cyrilzakka/clinical-trials huggingface dataset:
Impact of Prophylactic Low-molecular Weight Heparin Dosing on Clotting Parameters Following Cesarean Delivery

The aim of this study is to evaluate the efficacy of two dosing regimens of low molecular weight heparin (LMWH) to reach prophylactic anti-factor Xa levels in post-cesarean delivery women. Half of participants will receive a fixed dose of LMWH, while the other half will receive a weight-based dose. The hypothesis is that the use of a weight-based dose will result in more women reaching prophylactic levels.

Venous thromboembolism (VTE) is a major contributor to maternal morbidity and mortality. The immediate postpartum period is a high risk time for VTE, and cesarean delivery is an additional risk factor. In the United States, use of postpartum VTE prophylaxis with low-molecular weight heparin (LMWH) is commonly used but without a standard protocol or dose across all hospitals. A fixed-dose of LMWH is frequently used based on data from non-obstetric studies. However, there are concerns that in the postpartum population this fixed dose may not be adequate for prophylaxis.

This study aims to evaluate the efficacy of fixed dose versus weight-based LMWH to reach prophylactic anti-Xa levels in post-cesarean delivery women. This will be a randomized controlled trial (RCT) with half of participants receiving a fixed dose of LMWH and half of participants receiving a weight-based dose of LMWH. The hypothesis is that the use of a weight-based LMWH compared to a fixed dose will result in more women achieving prophylactic anti-Xa levels.

Eligibility Criteria:
Inclusion Criteria:

* Cesarean delivery
* Meet facility guidelines for postpartum venous thromboembolism (VTE) prophylaxis: Presence of 1 major, or 2 or more moderate, risk factors.
* Major risk factors: history of venous thromboembolism, high risk thrombophilia, BMI ≥40, high risk medical comorbidities (heart disease, sickle cell disease, systemic lupus erythematosus, inflammatory bowel disease), cesarean hysterectomy, nephrotic range proteinuria, or cesarean intrapartum/during labor
* Moderate risk factors: BMI \> 30, multifetal pregnancy, postpartum hemorrhage (\>1L blood loss), tobacco use, non-laboring or elective cesarean, preeclampsia, infection, preterm delivery (\< 37 weeks gestational age), age \> 35 years, low risk thrombophilia, family history of venous thromboembolism, stillbirth, varicose veins, prolonged labor (\> 24 hours)

Exclusion Criteria:

* Contraindication to anticoagulation
* Plan for therapeutic anticoagulation (antepartum or postpartum)
* Known renal dysfunction (Creatinine clearance \< 30 mL/minute)
Open-Label Extension Study for Subjects With H1 Antihistamine Refractory Chronic Spontaneous Urticaria Completing Study AK006-001

An open label extension (OLE) study offered to subjects with Chronic Spontaneous Urticaria that have completed the AK006-001 (NCT06072157) Part C referred to as the Main study portion of the study. Qualified subjects will receive up to four doses of the study drug (AK006) through an intravenous infusion every 4 weeks. There is a 16-week follow up period once all the scheduled infusions have been completed. Subjects will be follow for evaluation of safety, tolerability, PK, immunogenicity, and clinical response.


Eligibility Criteria:
Key Inclusion Criteria:

* Enrolled in Part C of Study AK006-001 (NCT06072157) and completed the randomized, double-blind, placebo-controlled treatment period and the Day 99 Visit.
* Acceptable demonstration of tolerance to study drug during the AK006-001 study as determined by the investigator.
* Acceptable demonstration of protocol compliance during the AK006-001 study as determined by the investigator.
* Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to use a highly effective method of contraception with \<1% failure rate or abstain from sexual activity from Screening until the end of the study, or for 16 weeks following the last dose of AK006, whichever is longer.

