cyrilzakka/clinical-trials huggingface dataset:
Combined Ketamine and eCBT Intervention for PTSD

An open label RCT assessing the efficacy of a combined treatment approach for PTSD, using Ketamine infusions and online Cognitive Behavioural Therapy.

OBJECTIVES

(i) To introduce a previously untreated patient population with PTSD to new therapeutic options.

(ii) To provide new insights into the functional role of Glutamate in affective disorders as well as in learning and memory.

(iii) To explore the utility of pharmacologically-enhanced psychotherapy.

OUTLINE

The present study is an open label randomized control trial assessing the efficacy of a combined treatment of sub-anaesthetic IV Ketamine in conjunction with online CBT (eCBT). In the study, 16 participants with refractory PTSD will be assigned either to an experimental group receiving a combination of Ketamine and eCBT over 12 weeks, or they will be assigned to a 12-week control group. Both groups will be assessed for symptoms of PTSD and comorbid disorders before treatment, at 2 midway points (4 and 8 weeks), and at the end of the 12 week experimental period. Symptoms of PTSD and comorbid disorders for participants in the experimental group are expected to improve significantly more than participants in the control.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PTSD by a psychiatrist on the team using the Clinician Administered PTSD Scale (CAPS-5) with a score of at least 50 and a medium presentation.
* Patients will have received at least 2 different types of prior treatment, both of which produced less than a 50% reduction in the participant's symptoms.
* Participants with hypertension or cardiovascular disease must be receiving stable treatment to participate.
* Participants must speak and read English, and will have consistent and reliable access to the internet.
* Patients with suicidal ideation will be included.
* Patients with a history of substance abuse will be included (except for opioid use disorder).

Exclusion Criteria:

Hypomanic/manic episodes, bipolar disorder, acute psychosis, opioid use disorder, treatment with Naltrexone, pregnancy, postpartum, breastfeeding, untreated hypertension, cardiovascular disease, ASPD, active homicidal ideation, and general noncompliance with the study protocol.
Relationship Between Strain and Stroke Volume in Cardiac Surgery

Patients undergoing coronary artery bypass grafting up tp 30% will develop postoperative right ventricle dysfunction. Its imperative for the physician to fully understand the severity of this complication in order to perform an early diagnosis and carry out the appropriate treatment.

Aim:

Investigate the correlation between echocardiographic measurements and hemodynamic changes at different time points in patients undergoing coronary artery bypass graft surgery

Hypothesis:

1. Weak correlation between echocardiographic measurements and hemodynamic changes during coronary artery bypass graft surgery
2. Echocardiographic measurements would change across different time points during surgery independent of hemodynamic values.


Eligibility Criteria:
Inclusion Criteria:

- Elective coronary artery bypass graft patients who require pulmonary catheter placement for intraoperative monitoring.

Exclusion Criteria:

* Patients with contraindication to Swan-Ganz catheter placement,
* Pre-existing atrial arrhythmias,
* Patients with moderate and/or severe mitral/tricuspid valve stenosis or regurgitation
* Patients with contraindication to transesophageal echocardiogram probe placement (i.e. esophageal stenosis).
iBCI Optimization for Veterans With Paralysis

VA research has been advancing a high-performance brain-computer interface (BCI) to improve independence for Veterans and others living with tetraplegia or the inability to speak resulting from amyotrophic lateral sclerosis, spinal cord injury or stoke. In this project, the investigators enhance deep learning neural network decoders and multi-state gesture decoding for increased accuracy and reliability and deploy them on a battery-powered mobile BCI device for independent use of computers and touch-enabled mobile devices at home. The accuracy and usability of the mobile iBCI will be evaluated with participants already enrolled separately in the investigational clinical trial of the BrainGate neural interface.

