cyrilzakka/clinical-trials huggingface dataset:
The Preemptive Analgetic Potency of Low Dose S-Ketamine

The primary hypothesis is improved postoperative analgetic quality using S-Ketamine, particularly in patients suffering from chronic pain.

The investigators are dealing mainly with the finding of the right dosage for the optimal safety and efficacy of S-Ketamine, but also discovering new possible areas of investigation (e.g. anti-depressive effect, anti-neuropathic effect).

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for major abdominal surgery
* Suitable for PCA
* Cardio-vascular stable
* Age: 18+
* Between 50-120kg BW
* ASA 1-3
* Good Compliance for pain monitoring

Exclusion Criteria:

* Allergy to S-Ketamine
* Severe liver or kidney dysfunction
* Severe coronary disease
* Pregnancy
* Present or past psychotic disorders
* Addiction to alcohol or opioids
* Poor compliance
Impact of Paresthesia on Postoperative Neurological Symptoms

In this study, the effect of paresthesia occurring during the interscalene block procedure on the incidence of postoperative neurological symptoms will be investigated. Paresthesia is defined as an abnormal sensation described as "tingling, pinprick, severe pain, or an electric feeling in the arm." The status of postoperative neurological symptoms in patients at the end of the block's effective duration will be assessed through phone interviews, evaluating symptoms such as arm numbness, tingling, abnormal sensations, pain, and weakness.

Our study includes patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I or II who undergo interscalene nerve block prior to arthroscopic shoulder surgery under general anesthesia. All patients will be fasting according to standard protocol. During the preoperative period, patients' age, comorbidities, gender, body mass index (BMI), ASA scores, and preoperative Quality of Recovery-15 (QoR-15) scores will be recorded.

In the operating room, possible complications related to the block (paresthesia, Horner's syndrome, dyspnea, hoarseness) will be monitored in the preoperative area. During the intraoperative period, data such as pulse, blood pressure, infusion fluids, intraoperative remifentanil requirements, anesthesia duration, and surgical time will be recorded.

In the postoperative period, postoperative pain status, block duration, postoperative nausea and vomiting, need for rescue analgesics and antiemetics, and QoR-15 scores on the first day will be assessed in the recovery room and ward. Additionally, postoperative neurological symptoms and QoR-15 scores will be followed via telephone on the 3rd, 7th, 10th, and 30th days after discharge.

For patients developing postoperative pain, pain intensity will be evaluated using an 11-point numeric rating scale, where 0 indicates no symptoms and 10 represents maximum severity.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I to II
* Age range of 18-65 years
* Patients planned for interscalene nerve block for analgesia prior to arthroscopic shoulder surgery in the beach chair position under general anesthesia

Exclusion Criteria:

* body mass index \>35 kg/m²)
* history of drug use
* Patient's refusal to participate in the study
* Psychiatric disorders
* Central nervous system diseases
* Vestibular disorders
* Presence of diabetes, neuropathy, and paralysis
* Pregnancy
* Open shoulder surgery
* Allergy to local anesthetics
* Coagulopathy
* Severe thrombocytopenia
* Infection at the puncture site
* Pre-existing neuropathy in the limb to be operated on
* Use of opioid and antiemetic medications before surgery
* Use of dexamethasone
* Lung disease
* Low baseline oxygen saturation
* Patients who cannot cooperate in the postoperative period (e.g., mental retardation, delirium, language acquisition deficiency, etc.)
Curcumin in Advanced Cervical Cancer

Determine the efficacy and safety of turmeric in the treatment of patients with advanced cervical cancer. Efficacy will be determined through radiological and histopathological criteria through the rate of response to treatment, duration of response, the rate of objective response and disease control, as well as overall survival and disease-free survival. The safety of therapy will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) classification

A placebo-controlled phase II clinical trial will be developed in patients with advanced cervical cancer who have an indication for radiotherapy. Those who accept to participate will receive the standard treatment with established chemo-radiation and will be randomized in two arms, the experimental will receive 500mg of the commercial presentation (curcugreen) c / 6h VO x 16 weeks and the control arm will receive placebo. The operative hypotheses are: the addition of curcumin to the treatment improves the cumulative probability of 3-year overall survival by 20% and improves the treatment response rate. The statistical analysis will include a Cox proportional hazards model and the results of the groups will be compared with the Student's T-test or ANOVA. This research hopes to collect tissue samples for future research that allows the identification of predictive biomarkers and disease prognoses.

