cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Preoperative Risk Factors in Children

1. The investigators aimed to make a more advanced risk assessment in predicting preoperative intensive care unit admission in pediatric patients.
2. The investigators aimed to better define the pediatric patient population and identify preoperative risk factors in detail in order to reduce perioperative complications.

The aim of this study was to evaluate preoperative risk factors and determine their efficacy in predicting ICU admission after emergency or elective surgery in pediatric patients of all age groups. To achieve this aim, data such as gender, age, height, weight, history of prematurity, post-conceptional week, ASA PS score, accompanying systemic diseases, history of previous anesthesia, history of emergency or elective surgery, tumor surgery, chemotherapy and radiotherapy, surgical risk classification, difficult airway will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Children under the age of 18 who will have an operation in the pediatric surgery operating room.

Exclusion Criteria:

* Children who are scheduled for surgery in pediatric surgery room but are hospitalized in the intensive care unit.(Children admitted directly from the intensive care units to the operating rooms)
Gender, Pain, and Placebo Analgesia

The response to standard pain stimuli in males and females is investigated, together with the effect of informing participants about the effect of a painkiller. Physiological response to pain is recorded.

The social context in which pain is reported has been found to modulate pain. Specifically, male participants reporting pain to female observers report significantly lower pain levels compared to male participants reporting to male observers. Female participants seem less affected by social context. This is a methodological problem in the study of pain and has consequences in the development of new drugs, and for pain research in general.

The present study has two aims: To investigate whether social context affects also the placebo response to pain, i.e. the reduced pain often observed after administration of a an inert substance the participants believes to be a painkiller. It is hypothesized that placebo analgesia will be larger in males reporting pain to females. Secondly, heart rate variability and skin conductance, measures of parasympathetic and sympathetic activity, will be recorded, to investigate if social context affects not only pain report, but also pain response.

Eligibility Criteria:
Inclusion Criteria:

* 18-40 years, healthy

Exclusion Criteria:

* pregnant, earlier serious disease or injury,
The Influence of The Ear Popper on Serous Otitis Media and on the Accompanying Conductive Hearing Loss in Children

This study is designed to check the effect of the use of the ear popper device on serous otitis media in children and on the conductive hearing loss accompanying the otitis. It is intended that 30 children aged 3-18 years will participate in the study. The inclusion criteria are : clinical serous otitis media for a duration of more then 3 months, a conductive hearing loss of at least 15 decibels air bone gap and tympanometry type B or C. The children will use the ear popper for 7 weeks. They will undergo otologic examination, audiometry and tympanometry at the beginning ao the trial, at 7 weeks and at 3 months from the beginning of the trial. The otologic findings and the audiometry and tympanometry results before and after the trial will be compared. We will try to determine whether the use of the ear popper in the test group will improve the conductive hearing loss and prevent the need for tympanostomy tube insertion.


Eligibility Criteria:
Inclusion Criteria:

* Serous Otitis Media for More Then 3 months
* Conductive Hearing Loss of More Then 15 decibels.
* Tympanometry type B or C.

Exclusion Criteria:

* No History of Tympanostomy Tube Insertion or Adenoidectomy
* No Cranio or Facial Malformations
* No Acute Upper Respiratory Tract Infection or Acute Otitis Media
Interferon-α for TP53 Myeloid Malignancy Post Allo-HSCT

To investigate the efficacy of interferon-α prophylaxis in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) with TP53 mutation who were negative for minimal residual disease (MRD) by flow cytometry within 2 months after allogeneic hematopoietic stem cell transplantation. To explore the efficacy of interferon-α in reducing the relapse rate of AML/MDS patients with TP53 mutation after allogeneic hematopoietic stem cell transplantation (allo-HSCT).


