cyrilzakka/clinical-trials huggingface dataset:
The Effect of GLP-1 Agonists Versus OCs on Reproductive Disorders and Cardiovascular Risks in Overweight PCOS

Polycystic ovary syndrome (PCOS) is a health problem that affects one in 10 women of childbearing age, which is usually characterized by hormonal imbalance and metabolism problems such as hyperandrogenism and obesity. Diane 35 pills are classified as oral contraceptives, which effectively reduces circulating androgens and are treatment for hyperandrogenism caused androgenic skin symptoms and irregular menstrual cycles. GLP-1 Receptor Agonist(e.g. exenatide, liraglutide) have the effects of lowering blood sugar and weight control by inhibiting of gastric emptying and reducing food intake. This study aims to evaluate the effect of metformin-GLP-1 Receptor agonist combination versus metformin-Diane-35 combination treatment on lipid metabolism and cardiovascular risks in overweight polycystic ovarian syndrome (PCOS) patients.

Groups:

Experimental treatment: Metformin-GLP-1 Receptor Agonist Therapy.

Regular treatment: Metformin-Oral Contraceptive(OC) Therapy.

Time Point:

Initial treatment;

Post-treatment (4w);

Post-treatment (8w);

Post-treatment (12w);

Assess reproductive functions and cardiovascular risk factors.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of PCOS according to the Rotterdam criteria based on the presence of two of three criteria: oligomenorrhoea, clinical or biochemical hyperandrogenism and polycystic ovaries on ultrasound after exclusion of other endocrine causes of hyperandrogenism.
* Participants had no concurrent illness and were not on any prescription or over-the-counter medication that was likely to affect insulin sensitivity or lipids for the preceding 12 weeks.
* Participants were advised not to change physical activity or dietary habits during the study period. All subjects were overweight/obese \[body mass index (BMI) \>=24 kg/m2 or waistline\>=85cm \].
* All subjects had normal thyroid-stimulating hormone and prolactin levels.

Exclusion Criteria:

* smoking, alcohol use, or having taken medication within 2 months of the study that is known to affect reproductive or metabolic functions.
* age below 18 yr or over 50 yr.
* postmenopausal.
* uncontrolled hypertension (blood pressure \>=160/100 mm Hg).
* preexisting OPs or GLP-1 agonists supplementation
* alcohol intake greater than 20 g/d, or pregnancy.
* signs of liver or renal failure or active liver disease (ALT \> 2.5× the upper limit of normal values).
* PLT\<60\*10\^9/L,Hb\<100g/L, smoking, alcohol use.
* The patient that cannot complete the intervention or have other conditions that is not appropriate to enter the group, such as patients who are taking glucocorticoid steroids or malignant tumor treatment, etc.
The Optimal Dosage of Rocuronium for Intraoperative Neuromonitoring During Thyroid Surgery

The investigators tried to explore an alternative non-depolarizing muscle relaxant (rocuronium) and its optimal dosage to replace succinylcholine for IONM during thyroid surgery.Time frame of outcome measure was during 30 to 70min after rocuronium injection. Specific time points at which the will be assessed and for EMG signals will be presented.

Recurrent laryngeal nerve (RLN) palsy is the most common and serious complication after thyroid surgery, and ranks among the leading reasons for medicolegal litigation of surgeons. Intraoperative neuromonitoring (IONM) are being applied to prevent RLN injury during thyroid surgery. IONM has been used as a means not only to localize and identify the RLN, but also to predict cord function and elucidate the surgical pitfalls during preparation of RLN.

Muscle relaxant is necessary for general anesthesia; it can facilitate tracheal intubation and stable conditions for surgery. However, the use of muscle relaxant might diminish the EMG response during IONM and interfere with the interpretation of IONM results. Eighty patients were randomized to receive one (group 1, n=40) or two (group 2, n=40) effective dose (ED95) of rocuronium to facilitate EMG endotracheal tube insertion. Evoked potentials were obtained per 5 minutes by stimulating vagus nerve from the time point of 30 to 70 minutes after administration of rocuronium. The magnitude of evoked potential at each time point and tracheal intubating condition were compared between groups. Accelerometry \[twitch (% TW)\] was used to monitor the quantitative degree of neuromuscular transmission. The aim of this study was to explore an alternative non-depolarizing muscle relaxant (Rocuronium) and its optimal dosage to replace succinylcholine for IONM. The ED95 of rocuronium is 0.3mg/kg and 2×ED95 is generally recommended as a standard intubation dosage.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of thyroid tumor

Exclusion Criteria:

* neuromuscular disease
The Chest Physiotherapy and Breathing Exercises Management of Patients Following Open Heart Surgery: a National Survey of Practice in Turkey.