Key Exclusion Criteria:

* Pregnant, breastfeeding, or planning to become pregnant while participating in the study.
* Planned use of an approved or investigational therapy to treat CSU other than a single 2nd- or later-generation H1-AH between 1× and 4× the licensed dose and frequency, during the study.
N-3 Polyunsaturated Fatty Acids Enriched Chicken Meet and Cardiovascular Function

Evidence from multiple experimental, epidemiological, and clinical studies indicate that n-3 polyunsaturated fatty acids (n-3 PUFAs) may exert their cardiovascular (CV) protective effect, at least in part, by improving vascular endothelium-dependent function. Previously, the investigators demonstrated the significant beneficiary effect of consumption of n-3 PUFA-enriched hen eggs on microvascular endothelium-dependent reactivity, even in young healthy individuals.

The hypothesis of this research is that the consumption of n-3 PUFAs in the form of functionally enriched chicken meet has a beneficial effect on vascular reactivity measured in different vascular beds, and the lipid profile with a positive effect on the reduction of oxidative stress and inflammatory response in healthy sedentary individuals.

The main goal of this study is to investigate the influence of n-3 PUFAs functionally enriched chicken meet on vascular and endothelial function in a population of healthy young subjects and active athletes.


Eligibility Criteria:
Inclusion Criteria:

* young healthy sedentary individuals - did not perform regular physical activities for at least 12 months before conducting the study
* young healthy active athletes - have a minimum of 5 training sessions per week (mainly endurance training) for at least 12 months prior to conducting the study

Exclusion Criteria:

* smoking
* hypertension
* coronary disease
* diabetes
* hyperlipidemia
* kidney damage
* cerebrovascular and peripheral artery diseases
* and any other disease that could have an impact on vascular and endothelial function
Metabolic Changes in Blood Samples From Patients With Acute Myeloid Leukemia

This research trial studies metabolic changes in blood samples from patients with acute myeloid leukemia. Studying samples of blood from patients with acute myeloid leukemia in the laboratory may help doctors learn more about cancer and the development of drug resistance.

PRIMARY OBJECTIVES:

I. To determine the metabolic adaptations that occur following exposure to standard chemotherapeutic agents using peripheral blood mononuclear cells from acute myeloid leukemia (AML) patients.

OUTLINE:

Patients undergo collection of peripheral blood mononuclear cell (PBMC) samples for analysis via cell isolation, glycolytic flux and oxygen consumption assays, viability assays, and western blot at baseline, 24, 48, and 72 hours after starting chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to initiate chemotherapy for either an initial diagnosis of AML or relapsed AML
* Starting the initial induction phase of therapy
* Exposure to hydroxyurea is acceptable but must be noted at the time of sample collection
* Ability to understand and the willingness to sign an institutional review board (IRB)-approved informed consent

Exclusion Criteria:

* Received at least one dose of chemotherapy during the current cycle (excluding hydroxyurea).
Comparison of Postoperative Early Period Quality of Life of Patients With Open and Robot Assisted Kidney Transplantation

The investigators aimed to investigate the quality of life in patients with end-stage renal disease who underwent open or robot-assisted renal transplantation. Also, the investigators sought to determine the parameters which can affect the quality of life in these patients

Patients who underwent open or robot-assisted renal transplantation at Bakirkoy Sadi Konuk Training and Research Hospital between June 2016 and December 2018 constituted the target population of this study. After application of the inclusion and exclusion criteria, the patient group was divided into two groups as per the surgical technique (i.e., open vs. robot-assisted). Demographic data, preoperative and postoperative data of all patients were collected prospectively. The quality of life of the patients was assessed preoperatively and on the postoperative 30th day

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 75
* Who were diagnosed with End Stage Renal Disease (i.e., estimated glomerular filtration rate loer than 20 ml/minute or symptomatic uremia or dialysis requirement)
* Received a kidney from a live donor

Exclusion Criteria:

* Patients with mental retardation, dementia, and psychotic or cognitive disorders, including delirium
* Patients who underwent deceased renal transplantation and who underwent simple bilateral nephrectomy or any other surgical procedure concurrent with Open renal transplantation
* Patients who died or had graft failure during the study period
A Randomised Controlled Trial of the Use of Topical Metronidazole (10%) to Reduce Pain After Haemorrhoidectomy

The purpose of this study is to determine whether metronidazole 10% ointment , applied topically three times a day in and around the anus, on the reduction of pain following haemorrhoidectomy.