Eligibility Criteria:
Inclusion Criteria:

1. Myelodysplastic syndrome (MDS) diagnosed according to the 2022 International Consensus Classification of Myeloid Neoplasms and Acute Leukemia (2022ICC) criteria, acute myeloid leukemia (AML) with TP53 mutation (unrestricted remission status), minimal residual disease (MRD) monitored by flow cytometry within 2 months after receiving the first allogeneic hematopoietic stem cell transplantation Negative patients
2. Male or female, aged 12-65 years
3. Karnofsky score \>60, estimated survival time \>3 months
4. No history of severe graft-versus-host disease (GVHD), uncontrolled GVHD, or severe systemic organ dysfunction:

   1. Absolute neutrophil count (ANC) greater than 0.5×109/L
   2. Creatinine \< 1.5mg/dL
   3. Cardiac ejection index \>55%
5. Signed informed consent.

Exclusion Criteria:

1. severe cardiac, renal, or liver dysfunction
2. combined with other malignant tumors requiring treatment
3. inability to understand or adhere to the study protocol due to clinical symptoms of brain dysfunction or severe mental illness
4. patients who are unable to complete the necessary treatment plan and follow-up observation
5. patients with severe acute anaphylaxis
6. clinically uncontrolled severe life-threatening infections
7. patients enrolled in other clinical trials
8. other reasons considered by the investigator to be inappropriate for clinical trial participants.
COVID-19: A POC Test Under Research & Evaluation

Collection of nasal/nasopharyngeal/throat swabs and blood samples from patients presenting at their designated care facility displaying symptoms of COVID-19 and undergoing a SOC SARS-CoV-2 test or those who have tested positive in the past to aid development, calibration and performance evaluation for the LumiraDx POC test.

CAPTURE is a two-stage sample collection study to complete the development, calibration and performance evaluation phases of the LumiraDx Point of Care (POC) device for the detection of the SARS-CoV-2 virus and the SARS-CoV-2 IgG/IgM status of infected patients. The study is split into two arms targeting separate populations throughout each stage.

Stage 1: Consists of sample collection only, to facilitate the in-house development and calibration of the LumiraDx SARS-CoV-2 assays.

Stage 2: Consists of sample collection to facilitate the performance evaluation of the LumiraDx SARS-CoV-2 studies. In this stage the testing will be completed onsite using the LumiraDx POC device.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is at least 18 years of age.
2. Patient meets either of the below categories:

   1. Patient is presenting with symptoms indicative of COVID-19 and will be completing SOC sampling for SARS-CoV-2 PCR testing. (Eligible for Arm A)
   2. Patient has had a confirmed positive SARS-CoV-2 PCR test result in the past. (Eligible for Arm B)

Exclusion Criteria:

1. The patient does not have the capacity to consent as determined by the Research Team (and the impartial witness if applicable).
2. The patient is deemed to be unsuitable for research at the research teams' discretion.
A Study of Renal Microvessel Imaging for Chronic Kidney Disease

The purpose of this research is to study the efficacy of ultrasound microvessel imaging for evaluation of Chronic Kidney Disease. Definity is an ultrasound contrast agent currently approved by the FDA for use on the heart, liver, and urinary tract. This study will look at its effectiveness on the kidney.


Eligibility Criteria:
Inclusion Criteria:

- Healthy volunteers or Chronic Kidney Disease (CKD) patients with clinically indicated renal biopsy.

Exclusion Criteria:

* Subjects lacking capacity to consent.
* Vulnerable subjects such as prisoners; pregnant women; nursing mother.
* Subjects with history of hypersensitivity allergic reactions to ultrasound contrast agents.
* Patients with high-risk cardiac diseases.
Low-dose Nifedipine-Valsartan Combination Compared to Up-titrated Valsartan Monotherapy in Essential Hypertension

