cyrilzakka/clinical-trials huggingface dataset:
An Effectiveness and Safety Study With RWJ-333369 (Carisbamate) for the Study of Postherpetic Neuralgia (PHN).

The purpose of this study is to evaluate the safety, effectiveness, and tolerability of 200 mg of RWJ-333369 given twice daily compared with placebo in the treatment of postherpetic neuralgia.

Postherpetic neuralgia is a distressing syndrome of neuropathic pain that continues for at least 3 months after the resolution of the varicella-zoster rash (shingles), can last up to years later, and for which therapies are often limited by incomplete pain relief and side effects. This is a randomized (study medication is assigned by chance), double-blind (neither the Investigator or the patient know the name of the assigned study medication), placebo-controlled, crossover, parallel-group, multicenter study to determine the effectiveness and safety of 200 mg of RWJ-333369 given twice daily for 4 weeks compared with placebo in patients with Postherpetic Neuralgia (PHN). The study hypothesis is that 200 mg of RWJ-333369 given twice daily for 4 weeks will be more effective than placebo in reducing pain due to PHN, as measured by average daily PHN pain scores. Patients will receive 200 mg of RWJ-333369 or matching placebo tablets, given in equally divided doses twice daily by mouth, with or without food, for 4 weeks in each of the 2 treatment periods.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of postherpetic neuralgia (PHN) with a history of varicella-zoster rash (shingles), persistent pain for at least 6 months after the healing of the rash
* Experienced postherpetic neuralgia pain on a daily basis for the past 3 months
* Women must be postmenopausal for at least 2 years, sexually abstinent, or if sexually active, be practicing an effective method of birth control, and have a negative serum pregnancy test at screening.

Exclusion Criteria:

* History of a poor response to 3 or more medications for postherpetic neuralgia (PHN), with poor response defined as treatment with medications in the following categories of therapy for at least 1 month at therapeutic dosages without at least moderate improvement, as judged by the study doctor: Antiepileptic drugs, antidepressants, serotonin norepinephrine uptake inhibitors (SNRIs), opioid analgesics, or lidocaine patch
* currently taking tricyclic antidepressants, Coumadin (warfarin), or continued treatment with an antiepileptic drug for any indication, Note: If taking these medications, to be eligible for the study, they must be tapered and discontinued
* past neurolytic treatment (destruction of nerves by the application of chemicals, heat or cold, neurosurgery, intrathecal pumps, or spinal cord stimulators for PHN pain
* currently using herbal topical creams or ointments for pain relief within 48 hours, capsaicin within 6 months, or systemic corticosteroids within 3 months of the baseline period
* Prior exposure to RWJ-333369 (carisbamate).
A Study Of The Analgesic (Pain-Relief) Effects Of Tanezumab In Adult Patients With Diabetic Peripheral Neuropathy

The purpose of this study is to determine the effectiveness and safety of the investigational drug, tanezumab, in adult patients with painful diabetic peripheral neuropathy.

This study was terminated on 18 November 2010 following a US FDA clinical hold for the tanezumab diabetic peripheral neuropathy clinical study which halted dosing and enrollment of patients on 19 July 2010 for potential safety issues.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of diabetes mellitus (high blood sugar) with HbA1c levels of ≤11% at Screening, and on a stable anti-diabetic medication regimen for the 30 days prior to randomization.
* Diagnosis of diabetic peripheral neuropathy pain in the legs or feet with decreased sensation in the feet or decreased/absent ankle jerk/ reflexes.
* Presence of ongoing pain due to diabetic peripheral neuropathy for at least 3 months.
* A pain score of greater than or equal to (≥) 4 for from diabetic peripheral neuropathy on the Numerical Rating Scale (NRS), a 11-point scale with 0 meaning no pain and 10 meaning worst pain at Screening.
* Be willing to stop all pain medications for diabetic peripheral neuropathy except for the limited use of acetaminophen (Tylenol) or ibuprofen-like (Motrin) medications between Screening and Baseline and not use prohibited pain medications throughout the duration of the study except as permitted by the study guidelines.

