cyrilzakka/clinical-trials huggingface dataset:
Efficacy Study of Two Different Strategies for Restenosis in Sirolimus-Eluting Stents

For lesions which develop restenosis after a drug-eluting stent, it is not known which the right strategy to use is, implantation of the same type of DES as the initial one or a DES with a different drug.

Treatment of in-stent restenosis after implantation of a DES has poorly been studied. Although there are no data, it may be assumed that certain lesions might be resistant to a given drug and in need of a different DES. Thus, for lesions which develop restenosis after a DES, it is not known which the right strategy to use is, implantation of the same type of DES as the initial one or a DES with a different drug. This prospective, randomized trial will compare the anti-restenotic efficacy of PES or SES in patients with restenosis after initial implantation of a SES

Eligibility Criteria:
Inclusion Criteria:

* Patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of \> 50% re- stenosis after prior implantation of Sirolimus eluting stents in native coronary vessels
* Written, informed consent by the patient or her/his legally-authorized representative for participation in the study
* In women with childbearing potential a negative pregnancy test is mandatory

Exclusion Criteria:

* Cardiogenic shock
* Acute myocardial infarction within the first 48 hours from symptom onset.
* Target lesion located in the left main trunk or bypass graft.
* Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
* Allergy to antiplatelet therapy, sirolimus, paclitaxel, stainless steel.
* Pregnancy (present, suspected or planned) or positive pregnancy test.
* Previous enrollment in this trial.
* Patient's inability to fully comply with the study protocol.
PreventiOn of DYSbioSis Complications With Autologous FMT in AML Patients

The investigators propose to use autologous fecal microbiota transplantation (AFMT) to acute myeloid leukemia (AML) patients treated with intensive chemotherapy and antibiotics in order to restore the balance of their intestinal microbiome and thereby eradicate treatment-induced multidrug resistant bacteria (MDRB), infection-related complications, as well as sequelae to the gastrointestinal tract. Therefore, the investigators propose to perform a single-arm multicentre prospective fecal microbiota transplantation (FMT) trial in AML patients receiving intensive chemotherapy, and who are usually heavily treated with broad-spectrum antibiotics during aplasia that generate a profound status of dysbiosis. For this purpose, at the time of admission and AML diagnosis, patients will be requested to donate stools that will be comprehensively screened, and if deemed appropriate according to protocol criteria, conditioned and stored frozen until future processing and transplantation after aplasia completion.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 and ≤ 75 years old with de novo diagnosis of AML or high-risk myelodysplastic syndrom for whom intensive induction chemotherapy is anticipated within 10 days after admission
* Patients willing to donate stool samples and to follow protocol recommendations
* Signature of informed and written consent

Exclusion Criteria:

* Acute promyelocytic leukemia (AML-M3)
* Known allergy or intolerance to trehalose or maltodextrin
* Pregnancy: positive urinary or blood test in female of childbearing potential
* Severe disease with a life expectancy \< 3 months
* Other ongoing interventional protocol that might interfere with the study
* Non eligibility for collection of autologous stools upon admission:

  * Patients refusing to consent
  * Antibiotherapy at the time of study inclusion ≥ 4 days
  * Concomitant or previous diagnosis of a significant inflammatory bowel disease (UC, CD) or other progressive digestive disease requesting treatment or further medical exploration
  * Presence of severe colitis of any etiology at the time of admission or severe digestive disorders (acute or chronic diarrhea) within 3 months preceding inclusion
  * Patient getting a recent colonoscopy (within 3 months preceding inclusion)
* Detection of MDRB, pathogenic bacteria, parasites, norovirus and/or rotavirus during screening of autologous stool collected at baseline
* Non eligibility for inoculum transplantation: persistent mucositis, colitis, or haemorrhoids, presence of blood in more than 50% of patient's faeces the week preceding the transplantation
* Non feasibility of inoculum procedure: patient refusal; technical or biological mismatch of the inoculum
* Absence of effective contraceptive method for female of childbearing potential
* Lactation
* Inability to give an informed consent
Acetyl-L-Carnitine Reduces Perceived Work Stress and Improves Work Ability and Work Performance in Hepatic Encephalopathy

This study evaluated the effects of acetyl-L-carnitine treatment on Perceived Work Stress, Work Ability and Work Performance in subjects with Hepatic Encephalopathy.


