cyrilzakka/clinical-trials huggingface dataset:
Prophylactic Tranexamic Acid Use After Vaginal Delivery

In this study, our aim was to evaluate the effectiveness of prophylactic tranexamic acid use after vaginal delivery in pregnant women aged 18-45 years and 34-42 weeks according to the risk of postpartum hemorrhage.

It was carried out as a double-blind prospective randomized controlled Phase 4 drug study with 480 singleton pregnant women in Bursa Yüksek İhtisas Training and Research Hospital between September 1, 2021 and February 28, 2022. The patients were divided into two groups as low risk (240 patients) and high risk (240 patients) according to their postpartum hemorrhage risks, and the patients in each group were randomly divided into two groups. Group 1: were given intravenous tranexamic acid and group 2: were given placebo. The blood loss at the 3rd and 4th stages of labor was calculated by weighing the blood collected with the help of a collecting pochette and using the estimated blood loss formula.

Eligibility Criteria:
Inclusion Criteria:

* singleton pregnant women
* woman between the ages of 18-45 years
* woman who gave birth at 34 weeks and above

Exclusion Criteria:

* Pregnancies with less than 1 hour period between hospitalization and delivery
* Women with placenta previa, invasion anomaly or diagnosis of abruptio placentae
* Women with previous uterine surgery or cesarean section
* Women with a history of thromboembolism
* women with serious illness
Transcriptome, Proteome and Microbiome Profile in Periodontal and Peri-implant Diseases

1. To investigate the transcriptomic profile of periodontitis and peri-implantitis. Patients with defined periodontitis, at two non-adjacent teeth and peri-implantitis at ≥ one implant in function of ≥ one year, will be included to investigate the gene expression profile in tissue affected by periodontitis and peri-implantitis. Subjects will undergo a full-mouth examination performed by a calibrated examiner, including assessment of caries, bone abnormalities and infections according to intraoral x-ray, plaque index and pocket probing depth, suppuration, bleeding on probing, alveolar bone loss, and the number of teeth. During surgical intervention, tissue biopsies (two specimens per site) will be collected by a periodontist from site with ongoing periodontitis and site from ongoing peri-implantitis.
2. To study the microbiome and biomarker profile associated with periodontitis and peri- implantitis. Patients with defined periodontitis, at two non-adjacent teeth and peri-implantitis at ≥ one implant in function of ≥ one year, will be included in this study to determine the bacteria composition, cytokine profile and inflammatory biomarkers profile. Subjects will undergo a full-mouth examination performed by a calibrated examiner, including assessment of caries, bone abnormalities and infections according to intraoral x-ray, plaque index and pocket probing depth, suppuration, bleeding on probing, alveolar bone loss, and number of teeth. Peri-implant crevicular fluid (PICF), gingival crevicular fluid (GCF), saliva and submucosal/subgingival plaque will be collected.The presence and composition of periodontal and peri-implant plaque samples are investigated.


Eligibility Criteria:
Inclusion Criteria:

≥18 years of age Defined periodontitis at two non-adjacent teeth Defined peri-implantitis at ≥1 implant Signed informed consent

Exclusion Criteria:

Surgical intervention of periodontitis and/or peri-implantitis during last 6 months.

Local or systemic use of antibiotics during last 6 months.
Normothermic Machine Perfusion of Steatotic Livers for Expansion of Donor Organ Pool

The goal of this clinical trial is to assess the ability of Normothermic Machine Perfusion (NMP) to resuscitate moderately steatotic livers for transplantation in patients. This will be a single-site clinical trial placing donor livers with 30-60% macrosteatosis on NMP, and then transplanting those that meet commonly accepted viability criteria. The results of this study could lead to a trial extending NMP transplantation to severely steatotic livers, further expanding the donor organ pool.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years
* Listed for liver transplantation at MGH
* Calculated MELD-Na score \<= 25
* Able to consent

Exclusion Criteria:

* Status 1a
* Cardiac or pulmonary disease
* Prior liver transplant
* Requiring pressors at the time of liver offer
* MELD\<15 and asymptomatic from liver disease
The Glycemic Indices of Five Common Varieties of Dates in the Tested Among Healthy and Diabetic Subjects

The main objectives of this study is to measure the composition of five common types of dates (Fara'd, Lulu, Abu ouma'n, Dabbas and Khalas) and to calculate their Glycemic Indices (GI) of these dates tested in healthy and diabetic subjects. Thirteen healthy volunteers and ten subjects with type 2 diabetes mellitus were enrolled in the study.