This will be a multi-center, prospective, randomized, open-label, parallel design, two arm comparator trial. In the proposed study, the investigators will compare low-dose combination therapy of Nifedipine GITS/OROS plus Valsartan with up-titrated monotherapy of Valsartan with respect to their blood pressure-decreasing effects in patients with essential hypertension.The study consists of a screening visit, followed by randomization and administration of either Nifedipine GITS/OROS 30 mg in combination with Valsartan 80 mg or Valsartan 160 mg for 12 weeks of treatment.The primary efficacy parameters will be mean SBP and DBP on office BP monitoring at 12 weeks of treatment compared to baseline.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 - 75 years
* Essential hypertension not well controlled by current low dose (80 mg) valsartan monotherapy for at least 4 weeks. Patients on prior treatment with monotherapy diuretic, ACE-I or beta blocker or an ARB other than valsartan and switched to the current low dose valsartan 80 mg monotherapy for at least 4 weeks are also eligible, provided the hypertension is still not well controlled.
* Office systolic blood pressure (sitting) \>140 mmHg (sitting for \>/= 5 min., no cigarettes and/or coffee/tea for \>/=30 min. before BP measurement).
* BMI \<33 kg/m2

Exclusion Criteria:

* Participation in any clinical investigational drug study within the previous 12 weeks
* Concomitant treatments with:

  1. Any anti-hypertensive treatment other than Valsartan 80 mg
  2. Cytochrome P450-3A4 inhibitors or inducers
  3. Potassium-sparing diuretics
* Severe hypertension (DBP \>/= 110 mm Hg and/or SBP \>/= 180 mm Hg) and/or evidence of secondary forms of hypertension
* Any of the following cardiovascular diseases:
* History of cardiovascular shock
* Myocardial infarction or unstable angina within the previous 6 months
* Severe cardiac valve disease
* Past or present severe rhythm or conduction disorder.
* Cerebrovascular ischemic event and/or history of intracerebral hemorrhage or subarachnoid hemorrhage (SAH) within the previous 12 months
* Type 1 or 2 diabetes mellitus
* Proteinuria
* Uncorrected hypokalemia or hyperkalemia, sodium depletion and/or hypovolemia
* Gastrointestinal disease resulting in the potential for malabsorption and/or severe gastro-intestinal tract narrowing; kock pouch (ileostomy after proctocolectomy)
* Cholestasis or biliary obstruction
* Liver disease or aspartate aminotransferase (AST) / alanine aminotransferase (ALT) levels \>3 x upper limits of normal (ULN)
* Renal failure, creatinine level \>2.0 mg/dl
Validity and Reliability of the Turkish Version of the Comprehensive Coordination Scale in Parkinson's Patients

The aim of this study is to investigate the Turkish adaptation of the Comprehensive Coordination Scale and its validity and reliability in Parkinson's patients.

A Turkish version of the Comprehensive Coordination Scale will be made. Then, Comprehensive Coordination Scale, 9-Hole Peg Test, Timed Up and Go Test, Berg Balance Scale, Functional Reaching Test and Modified Hoehn and Yahr Scale will be applied to patients with Parkinson's, respectively. In order to determine the reliability of the scale, only the "Comprehensive Coordination Scale" will be video recorded during the first evaluation and inter-rater reliability will be performed by another physiotherapist. For test-retest reliability, patients will be evaluated seven days later by the first physiotherapist who made the evaluation by watching the video again.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Parkinson's,
* Mini mental test score over 24,
* Those who have not experienced any serious neurological or orthopedic problems in the last 6 months,
* İndividuals who agreed to participate in the study

Exclusion Criteria:

* Mini mental test score \<24,
Paraneoplastic Neurologic Encephalitis and Mature Cystic Teratoma