Exclusion Criteria:

* Painful neuropathies other than diabetic peripheral neuropathy.
* Other types of diabetic neuropathies.
* Patients with a past history of carpal tunnel syndrome (CTS) with signs or symptoms of CTS in the one year prior to Screening are not eligible for participation.
* Patients with fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy or other moderate to severe pain.
* Patients with a present (current) history of sciatica are not eligible for participation.
* The presence of pain conditions that cannot be distinguished from diabetic peripheral neuropathy such as peripheral vascular disease.
* Amputations dues to diabetes.
* Patient with any clinically significant medical condition or laboratory abnormalities.
* History, diagnosis, or signs and symptoms of clinically significant neurological diseases (such as Alzheimer's disease, head trauma, epilepsy or stroke).
* History, diagnosis, or signs and symptoms of clinically significant psychiatric diseases (such as bipoar disorder or schizophrenia).
* History of known alcohol, analgesic or drug abuse within 2 years of Screening.
* Pregnant women, lactating mothers, women suspected of being pregnant, and women who wish to be pregnant during the course of clinical study.
Long-Term Follow-Up to the DEVO Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers

* Observe the long-term (1-year) outcomes of Dermagraft, compared with conventional treatment of four-layer compression bandaging therapy alone, in subjects who completed the ABH-Dermagraft-001-08 study.
* Study Hypothesis: N/A (Long-term follow-up study)


Eligibility Criteria:
Inclusion Criteria:

1. Subject has completed study ABH-Dermagraft-001-08
2. Subject understands study requirements
3. Subject is available to participate in the 1 year-long observational follow-up.

Exclusion Criteria:

1. Subject who withdrew or was terminated from ABH-Dermagraft-001-08 before completion
2. Subject is not available for the 1 year-long observational period.
3. Subject has any condition(s) which seriously compromises the subject's ability to complete the study
Intra-articular Corticosteroid Injection Compared With Single-Shot Hyaluronic Acid for Treatment of Osteoarthritis Knee

Corticosteroid and Hylan G-F 20 are both effective in improving pain and function of osteoarthritic knee patients.

Corticosteroid and Hylan G-F 20 are both effective in improving pain and function of osteoarthritic knee patients up to 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of knee OA
* Knee pain for most days of the prior month
* Radiographic evidence consistent with knee OA
* Aged between 40 and 80 years old

Exclusion Criteria:

* Lumbar spondylosis
* Gross deformity of the knee
* Co-existent inflammatory or crystal arthritis
* Prior knee surgery
* Injury to the knee in the preceding 6 months
* Any intra-articular injection in the preceding 3 months
* Pregnant or Lactating
* Current infection in the affected knee
* Inability to provide informed consent
Atmospheric Pressure and Epistaxis Relationship

In this study, investigators aim to understand the relationship between changes in atmospheric pressure and blood pressure, and to investigate whether these changes have an impact on the etiology of epistaxis.

This study aims to investigate the potential effects of changes in atmospheric pressure on epistaxis and, if such effects exist, to review treatment adjustments based on weather forecasts for hypertensive patients to prevent potential hypertensive emergencies and enhance patient comfort. This research poses no risk to patients and is purely observational and clinical in nature.

The study will be conducted prospectively over a period of 6 months at the Emergency Department of Ankara Etlik City Hospital, focusing on patients presenting with epistaxis.After initial evaluation upon presentation to the emergency department, patients will undergo routine emergency department monitoring for epistaxis, including physical examination, vital sign monitoring, evaluation of coagulation parameters, and hemoglobin levels. Apart from routine tests, no additional invasive or non-invasive procedures will be performed by us.

Data obtained from patients and daily atmospheric pressure parameters will be evaluated and analyzed.

Eligibility Criteria:
Inclusion Criteria:

Patients aged 18 and above Presenting to the emergency department with complaints of epistaxis, whether active or resolved.

