cyrilzakka/clinical-trials huggingface dataset:
The Benefit of Prophylactic Anticonvulsant in Post Cardiac Arrest Syndrome With Induced Mild Hypothermia

Cardiac arrest is a leading cause of sudden death, but the survival rate of cardiac arrest is only 5-35%.

Although, the first resuscitation of cardiac arrest patient would be success, the hypoxic brain injury after cardiac arrest is an important cause of the mortality and the morbidity.

For the management of the hypoxic brain injury after cardiac arrest, American Heart Association and European Resuscitation Council recommend induced mild hypothermia therapy. And, ILCOR(International Liaison Committee on Resuscitation) announced the standard treatment of post cardiac arrest syndrome(the success state of first resuscitation of the cardiac arrest patient) included the induced mild hypothermia therapy at September, 2008.

The generalized seizure and myoclonus arise in over 60% of post cardiac arrest syndrome patients and they are very difficult to control. Also, the occurrence of them implies poor prognosis of the patient.

Although, mild hypothermia therapy could be decrease the development and propagation of generalized seizure and myoclonus theologically, the therapy could not prevent the development and propagation of them entirely. Therefore, the use of prophylactic anticonvulsant should be needed. But, there is not randomized control study about the use of prophylactic anticonvulsant.

We hypothesized that the use of prophylactic anticonvulsant to post cardiac arrest syndrome patients would decrease the rate of occurrence of generalized seizure and myoclonus and would improve the neurologic outcome.

We planed that we used two anti-epileptic drugs - valproate, clonazepam - for the prophylactic anticonvulsant. The valproate and clonazepam are in general use for prevention and treatment of generalized seizure and myoclonus and are recommended to treat of generalized seizure and myoclonus to post cardiac arrest syndrome patients by 2008 guideline of ILCOR.


Eligibility Criteria:
Inclusion Criteria:

* Age : over 18, under 80
* Witnessed arrest
* Successful first resuscitation (ROSC should be last for 20 min.)
* Coma or Semicoma state
* Mean arterial pressure \> 60mmHg
* Peripheral Oxygen saturation \> 85%
* Expected life span before cardiac arrest \> 3 month.
* Performance scale before cardiac arrest \> 3 month.

Exclusion Criteria:

* Cause of arrest

  * Sepsis, Progression of malignancy, Trauma, Hemorrhagic shock
* Known Coagulopathy
* Major operation within 7 days
* Previous seizure history
* current use of valproate or clonazepam
Study of Vitamin D in the Severely Mentally Ill

Supplementation of Vitamin D in those with low levels will increase the level and result in some improvement in health and psychopathology measures.

Subjects with levels of Vitamin D between 7ng/ml and 30ng/ml will, after signing consent forms, be randomly assigned to either start immediately on Vitamin D for three months or to start after a delay of three months. Those with levels below 7gn/ml will start immediately. All will be evaluated monthly with blood tests, PANSS, movement disorder ratings and information on health and progress from the clinical chart.

Eligibility Criteria:
Inclusion Criteria:

* Age 19-70,
* Schizophrenia or Schizoaffective disorder
* stabilized but not expecting to be discharged soon
* capacity to give informed consent

Exclusion Criteria:

* acutely psychotic
* acutely medically ill
* renal insufficiency
* hypercalcemia
* hyperparathyroidism
Smartphone-Administered App Treatment for Adults With Body Dysmorphic Disorder

The investigators are developing and testing a Smartphone-based cognitive behavioral therapy (CBT) "app" for body dysmorphic disorder (BDD). The investigators hypothesize that app-based CBT for BDD will be feasible and acceptable to individuals with BDD, and will improve body image concerns and related outcomes.

