cyrilzakka/clinical-trials huggingface dataset:
Finhyst 2006: Study on Morbidity of Hysterectomies in Finland

The purpose of this study is to analyze prospectively all hysterectomies performed in Finland for benign indications including all 46 public hospitals performing hysterectomies and also 7 private clinics. Hypothesis is that vaginal and laparoscopic hysterectomies are safe and cost-effective methods of hysterectomy.

This Finhyst 2006 study evaluates nationwidely methods, indications, concomitant procedures, complications, hospital stay and convalescence time of all types of hysterectomies with questionnaires filled by doctors and patients. In addition, in the area of Helsinki University Central Hospital also the effect of quality of life and cost-effectiveness is studied.

Eligibility Criteria:
Inclusion Criteria:

* Bening indications for hysterectomy

Exclusion Criteria:

* Malignant indications for hysterectomy
* Postpartum hysterectomy
Using Cardiopulmonary Exercise Test as an Incentive to Outpatient Cardiac Rehabilitation for Acute Coronary Syndrome Survivors.

Exercise-based cardiac rehabilitation is a class I recommendation for acute coronary syndrome (ACS) patients. However, participate rate of outpatient rehabilitation is quite low and remains a global issue. The study is to propose a strategy in order to encourage post-ACS patients to participate in the outpatient cardiac rehabilitation.

Background: exercise-based cardiac rehabilitation is a class I recommendation for acute coronary syndrome (ACS) patients. However, participate rate of outpatient rehabilitation is quite low and remains a global issue. The study is to propose a strategy in order to encourage post-ACS patients to participate in the outpatient cardiac rehabilitation.

Hypothesis: cardiopulmonary exercise test (CPET) incentives ACS survivors to participate in outpatient cardiac rehabilitation.

Objectives: 200 ACS survivors who are eligible for cardiac rehabilitation will be allocated randomly into control and experimental groups.

Method: before discharge, both control and experimental groups will be informed of the importance of cardiac rehabilitation and invited to participate the outpatient rehabilitation. The experimental group will also be told that an important examination, i.e. the CPET, will be performed in order to evaluate their heart function at the outpatient department (OPD).

Primary outcome: the presence of ACS survivors at the OPD of rehabilitation in order to receive the rehabilitation/CPET.

Secondary outcomes: the adherence to cardiac rehabilitation, defined as completing a full course of cardiac rehabilitation (6 sessions) or home-based exercise.

Factors that might influence the presence of ACS survivors at OPD of rehabilitation will also be recorded and analyzed, including:

* Patient characteristics: age, sex, body mass index (BMI), cardiovascular disease (CVD) risk factors
* Electrocardiography (ECG): ST elevation myocardial infarction (STEMI) or non ST elevation myocardial infarction (NSTEMI)
* Lab data: peak troponin level.
* Days of hospitalization. Statistics: t-test, ANOVA

Eligibility Criteria:
Inclusion Criteria:

* acute coronary patients

Exclusion Criteria:

* acute illness that stayed in hospital for more than 2 weeks.
* patients who received surgical intervention
* severe complications (ex. respiratory failure, stroke, acute renal failure)
* contraindications of cardiopulmonary exercise testing
* patients who cannot perform the cardiopulmonary exercise testing
Examining the Clinical Characteristics, Treatment Patterns, Real-world Effectiveness, and Healthcare Resource Utilization of Patients With Dry Eye Disease

A prospective, non- interventional, observational, non-comparative, longitudinal cohort study design will be used to address the objectives of this study using data collected through a healthcare.

The study will identify patients with DED who newly initiated treatment with lifitegrast ophthalmic solution on or after the start of the recruitment period, which will last for 1 year since first patient first visit (FPFV) (index period). A minimum follow-up period of 6 months (post-index period) is set for each patient making the last patient last visit (LPLV) 6 months after the closure of recruitment period or after the last patient recruited, whichever comes first.

