than 60.
* Age ≥18 years.
* Estimated duration of life \>3 months.
* Hemoglobin ≥ 8 g/dl.
* Absolute neutrophil count at least 1,500/mm\^3.
* Platelet count at least 70,000/mm\^3.
* Bilirubin no greater than 1.5 times normal.
* SGOT and SGPT no greater than 3 times normal.
* Creatinine less than 1.5 mg/dL. PT-INR/APTT less than 1.5.
* Last patients data no older than 1 month.
* No prior radiotherapy of same location.
* Prior chemottherapy more than 2 weeks ago.

Exclusion Criteria:

* Progression of primary site of metastatic cancer.
* Pregnancy or Breast-Feeding.
* Decompensated concomitant diseases.
Adult Dengue Platelet Study

Retrospective data in children with dengue hemorrhagic fever (DHF) and dengue shock syndrome (DSS), and in adults with dengue fever (DF), suggested a lack of benefit from prophylactic platelet transfusion for severe thrombocytopenia in dengue patients without bleeding. However, in Taiwan and Singapore, platelet transfusion was given to 13-50% of hospitalised dengue patients. This is a prospective randomised study to examine the safety and efficacy of prophylactic platelet transfusion in adults with dengue and severe thrombocytopenia without bleeding.

The hypotheses are:

1. Prophylactic platelet transfusion is safe in hospitalised dengue patients with severe thrombocytopenia.
2. Prophylactic platelet transfusion is effective in preventing bleeding in hospitalised dengue patients with severe thrombocytopenia.

Patients fulfilling inclusion and exclusion criteria, and giving informed consent, will be randomised to a treatment arm of 4 units of platelets for every day they have a platelet count \<20x10\^3/uL, or a control arm with supportive care. Patients will be followed up daily till hospital discharge, and again at day 21.

It is assumed that the incidence of bleeding from randomization to Day 7 or discharge, whichever earlier, is 10% for the control (no transfusion) group and 5% for the intervention (transfusion) group. With 1:1 allocation ratio, to attain 80% power and one-sided 5% type I error rate, the required number of subjects in each arm is 382 by a Chi-square test with Yates' continuity correction. If a drop-out rate of 5% is allowed, the required number increases to approximately 400 per arm.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 21years
2. Probable or confirmed dengue

   a) Confirmed dengue: laboratory confirmation of acute dengue by either i) positive polymerase chain reaction (PCR) for viral ribonucleic acid (RNA), or ii)positive NS1 antigen test with a compatible clinical syndrome b) Probable dengue: Positive acute dengue serology and clinical presentation fulfilling either WHO 1997 or 2009 criteria for probable dengue.

   i) 1997 criteria: Acute febrile illness and two or more of the following:
   * headache,
   * retro-orbital pain,
   * myalgia,
   * arthralgia,
   * rash,
   * hemorrhagic manifestations,
   * leucopoenia ii) 2009 criteria: Fever and two of the following:
   * nausea/vomiting,
   * rash,
   * aches/pains,
   * positive tourniquet test,
   * leucopoenia,
   * one or more warning sign
   * abdominal pain/tenderness,
   * persistent vomiting,
   * clinical fluid accumulation,
   * mucosal bleed,
   * lethargy/restlessness,
   * liver enlargement \>2cm,
   * increase in haematocrit concurrent with rapid decrease in platelet count
3. Platelets ≤ 20x103/μL
Study of the Efficacy and Safety of Secukinumab in Participants With Active Psoriatic Arthritis With Axial Skeleton Involvement

The purpose of this study is to demonstrate the efficacy and safety of secukinumab 150 mg or 300 mg in the management of axial manifestations in PsA patients who have failed to respond to at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) over a 4-week period, according to assessment of spondyloarthritis international society (ASAS) recommendations for the treatment of axial spondyloarthritis (AxSpA).

In the anlalysis (CSR), there are 498 patients, as 5 patients were mis-randomized, i.e. had randomization number but did never take study medication. So there were 498 participants, and not 503

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained before any assessment is performed
* Diagnosis of psoriatic arthritis classified by Classification criteria for psoriatic arthritis (CASPAR) criteria
* Active spinal disease defined by Bath ankylosing spondylitis disease activity index (BASDAI) score ≥ 4
* Spinal Pain visual analog scale (VAS) ≥ 40 (on a VAS 100 scale)
* Inadequate Response to at least 2 non-steroidal anti-inflammatory drugs over a 4 weeks period

Exclusion Criteria:

* History of exposure to other IL-17 or IL-23 inhibitor biologic drug
* History of exposure to previous biologic disease modifying anti-rheumatic drugs (DMARDs) (Tumor necrosis factor (TNF) blockers or Ustekinumab)
* Current treatment with disease modifying anti-rheumatic drugs (DMARDs) other than Methotrexate
* Subjects taking high potency opioid analgesics (e.g. methadone, hydromorphone, morphine)
* Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician

Other protocol-defined inclusion and exclusion criteria may have applied.
Postoperative Concurrent Chemoradiotherapy in Treating Patients With High-Risk Salivary Gland Carcinomas

This is a non-randomized, phase II, open label study of postoperative current chemoradiotherapy for high-risk malignant salivary gland tumors of head and neck.The primary purpose of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy in these patients.


