cyrilzakka/clinical-trials huggingface dataset:
Clinical Trial, Open-label, Randomised, in Order to Compare the Quality of Life for Those VIH+ Patients That Start With Monotherapy on LPV/r Tablets Vs. Triple Therapy With a Boosted Protease Inhibitor

The Study will help to compare the Quality of Life for those HIV patients that are on monotherapy with LPV/r Vs. triple therapy with a boosted protease inhibitor

The Study will help to compare the Quality of Life for those HIV patients that are on monotherapy with LPV/r Vs. triple therapy with a boosted protease inhibitor.

Eligibility Criteria:
Inclusion Criteria:

* Patients infected with HIV-1, documented with a positive HIV-1 antibodies test and/or positive PCR confirmed for HIV-1 RNA.
* Patients on triple antiretroviral therapy with any boosted protease inhibitor.
* Patients with an undetectable viral load, which will be defined as \<50 viral RNA copies/mL within the last six months.
* Men or women aged≥18.
* For women with childbearing potential, negative urine pregnancy test during the Screening visit.
* Patients who would have granted a written informed consent prior to any Study-specific screening procedure.

Exclusion Criteria:

* Patients with a written proof of resistance in the accumulated genotype, which would lead to a sensibility loss to lopinavir/ritonavir, or, in case of genotype absence, a documented failure to a protease inhibitor therapy.
* Patients with a CD4 cells nadir CD4 \<100 cell/microL.
* Patients who, for any reason, could not be treated with lopinavir/ritonavir.
* Prior medical history of psychiatric disorders, such as depressive syndrome, schizophrenia or psychotic disease.
* Known previous medical history of drug abuse/addiction or alcohol chronic consumption, which in the Investigator's opinion, would be incompatible with his/her Study participation.
* Pregnant or breastfeeding women, or women of childbearing potential who do not use an appropriate contraceptive method, according to the Investigator's opinion.
* Documented past(within four weeks prior to screening) or active current opportunistic infection.
* Patients who, due to severe toxicities related to any of their current HAART compounds, there is a planned discontinuation or modification concerning any of the drugs from their triple therapy.
* Patients for which, according to the Investigator, will have to change their HAART, regardless of the reason, within the next six months.
* Renal disease with creatinine clearance \<60 mL/min.
* Concomitant use of Lopinavir/ritonavir contraindicated drugs, such as rifampicin, dihydroergotamine, ergotamine, methylergonovine, cisapride, hypericum perforatum, lovastatin, simvastatin, pimozide, midazolam and triazolam.
* Concomitant use of nephrotoxic or immunosuppressor drugs.
* Patients currently treated with systemic corticosteroids, interleukine-2 or chemotherapy.
* Patients treated with other Investigative Medical Product.
* Patients with acute hepatitis.
* Any disease or condition that, according to the Investigator, would be incompatible with the patient's participation in the Study.
CT7, MAGE-A3, and WT1 mRNA-electroporated Autologous Langerhans-type Dendritic Cells as Consolidation for Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation

The purpose of this study is to see if the investigator can help the immune system to work against myeloma.

This study will see if a vaccine made with altered dendritic cells will make T cells work against tumor cells. The stem cells collected for the transplant will also be used to grow dendritic cells in the lab. The dendritic cells will carry the antigens. These cells then will be injected under the skin. The investigators will do lab studies before and after the vaccination to find out if the vaccine is working.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic multiple myeloma, ISS stages I-III, within 12 months of starting therapy.
* Completion of induction therapy with Very Good Partial Response (VGPR), or better, by International Myeloma Working Group (IMWG) criteria.
* Deemed eligible for ASCT by standard institutional criteria.
* Age ≥18 years.
* Documentation of CT7, MAGE-A3, or WT1 expression in the bone marrow and/or bone marrow aspirate.