The primary aims of this study are to develop and test the feasibility, acceptability, and preliminary efficacy of a Smartphone-based CBT treatment for adults with BDD. This project aims to solve two healthcare problems: poor access to empirically-supportive treatment for BDD, and challenges of generalizing CBT skills outside therapy sessions. Inadequate treatment access is due to limited professionals offering this specialized treatment, economic barriers, and shame preventing sufferers from seeking in-person care. Mobile app-based CBT would solve this access gap by addressing each of these barriers. Among those who obtain CBT, practicing skills outside of therapy is critical for treatment effectiveness, as BDD symptoms occur around-the-clock and can be most impairing at home. However, BDD patients struggle to use skills without therapists' in-person support. App-based CBT that provides on-hand skills coaching addresses this treatment generalization challenge.

This study involves developing the app-based CBT for BDD treatment, and then investigating the initial feasibility, acceptability, and preliminary efficacy of the app-based treatment in an open pilot trial (N = 10), consisting of 12-weeks of active treatment plus a 6-month follow up period.

Eligibility Criteria:
Phase 1B (open pilot trial):

Inclusion Criteria:

* At least 18 years of age
* Outpatients
* Meets current diagnosis of primary DSM-5 BDD
* Has score on BDD-YBOCS of ≥ 20
* Currently living in the United States

Exclusion Criteria:

* Psychotropic medication changes within 2 months prior to enrollment
* Participants taking psychotropic medication have to have been on a stable dose for at least 2 months prior to enrollment and not change medication during study period
* Participated in CBT for BDD ever during lifetime
* Current substance dependence
* Lifetime bipolar disorder or psychosis
* Acute, active suicidal ideation
* Current severe comorbid major depression, defined by a PHQ-9 total score ≥ 20
* Personality disorder that could jeopardize treatment participation (e.g., borderline personality disorder with self-harm)
* Concurrent psychological treatment
* Do not own a supported mobile Smart phone with a data plan (currently iPhone 5S or more recent, running iOS 9 or newer)
* Intellectual disability or other cognitive impairment that would interfere with ability to engage in CBT
Morphologic and Biomechanical Analysis of the Carpal Ligaments

Compare various dynamic biomechanical markers (distances and angles) in the wrist during dynamic CT studies in three groups of patients: Normal subjects, with scapholunate instability and with other types of wrist instability.

Patients referred for the evaluation of wrist pain with CT arthrography will be eligible for inclusion. Patients will benefit from dynamic CT acquisitions before and after arthrography with three maneuvers: radio-ulnar deviation, clenching fist and dart throwing motion. Patients will also benefit from a wrist MR study on a 3 tesla scanner.

The morphology of the carpal ligaments will be evaluated on static imaging (MR and CT arthrograph) and on dynamic CT arthrography.

Distance and angular measurements will be obtained from dynamic CT studies using an appropriate post processing tool (4D-Ortho).

Data obtained with dynamic wrist evaluation will be correlated to ligament morphology, classical wrist instability criteria on conventional radiographs and with surgery (if available).

Eligibility Criteria:
Inclusion Criteria:

* Clinical signs of wrist instability or wrist pain
* Previous medical examination
* Informed consent
* Must have a social security number

Exclusion Criteria:

* MR or CT contra-indications
* No prior surgery
* Pregnancy
Study of STA-9090, Administered Twice-Weekly in Patients With Solid Tumors

An open-label dose escalation study of patients with solid tumors treated with STA-9090 (ganetespib)

This is an open-label Phase 1 dose-escalation study in patients with solid tumors treated with STA-9090 (ganetespib) to evaluate for safety, tolerance and efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be documented to be refractory or not candidates for current approved therapies. - Must have anECOG status 0-2. - Peripheral neuropathy ?2.
* Must have acceptable organ and marrow function per protocol parameters.
* No clinically significant ventricular arrythmias or ischemia.

Exclusion Criteria:

* Must not be pregnant or breastfeeding. -No chemotherapy or radiation within 3 weeks..
* No previous radiation to \>25% of total bone marrow.
* No previous high dose chemotherapy with autologous or allogeniec hematopoietic stem cell transplantation.
* No primary brain tumors or active brain metastases.
* No use of any investigational agents within 4 weeks.
* No treatment with chronic immunosuppressants.
* No uncontrolled, intercurrent illness.
Comparison of Hypertonic Saline and Mannitol on Brain Relaxation During Supratentorial Tumors Resection

Hyperosmotic agents are used to decrease intracranial pressure. The aim of the study is to compare the effects of continuous 3% hypertonic saline (HS), bolus HS and 20% mannitol on intraoperative brain relaxation in patients with raised intracranial pressure during surgery for supratentorial tumors.