Eligibility Criteria:
Inclusion criteria

1. Age ≥18 years at index date.
2. Confirmed diagnosis of DED.
3. Newly started on lifitegrast ophthalmic solution within the recruitment period and not receiving lifitegrast ophthalmic solution within 6 months prior to recruitment.
4. Received continuous medical care at the healthcare site defined as at least one clinical visit within 6 months.
5. Clinical decision made to initiate treatment with lifitegrast ophthalmic solution prior to enrollment in the study.
6. Patient agrees to be included after signing an informed consent.

Exclusion criteria

1. Known hypersensitivity to lifitegrast or its components.
2. Dry eye secondary to scarring or destruction of conjunctival goblet cells.
3. Patients with active or history of ocular herpes and or other ocular infection within the last 30 days.
4. Any contra-indication as per the label.
5. Refusal to give signed informed consent
Robotic vs. Open NSM for Early Stage Breast Cancer

This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.

This study is a prospective, two-arm, multi-center, randomized controlled clinical investigation between RSNM and open NSM.

This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.

Eligibility Criteria:
Inclusion Criteria:

* Female age 21 or older
* BMI \< 30
* Candidate for an NSM procedure with immediate reconstruction
* Diagnosis of early stage brest cancer
* Breast ptosis ≤ Grade 2.
* Cup size ≤ C.

Exclusion Criteria:

* Previous breast surgery
* Diagnosis of metastatic breast cancer
* Prior radiation treatment to the chest
* Current smokers
* Contraindication for general anesthesia or surgery.
* Known bleeding or clotting disorder.
* Pregnant or suspected to be pregnant, or actively breastfeeding
Efficacy and Safety of Everolimus in de Novo Heart Transplant Recipients

This study will test the safety and efficacy of everolimus on heart transplant recipients.

This study is not recruiting in the United States.


Eligibility Criteria:
Inclusion Criteria:

* Male or female cardiac recipients 18-65 years of age undergoing primary heart transplantation. The graft must be functional at the time of randomization.
* Calculated creatinine clearance (Cockroft-Gault) ≥ 50 mL/min at screening.
* Patients who have given written informed consent to participate in the study.

Exclusion Criteria:

Patients who are recipients of multiple solid organ transplants or have previously received organ transplants.

Patients who received any investigational drug or who have been treated with an immunosuppressive drug or treatment within 1 month prior to randomization Patients receiving induction therapy which is not standard per local practice Patients with donor greater than 60 years and/or with known donor coronary or heart disease at the time of transplant.

Donor heart cold ischemic time \>6 hours. Patients with Panel Reactive Antibodies \>20%. Patients who are recipients of ABO incompatible transplants Patients with platelet count \<50,000/mm3 at the evaluation before randomization.

Presence of severe hypercholesterolemia (≥350 mg/dL; ≥9 mmol/L) or hypertriglyceridemia (≥750 mg/dL; ≥8.5 mmol/L) Patients with an absolute neutrophil count of ≤1,500/mm3 or white blood cell count of ≤4000/mm3 at baseline before surgery Patients with a history of significant coagulopathy or medical condition requiring long term anti-coagulation after transplantation (low dose aspirin treatment is allowed) Patients who are HIV-positive or Hepatitis C (PCR+ only) or B surface antigen positive. Laboratory results obtained within 6 months prior to study entry are acceptable.

Recipients of organs from donors who test positive for Hepatitis B surface antigen or Hepatitis C (PCR+ only) are excluded Patients with a known hypersensitivity to similar drugs and to the components of the formulations Patients being treated with terfenadine, astemizole, or cisapride. Patients who are treated with drugs strong inducers or inhibitors of cytochrome P450 3A4.

