cyrilzakka/clinical-trials huggingface dataset:
Clinical Study on Efficacy and Safety of Hetrombopag in the Preoperative Patients of Thrombocytopenia

This is an investigator-initiated, single-arm, prospective clinical study to evaluate the efficacy and safety of heptapopal in the treatment of thrombocytopenia prior to elective surgery

It was planned to include 55 patients with immune thrombocytopenia with preoperative platelet ≤75×10\^9/L. After signing the informed consent letter, the patients will enter the screening period (up to 7 days), and after passing the screening, they will receive oral hexapopal treatment, the specific medication regimen is: 7.5mg, once a day, taken orally on an empty stomach before going to bed, for a maximum of 14 days, and stop the drug when PLT≥100×10\^9/L. During the oral administration of hexapopal, the administration was suspended when PLT≥200×10\^9/L, and continued when the blood image was monitored weekly until PLT \< 100×10\^9/L. During the treatment period, blood routine was monitored every 7 days, and when PLT≤30×10\^9/L or ≥300×10\^9/L, blood routine was monitored every 3 days. Patients will have an end-of-treatment visit within 7 days of stopping treatment, followed by a 30-day safe follow-up period.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old; diagnosis of immune thrombocytopenia.
2. Platelets ≤75×10\^9/L before scheduled elective surgery.

Exclusion Criteria:

1. History of allergy to Thrombopoietin Receptor Agonists (TPO-RA) drugs;
2. Severe bleeding symptoms, such as gastrointestinal bleeding, bleeding of important organs, and intracranial bleeding;
3. Thrombotic diseases, such as pulmonary embolism, arterial thrombosis and disseminated intravascular coagulation (DIC);
4. Positive anti-human immunodeficiency virus antibody or anti-treponema pallidum specific antibody;
5. New York Heart Association (NYHA) Grade 3 or 4 congestive heart failure;
6. History of angina pectoris, myocardial infarction or cerebral infarction within 6 months before the screening period;
7. Have an active infection that is difficult to control;
8. Pregnant or lactating women;
9. Other conditions determined by the investigator to be unsuitable for inclusion in the study
Reducing Maternal Stress to Improve Obesity-related Parenting Practices

Maternal stress is associated with children's risk for obesity controlling for socioeconomic status. The association between maternal stress and child obesity is particularly strong in Latinx families, whose children also have the highest rates of obesity in the United States. A mindful parenting program might reduce Latina mothers' psychological stress and lead to improved parenting practices and ability to create a healthier environment. The primary objective of the proposed research is to evaluate the feasibility and acceptability of a culturally-relevant intervention that integrates mindfulness-based stress reduction and mindful parenting in Latina mothers. The investigators will conduct a randomized clinical trial comparing the Calma, Conversa, y Cría (CCC) intervention to an active control condition in 50 Latina mothers of elementary-school age children. Participant satisfaction rates and qualitative interviews will provide evidence of the program's acceptability. Feasibility will be determined by examining recruitment rates, retention rates, and treatment fidelity. Completion of this project will inform the development of a full-scale efficacy trial.


Eligibility Criteria:
Inclusion Criteria:

* over the age of 18 years
* identify as female
* identify as Hispanic or Latina
* have a child between the ages of 3 and 11 years who primarily resides with them
* able to understand basic instructions in either Spanish or English

Exclusion Criteria:

* pregnant or planning on becoming pregnant in the near future
* actively dependent on a substance
* have untreated psychosis, PTSD, or social anxiety that would impair their ability to function in a group setting
* child has an obesity-associated genetic syndrome
* child has a pervasive developmental disorder
Effect of Standardization of Urine Collection Using PEEZY Device as Compared to Clean Peezy for DAB

This study aims specifically to compare the rates of contaminants between standard clean-catch urine collection and urine collected using the PEEZY device. In particular, this study will compare the rates of contamination as stratified by BMI status (i.e., BMI \< 30 and BMI ≥30). Based on previous studies through LUHS and the Wolfe lab, we anticipate a reduction in contamination from sample collected using the PEEZY device, particularly among those pregnant women with BMI ≥30. To investigate this hypothesis we have designed a prospective unblinded randomized controlled trial comparing voided urine specimens obtained for asymptomatic bacteriuria in pregnant women presenting for obstetric care with use of standard clean-catch (CC) sampling method versus specimen obtained using PEEZY collection device.