Willing volunteers consenting to participate in the study. Residing in central districts of Ankara

Exclusion Criteria:

Patients under the age of 18. Pregnant individuals. Those with a history of maxillofacial surgery. Patients reporting a history of trauma at the time of admission. Patients stating they are from a city other than Ankara.
A Registry Study Evaluating Outcomes in Breast Biopsy With the Intact™ Breast Lesion Excision System (BLES)

The purpose of this registry study is to collect use and clinical outcomes data following breast lesion excision or sampling with the Intact BLES.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Age ≥ 18 years
* BIRADS ≤ 5, as initially imaged
* Subject is willing and capable of providing informed consent and has a scheduled or planned breast lesion excision or sampling where the Intact BLES is expected to be used

Exclusion Criteria:

* Male
* Subjects with subglandular (pre-pectoral, or "single plane") breast implants
* Subjects with electronic implantable devices (such as pacemakers and defibrillators)
* Subjects who are contraindicated for surgery due to factors such as anti-coagulant use which cannot be safely reversed
Effects of an Innovative Balance Training Programme in Enhancing Postural Control and Reducing Falls in Patients With Parkinson's Disease

Falling is a complex and most disabling feature for patients with Parkinson's disease (PD). Previous studies suggested that falls in patients with PD are related to postural instability characterized by deficits in anticipatory postural adjustment (APA) for postural orientation in walking and standing and inadequate postural response to perturbation. The present study developed an innovative balance treatment with focus of anticipatory and compensatory postural control and examined its effects on enhancing balance and gait performance and decreasing fall rate in people with PD.

Participants: Forty-two eligible subjects with PD were randomly allocated into balance with focus of anticipatory and compensatory postural control (EXP) or control (CON) group with strength-focused training, with 26 subjects in each group.

Methods: Subjects in the EXP group were trained the speed and amplitude of anticipatory postural adjustment during stepping and walking and postural response to perturbation during walking. Subjects In the CON group were trained to improve the strength of lower limb muscles. Treatment period in both groups lasted for 12 weeks, which consisted of 4-week laboratory-based training (phase 1), 4-week home-based exercise (phase 2) and final 4-week laboratory-based training (phase 3). Outcome measures included reaction time(RT), movement velocity (MV) and endpoint excursion (EPE) of limit-of-stability test, one-leg-stance (OLS) time, gait velocity, stride length (SL), cadence, and fall rate. All tests were conducted for 6 time intervals including baseline, after each training phase, at 3-month follow-up and at 12-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. diagnosed as parkinson's disease
2. 45 years old or above
3. stable on anti-parkinsonian medications for at least 6 weeks prior to entry into the study, which will remain unchanged for the duration of the study
4. able to walk a 10 meter distance at least 3 times with or without walking aids independently
5. at stage 2 or 3 of the Hoehn and Yahr staging
6. able to provide informed consent

Exclusion Criteria:

1. neurological conditions other than PD
2. uncompensated cardiovascular disease
3. less than 23 score on the Mini-Mental State examination,
4. History of fracture or recent musculoskeletal disorders in back or lower limbs which would interfere with the balance during exercise and daily activities
5. visual disturbance or vestibular dysfunction limiting locomotion or balance
6. participation in other balance-related training program more than one time per week
Motor Learning and Multi-session tDCS in Parkinson's Disease

The present study seeks to examine the efficacy of multi-session transcranial direct current stimulation applied over the primary motor cortex in people with Parkinson's disease on sequential motor learning performance.

Parkinson's disease is characterised by deficits of motor control triggered by impaired basal ganglia function, such as bradykinesia and tremor. Beyond the visibly recognisable motor symptoms of Parkinson's disease, the ability to learn a sequence of movements is also compromised and poses a significant barrier to effective rehabilitation. In healthy individuals, transcranial direct current stimulation applied over the primary motor cortex during motor task practice has been shown to significantly improve motor learning compared to placebo conditions.

