cyrilzakka/clinical-trials huggingface dataset:
Quadratus Lumborum Block After Living Donor Kidney Transplantation

The aim of this study is to evaluate the postoperative analgesic effect of quadratus lumborum block in patient undergoing a living donor kidney transplant under general anesthesia.

The purpose of this study was to investigate whether postoperative pain is significantly reduced when TQL block was additionally performed after surgery in patients undergoing living-donor kidney transplantation. Therefore, investigator hypothesized that the analgesic consumption for postoperative 24 hours will decrease in TQL group compared to the control group. For secondary outcomes, the pain score at rest/ movement up to 48 hours after surgery, the time until the first pain reliever is requested, whether and how often rescue analgesics are administered for 48 hours, the incidence and severity of nausea and vomiting during the 48 hours after surgery, patient's satisfaction with post-pain control and the number of hospital stays were investigated. Overall, the aim of this study is to evaluate the postoperative analgesic effect of quadratus lumborum block in patients undergoing a living donor kidney transplantation under general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 19 years of age undergoing elective living donor kidney transplantation under general anesthesia in Seoul National University Hospital

Exclusion Criteria:

* Patients with severe pain before surgery

  * Patients with a history hypersensitivity reactions on fentanyl or ropivacaine

    * Patients who cannot maintain patient-controlled analgesia (PCA) by themselves

      ④ Patients with skin diseases or infections in the area where quadratus lumborum block is applied

      ⑤ Any other cases that researchers determine that it is inappropriate for this clinical trial
Study to Evaluate the Immunogenicity and Safety of a Second Vaccination With the Adjuvanted Influenza Vaccine Candidate

The purpose of this study is to evaluate the immunogenicity and the safety of a second vaccination with candidate vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years and above

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Eligibility Criteria:
Inclusion Criteria:

* A male or female age 60 years or older at the time of the revaccination, who previously participated in 107192 \& 107214 clinical trials.
* Subjects who the investigator believes can and will comply with the requirements of the protocol
* Written informed consent obtained from the subject.
* Free of an acute aggravation of the health status as established by clinical examination before entering into the study.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
* Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 3 months prior to the first vaccine dose.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
* Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
* Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after vaccination.
* History of hypersensitivity to a previous dose of influenza vaccine.
* History of confirmed influenza infection within the last 12 months.
* History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)
* Acute disease at the time of enrolment.
Augmented Macular Pigment-containing Nutraceutical and Central Visual Function

The purpose of this study is to prospectively analyze changes in macular pigment optical density and dermal carotenoid levels as they relate to visual field function in patients prescribed a macular pigment-containing medical food (Lumega-Z), in combination with a topical carbonic anhydrase inhibitor.

This is a prospective double-masked, randomized controlled trial which evaluates central visual field function as it relates to macular pigment optical density, contrast sensitivity, and dermal carotenoid levels in the presence of a commercial macular pigment-containing medical food (Lumega-Z). Participants will be randomized to twelve weeks of supplement + dorzolamide or twelve weeks of placebo. All packaging of supplement and dorzolamide and the placebo will be identical and distributed by a third party. Both subjects and the investigators examining patients will be masked to placebo and experimental group assignment.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Glaucoma diagnosis (H40. \*) with abnormal visual field as measured by 30-2 Humphrey Perimetry (mean deviation \< -2.00)
* Adequate IOP control (IOP \> 7 mmHg and \< 22 mmHg) by medical or surgical means measured by Goldman Applanation Tonometry for at least 3 months
* Visual field progression - decrease (more negative) in MD by 1.00 dB or more when compared to prior HVF)
* Refractive error ≤ 10 diopters and astigmatism ≤ 3 diopters

Exclusion Criteria:

* BCVA worse than 20/200
* Pt Is unable to tolerate MPOD, CS, dermal carotenoid measurement-taking procedures
* Loss of IOP control requires surgical intervention
* Patient already taking AREDS formula oral supplement
* Patient taking medication or dietary supplements that may interact with LM ingredients
* History of photosensitive epilepsy
* History of penetrating ocular trauma or vitrectomy
* History of ocular or orbital radiation therapy or is currently receiving chemotherapy
* Women who are nursing, pregnant, or are planning pregnancy
* Has a known adverse reaction (including sulfa allergy) and/or sensitivity to the study supplement or its ingredients including: N-acetyl-cysteine, acetyl-L-carnitine, L-taurine, quercetin, Co-enzyme Q-10, lutein, meso zeaxanthin, zeaxanthin, astazanthin, lycopene, alpha-lipoic acid.
* Currently enrolled in an investigational drug study or has used an investigational drug within 30 days prior to recruitment.
* Is planning on having ocular surgery at any time throughout the study duration, or had ocular surgery \< 3 months before enrollment
* Native lens opacity ≥ grade 3 on ARLNS standard photograph
* Blue light filter intraocular lens
Dasotraline Binge Eating Disorder Extension Study

Binge Eating Disorder Extension Study.