Exclusion Criteria:

* Prior autologous or allogeneic SCT.
* Previous immunization against CT7, MAGE-A3, other cancer-testis antigens, or WT1.
* Known immunodeficiency, HIV positivity, hepatitis B, or hepatitis C.
* History of autoimmune disease (e.g., rheumatoid arthritis, SLE), other than vitiligo, diabetes, or treated thyroiditis, which are allowed.
* History of severe allergic reactions to vaccines or unknown allergens.
* Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first immunization.
* Lenalidomide-related toxicities before ASCT necessitating its discontinuation as part of treatment.
Effectiveness of Er:YAG Pulse Therapy for Achieving Pre-emptive Dental Analgesia in Children

The aim of this study is to determine the effectiveness of Er:YAG pulse therapy for achieving pulpal analgesia in pediatric patients and to quantify the duration and extent of any effects assessed.

Design: a randomized split-mouth study with two-way repeated measures design.

The intention of the technique of "pre-emptive laser analgesia" is to reduce sensation in that small percentage of patients who may experience unpleasant sensations during caries removal. Laser analgesia is a non-invasive, non-thermogenic bio-modulation of the dental pulp reactivity aiming for reduction of impulse formation of the pulpal nociceptors. It is based on the idea that parallel with the ablative high-energy level laser action, simultaneous low level laser therapy (LLLT) may occur. We hypothesize that when operating at pulse energies below the Er:YAG laser ablation threshold of tooth structure, the laser energy leads to loss of impulse conduction of type A-delta nerve fibers in the dental pulp, leading to an analgesic effect.

Eligibility Criteria:
Exclusion criteria:

* Children who are considered medically compromised or medically complex patients. The absence of disease is confirmed by anamnestic interview with a parent or a care-giver of the child and excludes general acute or chronic disease, cognitive impairment, psychogenic nonepileptic events, radiotherapy in the maxillofacial region due to malignant process.
* Patients who are undergoing therapy with neurological, sedative, analgesic and/or anti-inflammatory drugs 7 days prior to treatment.
* Children, who are first time ever dental patients.

Inclusion criteria:

* Patients, identified as positive or definitely positive through Frankl behavioral rating scale.
* Patients who are not undergoing treatment or have been treated 6 months prior to inclusion with remineralizing agents.
* Patients, requiring conservative treatment of occlusal, caries on foramen caecum, and/or proximal caries on two first permanent upper jaw molars without prior restorations or dental sealants. Lesions are to be classified as moderate caries by the International caries detection and assessment system (ICDAS) with code 03 or code 04, which do not present spontaneous unprovoked pain, percussion or palpation pain or other symptoms, indicating of pulpal pathology. Included are carious lesions only on vital teeth, involving up to half of the dentine thickness, with no periodontal pathology. Laser fluorescence diagnosis of adjacent lesions with DIAGNODENT is limited to 20 - 35 scores included.
* Included are first molars which are not affected by hypoplasia or hypomineralization.

Obtained informed consent from parents or gave-givers to participate in the study, in which laser treatment and study procedures are explained in appropriate manner.
PoC-HCV Genedrive Viral Detection Assay Validation Study

The principal objective is to assess the diagnostic accuracy of the PoC assay (Genedrive, Epistem) to detect HCV RNA against the reference standard of commercial real-time polymerase chain reaction (RT-PCR) assay (RealTime HCV, Abbott) using stored heparinized plasma from patients with chronic hepatitis C and non-infected controls.


Eligibility Criteria:
Inclusion Criteria:

Criteria for case

* Age \> 18 years old.
* Patients with positive HCV RNA.
* Heparinized plasma samples are available before the initiation of antiviral HCV therapy.
* Patients have given a written consent that their blood samples will be further used for research.

Criteria for control

* Age \> 18 years old.
* Participants were tested negative for anti-HCV antibody
* Heparinized plasma samples are available
* Participants have given a written consent that their blood samples will be further used for research

Exclusion Criteria:

-
Relationship Between Right Atrial Volume Index, Functional Capacity and Inflammatory Biomarkers in Patients With COPD.