The dates' flesh composition analysis showed that the dates contain a high percentage of carbohydrate (total sugars, 65-68%).

The measured mean glycemic indices of the dates among healthy individuals were 54.0, 53.5, 46.3, 49.1 and 55.1 for Fara'd, Lulu, Abu Ouma'n, Dabbas and Khalas, respectively. Corresponding mean glycemic indices among individuals with type 2 diabetes were very similar 46.1, 43.8, 51.8, 50.2, and 53.0. Thus the tested five varieties of the dates are classified as low glycemic index food items.

The United Arab Emirates (UAE) has transitioned rapidly over the last 40 years. This has lead to a dramatic increase in the prevalence of obesity, metabolic syndrome, dyslipidaemia, hypertension, prediabetes and diabetes. Daily consumption of dates is the norm.The main objectives of this study is to measure the composition of five common types of dates (Fara'd, Lulu, Abu ouma'n, Dabbas and Khalas) and to calculate their Glycemic Indices (GI) of these dates tested equally in healthy and diabetic subjects. Thirteen healthy volunteers and ten subjects with type 2 diabetes mellitus were enrolled in the study. The dates' flesh composition analysis showed that the dates contain a high percentage of carbohydrate (total sugars, 65-68%).

The measured mean glycemic indices of the dates among healthy individuals were 54.0, 53.5, 46.3, 49.1 and 55.1 for Fara'd, Lulu, Abu Ouma'n, Dabbas and Khalas, respectively. Corresponding mean glycemic indices among individuals with type 2 diabetes were very similar 46.1, 43.8, 51.8, 50.2, and 53.0. Thus the tested five varieties of the dates are classified as low glycemic index food items with potential health benefits for healthy and diabetic individuals alike.

Eligibility Criteria:
Inclusion Criteria:

* Adult
* Healthy or having controlled type 2 diabetes mellitus

Exclusion Criteria:

* Morbid obesity (BMI \> 40)
* Presence of gastroenterological disorders
* Alimentary tract surgery
* A history of gastroenteritis in the prior six months
* Any disease that may affect glucose metabolism
* Alcohol intake
* Smoking
* Taking any medications (except metformin)
* Poorly uncontrolled diabetes (HbA1c \> 8%)
* The presence of chronic diseases or the presence of acute illness
Contrast Bath and Sympathetic Skin Response

This study evaluates the effects of contrast bath on sympathetic skin response in stroke patients with complex regional pain syndrome .

Contrast bath(CB) is a thermal modality. It is usually performed by keeping hands in hot and cold water for certain periods of time. CB is a mostly advised intervention in complex regional pain syndrome (CRPS) altough there is no certain evidence The investigators will study on stroke patients. Change in sympathetic skin response after the contrast bath will be evaluated.

Stroke patients who admitted to the inpatient rehabilitation programme in Istanbul Physical Medicine and Rehabilitation Training and Research Hospital were evaluated for this study. Patients who had CRPS after stroke were included in the study (CRPS group). Also patients who had not CRPS and had similar age, gender and stroke duration with CRPS group were included in control group. Stroke patients with pacemaker, polyneuropathy, neglect, sensory or motor aphasia, peripheral nerve injury, hand surgery and reynauld disease were excluded from the study.

Age, gender, dominant arm, comorbidities, stroke side, aetiology and duration were recorded. Brunnstrom stages were used to evaluate arm and hand. Spasticity of upper extremity was assed by modified aschworth scale.

In CRPS group, CRPS severity scale was performed to evaluate the CRPS severity. This scale includes sensorial, autonomic and motor function. Also, neuropathic pain was assesed by Douleur Neuropathique 4 (DN4) Questionnaire and visual analog scale(VAS).

