cyrilzakka/clinical-trials huggingface dataset:
Prospective Investigation of the Effects of Different Treatment Techniques on Myofascial Trigger Points in Patients With Temporomandibular Dysfunction (TMD)

In the literature, there are no studies comparing the use of occlusal splint and Low Level Laser (LLL) in the treatment of Temporomandibular Disfunction (TMD) and including Ultrasonography (USG) in these parameters. In this study, it is aimed to contribute to the literature in terms of determining which treatment method is more effective by evaluating the changes in the needles muscles with the use of occlusal splints and LLL with USG and other parameters in certain periods, as well as evaluating which parameters are more effective.


Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 who apply with Temporomandibular Joint (TMJ) problems
* Patients with pain in the joint and chewing muscle area

Exclusion Criteria:

* Syndromic patients
* Patients under the age of 18
* Patients with a history of orthognathic surgery
* Pregnants
* Antidepressant Users
* Patients Using Removable Dentures
* Patients who have had joint treatment in the past six months
Phase 2, Multicenter, Open-Label Extension Study With ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Study

This is a Phase 2, multicenter, 24-week OLE study to assess the safety and tolerability of ABT-122 in participants with rheumatoid arthritis (RA) who had had an inadequate response to methotrexate (MTX) therapy and who completed the preceding Study M12-963 randomized controlled trial, in which participants had been randomized to receive 1 of 3 doses of ABT-122 (60 mg every other week \[EOW\], 120 mg EOW, or 120 mg every week \[EW\]) or adalimumab 40 mg EOW given on background methotrexate.


Eligibility Criteria:
Inclusion Criteria: - Subjects who have completed the preceding Study M12-963 (ABT-122) randomized controlled study and have not developed any discontinuation criteria, as defined in Study M12-963.

* If female, subject must meet one of the following criteria:

  1. Postmenopausal (defined as no menses for at least 1 year).
  2. Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy).
  3. Practicing appropriate birth control, from the time of enrollment in this study until at least 150 days after the last dose of study drug.
* Male who agrees to follow one of the protocol-specified pregnancy avoidance measures, including refraining from donating sperm, for up to 150 days post last dose of study drug.
* Subjects must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
* Subject is judged to be in good health as determined by the Investigator based on the results of medical history, physical examination and laboratory profile performed.

Exclusion Criteria: - Pregnant or breastfeeding female.

* Ongoing infections at Day 1 (Week 0) that have NOT been successfully treated within 14 days.
* Anticipated requirement or receipt of any live vaccine during study participation including up to 120 days after the last dose of study drug.
* Current enrollment in another investigational study; with the exception of Study M12-963, which is required.
* Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-122.
A Reversal in the Vascularity of Metastatic Liver Tumors From Colorectal Cancer After the Cessation of Anti-VEGF Therapy

Objective: To assess the effect of bevacizumab on tumor vessels, and the reversibility of the effect, using contrast-enhanced ultrasonography (CEUS) and histology in patients with metastatic liver tumors derived from colorectal cancer.

Background Data: Direct evidence on the reversibility of any change in tumor vascularity upon bevacizumab cessation in the clinical setting is lacking.

Methods: The study included 10 patients who received chemotherapy including bevacizumab, experienced a reduction in tumor vascularity as demonstrated by CEUS and consequently underwent liver resection. CEUS was performed before and immediately after 4 courses of chemotherapy and one day before surgery. The number of microvessels highlighted by anti-CD34 antibody in the viable tumor tissue was counted to quantify the microvessel density (MVD). As a control, 10 surgical specimens from 10 patients who had not received chemotherapy were examined.


Eligibility Criteria:
Inclusion Criteria:

* patients who received chemotherapy (FOLFOX) including bevacizumab. The patients had an associated reduction in tumor vascularity as estimated by ultrasonography and consequently underwent surgical resection of the metastatic liver tumors for curative purposes.

Exclusion Criteria:

* none
Safety and Efficacy Reconyl for Cough With/Without Sore Throat

This study is a prospective, randomized, double-blind and placebo-controlled study to find out if reconyl may relieve the acute cough with/without sore throat.

Reconyl is a mixed extract from 4 Indonesian herbs, Vitex trifolia (Legundi), Zingiber officinale var. Amarum (Jahe Gajah), Abrus precatorius (Saga), and Phaleria macrocarpa (Mahkota Dewa), which have been known traditionally to relieve cough, respiratory congestion, and sore throat.