Chest physiotherapy and breathing exercises are an important non-pharmacological treatment modality in order to prevent and minimize postoperative respiratory complications in patients undergoing open heart surgery. Different respiratory techniques are used after cardiac surgery, but there is no opinion about which technique or exercise is effective. The purpose of this study, practical application of chest physiotherapy to patients who have had open heart surgery in Turkey and to identify methods of breathing exercises.

In this study, cardiovascular surgery in Turkey to employees or physiotherapist who worked in intensive care units was planned as e-mail or by reaching to answer the survey questions via telephone.

The universe of study in Turkey cardiovascular surgery physiotherapists are all actively working or have worked in intensive care.

Eligibility Criteria:
Inclusion Criteria:

* To worked or still working in cardiovascular surgery intensive care units
* To answer the survey questions

Exclusion Criteria:

* To Working or worked in cardiovascular surgery intensive care unit and but not answering questionnaire questions
Utilization of the Community Popular Opinion Leader (C-POL) Model in Alabama

Community members within the treatment city will report: 1)engaging in fewer sexual risk practices; 2)significantly higher condom use; 3) significantly higher rates of STD care seeking (including STD screening behaviors); 4) fewer having STDs in the past 6 months; 5) significantly higher awareness scores regarding syphilis and other STDs, as compared with those in the comparison city.

The C-POL in Alabama project is and intervention study which sought to impact the health behaviors of community residents who live in zip codes that have high syphilis morbidity. The study is being implemented in Birmingham and Montgomery with shelter clients.

The intervention model used for this study is the Popular Opinion Leader (POL) model, which is effective at reducing new HIV infections. The intent of this study was to determine the effectiveness of a diffusion model (e.g. POL) at reducing syphilis infections in affected communities.

For the intervention, community members identified as popular opinion leaders were recruited and trained to share accurate information about syphilis transmission, symptoms, testing, treatment and prevention. Prior to intervention implementation and several times after, community members were given a survey and screened for syphilis as well as 2-3 additional STDs. During each assessment, cross-sections of the community members were sampled.

Eligibility Criteria:
Inclusion Criteria:

* Clients who utilized two community homeless shelters in the affected community. The affected community was one that had significant syphilis morbidity at the onset of the study.

Exclusion Criteria:

* None
Evaluation of Two Different Non-invasive Techniques to Monitor the Clearance of Actinic Keratosis Lesions

The purpose of this study is to evaluate the performance of two techniques to monitor the clearance of AK lesions when treated with Aldara 5% cream.

Each technique will be assessed by comparison of lesion counts (clinical and sub-clinical) revealed by the techniques, at start and end of the study and those demonstrated during treatment. In addition a qualitative assessment of each technique will be made for performance and ease of use.

Eligibility Criteria:
Inclusion Criteria:

* At least 5 clinically typical, visible, discrete, nonhyperkeratotic, nonhypertrophic AK lesions
* Free of any significant findings (e.g tattoos) in the potential application site area.
* Willing to discontinue sun-tanning and use of sunbed/sun parlour use
* Willing to stop use of moisturisers, body oils, and over the counter retinol products or products containing alpha or beta hydroxyacids in the treatment or surrounding area.
* Willing ot withhold sunscreen and/or moisturiser use for 24 hours prior to each clinical assessment

Exclusion Criteria:

* Evidence of unstable or uncontrolled clinically significant medical condition.
* Any dermatological disease and or condition in the treatment of the surrounding area that may be exacerbated by treatment with imiquimod.
* Currently participating in another clinical study or have completed another study within an investigational drug within the past 30 days.
* Have active chemical dependency or alcoholism
* Have know allergies to any excipient or study cream
* Have received previous treatment with imiquimod for any indication within the treatment area.
* Known to be affected by porphyria
MFR Versus PFS Techniques on Pain,Range of Motion And Disability in Chronic Non Specific Low Back Pain.

