cyrilzakka/clinical-trials huggingface dataset:
iTBS Can Increase Frontal Dopamine Release in PET Dopamine Imaging.

Aim: 1. To confirm that patients with predominant negative symptoms in schizophrenia have deficits in frontal cortical dopamine release when compared with healthy control and patients with positive symptoms.

2. Our previous study found patients with negative symptoms have more possibilities to have disorders in glucose metabolism, we wonder whether dopamine release, negative symptoms or glucose metabolism can be improved by iTBS.

Study design: Case control study.

Eligibility Criteria: Predominant negative symptoms for Positive and Negative Syndrome Scale factor score for negative symptoms of 24 or more, and score of 4 or more on at least two of three core negative PANSS items, PANSS for positive symptoms of 19 or less, HAMD depression scale of 16 or less. Predominant positive symptoms for PANSS for positive symptoms of 20 or more. Healthy control will be recruited matching the age and sex of patient groups, Outcome Measures: Oral glucose tolerance test (OGTT), PET dopamine imaging.

Eligibility Criteria:
Inclusion Criteria for negative group

* diagnosed with schizophrenia according to ICD-10 or DSM-V
* Positive and Negative Syndrome Scale factor score for negative symptoms of 24 or moreand score of 4 or more on at least two of three core negative PANSS items
* PANSS for positive symptoms of 19 or less, and HAMD depression scale of 16 or less.
* drug-naive Inclusion Criteria for positive group
* PANSS for positive symptoms of 20 or more
* drug-naive

Exclusion Criteria:

* drug or alcohol addiction
* diagnosed with other major mental disorders according to ICD-10 or DSM-V
Identifying and Overcoming Barriers to Diabetes Management in the Elderly: An Intervention Study

The purpose of this research study is to identify barriers affecting self care in older patients with diabetes and to provide coping strategies for these barriers with help from a care manager (Geriatric Life Specialist) to improve clinical, economical, functional and psychosocial parameters.

This is a study to evaluate whether short term focused intervention by a geriatric diabetes team, with addition of a care manager, to help overcome barriers to diabetes care in older adults will result in improved clinical, functional, and quality of life measures compared to usual care. In addition, we will assess whether the support network formed during intervention by the geriatric diabetes team will empower patients, resulting in long lasting improvement in parameters after intervention is completed. We will also explore whether improved blood glucose control will improve blood circulation in the brain that is compromised in elderly with diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Age 70 years and older
* Diagnosis of type 1 or type 2 diabetes
* Seen at Joslin Clinic or Beth Israel Deaconess Medical Center for at least one year
* HbA1c 8% X 2 in past 6 months without fluctuation of more than 0.5% (i.e. stable poor control)
* No major change in medications in past 3 months, e.g. addition of insulin or another hypoglycemic agent

Exclusion Criteria:

* Patients with terminal diseases, e.g. malignancy with life expectancy of 12 months or less
* Patients who live more than 25 miles from Joslin Clinic/ Beth Israel Deaconess Medical Center
* Patients who live in an institutional setting, e.g. nursing home, group home, etc
* Patients who are not able to complete outcome assessments,(e.g. poor vision, diminished mental capacity/severe cognitive decline, unable to speak/read/write English, etc)
* Patients will be excluded from participation in Study Aim 3 if they have a history of orthostatic hypotension, TIA, or vertebral basilar insufficiency
Incidence of Delirium in Hip Fracture Patients Randomized to Regular Hypnotics vs Placebo

To examine the influence of regular hypnotic therapy on the incidence of delirium after hip fracture surgery

Delirium is prevalent after hip fracture surgery. Delirium has been linked to postoperative sleep disturbances. Zolpidem is a non-benzodiazepine hypnotic that preserves REM sleep. The present study investigates the incidence of delirium in hip fracture patients randomized to Zolpidem treatment 5 mg vs placebo in the perioperative phase.

