cyrilzakka/clinical-trials huggingface dataset:
Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris

This study is to evaluate the therapeutic equivalence and safety of Taro Product to RLD in the treatment of acne vulgaris.

The study objectives are to evaluate the therapeutic equivalence and safety of Taro Product to RLD in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of the test and reference products over the placebo control.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris
* Subjects who are 18 years of age or older (up to the age of 40) must have provided IRB approved written informed consent. Subjects 12 to 17 years of age, inclusive, must have provided IRB approved written assent; this written assent must be accompanied by an IRB approved written informed consent from the Subject's legally acceptable representative (i.e., parent or guardian).
* Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA).

Exclusion Criteria:

* Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
* Subjects with a known hypersensitivity to clindamycin or lincomycin and/or any ingredients in the study drugs.
* Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
Reducing Micro Vascular Dysfunction in Acute Myocardial Infarction by Ticagrelor

The current trial will compare the protective effect of ticagrelor and prasugrel on microvascular dysfunction in patients with revascularized ST elevation myocardial infarction.

Coronary microvascular dysfunction is highly prevalent in revascularized ST-elevation myocardial infarction and has important prognostic implications. Current data suggest that ticagrelor might be superior to prasugrel in the reduction of coronary microvasculature dysfunction. Thus, we have designed a clinical trial that will compare microvascular function in revascularized ST-elevation myocardial infarction patients at treatment steady state with ticagrelor or prasugrel. Coronary microvascular dysfunction will be assessed with the index of microcirculatory resistance after primary percutaneous coronary intervention and at 1 month follow-up in the infarct-related vessel and non-infarct related vessel.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent
2. Patients presenting with ST-elevation myocardial infarction \<12 hours after symptom onset
3. Successful percutaneous coronary intervention of the infarct-related vessel with a modern drug-eluting stent
4. Intermediate stenosis in non-infarct-related vessel (50-90%)

Exclusion Criteria:

1. history of myocardial infarction
2. Participation in another clinical study with an investigational product during the preceding 30 days
3. history of cerebrovascular accident (CVA) or 'transient ischaemic attack' (TIA)
4. History of intracranial haemorrhage
5. indication or use of oral anticoagulant therapy (i.e. acenocoumarol)
6. severe liver dysfunction (Child-Pugh score 10-15)
7. congestive heart failure
8. cardiogenic shock
9. left ventricular ejection fraction \< 35%
10. bleeding diathesis
11. age ≥ 75 or \< 18
12. body weight \< 60 kg
13. gout
14. coagulation disorders
15. severe pulmonary disease
16. pregnancy and breast feeding
17. limited life expectancy
18. platelet count \< 100 000/mm3
19. history of drug addiction or alcohol abuse in the past 2 years
20. need for chronic nonsteroidal anti-inflammatory drug
21. creatinine clearance \<30 mL/min or dialysis
22. chronic total occlusion (CTO)
23. Left main disease
24. allergy or contra-indication for ticagrelor or prasugrel
25. Contra-indication for adenosine
26. Patients unable to be followed on-site
27. Unable to undergo or contra-indications for MRI
28. Contra-indication for drug-eluting stent
29. Inability to obtain informed consent
30. Coronary artery bypass grafting in medical history
An Analysis of Dental Treatments Rendered by Undergraduates at Ajman University to Patients From Fujairah, Uae

A total of 650 dental records were selected from 6000 dental records of patients who had received dental treatment in the Dental Clinic, College of Dentistry, Ajman University(AU)-Fujairah Campus, between academic year,2015/2016 and 2016/2017

A total of 650 dental records was randomly selected from 6000 dental records of patients who had received dental treatment in the Dental Clinic, College of Dentistry, Ajman Universi-ty(AU),Fujairah Campus, between the academic years 2015/2016 and 2016/2017. The size of study sample was determined using, Cochran' formula at 95% confidence. Using the random table generated by Microsoft Excel, the records for 650 patients were then randomly selected. After all the dental records to be included in this study were chosen and retrieved from the achieves. The following types of dental treatments: Composite restorations, amalgam restorations, glass ionomer restorations, fixed prosthetic treatments, removable prosthetic treatment, endodontic treatments, extractions treatments, fluoride treatments, fissure sealants treatment, pulp therapy treatments and stainless steel crowns treatments were extracted from the patient's dental records, coded and recorded in Microsoft excel sheet.

