cyrilzakka/clinical-trials huggingface dataset:
A RCT Comparing Dronabinol to a Placebo for Post-operative Pain in Total Joint Arthroplasty

The primary purpose of this study was to determine if cannabinoid use decreases narcotic consumption in patients undergoing total knee arthroplasty (TKA).

Subjects enrolled will be randomized into one of two groups either receiving the study drug or a placebo and will be followed for the first 6 weeks with regards to outcomes data.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent from
* Stated willingness to comply with all study procedures and availability to attend all required visits for the duration of the study.
* Male or Female
* Age 21-75
* Unilateral total knee arthroplasty at Colorado Joint Replacement
* All individuals will be screened for drug use (including cannabis) at their preoperative appointment
* Ability to take oral medication and be willing to adhere to the dronabinol regimen
* For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation.
* For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.

Exclusion Criteria:

* Narcotic use in the past 6 weeks
* Regular cannabis use in the past 3 months
* Major depression or anxiety disorders
* Documented psychiatric illness (e.g. bipolar, schizophrenia)
* Seizure disorder
* Current or previous history of drug and alcohol abuse
* Known allergic reactions to components of dronabinol
* Tobacco use in the past 90 days
* Treatment with another investigational drug
* Patients that cannot receive spinal anesthesia
* Patients that cannot receive the standardized multimodal pain medications (i.e. Tylenol, gabapentin and meloxicam)
* Patients that are not able to go home after leaving the hospital and require a short term rehabilitation facility
A Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Olpasiran in Participants With Normal Renal Function and Participants With Various Degrees of Renal Impairment

The primary objective of this study is to evaluate the pharmacokinetics (PK) of a single dose of olpasiran in participants with normal renal function and participants with various degrees of renal impairment.


Eligibility Criteria:
Inclusion:

* Male participants or female participants of nonchildbearing potential between 18 and 75 years of age (inclusive) at the time of Screening.
* Body mass index between 18 and 40 kg/m\^2 (inclusive) at the time of Screening.
* Eligible participants classified based on established need for renal replacement therapy and eGFR at Screening. Assignment will be based on eGFR at Screening.

  1. Group 1 (Normal): eGFR ≥ 90 mL/min and no history of renal disease.
  2. Group 2 (Mild): 60 ≤ eGFR ≤ 89 mL/min.
  3. Group 3 (Moderate): 30 ≤ eGFR ≤ 59 mL/min.
  4. Group 4 (Severe): 15 ≤ eGFR ≤ 29 mL/min without dialysis.
  5. Group 5 (Kidney Failure): eGFR \< 15 mL/min and dialysis patients (off-dialysis).
  6. Group 6 (Kidney Failure): eGFR \< 15 mL/min and dialysis patients (on-dialysis).

Exclusion:

* Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase or alanine aminotransferase \> 2 times the upper limit of normal.
* Clinically significant hyperkalemia (defined by serum potassium concentration as \> 5.5 mEq/L for Groups 1 to 4, \> 6 mEq/L for Groups 5 and 6) at Screening or Check-in.
* History of hypersensitivity, intolerance, or allergy to any drug compound, or other substance, unless approved by the Investigator (or designee) and in consultation with the Sponsor.
* Female participants with a positive pregnancy test at Screening or Check-in.
* Participant has received a dose of an investigational drug within the past 30 days or 5 halflives, whichever is longer, prior to Check-in.

Participants in Group 1 only (participants with normal renal function) are excluded if:

• A history of renal disease or renal injury as indicated by medical history or an abnormal renal function profile at Screening or Check-in.