After VA IRB approval, this VA RR\&D study will engage participants in the BrainGate clinical trial (IDE, sponsor-investigator LR Hochberg). This study does not create a new clinical trial or modify the existing clinical trial as already listed on clinicaltrials.gov

This project builds on a custom, mobile neural signal processing device with exceptional processing and low power characteristics, which has been developed through previous VA RR\&D funded research. This project takes advantage of the exceptional processing system, previously developed and validated, to create and quantify advanced neural decoding algorithms that show promise (in preclinical studies) for improving the accuracy and reliability of neural decoding - but that are likely too computationally demanding to be viable on existing real-time BCI systems. Decoding methods will include magnitude kinematic decoding with recursive neural networks and high-dimensional discrete gesture decoding. Computational methods to be evaluated include latent space methods and stable manifolds to improve day-to-day reliability of high performance and high-dimensional orthogonalization approaches to improve the independence of kinematic and gesture decoding.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria are extensive and are determined by the associated BrainGate IDE(clinicaltrials.gov # NCT00912041)
* Informally, participants will be tetraplegic or anarthric with little or no functional use of the arms and legs

Exclusion Criteria:

* Exclusion criteria are extensive and are determined by the associated BrainGate IDE(clinicaltrials.gov # NCT00912041).
Comparison of Primary and Secondary Prevention of Postpartum Hemorrhage at the Community Level in Egypt

The objective of this study is to compare two community-level strategies: either selective, early administration of 800 mcg sublingual misoprostol to women for secondary prevention of postpartum hemorrhage (PPH) or universal use of 600 mcg oral misoprostol at the time of delivery for prophylaxis of PPH. The significance of this cluster randomized non-inferiority trial is its potential to inform service delivery programs on clinical outcomes, program feasibility, cost, and acceptability of two different community models of PPH care using misoprostol.1. The study hypothesizes that a service delivery model that administers misoprostol for secondary prevention is non-inferior to a model that administers misoprostol for universal prophylaxis.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to give informed consent
* Vaginal delivery
* Agrees to participate in follow-up interview
* Agrees to have pre- and post-hemoglobin taken
* Delivery at woman's home or at the primary health unit (PHU)

Exclusion Criteria:

* Too advanced into active labor to provide consent
* Known allergy to misoprostol and/or other prostaglandin
* Pregnancy complications, such as hypertension, suspected multiple pregnancy, previous caesarean section, suspected still birth, ante-partum hemorrhage, and previous complication in the third trimester
Steady-State Pharmacokinetic Comparison Study of TNX-102 SL 5.6 mg Versus AMRIX® 30 mg ER Capsules

This will be a single center, comparative pharmacokinetic, open-label, randomized, multiple-dose, 1-period, 2-arm, parallel study of TNX-102 SL 5.6 mg (administered as 2 x 2.8 mg tablets) to AMRIX® (cyclobenzaprine hydrochloride \[HCl\] extended-release \[ER\] capsules), 30 mg.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, non-smoker, ≥18 and ≤75 years of age (Treatment A) or ≥18 and ≤65 years of age (Treatment B), with Body Mass Index (BMI) \>18.5 and \<30.0 kg/m2
* Females of childbearing potential must be willing to use a medically acceptable method of birth control throughout the study
* Capable of consent

Exclusion Criteria:

* Any clinically significant abnormality or abnormal laboratory test results found during medical screening
* Positive hepatitis B, hepatitis C, HIV, urine drug screen, urine cotinine test, or alcohol breath test at screening
* History of allergic reactions to cyclobenzaprine, any of the formulation component, or other related drugs
* Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to the first study drug administration
* Positive pregnancy test at screening
* Clinically significant electrocardiogram (ECG) abnormalities or vital sign abnormalities at screening
* History of significant alcohol or drug abuse within one year prior to screening
* Participation in a clinical trial involving the administration of an investigational or marketed drug within 30 days prior to the first dosing or concomitant participation in an investigational study involving no drug administration
* Use of medication other than topical products without significant systemic absorption and hormonal contraceptives
* Donation of plasma within 7 days prior to dosing, or significant loss of blood within 54 days of dosing.
* Abnormal hemoglobin and hematocrit levels at screening
* Breast-feeding subject
* Presence of dentures, tongue piercings with ongoing use of tongue studs/jewelry, orthodontic braces, or surgical manipulations of the tongue
A Study to Evaluate the Safety, Tolerability, and Antitumor Activity of INCB001158 Plus Epacadostat, With or Without Pembrolizumab, in Advanced Solid Tumors