Eligibility Criteria:
Inclusion Criteria:

* overt hepatic encephalopathy (HE) or a history of overt HE

Exclusion Criteria:

* history of recent alcohol intake; infection; recent antibiotic use or gastrointestinal bleeding; history of recent use of drugs affecting psychometric performances like benzodiazepines, antiepileptics or psychotropic drugs; a history of shunt surgery or transjugular intrahepatic portosystemic shunt for portal hypertension; electrolyte imbalance; renal impairment; hepatocellular carcinoma; severe medical problems such as congestive heart failure, pulmonary disease or neurological or psychiatric disorder that could influence quality of life measurement; inability to perform neuropsycological tests.
Effects of Low Concentration Atropine on Pupillary Size and Accommodative Amplitude

To assess the two-week ocular responses, especially on pupillary size and accommodative amplitude, of nightly application of 0.01% or 0.02% or 0.03% atropine eye drops in children with myopia who were randomized to use of three different low-concentration atropine eye drops

Atropine was proven to be effective in controlling myopia progression. However, the most common side effects of the use of atropine eye drop are dilation of pupil and decrease of accommodation. The investigators wish to evaluate the ocular responses of three low concentration atropine eye drops, 0.01% or 0.02% or 0.03%, mainly on the pupillary size and accommodative responses in children aged between 6 to 12 years old over two-week usage.

Eligibility Criteria:
Inclusion Criteria:

* Able to read and comprehend Vietnamese and having parents or legal guardians who give informed consent as demonstrated by signing a record of informed consent.
* Be between 6 and 12 years old, male or female.
* Willing to apply eye drops once nightly at bedtime for two weeks and follow the clinical trial visit schedule as directed by the Investigator.
* Willing to answer the questionnaire about subjective measurements
* Have ocular findings deemed to be normal
* No contact lens wearing history
* Vision correctable to at least 20/25 or better in each eye with spectacles

Exclusion Criteria:

* Any pre-existing ocular irritation, injury or condition, including infection or disease.
* Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants.
* Use of or a need for concurrent category S3 and above ocular medication at enrolment and/or during the clinical trial.
* Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant's ocular health / physiology or contact lens performance either in an adverse or beneficial manner at enrolment and/or during the clinical trial.

NB: Systemic antihistamines are allowed on an "as needed basis", provided they are not used prophylactically during the trial and at least 24 hours before the clinical trial product is used.

* History of eye surgery
* History of use of any myopia control interventions such as Orthokeratology, Rigid Permeable Contact Lenses Eye surgery within 12 weeks immediately prior to enrolment for this trial.
* Currently treated with other interventions for myopia control
* Contraindications to atropine such as pulmonary disease, heart conditions and ADHD
* Known allergy or intolerance to ingredients to atropine eye-drops and other derivatives of anti-muscarinic receptor agents.
* Currently enrolled in another clinical trial.
Investigation of PICOPREP and PEG-ELS for Bowel Preparation for Colonoscopy

Eligible subjects undergoing a colonoscopy will randomly receive either PICOPREP or polyethylene glycol 4000 electrolyte lavage solution before the procedure to evaluate its effectiveness, tolerability and safety.


Eligibility Criteria:
Inclusion Criteria:

* Have signed the informed consent form and have been verbally explained the details of the trial and treatment procedures
* Chinese citizen
* Males or females aged between 18 and 70 years inclusive
* Patients scheduled for colonoscopy
* Patients who are able to observe instructions given during the study, and are able to complete the entire study procedure

Exclusion Criteria:

* Those pregnant, breastfeeding, or with the intention of becoming pregnant, or fertile women who are not on effective birth control
* Taking concomitant lithium
* Allergy to any ingredient in the study medication
* History of gastrointestinal diseases (active ulcers, gastric outlet obstruction, gastric retention, intestinal obstruction)
* Colon diseases (toxic megacolon, toxic colitis, idiopathic intestinal pseudo-obstruction, gastric retention, intestinal obstruction, lazy bowel syndrome) at screening
* Active (acute/severe/uncontrolled) Inflammatory Bowel Disease (IBD)
* Acute abdominal symptoms (acute intestinal obstruction, intestinal perforation, diverticulitis or appendicitis)
* Ascites
* History of surgery in upper gastrointestinal tract (gastrectomy, gastric banding, gastric bypass surgery)
* History of colorectal surgery (excluding appendectomy, hemorrhoidectomy and endoscopic surgery)
* Uncontrolled angina and/or myocardial infarction, congestive heart failure, or uncontrolled hypertension within 3 months prior randomisation
* Severe liver damage
* Kidney function impairment
* Diabetics currently on insulin treatment
* Having participated in any other clinical trial during the 3 month prior recruitment
* Patients who are unable to act in a legal capacity, unable to meet or perform study requirements
Comparison Between Effects of Active Release Technique and Post Isometric Relaxation on Adductor Strain in Mixed Martial Arts Fighters

This study is a randomized controlled trial and the purpose of this study is to compare the effects between active release technique and post-isometric relaxation on adductor strain in mixed martial arts fighters.

The purpose of this study is to compare the effects between active release technique and post-isometric relaxation on adductor strain in mixed martial arts fighters on flexibility, pain, range of motion, and functionality, in adults (age: 20-35 years )

1. Numeric pain rating scale
2. Goniometer
3. Bent Knee Fall Out Test
4. Lower extremity functional scale Data will be collected before and after the intervention protocol for each participant.

Data collection procedure: Participants of interest would be approached and explained about the research. Informed written consent will be taken. Pre and post-intervention scores will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Both male and female genders
* Ages 20-35 years
* Professional Mixed Martial Arts fighters involved in kicking, sprinting, jumping, hiking
* Grade 1 or 2 adductor strain
* Clinical adductor dysfunction (pain reproduced by palpation of the enthesis, passive stretching of the adductors, and active resisted adduction)
* Numeric Pain Rating Scale (NPRS) 1-8
* Positive Bent Knee Fall Out (BKFO test)

Exclusion Criteria:

* Any clinical or radiographic evidence of pathological involvement of the hip joint (femoroacetabular impingement: pincer and/or cam features, dysplasia)
* Grade 3 adductor strain
* History of recent fracture
A Prospective Randomized Trial of Uncemented Versus Cemented Hemiarthroplasty for Displaced Femoral Neck Fractures

There is increasing evidence that primary hemiarthroplasty is the treatment of choice for displaced femoral neck fractures in the elderly

No definite conclusions have been made in regards to what kind of arthroplasty is favourable

Cemented implants are associated with increased risk of perioperative cardiovascular incidents and increased mortality.

Cementless implants are associated with increased postoperative pain and decreased walking ability.

This study investigates the differences between one well-documented cemented femoral stem and one well-documented uncemented femoral stem. Previous studies have mostly used uncemented stems with different designs.

Null hypothesis: No (less than 10 points) difference in HHS between groups at 1 year and 5 years

Inclusion Criteria: Dislocated intracapsular femoral neck fracture in patients ≥ 70 years old Exclusion criteria: Pathological fracture, Systemic or local infection, Short life expectancy/not mobile at all, Symptomatic coxarthrosis.

Null hypothesis: No (less than 10 points) difference in HHS between groups at 1 year (SD of HHS is 15 points) Power: 95% Significance: 0.05 60 patients in each group needed. To compensate for high mortality and drop-out: 200 patients, 100 in each group

Randomized using www.randomization.org to create sealed opaque envelopes opened at inclusion after signed informed concent.

Recorded after surgery:

Operating time Arthroplasty components used Need of blood transfusion Blood loss Size of incision

Recorded at discharge, 3 months, 1 year and 5 years:

X-ray of pelvis and hip Harris Hip Score Barthels ADL-index Quality of life (EQ-5D) Use of analgetics Use of walking aids

Publication: International orthopaedic journal.