Recruitment procedures

1. All patients scheduled for "NOB" (new obstetrics) appointments at LOC will be screened for eligibility by residents and fellows
2. Residents and fellows will recruit participants at LOC and obtain informed consent.
3. There will not be any advertising for this study and no recruitment materials will be given to eligible participants.

   Study procedures
4. Residents and fellows will use a REDCaps database to assign randomization, generate de-identified study labels, and provide study participants with assigned urine collection device as well as instructions on use.
5. Participants will use a private bathroom to void and collect their urine specimen using either the PEEZY device or standard clean catch method as assigned.
6. Urine specimens will be handed to LOC nursing staff who will separate into 3 aliquots - 1 for clinical lab and 2 for Wolfe lab.
7. Wolfe lab aliquots will be labeled with the subject's study ID and placed at 4°C for \<4 hours before transport to Dr. Wolfe's laboratory for inventory, storage and analysis
8. Clinical lab specimen will be labeled with patient label and transported to clinical lab for standard urine culture per routine obstetric care.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant \< 20 weeks gestational age
* Age \> 18 years old
* English speaking

Exclusion Criteria:

* History of recurrent UTIs
* Need for ongoing antibiotics
* Urinary tract anomalies
Utility of Indwelling Catheter in Orthopaedic Patients Receiving Spinal Anesthesia

A study measuring utility of indwelling bladder catheter placement in orthopaedic surgical patients receiving spinal anesthesia. Study will track clinical outcomes, patient satisfaction and cost efficacy. Absence of indwelling bladder catheter may decrease urinary tract infection (UTI) incidence, increase patient satisfaction, and decrease cost burden without increasing postoperative urinary retention (POUR) incidence.


Eligibility Criteria:
Inclusion Criteria:

Elective orthopaedic surgical patients of all ages undergoing lower extremity adult reconstructive surgery with spinal anesthesia will be interviewed.

Exclusion Criteria:

Patients are excluded from the study preoperatively with a history of prostate or urological surgery, renal failure, previous documented POUR, current indwelling catheter, or acute UTI.
Bladder Catheterization After Mini-PCNL

60 patients

Inclusion Criteria:

* age from 18 to 70 years
* Indications for mini-PCNL
* ASA score: 1-3
* Single percutaneous access to pyelocaliceal system
* Size of solitary calculus up to 2.5 cm

Exclusion Criteria:

* Active urinary tract infection
* Coagulopathy
* Clinically significant infravesical obstruction (Qmax less than 10 ml / s, PVR more than 50 ml)

60 patients after PCNL will be recruited and randomized into 2 groups (30 vs 30):

* No Catheterization after mini-PCNL (study) - the bladder catheterization is not performed.
* Catheterization after mini-PCNL (control) - the bladder will be drained with the urethral catheter.

All patients will fill out the VASP in 2, 6, 12, 24 hours after mini-PCNL. Ultrasound examination of urinary bladder will be performed after mini-PCNL. All the AE will be registered.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 70 years
* Indications for mini-PCNL
* ASA score: 1-3
* Single percutaneous access to pyelocaliceal system
* Size of solitary stone up to 2.5 cm

Exclusion Criteria:

* Active urinary tract infection
* Coagulopathy
* Clinically significant infravesical obstruction (Qmax less than 10 ml / s, PVR more than 50 ml)
Evaluation of Advanced Glycation End-products (AGE) and the Erectile Dysfunction (DE) in Diabetic Patients

In diabetics there is an abnormally increased production of AGEs due to hyperglycemia. An association was shown between AGE measured by biopsy (invasive) and DE patients with diabetes (increase of AGE level in the corpora cavernosa). To date no studies have explored the link between DE and the measure of AGE by a non-invasive method of Auto-fluorescence (AF) Skin (AGEReaderTM).