The purpose of this study is to assess the safety and antitumor activity of INCB001158 plus epacadostat, with or without pembrolizumab, in participants with advanced or metastatic solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* For Phase 1, subjects with histologically or cytologically confirmed advanced or metastatic solid tumors that have failed prior standard therapy (disease progression; subject intolerance is also allowable).
* For Phase 2, subjects with the following tumor types who meet protocol-defined criteria: advanced or metastatic NSCLC, melanoma, urothelial carcinoma, SCCHN, SCLC, and CRC.
* Presence of at least 1 measurable lesion by computed tomography or magnetic resonance imaging per RECIST v1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
* Resolution of all toxicities and any toxic effect(s) of the most recent prior therapy to Grade 1 or less (except alopecia). Subjects with ≤ Grade 2 neuropathy are an exception and may enroll.
* Adequate renal, hepatic, and hematologic functions per protocol-defined laboratory parameters within ≤ 7 days before treatment initiation.

Exclusion Criteria:

* Participation in any other study in which receipt of an investigational study drug or device occurred within 2 weeks or 5 half-lives (whichever is longer) before first dose.
* Has received a prior monoclonal antibody within 4 weeks or 5 half-lives (whichever is shorter) before administration of study drug.
* Prior chemotherapy or targeted small molecule therapy within 2 weeks before administration of study treatment.
* Prior therapy with an IDO1 or arginase 1 inhibitor.
* Active autoimmune disease that has required systemic treatment in past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
* Receipt of a live vaccine within 30 days before the first dose of study treatment.
* Any history of serotonin syndrome after receiving serotonergic drugs.
* Use of protocol-defined prior/concomitant therapy.
* Known or suspected defect in the function of the urea cycle.
* History of gastrointestinal condition that may affect drug absorption.
Comparing Steroid Injections and Platelet Rich Plasma Injections in the Treatment of Plantar Fasciitis

In cases of Plantar Fasciitis not responding to conservative management, minimally invasive techniques may be used. These include platelet rich plasma injections and corticosteroid injections. Corticosteroids have long been used for symptomatic relief. However there are growth factors present in PRP injections that contribute to the healing of the pathology, and not just symptom control.

A single blind, prospective, randomized, comparative, control study will be performed. The study population consists of a total of 80 participants. They will be randomly assigned to receive either a corticosteroid injection, or a platelet rich plasma injection. Data will be collected through questionnaires and ultrasound findings. Patients will have a follow up at 3, 6, 12, and 24 weeks after they receive their injection.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18+
* Patients with Plantar Fasciitis for at least 6 months which has not responded to 6 weeks of conservative therapy
* Patients with a visual analogue score (VAS) of more than 5 in the morning
* Patients must be able to understand the informed consent and have the ability to follow up.

Exclusion Criteria:

* Patients who have had repeated corticosteroid injections within the past 3 months, or have taken a non-steroid anti inflammatory drug during the 1 week prior to receiving an intervention
* BMI \> 40
* Patients with a previous foot deformity
* Patients who have had previous foot surgery
* History of anemia (Hb \< 7)
* Confirmed diagnosis of neuropathy
* Patients who have the inability to follow up
The Situation of Re-infection of Helicobacter Pylori After Successful Eradication

The patients who accept the quadruple eradication program of the helicobacter pylori and success to eradicate helicobacter pylori will be followed-up to observe the situation of re-infection of helicobacter pylori.

The patients with helicobacter pylori accepted he quadruple eradication program of the helicobacter pylori.They will be followed-up from 1 year to 5 years to observe the situation of re-infection of helicobacter pylori.The rate of the re-infection will be described by frequency and percentage.