Patients with any past (within the past 5 years) or present malignancy (other than excised basal cell carcinoma) Patients with clinically significant systemic infection Patients who are unable to take oral medication Existence of any surgical or medical condition, which in the opinion of the investigator, might significantly alter the absorption, distribution, metabolism and excretion of study medication, and/or the presence of severe diarrhea or active peptic ulcer Abnormal physical or laboratory findings of clinical significance within 2 weeks of randomization which would interfere with the objectives of the study Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception
Efficacy and Safety of ATG-Fresenius Following a Renal Transplantation, Without Corticosteroids

The main objective of the study is the assessment of the overall graft rejection rate (acute, chronic and subclinical) between a treatment with ATG-Fresenius administered in addition to standard treatment consisting of CellCept® or Myfortic®/TAC and without corticosteroids and a treatment consisting of CellCept® or Myfortic®/TAC and corticosteroids during the first year after renal transplantation.


Eligibility Criteria:
Inclusion Criteria

* Signed and dated informed consent form,
* End-stage renal disease,
* Candidates for a first transplantation,
* Re-transplant patients are eligible if a graft loss after transplantation was NOT due to immunological reasons,
* Availability of a heart-beating cadaveric donor up to 70 years of age with a cold ischemia time shorter than 36 hours,
* Male or female patients between 18 to 75 years of age inclusive,
* Patients able to comply with all study related requirements,
* Patients able to receive oral medication,
* Women of childbearing age with a safe contraceptive method throughout the study.

Exclusion Criteria

* Women who are pregnant or breast feeding,
* Known Human Immunodeficiency Virus,
* Hepatitis B Virus or Hepatitis C Virus infection,
* Severe actual viral, bacterial or fungal infection not adequately controlled,
* Patients with anamnestically known hypersensitivity to rabbit immunoglobulin antibodies or positive rabbit immunoglobulin skin test or known allergies to any component of the immunosuppressive drugs per protocol,
* Patients at high immunological risk defined as current PRA \> 25% or historical PRA \> 50%,
* Patients receiving pre-transplant immunosuppressive treatment, including corticosteroids,
* Patients with current or history of malignancies (exception basal cell carcinoma or squamous cell carcinoma in remission),
* Patients with previous transplantation except 1st graft loss due to surgical complications,
* Patients receiving combined transplantation,
* Patients with major organ dysfunctions,
* Serious psychiatric or psychological disorders,
* Pre-transplant thrombocytopenia: \< 50,000 thrombocytes/µl, Pre-transplant leukopenia: \< 2,000 leukocytes/µl,
* Unable or unwilling to comply fully with the protocol,
* Participation in another study of an investigational medicinal product concurrently or within the last 30 days.
Effect of ProTaper Ultimate System on Post-endodontic Pain

This clinical trial aims to compare the effect of Pro Taper Ultimate and Pro Taper Gold files on post-endodontic pain in molars with symptomatic apical periodontitis.

The main question it aims to answer is:

If there is a difference in post-endodontic pain intensity following root canal preparation using Pro Taper Ultimate and Pro Taper Gold files in molar diagnosed with symptomatic apical periodontitis?

Participants will undergo root canal treatment using Pro Taper Ultimate and Pro Taper Gold files.

Researchers will compare \[Pro Taper Ultimate and Pro Taper Gold files\] to see the intensity of post-endodontic pain

The study will be conducted on 40 first mandibular molars; with 20 first mandibular molars in each group (n=20). The patient will be asked to pick an opaque sealed envelope that will contain a number from 1 to 2. The resultant number will determine in which group the participants will be placed.

Group I: Root canal preparation using Pro Taper Ultimate. Group II: Root canal preparation using Pro Taper Gold.