Eligibility Criteria:
Inclusion Criteria:

* Dental treatment performed in the time frame

Exclusion Criteria:

* Dental treatment not performed
Hepatitis B Challenge Dose in Adults (V232-059-10)

The purpose of this trial is to describe the Seroprotection Rate (SPR) at least 2 years following completion of a primary series with a hepatitis B vaccine (Base Study V232-059, NCT00440531) and 1 month following a challenge dose with a Modified Process Hepatitis B vaccine.


Eligibility Criteria:
Inclusion Criteria:

* In general good health based on a medical history.
* Received 3 doses of an Hepatitis B vaccine in Base Study V232-059, NCT00440531 at least 2 years prior to enrollment in this study.

Exclusion Criteria:

* Known history of previous Hepatitis B infection.
* History of vaccination with any Hepatitis B vaccine within the last 2 years.
* History of febrile illness.
* Known or suspected hypersensitivity to any component of HBVaxPro.
* Receipt of medication / vaccine that may interfere with study assessments.
* Known or suspected immune impairment.
* Pregnant women and nursing mothers.
Bile Acid-induced GLP-secretion. A Study in Cholecystectomized Subjects

PURPOSE

The goal of the present project is to unravel the importance of bile acid-induced GLP-1 secretion (via the G protein-coupled receptor TGR5) in human physiology.

In the present study the investigators examine the GLP-1 secretion in healthy subjects and cholecystectomised patients. Thereby the investigators aim to show, that cholecystectomised patients have reduced bileflow after a meal, and as a consequence exhibit a diminished GLP-1 response as compared to healthy subjects.


Eligibility Criteria:
Inclusion Criteria: (Healthy)

* Normal fasting plasma glucose
* Normal glucose tolerance
* Normal haemoglobin levels
* Informed content

Inclusion Criteria: (cholecystectomy group)

* Laparoscopic cholecystectomy \<6 months. Indication: Gallstones.
* Normal fasting plasma glucose
* Normal glucose tolerance
* Normal haemoglobin levels
* Informed content

Exclusion Criteria: (both groups)

* Diabetes
* Pre diabetes (impaired glucose tolerance or impaired fasting glucose)
* 1st degree relatives with diabetes
* Obesity (BMI \> 30)
* Inflammatory bowels disease
* Nephropathy
* Liver disease
* Medication which cannot be on hold for 24h
Oral Propanolol for Surgically Inaccessible Cavernous Malformations

The purpose of this study is to evaluate the role of propranolol as an alternative treatment for cavernous malformation in patients that may not be ideal candidates for surgery.

Patients between the ages of 1 and 80 years of age, that have been diagnosed with a spinal or cerebral cavernous malformation(s) that can not be surgically treated, will be enrolled in this randomized study. All eligible patients will be enrolled in one of two groups. Group 1 will receive oral propranolol tablets 3 times a day for 36 months. Group 2 will receive oral placebo tablets 3 times per day for 36 months. Prior to beginning treatment, all imaging, including MRIs, will be evaluated. During the first visit a blood sample will be collected for genomic analysis. Patients will return to clinic every 6 months. Each time the patient returns to clinic monitoring of how the patient is feeling and evaluation of how the patient is tolerating the propranolol will take place. At the end of the three years, evaluators will determine if the propranolol was able to stop the growth of the cavernous malformation and change the imaging features of the lesion on MRI. Once the study is completed patients will no longer receive the study drug.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of isolated or familial cavernous malformation syndrome:

   * symptomatic cavernous malformation not amenable to surgical resection.
   * familial cavernous malformation with seizure, other neurological symptom or surgically inaccessible lesion.
2. Written and informed consent obtained prior to study enrollment.
3. Subject is able and willing to return for outpatient visits.
4. Negative pregnancy test at time of enrollment for women and child-bearing potential.