Eligibility Criteria:
Inclusion Criteria:

* Patients, aged between 18 and 70 years old, with positive H. pylori infection that was not eradicated by previous therapies are included. The H. pylori infection is confirmed by the positive rapid urease test or 13C-breath test.

Exclusion Criteria:

* Patients with significant underlying disease including liver, cardiac, pulmonary, and renal diseases, neoplasia, coagulopathy and genetic diseases, history of gastric surgery, pregnancy, breast-feeding, active gastrointestinal bleeding, the use of PPI, NSAID or antibiotics during the 4 weeks prior to enrolment, and previous history of allergic reactions to any of the medications used in this protocol. Patients previously treated with H. pylori eradication regimens or those unwilling to participate in the study were also excluded.
Multidisciplinary Education in Lung Cancer Patients Who Receiving Chemotherapy Treatment

The purpose of this study is to compare the fatigue in lung cancer patients receiving chemotherapy treatment, between the education programme in self-care a multidisciplinary with the group who received standard care.

Educate of self-care by Oncology nurses to relieve and prevent the fatigue of cancer chemotherapy, and provide the manual to read at home, take about 15 minutes. By using home exercise program, 30 minutes of physical education. Teaching and demonstration exercises of the muscles to breath and conservation of energy during exercise and record the exercise/walking diary, the nutritional education nutrition counseling, psychiatric assessment,self-care prevention of depression.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 45-65 years.
2. Has been diagnosed lung cancer stages 3-4 must be chemotherapy is platinum-based, and had received chemotherapy for at least one time, must be in the range of 2-4 cycles of chemotherapy.
3. Performance status: ECOG 0-1
4. No problem hearing it.
5. Read and write Thai.
6. Be willing to cooperate in research. And signed a joint research

Exclusion Criteria:

1. The complications include: high fever, severe nausea and vomiting.
2. Injection drug use in diabetes treatment.
3. Ischemic heart disease with heart arrhythmia and the drug continuously.
4. Is unable to daily living. Caused by defects in movement, and severe osteoarthritis, muscle atrophy, paralysis or walking flat less than 10 meters.
Evaluation of Blood Glucose Monitoring Systems

The purpose of this study was to evaluate the performance of a Bayer Blood Glucose Monitoring System (BGMS) and two additional Blood Glucose Monitoring Systems (BGMS) from other companies. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).

The purpose of this study was to evaluate the performance of a Bayer Blood Glucose Monitoring System (BGMS) and two additional Blood Glucose Monitoring Systems (BGMS) from other companies. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer). Performance of the three systems was evaluated across the glucose range of the BGMSs using capillary blood. All testing and lancing was performed by study staff and some samples were tested from subject fingertips. Additionally, some blood samples were glycolyzed to lower the glucose concentration levels and glucose solution was added to other samples to raise glucose concentration levels.

Eligibility Criteria:
Inclusion Criteria:

* Males and females, 18 years of age or older
* Willing to complete all study procedures

Exclusion Criteria:

* Blood Borne infections like hepatitis or HIV or infections such as tuberculosis
* Hemophilia or any other bleeding disorder
* Pregnancy
Methotrexate Single-dose Treatment and Methotrexate/Actinomycin-D Single-dose Treatment in Low-Risk Gestational Trophoblastic Neoplasia

The investigators conducted a trial to determine whether methotrexate or methotrexate/dactinomycin single-course treatment work well as multiple courses of single methotrexate chemotherapy in low-risk gestational trophoblastic neoplasia. It is not yet known whether single-course of chemotherapy is as the same effectiveness as multicourse.


Eligibility Criteria:
Inclusion Criteria:

* Patients who FIGO Stage I, II, or III criteria for low-risk gestational trophoblastic neoplasia (GTN);
* WHO risk score 0-6;
* Age≤60 years; female, Chinese women;
* Initial treatment is chemotherapy; patients who received prior low-dose methotrexate for treatment of an ectopic pregnancy will be eligible for this study;
* Performance status: Karnofsky score≥60;
* Laboratory tests: WBC≥3.5×10(9)/L, ANC≥1.5×10(9)/L, PLT≥80×10(9)/L, serum bilirubin≤ 1.5 times the upper limit of normal, transaminase≤ 1.5 times the upper limit of normal, BUN, Cr≤ normal
* Provide written informed consent.

