cyrilzakka/clinical-trials huggingface dataset:
Intraperitoneal Infusion of ex Vivo-cultured Allogeneic NK Cells in Recurrent Ovarian Carcinoma Patients

This study investigates an innovative treatment for recurrent ovarian cancer exploiting ex vivo-generated allogeneic natural killer (NK) cells with or without preceding non-myeloablative conditioning chemotherapy.

This study investigates an innovative treatment for recurrent ovarian cancer exploiting ex vivo-generated allogeneic natural killer (NK) cells with or without preceding non-myeloablative conditioning chemotherapy.

This study is a phase I safety and feasibility study in a series of 12 patients who are suffering from recurrent ovarian, fallopian tube or primary peritoneal cancer. Prior to NK cell infusion, a laparoscopy is performed to place a catheter in the peritoneal cavity. The first cohort of three patients will receive an intraperitoneal infusion of allogeneic UCB-NK cells generated ex vivo from CD34+ hematopoietic progenitor cells obtained from an allogeneic UCB unit without a preparative regimen. In the second group of three patients the same UCB-NK cell dosage will be given with a preparative regimen of four days non-myeloablative immunosuppressive conditioning regimen with cyclophosphamide and fludarabine (CyFlu). If no severe toxicity is seen in these 6 patients, an extension cohort of 6 patients will be included to answer the secondary objective.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from their second recurrence of ovarian, fallopian tube or primary peritoneal cancer, with an elevated serum level of CA-125 on two successive time points with 28 days in between, reaching a value of more than 2 times nadir and above 35 U/ml without gastrointestinal symptoms.
* Able to undergo laparoscopic IP port placement and IP treatment administration
* Adequate organ function
* Age 18 years or older
* Age under 76 years.
* Karnofsky performance status \>70% (see appendix 2)
* Life expectancy \> 6 months
* At least 28 days after last anti cancer treatment, before start of preparative regimen
* Written informed consent
* Availability of a partially HLA-matched UCB unit

Exclusion Criteria:

* Patients on immunosuppressive drugs
* Patients with active infections (viral, bacterial or fungal) that requires specific therapy. Acute anti-infectious therapy must have been completed within 14 days prior to study treatment
* Laparoscopic adhesion score \>4 out of 9.
* Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease (appendix 4)
* Severe pulmonary dysfunction (CTCAE III-IV) (appendix 4)
* Severe renal dysfunction (MDRD\<50) (appendix 4)
* Severe hepatic dysfunction (serum bilirubin or transaminases \> 3 times normal level) (appendix 4)
* Severe neurological or psychiatric disease
Cyclophosphamide and Hydroxychloroquine for Thrombocytopenia in SLE

Treating severe thrombocytopenia is a challenge in the management of systemic lupus erythematosus. Although rheumatologists have followed some rules in real practice,there is very few evidence to support the current treatment algorithm. The purpose of this study is to compare the complete remission rate and partial remission rate of cyclophosphamide and hydroxychloroquine for treating severe thrombocytopenia in Chinese SLE patients.

This is a prospective,randomized,open-label,multi-center clinical trial. The aim of this study is to test the efficacy of GC(gluco-corticosteroid)+HCQ(hydroxychloroquine) and GC(glucocorticosteroid)+CTX(cyclophosphamide) with sequential AZA(azathioprine) in the induction and maintenance therapy of severe thrombocytopenia in SLE patients.

Eligibility Criteria:
Inclusion Criteria:

1. Patients fulfilled the 1997 ACR modified or SLICC classification criteria of SLE；
2. New onset thrombocytopenia: platelet count \<30X109/L(by both routine test and citric acid anti-coagulated blood count test) within 3 months

Exclusion Criteria:

1. Thrombocytopenia caused by other reasons, including drugs；
2. Positive for active HAV(hepatitis A virus)/HBV(hepatitis B virus) infection
3. Active HIV(human immunodeficiency virus) or HCV(hepatitis C virus) infection;
4. Active HP(Helicopter pylori) infection;
5. Severe liver and kidney dysfunction；
6. Severe neuropsychiatric lupus；
7. No response to high dose steroid and/or cyclophosphamide 1 month prior to study enrollment；
8. Uncontrolled diabetes or hypertension before entry
9. Active GI bleeding 3 months before entry
10. Intolerant to HCQ in the past treatment history；
11. Severe bone marrow suppression or liver damage caused by cyclophosphamide in the past history；
12. Active infection , including bacteria, virus, fungi, mycobacteria
13. Allergy to any of the study medications
14. Confirmed TTP(thrombolic thrombocytopenic purpura)or CAPS(catastrophic anti-phosphilipid syndrome)
15. Platelet count less than 20X109/L with active bleeding
16. Myelodysplastic diseases
17. Patients with heart and lung function impairment
18. thiopurine S-methyltransferase (TPMT) gene positive -
Evaluating Outcomes for Youth Receiving Hospital-based Violence Prevention With and Without a Community-level Initiative

The purpose of this research study is to test if a hospital-based violence prevention strategy with a community-level initiative is effective for cross-cutting violence prevention in violently injured youth.

