cyrilzakka/clinical-trials huggingface dataset:
Study Evaluating The Safety And Efficacy Of PF-03654746 In Adult Subjects With Tourette's Syndrome

The purpose of this study is to evaluate the safety and efficacy of an investigational compound designated PF-03654746 compared to placebo in the treatment of adults with Tourette's Syndrome. The study will also explore the pharmacokinetics of PF-03654746 in adults with Tourette's Syndrome.

The study was terminated 11-Apr-2012 due to an internal reassessment of priorities by the sponsor. The decision to terminate was not based on any safety or efficacy concerns.

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of Tourette's Syndrome in English-speaking male or female adults 18 to 55 years of age who are in generally good health.
* Free of medications to treat tics for at least 6 weeks prior to randomization.
* Females of childbearing potential must use medically acceptable birth control for the duration of the study and for 28 days after study participation.

Exclusion Criteria:

* Tic treatment including protocol-specified drugs, training in tic-suppressing behavioral techniques, habit reversal training or use of Onabotulinum toxin A injection.
* History or neurologic evidence of a secondary tic disorder, psychosis, bipolar disorder, tardive dyskinesia, untreated or unstable DSM-IV Axis I disorder requiring treatment.
Elobixibat for Chronic Constipation Without Defecation Desire

Patients of chronic constipation without defecation desire will be orally administered elobixibat 10 mg once daily before meals for 4 weeks. The primary endpoint of the pre/post comparative study will be the percentage of improvement in bowel movements from Week 2 of the observation period at Week 4 of the treatment period.


Eligibility Criteria:
Inclusion Criteria:

At the time of provisional registration

* Patients diagnosed with chronic constipation using the Rome IV criteria for the diagnosis of chronic constipation
* Age: 20 years or older (at the time of obtaining consent)
* Gender: Any
* outpatients
* Patients for whom written consent can be obtained
* Patients who can record defecation, etc. in the patient diary

At the time of registration ・Dosing start criteria Patients with the following ・'Loss of defecation desire'\* in the second week of the observation period (1 week before the start of the treatment period)

\*"Loss of defecation desire " refers to patients whose "presence or absence of defecation desire" on the patient questionnaire was "4. almost never" or "5. never".

Exclusion Criteria:

At the time of temporary registration Exclude patients with any of the following conditions

* Patients with organ-related constipation or suspected of having organ-related constipation
* Patients with or suspected of having functional ileus
* Patients with or suspected of having inguinal hernia
* Patients with a history of open abdominal surgery within 12 weeks prior to obtaining consent (excluding appendicitis resection)
* Patients with a history of surgical or endoscopic procedures related to gallbladder resection and papillotomy
* Patients with complications of malignancy However, patients who have undergone radical surgery or who have completed chemotherapy or radiotherapy may be registered.
* Pregnant women, lactating women, women who may be currently pregnant, or patients who cannot give consent to use contraception while participating in the study
* Patients with serious renal, hepatic, or cardiac disease
* Patients with drug allergy to the study drug
* Patients who are participating in other clinical studies, or who have participated in other clinical studies within 4 weeks prior to obtaining consent However, observational studies are excluded.
* Other patients who are judged by the principal investigator or sub-investigator to be inappropriate for this study.

At the time of registration、Dosing start criteria

* Patients who increased the dose of concomitantly restricted drugs during the observation period
* Patients who used concomitantly prohibited drugs during the observation period
MGB/OAGB Versus RYGB After Failed Sleeve

Sleeve Gastrectomy is the most performed bariatric procedure worldwide. But a growing number of data documents that some patients have to be surgical revised due to weight regain or gastro-esophageal reflux disease.

This study elaborates weather Roux-en-Y gastric bypass (RYGB) or Mini/One anastomosis gastric bypass (MGB/OAGB) is a better second step procedure after failed sleeve gastrectomy.