Eligibility Criteria:
Inclusion Criteria:

Women aged 18 years or older

* Voluntary acceptance of participation and signing of informed consent
* Radiotherapy indication
* Histological confirmation of squamous cervical cancer or histologically confirmed adenocarcinoma
* Stage IIB - VAT
* Chemo-radiation indication with Cisplatin, Cisplatin/fluorouracil, Carboplatin (if cisplatin intolerant)
* ECOG equal to or less than 1 and a Karnofsky index equal to or greater than 70%.

Exclusion Criteria:

* Being pregnant or breastfeeding
* Presence of second concomitant neoplasia
* Any previous surgical, radiotherapy or chemotherapy treatment.
* Diagnosis of invasive recurrent carcinoma of the cervix
* Receive anticoagulant therapy
* Receive immunosuppression therapy
* Presence of coagulation disorders, such as platelet count less than 100,000 at the time of the joint evaluation, absolute neutrophil count less than 1,500 / ml
* Presence of signs of systemic infection
* Renal failure, creatinine clearance less than 45 ml/min confirmed with glomerular filtration less than 45 ml / min; evidence of unilateral renal exclusion
* Patients with uncontrolled metabolic disease
Pyloroplasty Versus No Pyloroplasty in Patients Undergoing Esophagectomy

This research study is a phase III randomized trial to study the value of the addition of a pyloroplasty procedure versus no pyloroplasty procedure during the performance of esophagectomy. Pyloroplasty is a type of pyloric drainage procedure.

Patients selected for enrollment in this study will be adults (18-85 years of age) that have been scheduled for exploration, and possible esophagectomy. Prior to surgery, patients will be randomized to one of two groups. Group A will have a pyloroplasty performed as part of the esophagectomy procedure. Group B will not have a pyloroplasty performed. Postoperative patient outcomes will be assessed for 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be willing to undergo esophagectomy for benign or malignant condition
* Women and men 18-85 years of age
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Stomach is used as conduit

Exclusion Criteria:

* Previous operations of the pylorus
* Previous gastric resection
* Previous gastric bypass
* Patients who are unable to tolerate surgery
* Participants may be enrolled and randomized on the study but may be excluded at the time of the surgery because of findings by the surgeon that preclude performing esophagectomy, or using stomach as a conduit or findings which preclude following the randomized arm.
* Age \<18 years of age or \> 85 years of age
* BMI \> 50
* Liver cirrhosis or liver failure at physician's discretion
High Energy Formula Feeding in Infants With Congenital Heart Disease

High energy formula more positively affect growth in infants with congenital heart disease compared to standard formula

Infants with congenital heart disease (CHD) usually show growth retardation as they can not intake enough calorie due to fluid restriction. We hypothesize that high energy formula more positively affect growth in infants with congenital heart disease compared to standard formula

Eligibility Criteria:
Inclusion Criteria:

* infants \>35 weeks of gestational age
* infants with CHD
* İnfants fed with formula feeding

Exclusion Criteria:

* Major congenital abnormalities except CHD
* infants could not be fed enterally
Role of Menopause in Thermoregulation

The frequency and severity of heat waves has increased in the last decades. Older adults (over 65 years) have impaired responses to heat stress making them at increased risk for adverse events. Previous heat waves report that women over 65 experience worse health outcomes than any other age group and age matched men.