This study will test if youth who receive the Bridging the Gap (BTG) and Communities that Care (CTC Plus) will see greater improvements than youth who either receive BTG only, CTC Plus only or no intervention. This study will allow researchers to learn more about the intervention's effectiveness for a range of violent outcomes. It will also help researchers understand if violence prevention efforts affect other behaviors, such as drug use and rates of violent re-injury.

Participants will be asked to complete surveys about their behavior, personality, and experiences, and their parent/child's personality, behavior, and experiences. These surveys take about 45-60 minutes to complete. These questionnaires will be completed before the intervention has taken place and then again 6 months later. Participation in this study will last up to 6 months. Approximately 408 individuals will participate in this study.

Eligibility Criteria:
Inclusion Criteria:

1. Violently injured youth receiving treatment at VCU
2. Aged between 12 and 21 years old
3. Living in Richmond City

1. Parent/caregiver of the youth participant 2. Parent/caregivers must be 18 years old or older

Exclusion Criteria:

1. Non-English speaking
2. Ages \<12 and \>21 years
3. Prisoners are excluded
Smart Textile Solutions as Biofeedback Method for Injury Prevention for Latvian Football Youth League Players

Lower limb injuries are the most common in youth football leagues, accounting for 72% to 93% of all injuries. The leading prevention program in football today is the FIFA 11+ warm-up program, which reduces the risk of injury by 30%. Evidence from several studies confirms the addition of feedback during training reduces the incidence of injury by 40% . Recent studies have shown that the smart textile sock system is an objective, easy-to-use tool for real-time foot monitoring and is an interactive feedback tool for athletes. However, there is a lack of information on the impact of the objective feedback provided by the Smart Textile Sensor Socks System on the outcome measures of football players prevention programs. In the first phase of the project, a cross-sectional study involving youth league footballers will be conducted to identify the most effective feedback elements of the smart sock system. In the second phase, a pilot study will be conducted to evaluate the effectiveness of prevention exercises using the feedback provided by smart textile sensor socks. The results of the functional tests and the study outcomes will be selected as performance indicators to evaluate the smart textile sensor sock system. Conclusions on the use of the smart textile sensor sock system as a feedback method for injury prevention in Latvian Youth Football League players will be drawn based on the results obtained from the project.


Eligibility Criteria:
Inclusion Criteria:

1. youth football league players;
2. agree to participate in the study;
3. age from 14 to 18 years;
4. understands and speaks Latvian.

Exclusion Criteria:

1. operative treatment in the lower limb within the last 9 months;
2. injuries or pain in the lower limb during the last 6 months;
3. disorders of the vestibular apparatus
4. presence of metallic implants in the sensor application areas.
The Effect of Preoperative NLR Level on Epidural Analgesia Application in Thoracotomy

The aim of this study is to investigate the relationship of preoperative Neutrophil/Lymphocyte Ratio (NLR) with postoperative pain and the effect of preoperative NLR level on timing of epidural analgesia in thoracotomy.

The study was conducted prospectively in 60 patients aged 18-75 years, ASA I-III, who underwent thoracotomy. The patients were divided into 2 groups as NLR level above 2 (Group A) (n:32) and NLR level below 2 (Group B) (n:28). Each group was divided into subgroups with equal numbers of Prempative analgesia group and control group. Local anesthetic was administered to the preemptive analgesia group (Group P) 20 minutes before the surgical incision through the epidural catheter, and to the control group (Group K) 20 minutes before the patient was awakened from the epidural catheter. NRS levels and additional analgesia needs were recorded at 2, 4, 8, 12 and 24 hours postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Patient graded as American Society of Anesthesiologist (ASA) physical status, I, II or III
* Patient subjected to thoracotomy operation

Exclusion Criteria:

Patient having morbid obesity,

* Patient having renal failure,
* Patient having hepatic failure,
* Patient having neuropsychiatric disease,
* Patient allergy to the study drugs
Enhanced Pain Coping in Cancer (EPIC): A Study of Managing Treatment-Related Joint Pain in Breast Cancer Survivors

