cyrilzakka/clinical-trials huggingface dataset:
Comparison of Quadratus Lumborum Block With TAP Block for Postoperative Analgesia After Laparoscopic Nephrectomy

This is a randomised controlled trial which will compare the Quadratus Lumborum (QL) Block with the Transversus Abdominis Plane (TAP) Block in terms of analgesic efficacy, ease of performance and safety when administered postoperatively in patients who undergo laparoscopic nephrectomy.

To fulfill this purpose, three groups of patients each with 32 patients, will be formed. Patients in the Transversus Abdominis Plane (TAP) group and Quadratus Lumborum (QL) group will each receive the respective blocks with 0.4 ml/kg of 0.25% Bupivacaine, after completion of surgery. The third (Control group) will not receive any blocks. After shifting patients to recovery all three groups will be put into intravenous patient controlled analgesia (PCA) Morphine as rescue analgesic regimen as per a set protocol. Morphine consumption over the first postoperative 24 hours, ease of performance of individual blocks and associated adverse events, adverse events associated with opioid use, patient recovery and satisfaction will be noted.


Eligibility Criteria:
Inclusion Criteria:

* patients between 18-65 years of age,
* ASA class I or II,
* undergoing elective unilateral laparoscopic nephrectomy
* under general anaesthesia

Exclusion Criteria:

Patients with any of the following:

* refusal to participate in the study
* coagulopathy/ thrombocytopenia
* localised infection at the proposed site of injection
* inability to comprehend the scoring systems to be employed or use PCA due to physical or mental problems
* known allergy to the drugs to be used (local anesthetics, opioids)
* opioid tolerance/ dependence
* renal impairment
* hepatic impairment
* known cardio-respiratory impairment
* morbid obesity/ sleep apnoea
The Effect of Yoga and Laughter Yoga on Increasing the Psychological Resilience of Mothers

Objective: The study will carried out in a randomized controlled trial to determine the effect of yoga and laughter yoga on increasing the psychological resilience of mothers with their babies in the Neonatal Intensive Care Unit

Method: The research will be carried out with mothers whose babies are treated in the neonatal intensive care unit. Mothers will be divided into three groups as yoga (n=20), laughter yoga (n=20) and control (n=20) by block randomization method. Research findings; Data Form will obtained by using "Introductory Characteristics Form", "Depression, Anxiety, Stress Scale (DASS-21)" and "Psychological Resilience Scale".

Starting from the 1st week (5-7 days) after the birth, mothers will be given 10 sessions of laughter yoga (laughter group) and yoga (yoga group) twice a week for 45 minutes.DASS-21 and Resilience Scale will be administered to mothers in all groups at 1st, 3rd and 5th weeks.

Eligibility Criteria:
Inclusion Criteria:

* Mothers who are older than 18 years of age,
* whose gestational week is less than 32 weeks,
* whose baby has been treated in the neonatal intensive care unit for at least one week,
* who have internet access

Exclusion Criteria:

* Mothers with a genetic disease or congenital anomaly in their baby
Efficacy and Safety of JAK Inhibitors in Patients With AA: RWE Study

The introduction of Janus Kinase inhibitors (JAKi) seems to revolutionize the field of alopecia areata (AA) therapeutics. However, the ideal JAKi is not yet settled and the real-world data are still missing. To provide evidence about effectiveness and safety of different JAKi including tofacitinib, baricitinib, ritlecitinib，abrocitinib, upadacitinib and ifidancitinib in real-world settings and describe baseline disease characteristics and patients profiles that are considered good candidates for JAKi in the daily practice. Furthermore, we intended to investigate the efficacy and safety of JAK Inhibitors in patients With AA, as well as to provide clinical evidence for the clinicians and patients when they formulate individualized treatment plans.