The present study seeks to examine the effect of multi-session transcranial direct current stimulation applied over the primary motor cortex in people with Parkinson's disease on sequential motor learning performance. Participants will be required to attend eight laboratory sessions, comprising five intervention and three assessment sessions and will be tested on their ability to learn a 16-digit finger tapping sequence with their right hand. Sessions one to five will form the intervention and will be performed at the same time on consecutive days (i.e. mon-fri). In addition, session one will double as a baseline assessment and intervention session. Assessments sessions will be performed once before the intervention (session one), and three times following the intervention on day three, one week, and four weeks post intervention.

Eligibility Criteria:
Inclusion Criteria:

* Right-handed (Edinburgh Handedness Inventory; ≥50)
* Cognitively capable (Montreal Cognitive Assessment (MoCA); ≥23)
* Mild to moderate Parkinson's disease severity (Hoehn and Yar disease stage 2-3)
* On stable dopaminergic medication

Exclusion Criteria:

* History of stroke
* Comorbidity
* Cephalic implants
Teriparatide Use in Hip Replaced Subjects

A pilot study on the use of Teriparatide in severe osteoporotic women with hip fracture and submitted to hip replacement

The primary objective of this study is to obtain preliminary data, in a pilot group of postmenopausal women with established osteoporosis and a recent hip fracture, who underwent hip replacement 3-6 months before screening phase, about the effect of teriparatide on:

* bone turnover markers: CTx, PINP and BSAP when given at the dose of 20 mcg/day by subcutaneous route for 18 months.

The secondary objectives of the study are as follows:

* Effects of teriparatide on lumbar spine and non-prosthetic femur bone density, as assessed by BMD measurement with dual energy x-ray absorptiometry (DXA)
* Effects of teriparatide on quality of life and back pain during treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Ambulatory postmenopausal women with established osteoporosis, based on the disease diagnostic criteria
2. Presence of more than 1 clinical and/or radiological vertebral fractures OR more than 1 non-vertebral fracture
3. Presence of hip fracture with hip replacement surgical procedure (both uncemented or cemented total hip arthroplastics or endoprosthesis) in the 3-6 months before screening phase
4. Age range 55-85 years
5. Normal or clinically insignificant abnormal laboratory values (as determined by the investigator) including serum calcium, PTH(1 84), and 25 hydroxyvitamin D concentrations, and alkaline phosphatase activity.

Exclusion Criteria:

1. History of diseases which affect bone metabolism, other than primary postmenopausal osteoporosis, such as Paget's disease, renal osteodystrophy, osteomalacia, any secondary causes of osteoporosis (included glucocorticoid-induced osteoporosis), hypoparathyroidism, hyperparathyroidism, hyperthyroidism
2. Actual cancer disease or history of malignant neoplasms in the 5 years prior to Visit 2, with the exception of superficial basal cell or squamous cell carcinomas of the skin that have been definitively treated. Subjects with carcinoma in situ of the uterine cervix treated definitively more than 1 year prior to entry into the study may be enrolled.
3. Increased baseline risk of osteosarcoma: Paget's disease of the bone or unexplained elevations of alkaline phosphatase; Prior radiation therapy involving the skeleton
4. Significantly impaired renal function
5. Significantly impaired hepatic function
CNAP in Heart Surgery

The role of continuous non-invasive arterial pressure (CNAP) in high risk patients with pronounced variation of arterial pressure will be assessed under analgosedation.

Therefore, patients will be analyzed during normo-, hypo- and hypertension with standard IAP undergoing elective transfemoral aortic valve implantation procedures. Systolic, diastolic, and mean invasive arterial pressures (IAP) will be compared to those obtained by CNAP. Data will be analysed in different periods of arterial pressure for agreement of the two methods and for determination of precision (i.e. measurement error) and accuracy (i.e. systematic error). Additionally, we will compare both methods regarding the amplitude and time of very fast changes in arterial pressure during intervals of functional cardiac arrests (rapid pacing).


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted for elective transfemoral implantation of the aortic valve in analgosedation will be included.
* The patients' primary diagnosis was severe aortic stenosis, that was defined as a valve area of \<1cm² or a mean pressure gradient \>50mmHg.