The researchers are doing this study to compare two different types of group therapy and find out whether they are effective approaches for helping breast cancer survivors manage joint pain caused by aromatase inhibitors (AI). This type of joint pain is called AI-associated arthralgia, or AIA, and it is common in people taking AIs. AIA and its associated symptoms can make some people decide to stop taking their medication. The study will look at the effects of two different types of group therapy on participants' cancer-related symptoms (such as pain, fatigue, and anxiety), their ability to continue taking AIs on a regular schedule, and their quality of life. We will measure participants' quality of life by having them fill out questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* English-proficient women with a history of stage I, II, or III breast cancer
* Free of oncologic disease by clinical examination and history;
* Receiving third-generation AI therapy (anastrozole, letrozole, or exemestane) for at least 28 days prior to consent with plan to continue for at least another 12 months;
* Worst joint pain rated at least 4 or greater on a 0-10 numeric rating scale in the preceding week prior to consent;
* Reporting at least 15 days with pain in the preceding 30 days prior to consent;
* Experiencing joint pain for at least one month;
* Pain attributed to AI therapy;
* Willing to adhere to all study-related procedures, including randomization to one of two treatment arms: Mindfulness-Oriented Recovery Enhancement (MORE) or Supportive Group Psychotherapy (SG);
* Able to attend video-call sessions in a quiet/private location.

Exclusion Criteria:

* Metastatic breast cancer (stage IV);
* Completed chemotherapy, surgery, or radiation therapy less than 4 weeks prior to enrollment;
* Pain attributed to inflammatory arthritis (i.e. rheumatoid arthritis, gout, pseudogout);
* Surgery or joint injection involving the affected joints within the last month or planned within the next six months;
* Active suicidality or psychosis as determined by the Mini-International Neuropsychiatric Interview.
Effects of Cerebrolysin on Level of Consciousness and Brain Metabolism in Disorder of Consciousness After Stroke: Single Center Randomized Controlled Study

The purpose of this study was to determine the effect of stroke on post-stroke level of consciousness through a double-blind, placebo-controlled, randomized study design. And Brain 18F-FDG PET was used to reveal the mechanism of recovery after cerebrolysin administration.

Thirty patients with chronic stroke patients with minimal consciousness (MCS) or vegetative human (VS) level of consciousness disorder in the revised coma recovery scale were enrolled. Thirty patients were randomly divided into a Cerebrolysin group and a placebo group.


Eligibility Criteria:
Inclusion Criteria:

* Ischemic or hemorrhagic stroke patients
* Stroke with CT or MRI diagnosis
* Chronic patients with more than 3 months of stroke onset
* Patients with vegetative status or minimal consciousness (Coma Recovery Scale -revised: CRS-R)
* Age: 19 to 90 years old
* A person who voluntarily consents to the clinical trial in writing by the principal or legal representative

Exclusion Criteria:

* In case of contraindications, including allergies to cerebrolysin
* Patients with contraindications to PET
* Progressive or unstable stroke
* In case of accompanying serious neurogenic disease
* Major depressive disorder, schizophrenia, bipolar disorder, dementia, and other serious psychiatric diseases.
* History of alcohol or other drug addiction within 3 years of onset
* In case of accompanying serious liver, kidney, heart, or respiratory disease
* If you have the following medical abnormalities (Total serum bilirubin\> 4 mg/dL, alkaline phosphatase\> 250 U/L, SGOT/AST\> 150 U/L, SGPT/ALT\> 150 U/L, or creatinine) \> 3.5 mg/dL)
* In case of having a medical disease that is less than 1 year old
* During pregnancy or lactation
* Participating in other therapeutic research
Withings Devices Follow-up Study - Hypertension

The primary objective is to evaluate the accuracy to predict uncontrolled hypertension with Withings device data.


Eligibility Criteria:
Inclusion Criteria:

* Male or female who are 21 years of age or older,
* Participant living in the United States,
* Participant with data recorded in WITHINGS database,
* Active WITHINGS device users having at least 2 years of data,
* Subject able to read, understand, and provide written informed consent,
* Subject willing and able to participate in the study procedures as described in the consent form,
* Subject able to communicate effectively with and willing to follow instructions from the study staff.

Exclusion Criteria:

* Minors under 21 years old,
* Subject who refused to participate in the study,
* Subject who did not reply to the questionnaire,
* Subject who objected to the processing of his or her data after the start of the study.
Low Level Laser Therapy in Muscle Fatigue and Muscle Recovery

Muscle fatigue and muscle recovery after exercise are recent areas of research involving Low Level Laser Therapy (LLLT) and many factors remain unknown, such as optimal doses, power and application parameters, mechanisms of action, effects on long-term exercise and the long-term effects on skeletal muscle recovery.

The present research project aims to assess the effects of long-term recovery of LLLT in skeletal muscle after exercise and identify the optimal dose application of LLLT.

After defining the best dose of application, we recruited two groups which will be irradiated with different power, 100mW and 400mW in order to seek the optimal parameter of low level laser therapy in performance.

The investigators believed that the Low Level Laser Therapy can delay the physiological process of muscle fatigue, reduce injury or skeletal muscle microdamage arising from physical effort and accelerate muscle recovery after exercise.

