cyrilzakka/clinical-trials huggingface dataset:
Virtual Empowered Relief for Chronic Pain

The purpose of the current pilot study is to examine a feasibility and the preliminary efficacy of Empowered Relief (ER) class when it is delivered 'virtually' to patients with chronic pain who take methadone or buprenorphine. The ER class is a single-session pain management class, which has demonstrated to be effective in improving pain and pain-related distress in patients with chronic low back pain, but its efficacy has not been examined in patients with chronic pain who take methadone or buprenorphine. Class participants will learn self-regulatory skills and develop a personalized plan to use the skills every day. The current study will examine a feasibility and participant's perception and satisfaction of this class at post-class. The study will also follow participants 3 months by administering 5 surveys (baseline, 2 weeks and 1 month, 2 months, and 3 months post-treatment) to determine whether the class confers the short-term and medium-term benefits across various aspects of health.

Some patients with chronic pain are on long-term opioid therapy. Methadone and buprenorphine are often used in long-term opioid therapy for chronic pain. Additionally, chronic pain is highly prevalent in people receiving methadone or buprenorphine for opioid use disorder (MOUD). It is observed that up to 68% of people with MOUD have chronic pain condition. Therefore, a large number of people taking methadone or buprenorphine will suffer from chronic pain, but they frequently face limited availability of clinicians offering non-pharmacological pain management programs. Thus, a brief internet-based pain relief skills program may be one option that can overcome such treatment barrier. A recent randomized control trial on patients with chronic low back pain has demonstrated that a single-session, 2-hour, pain management class (Empowered Relief; ER) was effective to improve pain and pain-related distress. The ER class consists of pain neuroscience education and self-regulatory skills. While the ER is a promising and scalable option, it is not yet tested in patients with chronic pain who take methadone or buprenorphine. The current proposed, single-arm, uncontrolled pilot project will determine a) a feasibility in this patient population, b) patients' perceptions and satisfaction of the ER class and c) preliminary efficacy to inform the design of a future, larger, controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Age at least 18 years old
* Chronic Pain (\> 3 months)
* Taking Methadone or Buprenorphine
* English Fluency

Exclusion Criteria:

* Pregnant,
* Gross Cognitive Impairment,
* Acute Suicidality,
* Severe Depression
Comparative Evaluation of Contact Lens Centering of DAILIES® AquaComfort Plus® Versus 1-DAY ACUVUE® MOIST® in Japan

The purpose of this study is to evaluate lens centration and subjective impressions of DAILIES® AquaComfort Plus® (DACP) lenses compared to 1-DAY ACUVUE® MOIST® (1DAM) lenses in ball sports players.


Eligibility Criteria:
Inclusion Criteria:

* Those who can understand the clinical study objectives and provide written informed consent. Legal representative or parental consent required if under age 20
* Those who regularly wear soft contact lenses in both eyes for a minimum of 8 hours per day and 5 days per week
* Those who play ball sports at least 1 day per week
* Those who need vision correction because of myopia or mild myopic astigmatism, who are eligible for use of the study device, and who can attain a visual acuity of at least 1.0 with correction
* Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* Those who regularly wear the study device
* Those who require ocular treatment with eye drops
* Those who have a condition contraindicating soft contact lens wear, such as eye irritation
* Those who have had ocular disorder or ocular surgery that may affect soft contact lens wear within 3 months before the start of the study
* Those who are participating in another clinical study or research or have a plan of such participation during the present study
* Women who are pregnant or intend to become pregnant during the study
* Other protocol-defined exclusion criteria may apply
Folic Acid vs 5-methyltetrahydrofolate (5MTHF) in Recurrent Abortion

Recent data indicates that 5 methyltetrahydrofolate (5MTHF) can reduce serum homocystein level more efficiently than folic acid. On the other hand, folic acid is currently an important part of treatment in idiopathic recurrent abortion. There is no study comparing the effectiveness of these supplements in the treatment of recurrent abortion. The aim of this study is to compare the efficiency of these two agents in the treatment of recurrent abortion. In this study, patients with idiopathic recurrent abortion, referring to Avicenna clinic will be randomly allocated into two groups of those taking either folic acid (5 mg) or 5 MTHF (5mg) from 8 weeks prior to conception until the 20th week of pregnancy. The serum level of folate, homocystein, and ongoing pregnancy will be analysed and compared in the two groups.


