cyrilzakka/clinical-trials huggingface dataset:
Role of Magnesium Sulphate as an Adjuvant to Bupivacaine in U.S Guided Quadratus Lumborum Block in Lower Abdominal Cancer Surgeries

The aim of this study is to assess the efficacy of Mg sulfate ( 10% ) as an adjuvant to Bupivacain ( 0.25 % ) in an U.S guided QLB for postoperative analgesia and postoperative Morphine consumption in lower abdominal cancer surgeries.

It is vital to apply adequate postoperative analgesia following lower abdominal surgeries of cancer because Postoperative pain not only affects the patients' rest but also produces a series of pathological reactions. Postoperative analgesia, including regional anesthesia, is very important which not only provides effective postoperative analgesia but also reduces the need for postoperative opioids.In recent years, various ultrasound-guided regional anethetic techniques have been extensively used. One of them is Quadratus lumborum block which can provide postoperative analgesia of the segmental innervation from T6 to L1. In which the Local anesthetics can spread through the thoracolumbar fascia to the paravertebral space, thereby blocking part of the sympathetic nerves . Clinical studies have shown that compared with the current widely used transverse abdominal block, QLB provides longer analgesia and wider block levels when the same dose of local anesthetic is used unlike traditional trunk block, QLB cannot use the sense of falling during puncture and can only be performed under ultrasound guidance, which has the advantages of being real-time and dynamic. Ultrasound-guided nerve block provides more accurate positioning and benefits for patients with less injury. Magnesium sulfate plays an important role in the physiological function of the human body. A large number of studies have reported the safety and effectiveness of adding magnesium sulfate as an adjuvant in various regional anethetic techniques . Therefore, we designed a prospective randomized controlled trial to compare the analgesic efficacy of combining magnesium sulfate with bupivacaine in QLB.

Eligibility Criteria:
Inclusion Criteria:

1. Age from 18 to 80 years old
2. Both gender
3. Weight from 55 to 85 kg
4. ASA groups 2 and 3
5. Lower abdominal cancer surgeries

Exclusion Criteria:

* 1. Patient refusal 2. True local anesthetic allergy 3. Coagulopathy 4. Local infection at the procedure site 5. Psychic patients 6. Patient on chronic opioid use
Comparing Two Group Therapy Treatments for Binge Eating Disorder

This study will compare two different approaches for the treatment for Binge Eating Disorder.

Binge Eating Disorder (BED) is associated with impairments in physical, psychological, and social functioning. Research has revealed relationships between disordered eating and both low self-esteem and negative emotional states.

Participants in this study will complete assessment interviews regarding their eating disorder and associated problems. Similar assessments will be conducted at the end of the study. Participants will then be randomly assigned to one of two therapy groups. Participants in one group will focus on the role of self-esteem, self-awareness, and personal effectiveness in binge eating. Participants in the other group will focus on the role of negative emotions and binge eating. Both treatments will involve a 30 to 40 minute pre-treatment individual orientation session, followed by 20 weeks of weekly group therapy. Sessions will take place over 22 weeks, or approximately 6 months (18 weekly sessions followed by 2 biweekly sessions). Follow-up assessments will take place at 3 months, 6 months, and 12 months after study completion to assess maintenance of treatment effects.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Binge Eating Disorder
* Reside in the San Francisco Bay Area
* Willing to commit to the study requirements

Exclusion Criteria:

* Unstable medical problems
* History of bipolar illness or schizophrenia
* Receiving treatment for an eating disorder (or unwillingness to discontinue treatment upon study entry)
* Membership in weight-loss groups such as Weight Watchers or Jenny Craig (or unwillingness to discontinue membership upon study entry)
* Use of medications affecting weight or appetite. Antidepressants are acceptable, but doses of any psychiatric medication must have been stable for at least 3 months prior to study start
* Breast-feeding
* Require gastric-bypass surgery
Metformin for Treatment of Antipsychotic-induced Dyslipidemia

Almost all antipsychotics can induce dyslipidemia, but no treatment has been established. Metformin can improve lipid levels in obese patients. The investigators conducted a randomized, placebo-controlled study to test the efficacy of metformin for antipsychotic-induced dyslipidemia.