Participants in Groups 2 to 6 (participants with varying degrees of renal impairment) are excluded if:

• A change in disease status within 30 days of Screening, as documented by the participant's medical history, deemed clinically significant by the Investigator.
Detailed Clinical, Biochemical and Genetic Characterization in Gonadotropin-releasing Hormone (GnRH) Deficiency Disorders

In this study, we will measure levels of reproductive hormones and metabolic markers in subjects with isolated GnRH deficiency disorders and compare them to healthy control populations. Our goals are (1) to chart the range of hormonal and metabolic biomarkers in healthy subjects and those with reproductive disorders and (2) to correlate reproductive and metabolic phenotypes with genetic changes within patients with reproductive disorders and healthy controls.


Eligibility Criteria:
Inclusion Criteria:

* Over the age of 18 for men
* Between the ages of 18 and 40 for women
* For reproductive disorder population: Current or previous diagnosis of Idiopathic Hypogonadotropic Hypogonadism or Hypothalamic Amenorrhea

Exclusion Criteria:

* chronic disease (hypertension, high cholesterol, diabetes, asthma, etc)
* polycystic ovarian syndrome for women
* prescription medication use (other than allergy meds) for control populations
* irregular menstrual cycles for healthy female control population (cycle length longer than 35 days or shorter than 25 days. cycle length varies by more than 5 days. less than 9 periods per year)
Clinical Study of Weifuchun Treatment on Precancerous Lesions of Gastric Cancer

Research purpose To elucidate the effect mechanism and clinical effective of weifuchun in the prevention and treatment of chronic atrophic gastritis and precancerous lesions of gastric cancer. From genes related to cell differentiation, proliferation, apoptosis, tumor invasion and metastasis, genes related to immune inflammation and immune escape and other possible aspects to elucidate the effective and mechanism of weifuchun's treatment on chronic atrophic gastritis, reversing precancerous lesions of gastric cancer.

Clinical research abstract Title of Research Study：Randomized clinical trial: Weifuchun Treatment and mechanism on Precancerous Lesions of Gastric Cancer.

Main Responsibility Person: Mingyu Sun research center：Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine Trial Objective：Observe the clinical efficacy and mechanism of Weifuchun in the treatment of chronic atrophic gastritis (CAG) and precancerous lesions of gastric cancer (PLGC) Therapeutic Schedule：Select 60 cases of chronic atrophic gastritis with intestinal metaplasia or dysplasia from and 60 cases of chronic atrophic gastritis without intestinal metaplasia or dysplasia at the Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine. The treatment group was given Weifuchun tablets, 4 tablets each time, 3 times a day, and 1 hour after meals. The control group was given vitamin tablets (0.2 g), 4 tablets each time, 3 times a day, and 1 hour after a meal. The course of chronic atrophic gastritis with intestinal metaplasia or dysplasia group treatment is 24 weeks, the course of chronic atrophic gastritis without intestinal metaplasia or dysplasia is 12 weeks. The all patients'clinical symptoms, histopathology, gastroscopy, and physical and chemical examinations were compared between the two groups before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with chronic atrophic gastritis and precancerous lesions according to the pathological findings under gastroscope
2. Helicobacter pylori(-)

Exclusion Criteria:

1. Patients with Helicobacter pylori positive infection without radical treatment.
2. Patients with peptic ulcer, severe dysplasia or suspected malignant transformation.
3. Pregnant or lactating women and those who are pregnant and may not have effective contraception.
4. Patients with severe heart, lung, gallbladder, kidney, endocrine, hematopoietic system and neuropsychiatric diseases should not be included in this study.
5. Allergic constitution or known ingredients of this medicine.
6. Patients with other tumors.
7. Patients participating in other clinical trials within 1 month.
8. Patients with severe cirrhotic ascites and portal hypertension.
9. Other diseases that interfered with the study were deemed unsuitable for the patients included in the study.
Bioavailability of ABT-333 Within the Gastrointestinal Tract in Healthy Subjects

This open label, Phase 1 study is to investigate the relative bioavailability of ABT-333 when delivered within different sites of the gastrointestinal tract in 12 healthy subjects.