After obtaining approval from the ethics committee and informed consent, a total of 90 patients aged 18-70 years, conscious (GCS\>13) and American Society of Anesthesiologists (ASA) class I-III, who had intracranial shift \>0.5 cm or glioblastoma multiforme or metastatic tumor and who were scheduled for supratentorial mass resection under elective conditions, will be included in the present prospective, randomized, double-blind and placebo-controlled study. Patients with heart failure, kidney insufficiency, diabetes insipidus, electrolyte imbalance and who are unconscious will be excluded from the study.

The patients will randomized into 3 groups:

Group 1: %3 HS bolus 3 mL.kg-1 Group 2: %3 HS infusion 20 ml/h Group 3: %20 mannitol 0,6 gr.kg-1 After head fixation, all patients will be administered with HS or mannitol (over 20 minutes). Arterial blood gas (ABG) analysis (Cobas b 221 blood gas analyzer, Roche®, Basel, Switzerland) will be made at 30 minute,2,4,6,8. hours. Blood sodium, potassium, chlorine, base excess, lactate levels and blood osmolarity will be recorded in each time intervals. The brain relaxation scale will be recorded at the time of dura opening.

Eligibility Criteria:
Inclusion Criteria:

* Elective supratentorial tumor resection
* Glioblastoma multiforme
* Metastatic tumor
* Intracranial shift \>0.5 cm
* GCS\>13

Exclusion Criteria:

* Renal failure
* Heart failure
* Electrolyte imbalance
Efficiency of Placental Drug Melsmon® in Correction of Climacteric Symptoms in Premenopausal Women

The placental drug Melsmon® is effective for correction of insomnia and other climacteric symptoms in premenopausal women. Decrease of MMI is shown both in groups with Melsmon® and Placebo, but it was more significant in patients who used Melsmon®.

There were 40 women under the observation, with mild and moderate symptoms of climacteric syndrome with sleep disorders (for that the investigators evaluated modified Kupperman Index).

All patients were randomized with the help of the envelope method with the allocation ratio of 1:1 (one-to-one). 20 women were prescribed placenta extract Melsmon and 20 received placebo during 4 months.

Eligibility Criteria:
Inclusion Criteria:

* More than 40 years of age
* Irregular menstrual cycle
* Climacteric symptoms, including sleep disorders
* follicule-stimulating hormone \>20 milli international units/ml -

Exclusion Criteria:

* Non-controlled hypertension (more than 140 mm Hg)
* Decompensated chronic diseases of the cardiovascular system, myocardial infarction, history of stroke
* Diabetes mellitus
* Kidney and hepatic dysfunction
* Cancer
* Breast fibroadenomas, adenomas and cysts
* Uterine fibroids with dominant nodule diameter ˃ 2 cm,
* Endometrial hyperplasia
* Individual drug idiosyncrasy
* Intake of any drugs for correction of climacteric symptoms and sleep disorders
HIV-HEART Aging Study

The HIV/HEART Aging study (HIVH) is an ongoing, prospective, multicentre trial that was conducted to assess the incidence, the prevalence and the clinical course of cardiovascular diseases (CVD) in HIV-infected patients. The study population includes outpatients from specialized HIV-care units of the German Ruhr region, who were at least 18 years of age, were known to have a HIV-infection and exhibited a stable disease status within 4 weeks before inclusion into the trial. From March 2004 (Pilot phase) to October 2022 (15 year Follow-up) 1858 HIV+ patients were recruited in a consecutive manner. The standardised examinations included a targeted assessment of medical history and physical examination. Blood was drawn for comprehensive laboratory tests including HIV specific parameters (CD4 cell count, HIV-1 RNA levels) and cardiovascular items (lipid concentrations, BNP values and renal parameters). Furthermore, non-invasive tests were performed during the initial visit, including additional heart rate and blood pressure measurements, electrocardiogram (ECGs) and transthoracic echocardiography (TTE). Examinations were completed in accordance with previously defined standard operating procedures. CVD were defined as coronary, cerebrovascular, peripheral arterial disease, heart failure or cardiac vitium.