Exclusion Criteria:

1. Age less than 1 year-old.
2. Propranolol allergy or allergy to other b-blockers.
3. Estimated life expectancy of less than 1 year.
4. History of severe anemia, cardiac dysfunction, or diabetes.
5. A psychiatric or substance abuse problem that may interfere with study compliance.
6. Pregnant and lactating women.
RCT of Counseling Intervention on Post-op Opiate Use

This study is a randomized controlled trial to investigate the effect of a simple counseling intervention on post-operative narcotic requirements, with the hypothesis that women receiving this intervention will use fewer narcotics for pain management following cesarean section.

All women undergoing scheduled cesarean section at Brigham and Women's Hospital who meet eligibility for the study will be approached in the pre-operative area on the Labor and Delivery floor prior to her scheduled cesarean section. For eligible patients interested in participation, consent will be obtained, and the participant will be randomized to receive either an intervention script containing counseling about post-op narcotic use, or the control script containing information regarding post-partum depression. This script will then be read to the participant in the pre-operative area prior to her scheduled cesarean section.

Two types of data will then be collected: inpatient data, and outpatient data. Regarding inpatient data, study investigators will collect information from the electronic medical record about the quantity of narcotics used in the hospital, pain scores while in the hospital, and demographic information. In terms of outpatient data, study investigators will contact participants at 2 weeks and 6 weeks post-partum with questions from the Edinburgh post-partum depression scale score and the WHOQOL-BREF scale score, along with questions regarding their narcotic use at home. Specifically, participants will be asked during the informed consent process whether they agree to 1) receive an email with a brief online survey at 2 weeks post-partum, and 2) receive a follow-up phone call within the week after the email survey was sent if survey responses are not received, 3) receive a second email with a brief online survey at 6 weeks post-partum, 4) receive a follow-up phone call within the week after the second email survey was sent if survey responses are not received. Surveys will be emailed to participants using the Partner's REDCap service that is located behind the Partner's firewall. Investigators will also mine information about each participant's narcotic use from the MassPAT prescription monitoring database.

The endpoint of the study will be enrollment of our desired sample size.

Eligibility Criteria:
Inclusion Criteria:

* Delivery by scheduled cesarean section at Brigham and Women's Hospital

Exclusion Criteria:

* Answer "yes" to the question: "Has any provider talked to you this pregnancy about medications for pain control after your c-section?"
* History of opiate abuse
* Use of chronic opiates, benzodiazepines or gabapentin
* History of chronic pain
* Cesarean hysterectomy
* Vertical skin incision
* Myomectomy at the time of cesarean section
* Non English-speaking
* Patient of the investigator performing the recruitment
Efficacy and Safety of QL1012 in Women for Assisted Reproductive Treatment

The study is conducted to confirm equivalence between QL1012 (a new biosimilar formulation of Recombinant Human Follicle-stimulating Hormone) and Gonal-f® with respect to the number of oocytes retrieved in women for assisted reproductive treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. Aged 20 \~ 39 years(inclusive)
3. Body mass index (BMI) between 18\~30 kg/m2(inclusive)
4. Regular menstrual cycle (25\~35 days)
5. Basal FSH \< 10 IU/L (menstrual cycle day 2\~5)

Exclusion Criteria:

1. History of ≥3 previously completed IVF/ICSI-ET cycles without clinical pregnancy
2. History of ≥3 recurrent spontaneous miscarriages
3. Patients with high risk of ovarian hyperstimulation syndrome (OHSS)
4. Primary ovarian failure or poor responders to ovarian stimulation
5. Presence of pregnancy in previous 3 months
6. Presence of clinically significant systemic disease, endocrine disease or metabolic abnormalities
7. History of malignant tumors of the ovary, breast, uterus, hypothalamus, pituitary gland, etc.;
The Efficacy of Aerobic Exercise in the Rehabilitation of Patients With COVID-19-Related Myocardial Injury