There will be two parallel groups of 30 subjects per group (a total of 60 subjects) planned to be enrolled in this study.

The investigational product: tablets @ 225 mg of Reconyl. Dose administration: One tablet of Reconyl or Placebo, given 3 times daily, for 3 days.

Eligible subjects will be instructed to perform a daily self-assessment on the cough symptoms over the 3 days of treatment, in the Subject Diary. Subject shall return to the study clinic 3 days ± 24 hours after the first dose, for completion of the subject's participation in the study.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy men or women aged 18 to 60 years with cough with/without sore throat with a maximum onset of 3 days.
2. Signing the informed consent.

Exclusion Criteria:

1. Body temperature of \> 37.3˚C and/or refuse to follow health protocol for COVID-19
2. Known hypersensitivity to herbal drugs
3. Pregnant or lactating women
4. Have received any anti-inflammatory or cough-alleviating drugs within the past 24 hours
5. Presence of vomiting or diarrhea within the past 24 hours and still ongoing at the start of study
6. Severe illness, e.g. severe hypertension, any other chronic infections or diseases that may induce cough, such as: pulmonary tuberculosis, gastrointestinal reflux diseases (GERD)
Evaluation of PC 6 "Neiguan" With Conventional Acupuncture to Prevent PONV After Laparoscopic Cholecystectomy.

Assessment of the effectiveness of PC 6 "Neiguan" with conventional acupuncture for preventing PONV (PostOperative Nausea and Vomiting) after laparoscopic surgery.

Utilizing acustimulation, the effect of PC 6 "Neiguan" (acupuncture point Pericardium 6) has been studied in PONV . Conventional acupuncture has not been tested yet in laparoscopic cholecystectomy.

The incidence of postoperative vomiting during the first 24 hours is the main outcome. Secondary outcomes include: complete response rate, total rescue ondansetron dose used and patient satisfaction with PONV management.

Eligibility Criteria:
Inclusion Criteria:

* Female and male patients
* \> 18 y
* General anesthesia
* Undergoing laparoscopic surgery
* Patient with American Society of Anesthesiologists physical status I-II
* Written informed consent

Exclusion Criteria:

* Pregnant women and breastfeeding
* Patient with cardiac disease
* Surgery more than 2 h
* No bowel surgery
* Signs of skin infection at or near the purposed site of the acupuncture point
* Patient with American Society of Anesthesiologists physical status IIII-IV
Radiotherapy With Cisplatin Versus Radiotherapy With Cetuximab After Induction Chemotherapy for Larynx Preservation

Larynx preservation remains a very challenging approach in patients with larynx/pharynx cancer. A first attempt consisted of induction chemotherapy followed in good responders by irradiation. This approach allowed to preserve 60 % of the larynx without any significant difference in survival. The second attempt consisted of concurrent chemo-irradiation. This approach provided a higher larynx preservation rate but survival remained unchanged and mucosal toxicity was also higher. A third approach is currently under evaluation: induction chemotherapy followed by concurrent chemo-irradiation in good responders.

At ASCO 2004 there were 3 major presentations issuing an increasing in survival:

* the update of the MACH-NC meta-analysis showed that actually only concurrent chemo-irradiation trials found a significantly improved survival (in particular the addition of cisplatinum alone to radiotherapy)
* the addition of docetaxel to the cisplatinum-5FU regimen (TPF) when compared with cisplatinum--5FU (PF)
* the addition of cetuximab to irradiation

On this basis we decided to carry-out a randomized phase II for previously untreated patients requiring a total laryngectomy:

All patients after a complete work-up including a CTscan will receive 3 cycles of TPF(T: 75 mg/m², P: 75 mg/m² and 5FU 750 mg/m²).

Patients with response over 50 % (endoscopy and CTscan) will be randomized to receive either irradiation (70 Gy) and cisplatinum (100 mg/m² on D1, D22 and D43) or irradiation (70 Gy) with cetuximab (loading dose of 400 mg followed by weekly 250 mg for a total of 8 cycles.

Patients with less than 50% decease in tumour volume after TPF, patients with residual or recurrent disease after either RT-CDDP or RT-cetuximab will get salvage total laryngectomy.