A comprehensive detailed description of the study procedures had been previously published (European Journal of medical research 2007;12:243-248).

Comprehensive non invasive cardiovascular examination

* Anamnesis
* File recherche,Physical examination
* Documentation of the cardiovascular and antiretroviral medical therapy
* Electrocardiogram
* Transthoracic echocardiography (optional)
* Exercise electrocardiogram (optional)
* Exercise Montreal Cognitive Assessment test (optional)
* Exercise the Grooved Pegboard test (optional)
* Blood and stool sample collection (optional)
* Questionnaire to quality of life and health economics

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Known HIV-infection
* Signed informed consent

Exclusion Criteria:

* Acute cardiovascular disease
* Unstable hemodynamic status in the three weeks before inclusion
* Pregnancy
The Effect of Sleep Loss on Emotion Regulation

The study is designed to investigate the impact of three nights of sleep restricted to 4 hours per night, on the processing and regulation of emotional information compared to Insomnia Disorder and control. The investigators will address and attempt to answer two questions.

(i) How do three nights of reduced sleep or a diagnosis of Insomnia Disorder affect the processing and regulation of emotional information compared to typical, undisturbed sleep? (ii) What overlapping and distinct neural mechanisms are engaged and associated with behavioral effects when attempting to process and regulate emotions in a sleep restricted state or with a clinical diagnosis of Insomnia Disorder? This study will investigate sleep's role in emotion processing and regulation. The findings will help further understanding of the role of sleep in healthy emotional functioning.

Goal 1: How does sleep loss and clinical sleep disruption (i.e. Insomnia Disorder) impact emotion perception and emotion regulation? The investigators are interested in how chronic loss of sleep, either through artificially restricting sleep or clinically related sleep disturbance, impairs our ability to properly perceive and regulate our responses to emotional information using various emotion regulation strategies. There has been research on the effect of sleep loss on broad areas of cognition, such as attention, working memory, and reasoning ability, but the impact of long-term sleep loss on emotional processing and regulation remains largely unexplored. The investigators aim to characterize how sleep loss via experimentally reduced sleep in healthy control participants or clinical sleep disturbance in patients with Insomnia Disorder, affects the ability to accurately perceive emotion. Investigators will also investigate how it alters the intensity with which emotions are perceived, and the effect that these changes have on the ability to regulate emotional responses to these stimuli compared to healthy control participants that are allowed undisturbed sleep.

Goal 2: How are changes in subjective emotional responses reflected in the neural signal and psychophysiological measures? The investigators will utilize fMRI and measures of autonomic reactivity (heart rate and skin conductance) to characterize the neural and psychophysiological responses that are associated with behavioral changes following sleep restriction or in patients with Insomnia disorder compared to healthy sleep control participants.

Eligibility Criteria:
Inclusion Criteria:

* willing and able to follow the protocol
* willing and able to meet inclusion criteria for fMRI scanning
* willing to refrain from alcohol and recreational drugs for the duration of the protocol
* normal or corrected to normal vision is required

Exclusion Criteria:

* left-handedness or ambidexterity
* the use of any drugs that could affect either sleep or cognitive functioning (e.g., prescription sleeping pills or antidepressants)
A Clinical Trial to Evaluate the Safety and Efficacy of Enjuvia 0.3 mg for the Treatment of Vulvovaginal Atrophy

This is a two-arm, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy of Enjuvia 0.3 mg tablets for the treatment of moderate to severe symptoms of vulvovaginal atrophy in postmenopausal women with or without a hysterectomy and/or oophorectomy.