Eligibility Criteria:
Inclusion Criteria:

1. Pathologically proven diagnosis of a malignant salivary gland tumor of intermediate or high-grade
2. Pathologic stage T3-4 or N1-3 or T1-2, N0 with a close (≤ 5mm) or microscopically positive surgical margin
3. Surgical resection with curative intent within 8 weeks prior to registration, with no evidence of gross tumor residual
4. No evidence of distant metastases
5. No synchronous or concurrent head and neck primary tumors
6. Karnofsky score over 60
7. Adequate organ function including the following:

   1. Absolute neutrophil count (ANC) \>= 1.5 \* 10\^9/l
   2. Platelets count \>= 100 \* 10\^9/l
   3. Hemoglobin \>= 10 g/dl
   4. AST and ALT \<= 2.5 times institutional upper limit of normal (ULN)
   5. Total bilirubin \<= 1.5 times institutional ULN
   6. Creatinine clearance \>= 50 ml/min
   7. Serum creatine \<= 1 times ULN
8. Signed written informed consent

Exclusion Criteria:

1. Evidence of distant metastasis
2. Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region
3. Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma
4. Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures
5. Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
Behavioral Effects of Drugs: Inpatient (35)

This study will determine the influence of methylphenidate (Metadate®) and duloxetine (Cymbalta®), alone and in combination, on the reinforcing, subjective and physiological effects of cocaine.


Eligibility Criteria:
Inclusion Criteria:

* Recent cocaine use

Exclusion Criteria:

* Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant
* Current or past histories of substance abuse or dependence that are deemed by the study physicians to interfere with study completion
* History of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation
* Females not currently using effective birth control
* Contraindications to cocaine, methylphenidate or duloxetine
Pleiotropy and Mechanism of Peripheral Nerve Related Genes in the Progression of Amyotrophic Lateral Sclerosis

This study will establish a comprehensive exon database of ALS patients, lay the foundation for screening the genes related to the occurrence and development of the disease, support the theory of ALS disease progression from peripheral to central, and reveal the correlation between the functional level of peripheral nerve and the prognosis of the disease at the gene level for the first time, and provide the basis for the mechanism research at the molecular level.

Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disease that selectively invades superior and inferior motor neurons. Because there is no effective treatment, it is urgent to find the risk factors of ALS to guide the prevention and slow down the disease progression. In the early stage of the disease, the peripheral motor injury is more rapid and sensitive than the central response, which is an ideal window to observe the state of the disease. Protecting peripheral nerve integrity and maintaining its function can slow down the death of superior neurons, effectively relieve symptoms and prolong survival time, which has also been confirmed in patients with multiple stem cell-derived motor neurons and SOD1 G93A disease model mice. Reexamination of the role of peripheral motor nerve related factors in the development of ALS is of great significance for the study of disease mechanism, clinical classification, prognosis, evaluation of drug trial efficacy and individualized treatment plan. Previous studies have shown that NEFL gene, as the coding gene of light chain of neuron cytoskeleton, is closely related to axonal function, and its polymorphism is related to the occurrence and severity of axonal Charcot Marie Tooth disease. Exploring the role of similar peripheral nerve related genes in the progression of ALS will help us better understand the disease from the genetic level, establish an accurate and stable prognosis prediction model, and guide early treatment. This study will establish a comprehensive exon database of ALS patients, lay the foundation for screening the genes related to the occurrence and development of the disease, support the theory of ALS disease progression from peripheral to central, and reveal the correlation between the functional level of peripheral nerve and the prognosis of the disease at the gene level for the first time, and provide the basis for the mechanism research at the molecular level.

Eligibility Criteria:
Inclusion Criteria:

1. Since February 2021, he has been in the Department of Neurology, the Third Hospital of Beijing Medical University. He was diagnosed amyotrophic lateral sclerosis according to the revised EI Escorial diagnostic criteria of 2004 edition, and the patients within one year of onset.
2. Informed consent has been signed.

Exclusion Criteria:

1. Patients with ALS like syndrome caused by autoimmune diseases, paraneoplastic syndrome and simple demyelinating lesions were excluded.
Association Between the tDCS and FDS for Gait Rehabilitation After Stroke

The aim of this study is to verify the effectiveness of tDCS combined with foot drop stimulation (FDS) on gait rehabilitation of post-stroke subjects with mild and moderate compromise.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with ischemic or hemorrhagic stroke diagnosis.
* Mild, moderate or severe hemiparesis (chronic stroke - at least 6 months)
* Minimal cognitive ability to understand commands
* Able to walk 10 meters unassisted or with minimal assistance

Exclusion Criteria:

* No current use of antiepileptic drugs for seizures
* Secondary musculoskeletal disorder involving the lower limb
* Contraindication for electrical stimulation
Enhanced Recovery Programs and Small Bowel Obstruction

Small bowel obstruction surgery is frequent and would benefit from enhanced recovery programs. While some studies advocate for their feasibility, it has never been proved and prospective studies are required to confirm the feasibility of such program and the impact on postoperative outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Adhesionnal small bowel obstruction requiring surgical management

Exclusion Criteria:

* No surgery
* Patients disagreeing to participate