cyrilzakka/clinical-trials huggingface dataset:
Evolution of Vestibular Function After Treatment of a Vestibular Schwannoma by Gamma-knife Radio-surgery

The purpose of this study is to evaluate the vestibular effects of gamma-knife radiosurgery, as part of the treatment of vestibular schwannoma.

Vestibular schwannoma is a benign tumor located on the vestibulocochlear nerve. It represents 6 to 8% of intracranial tumors, 80% of ponto-cerebral angle tumors and its frequency is 13 cases per million inhabitants per year.

The main symptoms related to the development of vestibular schwannoma are unilateral deafness of perception, unilateral tinnitus, unilateral vestibular deficit vertigo, facial paralysis.

Management is divided into 3 options: monitoring, surgery and gamma-knife radiosurgery.

This study will focus on gamma-knife radiosurgery. The objective of this treatment is to stabilize the evolution of schwannoma.

This study aims to describe the vestibular effects of radiosurgery.

Eligibility Criteria:
Inclusion Criteria :

* Men and women aged 18 to 90 included
* Subject who benefited from gamma-knife radiosurgery as part of the treatment of vestibular schwannoma
* Non-opposition of the subject to participate in the study
* Affiliation to a French social security scheme or beneficiary of such a scheme

Exclusion Criteria :

* Subject with another vestibular pathology
* Subject who did not benefit from a vestibular assessment before treatment with gamma-knife radiosurgery
* Legal incapacity or limited legal capacity
* Subject unlikely to cooperate in the study and/or weak cooperation anticipated by the investigator
* Subject without health insurance
* Subject being in the period of exclusion from another study or provided for by the "national volunteer file".
Estrogen Sensitivity and Ovulatory Dysfunction in Obesity

The sole purpose of this study is to evaluate pathophysiology of disease. The disease state that is being evaluated is the obesity-related alterations in reproductive hormones

* The obesity epidemic in the United States is advancing at an accelerated pace. It is estimated that by 2015, 41% of U.S. adults will be obese as defined by a body mass index (BMI) of greater than 30 kg/m2. The U.S. government's 2010 Dietary Guidelines regard obesity as the single greatest health hazard in this century. Female adult obesity is associated with menstrual cycle irregularities, ovulatory dysfunction and a higher risk of obstetrical complications. This reproductive phenotype of obesity is worsened by further increases in BMI and is not solely due to anovulatory infertility. While the association of adiposity with subfertility is well documented in population studies, the underlying mechanisms remain poorly understood. The main objective of this proposal is to clarify the nature of the obesity-related reproductive endocrine abnormalities and identify potential etiologies amenable to therapy.
* Hypothesis: The hypothalamic-pituitary axis is abnormally sensitive to estradiol negative feedback in obesity.

* Design: paired assessments Pre and Post estrogen administration in obese and normal weight women
* AIM 1: To test the pituitary and hypothalamic responsiveness in obesity, we will examine the luteinizing hormone (LH) and follicle-stimulating hormone (FSH) pulsatility during frequent blood sampling.
* AIM 2: To test the ovarian responsiveness in obesity, we will examine urinary reproductive hormones (E1c, estrone conjugates, and Pdg, pregnanediol glucuronide) over an entire menstrual cycle.
* AIM 3: To test the hypothesis that central adiposity is associated with reproductive hormone alterations in obesity, we will quantitatively assess body composition by dual energy x-ray absorptiometry (DXA).

Eligibility Criteria:
Inclusion Criteria:

* Age 18-42 at study entry
* Regular menstrual cycles every 25-40 days
* BMI 18- 25 kg/m2 or ≥30kg/m2
* Good general health
* Prolactin and thyroid-stimulating hormone (TSH) within normal laboratory ranges at screening
* Baseline hemoglobin \>11 gm/dl.