The study will include a screening period up to 4 weeks and a 12-week treatment period. The overall study duration for participants will be approximately 16 weeks. Study participants will undergo physical and gynecological exams, and blood tests for clinical laboratory assessments. All patients with a uterus will undergo transvaginal ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* Naturally or surgically postmenopausal
* Moderate or severe symptoms of vaginal atrophy (ie, dryness, itching, pain, uncomfortable intercourse)

Exclusion Criteria:

* Known sensitivity or contraindication to estrogens or progestins
* History or current diagnosis of endometrial hyperplasia
* Recent history of vaginal bleeding of unknown cause
* Recent history or diagnosis of endometriosis
* Any contraindication to estrogen therapy
Research of Resistance to Antiplatelet Agents and Development of Tailored Treatment Model for Patients With Coronary Artery Disease

The purpose of this study is to evaluate the prognosis of patients with resistance to antiplatelet agent and develop tailored treatment model for patients with coronary artery disease.


Eligibility Criteria:
Inclusion Criteria:

* Age \>20
* Patients with coronary artery disease
* Patients with peripheral artery disease

Exclusion Criteria:

* Renal dysfunction
* Hepatic dysfunction
* Major surgery planned within 1 year
* Malignant tumor
* History of gastrointestinal bleeding
* low or high platelet count
The Use of Botulinum Toxin in the Management of Myofascial Pain Syndrome

The objective of this study was to assess the efficacy of Botulinum toxin type (A) (BoNTA) injection in Myofascial pain syndrome management in the terms of duration of function improvement and pain reduction.

Material and methods: Fourteen patients with Myofascial pain syndrome related to masticatory muscles were presented with trismus, pain and impairment of oral function. Treatment plan was established by utilizing thirty units of Botulinum toxin type (A) which was injected into masseter and sometimes temporalis muscle.

Myofascial pain syndrome (MPS) is acute or chronic musculoskeletal pain that characterized by the presence of unique trigger points of pain (TrPs) . Etiology of this condition may include psychogenic stress, prolong muscle strain, trauma to the joint or muscle, arthritis, myositis, chronic infection, and general fatigue. Current therapeutic approaches available for Myofascial pain syndrome involved pharmacological and non-pharmacological treatment options. The non-pharmacological techniques may include a) manual therapy by muscle stretch or massage, b) muscular taut band injection by local anesthesia or botulinum toxin, c) acupuncture, and d) therapeutic ultrasound .

Botulinum toxin is a neurotoxin protein produced by anaerobic bacteria (clostridium botulinum) . It was first discovered by a German physician named Justinus Kerner who observed that the toxin acts by impeding signal transmission in the somatic and autonomic motor systems, leaving the sensory signal transmission uninterrupted .

It blocked the acetylcholine release from the nerve endings thus prevent the neurological signals transmission at the neuromuscular junction. In turn, this reduces the muscle contraction and produces relaxation of the muscle . However, the clinical effects of Botulinum toxin are transit as these neurotoxins degenerate at nerve terminals and became inefficient after a period of time .

Although numerous articles were published on the Botulinum Toxin A (BoNTA) injection in the management of MPS, but there were diverse clinical results in the literature regarding this subject and its effectiveness is still questionable . The objective of this study was to evaluate the efficiency and outcomes of BoNTA injection in the management of MPS related to masticatory muscles.

Eligibility Criteria:
Inclusion Criteria:

1. Patient with myofascial pain related to the muscles of mastication (masseter and temporalis muscle).
2. Patient with regional pain.
3. Patient with or without limited mouth opening (trismus).
4. Presence of trigger points within the identified masticatory muscles.

Exclusion Criteria:

- 1. Hypersensitivity to Botulinum toxin. 2. Active infection in the virtual points of injection. 3. Patient with generalized musculoskeletal pain as in Fibromyalgia Syndrome (FMS).

4. Children younger than 12 years old and pregnant woman. 5-Patient recently undergone to one other modality of treatment