The study was designed as a double-blind randomized controlled trial, with research assessors and patients intended to be blind to the intervention status. The staff members performing the assessment were not involved in implementing any aspect of the intervention.162 patients were randomized to one of two 24-week individual treatments: metformin (1000mg/day)or placebo. Medications were provided in double-blind fashion.The assessments include lipid levels, body weight, body mass index, fasting glucose, fasting insulin and insulin resistance index.

Eligibility Criteria:
Inclusion Criteria:

Diagnostic and Statistical Manual of Mental Disorder-Fourth Edition (DSM-Ⅳ) criteria for schizophrenia dyslipidemia after antipsycotic treatment the duration of illness was less than 12 months taking only one antipsychotic stable outpatient the total score of Positive and Negative Syndrome Scale (PANSS)≤60.

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Exclusion Criteria:

liver or renal diseases pregnant or lactating women cardiovascular diseases hypertension or diabetes mellitus
Meals and Grazing Study

The purpose of this study was to determine the effects of low vs. high eating frequency (EF) on biomarkers of health and subjective appetite.

Observational studies have demonstrated an inverse relationship between eating frequency (EF), obesity, and other markers for disease risk. It has been suggested that consumption of several small, frequent meals may influence physiological mechanisms, reducing the risk for disease and lowering appetite. Participants in this randomized crossover study completed two intervention phases lasting three weeks each: one of low eating frequency ("low-EF"; 3 eating occasions/day) and one of high eating frequency ("high-EF"; 8 eating occasions/day). Fasting C-reactive protein, insulin-like growth factor, and leptin were measured at baseline and endpoint of each phase and an optional subjective appetite testing session lasting four hours was offered at the endpoint of each phase. During appetite testing sessions, participants consumed an amount of food equal in total energy and macronutrient content at either one occasion at 8:00 am ("low-EF" condition) or spread evenly over two smaller eating occasions at 8:00 am and 10:30 am ("high-EF" condition). Ratings of hunger, desire to eat, fullness, thirst, and nausea were made every 30 minutes using paper-and-pencil semi-anchored 100-mm Visual Analog Scales. A composite appetite score was calculated as the mean of hunger, desire to eat, and 100-fullness. The generalized estimating equation modification of linear regression was used to compare fasting plasma biomarkers and mean ratings of subjective appetite.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be overweight and obese (BMI 25 and over) males and females ages 18-50 years.
* Participants must be willing to report to FHCRC on 5 occasions (initial screening appointment + 4 testing sessions)
* Participants must be willing to provide a 7-day food record for analysis prior to Phase 1 and Phase 2 of the study
* Participants must be willing to follow diet protocol during Phase 1 of the study
* Participants must be willing to undergo 4 blood draws

Exclusion Criteria:

* Non-diabetic (self-report)
* Non-smokers (self-report)
* Not following a diet to gain or lose weight (self-report)
* Normal cholesterol (self-report)
* Normal blood pressure (self-report)
* Not currently taking any medication (self-report)
* Not pregnant or nursing (self-report and verification by DEXA)
* Not athletes in training (self-report)
Therapeutic Endpoint in Pediatric IBD Conditions

The purpose of this clinical study is the development of physiologic endpoint of inflammation in pediatric patients diagnosed with inflammatory bowel disease (IBD), specifically subtypes Crohn's disease (CD) and ulcerative colitis (UC). The novel medical device evaluates the patient's sensory response to each of the three sensory nerve fiber types. Data from the device provides an assessment of disease activity and a more precise approach to treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 6 years of age at screening.
* Documentation of an IBD diagnosis as evidenced by history

Exclusion Criteria:

* Documented history of eye disease precluding pupillometry
* Patients who are unwilling or unable to participate due to developmental delays or ongoing psychological diagnoses.
Pharmacokinetics of Injectable Estradiol and Progesterone Microspheres Suspension

Phase I pharmacokinetic study

Main objective:

To determine plasmatic profiles and pharmacokinetic parameters of estradiol and progesterone on each of the formulations studied, after multiple-dose administration

Study design:

Randomized, controlled, open-label, parallel, pharmacokinetic study

Sites: 1

Subjects: 30 postmenopausal women

Sites: 1

Phase: 1

Main objective:

To determine plasmatic profiles and pharmacokinetic parameters of estradiol and progesterone on each of the formulations studied, after multiple-dose administration.

