cyrilzakka/clinical-trials huggingface dataset:
Minocycline Treatment in Acute Hemorrhagic Stroke

The investigators will perform a double blind controlled study to investigate the efficacy of oral administration of 200 mg minocycline, on the neurological and functional outcome after acute hemorrhagic stroke and the effect on blood brain barrier permeability.

Minocycline, a semisynthetic second generation derivative of tetracycline, was shown to have a clear beneficial neuroprotective effect in animal models of multiple sclerosis, Parkinson's disease, Huntington's disease and amyotrophic lateral sclerosis. Animal models provide promising evidence of minocycline's ability to improve outcomes in an animal stroke model.

In light of these findings, we will perform a double blind controlled study to investigate the efficacy of oral administration of 200 mg minocycline, on the neurological and functional outcome after acute hemorrhagic stroke and the effect on blood brain barrier permeability.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute hemorrhagic stroke

  1. age \> 18
  2. NIHSS score \> 5
  3. onset of stroke 6 to 24 hours prior to beginning of treatment. Patients, who arrived within 0 to 6 hours post stroke, were treated with other medications according to the best accepted medical treatment guidelines.

Exclusion Criteria:

1. Evidence of other disease of the central nervous system, including brain tumor, demyelinating disease, inflammatory disease of the central nervous system, craniotomy in the past, severe brain injuries and benign intracranial hypertension
2. pre-existing neurological disability
3. known allergic response to tetracyclines
4. acute or chronic renal failure
5. pre-existing infectious disease requiring antibiotic therapy
6. swallowing difficulties
Comparison of Two Phacoemulsification-methods: EasyTip 2.2mm vs. Infusion Assisted EasyTip 2.2mm

The aim of this study was to compare the intraoperative efficiency, safety and postoperative outcomes of cataract surgery with two different "high-fluidic" settings.


Eligibility Criteria:
Inclusion Criteria:

* bilateral age-related cataract
* good overall physical constitution
* LOCS 2-5

Exclusion Criteria:

* previous intraocular surgery or ocular trauma
* previous corneal pathology
* previous endothelial cell count \<1200
* glaucoma
* uveitis
* PEX
* diabetic retinopathy and any other severe retinal pathology that would make a postoperative visual acuity of 20/40 (decimal equivalent = 0.5) or better unlikely
* intraocular complication like posterior capsular
* postoperative comlpications (e.g. postoperative uveitis)
A Feasibility Study Implant of the WiSE® CRT System With an Intracardiac Pacemaker to Achieve Totally Leadless CRT

Assess the safety and efficacy of the co-implantation of the WiSE CRT System with an intracardiac pacemaker to provide totally leadless CRT.

The WiSE CRT System is an implantable cardiac system to provide left ventricular (LV) pacing stimulation in conjunction with a co-implanted system that provides right ventricular (RV) stimulation. In combination, the devices deliver biventricular (BiV) pacing.

Single-arm, prospective, multicenter, observational study.

Eligibility Criteria:
Inclusion Criteria:

* Patient with a class I or IIa (1) or (2) indication for implantation of a CRT device according to current available guidelines 1,2,4 (with additional QRS criteria on Class IIa (1)):

  * Class I: NYHA II, III, IV, EF ≤ 35%, LBBB, QRS ≥ 150 ms
  * Class IIa (1): NYHA II, III, IV, EF ≤ 35%, LBBB, QRS ≥ 130 to \< 150 ms
  * Class IIa (2): NYHA II, III, IV, EF ≤ 35%, non-LBBB, QRS ≥ 150 ms
* Patient or legally authorized representative can provide written authorization and/or consent per institution requirements
* Male or Female, aged 22 years or above
* Meets criteria for one of the two patient groups

  * Group A: De novo totally leadless CRT implant in whom the physician believes a totally leadless approach would be beneficial (e.g., wish to avoid lifelong transvenous lead implant, anatomical constraints, history of device infection).