A study of the efficacy of aerobic exercise based on cardiopulmonary exercise test in the rehabilitation of patients with COVID-19-related myocardial injury


Eligibility Criteria:
Inclusion Criteria:

1. Between the ages of 18 and 65 years;
2. A history of new coronavirus infection;
3. Patients with a clinical diagnosis of COVID-19-related myocardial injury;
4. In the late stages of recovery from COVID-19-related myocardial injury, at least 3 months after diagnosis;
5. Negative cardiopulmonary exercise test;
6. After completing respiratory rehabilitation at our hospital in the previous period;
7. Normal blood biomarker tests and essentially normal 2D-STE, normal left ventricular systolic function, no spontaneous or inducible arrhythmias on electrocardiographic monitoring, and the patient's clinical status is stable, with most of the symptoms in significant remission, and the daily still activities are intolerant or do not reach the pre-disease exercise level;
8. Classification of nyha heart function of class I or II;
9. Voluntarily sign the informed consent form;
10. Not participating in other clinical trials.

Exclusion Criteria:

1. a previous history of coronary atherosclerotic heart disease and heart failure;
2. a combination of severe arrhythmia or cardiogenic shock;
3. a combination of severe hypertension, hypertrophic cardiomyopathy, valvular disease of moderate or greater severity, acute myocarditis or pericarditis;
4. a combination of any disease that severely affects limb movement, such as musculoskeletal disorders or severe hepatic or renal insufficiency
5. a combination of progressive malignant tumors, infectious diseases, bleeding disorders, autoimmune diseases, etc;
6. those who have serious mental illness and are unable to cooperate
7. those with incomplete clinical data;
8. those who have dropped out or terminated the trial by themselves.
Safety, Tolerability, and Antiviral Activity of ANA598 in Patients With Genotype-1 Chronic HCV Infection

The purpose of this study is to investigate the safety, tolerability, and antiviral activity of ANA598 in patients with genotype-1 chronic hepatitis C infection.

The safety, tolerability and antiviral activity of ANA598, administered orally twice daily for 3 days, will be compared to placebo in treatment-naïve subjects chronically infected with HCV genotype 1 infection. Thirty (30) subjects will be randomized to one of three cohorts described above. The ten patients in each cohort will be randomized 8 active: 2 placebo. At least 5 subjects with genotype 1a and 5 subjects with genotype 1b will be enrolled within each cohort.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, ages 18 to 65 years
* Documented chronic HCV infection, genotype 1a or 1b
* Treatment-naïve
* BMI = 18 - 35 kg/m2

Exclusion Criteria:

* Female patients who are pregnant or breast-feeding
* Previous treatment for HCV infection
* HIV or HBV positive
* Evidence of cirrhosis on previous liver biopsy or on previous imaging studies
* History of any other known cause of liver disease;
Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Basal Insulin With Oral Antidiabetic Therapy

Primary Objective:

* To compare the efficacy of insulin glargine new formulation and Lantus in terms of change in Glycated Hemoglobin A1c (HbA1c) from baseline to endpoint (scheduled Month 6) in adult participants with type 2 diabetes mellitus

Secondary Objective:

* To compare the efficacy of insulin glargine new formulation and Lantus in terms of occurrence of nocturnal hypoglycemia

The maximum study duration was up to approximately 58 weeks per participants, consisting of:

* up to 2 week screening period
* 6-month comparative efficacy and safety treatment period
* 6-month comparative safety extension period
* 4-week safety follow-up period in a subset of participants
* a 3-month administration substudy period starting after completion of the 6-month study period for participants willing to in a subset of participants randomized to HOE901-U300