Contrast bath was performed to patients' plegic side . There were two baths , one include hot water and other had cold degrees. Patients hold their plegic hands in hot water for 4 minutes, in cold water for 1 minute after hot water. Hot and cold bath were repeated four times.

Sympathetic skin response (SSR) was measured before the contrast bath and 30 minutes after the contrast bath finished. SSR was recorded from plegic side and contralateral side. The active electrode was placed at the palm of the hand and the reference electrode at dorsum of the hand to record the median nerve SSR. The latency and the amplitude of SSR was measured.

Eligibility Criteria:
Inclusion Criteria:

* stroke
* both gender

Exclusion Criteria:

* peripheral neuropathy
* pace maker
* skin lesion in hands
* anxiety
* sensory or motor aphasia
* peripheral nerve injury
* hand surgery and
* reynauld disease
Paravertebral Block Versus Epidural Anesthesia for Percutaneous Nephrolithotomy

This prospective, randomized study is aimed to assess the efficacy and safety of paravertebral block compared to epidural anesthesia for percutaneous nephrolithotomy. The investigators suppose that paravertebral block is not inferior in controlling the perioperative pain for percutaneous nephrolithotomy compared to epidural block.

Background: Percutaneous nephrolithotomy (PCNL) is generally performed under general or neuraxial anesthesia. The investigators have reported three patients who were at high risk of both general anesthesia and neuraxial anesthesia received percutaneous nephrolithotomy with ultrasound guided paravertebral block. Then，The investigators performed ultrasound guided paravertebral block for 45 patients who received percutaneous nephrolithotomy successfully. The investigators' impression is that paravertebral block is as effective as epidural anesthesia for surgical anesthesia of percutaneous nephrolithotomy.

Objectives:To assess the efficacy and safety of paravertebral block compared to epidural anesthesia for surgical anesthesia of percutaneous nephrolithotomy.

Methods: Fifty adult patients undergoing elective percutaneous nephrolithotomy will be randomized to receive ultrasound guided paravertebral block or epidural anesthesia. The primary outcome will be the pain score 12h postoperation. The secondary outcomes will include: time spent to perform block, dose of intraoperative opioids, rate of hypotension need for vasoconstrictors, muscle Power Grading of the lower legs at the end of the operation, anus exhaust time, opioid consumption postoperation, postoperative PONV score and the frequency of vomiting , hospitalization duration and patient satisfaction.

Clinical Implications: Ultrasound guided paravertebral block could be an equally effective and safe alternative to epidural block for surgical anesthesia of percutaneous nephrolithotomy.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical statusⅠ-Ⅲ
* Undergo first stage percutaneous nephrolithotomy
* Informed consent

Exclusion Criteria:

* BMI\>35
* Coagulopathy, on anticoagulants
* History of surgery on spine
* Spine deformity
* A known allergy to the drugs being used
* Tumor or infection at the site of puncture
* inability to provide adequate informed consent
* refusal to participate in the study
Phase 1A Study of the Safety of KSP/QRH Dimer

To evaluate the safety of orally administered KSP-QRH-E3-IRDye800 (Peptide 919288G), a topically administered Li-Cor IRDye800CW labeled heptapeptide dimer (KSP/QRH Dimer) specific for human epithelial growth factor receptor 2 (HER2) and epidermal growth factor receptor (EGFR).

This is a Phase IA study of the safety of an orally administered KSP-QRH-E3-IRDye800 (Peptide 919288G) heptapeptide dimer for detection of neoplastic tissues in multiple areas of the gastrointestinal tract in humans. The investigators intend to enroll 25 evaluable subjects. The investigators expect to be able to enroll about 2-3 subjects per week, so the study should take about 2-3 months to complete.

