cyrilzakka/clinical-trials huggingface dataset:
Effects of Antimuscarinics on Cognition in Spinal Cord Injury

Prospective evaluation of the cognitive function of in-house patients suffering from an acute traumatic spinal cord injury before and three months after the initiation of antimuscarinic treatment.

The following hypothesis will be tested: Antimuscarinic treatment results in significantly worse cognitive test results three months after traumatic spinal cord injury compared to the pre-treatment results and the results of the control group.

There will be two groups: 1) patients receiving antimuscarinic treatment 2) patients without antimuscarinic treatment (control).

The control group will be investigated in order to determine the effects of traumatic spinal cord injury on cognition and the natural history of potential cognitive impairment within the first three months after spinal cord injury.

Six to eight weeks after traumatic spinal cord injury, patients are examined in order to determine the type of neurogenic bladder dysfunction they are suffering from. Patients suffering from an overactive bladder will receive antimuscarinic treatment in order to prevent high urine storage and voiding pressures, that put the kidneys at risk.

Prior to the urologic examination, patients fulfilling inclusion criteria will be contacted. If informed consent is given, cognitive function will be evaluated in both patient groups using different standard neuropsychologic tests. The same neuropsychologic tests will be repeated three months later. Evaluation will take place under standardized conditions (e.g. time of day).

Furthermore,different factors influencing cognition, e.g. depression, pain, medication, will be assessed at the beginning and end of the study.

Eligibility Criteria:
Inclusion Criteria:

* acute traumatic spinal cord injury
* primary rehabilitation / in-house patient
* 18-65 years of age
* treatment group: indication for antimuscarinic treatment (oxybutynin, tolterodine
* willingness and motivation to participate in study

Exclusion Criteria:

* lesion level above C4
* traumatic brain injury (initial Glasgow Coma Score \< 13)
* pre-existing dementia
* pre-existing impaired cognitive function
* previous antimuscarinic treatment
* treatment group: antimuscarinic treatment other than oxybutynin, tolterodine
* acute psychologic disorders, diseases, schizophrenia
* alcohol abuse, consumption of illegal drugs (incl. marijuana)
* moderate to severe depression (Beck Depression Inventory Score \> 18)
* moderate to severe pain (International Spinal Cord Injury Pain Basic Data Set)
* progressive disease
* tricyclic antidepressant
* color blindness, impaired sight, blindness
* insufficient German language skills
* no informed consent
Prophylactic Uterosacral Ligament Suspension at the Time of Hysterectomy for Prevention of Vaginal Vault Prolapse

Is routine uterosacral ligament suspension an appropriate clinical adjunct at the time of hysterectomy?

The answers to these questions will facilitate the treatment of many American women. With the results of this study, the investigators would anticipate a reduction in the number of surgeries for pelvic organ prolapse. In addition, if uterosacral ligament suspension was shown to be ineffective, it would not be used routinely in the setting of hysterectomy and women will be spared the additional procedure and possibility of side effects or complications.

The relative risks and benefits of adding a prophylactic uterosacral ligament suspension at the time of hysterectomy in women without symptomatic prolapse symptoms have never been studied prospectively.


Eligibility Criteria:
Inclusion Criteria:

* Eligibility for primary procedure (hysterectomy either total or supracervical, performed either vaginally or abdominally, via laparoscopic or open approach)
* Eligibility for secondary procedure (uterosacral ligament suspension colpopexy)
* Prolapse in any compartment not extending beyond the hymen as measured by Pelvic Organ Prolapse Quantitative system
* No subjective complaints of Pelvic Organ Prolapse as determined by answer "no" to questions #3 of the short form of Pelvic Floor Distress Inventory: #3. Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?

Exclusion Criteria:

* Contraindication for uterosacral ligament suspension colpopexy. (Surgeon's judgment that a contraindication to uterosacral ligament suspension colpopexy exists).
* Anticipated geographic relocation within the 12 months after surgery
* Inability to provide informed consent or to complete testing or data collection.
Electrolysis in Patients With Low Back Pain

The goal of this observational study is to investigate the efficacy of percutaneous electrolysis compared with dry needling on pain sensations and multifidus muscle properties in subjects with low back pain. The main questions it aims to answer are:

The high-intensity and low-intensity percutaneous electrolysis may induce pressure pain threshold (PPT) changes in myofascial trigger points in the low back during the intervention compared with dry needling.

Percutaneous electrolysis interventions may reduce stiffness in the multifidus muscle during the intervention compared with dry needling.

A parallel-group, controlled, triple-blinded, randomized pilot clinical trial comparing the effects of a single session of high-intensity percutaneous electrolysis (HIPE), low-intensity percutaneous electrolysis (LIPE), and dry needling (DN) applied to the multifidus muscle most active MTrP in subjects with low back pain. This clinical trial will follow the Consolidated Standards of Reporting Trials for pragmatic clinical trials.