All patients who underwent RYGB or MGB/OAGB between October 2014 and December 2016 after failed sleeve gastrectomy will be recorded and analyzed in relation to weight loss, intra- and postoperative complications (Clavien-Dindo) and postoperative morbidity up to one year follow-up.

Eligibility Criteria:
Inclusion Criteria:

Patients with failed sleeve due to

* weight regain
* weight loss failure
* gastro-esophageal reflux disease Grade B

Exclusion Criteria:

-
Clinical Efficiency of Bioactive Pit and Fissure Sealant

This study will compare the performance of newly introduced bioactive resin based pits and fissure sealant versus fluoride releasing filled resin based pits and fissure sealant in posterior molars prone to carious lesions of fissures in patients at risk of caries. Visual tactile examination and VistaCAM will be used for evaluation.

New bioactive resin pits and fissures sealant BioCoat® by Premier® presenting SmartCap™ Technology involving semi-permeable resin microcapsules. The rechargeable SmartCap microcapsules are filled with ionic solutions of fluoride, calcium and phosphate, supposing greater fluoride uptake in the presence of calcium and phosphate ions.

With no enough evidence based information in literature about using bioactive fissure sealants in susceptible fissures , it isd beneficial to evaluate the newly introduced material using a randomized clinical trial to test the null hypothesis that bioactive resin pit and fissure sealant will have the same clinical performance as flouride releasing filled resin based pit and fissure sealant in susceptible fissures.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria of participants:

  * Patients with caries susceptible fiss- ures in fully erupted first permanent molars showing nosigns of caries.
  * Co-operative patients approving to part- icipate in the trial.
  * Good oral hygiene.
* Inclusion Criteria of teeth:

  * Caries susceptible occlusal pits and fissures.
  * Intact contact with opposing teeth.
  * Teeth with no previous restorations in other surfaces.

Exclusion Criteria:

* Exclusion criteria of participants:

  * patients with Disabilities, systemic disease or severe medical complications.
  * patients have allergic history concerning methacrylate.
  * patients with rampant caries, xerostomia, evidence of severe bruxism, clenching, or tempromandibular joint disorders
  * participants who show lack of compliance.
* Exclusion criteria of teeth:

  * Carious pits and fissures.
  * Developmental tooth defect.
  * Partially erupted teeth
  * Periapical pathology or signs of pulpal pathology.
  * Tooth hypersensitivity.
  * Heavy occlusion and occlusal contacts.
ERic Acute StrokE Recanalization (ERASER)

To monitor the effect of the ERIC® device in combination with SOFIA™ Distal Access Catheter on artery recanalization and on clinical outcomes in stroke patients using data from clinical routine application (ERASER).

To additionally evaluate the effect of the ERIC® device in combination with SOFIA™ Distal Access Catheter on the final infarct volume as determined by advanced image postprocessing methods in the subgroup of patients with acute middle cerebral artery stroke (ERASER+).

This is a prospective, international, single-arm, controlled, open label post-market, multicenter study to compare the safety and effectiveness of ERIC® device in combination with SOFIA™ Distal Access Catheter in acute ischemic stroke patients using clinical routine data.

Patients who meet the imaging inclusion criteria for ERASER will be included in the cohort where collected and additionally analyzed data will be compared to a historical patient cohort (referred to as ERASER imaging =ERASER+). All other patients will be included in a registry (referred to as ERASER), where clinical information will be collected. The overall study duration is expected to be 18 Months. The expected duration of each subject's enrolment is approximately 90 days. Subjects will be followed with assessments at 90 days post stroke.

The basic concept of ERASER+ is the use an infarct prediction algorithm that has been trained on a large dataset of historical imaging data of patients treated with IV tPA, apply it to the pre-treatment imaging and compare its predictions with the actual outcome.

