cyrilzakka/clinical-trials huggingface dataset:
Acute-phase Response & Periodontal Treatment in Obese Patients

The aim of this study is to compare quadrant scaling and root planing (Q-SRP) versus full-mouth treatment (FM-SRP) in terms of acute-phase responses following no surgical periodontal treatment in obese patients affected by periodontitis.

Periodontal treatment, consisting in both supra- and sub-gingival mechanical instrumentation of the root surface (scaling and root planing), will be performed by a single periodontist on obese patients with periodontitis.

The aim of this study is to compare quadrant scaling and root planing (Q-SRP) versus full-mouth treatment (FM-SRP) in terms of acute-phase responses following non surgical periodontal treatment.

Treatment will be provided using both hand and ultrasonic instrumentation with ﬁne tips.

FM-SRP patients will received treatment within 24 h. Q-SRP patients will received four quadrants sessions of periodontal treatment with an interval of 1 week between sessions.

Vital, endothelial function and blood inflammatory parameters will be evaluated at baseline, 24 hours after the first treatment and after 3 months. Periodontal parameters will be evaluated at baseline and after 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients affected by Periodontal Disease
* 20% of periodontal pockets of the entire dentition
* 20% bleeding on probing of the entire dentition
* documented radiographic bone loss
* diagnosis of Obesity as measured through Body Mass Index (BMI) superior than 30

Exclusion Criteria:

* age younger than 18 years and older than 80 years
* pregnant or lactating females
* need of antibiotic coverage for periodontal treatment
* treatment with statin and/or acetylsalicylic acid
* BMI \> 35
An Evaluation of Exenatide and Rosiglitazone in Subjects With Type 2 Diabetes Mellitus

This protocol is designed to evaluate the metabolic effects of adding exenatide, rosiglitazone, or both to an existing regimen of metformin in subjects with inadequate glycemic control.


Eligibility Criteria:
Inclusion Criteria:

* HbA1c of 6.8% to 10.0%, inclusive.
* Body mass index (BMI) of 25 kg/m\^2 to 40 kg/m\^2, inclusive.

Exclusion Criteria:

* Have participated in this study previously, or have received exenatide, pramlintide acetate, GLP-1 analogs, or dipeptidyl peptidase-IV (DPP-IV) inhibitors
* Have participated in an interventional, medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of study start. This criterion includes drugs that have not received regulatory approval for any indication at the time of study start.
* Treated with any of the following medications:

  * Thiazolidinedione within 5 months of screening;
  * Sulfonylurea within 3 months of screening;
  * Metformin/sulfonylurea combination therapy within 3 months of screening;
  * Alpha-glucosidase inhibitor within 3 months of screening;
  * Meglitinide within 3 months of screening;
  * Insulin for more than 1 week within the 3 months prior to screening.
  * Symlin (pramlintide acetate) injection or Byetta (exenatide) injection at any time
  * Chronic (more than 2 weeks) or recent (within 4 weeks of study start) use of a drug that directly affects gastrointestinal motility
  * Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within the 4 weeks immediately preceding study start
  * Regular use of a medication with addictive potential such as an opiate, narcotic, or tranquilizer
  * Systemic antineoplastic agent
  * Systemic transplantation medication
  * Drugs for weight loss, including over-the-counter medications, within the 4 months prior to study start
Electrophysiologic Mapping of the Bladder

The hypothesis is that the intrinsic electrical activity of the urinary bladder in response to filling is detectable and can be mapped. This is a pilot study to evaluate the feasibility of using cardiac electrical mapping catheters to measure bladder voltage in patients at the time of routine urodynamic and cystoscopic evaluation.

This pilot study is looking at the possibility of adapting some of the tools and techniques used by cardiac electrophysiologists (doctors specializing in the electrical activity of the heart) to help diagnose and treat Overactive Bladder. The rationale for this approach is based on the similarities of the two organs. In simple terms, the heart and bladder are both hollow muscular organs that expand and contract to hold and move fluid.