Bioavailability of ABT-333 in different areas of the gut

Eligibility Criteria:
Inclusion Criteria:

1. Body mass index of 18.0 to 35.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
2. Subjects must demonstrate their ability to swallow an empty size 000 capsule
3. Must be willing and able to communicate and participate in the whole study
4. Must provide written informed consent
5. Must agree to use an adequate method of contraception

Exclusion Criteria:

1. Participation in a clinical research study within the previous 3 months
2. History of any drug or alcohol abuse in the past 2 years or current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening
3. Females of childbearing potential who are pregnant or lactating (female subjects must have a negative urine pregnancy test at screening and admission)
4. Radiation exposure, including that from the present study, excluding background radiation but including diagnostic xrays and other medical exposures, exceeding 5 (micro sievert) mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study
5. Positive hepatitis A virus immunoglobulin M (HAVIgM), hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
6. Donation or loss of greater than 400 mL of blood within the previous 3 months
7. Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than 4 g per day paracetamol, hormone replacement therapy (HRT) and hormonal contraception) or herbal remedies in the 14 days before Investigational Medical Product (IMP) administration. Exceptions may apply on a case by case basis if considered not to interfere with the objectives of the study by both the Principal Investigator (or delegate) and sponsor's medical monitor
8. Acute diarrhoea or constipation in the 7 days before the predicted first study day. If screening occurs \>7 days before the first study day, this criterion will be determined on first study day. Diarrhoea will be defined as the passage of liquid faeces and/or a stool frequency of greater than 3 times per day. Constipation will be defined as a failure to open the bowels more frequently than every other day
9. Presence of non-removable metal objects such as metal plates, screws, etc, in the abdominal region of the body (with the exception of sterilisation clips)
Comparison Between Tuberculin Vaccine and Cryotherapy in Genital Wart Patients

Cutaneous and genital warts are common dermatological conditions caused by Human Papilloma Virus. Although it is a benign condition it causes disfigurement, has tendency to collect, can be transmitted to others, this makes adequate and timely treatment important, while many warts are resolve spontaneously over several years, most patients seek treatment because the warts are unsightly and often tender or painful.

Genital warts are highly contagious sexually transmitted diseases (STD) caused by infection of Human Papilloma Virus and, as the most common STD in developed countries, can currently be considered to be globally epidemic.

It is estimated that the frequency of Human Papilloma Virus infection among women in the world ranges from 2% to 44%.

The conventional modalities in treatment of warts include destructive therapies such as salicylic acid, trichloroacetic acid, cryotherapy, silver nitrate, phenol, cantharidin, surgical interventions and laser, antiproliferative agents such as bleomycin, vitamin D analogs, podophyllin, 5 fluorouracil and antiviral agents such as cidofovir and retinoids.

There are different mechanisms have been proposed for the resolution of warts with skin test antigens such as mumps, candida, trichophyton both at the injected as well as distant sites.

Tuberculin:

Purified protein derivative or tuberculin stimulates the cell mediated immunity non specifically by activating T helper 1 cells, Natural Killer cells, and cytokine production an increase in interleukin-12 as a process in boosting the cell-mediated immunity contributes to the mechanism of action.

Eligibility Criteria:
Inclusion Criteria:

* All types of genital and anal warts will be included in this study especially patients with 5 or more warts and more than 1 cm in size

Exclusion Criteria:

* Patients with immunodeficient diseases or receiving any immunosuppressive drugs
* Pregnancy and lactation
Developing a Model to Predict Inpatient Hypoglycemic Episodes

This study will create a new model to predict hypoglycemic events in diabetic inpatients on anti-hyperglycemic therapy using retrospective data with the goal of developing a model that will accurately predict hypoglycemic episodes in the patient population - piloting the risk score that was developed in the context of EndoTool being rolled out at the institution, to determine the feasibility and acceptability of viewing the risk score in the Electronic Health Record