Right ventricular (RV) dysfunction is associated with increased morbidity and mortality in patients with chronic obstructive pulmonary disease (COPD). Assessment of RV function by echocardiography is challenging. Easy visualization of the right atrium (RA) by echocardiography , allows quantitative, highly reproducible assessment of RA volume. The aim of the present study is to evaluate the relationship between the right atrial volume index (RAVI) and functional capacity in patients with COPD , quantified by the COPD assessment test (CAT) questionnaire as an early predictor of right heart affection.

1. Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University.
2. All participants agreed to take part in this clinical study and provide informed consent.
3. Patients who were selected from patients visited Chest Department or attending Chest outpatient clinic of Tanta University Hospitals, Echocardiography was done in the Cardiology Department..
4. Complete physical and laboratory assessment will be done for all patients.
5. Serum samples will be collected for measuring the biomarkers.
6. 150 patients with COPD and preserved left ventricular systolic function, ejection fraction (LVEF) \> 55% will enrolled. The RA volume calculated by biplane area length method using four chamber view twice and indexed to body surface area (RAVI). Assessment of RV systolic function was done using tricuspid annular plane systolic excursion (TAPSE), and peak systolic velocity (S'tri) using tissue Doppler imaging at the tricuspid annulus. The functional capacity was assessed by the COPD assessment test (CAT) questionnaire.
7. For each participant, blood samples were obtained and levels of adiponectin, IL-1B, high-sensitivity C-reactive protein and Neopterin will be determined in all studied subjects.
8. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
9. Results, conclusion, discussion and recommendations will be given.

Eligibility Criteria:
Inclusion criteria - Patients included were \> 18 years old of both sexes and left ventricular ejection fraction (LVEF) \>55%.The following clinical and demographic parameters were recorded; age, sex, Current cigarette smoking was defined as active smoking within the past 12 months. Coronary artery disease was obtained by history or previous medical records.

Exclusion criteria

- Patients with diagnosis of other respiratory diseases (e.g. asthma, interstitial pulmonary fibrosis , tuberculosis or lung cancer ), ischemic heart disease, congestive heart failure, valvular heart disease and congenital heart diseases, were excluded. Other chronic diseases, such as kidney or liver failure and cancer were also excluded.
Comparison of VentiBroncTM Anchor With Conventional Double-lumen Endobronchial Tube in Patients With High Risk of Malposition

The investigators intend to compare the group using triple-cuffed endobronchial tube (VentiBroncTM Anchor) with the group using the conventional double-lumen endotracheal tube (Shiley®) in patients at high risk of malposition of the double-lumen endotracheal tube. The aim of this study is to determine if the use of VentiBroncTM Anchor increases the success rate of optimal double-lumen intubation to left main bronchus.


Eligibility Criteria:
Inclusion Criteria:

Patients requiring left double-lumen endotracheal tube intubation for thoracic surgery.

ASA physical status classification 2-4. Female patients aged 20-85 with a height of 160cm or less and a body mass index (BMI) of 25.0 kg/m2 or higher.

Patients requiring VentiBroncTM Anchor 33Fr or Shiley® 32Fr intubation due to a left mainstem bronchus diameter of 11mm or less on chest CT.

Exclusion Criteria:

Intraluminal lesions in the left or right mainstem bronchi. History of airway surgery. Emergency surgery.
ACT34-CMI -- Adult Autologous CD34+ Stem Cells (Follow-Up Study)

The purpose of this 12-month, observational, follow-up study is to collect additional data (by telephone contact) with which to assess the efficacy, safety, and effects of intramyocardial injections of adult autologous CD34+ cells on quality of life (QoL) in subjects with chronic refractory myocardial ischemia. No treatments will be administered during this study. However, the investigators and other study site personnel and the subjects will remain blinded to the treatment assignments from the core therapeutic study (# 24779) so as to provide a total of 24 months of blinded data.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have received treatment with Auto-CD34+ cells or with placebo and who have completed the final study visit (Month 12) of the core therapeutic study 24779
* Subjects who are willing to comply with the specified follow-up evaluations in this study and to provide written informed consent to participate in this study
ARMONIA: An Observational Study of Biologic Drugs in Monotherapy or Combination With DMARDs in Italian Clinical Practice and the Efficacy and Safety of RoActemra/Actemra (Tocilizumab) Monotherapy in Patients With Rheumatoid Arthritis