Aging and reproductive hormones, specifically estrogen, independently alter responses to heat stress. However, the combined effects of low estrogen following menopause and aging on the response to heat stress are unknown. In this study, the investigators will identify the role of estrogen in pre and post menopausal women on thermoregulatory responses to heat stress.

Premenopausal and postmenopausal women will be recruited and different interventions will be given to each group. To mimic a postmenopausal hormone profile, premenopausal women will be given a GnRH antagonist, which acutely reduces estrogen concentrations. This induces a temporary post-menopausal state without compounding aging effects. Postmenopausal women will be given a transdermal estradiol patch to acutely raise estrogen concentrations. Supplementing estrogen in postmenopausal women allows for the effect of menopausal low estrogen concentration to be removed from the physiological effects of aging.

Subjects sign an informed consent form and undergo a medical screening prior to participation. The screening includes a physical exam, anthropometry, chemical and lipid profiles.

Each subject will complete 6 (3 for each treatment) experimental trials. For each intervention, participants will complete one passive heating experiment first, followed by two active heating experiments.

Eligibility Criteria:
Inclusion Criteria:

* Women ages 42-64

Exclusion Criteria:

* Chron's disease, diverticulitis, or similar gastrointestinal disease
* Abnormal resting exercise electrocardiogram (ECG)
* Tobacco use
* High-risk determined by the Atherosclerotic Cardiovascular Disease (CVD) Risk Factor
* Assessment
* Using hormone therapy
* Using hormonal contraceptives
High-Intensity Interval Training On Women With Polycystic Ovary Syndrome.

This RCT is aimed towards determining the effectiveness of exercises based intervention strategy involving high intensity interval training exercises in improving serum testosterone level, body fat composition and physical activity in hopes to provide a definitive exercise regime for the ever common symptoms of pcos. It will be based on the theory that exercise helps in decreasing testosterone level that in turn decrease high androgen levels in the body, exercise further decreases body fat composition (obesity is a common cause or manifestation of pcos).

High intensity interval training will be performed over the course of 12 weeks and will be compared with the group performing strength training. Baseline assessments will be done before the start of the first session and post-test assessment will be done after the last session of the study.

Envelope method is used for the purpose of randomization. 50 envelopes having a title of group A and group B will be made and divided into two (25 in each group). Mutually exclusive technique will be used and the envelope once picked will not be replaced within the groups.

Sample size is calculated by using a previous study conducted in 2015 titled as, 'Effects of High Intensity Interval Training and Strength Training on Metabolic, Cardiovascular and Hormonal Outcomes in Women with Poly cystic Ovary Syndrome: A Pilot Study' by taking a confidence interval CI of 95%, power of test 80%, standard deviation of 6.3 and mean difference of 5.2, a sample size of 50 is calculated.

For the analysis of the data MedCalc software version 19.0.5. will be used. Descriptive statistics will be performed for the purpose of demographic information and this data will be presented in terms of frequency and percentage. Skewness and Kurtosis will be used in order to determine the normality of data. If the data is normally distributed, then for within the group analysis dependent T test will be performed. However, in case the data is not normally distributed Wilcoxon Sign Rank test will be performed. Independent T test will be performed for the comparison between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* BMI:

  1. Overweight: 23-24.9 kg/m2.
  2. Obese: greater than or equal to 25 kg/m2 .
* Diagnosed and referred PCO patients to the rehabilitation unit would be selected for the study.
* Aged 18-40.
* High serum testosterone level: normal range 6-86 ng/dl.

Exclusion Criteria:

* On-going pregnancy.
* Any cardiovascular complication.
* Any other endocrine disorder
* Any musculoskeletal condition that hinders in performing the exercise training protocol.
Hysterosalpingography and Hysteroscopy in ICSI

unexplained infertility is a rising problem in clinical practice

Assessment of uterine cavity is very important before ICSI

Eligibility Criteria:
Inclusion Criteria:

* women with infertility

Exclusion Criteria:

* women with medical disorders
ENGAGE4HEALTH: A Combination Intervention Strategy for Linkage and Retention in Mozambique

Purpose: To compare the effectiveness of a combination intervention strategy (CIS), consisting of point of care (POC) CD4+ testing immediately following HIV diagnosis and accelerated ART initiation for eligible participants delivered by facility personnel, and cellular appointment reminders delivered by study personnel, to the standard of care (SOC) on linkage to and retention in HIV care at 12 months among adults testing positive for HIV in Mozambique. Additionally, the protocol will assess the incremental effectiveness of CIS+ non-cash financial incentives (FI) compared to CIS without FI on study outcomes.