Ovarian dermoid cyst, also known as benign mature teratoma, originate from germ cells in the ovary, and is the most common benign ovarian tumor (44-70%). Several reports documented a secretion of NMDA receptor antibodies from dermoid cyst. This receptor is found in different areas in the central nerves system (CNS) and the presence of plasma antibodies has been shown as a rare cause of neurologic presentation term paraneoplastic neurologic syndrome, which can be characterized by mood disorder, psychiatric and neurologic symptoms. In several case reports on young women, first presented with nonspecific neurologic symptoms, then followed by rapid deterioration of conscious, seizures and the need for ventilation support, ovarian teratoma was diagnosed. In 2007 an association between N-Methyl-D-Aspartic acid (NMDA) receptor antibody and encephalitis was first described. More than 50% of paraneoplastic encephalitis were related to teratomas, most often from an ovarian origin. Therapy includes tumor resection, steroids, plasmapheresis and immunosuppressive drugs. The investigators recently published a retrospective cohort study analyzing 233 patients who were operated in their institution with pathology proven dermoid. In this study 2 patients presented with paraneoplastic syndrome (0.85%). No prospective study has been published to date to examine the association between antibody titer and dermoid cyst characteristics and the paraneoplastic phenomenon. The investigators wish to conduct a prospective study in which plasma samples will be obtained from patients asymptomatic for neurologic or psychiatric symptoms, undergoing surgery for ovarian dermoid cyst, due to gynecology indication (e.g size, symptoms) in order to identify antibodies against CNS NMDA-R in their plasma prior to cyst removal. If NMDA receptor antibodies will be discovered in asymptomatic patients it may be prudent to examine all serums of women who are diagnosed with ovarian mature teratoma, and offer a surgical removal in order to prevent a possible neurologic sequela in the presence of these antibodies.

The data is collected by examining women's serum for the presence of NMDA-R antibodies, using special ELISA (enzyme-linked immunoabsorbent assay) kits. The analysis will be made by Dyn diagnostics labs. The investigators will obtain a blood sample prior to the operation for cystectomy or oophorectomy and after a written informed consent by the patient. All specimen are sent to pathology examination and only proven dermoid cyst will eventually be enrolled.

Eligibility Criteria:
Inclusion Criteria:

1. Women admitted for surgery for removal of suspected dermoid cysts
2. No neurologic symptoms

Exclusion Criteria:

1. No surgical specimen available
2. The cyst pathology does not show dermoid cyst characteristics
Efficacy Study of Ramosetron in the Setting of Hematopoietic Stem Cell Transplantation

1. The purpose of this study is to determine the efficacy of ramosetron for the prevention of emesis and the control of nausea and vomiting despite of the prophylactic antiemetic treatment during hematopoietic stem cell transplantation
2. The study hypothesis is that ramosetron is effective for the prevention of emesis and control of emesis and/or vomiting that develop after the prophylactic antiemetic therapy in the setting of hematopoietic stem cell transplantation


Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing hematopoietic stem cell transplantation conditioned with highly or moderately emetogenic drugs or total body irradiation (TBI) for hematologic malignancies
2. aged over 18 yrs
3. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
4. patients who are able to take oral medications
5. patients who get well-informed and sign the consent

Exclusion Criteria:

1. Patients complicating

   * severe hypertension (systolic blood pressure \> 210 mmHg or diastolic blood pressure \> 120 mmHg)
   * significant heart disease such as congestive heart failure
   * renal insufficiency (serum Cr \>= 3.0 mg/dL)
   * liver disease (Aspartate aminotransferase (AST), alanine aminotransferase (ALT) \> 3 upper normal limit; alkaline phosphatase (ALP) \> 2 upper normal limit)
2. Patients complicated by conditions such as gastrointestinal obstruction or active peptic ulcer causing emesis
3. Patients with brain tumor, brain metastasis and epilepsy
4. Patients with the history of extrapyramidal symptom
5. Patients with the history of allergy to serotonin antagonists
6. pregnant or lactating women
7. Patients with drug abuse or psychiatric illness, or patients who are not capable of the normal communications
Electrolyte State in Patients With COVID-19

Initial case reports and cohort studies have described many clinical characteristics of patients with coronavirus disease 2019 (COVID-19), an emerging infectious disorder caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). In early COVID-19 studies, some evidence has been provided that electrolyte disorders may also be present upon patients' presentation, including sodium, potassium, chloride and calcium abnormalities

the aim of the study is Identification of elements that affect COVID-19 pathology to improve survival and decrease mortality rate.