Secondary objectives:

To determine bioavailability of each of the formulations studied, after multiple-dose-administration. Describe tolerability of each of the formulations studied, after multiple-dose administration.

Study design: Randomized, controlled, open-label, parallel, pharmacokinetic study

Investigational Products:

* Estradiol and progesterone microspheres aqueous suspension (1 mg/20 mg)
* Estradiol and progesterone microspheres aqueous suspension (0.5 mg/15 mg)

Study subjects: 30 postmenopausal women 45 - 65 years old

Brief description: After written informed consent, 30 eligible women will be randomized to study treatments (one IM injection each 28 days, for a total of 4 doses). Blood samples will be obtained for pharmacokinetic study.

Eligibility Criteria:
Inclusion Criteria:

* Female
* 45 to 65 years old
* Able to read and write
* Postmenopausal
* Body Mass Index equal or below 34.99 kg/m2
* Healthy
* Normal uterus
* Time availability

Exclusion Criteria:

* Hypersensitivity to progesterone or related compounds
* Hypersensitivity to estrogens
* Hysterectomy
* History or present hormone-dependent tumor
* History or present uterine cervix dysplasia
* Abnormal and clinically-significant laboratory test results
* Family history of breast cancer
* History of thromboembolic disease
* Non-controlled hypertension
* History of stroke
* History of cardiac valve surgery
* Renal failure
* Hepatic failure
* Non-controlled diabetes
* History of serious neurologic disease
* Reduced mobility
* Anemia
* Previous or concomitant hormone therapy
* Previous or concomitant therapy with inhibitors or inductors of cytochrome
Adolescent Mother and Breastfeeding Education

In low-income and developing countries, 30% of adolescents marry before the age of 18, and 14% marry before the age of 15. Additionally, adolescents between the ages of 15 and 19 are often coerced into marriage or sexual relationships with partners older than themselves. 10% of adolescents under the age of 15 in the world are forced to have sexual intercourse and as a result, unwanted teenage pregnancies occur. In high-income countries like Latin America, there is a high prevalence of adolescent non-marital pregnancies. When considering the fertility, health, and social outcomes of adolescence, it emerges as a significant issue. Adolescent motherhood carries numerous adverse effects from both demographic and social perspectives.

In pregnancies occurring during adolescence, both maternal and infant mortality rates are two to three times higher compared to pregnancies at later ages. Many infant and child deaths occur due to preventable causes. Breastfeeding is a significant factor in reducing infant and child mortality. Since infants born to adolescent mothers are at higher risk of death and illness, breastfeeding these infants becomes even more important. However, one of the significant challenges adolescent mothers face during the postpartum period is initiating and maintaining lactation. Research has shown that maternal age plays a significant role in initiating and sustaining breastfeeding, with a strong positive correlation between maternal age and duration of breastfeeding. This study was designed as a randomized controlled trial to examine the effect of breastfeeding education provided to adolescent mothers on maternal breastfeeding self-efficacy, mother-infant attachment, and infant anthropometric measurements.


Eligibility Criteria:
Inclusion Criteria:

* Giving birth vaginally between the 37th and 40th gestational weeks,
* Being under 18 years of age,
* Primigravida,
* Not having any systemic/chronic diseases,
* Willing to breastfeed,
* Having received breastfeeding counseling provided by the hospital,
* Being able to speak Turkish, and
* Adolescent mothers in the postnatal 1st and 2nd weeks will be included in the study.