To compare effect of myofascial Release versus post facilitation stretch in term of pain ,range of motion and disability in chronic non specific low back pain in patients.


Eligibility Criteria:
Inclusion Criteria:

* Male and female adults already diagnosed with LBP
* Between ages group of 40-55 years.

Exclusion Criteria:

* Patients who had LBP originating from various pathologies, such as presence of
* cord compression,
* radiculopathy,
* osteoporosis,
uPAR PET/CT and FDG PET/MRI for Preoperative Staging of Bladder Cancer

The sensitivity and specificity of uPAR PET/CT with the radioligand 68GaNOTA-AE105 and FDG PET/MRI for preoperative detection of regional lymph node metastases in urinary bladder cancer

The sensitivity and specificity of 68Ga-NOTA-AE105 PET/CT and FDG PET/MRI for detection of regional lymph node metastases will be tested by observer-blinded readings and compared to diagnostic performance of conventional preoperative procedure. The reference test will be histopathology of lymph nodes obtained by operative lymph node dissection based on 6 regions. The suspected lymph nodes will be assigned to 6 regions based on the images. During the following operation the lymph nodes will be removed and analysed in each of these regions.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy-verified urinary bladder cancer
* The participants must be capable of understanding and giving full informed written consent age above 18 years

Exclusion Criteria:

* Pregnancy
* Lactation/breast feeding
* Age above 85 years old
* Weight above 140 kg
* Treatment with neoadjuvant chemotherapy
* Known allergy towards 68Ga-NOTA-AE105
* Other malignant disease within last 5 years, except for non-melanoma
Flavors and E-cigarette Effects in Adolescent Smokers- STUDY 2

This study is to examine if inhaled doses of an e-cigarette flavor, alone and in combination with menthol, changes the appeal of e-cigarettes containing low and high doses of nicotine. The hypothesis is that menthol and the other experimental flavor will interact with nicotine dose to improve taste and liking for e-cigarettes.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18-20 years
* Able to read and write
* Urine cotinine levels of \>250 ng/ml at screening appointment
* Use of e-cigarettes in the past month
* May or may not currently smoke traditional cigarettes

Exclusion Criteria:

* Seeking smoking cessation treatment
* Current/lifetime criteria for dependence on another psychoactive substance -Daily use of alcohol or marijuana or use of any other drugs including cocaine, opiates, stimulants
* Regular use of psychoactive drugs including anxiolytics, antidepressants and other psychostimulants
* Current or past history of psychosis or other psychiatric diagnosis such as major depression
* Any significant current medical condition
Study of Treatment for Opioid Dependence and Anxiety Disorders

Anxiety is highly prevalent among individuals with opioid dependence and confers greater risk for continued opioid use and poor treatment outcomes. However, there are currently no efficacious treatments available for co-occurring opioid dependence and anxiety. The ultimate aims of this trial are the development and testing of a novel integrated cognitive behavioral treatment (I-CBT) for co-occurring opioid dependence and anxiety disorders. This clinical trial consists of two phases: (1) open-trial pilot (2) randomized control trial. We hypothesize that I-CBT will be a feasible and acceptable treatment that will result in significant reductions in anxiety and opioid use.

This Stage 1 behavioral treatment development trial involves two stages: manual development and pilot testing in an open trial, and a small randomized controlled trial. In both phases, opioid use and anxiety symptoms will be measured as the primary clinical outcome, along with measures of feasibility and patient satisfaction. These results will be used to further refine the treatment manual and to evaluate whether this treatment may enhance outcomes for adults with co-occurring opioid dependence and anxiety disorders.