Eligibility Criteria:
Inclusion Criteria:

* Patients with alopecia areata between 2 to 18 years old
* Patients diagnosed with alopecia areata according to AA guideline
* AA Patients treated with JAKi including tofacitinib, baricitinib, ritlecitinib，abrocitinib, upadacitinib and ifidancitinib for more than 3 months

Exclusion Criteria:

* Patients had previously received hair implants
* Other alopecia
* Other diseases may induce alopecia including psoriasis, lichen planus, et al.
* Unable to estimate SALT score at baseline or at follow-up
* Patients are participating in other clinical trials
Preventing the Progression of Multiple Sclerosis: Early Rehabilitative Treatment and Multimodal Assessment - Part B

It is widely recognized that physical exercise is safe and people with moderate Multiple Sclerosis (MS) are encouraged to train regularly to improve their skills in motor task execution. Several studies demonstrated that these activities represent an effective low-cost therapy which leads to significant and clinically meaningful improvements in gait and balance in people with MS (PwMS) with mild to moderate walking dysfunction, possibly also by promoting brain plasticity.

There is general agreement within the scientific community on the importance of timing intervention also during the early stages of MS to preserve or improve walking and balance abilities and fostering brain functional adaptation, thus slowing down the disease progression. Previous studies highlighted the need to early identify and manage gait disorders using a multimodal approach tailored on individual's need. Moreover, Functional Near-Infrared Spectroscopy (fNIRS) measures blood flow which accompanies neuronal activity and thus, it can provide spatial information about changes in cortical activation patterns due to the possible effects of exercise on cortical plasticity.

To the best of the investigators knowledge, no published studies have assessed the effect of exercise on mobility and brain activity in PwMS with minimal or clinically undetectable disability. This emphasizes the need of trials investigating the effect of walking exercise as preventive strategy on MS clinical worsening.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 17 years
* Stable disease course (without worsening over 1 point at the Expanded Disability Status Scale in the last 3 months)

Exclusion Criteria:

* Major depression
* Mini-Mental State Examination \< 27
* Other cardiovascular or orthopedic diseases that interfere with physical exercise
* Progressive course of the disease
Performance and Safety of Hyalo Gyn Gel on the Treatment of Vaginal Atrophy in Postmenopausal Women

This clinical investigation evaluates the performance and safety of Hyalo Gyn, a hyaluronic acid derivative based vaginal gel for the treatment of symptoms of vulvo-vaginal atrophy in post-menopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal woman (≥12 months since last spontaneous menstrual period, or having 6 months of spontaneous amenorrhea with serum FSH levels \>40 IU/L), both natural postmenopause or medical postmenopause (breast cancer patients undergoing a concurrent treatment with aromatase inhibitors or tamoxifen).
* Women between 18 and 75 years of age.
* Vaginal pH ≥5.
* Vulvovaginal atrophy with VHI \< 15.
* At least one of the following symptoms of vulvar and vaginal atrophy, assessed as moderate to severe: vaginal dryness, vaginal and/or vulvar irritation/ itching, dysuria, vaginal pain associated with sexual activity.
* Women with active sex life.
* Patients who give written informed consent to participate in the trial.

Exclusion Criteria:

* Treatment with another investigational product within the previous 3 months.
* Previous participation in any clinical study with Hydeal-D based investigational products.
* Patients in previous treatment with any kind of no-hormonal products for local treatment of vaginal atrophy within 1 week
* Patients in previous treatment with either oral or topical hormonal products within 1 month.
* Patients that present clinical signs of vaginal infections such as trichomonas, candida, and bacterial vaginosis (BV); history of vulvovaginal contact allergy or with a diagnose of vulvovaginal lichen.
* Patients with acute hepatopathy, embolic disorders, severe primary disease of the kidney and hematopoietic system, and history of malignant tumors.
* Positive history of hypersensitivity hyaluronic acid or to any component of the medical device.
* Any condition in the investigator's opinion not suitable for the inclusion of the patient.
Sistas Informing Sistas on Topics About AIDS and Prevention (SISTA-P)

In this project, the investigators will provide a new HIV prevention training and empowerment sessions to Black women in Washington D.C. who are at high risk for getting HIV. This training is tailored to the experience of Black women and seeks to reduce the high HIV transmission rates in the Black community.

Experienced facilitators will implement two cycles of six 3-hour sessions with up to 15 participants per cycle while expert panelists observe. After each session, participants and subject matter expert observers will complete brief surveys. Surveys following each session include closed and open-ended measures: six items rating how well the session conveyed core information (e.g., I am confident I can communicate more effectively \[Session 3\]; I have a better understanding of the effects of alcohol on making sexual choices, \[Session 4\]) and single-item scales to evaluate the facilitator's performance and the session overall. In open-ended measures, respondents will be prompted to elaborate on their survey responses to identify ways the session could be improved.