Interested, healthy subjects ages 25-100 who respond to recruitment advertising on UMHealthResearch.org and appear to be eligible based responses to inclusion/exclusion criteria questions will be scheduled for a study visit at MCRU. At the study visit, the subjects will review and sign the informed consent and eligibility will be confirmed. If eligible, subjects will provide a blood sample for clinical labs and a urine sample for urinalysis, as well as have an EKG. A negative urine pregnancy test for women of child-bearing potential is required to be eligible. Eligible subjects will consume the reconstituted KSP-QRH-E3-IRDye800 (Peptide 919288G). After 5 minutes, subjects will drink a minimum 4-8 ounces of tap water and vital signs will be taken. Subjects will remain in MCRU for observation for 30 minutes. Vital signs will be recorded after 30 minutes, and another EKG will be conducted. Subjects are required to return to MCRU to have a repeat blood draw for clinical labs and urinalysis within 24 to 48 hours after KSP-QRH-E3-IRDye800 (Peptide 919288G) ingestion. The study team will conduct a verbal assessment for toxicity at this visit.

Eligibility Criteria:
Inclusion Criteria:

* Not pregnant (willing to have pregnancy test if applicable)
* No recent illness (infection, URI, virus or flu) within 2 weeks,
* Stable health status (i.e. no medication changes within 2 months, no recent surgery, etc. per PI)
* Willing and able to sign informed consent
* Willing and able to drink the peptide and a tap water chaser
* Willing and able to get baseline and 24-48 hours post ingestion labs
* Willing and able to get pre and post ingestion EKG

Exclusion Criteria:

* Known allergy to li-cor IRDye800CW, a near infrared fluorosphore or derivatives
* Subjects on active chemotherapy or radiation therapy
* Diabetics on insulin/hypoglycemic (due to fasting requirements)
To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 40 mg (0653-090)

To Evaluate and Compare the Efficacy and Safety of Ezetimibe Plus Atorvastatin Versus Atorvastatin in Hypercholesterolemic Patients at High Risk for Coronary Heart Disease Not Adequately Controlled on Atorvastatin 40 mg.


Eligibility Criteria:
Inclusion Criteria:

* Patient with LDL-C \>70 mg/dL \& on a stable dose of atorvastatin 40 mg

Exclusion Criteria:

* Pregnant or lactating women or intending to become pregnant
* Patient with sensitivity or intolerance to ezetimibe or atorvastatin
Embryo Transfer: Embryo Expulsion and Outcome

According to the studies, about 80% of patients undergoing in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) reach to the embryo transfer process, but only a few of them become pregnant.

The cause of this difference can be due to some factors such as the endometrial receptivity, quality of transferred embryos and embryo transfer technique. Retained or expelled embryo(s) following embryo transfer is (are) one of the factors which may be effective on outcome. The purpose of this randomized clinical trial study is "Lowering embryo expulsion following embryo transfer to improve outcome."

A total of 134 infertile women who undergo IVF or ICSI treatment cycle at Royan Institute (Infertility and Reproductive Medicine Research Centre) will enroll in this prospective randomized clinical trial study and will randomly be divided into two groups of 67 patients. This study has been approved by Royan ethics committee and written consent will be obtained from each patient. The patients with frozen-thawed embryo transfer cycle and those with oocyte donation cycle, the women with uterine abnormality and the subjects with submucosal and intramural myoma, will be excluded from this study.

After the ovarian stimulation and oocyte retrieval, The IVF and intracytoplasmic sperm injection (ICSI) procedures will be performed to produce the embryos.

Embryo transfer will be done only by one skilled physician. The patients will be divided into two groups of A and B by computerized randomly chart. In group A, the prevention technique of embryo expulsion will be carried out following embryo transfer, but no intervention will be performed in group B (control group).

After 2 weeks, the patients will be tested for serum β-hCG for assessing the pregnancy. The clinical pregnancy will be clarified by the number of women with gestational sacs on transvaginal sonography at 4-6 weeks of gestation. In the calculation of implantation, the number of gestational sacs will be considered.