Eligibility Criteria:
Inclusion Criteria:

* Have Grade 3 or 4 haemorrhoids (external disease with or without significant internal component)
* Be scheduled for diathermy haemorroidectomy with ≥2 quadrant involvement
* Be medically fit for surgery
* Subjects must be aged 18 years or over and of the legal age of consent.
* If female, the subject must not be lactating and must be (a) post-menopausal, (b) surgically sterilised, or (c) have a negative pregnancy test result prior to entry into the study and will use adequate contraception for the duration of the study.
* Must have provided written informed consent to participate.

Exclusion Criteria:

* They have had surgery to the anus or rectum in the past 8 weeks
* Suffer from a chronic pain syndrome which requires regular narcotic analgesia
* Have anal fissures
* Have diagnosed Crohn's disease
* Allergic to metronidazole
* Are taking any prohibited medication.
* Deemed mentally incompetent
* Considered by their physician unlikely to be able to comply with the protocol.
* Taken part in an experimental drug study in the preceding three months.
Effect of Antidepressants on White Matter Structure

Subjects with major depression will be evaluated and intensively characterized through questionnaires, computerized cognitive evaluation and laboratory investigations. Magnetic resonance imaging will be used to document baseline white matter structure. subjects will then receive desvenlafaxine which will be adjusted as clinically indicated. After 16 weeks the evaluations will be repeated.

40 subjects will be included in the study. Diagnosis will be confirmed by MINI. Participants will be characterised using questionnaires, pain threshold, cognition, facial expression recording and MRI. Desvenlafaxine will be initiated at 50mg AM. At week 8 Desvenlafaxine may be increased to 100mg as clinically indicated. Measures will be repeated at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Major depression
* Age 18 to 55
* Hamilton grater or equal to 20

Exclusion Criteria:

* Major neurologic disorder
* Major cardiovascular disorder
* Unstable medical condition
* Significant psychiatric co-morbidity
* Current substance dependance
* Pregnancy or lactation -Treatment resistance as defined by nonresponse to 2 or more antidepressant treatments (adequate dose and duration) -
Preoperative Biliary Drainage in Resectable Pancreatic or Periampullary Cancer

The purpose of this study is to demonstrate that preoperative biliary drainage using self-expanding metal stents (SEMS) does not negatively impact overall surgical outcomes in patients undergoing pancreaticoduodenectomy for treatment of pancreatic or periampullary cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Willing and able to comply with the study procedures and provide written informed consent to participate in the study
* Diagnosis of probable pancreatic cancer, distal common bile duct (CBD) cholangiocarcinoma and other periampullary cancers (histology not required)
* Biliary obstructive symptoms or signs
* Bilirubin level at/above 100 umol per liter (5.8 mg/dL)
* Distal biliary obstruction consistent with pancreatic cancer, distal CBD cholangiocarcinoma or other periampullary malignancy
* Location of distal biliary obstruction is such that it would allow the proximal end of a stent to be positioned at least 2cm from the hilum
* Patients deemed as resectable by pancreatic protocol CT or MRI
* Surgical candidate per pancreatobiliary surgeon after multi-disciplinary discussion
* Surgery intent within 4 weeks
* Endoscopic and surgical treatment to be provided by same team

Exclusion Criteria:

* Biliary strictures caused by confirmed benign tumors
* Biliary strictures caused by malignancies other than pancreatic cancer, distal CBD cholangiocarcinoma and other periampullary cancers
* Surgically altered biliary tract anatomy, not including prior cholecystectomy
* Neoadjuvant chemotherapy for current malignancy
* Palliative indication due to reasons other than surgical candidate status
* Previous biliary drainage by ERCP/PTC
* Patients for whom endoscopic techniques are contraindicated
* Participation in another investigational trial within 90 days
* Pregnancy
Mortality and Complications in Endovascular Procedures Performed With New Generation Low-profile Devices