Eligibility Criteria:
Inclusion Criteria:

* age 18 or older
* meet current Diagnostic and Statistical Manual of Mental Disorders 5th edition diagnostic criteria for opioid use disorder
* currently prescribed pharmacotherapy for opioid dependence
* have used opioids illicitly within the previous 90 days
* clinically-significant anxiety
* meet current diagnostic criteria for a Diagnostic and Statistical Manual of Mental Disorders 5th edition anxiety disorder
* able to read and provide informed consent
* intend to remain in the geographical area for the duration of the study period

Exclusion Criteria:

* meet criteria for a current substance use or psychiatric disorder requiring a level of care higher than outpatient
* currently receiving cognitive behavioral therapy
* recent initiation of a psychiatric medication, defined as less than 4 weeks on a stable dose; not including PRN medications for sleep
* are receiving and taking an as-needed (PRN) prescription for benzodiazepines
* presence of a psychiatric or medical condition that would interfere with participation or that requires additional care (e.g. psychosis, acute suicidality)
* were admitted to McLean Hospital for their current treatment episode on an involuntary status
Semantic and Syntactic Computerized Analysis of Free Speech

Subtle speech disorganization could be predictive of a transition to schizophrenia of ultra-high-risk patients. The aim of our longitudinal multicenter cohort study is to identify specific linguistic markers of the psychotic transition to validate a french predictive model of this transition using computerized speech analysis techniques

Different scales allow identification of patients at ultra-high-risk to develop psychosis. The current challenge is to identify a predictive marker of transition to schizophrenia. Language disorders, which reflect psyche, could be one of these markers. Computerized speech analysis techniques such as Latent Semantic Analysis (LSA) have already proven their reliability in schizophrenia. These techniques reveal subtle speech disorganization that would be predictive of a clinical transition of ultra-high-risk psychotic patients. A combination of semantic and syntactic analysis could accurately predict the psychotic transition. The aim of our longitudinal multicenter cohort study is to validate this predicitve model in french language as well as identifying specific linguistic markers of the psychotic transition.

The initial report including the CAARMS is completed with an audio recording from the initial medical interview. The recording will be transcribed and analyzed by computer following the method of lemmatization and vectorial analysis (LSA). An analysis of the grammatical function (number of words, rate of the various grammatical functions) will also be performed. This first analysis will emerge linguistic markers correlated to transition to psychosis that we will use to construct a predictive model for transition to schizophrenia.

Eligibility Criteria:
Inclusion Criteria:

* Major and/or minor from 15 to 30 years old
* Who alleged a suicidal gesture or idea or behavior that has repercussions in their emotional, social or professional life
* If patients receive neuroleptic treatment that impairs cognitive abilities, a one-week wash-out period will be scheduled prior to assessment.

Exclusion Criteria:

* History of psychosis
* Risk of self-harm or violence not compatible with outpatient treatment
* QI\<70 (WAIS)
* Neurological disorder or major health problem
* Impossibility to interrupt neuroleptic treatment for one week
* Refusal to participate
Quantification of Autonomic Nervous Activity During Hemodialysis

This study assesses autonomic nervous system function by power spectral analysis of RR interval dynamics in ultrafiltration subjects without blood pressure variation.

Variations over time in autonomic nervous activity due to differences in ultrafiltration rate will be evaluated by measuring heart rate variability in hemodialysis patients without blood pressure variations during HD session.

The subjects will be divided into 3 groups, those with UFR \< 10 ml/hr/kg; ≥10 ml/hr/kg but ≤ 15 ml/hr/kg; and \>15 ml/hr/kg, and Holter ECG are recorded continuously during HD session using frequency analysis of RR intervals.

Eligibility Criteria:
Inclusion Criteria:

* Patients with stable undergoing hemodialysis without hanging in blood pressure during hemodialysis.

Exclusion Criteria:

* Patients with chronic atrial fibrillation
* Patients with frequent ventricular premature beats
* Patients with a permanent pacemaker
* Patients with taking antihypertensive drugs
* Patients with medical treatment due to changes in blood pressure
Rhythmic Entrainment in Bilingual Speakers With Dysarthria

The objectives of this study are to determine i) the effect of rhythmic entrainment of speech with hand gestures and auditory rhythmic cues on intelligibility and speech naturalness in Spanish-accented speakers of English in two pathology groups: ataxic dysarthria and hypokinetic dysarthria secondary to idiopathic Parkinson's disease; and ii) the extent to which speech rate and effort are control parameters of entrainment. These objectives will be achieved with the following specific aims:

Specific Aim 1: Determine the effect of three rates of hand gestures and auditory rhythmic cues and the degree to which learning and carry-over occur.