If the hypothesis of an association between DE and AGE measured by AF was checked, screening for erectile dysfunction and measurement of AGEs could help to improve the overall management of diabetic patient (including cardiovascular) and their quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes Type 2

Exclusion Criteria:

* skin hyperpigmentation
BLI4700-202: A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects

The objective of this study is to evaluate the safety and efficacy of BLI4700 as a bowel preparation prior to colonoscopy in adult patients.


Eligibility Criteria:
Primary Inclusion Criteria:

1. Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication.
2. At least 18 years of age
3. If female, and of child-bearing potential, is using an acceptable form of birth control.
4. Negative urine pregnancy test at screening, if applicable
5. In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Primary Exclusion Criteria:

1. Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.
2. Subjects who had previous significant gastrointestinal surgeries.
3. Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.
4. Subjects with a prior history of renal, liver or cardiac insufficiency
5. Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
6. Subjects undergoing colonoscopy for foreign body removal and/or decompression.
7. Subjects who are pregnant or lactating, or intending to become pregnant during the study.
8. Subjects of childbearing potential who refuse a pregnancy test.
9. Subjects allergic to any preparation components.
10. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
11. Subjects who have participated in an investigational surgical, drug, or device study within the past 30 days.
Expression of HOXA10 and HOXA11 in the Endometrium of Infertility Patients With an Endometrial Polyp Before and After Polypectomy

The aim of this study is to measure the expression of HOXA10 and HOXA11 in the endometrium of infertility patients with an endometrial polyp before and after polypectomy. HOXA10 and HOXA11 are well-established markers of implantation. It is uncertain as to whether an endometrial polyp interferes with embryo implantation. A higher expression of HOXA10 and HOXA11 after polypectomy can indicate that endometrial polyp does interfere with embryo implantation.


Eligibility Criteria:
Inclusion Criteria:

* Infertile women with endometrial polyp

Exclusion Criteria:

* Endometriosis
* Polycystic ovary syndrome
* Hydrosalpinx
* Sub-mucus myoma
* Women who have taken hormonal therapy in the preceding month
Serum Concentrations of Antidepressant Drugs in Pregnant Women - a Naturalistic Study

The study was a prospective naturalistic PK study of five frequently used antidepressant drugs in pregnant women; citalopram (CIT), escitalopram (ECIT), sertraline (SERT), mirtazapine (MIRT) and venlafaxine VEN) and their major metabolites (Table 1). After signing informed consent pregnant women with ongoing antidepressant treatment, regardless of indication, were recruited at nine antenatal care centers in mid- and small cities and villages in the Southeast Sweden between April 2011 and September 2013.

Serum samples for the antidepressant drug and metabolite(s) concentrations, albumin and creatinine were collected at the first prenatal appointment and at gestational week 15, 20, 25, 35 and at partus. The time interval between drug intake and sampling was registered in all cases. At partus, a serum samples from the umbilical cord was collected drug concentration was assessed. At the first prenatal appointment a blood sample for analyzing the CYP2D6 and CYP2C19 genotype was also collected. All drug concentration analysis were executed post hoc, after last partus, whereas physiological parameters were part of normal routine sampling. Concomitant medication, weight changes and smoking habits were registered throughout the pregnancies.

Our main findings were that dose corrected serum concentrations of neither sertralin nor citalopram changed during the pregnancy. In addition, concentrations of escitalopram and venlafaxine and their metabolites appeared to be stable throughout pregnancy, even though a linear mixed models statistic calculation could not be done due small number of samples.

Results from previous research on sertraline PK during pregnancy are inconclusive. Two studies suggested decreased levels (Freeman, Sit 2), while one study indicated increased levels (Westin). Previous studies, except for Westin's are, however, limited by small sample sizes (six and eight) and a substantial inter-individual variance.

Eligibility Criteria:
Inclusion Criteria:

* Pregnancy
* Ongoing treatment with one of the five studied antidepressants.

Exclusion Criteria:

• None
Parkinson Atypical Rating of Oculometric Patterns Evaluated Routinely

This is an observational longitudinal study in 4 cohorts of patients with Parkinsonian syndromes, who are visiting the Movement Disorders outpatient clinics.