In an electrophysiology study looking at cardiac (heart) arrhythmia (irregular heartbeat), the cardiologist places one or more electrode catheters (thin hollow tube with an electrical conductor on the end) through a vein or artery in the leg or arm to contact heart tissue. By recording the electrical activity at multiple sites of the heart, the catheter allows for mapping of the electrical activity and the arrhythmia mechanism.

In this study, investigators will use the same electrode catheter to contact bladder tissue, introduce a low frequency current, and map the electrical activity of the bladder. A sterile cardiac electrical mapping catheter will be used to make contact with the walls of the bladder and introduce a low frequency current starting with the trigone and then the four quadrants of the dome. Electrical activity will be recorded for each volumetric milestone at each location. It is hoped that the information from this electrophysiological testing of the bladder may eventually lead to treatment of areas of electrical abnormality of interest. No actual treatment of the bladder will be done as part of this pilot study.

Eligibility Criteria:
Inclusion Criteria:

* Subject is a female \> = 18 years old.
* Subject is willing and able to provide informed consent.
* Subject has subjective and objective evidence for urinary urgency (with or without incontinence), stress incontinence, or mixed incontinence (with features of both urgency and stress).
* Subject requires urodynamic/cystoscopic studies to complete their workup.

Exclusion Criteria:

* Active urinary tract infection
* Pregnant women
* Patients on anticholinergic medicine for overactive bladder
* Patients with history of intravesical botulinum toxin injections
* Patients with a sacral neuromodulator implant
* Patients with a history of urinary tract malignancy
Effect of Balanced Saline Solution and Albumin on Volume Expansion in Shock Patients

To compare the direct effect of sodium acetate ringer injection or albumin on volume expansion in shock patients, and to provide reference for volume resuscitation strategy in shock patients

CI/SVI increase amplitude and maintenance time

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old, gender unlimited
2. Shock requires volume resuscitation:

   Insufficient tissue perfusion: wet and cold skin, decreased urine volume (\<0.5ml/kg/h), change of consciousness, blood lactate \>2.0mmol/l or vasoactive drugs are required to maintain map\>65mmhg
3. Presence of volume reactivity: (under controlled ventilation) PPV ≥ 15% or passive leg raising test (+) or (under controlled ventilation) IVC variability ≥ 18% or the presence of volume reactivity as judged by clinicians
4. The patient has no obvious restlessness, RASS ≤ 0
5. The legal representative of the subject signs the informed consent form-

Exclusion Criteria:

1. Pregnant and lactating women
2. End stage patients
3. BMI ≤ 15 or BMI ≥ 50
4. Contraindication of indwelling central vein catheter and invasive arterial catheter
5. Patients in ECMO and / or IABP therapy
6. Hemorrhagic shock, blood products such as concentrated red blood cells, plasma and platelets will be infused within 1 hour
7. Myocardial infarction, NYHA grade IV
8. Patients with hyperkalemia, hypercalcemia, hypermagnesemia and hypothyroidism
9. Allergic to compound sodium acetate ringer injection or albumin or with known side effects
10. Other factors that may affect the monitoring and evaluation of relevant indicators
A Phase 1 Study To Investigate The Pharmacokinetics, Safety And Tolerability Of CP-601,927 In Healthy Japanese Subjects

This Phase 1 study is the first clinical trial to be conducted in Japanese subjects. The pharmacokinetics, safety and tolerability of single and multiple doses of CP-601,927 will be evaluated in Japanese, healthy, non-smoking subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female Japanese subjects between the ages of 18 and 55 years, inclusive.
* Japanese defined as being able to document that all 4 grandparents were Japanese and were born in Japan.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Females of childbearing potential.
* Subjects with regular (daily or weekly) use of tobacco products or nicotine currently or within the past 6 months. Subjects with urine cotinine concentrations \>100 ng/mL at any time during the study will be excluded.
The Effect of Low Frequency STN DBS on Sleep and Vigilance in Parkinson's Disease (PD) Patients

The study design is a within-subject randomized cross-over design to evaluate the effects of DBS on sleep architecture, as measured by polysomnography, and on wake-time vigilance, as measured by a virtual reality street-crossing simulator.