Eligibility Criteria:
Inclusion criteria:

* Willing to participate in the study and filling out the informed consent form,
* History of 3 or more idiopathic abortion,
* the last abortion should be more than 6 months ago,
* no history of consumption of folate supplements or high folate containing foods during last 6 months,
* All previous abortions should be idiopathic without any anatomic, cytologic, hormonal, septic pathologic finding,
* no special diets

Exclusion Criteria:

* elective or induced abortion, molar or ectopic pregnancies,
* presence of any malignancy, chromosomal abnormality, uterine abnormality, Thyroid, kidney, or liver dysfunction, Glucose intolerance, seizure,
* Alcohol or drug abuse,
* Taking any drug affecting homocystein metabolism,
* not following the study protocol.
Diagnosis of Parkinson´s Disease by Means of Submandibular Gland Needle Biopsy

This study includes 35 PD patients who underwent submandibular gland needle biopsy. 25 neurologically healthy patients of the local otolaryngological clinic, in whom submandibular gland needle biopsy was performed due to a clinical indication, serve as controls.

Parkinson´s disease (PD) is a neurodegenerative disease which is characterized by a pathological aggregation of α-synuclein. This pathological α-synuclein aggregation results in the formation of Lewy bodies which are used for the histopathological diagnosis of PD. Neuropathological post mortem studies showed that pathological aggregations of α-synuclein may occur also outside the central nervous system in PD, for example in the cardiac plexus, in the major salivary glands and the innervating cervical superior ganglion, in the minor salivary glands, in the adrenal glands and in the mesenteric and pelvic plexus. The finding of pathologically aggregated α-synuclein in the major salivary glands offers the possibility to prove PD intra vitam by means of a small transcutaneous biopsy.

A recent post mortem study in the local Department of Neuropathology found, that there was pathologically aggregated α-synuclein in 12 of 14 patients with diagnosed and neuropathologically confirmed PD, whereas there was no pathologically aggregated α-synuclein in 13 persons without PD.

The present study includes 35 PD patients who underwent submandibular gland needle biopsy. 25 neurologically healthy patients of the local otolaryngological clinic, in whom submandibular gland needle biopsy was performed due to a clinical indication, serve as controls. Immediately after the biopsy, the obtained submandibular gland tissue is transported to the local Department of Neuropathology for histopathological analysis.

Eligibility Criteria:
Inclusion Criteria: major patients with Parkinson´s disease (PD)

Exclusion Criteria:

* Missing consent to participation in the study
* Pregnancy
* Indigestibility against local anesthetic
* Increased risk of bleeding
* Therapy with an anticoagulant
Conventional PCNL Versus Tubeless PCNL

prospective randomized study measuring the safety and efficacy of tubeless PNL in patients at assiut university hospital comparing to the standard PNL

Percutaneous nephrolithotomy (PNL) is considered to be the procedure of choice for the treatment of upper urinary tract calculi. It was first introduced in 1976, and since that the operative technique and the endoscopic equipments underwent many modifications to increase the success rates and to decrease complications.

Because of high success rate, low morbidity and complication rate, this minimally invasive modality has replaced the open surgical approach. the standard procedure is to place nephrostomy tubes within the tract of varying caliber and types.

