cyrilzakka/clinical-trials huggingface dataset:
Rifaximin for the Secondary Prevention of Spontaneous Bacterial Peritonitis Recurrence in Cirrhotic Patients

The aim of this study is to evaluate whether long-term rifaximin administration reduces spontaneous bacterial peritonitis recurrence rate in cirrhotic patients.

* Rifaximin is an antibiotic with a broad-spectrum activity against gram-positive and gram-negative microorganisms, both aerobes and anaerobes within the gastrointestinal tract. The main advantage of rifaximin is that it is poorly absorbable, which minimizes the antimicrobial resistance and adverse events and renders the drug safe in all patient populations. In addition, rifaximin has a better activity against gram-positive organisms than norfloxacin.
* The appreciation of the potential role of enteric flora in the pathogenesis of several gastrointestinal diseases has broadened the clinical use of rifaximin, which is now used for hepatic encephalopathy, small intestine bacterial overgrowth, inflammatory bowel disease, and Clostridium difficile infection. Theoretically, by reducing the total number of the gut bacteria, rifaximin could also be used to achieve intestinal decontamination in patients with liver cirrhosis and ascites, thus preventing spontaneous bacterial peritonitis.
* A small retrospective study concluded that rifaximin suppresses intestinal bacterial overgrowth, bacterial translocation in cirrhotic patients with ascites with no history of previous spontaneous bacterial peritonitis episodes. Prospective clinical trials are warranted to evaluate the role of rifaximin for prevention of spontaneous bacterial peritonitis recurrence in cirrhotic patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with cirrhosis based on clinical, biochemical, ultrasonographic and/or histological criteria
* Patients who had recovered from an episode of spontaneous bacterial peritonitis
* Age \> 18 and \<80 years

Exclusion Criteria:

1. Decompensated cirrhotic patients with

   * serum bilirubin \> 3.2 mg/dL
   * prothrombin time \< 25%
   * serum creatinine \> 3 mg/dL
2. Active gastrointestinal bleeding
3. Hepatic encephalopathy \> grade 2
4. Patients who have clinical, biochemical or radiological data suggesting hepatocellular carcinoma
A Pediatric Comparison of Remote Microphone Technologies

Speech intelligibility will be evaluated for school age children with hearing loss in a simulated classroom environment, using Phonak hearing aids and receivers and two different microphone transmitters: a Roger Touchscreen mic and a fixed directional microphone.

Speech intelligibility will be evaluated for school age children with hearing loss in a simulated classroom environment, using Phonak hearing aids and receivers and two different microphone transmitters: a Roger Touchscreen mic and a fixed directional microphone. The simulated classroom environment will include a teacher condition, in which speech is presented from a distance in front of the participant, and a small-group condition, in which speech is presented randomly from three different speakers around the participant. Both conditions will have diffuse background noise, and the various SNR (Signal to Noise Ratio) levels will be tested.

Subjective preference and fatigue questionnaires will also be collected from the participants after the use of each transmitter.

Eligibility Criteria:
Inclusion Criteria:

* Healthy middle and outer ear
* Mild, moderate or moderate-severe binaural sensorineural hearing loss
* Minimum AZ Bio score of 70% at 60 dB in quiet
* Experienced hearing aid users (6+ months)
* Able to read and follow directions
* English speakers with ability to communicate easily

Exclusion Criteria:

* Active middle ear infection
* Temporary or unilateral hearing loss
* Unable to follow verbal directions
* Unable to communicate easily
* Unable to tolerate the physical fit of the hearing aids
Methods of Etiological Diagnosis of Cerebral Amyloid Angiopathy

The purpose of this study is to

1. Early identify patients based on clinical manifestation, imaging, gene and histology, explore diagnostic tools
2. get gene repertoire of Chinese
3. Build a cerebral amyloid angiopathy (CAA) prospective cohorts, observing the disease history, and exploring prognostic factors of hemorrhage in CAA patients

We recruited consecutive patients with intracerebral hemorrhage(ICH). Clinical data and the results of laboratory tests and CT will be assessed and recorded. All the subjects will get gene tests including many genes related with Aβ and small vessel disease (Next-generation sequencing and target enrichment system) .