The aim of this study is to observe mortality and complications in procedures in which are used new generation low-profile endoprothesis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with indications for elective TEVAR

Exclusion Criteria:

* Incapability to provide consent
* Patients not eligible for TEVAR
* Pregnancy
Psychatric Effect of Ectopic Pregnancy

Assessment of anxiety,depressive symptoms and post traumatic stress after ectopic pregnancy Determine factors associated with development of anxiety,depressive symptoms and post-traumatic stress after ectopic pregnancy

Ectopic pregnancy is any pregnancy in which the fertilized ovum implants outside the intrauterine cavity. More than 95 percent of ectopic pregnancies occur in the fallopian tubes.

Another 2.5 percent occur in the cornua of the uterus, and the remainder are found in the ovary, cervix or abdominal cavity.

Ectopic pregnancy causes major maternal morbidity and mortality, with pregnancy loss, and its incidence is increasing worldwide.

Previous ectopic pregnancy becomes a more significant risk factor with each successive occurrence. With one previous ectopic pregnancy treated by linear salpingostomy, the recurrence rate ranges from 15 to 20 percent, depending on the integrity of the contralateral tube.

The unanticipated and sudden loss of a pregnancy can be a devastating and traumatic experience resulting in high levels of psychological morbidity for some women.

EPLs can significantly contribute to the overall burden of psychopathology within a population. Recognition of this impact is important, so that severely affected individuals may be screened and treated appropriately. Further research to establish risk factors to promptly identify and treat these patients, and to optimize their management, is crucial"

Eligibility Criteria:
Inclusion Criteria:

* All pregnant woman 18:45 years old presented with ectopic pregnancy.

Exclusion Criteria:

* intrauterine pregnancy
* previous diagnosis of psychiatric disorders
* Unwell to give consent
A Study Evaluating Venetoclax Alone and in Combination With Azacitidine in Participants With Relapsed/Refractory Myelodysplastic Syndromes (MDS)

This is a Phase 1b, open-label, multicenter study designed to evaluate the safety and pharmacokinetics of venetoclax as a single-agent and in combination with azacitidine in participants with relapsed/refractory Myelodysplastic Syndromes (MDS).


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have relapsed or refractory MDS.
* Subject enrolled in venetoclax monotherapy must have documented failure of prior therapy with a hypomethylating agent (HMA). HMA-failure is defined as:

  1. Relapse after initial complete or partial response or hematological improvement after at least 4 cycles of azacitidine or at least 4 cycles of decitabine within the last 5 years, OR
  2. Failure to achieve complete or partial response or hematological improvement after at least 4 cycles of azacitidine or at least 4 cycles of decitabine within the last 5 years
* Subjects must have presence of \< 20% bone marrow blasts per bone marrow biopsy/aspirate at screening.
* Subject is not a candidate to undergo allogenic hematopoietic stem cell transplantation (HSCT).
* Subject must have an Eastern Cooperative Oncology Group (ECOG) performance score of ≤2.
* Subject must have adequate hematologic, renal, and hepatic function.

Exclusion Criteria:

* Subject has received prior therapy with a BH3 mimetic.
* Subject has MDS evolving from a pre-existing myeloproliferative neoplasm (MPN).
* Subject has MDS/MPN including chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (CML), juvenile myelomonocytic leukemia (JMML) and unclassifiable MDS/MPN.
* Subject has received allogeneic HSCT or solid organ transplantation.
* Subject has received a live attenuated vaccine within 4 weeks prior to the first dose of study drug.
* Subject is pregnant or breastfeeding.
Body Water Content Sensor

Evaluation of hydration status during exercise and heat exposure.