The aim of the study is to assess the difference of oculometric measures in different neurodegenerative brain conditions and their accuracy over time, and as compared to clinical diagnosis, in order to find a change over time, difference between subgroups and correlations with accepted clinical endpoints in subjects who meet the inclusion criteria and who provide a signed Informed Consent.

As a part of the study, about 40 subjects will undergo a neurological evaluation including motor and cognitive assessments and a NeuraLight session including oculometric measurements and eye-tracking recordings using a novel software-based platform and an eye-tracking system (Tobii, CE-marked class B approved device). Test duration will be approx. 20 minutes. The oculometric evaluation will occur for at least 50% of the cohort 3 times (at baseline, at 6-months and at 12-month follow-up), and all subjects will be recruited over a period of 9 months. All assessments will be performed during a clinic visit unless authorized to be conducted remotely.

Eligibility Criteria:
Inclusion Criteria:

* Men and women, age between 40 and 80 years
* \<5 years since disease diagnosis
* Normal or corrected vision
* MOCA score ≥ 20
* Ability to follow instructions
* Willing and able to sign an informed consent form Specific
* PD cohort: Ages 50-80, Hoehn \& Yahr scale 1-3
* PSP cohort: diagnosed according to actual diagnostic criteria from Höglinger GU et al, 2017.
* MSA cohort: diagnosed according to actual diagnostic criteria from Wenning et al, 2022.

Exclusion Criteria:

-
Esophageal Sparing Intensity-modulated Radiation Therapy (IMRT) for Locally-Advanced Thoracic Malignancies

Hypothesis 1- Using IMRT, the radiation therapy (RT) dose can be safely escalated from 58 Gy to 74 Gy given as 6 fractions/week with concurrent chemotherapy.

Hypothesis 2- Esophageal motion can be used to customize planning organ at risk volumes.

Hypothesis 3- Biological predictors of acute esophagitis can be used to identify patients at high risk of developing esophageal toxicity from radiation therapy and chemotherapy.

Prospective phase I study designed to determine the maximum tolerated dose of radiation therapy given in an accelerated fashion (2 Gy/fraction, 6 fractions/week) with concurrent chemotherapy. Intensity-modulated radiation therapy (IMRT) will be utilized to spare the esophagus. All patients on the dose escalation study will participate in additional assessments evaluating esophageal motion and esophageal toxicity from radiation therapy.

Eligibility Criteria:
Inclusion Criteria:

* Histologic documentation of one of the following thoracic malignancies:

  * Non-small cell lung cancer (stage III or X (recurrent) with disease confined to local/regional sites)
  * Small cell lung cancer (stage II-III)
  * Thymoma (unresectable)
  * Thymic carcinoma (unresectable)
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Weight loss \< 10% in preceding 3 months prior to diagnosis
* ANC \> or = 1500 and platelet count \> or = 100,000.
* Creatinine clearance greater than 50 ml/min
* 18 years of age or older.
* Negative pregnancy test in women of child-bearing potential

Exclusion Criteria:

* Prior thoracic irradiation
* Medical contraindications to thoracic irradiation
Evaluation of White Sweet Potato Tube Feeding Formula on Type 2 Diabetic Residents in Long-term Care Institutions

In order to response the increasing of aging population cause losing ability that need long-care needs, the project entitled "10-year long-term care program" from Executive Yuan in 2007 is carried out to assist economically disadvantaged and disabled elderly to acquire daily nutrition. Therefore, the long-term care resident's nutritional status got more attention than before. Out of control in blood glucose will not only increase bed sores and urinary tract infection in tube feeding residents but also rise medical expenditures. The nutritional status of long-term care institutions, anyang homes and nursing home are generally bad in nutrition management due to high cost of nutritional supplements from foreign imports that cause the burden of families. In this study, we will recruit diabetic subjects that divide into white sweet potato group (experimental group) and commercial formula group (control group) by using randomized, parallel and open clinical study through tube feeding in sixty days.

All subjects will be evaluated the blood sugar and clinical nutrition assessment such as postural measurement, urine test and blood biomarker examination.

Eligibility Criteria:
Inclusion Criteria:

* Long-term stability nasogastric or gastrostomy-fed person.
* The physician diagnosed as diabetic and regular use of hypoglycemic drugs.

