cyrilzakka/clinical-trials huggingface dataset:
Serotonin Receptor Blockers in Ischemic Mitral Regurgitation

This study is intended to investigate the effect of cyproheptadine (a 5HT2B receptor blocker) on mitral regurgitation severity.

Ischemic mitral regurgitation (MR) is a common and morbid complication of myocardial infarction (MI), doubling heart failure and mortality with currently limited therapies. Its mechanisms have been previously linked to left ventricle (LV) remodeling with secondary deformation of otherwise normal mitral leaflets. Recent studies are introducing new mechanistic elements, allowing possibilities for potential pharmacotherapeutic approaches. Normal mitral leaflets have the capacity to enlarge and adapt to even the largest LV dilatation to prevent MR. However, this compensatory mechanism is insufficient after MI, and the leaflets are abnormally thick with fibrotic changes. Those fibrotic changes could be related to a variation in blood serotonin (5-HT) levels after MI, which has been previously reported. Serotonin is a known cause of valve fibrosis through its 5HT type 2B receptor. In sheep models, the investigators have tested the hypothesis that a 5HT type 2B receptor blocker (cyproheptadine) can prevent adverse remodeling in the valve after MI. Cyproheptadine treatment was associated with increased valve leaflet surface, attenuated leaflet thickening and collagen deposition. Importantly, treated animals had less MR compared to non-treated animals.

Thus the present study is a double-blind randomized trial to assess the effect of cyproheptadine on MR severity, mitral valve surface variation, and left ventricular size following MI. Serial imaging (3D echo and MRI) will assess valve adaptation, LV remodeling and MR.

Eligibility Criteria:
Inclusion Criteria:

1. Patients 18-80 years old with a 1st episode of STEMI with documented coronary obstruction.
2. Left ventricle ejection fraction (LVEF)\<50% and mitral tenting area ≥ 4 cm2, OR LVEF ≤ 40% and inferior/posterior wall motion anomaly, OR LVEF≤30% and wall motion in any territory.

Exclusion Criteria:

1. Inability to provide informed consent
2. Hemodynamic instability / cardiogenic shock / papillary muscle rupture
3. Prior mitral valve procedure/surgery
4. Permanent atrial fibrillation (limiting imaging and MR quantification)
5. Primary mitral disease (endocarditis, rheumatic, degenerative or congenital)
6. More than mild valvular disease (other than mitral) at baseline
7. Planned cardiac surgery (CABG or valve intervention) within 3 months
8. Contraindications for MRI
9. Ongoing treatment with selective serotonin reuptake inhibitor (SSRI)
10. Chronic use of sedative medication
11. Ongoing or planned pregnancy
12. Chronic renal failure with Estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min
13. Neurocognitive disorder
14. Symptom or prior episode of urinary obstruction or glaucoma (relative contraindications for cyproheptadine)
1-year Clinical Outcomes in Recombinant Tissue Plasminogen Activator (Rt-PA) Treated Chinese Acute Ischaemic Stroke (AIS) Patients

The objective of the study is to find out the 1-year clinical outcomes among Acute Ischaemic Stroke (AIS) patients who were treated with intravenous (IV) Recombinant Tissue Plasminogen Activator (rt-PA) within 4.5 hours of symptom onset compared with those who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive any reperfusion treatment in a real-world clinical setting.


Eligibility Criteria:
Inclusion criteria:

* Patients registered in the ZSQCC platform from Jan 2017 to Mar 2020
* ≥ 18 years of age
* Diagnosed with AIS at admission
* Arrived or admitted to the hospital within 4.5 hours of symptom onset
* If treated with IV rt-PA: received IV rt-PA within 4.5 hours of symptom onset

Exclusion criteria:

* Documented Intravenous Thrombolysis (IVT) contraindication except age to IV rt-PA treatment according to the Summary of Product Characteristics (SmPC)
* Missing any one of the key data (age, gender, baseline National Institutes of Health Stroke Scale \[NIHSS\], time of symptom onset, time of hospital arrival or admission, IVT or not, time of IV rt-PA treatment)
* Received thrombolysis agents other than rt-PA (urokinase, tenecteplase, recombinant plasminogen activator, prourokinase, streptokinase)
* Received endovascular treatment
* Received IV rt-PA after 4.5 hours of symptom onset
The Effects of Different Tooth Brushing Explanations in Fixed Orthodontic Treatment

The aim of this study is to investigate the effects of tooth brushing training methods on orthodontic patients and to determine the most effective oral hygiene methods for individuals receiving orthodontic treatment.