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing IVF or ICSI treatment cycle
* Patients with "long or antagonist" protocol

Exclusion Criteria:

* The patients with frozen-thawed embryo transfer cycle
* Those with oocyte donation cycle
* The women with uterine abnormality
* The women with submucosal and intramural myoma
* Who does not have good-quality embryos appropriate
Impact of Budesonide Irrigations on Patients With Chronic Rhinosinusitis and Impact on Sinus Surgery Rates

This study is intended to assess the impact of a 90 day course of high volume budesonide irrigations for patients who have failed other medical therapy and assessing the impact of the budesonide irrigations on the need for sinus surgery.

Patient who meet eligibility requirements will be given the opportunity to use a budesonide saline rinse twice daily for 90 days. At the completion of this therapy, their clinical situation will be reassessed and patients will either proceed to surgery or not. If eligible patients choose not participate, they will be offered surgery up front. The study will be assessing symptom scores using the SNOT-22 validated patient reported symptoms score, CT scans, and other measures. The study hypothesizes that a significant portion of patients that otherwise would have progressed to surgery will no longer need to have surgery based upon improvements in their overall symptoms scores after using budesonise irrigations.

Eligibility Criteria:
Inclusion Criteria:

* adult (\>18 yo)
* symptoms consistent with sinusitis for at least 12 weeks,
* undergone maximal medical therapy, including: extended course of antibiotics (21 days minimum), use of topical corticosteroids for a minimum of 6 weeks, use of saline rinses at least once a day for a minimum of 3 weeks
* CT showing evidence of chronic sinusitis.

Exclusion Criteria:

* pregnant women,
* age below 18,
* presence of nasal polyps or other nasal masses,
* failure to complete medical therapy,
* normal CT scan,
* intolerance to budesonide or saline irrigations via squeeze bottle (high volume, high flow).
Population Versus Practice-based Interventions to Increase Immunizations

One of the nation's major health priorities, as outlined in Healthy People 2010, is to increase the proportion of children aged 19 to 35 months who have received all universally recommended vaccines. This study will compare two interventions for increasing immunization rates in this age group, one using well-studied primary care practice-based methods and the other using innovative technologies to increase immunization rates at the population-level. Results of this study will provide data that will be relevant nationally in guiding future investment of resources to increase up-to-date rates in young children prior to school entry.

Hypothesis: Population-based approaches will be more effective than practice-based interventions at increasing immunizations among 19-35 month olds.


Eligibility Criteria:
Inclusion Criteria:

* child between the age of 19-35 months
* has an address in a specified study county in the state immunization registry
* child is in need of at least one recommended immunization

Exclusion Criteria:

* child has opted out of the state immunization registry
* child is up-to-date on all recommended immunizations
Prospective Evaluation of Ivosidenib Maintenance Following Allogeneic Stem Cell Transplantation in Patients With Acute Myeloid Leukemia or High-risk Myelodysplastic Neoplasia With IDH1 (Isocitrate Dehydrogenase 1) Mutation

maintenance of AML or MDS patients with known IDH1 mutation after allogeneic stem cell transplantation within past 100 days

Determination of the efficacy of Ivosidenib to improve event-free survival when given as maintenance therapy following alloSCT.

Eligibility Criteria:
Inclusion criterion:

* AML or MDS with IDH1 mutation

Exclusion criteria:

* active GvHD (graft vs host disease) grade III-IV according to Harris criteria requiring steroids \>1mg/ kg prednisolone equivalent
A Long-term Follow-up Study in Participants Who Received CS-101

This is a study to evaluate the long-term safety and efficacy of CS-101 in participants who received CS-101 in study CS -101-03 (NCT06065189)

This is a study to evaluate the long-term safety and efficacy of CS-101 in participants who received CS-101 in study CS -101-03 (NCT06065189) .

Subjects in the CS-101-03 study will be entered into long-term follow-up of this study up to 2 years post-infusion at the completion of the last (6-month) follow-up visit after treatment with CS-101 Injection.

Eligibility Criteria:
Inclusion Criteria:

* Participants (or his or her legally appointed and authorized representative or guardian) must sign and date informed consent form (ICF) and, where applicable, an assent form
* Participants must have received CS-101 infusion in last IIT study

Exclusion Criteria:

* There are no exclusion criteria