Eligibility Criteria:
Inclusion Criteria:

* Dislocated intracapsular femoral neck fracture
* ≥ 70 years old

Exclusion Criteria:

* Pathological fracture
* Systemic or local infection
* Short life expectancy/not mobile at all
* Symptomatic coxarthrosis
Evaluation of the BodyGuardian End-to-end Remote Monitoring Platform in an Outpatient Heart Failure Population

We will evaluate the end to end remote monitoring system in a less controlled environment and concurrently develop the infrastructure to support the back end of the system

The overall objective of our research is to test, adapt, refine and validate the BodyGuardian technology and related end-to-end remote monitoring system to be used outside usual medical care environments to reduce hospital readmissions and facilitate independent living for heart failure patients. An important component of our overall strategy for continued development and refinement of the remote monitoring system is the incorporation of iterative behavioral evaluations to facilitate assessment and refinement in order to optimize adherence, utilization, and usability for patients as well as efficiency and functionality for providers.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients
* Stable New York Heart Association Class I-III HF (defined as no admissions for \> 1 year)
* Recruited from the Mayo Heart Failure Clinic, including 15 men and 15 women
* Age \> 50 years
* Reside in Olmsted County

Exclusion Criteria:

* Hospital admission for HF within past year
* Dementia
* Overall life expectancy \< 2 months
* Blindness
* Pregnancy or women able to become pregnant
* Skin allergy to adhesives
* Inadequate cell phone coverage (international patients or international travel during study period)
* Documented Ejection Fraction of \>40%
Intraperitoneal Ropivacaine Nebulization for Pain Control After Gynecologic Laparoscopic Surgery

The purpose of this study is to assess if intraperitoneal nebulization of Ropivacaine 150 mg may prevent the use of morphine during the first day after laparoscopic ovarian cyst surgery.

In a recent study the investigators found that nebulization of Ropivacaine 30 mg before or after gynaecologic laparoscopic surgery significantly reduces postoperative pain and postoperative morphine consumption.

Ropivacaine was effectively administered with non-heating nebulizers (AeronebPro®).

However, almost all patients still use morphine after surgery.

The investigators hypothesize that intraperitoneal nebulization of Ropivacaine 150 mg may prevent the use of morphine after the laparoscopic ovarian cyst surgery.

Eligibility Criteria:
Inclusion Criteria:

* Females 18-65 years old
* ASA Score I-III
* Scheduled for ovarian cyst laparoscopic surgery
* Free from pain in preoperative period
* Not using analgesic drugs before surgery
* Without cognitive impairment or mental retardation
* Written informed consent

Exclusion Criteria:

* Emergency/urgency surgery
* Postoperative admission in an intensive care unit
* Cognitive impairment or mental retardation
* Progressive degenerative diseases of the CNS
* Seizures or chronic therapy with antiepileptic drugs
* Severe hepatic or renal impairment
* Pregnancy or lactation
* Allergy to one of the specific drugs under study
* Acute infection or inflammatory chronic disease
* Alcohol or drug addiction
Drug Drug Interaction Study With Lu AG06466 in Young Healthy Men

The purpose of this study is to evaluate the effect of repeated doses of the drug Lu AG06466 on the exposure of metoprolol, midazolam and bupropion

On Day 1, midazolam and metoprolol will be dosed as an oral single-dose cocktail and PK sampling will be performed for 48 hours.

On Day 3, bupropion will be dosed as a single oral dose and PK sampling will be performed for 48 hours.

On Days 5-18, subjects will be dosed with Lu AG06466 once daily.

On Day 15, midazolam and metoprolol will be dosed as an oral single-dose cocktail and PK sampling will be performed for 48 hours.

On Day 17, bupropion will be dosed as a single oral dose and PK sampling will be performed for 48 hours.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) of 18.5 to 30 kg/m2 (inclusive) at the Screening and Baseline Visits

Exclusion Criteria:

* The subject has any concurrent disorder that may affect the pharmacological target or absorption, distribution, or elimination of the investigational medicinal product.

Other in- and exclusion criteria may apply
Efficacy of ARISTA-AH for Restoring Hemostasis Following Posterior Long-segment Spinal Fusion.