Because orthodontic appliances cause food retention, a good level of oral hygiene is needed to maintain dental health. Inadequate tooth brushing can lead to gingival diseases on periodontal tissue, cavities and white lesions on tooth enamel. Antimicrobial agents and fluoride products are useful but it cannot replace the mechanical removal of plaque. Because the mechanical plaque control is still considered the most important oral hygiene tool during orthodontic treatment.

In the literature, it has been reported that the motivation to maintain oral hygiene during the orthodontic fixed treatment phase has a very positive effect on periodontal health, and in the same studies, plaque index scores increased over time in control groups that were not given repeated oral treatment. If patients are not given repeated and regular oral hygiene motivation in every session in the clinical routine, gum health may deteriorate. More invasive methods may be required to correct this condition. Because poor oral hygiene, if left unchecked, can compromise the outcome of orthodontic treatment.

When performing manual tooth brushing, the modified Bass technique (MBT) is often recommended to provide optimum plaque reduction by protecting oral tissues from mechanical irritation. The problem with this brushing technique is that it consists of a complex sequence of movements. First of all, the toothbrush should be positioned at a 45° angle to the gingival edge. Secondly, the brush should be moved back and forth with small horizontal vibrations. Thirdly, debris must be removed by sweeping the brush towards the occlusal face in a vertical motion (upward in the lower jaw, downwards in the upper jaw). This sequence of movements requires dexterity and attention to technique. Brushing demonstration techniques or sequences have been developed through a brochure, a model, or video.

Eligibility Criteria:
Inclusion Criteria:

* The patient with orthodontic attachments at least 4 months
* with permanent dentition

Exclusion Criteria:

* impacted or atypically erupted teeth
* with prosthetic restorations such as crowns or implants
* open bite
* deep bite
* crowding more than 7 mm or polydiastema cases
* Individuals diagnosed with periodontitis
* ndividuals with cleft lip and palate or other craniofacial anomalies
Ilaprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Chinese Patients

This study is designed to evaluate the efficacy and tolerability of ilaprazole relative to that of esomeprazole in healing erosive esophagitis and resolving accompanying symptoms of GERD.


Eligibility Criteria:
Inclusion Criteria:

* Consenting patients will be eligible for enrollment if they:
* are 18-70 years of age,
* have at least one of the two symptoms, heartburn and reflux,
* have photographically documented erosive esophagitis confirmed by esophagogastroduodenoscopy(EGD), and graded according to the Los Angeles (LA) Classification (A-D), within 5 days before randomization to treatment. Female patients are required to be nonpregnant, nonlactating, postmenopausal, surgically sterilized, or using a medically acceptable form of birth control, as determined by the investigator. Women of child- bearing potential will receive a pregnancy test.

Exclusion Criteria:

* Patients will be ineligible if they:
* have cancerous or peptic ulcers, Zollinger-Ellison syndrome, varices of esophagus or fundus of stomach
* have a known history of gastric acid suppression operation, esophageal operation or peptic operation other than simple closure of perforation,
* have severe complications, severe other diseases of digestive tract such as Crohn's disease and ulcerative colitis, and severe other systemic diseases,
* have taken proton pump inhibitors within the 5 days or for more than three consecutive days within the two weeks immediately preceding start of study drug,
* participated in a clinical trial with an investigational drug or device within the past three months,
* have hypersensitivity or idiosyncratic reaction to ilaprazole, esomeprazole or any other benzimidazole,
* have alcoholic intemperance, drug addiction or any other improper habits.
Measuring the Impact of Onco4D® Guidance on Chemotherapy Selection and Outcomes

Millions of cancer patients each year receive chemotherapy causing adverse side effects that lower quality of life without prolonging it. Reliable identification of ineffective therapies can eliminate needless human suffering while increasing overall probability of positive response to treatment. Chemotherapy resistance profiling entails testing whether a patient exhibits strong resistance to a therapy prior to its final selection by the oncologist.

The Onco4D® chemotherapy selection assay has recently emerged as means to measure the response of intact tumor biopsies to applied therapeutics by using Doppler detection of infrared light scattered from intracellular motions inside living tissue (known as Motility Contrast Tomography or MCT). Several studies have shown this phenotypic profiling technique to offer high accuracy predicting response and resistance to chemotherapy\[1-5\].