This was done to facilitate maximal collecting system drainage, to tamponade the access tract and also securing the access in case of 2nd look PNL was needed. multiple studies demonstrate significant morbidity associated with nephrostomy tube following PNL, mainly postoperative pain that requires significant narcotic and also long hospital stay. the idea of the "tubeless" PCNL was born, whereby a nephrostomy tube is not left in place following the percutaneous procedure, but rather renal drainage is established with an indwelling ureteral stent. Tubeless PNL has been challenged by certain problems as regard the selection of the patients. Another problem that is facing the tubeless PNL may be is the question regarding the access tract and how to deal with?. Finally, Percutaneous nephrolithotomy (PCNL) has become the standard treatment for kidney stones and/or upper ureter, but Whether nephrostomy tube placement is necessary after PCNL is still a matter of debate

Eligibility Criteria:
Inclusion Criteria:

* Patients above 18 years old 2. Patients with any stone burden and stone number requiring single procedure

Exclusion Criteria:

1 - Patients aged below 18 years old. 2. Anatomical variation of the kidney in shape or position, e.g. horseshoe kidney or malrotation.

3. Complex or staghorn stones requiring staged procedure.

Intra operative criteria:

4. Three or more access tracts. 5. Significant intraoperative bleeding. 6. Intraoperative pelvi calyceal system perforation. 7. Residual stones necessitate 2nd look PNL
Clinical Trial of SL1904B CAR-T Cells for Relapsed or Refractory Non-Hodgkin Lymphoma

This is a study of patients with relapsed or refractory non-Hodgkin's lymphoma. To evaluate the safety and efficacy of SL1904B in patients with relapsed or refractory non-Hodgkin's lymphoma.

The CARs consist of an anti-CD19 single-chain variable fragment（scFv） that was derived from the FMC63 mouse hybridoma, a portion of the human CD137（4-1BB） molecule, and the intracellular component of the human CD3ζ molecule. Prior to CAR-T cell infusion, the patients will be subjected to preconditioning treatment. After CAR-T cell infusion, the patients will be evaluated for adverse reactions and efficacy.

The Main research objectives:

To evaluate the safety and efficacy of SL1904B in patients with recurrent or refractory non-Hodgkin's lymphoma

The Secondary research objectives:

To investigate the cytokinetic characteristics of SL1904B in patients with recurrent or refractory non-Hodgkin's lymphoma.

Eligibility Criteria:
Inclusion Criteria:

1. Sign the informed consent form and be willing and able to comply with the visit, treatment regimen, laboratory examination and other requirements of the study as stipulated in the trial flow chart;
2. The diagnosis of patients with relapsed or refractory non-hodgkin lymphoma;
3. There should be at least one measurable tumor focus according to the RECIST version 1.1;
4. ECOG Scores: 0\~2;
5. The expression of CD19 on the tumor cells was reported as positive by either immunohistochemistry or flow cytometry;
6. Estimated survival time was longer than 3 months;
7. main organ functions shall meet the following requirements including: serum creatinine ≤1.5 times the upper limit of normal value (ULN); ALT ULN 2.5 or less; AST ULN 2.5 or less; Total bilirubin ≤ 1.5ULN; Left ventricular ejection fraction (LVEF) ≥45%; Hemoglobin ≥90g/L; Platelet count ≥50×109/L; absolute Neutrophil count (ANC) ≥1.0×109/L; Blood oxygen saturation \>92%；
8. Peripheral blood mononuclear immune cells must be collected at least 2 weeks after the last radiotherapy or systemic treatment.

Exclusion Criteria:

1. Serious cardiac insufficiency；
2. Has a history of severe pulmonary function damaging;
3. With other tumors which is/are in advanced malignant and has/have systemic metastasis;
4. Merging the metabolic diseases (except diabetes);
5. Merging severe autoimmune diseases or immunodeficiency disease;
6. Patients with active hepatitis B or hepatitis C virus infection;
7. Patients with HIV infection or syphilis infection;
8. Has a history of serious allergies on Biological products (including antibiotics);
9. Participated in any other clinical drug trial for the last six months;
10. Being pregnant and lactating or having pregnancy within 12 months;
11. With other uncontrolled diseases and considered not suitable to participate by the researchers;
12. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.
Perioperative Hypothermia in Patients Submitted to Laparoscopic Urological Surgery

Hypothermia is a frequent perioperative complication. Its appearance can have deleterious effects such as perioperative bleeding or surgical site infection. Once the temperature has decreased, its treatment is difficult.