Design a model to predict hypoglycemic episodes in real time, rather than retrospectively identifying high risk patients who experienced a hypoglycemic event at some point during their hospitalization, as has been done prior. Potential predictors of hypoglycemia identified in prior work and additional predictors identified by the clinical team to develop a discrete-time multinomial logistic regression model to predict hypoglycemic events in real time. The risk score then will be piloted in the context of our institution's EndoTool Subcutaneous implementation determine the feasibility and acceptability of viewing the risk score in the Electronic Health Record

Eligibility Criteria:
Inclusion Criteria:

* Providers taking care of adult patients (18 years and older) on the selected medical floors who are receiving anti-hyperglycemic medications on the chosen services (EndoTool and risk score implementation) and comparison groups (one group with EndoTool implementation and the other group without EndoTool implementation)

Exclusion Criteria:

* Providers not on the chosen services
COVID-19 Glycemic Control Study

Diabetes mellitus is a chronic disease characterized by the inability of the body to maintain normoglycemia. Treatment of diabetes relies mostly on diabetes self-management, requiring a large investment of time and energy on a daily basis. Psychological wellbeing, behavioral patterns and social context play a major role in diabetes self-management and glycemic control. Social isolation behavior (self-quarantining) may impact glycemic control by influencing daily routines, therapy adherence, physical activity, and self-measurement and eating behaviors. Therefore, a period of nationwide self-quarantine, such as during the lockdown issued during the COVID-19 outbreak in the Netherlands, may have a large effect on glycemic control in patients with diabetes.

In this observational cross sectional study, we aim to assess the impact of long-term self-quarantine on glycemic control, diabetes self-management and distress in patients with type 1 and type 2 diabetes mellitus.

A specific subgroup of patients with T1D are those with complicated diabetes who have received a pancreas or islet transplantation and use immunosuppression, having multiple risk factors for severe COVID-19. The impact of lockdown strategies on mental and physical health is expectedly even greater in patients at even higher risk for severe COVID-19. We therefore additionally investigated differences in behavioral, mental and physical implications of a nationwide lockdown on patients with type 1 diabetes with and without islet or pancreas transplantation.

Measurements will be performed during the lockdown period. Patients will be asked to perform a fingerprick HbA1c measurement once, sent back to the LUMC by mail. Data from continuous or flash glucose monitoring devices will be collected according to standard clinical practice. Furthermore, patients will be asked to fill out an online questionnaire once on diabetes self-management behavior, well-being and distress, along with questions about health status, level of education, medication use, employment, social situation and the impact of self-quarantine on daily routines. In this questionnaire, we ask patients to compare certain aspects of their life (e.g. anxiety, stress, weight, physical activity, glycemic control) at the time of the lockdown to before the lockdown. Data on demographics, type of diabetes, weight, BMI and HbA1c prior to the COVID-19 outbreak will be derived from the patient's electronic health file.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Diagnosed with type 1 or type 2 diabetes
* Ability to perform fingerpricks
* Sufficient comprehension of the Dutch language
* Ability to fill out online questionnaires

Exclusion Criteria:

* Pregnancy
* Newly diagnosed malignancy, with the exclusion of non-melanoma skin cancer, in the previous 6 months
* Chemotherapy or immunotherapy for malignancy
* Admission to hospital or rehabilitation center
New-Onset Atrial Fibrillation Complicating Acute Myocardial Infarction in China

To investigate the prognostic impacts of the atrial fibrillation burden (AFb) in acute myocardial infarction (AMI) patients who developed paroxysmal new-onset atrial fibrillation (NOAF) during the index AMI hospitalization.

In the present study, investigators retrospectively reviewed the medical records of all acute MI patients who were admitted to the coronary artery unit (CCU) of Shanghai Tenth People's Hospital, KaiFeng Central Hospital, and the First Affiliated Hospital of Zhengzhou University between January 2014 and January 2022. All patients will routinely receive continuous electronic monitoring (CEM) throughout their hospital stay to detect cardiac arrhythmias including the AF events. Of these, patients with AMI without a history of AF who developed a first documented AF episode will be considered for inclusion. The AFb is measured as a percentage (%) by dividing the total AF duration by the total CEM duration.