Exclusion Criteria:

* Mothers giving birth before the 37th gestational week or after the 40th gestational week,
* Those with barriers hindering effective communication,
* Those unable to speak Turkish,
* Mothers who have not received breastfeeding counseling from the hospital,
* Non-breastfeeding mothers,
* Those experiencing interruptions in breastfeeding due to seasonal work or any other reason,
* Those supplementing breastfeeding with formula,
* Adolescent mothers who discontinue breastfeeding education provided through LSM will be excluded from the study.
Safety and Compliance of Taking Mesalamine Once a Day in Pediatric Patients

To determine whether once a day administration of Mesalamine is at least as safe and efficacious and administration of multiple doses a day in preventing clinical relapse of ulcerative colitis in children and adolescence.

Is taking total dose in mg/kg once a day, as safe as taking total dose divided in mg/kg spreadout during the day in preventing clinical relapse of ulcerative colitis in children and adolescence.

Eligibility Criteria:
Inclusion Criteria:

* Ages 6 to 18 years,
* Must be able to swallow tablets, and
* Biopsy proven ulcerative colitis

Exclusion Criteria:

* Allergy or hypersensitivity to Mesalamine or other salicylates
* Use of rectal medications
Post-COVID-19 Pneumo-hematocele

Introduction. As the COVID-19 pandemic has continued, an increasing number of long-term complications are emerging. Recently, the appearance of characteristic pulmonary lesions has been noted, being described as post COVID-19 pneumatocele. The aim of this study is to describe the clinical, histopathologic and imaging features of post COVID-19 pneumo-hematoceles (PHC) and secondarily to suggest a treatment algorithm in these patients.

Methods. A retrospective study was performed in patients admitted with diagnosis of SARS-CoV2 infection from March 2020 to September 2021 who presented PHC on imaging studies. Clinical and demographic variables were recorded and CT scans were analyzed. A logistic regression analysis was performed to determine the risk for rupture according to PHC characteristics.

It appears that PHC occurs secondary to encapsulation of blood accumulation, the result of micro capillary bleeding, with partial reabsorption of blood and subsequent air filling. The recommendation is to operate on patients with PHC of 5cm and those with persistent lesions of 3cm.


Eligibility Criteria:
Inclusion Criteria:

* Adults with a positive protein chain reaction for SARS-CoV2,
* PHC on imaging studies.

Exclusion Criteria:

* loss of follow up
* age out of range.
Omega-3 and Vitamin E Supplementation in Patients With Rheumatoid Arthritis

The purpose of this study is to determine whether simultaneous supplementation with omega-3 fatty acids and vitamin E is effective in the treatment of patients with rheumatoid arthritis.

The purpose of this study is to determine whether simultaneous supplementation with omega-3 fatty acids and vitamin E is effective in the treatment of patients with rheumatoid arthritis.

Most of studies on omega-3 fatty acids (omega-3) supplementation in patients with rheumatoid arthritis (RA) have clearly shown potentially beneficial changes in cytokine and eicosanoid metabolism. The overall clinical improvement, however, has been only moderate. One explanation is that an increased intake of omega-3 leads to a reduction in the availability of antioxidants and an increased generation of lipid peroxides. The majority of the anti-inflammatory drugs routinely used nowadays are COX (cyclo-oxygenase) inhibitors. Mechanism of COX II inhibitors is similar of omega-3. So, it is difficult to differentiate omega-3 net effects in some situations. Existing clinical trials on omega-3 and vitamin E (Vit E) are sometimes questioned due to using omega-6 fatty acids as placebo and neglecting omega-6 fatty acid intake in the diet. A comprehensive randomized controlled double-blind trial would have omega-6 fatty acids served as placebo in patients who are well matched in terms of therapies and drugs.

Comparison(s): Comparison of groups supplemented with omega-3, omega-3 with Vit E, and placebo (Medium chain triglycerides: MCT).

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of rheumatoid arthritis according American college of rheumatology (ACR)

Exclusion Criteria:

* Infection
* Major joint malformations
* Simultaneous diseases like metabolic and gastrointestinal
* Being class IV according to ACR
* Drug dose fluctuations
* History of Vit E and/or omega-3 supplements during past six months
* Gastric irrigations
Expanded Access Program to Provide Treatment With Pitolisant to Adult Patients in the U.S. With Excessive Daytime Sleepiness Associated With Narcolepsy With or Without Cataplexy

This EAP will be open to provide access to treatment with pitolisant while a U.S. New Drug Application (NDA) is being prepared and submitted for review for marketing approval. This program will be open to adult patients in the U.S. with Excessive Daytime Sleepiness (EDS) associated with narcolepsy, with or without cataplexy. Pitolisant will be made available through treating physicians participating in the program.