Eligibility Criteria:
Inclusion criteria :

* Participants with type 2 diabetes mellitus
* Substudy inclusion criteria:

  * Completion of the 6-month study period in main study (Visit 10)
  * Randomized and treated with insulin glargine new formulation during the 6- month treatment period (Baseline - Month 6)

Exclusion criteria:

* Age less than (\<) 18 years
* HbA1c \<7.0% or greater than (\>) 10% at screening
* Diabetes other than type 2 diabetes mellitus
* Less than 6 months on basal insulin treatment together with oral antihyperglycemic drug(s) and self-monitoring of blood glucose
* Participants using sulfonylurea in the last 2 months before screening visit
* Any contraindication to use of insulin glargine as defined in the national product label
* Use of insulin pump in the last 6 months before screening
* Initiation of new glucose-lowering medications in the last 3 months before screening visit
* History or presence of significant diabetic retinopathy or macular edema likely to require laser or injectable drugs or surgical treatment during the study period
* Pregnant or breast-feeding women or women who intend to become pregnant during the study period
* Substudy exclusion criteria:

  * Participant not willing to use the adaptable injection intervals on at least two days per week

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Real-world Effectiveness and Safety of Trastuzumab Deruxtecan in Patients With Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma in China

Trastuzumab deruxtecan's (T-DXd's) efficacy and safety has been confirmed in traditional clinical trials, there is a lack of real-world evidence, especially among Chinese patients. The objective of this study is to evaluate real-world effectiveness and safety profile of T-DXd by collecting real-world data treating in patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.

The primary objective of this study is to evaluate the effectiveness of T-DXd in real-world setting (real-word time to treatment failure).

The secondary objectives of this study are to assess the safety profile of T-DXd (treatment related adverse events \[TRAE\] regardless of grade, and physician reported adverse events of special interest \[AESI\] regardless of grade, etc.) and to evaluate effectiveness of T-DXd (real-world time to next treatment).

Eligibility Criteria:
Participants must meet all the following inclusion criteria to be eligible for the study:

1. Participants with pathologically diagnosed locally advanced unresectable or metastatic gastric cancer/gastroesophageal junction adenocarcinoma (GC/GEJA).
2. ≥18 years of age at the time of starting the first dose of T-DXd and signing informed consent form (ICF), capable of providing informed consent.
3. HER2-positive status (IHC 3+ or IHC 2+/ISH +).
4. Received prior anti-cancer treatment regimens according to National Medical Products Administration indication or clinical judgement of physician.
5. Decision to newly initiate T-DXd before study ICF signing. If the participants have started the first dose of T-DXd no longer than 21 days before enrollment, they could be enrolled if the signed and dated ICF could be obtained.

Exclusion Criteria：

Participants who meet any of the following criteria will be excluded from the study:

1. Pregnancy or breastfeeding.
2. Participants who at the time of data collection of the study are participating in or have participated in an interventional study that remains blinded.
3. Known hypersensitivity to either the drug substances or inactive ingredients in the drug product.
4. Judged by the investigator to be unfit to participate in the study.
Qp/Qs Ratio by Noninvasive Methods in Children With Shunt Dependent Pulmonary Circulation

In pediatric cardiac patients with shunt dependent pulmonary circulation, Qp/Qs ratio is a important parameter indicating the balance of pulmonaty and systemic circulation.

This study will calculate Qp/Qs using variables measured using non-invasive monitors (cerebral oximeter and pulse oximeter). This value will be compared with Qp/Qs calculated using variables obtained from blood sample.

Blood sampling will be performed in both arterial and central venous lines.

Eligibility Criteria:
Inclusion Criteria:

1. pediatric cardiac patients scheduled to cardiac operation (shunt dependent pulmonary circulation)
2. preoperative SpO2\<97%

Exclusion Criteria:

1. unable to measure pulse oximeter or cerebral oximeter signal
2. unable to measure SaO2 or SmvO2
3. unstable vital sign