Eligibility Criteria:
Inclusion Criteria:

* Black women are eligible if you:
* Have sex with men
* Are age 18+
* Live in Washington D.C.
* Are not HIV+

Exclusion Criteria:

* HIV+
Trephine Osteotomy in Lateral Sinus Lift

Trephine osteotomy was used for lateral sinus lifting technique associated with sinus floor augmentation using the autogenous bone resulting from implant drilling using specialized trephine drills.

The study includes 14 patients in whom the lateral sinus lift technique was performed using the trephine osteotomy with simultaneous implant placement.

Sinus floor augmentation with autogenous bone graft resulting from implant site preparation with trephine drills.

Implant stability and rate of complications such as Schneiderian membrane perforation and bleeding will be assessed.

Patients will also provide their subjective assessment of postoperative pain and swelling. Vertical bone height, that will be gained, will be assessed radiographically

Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders requiring implant placement in the posterior maxilla.
* Age between 20-50 years.
* Tooth extractions at the implant sites were performed at least 4 months before surgery.
* Residual bone height between the alveolar bone crest and the sinus floor ranges from 4 to 6 mm.
* Patients who are willing and fully capable to comply with the study protocol

Exclusion Criteria:

* Maxillary sinus pathologies (sinusitis, long standing nasal obstruction)
* Any disease contraindicating surgery (e.g. uncontrolled diabetes)
* Heavy smokers
* Acute oral infections
* Poor oral hygiene
* A history of radiotherapy or chemotherapy of the head and neck region
Parvovirus H-1 (ParvOryx) in Patients With Progressive Primary or Recurrent Glioblastoma Multiforme.

Investigation on safety, tolerability and efficacy of H-1 parvovirus (H-1PV) in subjects suffering from glioblastoma multiforme.

Investigation on safety, tolerability and efficacy of H-1 parvovirus (H-1PV) in subjects suffering from glioblastoma multiforme.

H-1PV will primarily be administered either intratumoral or intravenously. Ten days thereafter a complete or a subtotal tumor resection with a subsequent administration of H-1PV into the walls of the resection cavity will be carried out.

Eligibility Criteria:
Inclusion Criteria:

* Age over or equal to 18 years old,
* Diagnosis of glioblastoma multiforme,
* Written informed consent,
* Recurrent or progressive disease despite previous radio- and/or chemotherapy,
* Indication for complete or subtotal tumor resection,
* Life expectancy of at least 3 months,
* Consent for sampling and investigation of biological specimens,
* Karnofsky Performance Score over or equal to 60,
* Adequate seizure control,
* Adequate bone marrow function: neutrophils \> 1.5 x 10exp9/L, platelets \> 100 x 10exp9/L, hemoglobin \> 9.0 g/dL,
* Adequate liver function: Bilirubin \< 2.0 g/dL, ASAT, ALAT, AP, GGT \< 3 x ULN,
* Adequate renal function: Creatinine \< 1.8 g/dL,
* Adequate blood clotting: aPTT \< 35 sec, INR \< 1.2,
* Negative serology for HIV, HBV and HCV,
* Negative Beta-HCG test in women of childbearing potential,
* Commitment to use adequate contraception (in both genders) for up to six months after study entry,
* Commitment to omit exposure to infants \< 18 months of age or immunocompromised individuals for up to 28 day after first administration of IMP.

Exclusion Criteria:

* Multifocal disease,
* Evidence of distant tumor metastases,
* Contraindications for MRI,
* Active infection within 5 days prior to the study inclusion,
* Chemotherapy within 4 weeks prior to the study inclusion,
* Radiotherapy within 6 weeks prior to the study inclusion,
* Participation in another interventional trial within the last 30 days,
* Treatment with antiangiogenic substances within 21 days prior to therapy.
The Effectiveness of Probiotics in Neonatal Jaundice

Hyperbilirubinemia is a prevalent problem in babies that necessitates medical attention. Probiotic administration as adjuvant therapy may have a positive impact on the pathological neonatal unconjugated hyperbilirubinemia.