Eligibility Criteria:
Inclusion Criteria:

* Primary hip fracture, no substance abuse, no regular opioid, corticosteroid or benzodiazepine therapy, hepatic insufficiency, myastenia gravis, allergies to drug components

Exclusion Criteria:

* Severe respiratory insufficiency
Efficacy, Safety, and Tolerability of Dupilumab in Patients With Persistent Moderate to Severe Eosinophilic Asthma

Primary Objective:

To investigate the effects of Dupilumab (SAR231893/REGN668) administered subcutaneously (SC) once weekly (qw) for 12 weeks as compared to placebo on reducing the incidence of asthma exacerbation in participants with persistent moderate to severe eosinophilic asthma.

Secondary Objectives:

* To assess the safety and tolerability of Dupilumab administered SC qw for 12 weeks in participants with persistent moderate to severe eosinophilic asthma.
* To assess Dupilumab serum concentrations following qw SC dosing for 12 weeks in participants with persistent moderate to severe eosinophilic asthma.

The total duration of the study period per participant was 20-22 weeks broken down as follows:

* Screening period: up to 14 days,
* Treatment period: 12 weeks,
* Follow-up period: 6-8 weeks.

Eligibility Criteria:
Inclusion criteria:

Medical diagnosis of persistent asthma for at least 12 months whose:

* airway inflammation likely to be eosinophilic,
* asthma partially controlled or uncontrolled on ICS plus LABA therapy.
* On a stable dose of either Fluticasone/Salmeterol, Budesonide/Formoterol, Mometasone/Formoterol combination therapy for at least 1 month prior to screening.
* Signed an Informed Consent Form and Health Insurance Portability and Accountability Act (HIPAA) Authorization Form.

Exclusion criteria:

* Less than 18 years or greater than 65 years of age.
* Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further evaluation.
* Chronic obstructive pulmonary disease and/or other lung diseases impairing Pulmonary Function Tests.
* Beta-adrenergic receptor blockers required for any reason.
* Current smoker or cessation of smoking within the 6 months prior to screening.
* Previous smoking with a smoking history \>10 cigarette pack/years.
* Participation in another study within 6 months prior to screening if the study medication was an antibody or within 30 days prior to screening for all other study medications.
* Known or suspected non-compliance, alcohol or drug abuse.
* Inability to follow the procedures of the study (e.g, due to language problems, psychological disorders).
* Concomitant severe diseases or diseases for which the use of ICS or LABA were contraindicated.
* Known allergy to doxycycline or related compounds.
* Pregnancy or intention to become pregnant during the course of the study, breast feeding, or unwillingness to use a highly effective method of contraception throughout the study in women of childbearing potential.
* Recent history of a parasitic infection or travel to a parasitic endemic area within 6 months prior to screening.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Short Term Reproducibility of Office White-coat Effect

While a theoretical increase in systolic blood pressure (BP) of 10 mmHg can triple the relative risk of cardiovascular disease (CVD), the potential presence of a white coat effect (WCE) can interfere with the assessment of blood pressure control in the consultation. However, it is often difficult to assess the presence of a white coat effect (a quantitative variable) in general practice because of the difficulties in performing ambulatory BP measurements (self-measurement of blood pressure or ambulatory BP measurements). We have therefore previously described a surrogate concept of WCE obtained during a consultation with a general practitioner. It corresponds to a reduction of 10mmHg or more in systolic BP between the start and the end of the consultation. We have named it 'office white coat effect tail' (OWCET) and we have shown that OWCET, as a dichotomous variable, in a large Italian population cohort, with a follow-up of more than 18 years, was associated with an excess incidence of stroke, myocardial infarction (MI) and CVD and with excess mortality from MI and CVD. This concept appears to be more prevalent in women and is independent of blood pressure variability (regression to the mean). In addition, there is a genuine correlation between WCE and OWCET. To our knowledge, the reproducibility of the OWCET has never been studied, which could distort the relevance of this concept in the context of cardiovascular risk stratification in primary care.


Eligibility Criteria:
Inclusion Criteria:

* adult patients ;
* not taking any antihypertensive medication;
* free of any cardiovascular pathology.