    * Patients with symptomatic AF and an uncontrolled heart rate who are candidates for AV node ablation (irrespective of QRS duration and LVEF), and in whom the physician believes a leadless pacing approach would be beneficial.
    * Patients with high degree AV block who have an indication for permanent pacing (with a LVEF ≤ 50%), are expected to require ventricular pacing more than 40% of the time, and in whom the physician believes a leadless approach would be beneficial.
  * Group B: Upgrade chronic intracardiac pacemaker to CRT

    * Patients with existing intracardiac pacemakers with greater than 20% RV pacing, who have developed symptomatic HF.

Exclusion Criteria:

* Patient who is or is expected to be inaccessible for follow-up visits
* Female participant who is pregnant, lactating, or planning pregnancy during the course of the study
* Inability to comply with the study follow-up or other study requirements
* History of chronic alcohol/ drug abuse and currently using alcohol/ drugs
* Non-ambulatory (or unstable) NYHA class 4
* Life expectancy less than 12 months
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
* Patient who is enrolled in another clinical study that could confound the results of this study (Note: patients enrolled in complementary study are eligible for enrolment)
The Effectiveness of Laparoscopic Treatment of Superficial Endometriosis for Managing Chronic Pelvic Pain

Endometriosis is a chronic, incurable condition that affects about 10% of women of reproductive age. It is defined as a growth of cells similar to the womb lining outside of the womb in the pelvis, and is associated with chronic pelvic pain, excessive period pain, pain with sexual intercourse and difficulties in getting pregnant. If the disease is found only on the lining of the pelvis it is known as "superficial peritoneal" and is usually treated during a laparoscopic surgery by cutting out (excision) or burning off (ablation). However, many women do not find improvement in their symptoms after the surgery and can have complications from the procedure. The aim of this study is to determine if removal of the superficial peritoneal endometriosis improves pain symptoms and quality of life, which method of removal (excision or ablation) is more effective or if surgical removal is of no benefit to the patients and can potentially cause harm. The investigators plan to recruit up to 90 women from four NHS hospitals in Scotland over a period of 12 months. Women who are attending gynaecology departments with pelvic pain who have not previously had a diagnosis of endometriosis via laparoscopy will be approached. Patients will be asked to read an information sheet about the trial. Women who consent to the trial will be randomised during the surgery, if superficial endometriosis is found, to either having the endometriosis removed or not. For this pilot, follow up will be at 3 and 6 months (and obtain permission to continue to follow them up at 12 and 24 months should time and finding permit). Patients who do not consent to take part in the trial will be asked if the investigators can collect data on their demographics and reasons on why they did not wish to take part.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing laparoscopy for the investigation of chronic pelvic pain
* In order to be randomised, isolated superficial peritoneal endometriosis (SPE) must be identified at laparoscopy (macroscopically)
* Able to give informed consent

Exclusion Criteria:

* Previous surgical diagnosis of endometriosis
* Pregnant or are actively trying for pregnancy within the next six months
* Deep endometriosis or ovarian endometrioma on imaging or at laparoscopy
* Peritoneal 'pockets' only noted at laparoscopy
Description of Insulin Resistance in Patients With Chronic Heart Failure

The purpose of this study is to describe insulin resistance in a general chronic heart failure population, in combination with muscle strength, body composition and cardiac function.

It is assumed that insulin resistance is increased in CHF patient, and that this is related to decreased muscle strength and decreased lean tissue mass.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of chronic heart failure for at least 6 months,
* clinically stable (not hospitalized) for more than 3 months prior to the onset of the study,

Exclusion Criteria:

* glucose lowering medical therapy
Assessment of Systemic Pharmacokinetics of Levobupivacaine and Ropivacaine During Continuous Epidural Infusion

The aim of the study is the assessment of the systemic absorption of local anesthetics during continuous epidural infusion for postoperative pain control.

In literature the systemic toxicity of bupivacaine is widely demonstrated, like the minor toxicity of levobupivacaine and ropivacaine at the same anesthetic potency. The are actually no studies in humans confronting levobupivacaine and ropivacaine under the aspect of efficacy and toxicity.The aim of the study is the assessment of the systemic absorption of local anesthetics during continuous epidural infusion for postoperative pain control.