Exclusion Criteria:

* Positive screen for Activated Protein C resistance
* Any contraindications to exogenous estrogen, including previous thromboembolic events or stroke, history of an estrogen-dependent tumor, active liver disease, undiagnosed abnormal uterine bleeding, hypertriglyceridemia, smoking, hypertension
* History of chronic disease affecting hormone production, metabolism or clearance (including diabetes mellitus) or abnormal renal or liver function at screening, such as elevated aspartate or alanine aminotransferases or elevated blood urea nitrogen (BUN) or creatinine
* Current use of thiazolidinediones or metformin (known to interact with reproductive hormones)
* Use of hormones affecting hypothalamic-pituitary ovarian axis within three months of enrollment
* Strenuous exercise (\>4 hours per week)
* Pregnancy, breast-feeding or current active attempts to conceive
Effects of the Myofascial Arm Pull With and Without Active Release Technique in Adhesive Capsulitis

The aim of the study is to determine the effects of the myofascial arm pull with and without active release technique on pain, ROM and disability in adhesive capsulitis.

Adhesive capsulitis (frozen shoulder), a painful disorder caused by capsular inflammation that results in fibrosis and rigidity of the glenohumeral joint capsule, is characterized by a progressive loss of both active and passive glenohumeral movements. Frozen shoulder can be primary (also known as idiopathic) if there is no underlying cause of disease or it can be secondary. The term "secondary frozen shoulder" is associated with injury, trauma, cardiovascular diseases, hemiparesis, or diabetes.Active release technique and myofascial arm pull technique are both effective treatment options for patients with adhesive capsulitis. These techniques help to improve range of motion and reduce pain by releasing tension and adhesions in the affected area. Active release technique focuses on releasing tension and adhesions in the soft tissues surrounding the affected joint, while the Myofascial arm pull technique aims to improve range of motion by stretching the muscle and fascia in the affected area. By incorporating these techniques into a comprehensive treatment plan, patients of adhesive capsulitis can see significant improvement in their pain, range of motion and disability.

Because the method of treatment is inexpensive, findings of this study could be beneficial in revision of the clinical protocols to manage the patients of adhesive capsulitis.

Eligibility Criteria:
Inclusion Criteria:

* Both Male and Female; mean age (35-60).
* Case diagnosed with adhesive capsulitis, both primary and secondary origin.
* Freezing stage of adhesive capsulitis.
* Those with at least a 50% reduction in the range of motion (ROM).

Exclusion Criteria:

* History of shoulder surgery or manipulation under anesthesia, local corticosteroid injection administration to the affected shoulder within the last 3 months.
* Neurological deficit affecting the shoulder functioning during daily activities.
* Pathology of the shoulder joint other than adhesive capsulitis.
* Pain or disorder of the cervical spine, elbow, wrist or hand.
* Patients diagnosed with cancer
Treatment of Breakthrough Cancer Pain According to European Guidelines

Pain is a frequent symptom in cancer patients with a negative impact on the quality of life (QoL).Breakthrough cancer pain (BTcP) is defined as "a transient exacerbation of pain, manifesting spontaneously or related to a specific predictable or unpredictable triggering factor, despite stable and adequately controlled basal pain". The present study assesses the percentage of patients who are treated according to the European guidelines (ESMO, 2018) for BTcP management in 4 European countries and the impact of the adherence to guidelines on patients' pain relief and QoL.

Typical BTcP episodes are of short duration (15-30 minutes/episode), moderate to severe intensity and rapid onset (maximum peak between 3-15 minutes). The best management of BTcP requires a thorough evaluation to tailor the treatment strategies. Indeed, patients with breakthrough pain should have this pain specifically assessed, starting from the appropriate diagnosis. Recently developed European guidelines support this approach and recommend treating BTcP using rapid-onset opioids (ROOs), with pharmacodynamics that mirror the quick start and short duration of the pain episode.Nevertheless, despite the drug treatment for BTcP has undergone knowledge advances in recent years and several guidelines have been published, this condition is still often inadequately managed.