Design: Two-arm cluster site-randomized trial with a pre-post intervention two-sample design nested in the intervention arm.

Study Population: The study population is any adult who tests HIV positive at the HIV counseling and testing points participating in this study. The study unit (SU), the level of randomization for the study, includes specific HIV counseling and testing points at primary health care clinics and the HIV care and treatment services located in the same health facility. A total of 10 SU will be included.

Sample Size: A total of 2,250 adults from the 10 study units will be included in the study, 750 in the SOC arm, 750 receiving CIS without FI and 750 receiving CIS+FI.

Participants will be enrolled and followed for 12 months after enrollment.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Testing HIV positive at the largest-volume HIV point of testing (other than prevention of mother-to-child transmission or tuberculosis) at SU with written proof of test result
* Agreeing to be referred to the HIV care services associated with the SU
* Agreeing to provide locator information
* Agreeing to adhere to study procedures, including a baseline interview, interviews 1 and 12 months after study enrollment, and extraction of data from the HIV care and treatment electronic database
* Able to provide informed consent

Exclusion Criteria:

* Being pregnant at study enrollment
* Planning on leaving the community where they currently reside in the next 12 months
* Enrolled in HIV care in the past 6 months at any clinic
* Initiated ART (for any duration) in the past 6 months at any clinic
* Currently on ART
* Does not speak or understand Portuguese or Xitswa/Matswa
24 Vs 48 Hours of Cefazolin or Cefuroxime as Prophylaxis

A randomized control trial studying the effect of prophylactic antibiotics to reduce surgical site infections following cardiac surgery in adults using 1st generation cephalosporin (Cefazolin) or 2nd generation cephalosporin (Cefuroxime).

A prospective randomized controlled patient blinded study with 2x2 factional design. It aims to study optimal duration of antibiotic to reduce surgical site infections following cardiac surgery in adults 24 or 48 hours using 1st generation cephalosporin (Cefazolin) or 2nd generation cephalosporin (Cefuroxime). Patients shall remain on either medicines for 24 or 48 hours. The primary endpoints of the study are:(1) 48 hours antibiotic prophylaxis is superior to 24 hours in adult cardiac surgery (2) Cefuroxime is superior to Cafazolin as a prophylactic antibiotic in adult cardiac surgery. Secondary endpoints include; organisms causing surgical site infections, length of hospital and ICU stay, and worsening in renal function.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide informed consent
* Planned to undergo a cardiac surgical procedure

Exclusion Criteria:

* Patients on antibiotics on the day of surgery or those who received any within 7 days for any reason
* Patients taken to operating room as salvage
* Patients who are allergic to either cefuroxime or cefazolin
* Patients for LVAD or ECMO
* Patients who are known MRSA carriers
* Patients receiving steroid therapy
A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease and Ulcerative Colitis

The purpose of this study is to estimate and compare the incidence of overall malignancy, serious infection, and opportunistic infections between new users of ustekinumab and new users of other biologic therapies among adult participants with Crohn's disease (CD) or ulcerative colitis (UC).