This procedure consists of three trials, i.e., (1, HIPE) 660 uA x 30"; (2, LIPE) 220uA x 30"; and (3, DN) with 1 twitch response, and the needle inserted 30".

Eligibility Criteria:
Inclusion Criteria:

* to report low back pain of at least six months duration,
* aged 35 to 50 years,
* at least one active trigger point is present in the multifidus muscle.

Exclusion Criteria:

* pharmacological (e.g., analgesics) or physiotherapy treatment before or during their participation in the study,
* needle fear,
* prior lower extremity or spine surgery, absence of pain, any musculoskeletal or neuropathic conditions (e.g., peripheral compressive neuropathy, radiculopathy, sarcopenia, fibromyalgia, muscle ruptures), traumatic injuries (e.g., fractures or fissures), or any medical condition or contraindication for needling treatment (e.g., anticoagulants).
Assessment of Educational Effect of Home-made Robotic Surgery Simulator for Novice Robotic Surgeons

To overcome the obstacles of endoscopic surgery, the da vinci surgical robot system was applied to the various surgery area . And the complete understanding and practice of the robotic system is very important condition for successful robotic surgery.

Investigator developed a home made robotic surgery simulator for novice robotic surgeons. And investigator want to study about the ability of home made robotic surgery simulator versus existing robotic simulation system.


Eligibility Criteria:
Inclusion Criteria:

1. medical student of Yonsei University College of Medicine
2. first time of robotic surgery system
3. voluntary participation of this study

Exclusion Criteria:

1. minors \& foreigner
2. involuntary participation of this study
3. refuse to sign a consent form
The Safety and Effectiveness of RMP-7 Plus Amphotericin B in Patients With HIV and Cryptococcal Meningitis

To evaluate the safety of escalating doses of RMP-7 administered in persons with HIV infection and cryptococcal meningitis and to determine the MTD of the drug. To evaluate the pharmacokinetics, including cerebrospinal fluid (CSF) penetration, of amphotericin B when administered with RMP-7.

Patients receive intravenous RMP-7 added to conventional therapy with intravenous amphotericin B (with or without flucytosine). Treatment continues for 14 days, with follow-up visits 4 and 12 weeks later.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Up to 1 mg/kg amphotericin B for the current episode of cryptococcal meningitis.

Patients must have:

* HIV infection.
* Acute cryptococcal meningitis.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Cardiovascular disorders including congestive heart failure, uncontrolled hypertension (seated diastolic blood pressure \> 95 mm Hg), or symptomatic ischemic heart disease (angina).
* Orthostatic hypotension, defined as a decrease in systolic blood pressure of \>= 20 mm Hg upon standing.
* Coma.
* Other CNS disease (e.g., other intracranial infections) that may interfere with assessment of response.
* Opening CSF pressure \>= 350 mm or papilledema. (For patients with recurrent disease, evidence of mass effect on either MRI or CT excludes.)
* Any concurrent disease that would preclude participation in the study.

Patients with the following prior conditions are excluded:

* History of any bleeding disorder.
* History of active renal or hepatic disease.
* Myocardial infarction within the previous 3 months.
* Stroke within the previous 3 months.
Peer-led Group Intervention for Coping With Disaster

The present project partners with leading faith communities in Houston to provide expert-led educational workshops to a diverse sample of adults on normative and concerning response to disaster. Secondly implementing peer-led interventions where a trained adult leads others through an evidence-based manualized intervention. Lastly, identifying and referring individuals who require more intensive services to a higher level of care.

Approximately 20% of individuals have significant behavioral health concerns. Exposure to a disaster like Hurricane Harvey and its aftermath often exacerbates pre-existing issues and/or brings new issues, with post-traumatic stress presenting in manners such as anxiety, depression, conduct issues and/or somatic issues. Approaches are needed that educate community members about both normative and concerning responses to disaster focused on coping skills development. A particular approach, peer-led intervention groups have been shown effective at delivering these types of intervention. Brief, psycho-educational peer-led programs have shown effectiveness in a variety of forums including helping promote adjustment among those who have experienced trauma. There will be six group sessions every two weeks. Sessions will include how to teach appropriate coping techniques to respond to the distress, confronting distressing memories related to the disaster, and emotion regulation techniques. After the group sessions end, individuals who require a more intensive service will be referred to a higher level of care.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older and English speaking.

Exclusion Criteria:

* Individuals under the age of 18 and non-English speaking and participants who do not wish to participate in this study.
A Taste Assessment of BMS-986165 in Healthy Participants

The purpose of this study is to assess the taste characteristics of BMS-986165 formulations, alone and mixed, in order to develop a pediatric oral form of BMS-986165.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* WOCBP must agree to follow instructions for method(s) of contraception for 5 half-lives of BMS-986165 (2 days) plus 30 days (duration of ovulatory cycle) for a total of 32 days after each tasting day.
* Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception 5 half-lives of the study drug (2 days) after each tasting day.