The present study will assess the percentage of patients who are treated according to the European guidelines for BTcP management in 4 European countries and the impact of the adherence to guidelines on patients' pain relief and QoL.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients of any ethnic origin of ≥ 18 years.
* Patients diagnosed with locally advanced or recurrent metastatic cancer (histologic or cytologic diagnosis), with BTcP, as assessed by the Investigator.
* Opioid-tolerant patients receiving doses of oral morphine equivalent daily doses (OMEDD) of at least 60 mg.
* Drugs for BTcP treatment, if any, must be used according to the relevant SmPC.
* Eastern Cooperative Oncology Group (ECOG) performance status with a score of 0, or 1, or 2.
* Patients with life expectancy \> 3 months.
* Patients legally capable of giving their consent to participate in the study and available to sign and date the written informed consent.

Exclusion Criteria:

* Patients with previous or current history of a clinically significant neurological/psychiatric disorder and/or any substance abuse or dependence that, according to the Investigator's judgement, can impair the study end-points/results.
* Patients who have been taking antidepressants and/or drugs acting on pain and who take them on a regular basis during the observation period, can be enrolled.
* Any medical condition or situation complicating the collection of study data, as determined by the Investigator.
Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease.

Phase 3, international, multicenter, open-label 12 month safety study.

Each patient will participate for up to 52 weeks, which includes a Screening Period, followed by a Baseline Visit and open-label treatment for 1 year with a safety Follow-up 4 weeks after the last treatment.

* Screening Period: up to 6 weeks.
* Open-Label Treatment Period: 52 weeks (1 year)
* Post-Treatment Safety Follow Up: 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patient understands study requirements and has given his/her written informed consent on an Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved consent form.
* Parkinson's disease diagnosis consistent with UK Parkinson's Disease Society Brain Bank Diagnostic criteria
* Minimum of 3 years since diagnosis.
* Meet Hoehn and Yahr PD stage
* Good response to levodopa
* Stable regimen of anti-PD medications
* Patients must have been taking a levodopa-containing anti-PD medication continuously for at least the previous 12 months
* Patient has documented a minimum amount of Off time.
* If of childbearing potential (male and female) must use an acceptable method of contraception

Exclusion Criteria:

* Previous tozadenant study participation
* Current or recent participation in another study.
* Secondary or atypical parkinsonism
* Neurosurgical intervention for PD (except DBS if electrode placement has been performed over 12 months prior to screening)
* Patient is taking apomorphine, budipine, istradefylline, tolcapone, or DUOPA™/Duodopa®
* Treatment with excluded medications
* Untreated or uncontrolled hyperthyroidism or hypothyroidism
* Clinically significant out-of-range laboratory
* MMSE out of range
* Current episode of major depression (stable treatment for depression is permitted).
* Recent suicide attempt or suicidal ideation type 4 or type 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS)
* Women lactating or pregnant
* Hypersensitivity to any components of tozadenant or excipients
* Abnormal findings on the physical or neurological examination, or medical history that would make the patient unsuitable for the study
* History of hepatitis or cholangitis
Immediately Placed Implants Using Simvastatin and Autogenous Tooth Graft Combination in Periodontally Compromised Sites

Recently, autogenous tooth graft (ATG) made from compromised teeth was applied in bone defects and resulted in a good clinical efficacy.(6) Moreover, it is more accepted by patients to use extracted teeth as a bone graft material, especially in the case of immediate implant placement. Simvastatin (SMV), known as a 3-hydroxy-3-methylglutaryl-CoA (HMG-CoA) reductase inhibitor, is widely used to decrease serum cholesterol because of its safe and effective treatment. Apart from cholesterol-lowering effects, SMV is also found to promote osteogenic differentiation of bone marrow stem cells (BMSCs), suppress osteoclastic differentiation in bone tissue and promotes osseointegration around implants in animal studies. SMV is reported to enhance autophagy and alleviates the ROS of BMSCs in the osseointegration of implants. The present study will be carried out to evaluate the effect of SMV combined with ATG on bone formation around immediately placed dental implants.