This is a multicenter observational study in patients with rheumatoid arthritis in routine clinical practice in Italy. In the retrospective Part 1 of the study, clinical and demographic factors associated with the use of a biologic drug in monotherapy as compared to therapy in combination with Disease-modifying anti-rheumatic drugs (DMARDs) will be evaluated. In the retrospective/prospective Part 2 of the study, efficacy and safety of the use of RoActemra/Actemra (tocilizumab) in monotherapy will be evaluated. Patients will be followed for up to18 months.


Eligibility Criteria:
Inclusion Criteria:

Part 1:

* Adult patients, \>/= 18 years of age
* Diagnosis of rheumatoid arthritis according to American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) criteria
* Patients who received at least one cycle of biologic therapy, either in monotherapy or in combination, in the 12 months preceding the opening of the first site

Part 2:

* Patients on monotherapy with RoActemra/Actemra already enrolled in Part 1 of the study

Exclusion Criteria:

* Patients simultaneously participating in other studies with RoActemra/Actemra at the time of signing informed consent
Randomized, Double Blind, Placebo Control Trial to Evaluate the Efficacy of Wu-Chu-Yu Tang on Gastroesophageal Reflux Disease (GERD)

GERD is due to gastric content reflux to esophagus cause symptom and complication including intra-esophagus such as reflux esophagitis, and extra-esophagus such as cough etc. Because the changes of dietary habit, and improvement of examination skill and data analysis, the prevalence of GERD increased 2.5 multiple from 1995 to 2002, and suggesting the prevalence is 25% in Taiwan community.

Although proton pump inhibitor (PPI) can inhibit gastric acid secretion, relief symptom and enhancing repair of esophageal damage, therefore, PPI is a main drug for the treatment of GRED, but because of PPI has disadvantage of poor compliance, and slow gastric empty time and hypersensitivity, and about 40-50% of GERD patients is inefficacy. In addition, PPI produces bone fracture, community pneumonia and diarrhea in patient with long-term use.

Wu-Chu-Yu tang consists of Evodia fargesii Dode (Evodia Fruit), Panax ginseng C. (Ginseng), Ziziphus jujube Mill (Chinses Date), Zingiber officinale Rosee (Fresh Ginger). According to "I-Fang-Chi-Chieh" and "Shanghonzobinglun" recordings that Wu-Chu-Yu tang can treat vomiting, and also can relax gastric tonicity and can enhance peristalsis of stomach.

Therefore, the purpose of the present study was to investigate the efficacy of Wu-Chu-Yu tang on GRED, and this effect of Wu-Chu-Yu tang compared to PPI Omeprazole.


Eligibility Criteria:
Inclusion Criteria:

1. Gender:Male or female.
2. Age: from 20 y/o to 75 y/o.
3. The diagnosis is Gastroesophageal Reflux Disease.
4. With the symptoms of heartburn or acid regurgitation.
5. After explaining thoroughly the whole research purpose or process, the clients are willing to sign the agreement.

Exclusion Criteria:

1. Exclude peptic ulcer, gall bladder stone (including intraheptaic and common hepatical duct) and major diseased of cancer.
2. Barrett's esophagus or esophagus stricture.
3. The operation history of esophagus or gastroduodenoal regions.
4. Tarry stool suspected GI tract bleeding.
5. With the history of alcohol or drug abuse.
6. The clients with the history of study drug allergy.
7. The clients with psychologic cannot cooperate with each other.
8. The pregnant woman or the lactating women.
9. Abnormal liver function such as GOT, GPT elevated over double the normal range.
Single-portal Endoscopic Carpal Tunnel Release Versus Knifelight for Carpal Tunnel Syndrome. A Randomized Control Trial