Eligibility Criteria:
Inclusion Criteria:

* Larynx or hypopharynx squamous cell carcinoma proven by histology, locally advanced, only eligible for surgery as total or sub-total (pharyngo-)laryngectomy
* Performance status 0-1
* Neutrophils \>=1.5 x 109/l, Platelets count \>=100 x 109/l, haemoglobin \>=10 g/dl
* Total bilirubin \<= 1.5 x upper reference range
* ASAT and ALAT \<= 2.5 x upper reference range, Alkaline Phosphatases \<= 5 x upper reference range
* Serum creatinine \<= 120 µmol/l
* Weight loss \< 10 % within last 3 months
* Written inform consent

Exclusion Criteria:

* Infiltrative transglottic tumor or clinical cartilage invasion
* Distant metastasis
* Previous chemotherapy or radiotherapy
* Contra-indication to chemotherapy
Minimally Invasive Non-surgical Therapy With or Without Injectable Bone Putty

• All periodontitis patients with infra bony pockets to be included in this study will diagnosed as having stage III periodontitis with probing pocket depth (PPD) ≥ 6 mm, and clinical attachment loss (CAL) ≥ 5mm will be treated by minimally invasive non-surgical therapy or by injectable bone putty

The present study will be designed as a randomized controlled clinical and radiographic. The study will be carried out on stage III grade (B) periodontitis patients with intra-bony defects. Those patients will be selected from the outpatient clinics of the Department of Oral Medicine and Periodontology, Faculty of Dental Medicine, Al-Azhar University, Assiut branch.

The study has bee approved by the ethical committee, Faculty of Dental medicine, Al-Azhar University, Assiut branch.

2. All patients will be fully informed about the study's nature and the possible risks of the study procedures; they sign the consent form before the work.

Eligibility Criteria:
Inclusion Criteria:

* • All periodontitis patients to be included in this study should be diagnosed as having stage III periodontitis with probing pocket depth (PPD) ≥ 6 mm, and clinical attachment loss (CAL) ≥ 5mm.

  * 2- or 3-wall intra-bony interproximal defect with depth ≥3 mm, a width of ≥3 mm at its most coronal part and 45-55-degree angulation will be selected in order to reduce defect variability
  * All patients will be free from any systemic diseases according to the American Dental Academy general guidelines for referring dental patients to specialists and other care settings.

Exclusion Criteria:

• Any patients with any systemic condition that contraindicate any surgical intervention
Interpretation Bias as a Mechanism of Treatment Response in OCD

This study will conduct a randomized controlled trial of Cognitive Bias Modification for Interpretation (CBM-I) as an augmentation to treatment as usual for obsessive compulsive disorder (OCD). CBM-I is a digital intervention designed to directly manipulate interpretation bias through repeated practice on a training task, thereby inducing cognitive changes in a relatively automatic or implicit manner. Specifically, this study will examine the feasibility, acceptability, and clinical outcomes associated with CBM-I.

Adults with obsessive compulsive disorder (OCD) will be recruited from a treatment program for this disorder and participants will be randomly assigned to either receive: 1) up to 12 sessions of CBM-I, or or up to 12 sessions of psychoeducation as a control condition.


Eligibility Criteria:
Inclusion Criteria:

* 1) OCD Institute patients
* 2) adults (\> 18 years old)
* 3) able to complete a computer task for 20 minutes
* 4) consent to main OCD Institute study protocol
* 5) primary diagnosis of OCD (as measured by a score of \>16 on the Y-BOCS and a clinical diagnosis of OCD by their treatment team
* 6) score of \>131 on the Obsessive Beliefs Questionnaire-44 at admission \[which is 1 SD above the mean score of the non-clinical sample reported in the original validation paper by the Obsessive Compulsive Cognitions Working Group (2005)\]

Exclusion Criteria:

* 1) Currently experiencing acute symptoms of psychosis
* 2) Psychotic disorder diagnosis
Open-label Extension (OLE) Study to Assess Safety and Efficacy of Evolocumab

The purpose of this study was to characterize the safety and tolerability of long-term administration of evolocumab in adults with known coronary artery disease and hypercholesterolemia.


Eligibility Criteria:
Inclusion Criteria:

* Completed week 80 of study 20120153 (NCT01813422).