To achieve the proposed objectives it was performed a randomized, double-blinded, placebo-controlled trial, with voluntary participation of high-level soccer athletes.

Participants received an application of low level laser prior to execution of a strenuous exercise. It was used a laser with a cluster of 5 diodes (810 nm, 200 mW each diode) with different doses (placebo, 2J, 6J, 10J) and power of 200mW.

In a second step, with the optimal dose already defined, this was used to be applied with different powers in two experimental groups, 100mW and 400mW.

The investigators analysed parameters related to volunteers exercise performance (torque peak / maximum voluntary contraction), delayed onset muscle soreness, and biochemical markers of muscle damage (CK and LDH), inflammation (interleukin 1 and 6, alpha tumoral necrosis factor) and oxidative stress (TBARS, CAT, SOD and carbonylated proteins). The analysis was performed before exercise protocols, after 1 minute, and 1, 24, 48, 72 and 96 hours after the end of exercise protocol in both parts of the study.

Eligibility Criteria:
Inclusion Criteria:

* professional soccer players aged between 18 and 35 years old;
* not presenting historical musculoskeletal injury in regions of the hip and knee in the 2 months preceding the study;
* not making use of pharmacological agents and/or nutritional supplements;
* participating with minimum frequency of 80% of the training team

Exclusion Criteria:

* athletes who experience musculoskeletal injury during the study;
* athletes who for whatever reason have their training routine changed with respect to the rest of the team during the course of study.
A Survey on Consumer Use of Over-the-Counter (OTC) Nicotine Patches

Since 1996, the nicotine patch has been re-classified from prescription to over-the-counter (OTC) status in the United States. Little is known about how the public uses the OTC nicotine patch due to lack of monitoring. The purpose of this observational study is to describe the characteristics of consumers who purchase OTC nicotine patches from community pharmacies and to determine the factors associated with the appropriate use of nicotine patches.

The nicotine patch is an effective aid for smoking cessation. Since 1996, the nicotine patch has been re-classified from prescription to over-the-counter (OTC) status in the United States. Unlike prescription medications, post-marketing surveillance does not exist for OTC medications. The purpose of this study is to describe the characteristics of consumers who purchase OTC nicotine patches from community pharmacies and to determine the factors associated with appropriate use of nicotine patches.

This prospective, cross-sectional, observational study will include a survey of 600 consumers who purchase OTC nicotine patches at a random sample of 30 community retail pharmacies. Consumers will be recruited by an ad located in the pharmacy next to the nicotine patch product. Participants will fill out a self-administered, anonymous questionnaire at the time of OTC nicotine patch purchase at the pharmacy counter. The questionnaire will gather information about demographics, medical history, smoking history, attitudes toward the nicotine patch, and motivation to quit smoking. No study visits will be required for this study.

Eligibility Criteria:
Inclusion Criteria:

* Purchased OTC nicotine patch (NicoDerm CQ Step I, II, III or Sav-on Nicotine Patch) for personal use

Exclusion Criteria:

* Purchased OTC nicotine patch for someone other than self (e.g., friend or family member)
Evaluation of the Effects of Flat and Modified Inclined Fixed Anterior Bite Planes on Mandibular Position in Growing Females With Skeletal Class 2 Malocclusion Due to Mandibular Deficiency and Deep Bite

This study will be conducted to see if unlocking mandible from deep bite in growing females by flat fixed anterior bite plane will change mandibular position in skeletal mandibular deficiency and if there is a difference in the change of mandibular position if we assisted the mandible by holding it in a more forward position by modified inclined fixed anterior bite plane .These results will be compared to normal mandibular growth from previous records of a matched control group in the discussion afterthat.

Two groups of patients the first for flat fixed anterior bite plane, the second for modified inclined fixed anterior bite plane.Full records are taken to patients. Then bands selection for upper first molars,impressions for upper arch with bands fitted and impression to lower arch, fabrication of either flat/ modified inclined fixed anterior bite planes and cementation in patient's mouth,evaluation of results after 8 months.

Eligibility Criteria:
Inclusion Criteria:

* (1)Growing females aged 10-13 (2)Skeletal maturational stage: stages 3,4 of the cervical maturational index CVMI.

  (3) low-angle/moderate normal growth pattern (4) Overjet of 4-7 mm as measured from labial surface of upper incisors to labial surface of lower incisors (5)Skeletal class 2 due to mandibular deficiency 77 degrees \<SNB\> 73 degrees (6) Normal or slightly protruded maxillary base (7) All cases had dental deep bite; with the upper incisors covering more than 50% of the height of the lower incisors.

  (8)Only deep bite cases that required extrusion of posterior teeth.

Exclusion Criteria:1- No syndromic or medically compromised patients 2- No growth disorders 3- No use of other appliances before or during the period of functional treatment

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