Exclusion Criteria:

* patients who are minors or protected adults ;
* patients with BP ≥160/105 mmHg;
* history of secondary hypertension;
* taking a treatment that may affect blood pressure.
Effects of Volume and Pressure-Controlled Ventilation on Cerebral SpO2, PI, and PVI Index in Septoplasty

Objective: This study was designed to evaluate the accuracy of Pleth Variability Index (PVI), Perfusion Index (PI) and Regional Oxygen Saturation (rSO2) in both ventilation modes in patients undergoing septorhinoplasty operation under general anaesthesia. Materials and Methods: After anaesthesia induction, ventilation was provided with volume control for 20 minutes. Heart Rate (HR), PI, PVI, Oxygen Saturation (SpO2), Non-Invasive Blood Pressure (NIBP) and rSO2 values were recorded every 5 minutes. At the 20th minute of the surgical procedure, the ventilation mode was set as the pressure-controlled mode. After switching to pressure-controlled mode, HR, PI, PVI, SpO2, NIBP and rSO2 values were recorded every 5 minutes for 20 minutes.


Eligibility Criteria:
Inclusion Criteria:

* patients with American Society of Anesthesiologists (ASA) score I-III between the ages of 18-80 were included

Exclusion Criteria:

* Those patients with any Liver and/or Kidney Failure
* obese patients (Body Mass Index (BMI) 30 and above)
* trauma patients
* cancer patients
* ASA IV patients
* those patients with emergency surgery
* cardiac arrhythmia
* implanted pacemakers
* those with a history of chronic pain
A Study of Visual Effects of Erectile Dysfunction Medications Dosed Daily for Six Months

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the effects on vision of six months of daily dosing of 5 mg tadalafil or 50 mg sildenafil compared with placebo.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects or males with mild erectile dysfunction (ED).
* Between the ages of 30 and 65 years, inclusive.

Exclusion Criteria:

* Phosphodiesterase type 5 (PDE5) inhibitor therapy (tadalafil, sildenafil, or vardenafil) within 6 weeks of the start of the study.
* Diagnosis of diabetes mellitus.
* Any chronic illness or medication that is a risk factor for eye disease or any medication that causes retinal toxicity or affects visual function.
* Certain chronic medical conditions including unstable angina pectoris, severe renal \[kidney\] insufficiency, clinically significant hepatobiliary \[liver, bile duct\] disease, cancer, and AIDS/HIV.
* A history of clinically significant chronic ophthalmologic disease or any significant visual abnormality identified at the start of the study.
The Effect of Advanced Improvement Program (ERAS) on Postoperative Outcomes in Patients Undergoing Open Heart Surgery

Investigation of the effect of Enhanced Recovery After Surgery (ERAS) program on postoperative results of patients operated for open heart surgery.

The ERAS protocol, also known as evidence based "fast-track surgery" (FTS), is an evidence based combination of findings regarding suggestions for patient care on various levels of the perioperative period, which work in synergy for accelerating the postoperative recovery period. It has been used sucessfully for many surgical disciplines, primarily colorectal surgery, since it was first reported in 1997. However, there is a significant insufficiency of this patient oriented rehabilitation program regarding cardiovascular surgeries. This study is to compare the postoperative follow up periods of patients with ERAS protocol and patients with standard protocol who were both operated for cardiac surgery.

Following approval of the local ethics committee, 210 patients who are operated for elective cardiac surgery are enrolled in this prospective randomized clinical trial. The patients who are not applied the ERAS protocol are evaluated in the control group (n=51). The findings regarding the patients under ERAS protocol are evaluated based on evidence. Our primary is to compare the durations of stay in the intensive care unit and in hospital; our secondary is to compare the incidences of complications of the groups. The demographic data, operative measurements, complication rates, the amounts of perioperative bleeding and drainage and the duration of stay in the intensive care unit and hospital are recorded.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years old;
* Patients undergoing elective open heart surgery (cardiopulmonarybiasis, aortic and mitral valve replacement);
* ASA III ;
* Patients with informed consent for the study.

Exclusion Criteria:

* Patients who refuse to participate in the study;
* Patients under emergency conditions.
The Optimal Duration of Preoperative Anti-tuberculosis Treatment of Spinal Tuberculosis

The purpose of this study is to determine the better preoperative anti-tuberculosis treatment period of patients with spinal tuberculosis.