This is a Phase 3, 12 month, multicenter, open-label, flexibly-dosed, safety study in adults with Binge Eating Disorder.

Eligibility Criteria:
Inclusion Criteria:

* Completion of the treatment period of a dasotraline core study (ie, SEP360 221 or SEP360-321) for the treatment of BED.
* Subject has agreed to participate by providing written informed consent and is willing and able to comply with the protocol, in the opinion of the investigator.
* Subject has not taken any medication other than the study drug for the purpose of controlling BED symptoms during the core study.
* Female subject must have a negative urine pregnancy test at open label (OL) Baseline; females who are post-menopausal (defined as at least 12 months of spontaneous amenorrhea) and those who have undergone hysterectomy or bilateral oophorectomy will be exempted from the pregnancy test.
* Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to use an effective and medically acceptable form of birth control (see Section 22, Appendix III) throughout the study period. Note: Continued use of an effective and medically acceptable form of birth control is recommended for 30 days after study completion.
* Subject is judged by the investigator to be suitable for participation in a 12 month clinical trial involving open-label dasotraline treatment.
* Subject can read well enough to understand the informed consent form and other subject materials.

Exclusion Criteria:

* Subject is considered by the investigator to be at imminent risk of suicide, injury to self or to others, or damage to property.
* Subject is considered a suicide risk in the investigator's opinion or has any previous history of suicide attempt within the past 12 months.
* Subject answers "yes" to "suicidal ideation" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C SSRS assessment at OL Baseline. Subjects who answer "yes" to this question must be referred to the Investigator for follow up evaluation.
* Subject has a clinically significant abnormality including physical examination, vital signs, ECG, or laboratory tests that the investigator in consultation with the medical monitor considers to be inappropriate to allow participation in the study.
* Subject has a positive urine drug screen (UDS) or breath alcohol test at OL Baseline.
* Subject is breastfeeding.
* Subject is at high risk of non-compliance in the investigator's opinion.
Treatment Results and Health Care Consumption From a Web-based Support System in Behavioural Childhood Obesity Treatment

This study aims to evaluate if a web-based support system with daily self-monitoring of weight, use of an activity measuring wrist-band, and communication between the clinic and the parents gives better results on degree of obesity compared with usual care. Changes in BMI standard deviation score (SDS) are compared between usual care (control) and usual care with complementary web-based support system (intervention).

In this study children with obesity will be randomized to either usual care according to regular routine (control) or to usual care plus a web-based support system (intervention). Based on previous reviews on mobile health and obesity in combination with the investigators' experiences of childhood obesity treatment components were identified which the researchers hypothesize are of major importance for a web-based system for childhood obesity treatment: Frequent self-monitoring of weight and physical activity, goals for weight loss, and feedback from the treatment team. The system is based on a smart phone application connected to a scale and an activity measuring wrist-band. Data is automatically transferred from the accessories to the smart phone, where data is presented graphically. The data is further transferred to the clinic for support and communication between the clinic and the parents. The randomization will be done at the start of individual treatment and will last for 12 months. The main aim is to evaluate if use of the web-based support system will give better results on degree of obesity compared with usual care.

Eligibility Criteria:
Inclusion Criteria:

* Obesity according to International Obesity Task Force (IOTF)
* Swedish speaking parents
* Parents able to use a smart phone
* Patients new in treatment or in treatment during the past 9-15 months with a decrease of BMI SDS with ≤0.25

Exclusion Criteria:

* Diagnosed with or undergoing assessment of neuropsychiatric disorder
* Hypothalamic obesity
* Pharmacological treatment that could intervene the obesity treatment
Trial of Citicoline Therapy in Patients With Mania or Hypomania and Cocaine Abuse/Dependence

The purpose of this research is to determine if a citicoline supplement is associated with a reduction in cocaine use and craving in patients with bipolar disorder (a mental disorder marked by alternating periods of mania and depression) or schizoaffective disorder/bipolar type (a psychotic disturbance in which there is a mixture of schizophrenic and manic-depressive symptoms) and cocaine abuse/dependence. This research also wants to explore if citicoline supplements are associated with greater improvement in symptoms of mania and on memory and cognition (the mental faculty of perception, reasoning, and judgement) in these patients.