Exclusion Criteria:

* A known sensitivity to BMS-986165
* A history of any illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug(s) to the participant. This may include but is not limited to: a history of relevant drug or food allergies; history of cardiovascular or central nervous system disease; history or presence of clinically significant pathology; or history of mental disease

Other protocol defined inclusion/exclusion criteria could apply
Evaluation of the Prevalence of Germs Slow Growth in the Intervertebral Disc (IVD) During Spinal Surgery

Low back pain is one of the most frequent reasons for consultation in rheumatology. There is a strong correlation between low back pain, and the presence of a type of Modic 1 signal on MRI.

The anomaly Modic 1 results in a hypointense signal T1-weighted images and hyperintense on T2-weighted sequences (including T2 STIR and / or Fat Sat) and contrast enhancement of the endplates after gadolinium injection; it corresponds to a replacement of normal cancellous bone of fibrovascular tissue.

The origin of this inflammatory process Modic 1 into the vertebra is still unknown.

infectious hypothesis was raised, including contamination by germs called "slow-growth" such as Propionibacterium acnes (PA).

Many studies interesting Bacteriological analysis of disc material found the presence of bacteria (prevalence between 0 and 54%).

A recent clinical trial evaluating the efficacy of antibiotic treatment compared to placebo in low back pain with Modic 1; a show effectiveness of this treatment on the different clinical parameters evaluated.

However skin contamination is not formally excluded, particularly in patients previously infiltrated (including epidural).

Our hypothesis is that the slow-growing bacteria are not involved in Modic 1 type of disc disease, and the possible presence of PA or other slow-growing bacteria in samples obtained discal posterior approach would be related to intraoperative contamination or during preoperative spinal infiltrations The main objective is to assess the prevalence of germs slow growth in the intervertebral disc in the spinal surgery by anterior disc disease in type 1 Modic.


Eligibility Criteria:
Inclusion Criteria:

* Major patients accepted to participate in the study and who signed an informed consent.
* Patients with low back pain lasting for more than 6 months, disabling, with disc disease type 1 Modic eligible for a disc prosthesis or arthrodesis anterior approach.
* Patients underwent surgery for nerve root pain by disc herniation on MRI viewable with a radio-clinical concordance with or without Modic 1 disc disease in the operated disc

Exclusion Criteria:

* Lumbar spine surgery history within 12 months and / or presence of osteosynthesis material.
* Immunocompromised patients (HIV, cancer, immunosuppressive treatment, lupus, chronic infection, ...)
* Patients previously treated with antibiotics exceeding 15 days during last 3 months prior enrollment for a period
BioComp Implants in Anaplastology - Pilot Study

At the department of Cranio-Maxillofacial Surgery, Maastricht University Medical Center (MUMC) the routine procedure after ablation of the nose, ear or eye is reconstruction with an episthesis. Retention can be achieved using adhesives, undercuts or bone implants. Implant based episthesis are now commonly used because of the good retention and episthesis stability. This results in a better patient quality of life.

Today we use machined surface implants in the craniofacial region of different brands. Each system has its own instruments and application method. To enhance the clinical usability, we are searching for one system for all extra-oral implant regions.

Furthermore, implant patients may be compromised by aging, diseases, smoking, medication and radiation therapy, which can affect the bone healing process. In these cases, implants are known to have higher failure rates compared to the application in healthy cases. Therefore implants with biomechanical surface modifications, such as the HAVD implants of BioComp, may have a positive effect on osseointegration, resulting in higher success rates in the compromised patient.

The aim of this pilot study is to collect information about the functionality and safety of a surface treated implant system (HAVD, BioComp) for episthetic reconstruction after ablative surgery in the nasal, orbital and auricular region for a potential future RCT.


Eligibility Criteria:
Inclusion Criteria:

* In need of an auricular, nasal or orbital episthesis
* Be able to maintain a good personal hygiene

Exclusion Criteria:

* Contraindications for general anesthesia
* DEmentia or other psychiatric disorders/ unable to maintain a good personal hygiene
* Poor personal hygiene
* Pregnancy
* Acute infection
* Immunosuppression
* Compromised by medication
* Local irradiation \>50Gray
Effects of Dry Needling and Strain Counter Strain Technique in Myofascial Trigger Points of Upper Trapezius

To determine the effects of Dry Needling and Strain Counter Strain Technique in Myofascial Trigger Points of Upper Trapezius

It is Randomized Controlled trail will be conduct in Mayo Hospital Lahore and Alnoor Hospital Awan town Lahore. Non probability consecutive sampling technique will be used to collect the data. Each group contain the 14 patients, Patient will be divided into two groups. Group A will be experimental group treated by Dry needling and strain counter strain with baseline treatment and Group B will be control group treated by Strain counter strain with baseline treatment(Hot pack 10 mints,stretching,Neck isometrics). Neck Disability index (NDI) ,visual analogue scale(VAS) and goniometer will be used as data collecting tools.