The purpose of this study is to determine whether Single-portal Endoscopic Carpal Tunnel Release (Agee technique, SmartRelease™, MicroAire) and mini-open technique (Knifelight®, Stryker) are equally effective and safe surgical options for the treatment of primary Carpal Tunnel Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* primary Carpal Tunnel Syndrome
* no symptoms' relief after 3 months of conservative treatment (NSAIDS, Cast, rest)

  * electrophysiological examination confirms the Carpal Tunnel Syndrome

Exclusion Criteria:

* Secondary Carpal Tunnel Syndrome
* Pregnancy
* Rheumatoid diseases
* Previous trauma at hand or other condition that may effect the anatomy (eg infections)
School-Based Mental Health Program Implementation in Uganda

Implementation of an adapted ParentCorps program in Ugandan schools will improve school mental health service resources, teachers' knowledge about child mental health, and teachers' classroom behavioral management and parent involvement skills.

Participating schools are randomly assigned to a 6-month long school-based intervention or to a wait-list control group. The intervention focuses on improving teacher's classroom behavioral management practices, parent engagement, and child mental health knowledge.

Teachers are assessed at the beginning and the end of the study, and again after 6 months of intervention. Teachers' parent engagement, mental health knowledge, and behavioral practices in the classroom are assessed through observations and teacher ratings.

Eligibility Criteria:
Inclusion Criteria:

* Early childhood teachers

Exclusion Criteria:

* Not early childhood teachers
Comparasion of Autogenic Inhibition and Reciprocal Inhibition Muscle Energy Techniques (METS) in Piriformis Syndrome

To compare the effects of Autogenic Inhibition and Reciprocal Inhibition Muscle Energy Techniques (METS) in Piriformis Syndrome

Piriformis syndrome is when the piriformis muscle, located in the buttock region, spasms and causes buttock pain. The piriformis muscle also can irritate the nearby sciatic nerve and cause pain, numbness, and tingling along the back of the leg and into the foot (similar to sciatic pain). The functional limitations experienced by hip pain patients in the lower limb profoundly impact their quality of life. This study aims to investigate the effectiveness of an integrated approach that compares the Effects of Autogenic Inhibition versus Reciprocal Inhibition Muscle Energy Techniques on Pain, Range of motion, and Disability in patients with Piriformis Syndrome.

This randomized clinical trial will be conducted at DHQ Hospital Jhang over six months. The sample size will consist of 32 participants. Participants who meet the inclusion criteria will be taken through a non-probability convenience sampling technique, that will be randomized through a sealed envelope method. 16 Participants will be assigned to Group A that will be treated with the Autogenic Inhibition Muscle Energy Technique, 16 Participants will be assigned to Group B and will be treated with Reciprocal Inhibition Muscle Energy Technique at the frequency of 1 set and 3 repetitions per session for two sessions per week and total six sessions for three weeks with follow up at one month. The duration of contraction is 7-10 seconds. Pre and post-intervention values will be taken on the 1st day in the 3rd week and at one-month follow-up. Data will be collected using various assessment tools, including the FAIR test, Freiberg test, Lasegue test, Beatty test, Pace sign, Numeric Pain Rating Scale (NPRS), and Universal Goniometer. Pre-intervention assessments will be conducted for all two groups. The effects of the interventions will be measured either by parametric or non-parametric tests after assessing the normality of data by the Shapiro-Wilk test Independent t-test. Data analysis will be performed by using SPSS 25 software.

Eligibility Criteria:
Inclusion Criteria:

* Both genders with ages between 25-45 years.
* Patients diagnosed with Piriformis syndrome using the Piriformis FAIR test, Freiberg test, Lasegue test, Beaty test, and pace sign.
* Hip pain with a threshold of NPRS 3-6.
* Limited ROM of Hip Internal Rotation and Abduction measured using a goniometer.
* Buttock pain ≥ 3 months.
* Pain with prolonged sitting (more than 20 minutes)

Exclusion Criteria:

* Hip Degenerative changes.
* History of Trauma or Fracture
* Other Systemic Conditions
* Postural abnormality/deformity
* Diagnosed Psychological Disorders
* Pregnancy