Forty-four outpatients meeting the inclusion and exclusion criteria were enrolled after completing an Institutional Review Board (IRB)-approved informed consent process. Baseline evaluation included a medical and psychiatric history, structured diagnostic interview using Diagnostic and Statistical Manual (DSM)-IV criteria, mood assessment with the Inventory of Depressive Symptomatology-Self Report (IDS-SR), Young Mania Rating Scale (YMRS), and cognitive assessment with the Rey Auditory Verbal Learning Test (RAVLT). Alternate but equivalent versions of the RAVLT were used to minimize practice effects with repeated administration. Cocaine use was assessed at each biweekly visit with urine drug screens. Citicoline or placebo was given beginning at one tablet (500 mg)/day with an increase to two tablets (1000 mg/day) at week 2, three tablets (1500 mg/day) at week 4, and four tablets (2000 mg/day) at week 6. Doses were decreased, if needed, due to side effects.

Eligibility Criteria:
Inclusion Criteria:

* Men and women ages 18-70 years
* History of mania or hypomania (bipolar I,II, not otherwise specified (NOS) or cyclothymic disorder or schizoaffective disorder/bipolar type)
* Early recovery for cocaine abuse/dependence (between 7 days and 12 weeks of enrollment).
* Any current mood state as indicated by structured diagnostic interview
* No psychotropic medication changes within 7 days prior to enrollment.
* English or Spanish speaking

Exclusion Criteria:

* Pregnant/nursing woman
* Current or past citicoline therapy
* Active suicidal or homicidal ideation with plan and intent
* Dementia, mental retardation or other severe cognitive impairment
* Severe or life threatening medical condition
PECs Block for Pacemaker Insertion in Children

Evaluation of Ultrasound Guided Modified Pectoral Nerves Blocks in Transvenous Subpectoral pacemaker insertion in Children: Randomized Controlled Trial

BACKGROUND Pectoral nerve blocks (PECs) can reduce intraprocedural anesthetic requirements and postoperative pain. Little is known about the utility of PECs in reducing pain and narcotic use after pacemaker (PM)placement in children. OBJECTIVE The purpose of this study was to determine whether PECs can decrease postoperative pain and opioid use after PM placement in children.

METHODS A single-center controlled trial of pediatric patients undergoing transvenous PM placement between 2020 and 2021 will be performed. Demographics, procedural variables, postoperative pain, and postoperative opioid usage will be compared between patients who undergone PECs and those who undergone conventional anesthetic (Control).

Eligibility Criteria:
Inclusion Criteria:

* congenital or post-operative heart block.

Exclusion Criteria:

* ⦁ Redo patient

  * History of allergic reactions to local anesthetics.
  * Bleeding disorders with International Normalization Ratio( INR) \> 1.5 and/or platelets \< 50 000.
  * Rash or signs of infection at the injection site.
  * Emergency procedure
Shingrix in Recipients of Allogeneic Transplants

This research is designed to determine if the adjuvanted recombinant glycoprotein E (gE) herpes zoster (HZ) vaccine (Shingrix) has acceptable immunogenicity and safety in people who have undergone allogeneic stem cell transplant (allo-SCT). Specifically, it will determine the effect of the interval after transplantation on the immune response and if an additional dose of vaccine is needed to improve the vaccine-induced responses.

This is a phase II, single center, prospective, unblinded, immunogenicity and safety study. It is anticipated that enrollment will take approximately 6 months. Duration of participation for study subjects is approximately 1 year. During this interval, participants will continue to receive clinical care from the BMT center, which will ensure retention.

Participants will be recruited at their routine clinic visits, which take place every 6 months post-transplantation, or will be recruited by phone. Participants will be consented by study personnel in coordination with the BMT health care providers and subsequently followed in Dr. Levin's Vaccine Research Clinic, where they will also receive the 3rd dose of vaccine.

Eligibility Criteria:
Inclusion Criteria:

* Allo-SCT recipients being age 18 - 79 years at time of allo-SCT.
* Written informed consent being obtained from the subject
* Two doses of RZV, separated by 2 to 6 months, administered at least 1 year after allo-SCT.
* Enrollment at \>/= 18 months after second dose of Shingrix.
* Female subjects of childbearing potential (FOCBP) enrolled in the study only if they:

  * have practiced adequate contraception for 30 days prior to vaccination with any dose of zoster vaccine and
  * have a negative pregnancy test on the day of each dose of zoster vaccine and
  * agree to continue adequate contraception during the vaccination period and for 2 months after receipt of the vaccine.
* Investigator belief that the participant will comply with the requirements of the protocol

Exclusion Criteria:

* Active Graft Versus Host Disease (aGVHD) at the time of enrollment and receipt of the third dose of RZV
* Having received ≥20 mg prednisone for more than 2 weeks (or equivalent) in the 8 weeks preceding enrollment.
* Receiving any significant immunosuppressive therapy other than for graft maintenance, in the opinion of the investigator.
* Having received a live attenuated vaccine within the last 4 weeks, or inactivated vaccine in the last 2 weeks, prior to enrollment.
* Having a history of HZ after the administration of the primary 2-dose RZV immunization regimen.
* Pregnancy or breastfeeding
* Receiving investigational drugs from 30 day before enrollment or planned during the study
* Inability of participants unable to comply with the study schedule in the opinion of the investigator
Safety and Efficacy of Laser Therapy in Gynaecology

The aim of this study is to retrospectively evaluate the effectiveness and safety of Er:YAG laser for treatment of different gynecological indication, e.g. genital lesions, Bartholin's cyst, condyloma, episiotomy scars, lesions of hydradenitis suppurativa and use of laser in genital surgery used in private practice.