Exclusion Criteria:

* Psychosis or depression.
* Hba1c\> 8.5%.
* High taking nutritional supplements or steroids drugs.
* Have undergone abdominal surgery caused by intestinal sticky.
* Suffering from cancer, ulcers, respiratory infections and other diseases.
* Currently receiving central venous nutrition therapy or intravenous nutrition therapy.
* Liver dysfunction (ALT ≧ 100 U / L), renal insufficiency (creatinine ≧ 3mg / dl), heart failure (NYFc II above), moderate anemia (hemoglobin \<9 g / dl).
Cholecalciferol to Improve the Outcomes of COVID-19 Patients

The recent inception of the coronavirus SARS-CoV-2, responsible for the coronavirus disease (COVID-19), has caused thousands of deaths globally. The most frequently reported complications among COVID-19 patients are from respiratory involvement.

Vitamin D has immunomodulatory effects that could protect against COVID-19 infection. Indeed, there is good evidence from randomized clinical trials suggesting that high doses of vitamin D administered during cold seasons prevent viral respiratory infections in at risk individual, and more recently, observational studies suggested that the mortality rate from COVID-19 is inversely correlated with levels of serum 25(OH)vitamin D.

The hypothesis of the study is that a high dose of vitamin D given orally to patients admitted to the hospital for COVID-19 will prevent the occurrence of respiratory deragement and other adverse clinical events.

To evaluate the aforementioned hypothesis, a randomized, controlled, double-blind, clinical trial comparing a 500.000 UI dose of vitamin D versus placebo among COVID-19 patients at moderate risk, requiring hospitalization but without requirements of critical care at admission was designed. The intervention will be one dose of 500.000 UI given orally or matching placebo.

The trial has a sequential design with two steps:

* The first step, projected to include 200 patients, will assess the effects of the intervention on the respiratory SOFA; and
* If there is a detectable effects, the second step, projected to include 1264 patients, will assess the effects on a combined event that includes need of high dose of oxygen or mechanical ventilation.

All study outcomes will be measured during the index hospitalization.

See above.

Eligibility Criteria:
Inclusion Criteria:

* SARS-CoV-2 confirmed infection;
* Admission to a hospital;
* Expected hospitalization in the center for at least for 24 hs;
* Oxygen Saturation \>90% breathing without oxygen supplement;
* Age at least 45 years or the presence of one of the followings risk factors:
* Hypertension;
* Diabetes (type I o II);
* At least moderate COPD or Asthma;
* Cardiovascular disease (history of myocardial infarction, coronary angioplasty, coronary artery bypass grafting or valve replacement surgery);
* Body Mass Index \>=30;
* Signed Written consent.

Exclusion Criteria:

* \<18 years old;
* Women in childbearing age;
* \>= 72 hs since current admission;
* Requirement for high dose of oxygen (\>5 liters/minute) or mechanical ventilation (non-invasive or invasive);
* History of Chronic kidney disease requiring hemodialysis or chronic liver failure;
* Inability for oral intake;
* Previous treatment with pharmacological vitamin D;
* History of:
* previous treatment with anticonvulsants;
* sarcoidosis;
* malabsorption syndrome;
* Known hypercalcemia.
* Life expectancy less than 6 months;
* Known allergy to the study medication;
* Any condition impeding to bring informed consent.
Non Cardiac Chest Pain and Benign Palpitations

All Patients between 18 and 65 years are asked 6 month after investigation for chest pain or palpitation at Cardiological Out-patient Clinic, Molde Hospital, about if they still have symptoms of chest pain or palpitation. If they still have some of the symptoms they are invited to participate in a coping course to learn a better way to deal with their symptoms.

The coping course consist of three sessions of cognitive behaviour therapy.


Eligibility Criteria:
Inclusion Criteria:

* investigated for chest pain or palpitation 6 month ago at Cardiological Out-patient Clinic, Molde Hospital
* suffer of chest pain or palpitations

Exclusion Criteria:

* do not speak norwegian properly
* mentally retarded
* psychosis last 6 month
* current alcohol or drug misuse