Eligibility Criteria:
Inclusion Criteria:

1. In the opinion of the treating physician, the patient is capable of understanding and complying with protocol and program requirements, oral drug administration and care instructions.
2. The patient or, when applicable, the patient's legally acceptable representative, signs and dates a written, ICF and any required privacy authorization prior to the initiation of any program procedures.
3. Men or women, 18 years of age and over.
4. Patients with a diagnosis of narcolepsy with or without cataplexy according to the ICSD or DSM criteria at the time of diagnosis.
5. Patients should be free of prohibited treatments or have discontinued them for at least 7 days prior to the start of treatments.
6. Women of child-bearing potential must have a negative serum pregnancy test performed at the screening visit.
7. Due to the effectiveness of hormonal contraceptives potentially being reduced when used with pitolisant, alternative or concomitant barrier methods of contraception are required for patients taking hormonal contraceptives (e.g., ethinyl estradiol) when taking pitolisant and for at least 21 days after discontinuation of pitolisant treatment.

Exclusion Criteria:

1. The patient has severe hepatic impairment (Child-Pugh C).
2. The patient is a woman who is breastfeeding or plans to breastfeed during their participation.
3. The patient has, in the judgment of the treating physician, a history or current medical condition that could affect safety or poses an additional risk to the patient by their participation in the program.
4. The patient is at high risk for suicide defined as a suicide attempt within the past year, significant risk determined by the investigator interview, or use of the Columbia Suicide Severity Rating Scale (C-SSRS).
5. The patient has a history of hypersensitivity or allergic reaction to pitolisant or any inactive ingredient of the formulation.
6. Current or recent (within one year) history of a substance abuse or dependence disorder including alcohol abuse as defined in Diagnostic and Statistical Manual of Mental Disorders (DSM-V).
7. Patients with a known history of long QTc syndrome (e.g. syncope or arrhythmia) or any significant history of a serious abnormality of the ECG (e.g. recent myocardial infarction), or QTc Fridericia higher than 450 ms for male and 470 ms for female (electrocardiogram Fridericia's corrected QT interval = QT / 3√ RR).
8. Significant abnormality in the physical examination or clinical laboratory results.
9. Prior severe adverse reactions to CNS stimulants.
The Effect of n-3 Fatty Acids and Fish on Glucose and Lipid Metabolism in Subjects With Impaired Glucose Metabolism

The aim of the project is to examine whether the sources of n-3 fatty acids and fish itself differ in their effects on glucose metabolism, lipid metabolism, blood pressure, and serum inflammatory markers. Lipidomic profiles and gene expression will be used for thorough assessment of the possible clinical changes. The study will compare the effects of alpha-linolenic acid containing vegetable oil, fatty fish, lean fish and control diet. The results of this project will help to identify the optimal source of n-3 fatty acids, and reveal the significance of the components of fish other than fatty acids. These data will be useful both nationally and internationally, since highly controlled dietary interventions utilizing new methodology are scarce.


Eligibility Criteria:
Inclusion Criteria:

* age 40-70 years
* BMI 25-32 kg/m2
* fasting plasma glucose 5.6-7.0 mmol/l
* 2 h plasma glucose in oral glucose tolerance test \<=11 mmol/l
* fasting serum total cholesterol \<=7 mmol/l
* fasting serum LDL cholesterol \<=5 mmol/l
* fasting serum triglycerides \<=4 mmol/l

Exclusion Criteria:

* any chronic disease or condition that hamper the ability to follow dietary intervention
* chronic liver, thyroid or kidney disease
* alcohol abuse
* diabetes
* recent weight loss
* recent myocardial infarction
* corticosteroid therapy
* psychiatric disorders which need drug treatment
* cancer under treatment
* fish allergy or other extensive food allergies
* exceptional diets (like Atkin's or vegan diet)