Procedural steps:

1. Vitality will be assessed using cold tests and electric pulp testing before the procedure is carried out. Besides, mobility, palpation, and percussion tests will be done to assess periapical health. In order to ensure that the cold and electrical pulp tests are working, and a response is elicited, both tests will be carried out on patients not included in the study.
2. All the patients will receive local anesthesia: 2% lidocaine with 1:100,000 epinephrine.
3. Each tooth will be isolated using a rubber dam, and the access cavity will be prepared using a round bur (no.4) and tapered fissure diamond bur under copious water.
4. After removal of coronal pulp tissues using a sterile excavator, the working length will be determined with stainless steel hand K-files size #10 and the use of an apex locator and confirmed using intraoral periapical radiographs.
5. Hand instrumentation to 15-size K files.
6. Group I will be prepared using ProTaper Ultimate files.
7. Group II will be prepared using ProTaper Gold files.
8. Apical patency will be maintained throughout the shaping procedure using the #10 file between each instrument.
9. All the canals will be irrigated with 10 mL of 3% NaOCl between each file during the whole preparation procedure.
10. All the root canals will be obturated directly after preparation.
11. All the teeth will be restored using resin composite restoration.

Eligibility Criteria:
Inclusion Criteria:

* Patient was diagnosed with symptomatic irreversible pulpits and symptomatic apical periodontitis.
* 18-70 years old patients
* Permanent mandibular first molars.
* Teeth with a fully matured root.
* Restorable teeth indicated for endodontic treatment.
* Healthy patients.

Exclusion Criteria:

* Complex root canal morphology
* Calcified roots.
* Teeth with internal and external resorption.
* Medically compromised patients.
* Restricted mouth openings (trismus).
Presence of the Father During Hyperacute Cesarean Section in General Anesthesia

This study concerns cesarean sections, category 1, meaning those cases where the life of mother and/or fetus is in immedeate danger and the child must be delivered within 15 minutes from activating the cesarean section team. In most hospitals in Denmark, these cesarean sections are most often performed in general anesthesia and the mother is endotracheally intubated.

Previously in these situations, as the mother was rushed from the Labour Ward to the operation room (OR), her spouse/partner, would be placed outside the operating room (OR), and would stay there until the child had been delivered.

In Lillebaelt Hospital, Kolding, Denmark, the newborn-resuscitation table is placed inside the OR. The father would most often be allowed to enter the OR when the child was delivered and placed on the resuscitation table (no matter the status of the child).

However, during spring 2021, Lillebaelt Hospital Kolding updated the policy regarding the handling of the father/partner during cesarean section category 1. Now the father/partner is present in the OR during the whole procedure, including induction of general aesthesia, endotracheal intubation, performance of the cesarean section (drapings are positioned so that the father cannot see the operation field) and potential resuscitation efforts of the newborn.

In another hospital in the same region (Region of Southern Denmark), Aabenraa Hospital, the father is not present in the OR during the cesarean section. He waits in the labour ward.

The investigators therefore wish to investigate how the cesarean section category 1 is experienced by: the father/partner; the mother; the obstetrician; the anestesiologist; the midwife; the OR nurse; the anesthetic nurse, both in Kolding where the father/partner is present in the OR, and in Aabenraa, where the father/partner is not present in the OR during the cesarean sectio.


Eligibility Criteria:
Inclusion Criteria:

* cesarean section category 1

Exclusion Criteria:

* none
A Study of IMC008 for Advanced Solid Tumors

An open label, multi-center, dose-escalating study to evaluate the safety and preliminary efficacy of IMC008 in CLDN18.2 positive advanced solid tumors.

This study is an open label, multi-center, dose-escalating clinical study to evaluate the safety and preliminary efficacy of IMC008 in the treatment of CLDN18.2 positive advanced solid tumors. DLTs observations will be performed 28 days after IMC008 administration. During the study, regular safety meetings will be held according to the progress of the study, and recommendations will be made on dose escalation, safety of subjects and possible study change.