Evaluation of hydration status during exercise and heat exposure.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-35
* Participates in regular exercise
* Able to tolerate exercise in the heat

Exclusion Criteria:

* Abnormal hemoglobin
* Any exercise limitations
* Pregnancy
* Cardiovascular or orthopedic disease/conditions
Comparison of Cervical Region Characteristics of People With Smartphone Addiction

In healthy participantsng adults, the anterior tilt position of the head and consequently flattening of the cervical lordosis may results in impaired neutral posture of the spine during daily long-term computer etc. use with today's technology. In addition, the increasing use of smart phones may also promote this negative results. According to a study, the estimated total smartphone sales for 2012 was 660 million, but as of 2015, it is estimated that a total of one billion units worldwide. It is also thought that phone sales will continue to increase over the years, as it facilitates daily life activities.

As a result of our literature review, the investigators have not come across a study that evaluates demographic information such as the duration of using smartphones or computers, cervical position sense, neck muscle strength, physical activity and general psychological status, which the investigators think may affect the performance of deep cervical flexor muscles in healthy participantsng adults. With this study, it will be ensured that more information about the factors affecting the performance of deep cervical flexor muscles will be determined in advance and necessary steps will be taken to prevent the factors that may cause neck problems in the future.


Eligibility Criteria:
Inclusion Criteria:

* Being in the age range of 18-30,
* Not having mental - cognitive problems,
* Being a volunteer participant.

Exclusion Criteria:

* Having any surgery on the vertebral column,
* Having an inflammatory disease,
* Having a rheumatological disease,
* Having a history of malignancy,
* Having congenital spinal cord anomalies, congenital and / or subsequent spinal deformities,
* Having radiculopathy, myelopathy and / or other neurological disorders, vestibular disorders,
* Having a history of acute trauma.
Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

The primary objective of the study is to determine whether armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood stabilizers for treatment of adults with major depression associated with bipolar I disorder.


Eligibility Criteria:
Inclusion Criteria:

* The patient has a diagnosis of bipolar I disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (Text Revision) (DSM-IV-TR) criteria and is currently experiencing a major depressive episode.
* Documentation that the patient has had at least 1 previous manic or mixed episode.
* The patient has had no more than 6 mood episodes in the last year.
* The patient's current major depressive episode must have started no less than 2 weeks and no more than 12 months prior to the screening visit. The current depressive episode must have begun after the patient's current mood stabilizer regime began.
* The patient must have been taking 1 (or 2) of the following protocol-allowed mood stabilizers: lithium, valproic acid, lamotrigine, aripiprazole, olanzapine, quetiapine, risperidone, ziprasidone (only if taken in combination with lithium, valproic acid, or lamotrigine). The following criteria must also be met:

  1. The mood stabilizer(s) must have been taken a minimum 4 weeks before the onset of the major depressive episode and still be taken at the time of the screening visit at dose or blood level considered appropriate for maintenance therapy by the patient's physician.
  2. The patient must continue to take the same mood stabilizer(s) during the screening period; no mood stabilizer may be added during the screening period.
  3. The mood stabilizer(s) must be taken for a minimum of at least 8 weeks prior to the baseline visit.
  4. The dosage of the mood stabilizer(s) must be stable for a minimum of 4 weeks prior to the baseline visit.
  5. The mood stabilizer(s) must be taken in an oral formulation, with the exception of risperidone, which can be either in an oral or long-acting injection formulation.
  6. The patient may be taking 2 protocol-allowed mood stabilizers only if 1 of the drugs is lithium, valproic acid, or lamotrigine.

Exclusion Criteria:

* The patient has any Axis I disorder apart from bipolar I disorder that was the primary focus of treatment within 6 months of the screening visit or during the screening period.
* The patient has psychotic symptoms or has had psychosis within 4 weeks of the screening visit or during the screening period.
* The patient has current active suicidal ideation, is at imminent risk of self-harm, or has a history of significant suicidal ideation or suicide attempt at any time in the past that causes concern at present.
* The patient has a history of an eating disorder or obsessive compulsive disorder (OCD) within 6 months of the screening visit or during the screening period.