Primary outcome:

Assessment of the plasmatic equimolar concentrations of levobupivacaine and ropivacaine during continuous epidural infusion

Secondary outcome:

Assessment of the safety level of the local anesthetic (major difference between haematic concentration of the local anesthetic and neuro-cardiotoxic dose).

Difference of the analgesic efficacy between levobupivacaine and ropivacaine. Differences in collateral effects due to the local anesthetic: hypotension and sensitive block.

Prospective randomized double-blinded clinical trial

Eligibility Criteria:
Inclusion Criteria:

* ASA I or ASA II
* Scheduled for major surgery
* written informed consent

Exclusion Criteria:

* ASA III, IV
* Emergency surgery
* Recovery in intensive care unit after surgery
* habitual opioid consumption
* cognitive or mental alterations
* coagulopathy
* piastrinemia \< 100.000/mm3
Prenatal Consult With Illustrated Literature

The overall purpose of this study is to determine whether implementing a 'Prenatal Consult Bundle' to the existing prenatal consult, including provision of sample questions, added discussion points and handouts, and a return visit, will decrease parental anxiety and improve information recall. Additionally, this study will determine if this effect is further increased with the use of illustrated literature.

This study will be a prospective randomized control trial. Seventy participants will be enrolled for the 'Standard' consult. These women will receive a questionnaire 6-24 hours after their consult. Then 140 participants will be randomized to either the 'Standard Upgrade' or 'Illustrated Upgrade' arm. Randomization will additionally be stratified based on estimated gestational age. These participants will receive an upgraded consult implementing the 'Prenatal Consult Bundle' which emphasizes the parents' role and follow up, with or without an illustrated handout. These participants will receive the same questionnaire 6-24 hours after their consult. Demographic information collected will include maternal age, gravidity, use of magnesium, social support and health literacy. All data will be collected to assess whether either arm of the consult 'upgrade' reduces anxiety or improves knowledge retention after the prenatal consult. Analyses will be completed using Statistical Analysis Software (SAS) using appropriate statistical testing.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women admitted to OB unit at the University of Virginia Medical Center
* Estimated gestational age of \>25 weeks and \<35 weeks

Exclusion Criteria:

* Non-English Speaking
* Pregnant women \<15 years of age
* Known critical conditions or congenital anomalies
* Women who have had any prior prenatal consultations regarding current pregnancy
Shark Screw® - Hand- and Foot Surgery Study

This observational study aims to determine the efficacy and safety of the Shark Screw® transplant for osteotomy and arthrodesis in hand and foot surgery.

The Shark Screw® transplant (surgebright GmbH) is a human cortical bone allograft for osteosynthesis and can replace metal or bioabsorbable devices in various procedures. In total, the clinical records from 32 patients who had undergone surgical procedure at the hand or foot between October 2016 and January 2018 with the use of a Shark Screw® transplant for joint arthrodesis or for the stabilization of osteotomies serve as data sources for this study. The aim of this study is to evaluate the efficacy and safety of the Shark Screw® transplant in hand and foot surgery by analyzing the recovery, wound and bone healing process.

Eligibility Criteria:
Inclusion Criteria:

* Application of the human bone graft Shark Screw® in a Hand- or Foot surgical procedure between October 2016 and January 2018
* Data from at least 1 follow-up examination after surgery around the 6th post-operative week or other information about the health status of the patient in the first 6 post-operative weeks

Exclusion Criteria:

* not enough data for an objective analysis
A Study to Learn About the Relationship Between Hepatic Impairment and Myelosuppression (Decreased Bone Marrow Function) in Breast Cancer Patients Treated With the Study Medicine Palbociclib (Pal-bow-sai-klib)

The purpose of this study is to evaluate incidence of grade 4 neutropenia in patients who have hepatic impairment and use the study medicine Palbociclib.

This study is seeking participants:

* treated with the study medicine Palbociclib
* having any breast cancer records in same month as the index date (the first prescription date)
* having prescription records of palbociclib from 20 December 2016 to 29 February 2024

The study design is a cohort study. This study design uses de-identified patient data from a hospital based electronic medical record and claim database in Japan.