SPECIFIC AIMS The scope of this study is to measure the impact of Onco4D® therapy guidance on treatment and outcomes among cancer patients for whom the test is ordered.

PRIMARY ENDPOINT: Difference in pathologic complete response (pCR) to neoadjuvant chemotherapy among recipients of Onco4D® guided therapy as compared to baseline unguided pCR rates.

SECONDARY ENDPOINTS: Difference in distribution of chemotherapy regimens among recipients of Onco4D® guided therapy as compared to baseline unguided regimens, adjuvant chemotherapy response, 2 and 5 year event free survival (EFS), pre- and post-chemotherapy cancer staging scores (TNM, ACJJ, RCB, etc..), radiologic chemotherapy response, additional exploratory endpoints as appropriate

RESEARCH DESIGN AND METHODS

STUDY DESIGN: Non-randomized multi-center prospective outcomes registry

PARTICIPANT IDENTIFICATION: Cancer patients of all races and ethnic groups are eligible for this registry. All patients treated at participating sites and meeting the inclusion criteria will be offered the opportunity to participate in the registry. Potential participants will be presented with the purpose of the study and the potential risks and benefits of participation. Participants will be considered registered to the study upon receipt of a signed informed consent statement. Registration information will be maintained by the Principal Investigator. All participants will be assigned a unique study ID.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically proven cancer of any type
2. Onco4D® test ordered by treating physician
3. Ability to understand and willingness to sign an informed consent
4. ≥ 18 years old at time of consent

Exclusion Criteria:

n/a
Multicenter Observational Study to Validate a New Index for Sleep Fragmentation Analysis: Sleep Diversity Index (SDI)

The investigators want to validate the Sleep Diversity Index as a diagnosis tool of sleep fragmentation on 405 patients who will perform a polysomnography under spontaneous breathing.

Sleep fragmentation is one of the main problems of sleep disorders especially in respiratory failure. During this last decade, several indicators of sleep fragmentation were introduced but none of them seems to take into account the succession of sleep stages. To tackle with this problem, The investigators used the Shannon entropy index for modelling sleep stages diversity from an hypnogram and for assessing more accurately sleep quality by quantifying its fragmentation. The investigators developed a new tool we called Sleep Diversity Index (SDI).

In a retrospective study, the investigators calculated Sleep diversity index for 55 healthy subjects and 56 patients with suspected sleep apnea syndrom. Using the receiver operating characteristic (ROC) curves the threshold of fragmentation was determined at 20%. If SDI is lower than 20%, then sleep is considered as non-fragmented and otherwise, sleep is considered as fragmented.

To validate our SDI it is necessary to compare this diagnosis tool to a "gold standard" based on the clinician diagnosis and a mathematical diagnosis index created from objective criteria of polysomnography. The investigators propose a multicenter study to validate the SDI as a diagnosis tool of sleep fragmentation.

Eligibility Criteria:
Inclusion Criteria:

* Spontaneous polysomnography

Exclusion Criteria:

* Insomnia
* Patients with psychoactive drug having an important effect on sleep
CD30-directed Chimeric Antigen Receptor T (CART30) Therapy in Relapsed and Refractory CD30 Positive Lymphomas

Chimeric antigen receptor-modified T cells (CART) holds great promise for treatment of tumors. In this trial, CD30 positive Hodgkin's lymphoma and Non-Hodgkin's lymphoma will be treated by CD30-specific CART cells (CART30).

When patients enroll on this trial, autologous CART-33 cells were generated from the mononuclear cells of 50 to 90 ml of the patient's peripheral blood (PB). During the term of cell preparation of CART30, patients will receive a conditioning regimen including cyclophosphamide and fludarabine. One day after completing conditioning regimen, the patient will be given infusions of CART30 cells into the vein in escalating doses over a period of 3 to 5 consecutive days.