Eligibility Criteria:
Inclusion Criteria:

1. Patients hospitalized for AMI including both STEMI and NSTEMI between January 2014 and January 2022 at the CCU department of Shanghai Tenth People's Hospital, KaiFeng Central Hospital, and the First Affiliated Hospital of Zhengzhou University.
2. Patients who developed a first documented AF (NOAF) during the index AMI hospitalization；
3. Adult patients (\>18 years old).

Exclusion Criteria:

1. Patients with a medical history of pre-existing AF;
2. Patients with a medical history of rheumatic valvular disease;
3. Patients with a medical history of sick sinus syndrome;
4. Patients undergoing emergent coronary artery bypass surgery;
5. Patients' medical records with serious deficiencies and CEM data cannot be retrieved;
Effects of Intraovarian Platelet Rich Plasma in Women With Poor Ovarian Response and Premature Ovarian Insufficiency

Reproductive age women diagnosed with poor ovarian response (POR) based on Poseidon criteria and premature ovarian insufficiency (POI) based on ESHRE criteria and with a history of at least one prior failed IVF cycle will be recruited for the study. Antral follicle count (AFC), serum anti-mullerian hormone (AMH), and early follicular phase serum follicle stimulating hormone (FSH) levels will determined at baseline. Autologous blood obtained from peripheral vein will be used to prepare PRP following standard protocols and will be injected to at least one ovary. Ovarian reserve parameters and IVF outcomes will be determined.

Reproductive age women diagnosed with POR based on Poseidon criteria and POI based on European Society of Human Reproduction and Endocrinology (ESHRE) criteria with a history of at least one prior failed IVF cycle will recruited for the study. Antral follicle count (AFC), serum anti-mullerian hormone (AMH), and early follicular phase serum follicle stimulating hormone (FSH) levels will be determined at baseline. Autologous blood obtained from peripheral vein will be used to prepare PRP following standard protocols. PRP injection will be performed under sedation anesthesia, using a 35 cm 17 G needle under transvaginal ultrasound guidance. On the 2-4th days of the first six menstrual cycles following the procedure, AFC, AMH, and FSH levels will be re-assessed. Patients with at least one antral follicle will be started on ovarian stimulation for in-vitro fertilization- intracytoplasmic sperm injection (IVF-ICSI), followed by embryo banking/ preimplantation genetic testing- aneuploidy (PGT-A) or embryo transfer. Markers of ovarian reserve (AFC, FSH, AMH), and IVF laboratory outcome parameters (number of metaphase II (MII) oocytes, 2PN(pronucleus) embryos, cleavage stage, blastocyst embryos) will be followed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a history of \>1 year infertility duration with at least one ovary, who fulfilled the ESHRE criteria,
* Patients diagnosed with POR based on Poseidon criteria and with a history of at least one prior failed IVF cycle

Exclusion Criteria:

* Presence of pregnancy,
* previous diagnosis of any malignancy,
* ovarian insufficiency secondary to sex chromosome etiology,
* prior major lower abdominal surgery resulting in pelvic adhesions,
* anticoagulant use for which plasma infusion is contraindicated,
* current or previous (Immunoglobulin A (IgA) deficiency
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Depression

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records

The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to depression.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study

   a. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent
2. Male or female of all ages. (interest is given to children who present with autism or Crohn's and whose parents wish to analyze their children's gut flora. Also of interest analysis of development of the child's microbiome. In the case of autism, the younger the child, the better to correct the neurological problems if an association is found between autism and the microbiome)
3. Diagnosis of depression based on DSM-V criteria

Exclusion Criteria:

1. Refusal to sign informed consent form
2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
3. Postoperative stoma, ostomy, or ileoanal pouch
4. Participation in any experimental drug protocol within the past 12 weeks
5. Treatment with total parenteral nutrition