Specific Aim 2: Determine the effect of increased speech effort, operationalized as clear speech, and the interaction effect of clear speech with hand gestures and auditory rhythmic cues.

Specific Aim 3: Investigate the perception of speech rhythm and its relationship to entrainment.

The objectives of this study are to determine i) the effect of rhythmic entrainment of speech with hand gestures and auditory rhythmic cues on intelligibility and speech naturalness in Spanish-accented speakers of English in two pathology groups: ataxic dysarthria and hypokinetic dysarthria secondary to idiopathic Parkinson's disease; and ii) the extent to which speech rate and effort are control parameters of entrainment. These objectives will be achieved with the following specific aims:

Specific Aim 1: Determine the effect of three rates of hand gestures and auditory rhythmic cues and the degree to which learning and carry-over occur.

Specific Aim 2: Determine the effect of increased speech effort, operationalized as clear speech, and the interaction effect of clear speech with hand gestures and auditory rhythmic cues.

Specific Aim 3: Investigate the perception of speech rhythm and its relationship to entrainment.

The protocol calls for 12 talkers to participate in a single case experimental design: 6 Spanish-accented speakers of English and 6 native English speakers, and each language group consisting of 2 healthy controls, 2 adults diagnosed with ataxic dysarthria and 2 adults diagnosed with hypokinetic dysarthria secondary to idiopathic Parkinson's disease. Sixty monolingual healthy adult listeners will rate intelligibility, accentedness, and ease of understanding.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of idiopathic Parkinson's disease (4) or dysarthria secondary to ataxia (4) or healthy (4)
* monolingual speaker of American English (6) or native speaker of Spanish who speaks English with a Spanish accent (6)
* age 21 or older

Exclusion Criteria:

* Cognitive impairment that prevents participation in the therapy
* Fluent speakers of languages other than English or Spanish
* younger than 21 years
Treatment of Alcohol Withdrawal Syndrome With Alpha-2 Agonists and/or Anticonvulsants

Complicated alcohol withdrawal syndrome (AWS) increases morbidity and mortality of hospitalized, medically ill patients. The Psychosomatic Medicine Service is commonly consulted to assist in the management of these patients when admitted to medical/surgical units. During the last 15 months, the investigators have implemented a benzodiazepine-sparing management approach with very positive clinical outcomes. The BZDP-sparing protocol consists of a combination of alpha-2 agonist and/or anticonvulsant agents; all currently being used for the management of other medical conditions. This project intends to collect and analyze the data of all subjects managed with this approach to better understand its effectiveness and assess for potential adverse effects.

Complicated alcohol withdrawal syndrome (C-AWS) increases morbidity and mortality of hospitalized, medically ill patients. The Psychosomatic Medicine Service is commonly consulted to assist in the management of these patients when admitted to medical/surgical units. During the last 15 months, the investigators have implemented a benzodiazepine-sparing management approach with very positive clinical outcomes. The BZDP-sparing protocol consists of a combination of alpha-2 agonist (e.g., clonidine, guanfacine, dexmedetomidine) and/or anticonvulsant agents (e.g., gabapentin, valproic acid, carbamazepine); all currently being used for the management of other medical conditions. The proposed study consists of an exhaustive chart review of these records to better understand the safety and effectiveness of alpha-2 agonists and anticonvulsants in the prophylaxis and treatment of AWS. Specifically the investigators want to understand the time to resolution of AWS symptoms, whether there are any limiting side effects to this regimen, and the need of for rescue with benzodiazepine agents. The information obtained from this study will be very helpful in assisting in the design of safer and more effective treatment of AWS.

Eligibility Criteria:
Inclusion Criteria:

* All the cases referred to the Psychosomatic Medicine Service for assistance with prophylactic or symptomatic management of AWS starting 8/1/2011 until 8/31/2014.

Exclusion Criteria:

* Patients who through chart review were found to have been primarily suffering from delirium from causes other than AWS.