Neonatal jaundice is a common health care issue that affects approximately 9% of newborns after birth. The percent of neonates who acquire jaundice in the first week of their birth is about 60%. while the percent of breasted neonates who develop jaundice during the first month of their birth is about 10%.

Phototherapy is the standard therapy for neonates who develop pathological jaundice, as it can alter bilirubin structure and increase its excretion.

Probiotics can also be used for the treatment of jaundice. The efficacy of probiotics depends on their ability to pass across the GIT and cause colonization in the intestinal lumen. Hence, it leads to a decrease in the bacterial growth in the small bowel, a reduction in the function of the gastrointestinal barrier, and a regulation of the immune system of the host.

Eligibility Criteria:
Inclusion Criteria:

* Neonate suffered from pathological unconjugated hyper-bilirubinemia with Total serum bilirubin (TSB) between 5-15mg/dl and need phototherapy.

Exclusion Criteria:

* neonates who have kernicterus.
* neonates who have ventilation problem.
* neonates who have heart failure.
* -neonates who have asphyxia.
* neonates who have history of Rh incompatibility
Effect of Intensive LDL-cholesterol Targeting for Elderly Patients With Cardiovascular Disease: I-OLD Trial

Although there have been studies regarding intensive lowering of low-density lipoprotein (LDL)-cholesterol with high intensity statins in patients with cardiovascular disease, elderly patients were either excluded or accounted only a small portion of study subjects. Therefore, this study sought to compare the clinical outcomes according to the LDL-cholesterol therapy targeting (intensive targeting \[LDL-cholesterol \<55mg/dL\] vs. conventional therapy \[moderate intensity statin therapy\]) in elderly patients with ≥75 years and documented cardiovascular disease.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥75 years
2. Documented cardiovascular disease (at least 1 of the following) A. Previous acute coronary syndrome (MI or unstable angina) B. Or stable angina with imaging studies of coronary artery disease or functional studies of myocardial ischemia C. Or coronary revascularization (percutaneous coronary intervention or coronary artery bypass graft) D. Or peripheral artery disease.

Exclusion Criteria:

1. MI or stroke within 1 year
2. LDL-cholesterol level less than 55 mg/dL without statin therapy
3. Active liver disease or persistent unexplained serum AST/ALT elevation more than 2 times the upper limit of normal range
4. Allergy or hypersensitivity to any statin
5. Life expectancy less than 1 years
6. Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
Observational, Retrospective, Multicenter Study to Describe the Reasons for the Change of the Regimen of Antiretroviral Therapy in HIV Patients

The study aims to describe the changes of combination antiretroviral therapy and the causes that motivated them.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years
* Patients with HIV
* Patients in antiretroviral regimen, that have changed the antirretroviral treatment.

Exclusion Criteria:

* Patients unable to sign the consent form
* patients that changing their treatment are going to take the same components in co-formulated
* patients that changing their treatment are going to take the same components separately
* Total or selective interrupts not indicated by the specialist
* Patients that after changing antiretroviral therapy between January 2011 and July 2012, and during the next year, again suffered another change of treatment
Magnetic Resonance Flow Measurements of Mesenteric Arteries and Veins and Portal Vein

To determine the difference in baseline MR flow measurements and post-prandial MR flow measurements between patients diagnosed with CGI and patients not diagnosed with CGI.

The diagnosis of chronic gastro-intestinal ischemia (CGI) remains a clinical challenge because this diagnosis is difficult to distinguish by the frequent incidence of chronic abdominal pain and asymptomatic stenosis of the mesenteric arteries1. The standard diagnostic work up includes medical history, anamnesis and physical examination, radiological imaging and a functional test as visible light spectroscopy (VLS)2-4 or tonometry5-7. A multidisciplinary team consisting of a gastroenterologist, a vascular surgeon and an interventional radiologist, all specialized in CGI, discusses all patients which results in an expert based consensus diagnosis. Currently, there is no specific test to diagnose CGI. In literature, Magnetic Resonance (MR) techniques are described by which the flow in the mesenteric vessels is measured pre- and post-prandial in healthy volunteers and CGI patients8-12. The flow in the mesenteric vessels increases post-prandial (hyperemia). However, this increase in post-prandial flow compared to pre-prandial appeared less in CGI patients compared to the healthy volunteers. In some CGI patients, even a decrease of the post-prandial compared to pre-prandial flow was seen. We might be able to distinguish patients with CGI from patients without CGI with MR flow measurements with food stimulation.