One of the important side effects of taking Palbociclib is neutropenia (decreased count of neutrophils - a type of white blood cell). In this study, the relationship between neutropenia caused by Palbociclib and hepatic impairment was studied after it was released to the market. To do that, the study gathered details of breast cancer patients newly treated with Palbociclib from 23 hospitals and 10 medical institutes across Japan.

The below patient details were collected:

* dose of Palbociclib
* other medicines prescribed for cancer
* age
* gender
* past information on cancer treatments
* laboratory findings at baseline

The result was based on the neutrophil count collected from the laboratory data. Around 1300 patients newly treated with Palbociclib for breast cancer was calculated by the medical information database network (MID-NET) in 6 years from 15 December 2017.


Eligibility Criteria:
Inclusion Criteria:

* Having prescription records of palbociclib from 15 December 2017 to 29 February 2024.
* Having any breast cancer records in same month as the first prescription date.
* Having laboratory tests and visit records (SS-MIX2) on or before 180 days prior to the first prescription date
* Having SS-MIX2 hospital-visit records within 180 days before the first prescription date

Exclusion Criteria:

* Having an absolute neutrophil count (ANC) less than the threshold value for grade 4 neutropenia within 30 days of the first prescription of palbociclib
* Having any records of anti-HER2 medication
Predictive Factors of Analgesic Response in Patients With Pain Associated With Bone Metastasys

The study aims to improve the knowledge of pain associated with bone metastases, in particular to analyze the clinical course of patients who are affected by pain due to bone metastases, in order to better understand which factors may be related to a faster response to pain therapy.

This is a non-profit, non-pharmacological, multicenter prospective observational study. Enrollment will last for 24 months from the opening of the study.

The overall duration of the study will be 36 months.

Based on the primary endpoint, patients will be stratified into 5 groups, corresponding to different times of achievement of stable pain:

1. patients who achieve stable pain at the first assessment (3 days)
2. patients who achieve stable pain at the second or third assessment (6-9 days)
3. patients who achieve stable pain at the fourth or fifth assessment (12-15 days)
4. patients who achieve stable pain at the sixth or seventh assessment (18-21 days)
5. patients who do not reach stable pain on the twenty-first day Based on the secondary endpoints, patients with and without neuropathic pain and with and without reaching PPG will be compared with the results of the HADS, EORT-QLQ-C30 \[11\] and Karnofsky scale \[12-13\] tests, in terms of final MEDD (morphine equivalent daily opioid dose) and type of drugs taken.

Enrolled patients will undergo validated tests, administered by appropriately trained personnel. All the tests mentioned here are in use in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

Obtaining informed consent; age greater than or equal to 18 years definite diagnosis of solid tumor (histological and/or radiological, as indicated by the corresponding guidelines), already in charge of an Oncology service. bone metastases at any site, regardless of the type of primary tumor; patient with pain related to established, new-onset, or current bone metastases of the recrudescence of painful symptoms Enrollment must occur at the time of requesting medical intervention for pain related to bone lesions, within 72 hours of reporting.

Exclusion Criteria:

patients with cognitive and/or conscious impairments that could affect the evaluation; Patients with a history of substance/alcohol abuse/dependence or conditions that contraindicate administration of opioid analgesics; presence of non-oncological pathologies in the decompensation phase. non-understanding of the Italian language, both spoken and written.
Glossopharyngeal Nerve Blockade for Awake Videolaryngoscope Assisted Endotracheal Intubation in the Morbidly Obese

The investigators wish to determine if application of 2% lidocaine soaked gauze to the peritonsillar pillars will decrease the amount of gagging caused by awake videolaryngocope assisted tracheal intubation in the morbidly obese.


Eligibility Criteria:
Inclusion Criteria:

* morbid obese patients scheduled for bariatric surgery, with a planned awake intubation.

Exclusion Criteria:

* inability to communicate in English or french
* allergies to any study drugs
* any patient with an American society of anesthesiologists score of 4 or more
Pregnant Women Vaccinated Against Covid-19.