SARS-CoV-2 invades human cells through binding angiotensin I converting enzyme 2 (ACE2) on the cell membrane. ACE2 is widely distributed in many types of human tissues, especially in the vital organs, such as heart, liver, kidney, and lungs. ACE2 is viewed as the principal counter-regulatory mechanism for the main axis of renin-angiotensin system (RAS) that is an essential player in the control of blood pressure and electrolyte balance. The final effect is to increase reabsorption of sodium and water, and thereafter increase blood pressure and excretion of potassium (K+). Besides, patients with COVID-19 often had gastrointestinal symptoms such as diarrhea and vomiting

Early studies proved that high percentage of COVID-19 patient were presented with electrolyte disorders, including sodium, potassium, chloride and calcium abnormalities. Such electrolyte disturbances have important implications not only for patient management but also for identifying potential pathophysiologic mechanisms underlying COVID-19 that could drive novel therapeutic opportunities

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years old who were confirmed by the real-time PCR on the respiratory tract samples as positive of SARS-CoV-2.

Exclusion Criteria:

* Patients who had other causes of electrolyte disturbances (9):
* Chronic organ dysfunction (e.g., hepatic or renal dysfunction),
* Terminal cancer, immunodeficiency, and
* Patients with a history of long-term use of hormones \& Diuretics were excluded.
Prevention of Renal and Vascular Endstage Disease Intervention Trial

The Prevention of Renal and Vascular Endstage Disease Intervention Trial (PREVEND IT) was designed to determine whether intervention with the angiotensin-converting enzyme (ACE) inhibitor fosinopril and/or the hydroxymethylglutaryl coenzyme A reductase inhibitor pravastatin reduced cardiovascular and renal events in nonhypertensive, nonhypercholesterolemic subjects with microalbuminuria.

This study describes the rationale, design, and baseline characteristics of a trial to determine whether treatment with fosinopril 20 mg/day and/or pravastatin 40 mg/ day will prevent cardiovascular and renal disease in nonhypertensive (RR \<160/100 mm Hg and not using antihypertensive medication) and nonhypercholesterolemic (total cholesterol \<8.0 or \<5.0 mmol/L in case of previous myocardial infarction and not using lipid lowering medication) men and women with persistent microalbuminuria (urinary albumin excretion \>10 mg/L once in an early morning spot urine and 15 to 300 mg/24-hour at least once in two 24-hour urine collections). The Prevention of REnal and Vascular ENdstage Disease Intervention Trial is a single-center, double-blind, randomized, placebo-controlled trial with a 2 x 2 factorial design. The 864 randomized subjects will be monitored for a minimum of 4 years and a maximum of 5 years. The primary efficacy parameter is defined as the combined incidence of all-cause mortality or hospital admission for documented (1) nonfatal myocardial infarction, (2) myocardial ischemia, (3) heart failure, (4) peripheral vascular disease, (5) cerebrovascular accident and/or (6) end-stage renal disease.

Eligibility Criteria:
Inclusion Criteria:

* Persistent microalbuminuria (urinary albumin excretion \>10mg/L once in an early morning spot urine and 15 to 300 mg/24 hours at least once in two 24-hour urine samples)
* No hypertension (RR \<160/100 mm Hg, no anti-hypertensive medication)
* No hypercholesterolemia (total cholesterol \<8.0 or \<5.0 mmol/L in case of previous myocardial infarction and not using lipid-lowering medication)

Exclusion Criteria:

* Creatinine clearance \>60% of the normal age-adjusted value
* Serum potassium \>5.5 mmol/L
* History of chronic liver disease
* Lactate dehydrogenase, aspartate-amino transferase or alanine-amino transferase \>3 times the upper limit of normal
* Use of angiotensin-converting enzyme inhibitors or angiotensin II receptor antagonists
* Use of insulin
* Previously documented allergy or intolerance to study drugs
* Pregnant or nursing women