Eligibility Criteria:
Inclusion Criteria:

1. Patients suspected of CGI referred to our hospital for further analysis
2. Age ≥ 18 years
3. Patients who gave informed consent

Exclusion Criteria:

1. Age \< 18 years
2. Unable to give informed consent
3. Pregnancy
4. Contra-indications for MRI: a. Metal implants which cannot be removed. E.g. cardiac pacemakers/ICD, aneurysm clips, metal stents, artificial heart valve, cochlea/retinal implants, hearing aids, dentures with magnetic click system or with other metal accessories, tattoos with metallic dye, metal plates/pins/screws of bones, piercings b. Claustrophobia c. Inability to lie still for 1 hour to 1,5 hours
5. Other criteria the physician considers are not compatible with this study
Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN)

The purpose of this study is to evaluate the long-term safety and tolerability of SUZ and long-term effectiveness of SUZ in treating pain associated with DPN.


Eligibility Criteria:
Key Inclusion Criteria:

• Completed the final visit in the Treatment Period (i.e., Week 12) and subsequent 7-day period (to allow for taper of blinded capsule study drug) in a parent study such as VX24-548-110 or VX24-548-111

Key Exclusion Criteria:

* Any sensory abnormality (excluding DPN)
* History of drug intolerance in a parent study that would pose an additional risk to the participant in the opinion of the investigator
* Current participation in an investigational drug trial (other than a parent study)

Other protocol defined Inclusion/Exclusion criteria may apply.
Mechanisms of Skin Repair by Topical Estrogen

The purpose of this study is to investigate the way by which estrogen improves the appearance of sun damaged human skin. Accumulating evidence suggests that estrogen, taken by post menopausal women, may cause skin to look younger as a consequence of reduced wrinkles. Collagen is the most abundant protein in human skin and gives skin its strength and shape. Recent data indicate that short-term topical estrogen (17-beta estradiol) treatment increases collagen production in sun damaged skin. This study will compare the molecular and microscopic effects from topical 17-beta estradiol (E2) when applied to the skin for a short-term duration. It is anticipated that the new knowledge from this study will enable development of new ways to improve the function of aged skin.

The objectives of the study are to determine if topically-applied 17-beta estradiol (E2), alone or in combination with clobetasol, will produce histological and molecular effects distinguishable from vehicle in human skin. Specifically, the study will focus on regulation of collagen, elastin, and hyaluronic acid production and degradation in human skin, by steroid hormone receptors that are activated by estrogen or clobetasol. The sites to be treated will be buttock, hip, forearm, or facial skin. Subjects will receive between one to twelve vehicle (matching solution without any active ingredients), estrogen, and/or clobetasol topical applications. Skin biopsies of treated areas will be obtained at baseline and at subsequent timepoints. The study will last up to two weeks. Endpoints will include protein and mRNA levels of collagen, elastin, hyaluronic acid, and other components of skin connective tissue. In addition, we will perform cDNA microanalysis to determine estrogen/clobetasol target genes in human skin. The results from our studies will provide new knowledge regarding the molecular basis of skin aging. This new knowledge will enable development of new ways to improve the function of aged skin.

Eligibility Criteria:
Inclusion Criteria:

* Healthy post-menopausal (without spontaneous menstrual bleeding for at least 1 year) women, and men, at least 50 years of age and any racial/ethnic type.
* Subjects must understand and sign the informed consent prior to participation.
* Subjects must be in generally good health.
* Subjects must be available for follow-up visits to comply with the requirements of the protocol.
* Not on estrogen replacement therapy within the past 3 months.
* No nonsteroidal anti-inflammatory drugs two weeks prior to study entry.
* No topical steroids two weeks prior to study entry.
* You must live within a reasonable driving distance of Ann Arbor, Michigan, and/or be able to attend all of the scheduled appointments during the study.

Exclusion Criteria:

* History of keloid formation or hypertrophic scarring.
* History of reaction to lidocaine anesthetic.
* Subjects with significant medical history or concurrent condition which the investigator(s) feel is not safe for study participation and which would impair evaluation of test sites.