The aim of this study is to assess the efficacy of the ARISTA AH for restoring hemostasis following a long segment posterior spinal fusion.

After being informed about the study and potential risks, all patients giving written inform consent will be included in the study during their preoperative visit. After eligibility criteria checking and based on their respective surgical indication, participants will be randomized in a single-blinded and stratified manner (participant only) in a 1:1 ratio to ARISTA-AH or no ARISTA-AH. The stratification process will consider the number of instrumented vertebra during each surgery (level 1: 5 to 8 vertebra; level 2: 9 or more instrumented vertebra).

Eligibility Criteria:
Inclusion Criteria:

1. Patient eligible to a posterior lumbar or thoraco-lumbar long-segment spinal fusion.
2. Surgery targeting at least 5 adjacent vertebra combined with one of the following procedure:

   1. Intersomatic bone graft;
   2. Pedicle substraction osteotomy;
   3. Any other intervertebral osteotomy (e.g. Smith-Petersen osteotomy);
3. The use of a surgical drain inserted at the operative site is mandatory (suction drain and other drain are eligible);

Exclusion Criteria:

1. Subject under the age of 18 years old;
2. Subject with a known haemostatic disorder;
3. Subject with any infection or any immune system disorder;
4. Subject not eligible to a posterior spinal surgery;
5. Subject with a known allergy or any contraindication to the use of the study device;
6. Currently pregnant or planning pregnancy;
7. Prisoner or a ward of the state;
8. Subject no willing to participate in the study;
9. Subject not affiliated to a social security insurance.
Intrapartum Vancomycin for Group B Streptococcus (GBS) Prophylaxis

While it is clear that intrapartum antibiotics reduce neonatal GBS infection rates, the mechanism by which these drugs prevent neonatal GBS is not well established. One postulated theory is antibiotics work to reduce bacterial load in the birth canal; thus decreasing fetal exposure during labor and delivery. To our knowledge, the relationship between vancomycin and vaginal GBS colony counts has never been studied. In this prospective cohort study, our objective is to determine the relationship between intrapartum IV vancomycin and vaginal GBS colony counts.

Charts of patients presenting for induction of labor will be reviewed for potential eligibility. After provider permission, eligible patients will be approached for screening who are presenting for induction with documented GBS positivity and plan for vancomycin for intrapartum antibiotic prophylaxis. Patients presenting to the emergency room for labor evaluation/labor evaluation/pre-term labor evaluation, may be pre-screened for potential eligibility. Patients subsequently admitted in labor/preterm labor or with rupture of membranes with documented GBS positivity and plan for vancomycin for intrapartum antibiotic prophylaxis will be approached for screening. Additionally pharmacy will alert study staff when a patient is admitted to the labor floor or antenatal care unit and vancomycin has been ordered for antibiotic prophylaxis. These patients will then be approached for screening

Data collection: Demographic information such as age, race, date of initial GBS culture and time of rupture of membranes will be abstracted from enrolled patients' charts. Intrapartum vaginal cultures will be collected with a vaginal swab from the distal vagina by trained obstetrics and gynecology residents, attendings, nurses, nurse midwives and nurse practitioners prior to the initiation of antibiotics and at two hour intervals until delivery or after eight hours has elapsed.

Swabs will be transported to the lab. Colony counts will be determined via serial dilution. Specimens will be diluted in sterile saline and inoculated onto Columbia Agar containing 5% sheep blood, colistin (10 mg), and nalidixic acid (10 mg/L). After incubation for 48 hours at 35 C in ambient air, the number of colonies on the dilution plates will be visually counted and multiplied by the appropriate dilution factor for that particular plate.

Eligibility Criteria:
Inclusion Criteria:

* Women with documented GBS-positive antenatal screening culture or documented GBS bacteruria during pregnancy with plan to receive vancomycin for intrapartum antibiotic prophylaxis,
* ability to give informed consent,
* aged 18-48,
* English and or Spanish speaking, admitted in labor or undergoing induction of labor

Exclusion Criteria:

* Inability to give consent,
* currently receiving antibiotics for another indication,
* recent antibiotic use (within the previous 7 days),
* allergy to vancomycin