The result of the MRI Scans including cerebral microbleeds(CMBs)、Cortical superficial siderosis（cSS）, white matter change(WMC) and enlarged perivascular spaces (EPVS) will be assessed using scales. Ocular fundus exams such as funduscopy and imaging will be used to assess multiple dot and blot hemorrhages and microaneurysms by ophthalmologist. Mini-mental state examination(MMSE) will be used to assess the cognitive function.

Patients who need operation on the hematoma for the treatment will accept a brain tissue pathological exams According to this, a prospective cohort of CAA patients based on clinical manifestation, imaging, gene and histology will be built, and diagnostic tools such as gene and MRI results, etc will be explored. And we will get gene repertoire of Chinese patient with ICH.

Then, the subjects will be followed up on 30-day, 3-month, 6-month, and 1-year.The patients' clinical outcome will be assessed , and the results of laboratory tests and therapy will be recorded. Prognostic factors of patients with CAA related ICH will be explored.

Eligibility Criteria:
Inclusion Criteria:

①diagnosed wiht spontaneous cerebral hemorrhage after the head CT.

② the patients and their family members agreed to participate in this study.

Exclusion Criteria:

①cerebral hemorrhage caused by traumatic, cerebral infarction, tumor and arteriovenous malformation.

②patients who can not provide reliable information or are considered unsuitable for the study.
LARC Forward Counselling

Training of health care providers and structured LARC forward counseling may contribute to increased LARC uptake. The hypothesis to be tested is that by introducing LARC forward counselling an increase in LARC usage will be the result as well as decreased unplanned pregnancy and abortion. It is expected that the results of this study will highlight the importance of LARC forward counseling and thus provide the evidence needed to train health care providers and increase access to LARC in youth clinics, midwifery clinics and for post abortion contraception.


Eligibility Criteria:
Inclusion Criteria:

* At risk for pregnancy (sexually active with men or anticipate becoming sexually active in the next 6 months).
* Do not desire pregnancy .
* No contraindications to LARC

Exclusion Criteria:

* Undergone tubal ligation or other sterilization procedure.
* Use of contraceptives for other purposes than contraception
the Predictive Value of Immune Cell in Locally Advanced Cervical Cancer

To explore the predictive value of immune cells by single-cell sequencing on the outcome of locally advanced cervical cancer treated by concurrent chemoradiotherapy Followed by PD-1 inhibitor

Concurrent chemoradiotherapy is the standard treatment for patients with locally advanced cervical cancer, but the treatment failure rate is up to 40% in previous studies. Immunotherapy using PD-1 inhibitor showed an objective response rate of 12-50% in studies, and pembrolizumab was approved by the US Food and Drug Administration for patients with advanced PD-L1-positive cervical cancer who experienced progression during or after chemotherapy. And according to KEYNOTE-A18, the addition of PD-1 inhibitor Pembrolizumab to the current concurrent chemoradiotherapy improved the PFS of such group of patients. But the detailed change of immune cells (tumor microenvironment and PBMC) during treatment is unknown, and studies on the relationship between immune cells and treatment-related side effect and efficiency is also in need.