Eligibility Criteria:
Inclusion Criteria:

* Teeth need to be extracted for periodontal reasons with a defect of labial bone (horizontal or vertical bone defect).
* the teeth without acute inflammation.
* no uncontrolled systemic disease which is not suitable for implantation.
* Good systemic and oral health.

Exclusion Criteria:

* patients with systemic diseases or medications known to alter healing processes.
* Psychiatric disorders.
* Root canal treated teeth.
* patients undergoing or who had undergone radiation therapy and chemotherapy to the head and neck region during 12 months.
* patients with para-functional habits.
* alcoholics.
* drug abusers.
* heavy smokers
Osteonecrosis of the Jaw (ONJ) and Infection Among Nordic Cancer Patients Treated With XGEVA™ or Zoledronic Acid

A non-interventional study to assess incident rates of Osteonecrosis of the Jaw and Infections leading to hospitalization in Cancer patients treated with XGEVA™ in Sweden, Denmark and Norway.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* diagnosed with cancer
* subsequent to cancer diagnosis, initiating cancer-related antiresorptive treatment during the treatment cohort identification period with XGEVA or zoledronic acid or switching to XGEVA from cancer-related treatment with oral or IV bisphosphonates at the dose indicated for SRE prevention of less than 2 years duration (≤ 24 IV infusions or ≤ 24 monthly oral prescriptions)

Exclusion Criteria:

* history of radiation treatment for head and neck cancer before a subject's potential index date
* hypercalcemia of malignancy as the sole indication for treatment with an anti-resorptive agent
Comparison of Ultrasound-Guided Quadratus Lumborum Plane Block Versus Intraperitoneal and Periportal Bupivacaine Infiltration in Postoperative Analgesia After Laparoscopic Cholecystectomy

The primary outcome: is measured by pain at rest and upon mobilization according to VAS. VAS for pain (ranging from 0 to 10, where 0 no pain and 10 maximum pain) will be evaluated postoperatively and every 2 hours during the first 6 hours and then every 6 hours for 24 hours postoperatively.

Since the concept of day case surgeries is getting more popular, surgeons and anesthesiologists are trying their best to provide adequate post-operative analgesia. The proper management of post-operative pain ensures early ambulation of patients and obviates many post-operative complications.

The most common modality for post-operative pain management has remained the parenteral use of non-steroidal anti-inflammatory drugs (NSAIDs) and opioids.

Intraperitoneal and periportal infiltration with local anesthetic agents has also remained a popular method to take care of immediate postoperative pain. This technique is virtually cost-free, rapid, and hardly requires any special technical experience or equipment for its use. But as there are advances in anesthetic techniques, more and more regional blocks are being tried to take care of post-operative pain. The choice of anaesthetic block technique depends upon the site of surgical incision proposed.

Quadratus lumborum (QL) block is a posterior abdominal wall block which permits the spread of local anesthetic agent behind the quadratus lumborum muscle into a triangular space known as a lumbar interfacial triangle, which lies beside the middle layer of the thoracolumbar fascia.

This interfacial plane is in adjoining proximity with numerous sympathetic fibers and conjoin with the thoracic paravertebral space, thus preceding to a long-standing block with the capability to provide visceral analgesia (Kadam, 2013).

Eligibility Criteria:
Inclusion Criteria:

* Age 21-60 years of both sexes.
* Elective laparoscopic cholecystectomy under general anesthesia.
* Physical Status: ASA I and II patients after taking written and informed consent.

Exclusion Criteria:

* • Refusal of procedure or participation in the study by patients.

  * Physical status: ASA III or above.
  * Infection at site of injection.
  * Psychiatric illness that leads to inability to cooperate, speak or read.
  * Daily use of opioids.
  * History or evidence of coagulopathy especially if INR\>1.5 and platelet \<100.000
  * Allergies to drugs used (Bupivacaine 0.5%).
Anal Incontinence After Obstetrical Anal Sphincter Injury

Obstetrical Anal Sphincter Injury is an identified risk factor for anal incontinence. The mechanisms and the risk factors for anal incontinence in Obstetrical Anal Sphincter Injury women are not well known.