Quality assurance plan：All the investigators will receive uniform training. Standard cases follow-up,collection,management systems will be established.The process of cases follow-up,collection,management will be supervised by the third party.Data entry will be in the manner of independent parallel entry.The endpoints events are judged by third party.Statistical analysis are implemented by the statistics institutions of the third party.In order to control the bias,this study takes multicenter,random,control study design.

Sample size assessment:Under the condition of multicenter,random,control design, computational formula takes the rate comparisons of two groups.The key endpoints event is soft tissue width of vertebral side measured by computed tomography. The incidence of the key endpoints event in two weeks group is 30%.The incidence of the key endpoints event in four weeks group is 15%.When alpha value is 0.5 and power value is 0.9,the sample size is 161 patients.If loses visit rate is 20%,the sample size is 194 patients.

Statistical analysis plan:The key events are analyzed by chi-squared test.The statistical significance factors among them are calculated by relative risk.

Data checks and source data verification are supervised by a third-party organization (contract research organization，CRO).

Standard Operating Procedures:Investigator's brochure has explained in detail about the standard operating procedures of everything.Data dictionary can be found in standard operating procedures.

Plan for missing data: The investigators Set a 20% rate of lost to follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients are diagnosed as spinal tuberculosis clinically,and they do not receive antituberculosis therapy or with 2 weeks.
* The age is between 15 years old and 75 years old.
* Patients have good compliance,and have clear surgical indications.4.Willing to join the research

Exclusion Criteria:

* Patients have surgical contraindications.
* Patients have bad habits:taking drug,drinking.3.Patients have mental disease.
* Patients have bad compliance.
* Patients have hematogenous disseminated pulmonary tuberculosis, serious central nervous system tuberculosis,and serious extrapulmonary tuberculosis.
* Patients with drug resistance for Antituberculosis drugs,and patient have to change the treat plan,and patients have immunodeficiency diseases.
* Patients are not diagnosed as spinal tuberculosis clearly.
* Not willing to join the research
Back Pain - Linking Phenotype to Pain Mechanism and Outcome.

To investigate whether different clinical, psychophysical and neurophysiological phenotypes can be identified among low back pain patients

Low back pain patients will fill in a detailed questionnaire (incl. pain drawing) about their pain. Some of them will undergo a standardized quantitative sensory testing protocol and an fMRI procedure.

Eligibility Criteria:
Inclusion Criteria:

-primary complaint: low back pain clinically not attributable to red flags

Exclusion Criteria:

* any major medical or psychiatric condition that affects pain sensitivity
* contraindications to MRI
Effects of Combined Alcohol and Nitrous Oxide Intake - 15

The purpose of this study is to determine the effects of combined alcohol and nitrous oxide intake on mood, psychomotor performance, and the pain response in healthy volunteers.


Eligibility Criteria:
Please contact site for information.
Lidocaine Combined Dexmedetomidine for Obturator Nerve Block

Hypothesis: Dexmedetomidine as an adjuvant of lidocaine can decrease the median effective concentration(EC50) of lidocaine for obturator nerve block during transurethral resection of bladder tumor

A selective obturator nerve block(ONB) is an effective alternative to suppress the obturator nerve reflex which is defined as a sudden, violent adductor muscle spasm when the obturator nerve is stimulated directly by the electronic resector during transurethral resection of the tumor on the lateral bladder wall. Studies showed Dexmedetomidine as an adjuvant to local anesthetic prolongs peripheral nerve block duration without any nerve toxicity. In the following randomized, non-crossover study, the investigators test if Dexmedetomidine as an adjuvant can decrease the median effective concentration(EC50) of lidocaine for obturator nerve block during transurethral resection of bladder tumor.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects scheduled to undergo elective operation of TURBT on lateral wall for whom ONB was needed diagnosed through cystoscopy or CT examination preoperatively.
2. Subject's American Society of Anesthesiologists physical status is I-II.
3. The subject's parent/legally authorized guardian has given written informed consent to participate.