Extra blood will be drawn to measure the persistence of CART30 in vivo.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects with CD30+ Hodgkin lymphoma and Non-Hodgkin lymphoma relapsing after autologous stem-cell transplantation (ASCT), or refractory to 2 multidrug regimens and/or anti-CD30 antibody treatment.
* Newly diagnosed CD30+ Hodgkin lymphoma and Non-Hodgkin lymphoma patients who are unable to receive or complete standard chemotherapy.
* Karnofsky or Lansky score greater than 60%.
* Expected survival\>12 weeks.
* Creatinine\<2.5mg/dl.
* ALT (alanine aminotransferase)/AST (aspartate aminotransferase)\<3 fold normal.
* Bilirubin\<2.5mg/dl.
* Pulse oximetry of \>90% on room air.
* Adequate pulmonary function with FEV1, FVC and DLCO greater than or equal to 50% of expected corrected for hemoglobin.
* Available autologous T cells with 10% or more expression of CD30 CAR determined by flow-cytometry.
* Patients or legal guardians must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects. Patients or their guardians will be given a copy of the consent form.

Exclusion Criteria:

* Active infection such as hepatitis B or C.
* Receive anti-CD30 antibody-based therapy within recent 6 weeks.
* Current use of systemic corticosteroids.
* Pregnant or lactating.
* Confirmed tumor in pulmonary and archenteric tissues.
Brain Tissue Specimen Collection

The Molecular Neurosurgical Tissue Bank will function as a tissue or specimen repository for biopsy specimens from patients (both adult and pediatric) undergoing brain surgery and brain procedures.

The Molecular Neurosurgical Tissue Bank will function as a tissue or specimen repository for biopsy specimens from patients (both adult and pediatric) undergoing brain surgery and brain procedures. Leftover tissue removed during the course of brain surgery will be collected and stored in neurosurgical laboratories for use in medical research that might be currently ongoing or for future research. In addition, blood and cerebral spinal fluid samples will also be collected and stored. Leftover cerebral spinal fluid (CSF) will be collected during standard of care procedures (lumbar punctures or ventricular drains) that take place at time of diagnosis, completion of therapy and relapse of disease or during neurosurgery. Blood will be drawn at time of routine lab draws required during the surgery or procedure.

Eligibility Criteria:
Inclusion Criteria:

* Subjects having any type of brain surgery, where a specimen will be collected.

Exclusion Criteria:

* none
Effects of 12- Weeks of Quantitative Weight-bearing Progressive Resistance Exercise Training on Glycemia Control and Improving Muscle Strength With Type 2 Diabetes Combine Pre-sarcopenia.

According to the International Diabetes Federation (IDF) in 2017 investigator found that the incidence of type 2 diabetes is currently 425 million people aged 20 to 79 in the world, and this data will increase o 629 million at 2045, The etiology of more than 90% is related to aging, it has become a serious challenge to public health.

Sarcopenia is a newly noticed severe syndrome characterized by reduced walking speed, decreased grip strength, and decreased muscle mass. Patients with type 2 diabetes are at risk of sarcopenia and are those with normal blood sugar. One of the main ways to improve the face of sarcopenia is to exercise intensity. By carrying out a gradual training plan instead of using different weights, it will lead to muscle hypertrophy and increase in muscle strength to achieve muscle gain. In view of the fact that the commercially available sandbags are cheap and easy to obtain, the weight is fixed, and the use variability is high, it is expected to introduce quantitative weight-bearing progressive exercises in type 2 diabetes and have symptoms of muscle loss to improve muscle mass, and to control blood sugar. The quality of life can have better benefits.

Purpose:This study aim is effectiveness of 12 weeks quantitative weight-bearing progressive exercise training in patients with type 2 diabetes mellitus(T2DM) with pre-sarcopenia promotion muscle strength and blood sugar control.

Hypothesis:After 12 weeks of quantitative sandbag training , the experimental group can have a significant increase in the muscle mass of the upper and lower limbs、grip strength、5-time chair stand test、Lipid profile、glycemic control(HbA1c) and quality of life.

Methods:This study will be a randomized controlled trial. Forty adult diagnosis with T2DM with pre-sarcopenia patient randomly assigned to experimental group and control group. Experimental group wearing 0.5 kg quantitative sandbag 12\~15 Repetitions/set X 5 set X 3day. Weight adjustment: After the first month of intervention, if the experimental can perform for more than 20 repetitions/set , we will asked to increase the weight of the sandbag to 1 kg until the end of the experiment Conditions:The effectiveness of 12 weeks quantitative weight-bearing can improvement of Glycemic control and limb muscle strength.