Exclusion Criteria:

* Did not complete investigational product in the 20120153 parent study
* Have an unstable medical condition, in the judgment of the investigator
* Known sensitivity to any of the products to be administered during dosing
* Currently enrolled in another investigational device or drug study (excluding evolocumab (AMG 145) parent study), or less than 30 days since ending another investigational device or drug study(s),or receiving other investigational agent(s)
LNK in Polycystic Ovary Syndrome With Insulin Resistance

Insulin resistance (IR) is an important pathological feature of polycystic ovary syndrome (PCOS), with an incidence rate of up to 85%, which seriously affects the patient's fertility, quality of life, and offspring health, but the mechanism is unknown. The adaptor protein LNK is closely related to metabolic diseases. Our exome sequencing has found that the mutation rate of LNK gene in patients with PCOS and IR is high. Studies have found that LNK can affect adipose inflammation and impair glucose tolerance. Whether LNK is related to fat metabolism is worth further study. Our previous research found that: LNK expression was significantly increased in adipose tissue of patients with PCOS and IR. Knockout of LNK in PCOS IR model mice can reduce serum triglycerides, free fatty acids, high-sensitivity C-reactive protein levels and reduce fatty liver occurrence, which indicates that LNK has a mitigating effect on IR. Mechanism studies have shown that LNK knockout can upregulate the glucose transporter Glut4, also LNK and insulin receptor substrate IRS-1 can form protein complexes. Based on the above research basis, we propose the following scientific hypothesis: LNK in adipose tissue can regulate insulin signaling pathway by binding to IRS-1, downregulate Glut4, and participate in PCOS IR occurrence. This project intends to clarify the specific mechanism by which LNK regulates glucose transport and participate in IR in combination with clinical specimens, animal models and cell experiments, and provide scientific basis for LNK as a potential therapeutic target for PCOS IR.


Eligibility Criteria:
Inclusion Criteria:

* Patients with polycystic ovary syndrome who meet the 2003 Rotterdam criteria

Exclusion Criteria:

* Do not meet the diagnostic criteria for polycystic ovary syndrome
Evaluation of Implants Placed in the Regular Dentist's Practice

This study is an evaluation of the implants placed in a regular dentist's practice regarding:

* gingiva condition
* stability of implant
* prothetic quality
* questionnaires for the patients


Eligibility Criteria:
Inclusion Criteria:

* Patients with implants placed in a regular dentist's practice
R&D Study to Evaluate Cordio's Usability and to Collect Patient Speech Utterances

To determine the usability and technical aspects of Cordio HearO™

The system (including App and server) will be tested under simulated use conditions with representative users to identify potential changes required to the application user interface, to improve user performance and satisfaction, and to inform future design options.

The recordings data will also be used for algorithm improvement

Eligibility Criteria:
Major inclusion Criteria:

1. Adults patients
2. Diagnosed with Symptomatic Chronic Heart Failure \[NYHA II-IVa (ambulatory)\]
3. At least one of the following:

   1. One ADHF hospitalization in the last 12 months
   2. One unplanned IV/SC diuretic administration in the last 6 months
   3. Two unplanned IV/SC diuretic administration in the last 12 months
   4. NTProBNP \>500 pg/ml or BNP\*\> 150 pg/ml at screening visit
4. Clinically stable HF
5. Willing to participate as evidenced by signing the written informed consent.
6. Male or non-pregnant female patient (pre-menopausal women will confirm verbally).

Major exclusion Criteria:

1. Not able to read in Hebrew, Russian, Arabic, English and/or Spanish.
2. Unable to comply with daily use of the App
3. Major cardiovascular event
4. Had a Cardiac Resynchronization Device (CRT) implanted or upgrading ≤ 1 month prior to screening visit.
5. Has estimated Glomerular Filtration Rate (eGFR) \< 30 ml/min/1.73 meter square (Cockroft-Gault formula).
6. Is likely to undergo heart transplantation/ LVAD within 6 months of Screening Visit.
Estimating and Predicting Hemodynamic Changes During Hemodialysis

Machine learning techniques and algorithms originally developed for use in the field of robotics can be applied to continuous, noninvasive physiological waveform data to discover hidden, hemodynamic relationships. Newly developed algorithms can, in real-time: 1) estimate acute blood loss volume, 2) monitor and estimate fluid resuscitation needs, 3) predict cardiovascular collapse well ahead of any clinically significant changes in standard vital signs, and 4) estimate intracranial pressure. We hypothesize that these same methods can be used to monitor volume loss during hemodialysis, as well as predict intradialytic hypotension, well before it occurs.