Eligibility Criteria:
Inclusion Criteria:

* Adult men and women with CD or UC who are new users of ustekinumab or the comparator drugs during the study period
* Participants must have at least 1 year of enrollment history with the DoD EHR database immediately prior to new use (that is, exposure index date) of ustekinumab or the comparator drugs

Exclusion Criteria:

* Participants below 18 years of age on the exposure index date
* Participants who do not meet the definition for CD or UC prior to or on the exposure index date
* Participants with any records of human immunodeficiency virus (HIV) diagnosis, organ or tissue transplant, or malignancy (excluding non-melanoma skin cancer \[NMSC\]) at any time prior to or on the exposure index date
* Participants with a physician diagnosis of rheumatoid arthritis, ankylosing spondylitis, or psoriatic arthritis within 12 months prior to or on the exposure index date
* In the analysis of infection outcomes, participants diagnosed with the same infection of interest both within 60 days prior to or on the exposure index date and within 60 days after the exposure index date will be excluded
Flaxseed Mucilage and Satiety

The effect of a single dose of flaxseed mucilage incorporated into either drinks or tablets will be tested in term of their effect on appetite sensation measured using visual analogue scales over 120 minutes and ad libitum energy intake hereafter in two studies.

Study I:

Control drink vs. Flaxseed drink consumed and appetite sensation registered over 120 minutes. Hereafter energy intake was measured.

Study II:

Flaxseed drink vs. Flaxseed tablets+control drink consumed and appetite sensation registered over 120 minutes. Hereafter energy intake was measured.

Eligibility Criteria:
Inclusion Criteria:

* healthy adults
* 18-40 years
* BMI 19-28

Exclusion Criteria:

* smoking
* pregnancy or lactation
* excessive exercise
* medication (oral contraceptives the only exception)
Study of Histological Findings of the Internal Inguinal Ring in Patients With Indirect Inguinal Hernia

The histology of the internal inguinal ring in patients with indirect hernia submitted to elective surgery was studied. In contrast with recently published studies, the investigators believe that histological findings of the internal inguinal ring would reflect those associated and expected with normal aging.


Eligibility Criteria:
Inclusion Criteria:

* Male gender
* Older than 15 years-of-age
* Unilateral indirect inguinal hernia
* Non-smokers
* Non-diabetics
* Non-connective tissue conditions
* Primary inguinal hernia

Exclusion Criteria:

* Female gender
* Younger than 15 years-of-age
* Bilateral inguinal hernia
* Direct or combined direct-indirect inguinal hernia
* Femoral hernia
* Smokers
* Diabetics
* Other connective tissue diseases
* Recurrent inguinal hernia
Safety and Efficacy of a Switch to Doravirine/Islatravir in Participants With HIV-1 (MK-8591A-017)

This study will evaluate the safety and efficacy of a switch to MK-8591A (a fixed dose combination of doravirine and islatravir) in human immunodeficiency virus -1 (HIV-1)-infected participants virologically suppressed on a protocol-specified background antiretroviral regimen. The primary hypothesis is that a switch to MK-8591A will be non-inferior to continued treatment with baseline antiretroviral therapy (ART) as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48.


Eligibility Criteria:
Inclusion Criteria:

* Is HIV-1 positive
* Has been receiving continuous, stable oral 2-drug or 3-drug combination (± pharmacokinetic (PK) booster) with documented viral suppression (HIV-1 RNA \<50 copies/mL) for ≥3 months prior to signing informed consent and has no history of prior virologic treatment failure on any past or current regimen.
* Female is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of childbearing potential (WOCBP); is a WOCBP and using an acceptable contraceptive method, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle; a WOCBP must have a negative highly sensitive pregnancy test (\[urine or serum\] as required by local regulations) within 24 hours before the first dose of study intervention; if a urine test cannot be confirmed as negative (e.g. an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive

Exclusion Criteria:

* Has HIV-2 infection
* Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
* Has an active diagnosis of hepatitis due to any cause, including active Hepatitis B Virus (HBV) co-infection
* Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi's sarcoma
* Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapies
* Is currently taking long-acting cabotegravir-rilpivirine
* Is currently participating in or has participated in a clinical study with an investigational compound or device from 45 days prior to Day 1 through the study treatment period
* Has a documented or known virologic resistance to DOR
* Female expects to conceive or donate eggs at any time during the study