Preoperative warming prevents hypothermia, lowering the temperature gradient between core and peripheral compartments and reducing thermal redistribution. The most recent clinical practice guidelines advocate for active prewarming before induction of general anaesthesia since it is very effective in preventing perioperative hypothermia. However, the ideal warming time prior to the induction of anesthesia has long been investigated. This study aims to evaluate if different time periods of preoperative forced-air warming reduces the incidence of hypothermia at the end of surgery in patients submitted to laparoscopic urological surgery under general anesthesia. This is an observational prospective study comparing routine practice of pre-warming in consecutive surgical patients scheduled to laparoscopic prostatectomy or nephrectomy between August and December 2018. In this study 64 - 96 patients will be included and prewarming will be applied following routine clinical practice. The prewarming time will depend on the time the patient has to wait before entering in the operating theatre. Measurement of temperature will be performed using an esophagic thermometer. Patients will be followed throughout their hospital admission. Data will be recorded using a validated instrument and will be analysed using the statistics program R Core Team.

Maintaining patient's temperature above 36 grades Celsius throughout the perioperative period is challenging. Thus, it is essential to monitor temperature in order to be able to take measures to avoid the appearance of hypothermia. Once the temperature has decreased, its treatment is difficult since the application of heat to the body surface takes a long time to reach the core thermal compartment. Intraoperative warming alone cannot avoid postoperative hypothermia. The application of forced-air warming system during the preoperative period has been shown to be the most effective measure to prevent hypothermia and maintain intraoperative normothermia. However, long time periods of prewarming would not be efficient. Thus, the ideal warming time prior to the induction of anesthesia has long been investigated.

Due to the searching of optimal prewarming time, the conductance of this study is justified.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective laparoscopic urological surgery under general anesthesia.

Exclusion Criteria:

* Active infection
* Intake of antipyretics within 24 hours before surgery
* Neuropathy
* Thyroid disorders
* Peripheral vascular disease
* Skin lesions
* History of hypersensitivity to skin contact devices.
An Ascending Multiple Dose Study of VTP-38543 in Adult Participants With Mild to Moderate Atopic Dermatitis

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary clinical efficacy of VTP-38543 administered as a cream, twice-daily, for 28 days in otherwise healthy adult male and female participants with mild to moderate atopic dermatitis.

This is a randomized, double-blind, vehicle-controlled study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary clinical efficacy of VTP-38543 following twice-daily, every twelve hours (Q12h) administration for 28 days in otherwise healthy adult male and female participants with mild to moderate atopic dermatitis.

Evaluation of three ascending doses in three dose panels is planned for this trial. Dose Panel 1 (VTP-38543 0.05%) and Panel 2 (VTP-38543 0.15%) will each enroll 30 participants and randomize 20 to VTP-38543 and 10 to matching vehicle control (Vehicle without Transcutol®P). Dose Panel 3 (VTP-38543 1%) will enroll 40 participants and randomize 20 to VTP-38543 and 20 to matching vehicle control (Vehicle with Transcutol®P). A total of approximately 100 participants will participate in the trial.

Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate atopic dermatitis with a minimum of 3 to a maximum of 15% body surface area (BSA) involvement
* Investigator Global Assessments (IGA) score of 2 or 3
* Body Mass Index (BMI) = 18 - 35 kg/m\^2
* Negative Pregnancy test for females

Exclusion Criteria:

* Treatment for atopic dermatitis with systemic medications, topical agents, and parenteral biological/monoclonal antibody agents, within specific time period prior to dosing.
* Organ dysfunction or any clinically significant deviation from normal in vital signs, physical examinations, labs, and Electrocardiogram (ECG) findings
* Major surgery within 3 months of Screening
* Use of prescription drugs, sedative antihistamine, medical devices for treatment of atopic dermatitis (AD), and topical products containing urea and/or ceramides within 14 prior to dosing
* Excessive sun exposures, use of tanning booths or other ultraviolet (UV) light sources 4 weeks prior to dosing
Primary Tumor Resection for M1a Stage Lung Cancer

This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1023. This study aims to explore the safety and efficacy of primary lesion resection in the treatment of M1a stage lung cancer with pleural dissemination found during surgery, and to more accurately evaluate whether primary lesion resection can improve the OS and quality of life of the corresponding patients.