Eligibility Criteria:
Inclusion Criteria:

* patients with any of the selected gynecology indications, treated with laser in the period 2013-2018
* signed informed consent

Exclusion Criteria:

* N/A
Drug Abuse Prevention Among Girls Through a Mother-Daughter Intervention

The purpose of this study is to determine a computer- and family-based drug abuse prevention program is able to reduce drug use among early adolescent girls.

This study longitudinally tested a computerized, parent-involvement substance abuse prevention program for adolescent girls and their mothers. The prevention program aimed to strengthen and sustain the mother-daughter bond while equipping girls with the necessary information and skills to increase protective factors and reduce risk factors associated with tobacco, alcohol, and other harmful substance use.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking New York City (NYC) area girls
* Ages 11 - 13 years
* Must have private access to a computer with high-speed connectivity

Exclusion Criteria:

* Non-English-speaking girls who do not live in the NYC area
* Younger than 11 or older than 13 years of age
* Those who lack of private access to a computer with high-speed connectivity
Effects of Cranberry-Containing Products in Women With Recurrent Urinary Tract Infections (UTIs)

The purpose of this study is to determine the role of cranberry-containing products in preventing urinary tract infections (UTIs).

Although cranberry-containing products are commonly taken to prevent UTIs and other urinary symptoms, an optimally effective dose has not been established, and the chemicals responsible for the UTI-preventing properties in cranberry-containing products have yet to be determined. This study will determine the minimum dose of cranberry-containing product necessary to prevent UTIs, the effectiveness of cranberry-containing products in fighting different strains of E. coli, and the long-term effects of cranberry-containing product consumption. This study will also determine whether plant pigments called proanthocyanidins influence the UTI-preventing properties of cranberry-containing products.

This study will last 2 years. Participants will be randomly assigned to receive varying doses of either cranberry-containing products or placebo for 1 year. Some participants will receive cranberry or placebo supplement tablets; others will receive cranberry juice or a placebo beverage. Clinic visits will occur every 2 months; urine collection will occur at each visit. Some participants will be asked to collect 24-hour urine samples every 8 weeks and provide urine samples on Days 1, 3, 5 and 7.

Laboratory tests will be used to assess participants during the study. A 3-day course of antibiotics will be provided to participants developing a UTI during the course of the study. Telephone interview follow-up at 6 and 12 months after the study will determine whether cranberry-containing product use has continued and whether UTIs have recurred.

Eligibility Criteria:
Inclusion Criteria:

* At least two UTIs in the year prior to study entry
* Willing to use acceptable methods of contraception
* Willing to refrain from consuming other forms of cranberry supplementation

Exclusion Criteria:

* Current UTI
* Allergy to cranberry-containing products
* Active urinary stone disease
* Insulin-dependent diabetes
* Immunosuppressive disease
* Current corticosteroid use
* Intermittent or indwelling catheterization
* Pregnancy
Priming of Cardiopulmonary Bypass With Hydroxyethyl Starch 130/0.4 or Sodium Chloride 0.9% : Pilot Study in Adult Elective Conventional Cardiac Surgery

Best priming for cardiopulmonary bypass in cardiac surgery is unknown. Efficacy and toxicity of Hydroxyethyl Starch 130/0.4 used in this context are uncertain.

The aim of this pilot study is to determine if Hydroxyethyl Starch 130/0.4 is more effective than Sodium Chloride 0.9% in short term hemodynamic purpose without side renal or hemostatic effect.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective conventional cardiac surgery with cardiopulmonary bypass
* Patients insured under the French social security system

Exclusion Criteria:

* Pregnancy
* Patients placed under guardianship
* Urgent surgery
* Cardiac surgery without cardiopulmonary bypass
* Anterior cardiac surgery
* Non conventional cardiac surgery (mini-invasive surgery, dual valve replacement, right heart surgery)
* Simultaneous inclusion in another study with potential interference in outcomes
* Heparin-induced thrombocytopenia
* Chronic renal insufficiency (glomerular filtration rate \< 60mL.min-1.m-2)
* Nature/nurture hemostasis disorders, in particular Von Willebrand disease and hemophilia
* Hydroxyethyl Starch allergy
* Weight under 33 kg
* Mechanical hemodynamic support at the end of the surgery