Exclusion Criteria:

* an advanced dysfunction of peripheral perfusion (i.e. pronounced arterial peripheral artery occlusive disease or Raynaud's syndrome)
* arterio-venous shunts for haemodialysis, and vascular surgery of the upper extremities
CYSTEA-BONE Clinical Study

Nephropathic Cystinosis (NC) is an orphan inherited autosomal recessive disease characterised as a generalized lysosomal storage disease due to a deficiency of the cystine lysosomal transport protein, cystinosin.

Patients with NC usually receive cysteamine. Bone impairment was recently recognized as a late complication of NC, occurring at adolescence or early adulthood. Even though the exact underlying pathophysiology is unclear, at least six hypotheses are discussed, and mainly cysteamine toxicity and/or direct bone effect of the Cystinosin (CTNS) mutation. Because of the potential dramatic impact on quality of life of this novel complication, research should aim to better understand bone disease in NC.

The primary objective of this study is to evaluate the action of cysteamine on osteoclastic differentiation and resorption activity of NC patients, depending on the underlying genotype. The Secondary objective is to describe the clinical bone status of NC patients depending on their underlying genotype.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects with confirmed diagnosis of nephropathic cystinosis (defined by clinical signs, White Blood Cells (WBC) cystine level and/or mutation), currently receiving oral cysteamine.
* Age \> 2 years.
* Subjects and/or their parents/ legal guardian must provide non opposition prior to participation in the study.

Exclusion Criteria:

* Subjects who, in the opinion of the Investigator, are not able or willing to comply with the protocol.
Effectiveness of Single Step Culture Media and Sequential Culture Media on Blastulation Rate

To compare the effectiveness of single step culture media and continuous uninterrupted culture media on blastulation rate

Sequential culture media are designed to mimic the changing environment in the ovary ducts and the uterus in vivo. However, there are some differences between in vivo and in vitro culture conditions. Hence, single step media are created which allow the embryo itself to choose the necessary nutrients while maintaining a more stable culture environment. Previous studies suggest higher blastulation rate in the single step media than the sequential media.

This is an Randomized controlled trial (RCT) study comparing the blastulation rate of single step culture media and sequential culture media. Stimulation protocol is antagonist. Patient will be consulted on the day of ultrasound if they meet the inclusion criteria and sign the consent form. Then, the nurse will open the letter containing the type of media for that case. The media is prepared inside the lab a day before oocyte pick-up.

After oocyte pick-up, the oocyte-cumulus complex (OCC) will be cultured for 2 hours at 37°C, 6% Carbon dioxide (CO2) and 5% oxygen (O2). Meanwhile, sperm preparation will be performed using gradient technique. After 2 hours, OCC will be denuded and will be cultured for 1 hour until Intracytoplasmic Sperm Injection (ICSI). Oocytes after ICSI will be cultured in groups of 3-4 oocytes in the same conditions of 37 ° C, 6% CO2 and 5% O2. Fertilization check procedure is at 16-18 hours after ICSI. On day 3, the embryos will be evaluated in 66-68 hours after ICSI, grade 1 embryos are identified with 7-9 blastomeres and fragmentation is from 0-10%. The patients will be informed about the embryo quality. If the embryos are not decided to have day 5 transferring, patient will be consulted to transfer on day 3. Blastulation rate will not be recorded.

For the sequential culture media group, embryos will be transferred to Sequential Blast medium. For the single step culture media group, embryos will be transferred to the new culture dish with the same medium. On day 5, embryo quality assessment will be at 116±1 hours after ICSI. Blastocyst grading is based on the expansion, inner cell mass quality, and trophectoderm quality. Two good blastocyst will be transferred. After 11 days, beta-human chorionic gonadotropin (hCG) test will be required. If the beta-hCG result is positive, examination will be needed after 3 weeks and the luteal support will be given until 7 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Number of previous failure IVF cycles ≤2
* Using Gonadotropin-releasing hormone (GnRH) - Antagonist protocol for IVF
* Using GnRH for oocyte triggering.
* Read and sign consent form to participate in the study and have not been recruited for any other researches.

Exclusion Criteria:

* Oocyte donation cycles
* Abnormal uterine.