In the proposed study, we will use a within-subject randomized clinical trial to measure objective changes in sleep architecture with DBS "on" and to compare effects of different DBS stimulation parameters on sleep architecture as measured by sleep studies. The study design will allow us to address our hypothesis that low frequency deep brain stimulation parameters are more effective than the conventional settings at improving sleep architecture and wake-time vigilance. If our hypothesis is correct, low frequency settings could be used during sleep and this would prolong stimulator battery life, therefore decreasing the frequency of required surgical battery changes for DBS. These data will be valuable in considering clinical treatment strategies and provide insight into the basic mechanisms of sleep dysfunction in PD. The study may also contribute to understanding how to achieve maximum clinical benefit from DBS while minimizing morbidity and cost.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who have undergone bilateral subthalamic nucleus (STN) DBS surgery for treatment of PD.
2. Stable DBS stimulator settings and medication regimen for at least 6 weeks prior to the sleep studies.
3. Sleep dysfunction as measured by the Pittsburgh Sleep Quality Index (PSQI) (score \>5)
4. 19 years of age or older
5. Ability to walk up and down stairs

Exclusion Criteria:

1. Known narcolepsy
2. Other previous surgical treatment of Parkinson's disease(with the exception of unilateral STN DBS) including pallidotomy, thalamotomy, or gene therapy procedures.
3. Pregnant women will be excluded from this study.
4. Untreated obstructive sleep apnea. If obstructive sleep apnea is discovered during the first sleep study, the subject will be removed from the study. After they have been treated for at least 6 weeks with continuous positive airway pressure (CPAP), they can re-start the study.
5. Inability to walk without assistance, including a cane, wheelchair, or walker
6. Cognitive dysfunction that would prevent subject's ability to participate in the study.
7. Blindness
Reinnervation of Facial Muscles After Lengthening Temporalis Myoplasty

The purpose of this study is to determine the physiology of nerve healing and the neurotization of the facial muscles after lengthening temporalis myoplasty.

The investigators want to study the physiology of nerve healing after lengthening temporalis myoplasty done for facial nerve impairment. The investigators already observed few cases of spontaneous neurotization and the investigators want to check the nerve command of the facial muscles. Clinical and photographic evaluations will be performed before and after a facial nerve block using 1% lidocaine.

Eligibility Criteria:
Inclusion Criteria:

* patient who were operated for a facial paralysis by the lengthening temporalis myoplasty procedure in the University Hospital of Caen and who present signs of contraction of the facial muscles on the plasy side after the procedure.

Exclusion Criteria:

* Patient with contraindications to the injection of lidocaine
* Patient treated with beta-blocker
* Patient on anti-coagulants
* Pathology cause of facial paralysis evolving
* Pregnant or lactating
* Patient incapacitated adult
* Patient undergoing another study at the same time
Magnetic Reflexologic Insoles for Primary Dysmenorrhea

In the study, easy-to-access and easy-to-use reflexologic magnetic insoles were used in women with primary dysmenorrhea who did not want to receive medical treatment; In addition to reducing symptoms such as pain, nausea, dizziness, fainting, vomiting, weakness, constipation/acute gastroenteritis, it is aimed to increase individuals' participation in daily life activities and increase their quality of life by increasing their emotional state.

60 women diagnosed with primary dysmenorrhea through examination by a gynecologist will be included in the study. 60 women will be randomly divided into 2 groups. These groups; Reflexologic Magnetic Insoles Sham Group: They will use orthopedic insoles.

Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with primary dysmenorrhea
* Visual Analogue Scale (VAS) value is 3 and above
* The patient has cooperation
* Having regular menstruation

Exclusion Criteria:

* Getting pregnant during treatment
* Using analgesic medication
* Visual Analogue Scale (VAS) value should be between 0-3
* Having pain in another part of the body
Knee Arthroplasty Performed With Conventional and Customized Instrumentation

The main purpose of this study is to determine whether the surgical time required for primary total knee arthroplasty is significantly less when performed with Customized Patient Instrumentation (CPI) than with conventional instrumentation. Each case will be recorded by video camera, in order to time the length of surgery and each surgical step. The number of surgical trays required for each case will be recorded. As an additional endpoint, the investigators will measure limb and component alignment on x-rays to determine if these two methods achieve equivalent alignment results. The thickness of bone cuts will be compared to the surgical plan and to each other.

The primary hypothesis is that the use of customized patient instrumentation will reduce the operative time required for total knee arthroplasty.

Patient-specific instrumentation (PSI) has been developed for total knee arthroplasty (TKA) with several potential advantages over traditional instrumentation (TI). Shortened surgical time, fewer surgical instruments, and improved alignment are some of these proposed advantages. We sought to examine these assertions.

52 patients (26 per group) were enrolled in a prospective, randomized trial comparing CT-based PSI with TI. No difference was seen in average patient age (68 years) or BMI (31) between groups (p=0.84 and p=0.89), although there were more males in the PSI group (14 vs 7, p=0.002). A single surgeon and consistent staff performed the surgeries with the same knee prostheses, and all cases were videotaped to measure the length of surgery and each individual step. Any additional bone cuts, size changes, or ligament releases made to achieve correct alignment and balance were documented. The number of instrument trays opened for each case was recorded. Postoperative long alignment and lateral radiographs were taken to measure the coronal and sagittal plane component alignment and mechanical axis in each patient.

Eligibility Criteria:
Inclusion Criteria:

* Patient requires unilateral primary total knee arthroplasty

Exclusion Criteria:

* Body mass index greater than 41
* Previous ipsilateral hip or ankle replacement
* Knee flexion contracture greater than 20 degrees
Identify Specific Peripheral Blood Mononuclear Cell (PBMC) MiRNA as Biomarkers for Inflammatory Bowel Disease (IBD)

To find high sensitivity and specificity biomarkers to better diagnose and monitor progression of inflammatory bowel disease (IBD). In this study, we try to find miRNAs that can used to diagnose or monitor progression of IBD by exploring differential expression of miRNAs in peripheral blood mononuclear cells (PBMCs) from Crohn's disease, ulcerative colitis and healthy controls. And we further validate these miRNAs in a larger population to assess their function as biomarkers.

Incidence of inflammatory bowel disease (IBD) has been rising in the past decades. However, diagnosis and differential diagnosis of IBD still lack gold standard. To diagnose IBD, physicians need to combine clinical manifestation, lab results, image examination, endoscopy examination and pathology. After diagnosis, patients still need to monitor their disease progression. The most accurate way is to do endoscopy examination, however, endoscopy examination is an invasive, expensive and uncomfortable procedure. At present, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) and fecal calprotectin are used as main noninvasive biomarkers to monitor progression routinely. But their specificities are still unsatisfactory. So, it's urgent to find high sensitivity and specificity biomarkers to better diagnose and monitor progression of IBD. In this study, we try to find miRNAs that can used to diagnose or monitor progression of IBD by exploring differential expression of miRNAs in peripheral blood mononuclear cells (PBMCs) from Crohn's disease, ulcerative colitis and healthy controls. And we further validate these miRNAs in a larger population to assess their function as biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as Crohn's disease (CD) or ulcerative colitis (UC) according to World Health Organization (WHO) criteria
* Vital signs are stable

Exclusion Criteria:

* Refuse to sign consent
* Refuse to do examination to assess their disease progression
* CD patients only upper gastrointestinal tract (GI) is involved (L4)
* Had colectomy or in artificial opening status
* Have other autoimmune comorbidity
* Had severe infection within a week
* Had surgery within a month
* Have malignant tumor
* Pregnancy or lactation
Acceptability of Identifying and Managing Psychological Distress in Inflammatory Bowel Disease: the COMPASS-IBD Study

This study is a single-centre, interventional implementation and feasibility study.