Exclusion Criteria:

1. Subject has a diagnosis of abnormal coagulation function.
2. Subject has a diagnosis of Diabetes mellitus.
3. Subject has a preexisting neurologic deficits of the lower extremities.
4. Subject has a history of alcohol or drug abuse.
5. Subject is pregnant or breast-feeding.
6. Subject is obese (body mass index \>30kg/m2).
A Cohort Study of PCI Strategies for Severely Calcified Lesions of Complex Coronary Arteries in the Elderly

The aim of this observational study is to compare the prognostic outcomes of various PCI strategies in elderly patients with complex coronary calcified lesions. The patients will be classified into two groups and assigned different PCI strategies, either stenting or stenting combined with pharmacologic balloon implantation. The investigators will assess the one-year prognosis for major adverse cardiovascular events in these patients.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 60 years;
2. Meet the indications for coronary intervention;
3. IVUS examination suggests severe calcified lesions (calcification angle \>270°) or OCT examination suggests severe calcified lesions (calcification angle \>180° and/or length \>5mm and/or thickness \>0.5mm);
4. The diameter of the target lesion vessel is greater than 2.75mm;
5. The total length of the lesion is more than 60mm and/or the number of lesions to be treated is ≥3 and/or the number of vessels to be treated is ≥2.

Exclusion Criteria:

1. inability to provide written informed consent;
2. inability to administer antiplatelet agents and anticoagulant therapy;
3. the subject is participating in other unfinished clinical trials;
4. life expectancy \<1 year;
5. non-in situ vascular lesions;
6. patients with haemodynamic instability;
7. Previous stroke within 6 months.
8. left main stem lesions.
Bladder Wall Thickness in Symptomatic Urinary Stress Incontinence and Its Correlation with Urodynamics Results

This clinical study aims to assess the utility of ultrasonographic bladder wall thickness (BWT) measurement in patients suffering from symptomatic stress urinary incontinence (SUI). SUI is a condition characterized by involuntary leakage of urine during activities that increase intra-abdominal pressure and represents a very frequent disorder impacting women's quality of life. To diagnose SUI more accurately and especially before surgical treatment, patients undergo invasive urodynamic examination. This examination allows us to objectify the presence of any bladder dysfunction and, in particular, to evaluate the presence of detrusor overactivity. Detrusor overactivity is defined as any occurrence of detrusor contraction(s) during filing cystometry. These contractions, which may be spontaneous or provoked, produce a waveform on the cystogram, of variable duration and amplitude and may cause or not urgency symptoms. In absence of any urodynamic detrusor overactivity, the patient may be diagnosed with pure SUI. This is essential to assess before surgical treatment to avoid worsening of symptoms and to decide whether to treat the patient with concomitant pharmacological treatment. On the contrary, ultrasonography offers a non-invasive and accessible approach to evaluate bladder function. This study will involve a cohort of patients with SUI, who will undergo ultrasonographic assessment of BWT and preoperative urodynamic assessment. The objective is to determine whether BWT correlates with the urodynamics results and whether it can predict the presence or absence of detrusor overactivity and confirm the pure stress urinary incontinence


Eligibility Criteria:
Inclusion Criteria:

1. Participant is willing and able to give informed consent for participation in the study.
2. Women aged \> 18 y.o.
3. Women symptomatic for pure or predominant stress incontinence attending the urogynecology outpatient clinic at our institution.
4. Patients undergoing urogynecological standard evaluation for their symptoms, including outpatient gynecological visit and a transvaginal ultrasound.
5. Patients undergoing invasive urodynamic examination for objective assessment of their symptoms or in preparation for possible anti-incontinence surgery.

Exclusion Criteria:

1. Patients with pure or predominant OAB symptomatology
2. Current use of antimuscarinic agents or beta3-agonists (for example Mirabegron)
3. Presence of urological or gynecological cancer.
4. Patients with previous anti-incontinence surgery.
5. Patients with pelvic organ prolapse \> II stage.
6. Patients with chronic bladder retention.
7. Patients with neurological diseases that may affect bladder function and urodynamic results.
8. Participants unwilling or unable to give informed consent for participation in the study.