Establish a cohort of pregnant women exposed to a COVID19 vaccine, whether or not they have experienced an adverse event, to assess the potential effects of vaccines on the course of pregnancy, on the fetus or newborn and on the mother.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 years and over,
* Pregnant,
* Vaccinated against COVID-19,
* Not having expressed any objection to inclusion in the cohort

Exclusion Criteria:

* No agreement at inclusion,
* Age under 18 years
Fr1da Early Diagnosis and Care of Type 1 Diabetes

The Fr1da study: "Early diagnosis and care of type 1 diabetes" aims to carry out a comprehensive, population-based screening for the early diagnosis of type 1 diabetes as part of the U7 to U11 preventive medical check-up for children or between the ages of 2 and 10 years in Bavaria and to implement it in other federal states. Screening is recommended at two time points: 1st screening at the age of 3 years (U7a) and 2nd screening at the age of 7 years (U10). In addition, relatives of patients with type 1 diabetes between the ages of 1 and 21 can be screened repeatedly at intervals of 3 to 5 years for an early-stage of type 1 diabetes.

With the Fr1da study, 100,000 children in the Free State of Bavaria were offered a one-off screening for the early diagnosis of type 1 diabetes from January 1, 2015 to 2019 as part of the U7 (21st month of life) to U9 (64th month of life) check-ups, or as part of any other visit at the paediatrician between the ages of 2 and 5. After 100,000 children had been screened in the Fr1da study, the screening was continued as part of Fr1da (formerly Fr1da-Plus). The screening was then extended to a second age group from 6 to 10 years (U10-U11). As relatives of people with type 1 diabetes have an up to 10-fold increased risk of developing type 1 diabetes themselves, the screening is also offered to these people between the age 1 to 21 years. The aim of the Fr1da study is 1) to prevent life-threatening ketoacidosis at clinical manifestation of type 1 diabetes, 2) to reduce anxiety, uncertainty and psychological stress through training and intensive support for those affected, 3) to test the feasibility of two-time nationwide screening and evaluate the benefits, 4) to determine the prevalence of early-stage type 1 diabetes in children in defined age groups and in first and second screening, 5) to identify geographical differences and associations with environmental factors in the development and progression of the disease and 6) to prevent disease progression by means of preventive therapies. From 2024, the screening will also be offered in other federal states outside of Bavaria.

Eligibility Criteria:
written informed consent by one custodial parent
Effect of Molecular Hydrogen Inhalation on Metabolic Response During Low-intensity Exercise on a Bicycle Ergometer

This trial evaluates the effect of molecular hydrogen inhalation on metabolic response, heart rate, and rating of perceived exertion in healthy females during 30 minutes of exercise on a bicycle ergometer.

The objective of this randomized, double-blind, placebo-controlled crossover trial is to assess the effect of molecular hydrogen inhalation on metabolic response during 20 min of rest and during exercise on a bicycle ergometer with a workload of 0.5 W/kg for 10 min, 0.75 W/kg for 10 min, and 1 W/kg for 10 min. The trial recruits healthy females aged 20-35 years and the planned sample size is 20. The trial consists of two experimental sessions, one using molecular hydrogen inhalation and the other using placebo inhalation. The washout period between sessions is one week. Randomization of the order of the sessions is performed using a computer random generator. Molecular hydrogen is produced using a hydrogen generator via electrolysis of water and administered through a mouthpiece. Ambient air is used for placebo inhalation. Molecular hydrogen is colorless, odorless, and tasteless, making it indistinguishable from placebo by the human senses. During the session, the following variables are measured: ventilation, oxygen uptake, respiratory exchange ratio, heart rate, rating of perceived exertion, and oxygen saturation. Energy expenditure, fat oxidation rate and carbohydrates oxidation rate are calculated from oxygen uptake and respiratory exchange ratio. Statistical analysis is performed at the 0.05 significance level and data are evaluated using analysis of variance for repeated measures with Fisher's post hoc tests.

Eligibility Criteria:
Inclusion Criteria:

* Free of major diseases.
* Signed informed consent.

Exclusion Criteria:

* Acute conditions contraindicating laboratory testing of exercise.
* Cardiorespiratory disease.
* Pharmacotherapy affecting metabolism.
* Musculoskeletal problems.