Eligibility Criteria:
Inclusion Criteria:

1. Volunteer to participate in clinical research, willing to follow and able to complete all trial procedures;
2. Aged 18-80 years (including critical values) when signing the informed consent form;
3. ECOG score 0 or 1;
4. No previous lung cancer surgery;
5. Intraoperative or postoperative pathological confirmation of M1a stage lung cancer;
6. Occult pleural metastasis found during surgery;
7. Preoperative lymph node staging is cN0;
8. First-time treatment and no radiotherapy or chemotherapy.

Exclusion Criteria:

1. The lesion cannot be completely removed surgically;
2. Cytological or histological pathology confirms other lung malignancies other than lung cancer;
3. Patients who have undergone lung cancer surgery before;
4. Patients who have received radiotherapy or chemotherapy and are not treatment-naive patients.
Effect of Patient Resilience on Return to Sport Post ACL Reconstruction Surgery

Despite the large majority of patients that undergo ACL reconstruction reporting successful outcomes in regard to tests of knee function, only about 2/3 return to their prior level or athletic activity after surgery. A large amount of research has been conducted investigating the effects of psychological factors on return to sports after ACL reconstruction; however, the specific role of resilience has yet to be solely analyzed. This study aims to determine the effect of variations in patient resilience on their return to sports after surgery.

Meta-analysis of post ACL reconstruction return to sport suggests that despite approximately 90% of patients achieving successful outcomes in terms of objectively measurable knee function, only 63% return to their pre-injury sport participation rate. This leads one to question what factors other than knee function may contribute to such a discrepancy. Prior studies have shown psychological factors, such as fear of re-injury, can play in role in whether a patient returns to play. However, the role of patient resilience on recovery is less clear. This research will examine the effect of patient resilience on post-ACLR return to sport. The Brief Resiliency Scale (BRS), a proven method of assessing ability to recover from stressful situations, will be used to evaluate patient resilience. The role of resilience on recovery post shoulder surgery, as well as rehabilitation in post-operative orthopaedic geriatric patients has been examined; however, the effect of resilience on specifically ACLR return to sport has yet to be studied.

This research will provide insight as to how to identify patients at high risk for not returning to sport, the first step in improving return to sport outcomes in ACL reconstruction patients.

Eligibility Criteria:
Inclusion Criteria:

* English speaking patients
* Isolated ACL tear having undergone surgical reconstruction.

Exclusion Criteria:

* Non-English speaking patients.
Dental Plaque Removal Evaluation and Comparison of Kid's Battery-Operated Toothbrush and Manual Toothbrush

To evaluate and compare the plaque removal efficacy of a children's battery-powered toothbrush and a children's manual toothbrush following a single brushing.

This is a single use, examiner blinded, randomized, two-period, cross-over, IRB-approved research study evaluating the single-use plaque removal efficacy of a new children's battery-operated toothbrush and a marketed children's manual toothbrush. This study will accept up to 60 juvenile subjects, 5-8 years of age, in anticipation that 50 subjects will complete the study. Qualified subjects with sufficient plaque, according to Rustogi Modified Navy Plaque Index (RMNPI) will be randomly assigned to one of two sequence treatment groups.

After the pre-brushing plaque evaluation at each of the evaluation visits, subjects will brush with the assigned toothbrush and toothpaste provided for timed brushing under supervision, in front of mirror.

Eligibility Criteria:
Inclusion Criteria:

1. 5 to 8 years
2. Be a regular manual toothbrush user.

Exclusion Criteria:

1. Have any physical limitations or restrictions which might preclude normal tooth brushing.
2. Have evidence of poor oral hygiene or rampant dental caries or presence of extrinsic stain or calculus deposits that may interfere with plaque assessments.
3. Have fixed or removable orthodontic appliances.