Eligibility Criteria:
Inclusion Criteria:

* Age between 50 \~80 years
* T2DM
* Physician and check Calf circumference (M: \<34 cm, F: \<33 cm)、handgrip strength (M: \<28 kg, F: \<18 kg)

Exclusion Criteria:

* Inability to perform any self -activity
* DM with lower limb neuropathy, r
* DM with Retinopathy
* Stroke
* Foot opening wound
* Past history even doing limb resistance training;
* Easy fall down high risk patients
Adalimumab in Rheumatoid Arthritis. An Investigation of Wholebody MRI, Conventional MRI, CT and Circulating Biomarkers

Adalimumab in rheumatoid arthritis. An investigation of changes in disease activity and course of joint destruction by use of 3 Tesla Whole-Body MRI, dedicated 3 Tesla MRI and CT of the hand, and soluble biomarkers. Furthermore to compare ultrasound examination with wholebody MRI etc.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old and \< 85 years old
* RA in accordance with American College of Rheumatology 1987 criteria
* Moderate or highly active RA defined as DAS28 \> 3,2 (CRP based)
* Clinical indication for TNF-α inhibitor treatment by the treating physician
* No contraindications for TNF-α inhibitor treatment
* No contraindications for MRI
* Serum creatinine in normal range
* Sufficient contraception for fertile women
* Capable of giving informed consent
* Capable of complying with the examination program of the protocol

Exclusion Criteria:

* Other DMARDs than MTX from less than 4 weeks before inclusion and throughout the study period
* Cyclophosphamide, Chlorambucil or other alkylating agents from less than 4 weeks before inclusion and throughout the study period
* Intramuscular or intravenous injection of glucocorticoid from less than 4 weeks before inclusion and throughout the study period
* Pregnancy wish, pregnancy or breast-feeding
* Contraindications for TNF-α inhibitor treatment
* Contraindications for MRI
* Known recent drug or alcohol abuse
* Failure to provide written consent
* Incapable of complying with the examination program for physical or mental reasons
First Time Use of SD-809 in Huntington Disease

The purpose of this study is to determine whether SD-809 tablets are effective in the treatment of chorea associated with Huntington's Disease.

This is a randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety and tolerability of SD-809 for the treatment of chorea associated with Huntington's Disease. Approximately 90 subjects will be randomized (1:1) into the study, with approximately 45 subjects receiving SD-809 and 45 subjects receiving placebo. The study will be conducted at approximately 30 centers in the U.S. and Canada.

Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18 years of age or the age of majority (whichever is older) at Screening.
* Subject has been diagnosed with manifest HD
* Subject is able to swallow study medication whole.
* Female subjects of childbearing potential agree to use an acceptable method of contraception from screening through study completion.
* The subject has a reliable caregiver who interacts with the patient on a daily basis, oversees study drug administration, assures attendance at study visits and participates in evaluations, as required.
* Subject is able to ambulate without assistance for at least 20 yards (Note: The use of assistive devices (i.e., walker, cane) is permitted during ambulation).

Exclusion Criteria:

* Subject has a serious untreated or under-treated psychiatric illness, such as depression, at Screening or Baseline.
* Subject has active suicidal ideation at Screening or Baseline.
* Subject has history of suicidal behavior at Screening or Baseline:
* Subject has evidence for depression at Screening or Baseline.
* Subject has an unstable or serious medical or psychiatric illness at Screening or Baseline.
* Subject has been recently exposed to tetrabenazine.
* Subject has received any of the following concomitant medications within 30 days of Screening or Baseline:

  * Antipsychotics
  * Metoclopramide
  * Monoamine oxidase inhibitors (MAOI)
  * Levodopa or dopamine agonists
  * Reserpine
  * Amantadine
  * Memantine
* Subject has significantly impaired swallowing function at Screening.
* Subject has significantly impaired speaking at Screening.
* Subject requires treatment with drugs known to prolong the QT interval.
* Subject has a prolonged QT interval on 12-lead ECG at Screening.
* Subject has evidence of hepatic impairment at Screening.
* Subject has evidence of significant renal impairment at Screening.
* Subject has known allergy to any of the components of study medication.
* Subject has participated in an investigational drug or device trial within 30 days (or 5 drug half-lives) of Screening, whichever is longer.
* Subject is pregnant or breast-feeding at Screening or Baseline.
* Subject acknowledges present use of illicit drugs at Screening.
* Subject has a history of alcohol or substance abuse in the previous 12 months.