Eligibility Criteria:
Inclusion Criteria:

* Acute ischemic stroke with NIH-SS score of 8-25
* CTP/ MRP \<4.5h after symptom onset completed
* CTA/ MRA confirms M1-occlusion
* Groin puncture estimated \<6h after stroke onset
* Intended usage of ERIC® as first device in combination with SOFIA™ Distal Access -Catheter (secondary bail-out with other devices allowed)

Exclusion Criteria:

* MCA \>1/3 abnormal in DWI or CBV (ASPECTS ≤ 7, \>100 mL)
* Pre stroke mRS ≥ 2
* Necessity of ipsilateral internal carotid artery (ICA) angioplasty
* Age \<18 years
Evaluation of Influencing Variables in Awakening Concentration and Concentration at Body Movements of Propofol TCI (Targeted Controlled Infusion) Targeted at the Effector Site

Age has been related to awakening propofol concentration at effector site of TCI, but not to the loss of consciousness concentration, neither to the concentration of body movements during surgery, that can be interpreted as a sign of light anesthesia and lead to awareness.

This study aims to determinate the incidence and the propofol TCI concentration at the effector site, in patients undergoing general anaesthesia without NBDs, of any patients body movements, defined as any spontaneous movements (but no reflex movements) during surgery.

Target-Controlled-Infusion (TCI), estimating the effect-size concentration (Ce) of propofol and its elimination time with a computerized system, provides the anaesthesiologist useful information to guide anaesthesia.

Although the correlation between propofol at the effector site at loss of consciousness (Ce LOC) and age is still debated with contrasting results, the correlation between propofol at the effector site at return of consciousness (Ce ROC) and age is well established, and some authors suggested that, due also for age-related changes in both pharmacokinetics and pharmacodynamics of propofol, its dosage should be reduced in elderly patients.

Lowering propofol dosage however, can lead to an higher incidence of awareness during general anaesthesia, even if anaesthesia management is guided by consciousness monitors.

Awareness during anaesthesia has recently been defined not as a binary phenomenon, but as a graded spectra of states and, during general anaesthesia without using neuromuscular blocking drugs (NBDs), body movement on the operating table can be taken as an indication of increasing probability of consciousness or 'light' anaesthesia.

Hence, this study aims to evaluate the impact of age on the concentration at the effector site of propofol-remifentanil anaesthesia administered with TCI pump and without NBDs. Concnetration at the effector site of Propofol at the return of consciousness (CeP ROC) and at any clinical sign of superficialization such as body movements (CeP BM) will be considered.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing general anesthesia with propofol and remifentanil delivered with TCI infusion pump

Exclusion Criteria:

* neurological or psychiatric or cerebrovascular diseases
* renal insufficiency
* patients unable to understand the information contained in the informed consent form,
* patients with intraoperative hemodynamic instability or
* patients who was delivered curare agents during anaesthesia
Impact of TMAO Serum Levels on Hyperemic IMR in STEMI Patients

Trimethylamine N-oxide (TMAO) is a gut microbiota-dependent metabolite of dietary choline, L-carnitine, and phosphatidylcholine-rich foods. On the basis of experimental studies and patients with prevalent disease, elevated plasma TMAO may increase risk of atherosclerotic cardiovascular disease (ASCVD). However, to our knowledge, no data is available on its impact on coronary microcirculation.


Eligibility Criteria:
Inclusion Criteria:

1. Patient diagnosed with STEMI
2. Availability of non- left anterior descending artery (LAD) non culprit lesion, which is planned for a staged Percutaneous coronary intervention (PCI)

Exclusion Criteria:

1. patient undergoing cardiopulmonary resuscitation;
2. patients with a history of old myocardial infarction or history of coronary artery bypass grafting (CABG) or Percutaneous coronary intervention PCI
3. Patients with signs of chronic infection, prolong usage of corticosteroids or compromised immune system
4. patients had thrombolysis before primary Percutaneous coronary intervention (pPCI)
5. had contraindication of adenosine triphosphate (ATP);
6. had a history of liver or renal function dysfunction
7. Patients with dementia
8. Patients being referred to CABG after primary PCI
9. unable to provide informed consent;
10. had pregnancy or life span \< 1 year.
11. Presence of sever structural valvular heart disease
12. Presence of significant left main disease
13. Unability to measure the index of microcirculatory resistance due to (death or retraction from the study ...etc)
14. Inability to perform successful PCI
Image Driven Hepatocellular Carcinoma Invasiveness Evaluation Research