Patients in the IBD service will be able to access COMPASS, an online cognitive-behavioural therapy (CBT) programme, as part of standard care at Guy's and St Thomas's NHS Foundation Trust.

COMPASS is an online program. It will consist of 11 online modules which target challenges associated with living with IBD (and other long-term conditions) and includes, amongst other things, psycho-education, patient examples, interactive tasks and goal setting. Participants are linked to a therapist; 'guide', who will provide 5-6 x 30 minute support sessions delivered fortnightly in the format preferred by the client (phone and/or in-site message).


Eligibility Criteria:
PATIENT PARTICIPANTS

Inclusion Criteria:

1. Aged 18 or over
2. Have an IBD diagnosis
3. Have English proficiency
4. Have access to a computer
5. Have mild to moderate symptoms of depression and/or anxiety (PHQ-9 score 5-19 and/or GAD-7 score 5-14, or PHQ-ADS score 10-29) or severe depression and/or anxiety (PHQ-9 score≥20 and/or GAD-7 score ≥15, or PHQ-ADS score ≥30 but no acute suicidal risk) and awaiting treatment from clinical psychologist as specified above.
6. Have evidence of illness-related distress

Exclusion Criteria:

1. Evidence of substance dependency, cognitive impairment, severe mental health conditions
2. Evidence of acute suicidal risk PHQ-9 item-9 \>1 and recent serious suicidal intent and/or planning
3. Are receiving current psychological treatment or are on a wait-list to receive treatment within the study period (next 6 months)
4. Have depression and/or anxiety unrelated to IBD (e.g. where disease long-standing/well-controlled unrelated to current presentation of distress)

HEALTHCARE PROFESSIONAL PARTICIPANTS

1. Work in the Gastroenterology IBD service at Guy's and St Thomas' Hospitals NHS Trust (GSTT).
2. Have experience of either: i) Utilising the routine mental health screening tools ii) Assessing and triaging patients onto the COMPASS programme and/or iii) Providing therapist support to the users of COMPASS.
Clinical Study to Determine if Ecopipam Can Reduce Urges to Gamble

This study is designed to test the hypothesis that ecopipam is able to reduce urges to gamble in patients diagnosed with Pathological Gambling.

The purpose of this study is to determine if ecopipam is able to stop urges to gamble in patients diagnosed with Pathological Gambling. Nerves communicate with each other by releasing chemicals called "neurotransmitters". One of these neurotransmitters in the brain is called "dopamine". After dopamine is released by the nerve it "talks" to other nerves by interacting with receptors that are unique to that neurotransmitter. Ecopipam is a drug that selectively blocks one family of dopamine receptors. Some scientists believe that the urge to gamble is related to having too much dopamine in the brain. By blocking the receptors that dopamine uses, ecopipam may be able to relieve the urge to gamble.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be diagnosed with Pathological Gambling according to DSMIV criteria
* Subject must have at least 2 episodes of gambling behavior within the previous 2 weeks before screening
* Subject must have gambling urges of at least moderate intensity

Exclusion Criteria:

* Subjects must not have unstable medical illness or clinically significant abnormalities on lab tests, ECG, or physical exam
* Subjects with major depressive episode within the last 2 years
* Subjects with a history of attempted suicide
* Subjects with first degree relative with major depressive episode that resulted in hospitalization, attempted or completed suicide
* Subjects with a history of epilepsy or seizures
* Subjects with a myocardial infarction (heart attack) with in the last 6 months
* Subjects with a lifetime history of bipolar disorder, dementia, schizophrenia, or any psychotic disorder
* Subjects with current of recent DSM-IV diagnosis of substance abuse or dependence (with the exception of nicotine)