Anal incontinence in such women is not well documented and probably underestimated. Cohort studies estimated that up to 53% of Obstetrical Anal Sphincter Injury women are incontinent but that most of them does not complain their doctor.


Eligibility Criteria:
Inclusion Criteria:

* Childbirth between 2005 January 1st and 2019 December 31th
* Obstetrical Anal Sphincter Injury -≥ 18 y

Exclusion Criteria:

* Patients' refusal
* lost of view or deceased
* anal incontinence before the Obstetrical Anal Sphincter Injury
Enhancing STDP After Spinal Cord Injury

The overall goal is to develop new clinical approaches to restore limb function after spinal cord injury (SCI). Corticospinal tract (CST) axons are involved in controlling limb function. Paired pulse induced spike-timing dependent plasticity (STDP) enhances synaptic strength between residual CST axons and spinal motoneurons (SMNs) resulting in temporary improvements in limb function in humans with incomplete SCI. Motor training will be combined with paired-pulse STDP stimulation to further enhance plasticity and behavioral recovery.

To induce STDP with paired pulse, corticospinal volleys evoked by either transcranial magnetic stimulation over the primary motor cortex for upper extremities or electrical stimulation over the thoracic spine for lower extremities arrive at corticospinal-motor neuronal synapses of upper- or lower-limb muscles, 1-2 ms before antidromic potentials were elicited in motor neurons by electrical stimulation of corresponding peripheral nerves.

Eligibility Criteria:
Inclusion Criteria:

Participants who are unimpaired healthy controls:

* Male and females between ages 18-85 years
* Right handed
* Able to complete precision grips with both hands
* Able to complete full wrist flexion-extension bilaterally
* Able to walk unassisted
* Able to complete full ankle flexion-extension bilaterally

Participants who have had a spinal cord injury:

* Male and females between ages 18-85 years
* SCI ( 6 months of injury)
* Spinal Cord injury at or above L5
* The ability to produce a visible precision grip force with one hand
* Able to perform some small wrist flexion and extension
* The ability to perform a small visible contraction with dorsiflexion and hip flexor muscles
* No subjects will be excluded based on their race, religion, ethnicity, gender or HIV status.
* ASIA A,B,C, or D

Exclusion Criteria:

Exclusion criteria for enrollment For SCI and Healthy Control Subjects (4-8 exclusion for non-invasive brain stimulation only):

* Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease
* Any debilitating disease prior to the SCI that caused exercise intolerance
* Premorbid, ongoing major depression or psychosis, altered cognitive status
* History of head injury or stroke
* Metal plate in skull
* History of seizures
* Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold (see appendix 2)
* Pregnant females
* Ongoing cord compression or a syrinx in the spinal cord or who suffer from a spinal cord disease such as spinal stenosis, spina bifida, MS, or herniated disk
* Individuals with scalp shrapnel, cochlear implants, or aneurysm clips.
Evaluation of Effect of Integrated Treatment by Traditional Chinese and Western Medicine for Severe Acute Pancreatitis

With multicenter randomized control clinical evaluation investigations, the scheme of integrated medicine treatment of severe acute pancreatitis (SAP) was further improved, and the therapeutic effects, safety and indications assured. Drawing in latest research fruits at home and abroad, a clinical practical guideline for integrated medicine of diagnosis and treatment of SAP would be formed, to be popularized all over China.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients 18yr-70yr, complying with the diagnostic standard of acute pancretitis (clinical symptoms and signs, elevated blood and urine amylase, and imaging criteria), conforming to 3 or more Ranson's criteria and APACHE-II score larger than 8, Balhazar CT score larger than 5.

Exclusion Criteria:

* Pregnancy, nursing mother, critical cases of advanced tumor, on the verge of death (estimated to be moral in 12h), severe visceral function disturbance, patients undergoing other therapeutic research that might interfere with the present study.