Eligibility Criteria:
Inclusion Criteria:

* Patients with non-specific neck pain, having active myofascial trigger points in upper trapezius muscle.
* Patient of both gender under the age of 20-40 year
* bilateral pain involving the upper trapezius
* a duration of pain of at least 3 months
* pain localized in the cervical and occipital regions but not in the orofacial region.
* restricted cervical range of motion(side flexion)

Exclusion Criteria:

* history of traumatic injuries (e.g., contusion, fracture, and whiplash injury)
* needle phobia patients.
* systemic diseases such as blood coagula tion disorders, chronic pain syndrome, cancer,allergies fibromyalgia, systemic lupus erythematous, and psoriatic arthritis.
* cervical spine surgery patients.
* orofacial pain and temporomandibular disorders
* neurologic disorders (e.g., trigeminal neuralgia or occipital neuralgia)
* medical diagnosis of any primary headache (tension type or migraine) clinical diagnosis of cervical radiculopathy or myelopathy
* history of previous physical therapy intervention for the cervical region in last 6 month
* use of anticoagulants, opioids or antiepileptic medications
A Study Investigating the Efficacy and Safety of Intravitreal (IVT) Injections of ANX007 in Participants With Geographic Atrophy (GA)

The primary purpose of the study is to determine if IVT injections of ANX007 every month reduce vision loss in participants with GA secondary to age-related macular degeneration (AMD).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of GA of the macula secondary to AMD as determined by the Investigator and confirmed by the independent Central Reading Center.

Exclusion Criteria:

* Geographic atrophy due to other causes than AMD such as Stargardt disease, cone-rod dystrophy, pathologic myopia, or toxic maculopathies (for example, plaquenil maculopathy) in either eye.

NOTE: Other protocol-defined inclusion and exclusion criteria may apply.
Effect of Different Wavelengths of Repeated Low-Level Light Therapy on Choroidal and Retinal Blood Flow Among Adults

The purpose of this clinical trial is to evaluate the effect of different intensity of repeated low-level red-light (RLRL) therapy on the choroidal and retinal blood flow among adults.

Repeated low-level red-light (RLRL) therapy is an emerging innovative and non-invasive treatment for a variety of eye diseases. Notably, RLRL was found to be effective in thickening choroidal thickness in a 1-year randomized controlled trial, indicating its potential in modulating blood flow in the fundus. However, it remains unclear how long it takes for the RLRL to make a difference in fundus blood flow and whether there is a dose-response.

The purpose of this study is to evaluate the different wavelengths of of repeated low level light therapy on the choroidal and retinal blood flow among adults. This study will be conducted with a randomized cross-over design with a total follow-up of 3 months. The repeated low level light therapy will be carried out in the study site under supervision according to a standard protocol. Detailed ophthalmic examinations, including visual acuity, intraocular pressure, optical coherence tomography/angiography, optical coherence tomography angiography, cycloplegic spherical equivalent refraction, slit lamp, and biological parameters will be evaluated at enrollment and during follow-ups.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-40 years at enrolment.
2. Healthy adults with best corrected visual acuity equal to or better than 1.0 in both eyes.
3. Provision of consent and able to participate in all required activities of the study.

Exclusion Criteria:

1. Secondary myopia, such as a history of retinopathy of prematurity or neonatal problems, or syndromic myopia with a known genetic disease or connective tissue disorders, such as Stickler or Marfan syndrome; or high myopia \< -8 diopters.
2. Strabismus and vision abnormalities (astigmatism \> 3.5 D) in either eye.
3. Refractive media opacity: corneal opacities, cataracts, or implanted intraocular lens, etc.
4. Ocular abnormalities that affect retinal function: macular degeneration, diabetic retinopathy, retinal detachment, glaucoma, or ocular hypertension, endophthalmitis, uveitis, optic neuropathy, etc.
5. Previous history of refractive surgery, intraocular surgery, laser therapy, and intravitreal injection, etc.
6. Systemic abnormalities: diabetes, hypertension, etc.
7. Drugs therapies with toxicity effects on the retina: hydroxychloroquine, etc.
8. Prior treatment of myopia control in the past three months including drugs, orthokeratology, progressive addition lenses, bifocal lenses, etc.
9. Other contraindications, including but not limited to ocular or other systemic abnormalities, that the physician may consider inappropriate for enrolment.