Eligibility Criteria:
Inclusion Criteria:

* Advanced gastric cancer /esophagogastric junction adenocarcinoma advanced pancreatic cancer.
* Tumor tissue samples of subjects expected to be available with positive for CLDN18.2 immunohistochemistry.
* The expected survival period of the subject is ≥12 weeks.
* The subject needs to have at least one target lesion that can be stably evaluated.
* The ECOG score is 0-1.
* Subject has adequate organ and bone marrow function
* All toxic reactions caused by previous anti-tumor therapy were relieved to grade 0-1.
* Fertility status : Women of childbearing age or men whose sexual partners are women of childbearing age are willing to take medically approved high-efficiency contraceptive measures.
* Subjects must sign and date written informed consent.

Exclusion Criteria:

* Pregnant and lactating women.
* Known history of human immunodeficiency virus infection; acute or chronic active hepatitis B; acute or chronic active hepatitis C. Syphilis antibody positive; Epstein-Barr virus infection; CMV infection.
* Serious infection that is active or poorly controlled clinically.
* Uncontrollable pleural effusion, pericardial effusion, peritoneal effusion existed before enrollment.
* Extensive or diffuse lung metastases or extensive or diffuse liver metastases.
* Oxygen saturation ≤ 95% without oxygen inhalation.
* Suffering from other research diseases that may limit their participation in this study.
* Known past or current hepatic encephalopathy requiring treatment; patients with current or history of central nervous system disease.
* There are heart diseases that need to be treated or hypertension that is poorly controlled by the investigator, poorly controlled after standard treatment type 2 diabetes mellitus.
* Presence of any cardiac clinical symptoms or disorders.
* Evidence of significant coagulopathy or other significant bleeding risk.
* Received systemic steroids equivalent to \>15 mg/ day prednisone cumulatively for more than 3 days within 2 weeks prior to apheresis , excluding inhaled steroids.
* Prior or concurrent occurrence of other malignancies, with the following exceptions.
* Subjects who have previously received other gene therapy.
* Allergic/ intolerance to lymphodepletion regimen or CRS treatment drugs or IMC008.
* Subjects with severe mental disorders.
* The investigator assessed the subject's inability or unwillingness to comply with the requirements of the study protocol .
Implementation of a Smartphone Application in Medical Education

This study addresses the effectiveness of a smartphone application to improve academic performance among medical students. Participants will be randomised to receive an application developed by a team of physicians and engineers, designed to review key concepts in internal medicine and its subspecialties. The primary outcome will be the number of correct answers in a multiple choice test 4 weeks after randomisation.

Smartphones are devices that are commonly used by medical professionals. Their adoption by students and physicians is increasing, with reported use rates of roughly 85%. Reasons behind these implementation rates stem from their versatility, since this technology provides mobile communications and advanced informatics in a handheld device that can be used at the bedside. However, data regarding their use in medical education is scarce.

This study aims to address whether a smartphone application designed to review key concepts in internal medicine and its subspecialties might increase the overall academic performance of medical students. Eligible participants will be interns in their final year of study who own a smartphone with an operating system based in Android® or iOS®. Only those that do not wish to participate will be excluded from this trial.

All participants will undergo a baseline test aimed at addressing their knowledge of internal medicine and its subspecialties. Multiple choice questions will be used in this test, which have been developed by a team of internists with 5 years experience in formulating them. These questions have also been designed to resemble a national examination that is required to practice medicine in the Chilean Public Health System, and have shown a good correlation with performance in the latter exam in previous reports. In order to optimise adherence, the application will also provide feedback to its user, showing overall performance in terms of correct answers and time required to solve a clinical vignette.

After this test, participants will be randomised to receive the smartphone application by a statistician. Investigators will be kept unaware of the allocation sequence used in this trial. The contents of the application will include clinical vignettes that will review core concepts in internal medicine and its subspecialties. After 4 weeks, participants will undergo a second test and the overall performance between groups will be compared. Both outcome assessors and statisticians will be kept unaware of participant allocation. Data regarding the overall application use will be collected as well.

Eligibility Criteria:
Inclusion Criteria:

* Medical student coursing their internship.
* Owns a smartphone with an Android® or iOs®-based operating system

Exclusion Criteria:

* Refusal to participate.