Exclusion Criteria:

* Patients with unconfirmed diagnosis of GTN;
* Patients with placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT)
* WHO risk score \>6;
* With severe or uncontrolled internal disease, unable to receive chemotherapy;
* Concurrently participating in other clinical trials
* Unable or unwilling to sign informed consents;
* Unable or unwilling to abide by protocol.
The Effect of Trunk Control on Respiratory Muscle Strength

Cerebral palsy (CP) can be defined as a group of disorders of movement and posture, causing activity limitation that are attributed to nonprogressive deficits that take place in the immature brain. The motor disorders of CP are often accompanied by deficits in sensation, cognition, communication, perception, behavioral and respiratory system .

Children with CP have many primary motor impairments such as selective mobility, muscle weakness, abnormal muscle tone, impaired coordination between agonist-antagonist muscles and insufficient postural control. These motor impairments also lead to secondary problems such as contractures and bone deformities. Whether primer or secondary, all these problems can reduce independence in activities of daily living (ADL) by affecting CP children at different levels.

There are several studies in children with CP that investigate the effects of trunk control and/or respiratory functions. However, there are very few studies examining the relationship of these functions which have direct effects on ADL. In these studies, the functions of children who are more heavily affected and unable to move have been examined. However, there are no studies examining the effect of trunk control on respiratory muscle strength in children with CP with a better mobility level. There are many factors affecting both trunk control and respiratory functions in these children. Therefore, in children with CP, who have better functional level and can move on their own, revealing the interaction between trunk control and respiratory functions may contribute significantly to the treatment process. For this reason, this study was planned to investigate the effect of trunk control on ADL and respiratory muscle strength in children with CP having a Gross Motor Functional Classification System (GMFCS) levels of 1 and 2 and to compare them with healthy children.

Trunk control was evaluated by Trunk Control Measurement Scale (TCMS), ADL was evaluated by Pediatric Evaluation of Disability Inventory (PEDI) and respiratory muscle strength was evaluated by mouth pressure meter.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CP by a pediatric neurologist
* No significant scoliosis during postural evaluation
* Were having a level of 1 or 2 of GMFCS
* No orthopedic surgery or not having Botulinum Toxin-A injection in the last 6 months

Exclusion Criteria:

* Having speech or cooperative problems
R1vascular Hepatectomy for HCC Patients

Since the previous decade, the authors introduced the R1 vascular (R1vasc) resection for the treatment of hepatocellular carcinoma (HCC), and colorectal liver metastases (Torzilli et al. J Am Coll Surg 2005; Viganò et al. Ann Surg Oncol 2016; Torzilli et al. Surgery 2017). However, oncological reliability of tumor exposure in surgery for HCC remains controversial since it has never been validated. The aim of the study is to determine the oncological adequacy of R1vasc hepatectomy in patients with HCC.

A prospective cohort of patients who underwent hepatectomy for HCC between January 2005 and December 2015 is reviewed. The following definitions are adopted: R0 is any resection with at least 1 mm of negative margin; R1vasc is any resection with tumor exposure due to the detachment from major intrahepatic vessel (1st/2nd order glissonean pedicles and hepatic vein at caval confluence); R1-parenchymal (R1par) is any resection with tumor exposure at parenchymal margin.

Eligibility Criteria:
Inclusion Criteria:

* only patients with a primary untreated HCC were included;
* complete follow-up data with available computed tomography (CT) and/or magnetic resonance imaging (MRI) images showing the first recurrence

Exclusion Criteria:

* patients who underwent vascular resection for direct infiltration of the vessel wall
* patients who had radiofrequency ablation in association to surgery