1. Collect physiological waveform data from patients undergoing hemodialysis at the University of Colorado Hospital, Children's Hospital Colorado, and Fresenius Medical Centers using non-invasive monitoring techniques.
2. Combine the physiological data from patient monitors with clinical and demographic data, including age, gender, race, problem list, reason for dialysis, estimated dry weight, volume removed, arterial and venous pressures, etc. for use in developing mathematical models of hemodialysis.
3. Develop robust, real-time, computational models for:

   * estimating acute intravascular volume loss during hemodialysis
   * predicting an optimal, individual specific, intravascular volume to be removed during a hemodialysis session
   * predicting intradialytic hypotension
4. Determine:

   * which non-invasive signals are relevant to each model type
   * which features extracted from these signals are relevant
   * which algorithms are capable of using the extracted features for each decision type

Eligibility Criteria:
Inclusion Criteria:

* Age: 2 - 89 years
* Undergoing hemodialysis at the Fresenius Medical Centers, University of Colorado Hospital or Children's Hospital Colorado

Exclusion Criteria:

* Pregnant
* Incarcerated
* Decisionally challenged
* Positive for hepatitis B surface antigen
* Limited access to or compromised monitoring sites for non-invasive finger and ear or forehead sensors
Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg Once Daily (QD) in the Treatment of Seasonal Allergic Rhinitis (Study P05067)(COMPLETED)

This study is designed to assess the effectiveness of mometasone furoate nasal spay (MFNS) once daily (QD) compared with placebo in subjects with seasonal allergic rhinitis (SAR) in reducing the total nasal symptom score and the total ocular symptom score.


Eligibility Criteria:
Inclusion Criteria:

* Must be 12 years of age or older, of either sex and of any race.
* Must have at least a 2-year documented history of SAR which exacerbates during the study season.
* Must have a positive skin-prick test response to an appropriate seasonal allergen at Screening (Visit 1). Immunoglobulin E (IgE)-mediated hypersensitivity to an appropriate seasonal allergen (ie, prevailing trees and/or grasses) must be documented by a positive response to the skin prick test with wheal diameter at least 3 mm larger than diluent control after 20 minutes.
* Must be clinically symptomatic at the Screening Visit.
* Must be clinically symptomatic at the Baseline Visit.
* Must be in general good health as confirmed by routine clinical and laboratory testing and electrocardiogram (ECG) results. Clinical laboratory test (complete blood count \[CBC\], blood chemistries, and urinalysis) must be within normal limits or clinically acceptable to the investigator and the sponsor.
* Must be free of any clinically significant disease, other than SAR, that would interfere with the study evaluations.

Exclusion Criteria:

* A history of anaphylaxis and/or other severe local reaction(s) to skin testing.
* A subject with asthma who requires chronic use of inhaled or systemic corticosteroids.
* Current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip.
* A subject with rhinitis medicamentosa.
* A history of allergies to more than two classes of medications or who are allergic to or cannot tolerate nasal sprays.
* A subject who has had an upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or who has had a viral upper respiratory infection within 7 days before the Screening Visit.
* A subject who has nasal structural abnormalities, including large nasal polyps and marked septal deviations, which significantly interfere with nasal air flow.
* A subject who, in the opinion of the investigator, is dependent on nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids.
Effect of Intraoperative Nefopam on Acute Pain After Remifentanil Based Anesthesia

Many anesthesiologists use the Remifentanil for reducing a surgical pain and stabilizing a vital sign. However, this drug induce postoperative hyperalgesia. Nowadays, many studies report that low-dose Ketamine prevents the opioid-induces hyperalgesia. Nefopam,which is non-opioid analgesic, has similar mechanism with Ketamine. It will be helpful for postoperative pain control, and reduce the needs of opioid.


Eligibility Criteria:
Inclusion Criteria:

* patient who scheduled laparoscopic cholecystectomy under general anesthesia
* American Society of Anesthesiologist(ASA) class I or II
* adult patient (age 20 - 65)

Exclusion Criteria:

* patient who has liver disease
* patient who has kidney disease
* patient who has diabetes mellitus(DM) or heart disease
* patient who takes opioid or beta-blocker
* patient who has airway disease
* patient who has allergy with the drug