Hepatocellular carcinoma (HCC) is a highly heterogeneous malignant tumor with significant differences in invasion, proliferation ability and patient prognosis. Currently, there is a lack of non-invasive and simple indicators to predict the prognosis of HCC patients and assist clinical decision-making. The identification of HCC macroscopic or histopathological classification requires large pathological specimens obtained through surgical resection, but only about 20% of patients are eligible for surgical treatment. Moreover, most liver cancer diagnoses can be confirmed by imaging examinations without relying on pathological results. For patients who have not undergone surgical resection, the lack of histopathological information during treatment means that there is no basis for judging tumor proliferation and obtaining rich prognostic information. Therefore, evaluating the invasion and proliferation ability of HCC based on macroscopic imaging assessment has important implications for guiding individualized diagnosis and treatment throughout the entire process including surgical strategy guidance, local treatment selection, systemic therapy planning as well as patient follow-up and prognosis evaluation.

Ultrasound and MRI are ideal entry points as first-line imaging methods for liver cancer diagnosis. This study aims to evaluate HCC macroscopic or histopathological classification based on multimodal imaging (ultrasound, CT, MRI), thereby assessing its invasion and proliferation ability which has important implications for guiding individualized diagnosis and treatment throughout the entire process including surgical strategy guidance, local treatment selection, systemic therapy planning as well as patient follow-up and prognosis evaluation.

By analyzing macroscopic image features we aim to explore their cross-scale correlations with HCC macroscopic classification,histopathological classification,and gene molecular typing.


Eligibility Criteria:
Inclusion Criteria:

* According to the WHO classification, the pathological diagnosis is hepatocellular carcinoma.
* The initial treatment is curative-intent hepatectomy.
* There is no evidence of major vascular/hepatic portal invasion, extrahepatic/lymph node metastasis, or other malignant tumors.
* Age 18-80 years old.

Exclusion Criteria:

· Not meeting any one of the inclusion criteria or being unwilling/unable to follow-up.
Qvar vs FP in Pediatrics

The primary aim of this study was to compare the absolute and relative effectiveness of asthma management in paediatric patients in the UK on inhaled corticosteroid (ICS) maintenance therapy as extra-fine HFA-BDP (Qvar®) pressurised metered dose inhaler (pMDI) compared with fluticasone propionate (FP) pMDI.

Comparison of asthma control with extrafine-particle hydrofluoroalkane-beclometasone (EF HFA-BDP) vs fluticasone propionate (FP) in paediatric patients (5-11year olds). Patients identified from the General Practice Research Database (GPRD) and the Optimum Patient Care Research Database (OPCRD). Two analyses were conducted:

1. Comparison of outcomes achieved by EF HFA-BDP and FP in 5-6year old patients with those achieved in 7-11yr old patients.
2. Comparison of outcomes achieved by EF HFA-BDP used with or without a spacer to those achieved by standard particle fluticasone propionate (FP) used with a spacer.

Eligibility Criteria:
Inclusion Criteria:

1. Aged: 5-11 years
2. Evidence of asthma (diagnostic code and/or current asthma therapy);
3. Have at least one year of up-to-standard (UTS) baseline data (during which the step-up to FP/SAL occurred) and at least one year of UTS outcome data (following the IPD).

Exclusion Criteria:

1. Had any chronic respiratory disease, except asthma, at any time; and/or
2. Patients on maintenance oral steroids during baseline year
Evaluation of the Coloplast Titan® IPP for Maintaining Penile Length While Treating Erectile Dysfunction (ED)

This study is designed to assess the effectiveness of the Coloplast Titan® Inflatable Penile Prosthesis (IPP) at maintaining or increasing penile length after implantation of the device. It will incorporate a modified method of cylinder sizing during implantation and a max-inflate technique after implantation.


Eligibility Criteria:
Inclusion Criteria:

* Has an estimated life expectancy of more than 5 years
* Has been diagnosed with erectile dysfunction
* Is willing to have the Titan IPP implanted
* Is able and willing to complete all follow-up visits and procedures indicated in this protocol
* Has been informed of the nature of the study and agrees to its provisions and - Has provided written informed consent as approved by the Institutional Review board of the respective site

Exclusion Criteria:

* Participant has had a previous penile prosthesis or prior penile enlargement surgeries
* Participant has a compromised immune system
* Participant has had a myocardial infarction or coronary artery stent placement within 2 months prior to treatment
* Participant does not have manual dexterity or mental ability to operate the pump
* Participant has an active urogenital infection or active skin infection in region of surgery
* Participant is diagnosed with fibrotic disease, such as priapism or Peyronie's disease
* Participant is diagnosed with Chordee
* Participant has neuropathy
* Participant has a serious bleeding disorder or coagulopathy
MultiOrgan Multi-Parametric MRI Study

To determine the reproducibility of a single quantitative multiparametric MRI for the assessment of body composition and multiple organ structures.


Eligibility Criteria:
Inclusion Criteria:

* Any person over 18 years of age.
* Participant is willing and able to give informed consent for participation in the investigation.
* EITHER: Participant has Type 2 Diabetes OR: Person is a healthy volunteer

Exclusion Criteria:

* The participant may not enter the investigation if they have any contraindication to magnetic resonance imaging (incl. pregnancy, extensive tattoos, pacemaker, shrapnel injury, severe claustrophobia).
* Any other cause, including a significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the investigation, or may influence the result of the investigation, or the participant's ability to participate in the investigation
Telephone Based Management of Hyperlipidemia

The purpose of the study is to demonstrate that systematic self measurement of blood lipids reduces LDL cholesterol more effectively than standard care. The hypothesis is that cholesterol lowering medication adherence will be improved with self monitoring and reporting of frequent blood lipids and the percentage of patients achieving LDL goal will be greater than without home monitoring.

The study utilizes a telephone reporting system to self report lipid values and provide educational counseling regarding lifestyle modification methods to reduce cardiovascular risk. Study patients will be randomized to receive a home monitoring device and will be instructed on its use. Generic simvastatin will be given to reduce LDL levels in all groups. It is the hypothesis that those study patients receiving a home device will reach target LDL (goal LDL) more frequently than those randomized to usual care( no device).

Eligibility Criteria:
Inclusion Criteria:

* LDL \> 130mg/dl

Exclusion Criteria:

* Pregnant patients
* liver disease
* allergic reaction to statins
A Clinical Study of KDT-3594 in Patients With Early Parkinson's Disease.

Objective of this study is to investigate the efficacy, safety and pharmacokinetics of KDT-3594 in patients with early Parkinson's disease without a concomitant medication of L-dopa.


Eligibility Criteria:
Inclusion Criteria:

* Japanese patients
* Patients who are diagnosed with Parkinson's disease according to UK Parkinson's Disease society brain bank clinical diagnostic criteria
* Patients with Parkinson's disease in Stages 1 to 3 on the Modified Hoehn and Yahr Scale

Exclusion Criteria:

* Patients who are suspected any parkinsonism except for idiopathic Parkinson's disease
* Patients who underwent neurosurgical treatment (stereotaxic destruction, deep brain stimulation etc.) for PD, or patients for whom surgical treatment is scheduled during the study
* Patients with a complication of obvious dementia, or patients with Mini-Mental State Examination (MMSE) score \< 24 points