Eligibility Criteria:
Inclusion criteria:

1. Age between 18 and 75;
2. Untreated patients with pathologically proven locally advanced cervical cancer;
3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
4. Adequate hematological, renal and hepatic functions:

   4.1 Hemoglobin \> 8.0 g/dl 4.2 Neutrophils \> 2000 cells/μl; Leukocytes \> 4 × 109/L 4.3 Platelets \> 100 × 109/Lg. 4.4 Serum urea nitrogen (BUN) ≤ 1.5 × upper normal limit (UNL) 4.5 Serum creatinine (Cr) ≤ 1.5 × upper normal limit (UNL) 4.6 Serum ALT/AST ≤ 2.5× UNL 4.7 Serum Total bilirubin ≤ 1.5× UNL
5. Life expectancy \> 6 months
6. Eligible for concurrent chemoradiotherapy assessed by principle investigator;
7. No obvious active bleeding;
8. Written informed consent must be available before study registration

Exclusion criteria:

1. Recurrent or distant metastatic disease;
2. Prior malignancies (other than curable non-melanoma skin cancer) within 5 years;
3. Active autoimmune diseases requiring systemic treatment or other diseases requiring long-term use of substantial amount of hormones or other immunosuppressants;
4. Patients who need to receive systemic corticosteroids (dose equivalent to or higher than prednisone 10mg qd) or other immunosuppressants within 14 days before enrollment or during the study;
5. Vaccination of live attenuated vaccine 30 days before enrollment, or planned vaccination of live attenuated vaccine during the study;
6. Previous organ transplantation or HIV patients;
7. Allergic to macromolecular proteins /monoclonal antibodies, or to any test drug component;
8. Active acute or chronic viral hepatitis B or C. Hepatitis B virus (HBV) DNA\> 2000IU/ml or 104 copies/ml; hepatitis C virus (HCV) RNA\> 103 copies/ml.
MagnetisMM-5: Study of Elranatamab (PF-06863135) Monotherapy and Elranatamab + Daratumumab Versus Daratumumab + Pomalidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

The purpose of this study is to evaluate whether the BCMA-CD3 bispecific antibody elranatamab, alone and/or in combination with the anti-CD38 monoclonal antibody, daratumumab, can provide more benefit to people with multiple myeloma compared to a combination therapy including daratumumab, pomalidomide, and dexamethasone. People with multiple myeloma who have received previous treatment including lenalidomide and a proteasome inhibitor will be enrolled in the study. Part 1 of the study will assess the safety and activity of different doses of elranatamab in combination with daratumumab. People participating in Part 2 of the study will be randomly assigned to receive either elranatamab alone, elranatamab plus daratumumab, or daratumumab, pomalidomide, and dexamethasone. Part 2 will compare the safety and activity of (1) elranatamab alone compared to daratumumab, pomalidomide, and dexamethasone, and (2) elranatamab plus daratumumab compared to daratumumab, pomalidomide, and dexamethasone. Participants in all parts of the study will receive study treatment until their disease progresses, they experience unacceptable side effects, or they choose to no longer participate in the study.


Eligibility Criteria:
Inclusion Criteria:

* Prior diagnosis of multiple myeloma as defined by IMWG criteria (Rajkumar et al, 2014).
* Measurable disease based on IMWG criteria as defined by at least 1 of the following:

  * Serum M-protein ≥0.5 g/dL.
  * Urinary M-protein excretion ≥200 mg/24 hours.
  * Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\<0.26 or \>1.65).
* Prior anti-multiple myeloma therapy including treatment with lenalidomide and a proteasome inhibitor.
* ECOG performance status ≤2.
* Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.
* Not pregnant and willing to use contraception.

Exclusion Criteria:

* Smoldering multiple myeloma.
* Plasma cell leukemia.
* Amyloidosis.
* POEMS Syndrome.
* Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease.
* Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection.
* Any other active malignancy within 3 years prior to enrolment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
* Previous treatment with a BCMA-directed therapy.
* Anti-CD38-directed therapy within 6 months preceding the first dose of treatment in this study.
* Live attenuated vaccine within 4 weeks of the first dose of study intervention.
* Administration with an investigational product (e.g. drug or vaccine) concurrent with study intervention or within 30 days preceding the first dose of study intervention used in this study.
Effects on the Airway Lumen of Talsaclidine in Combination With Propranolol in Comparison to the Effects of the Monosubstances in Healthy Elderly Male Volunteers

To investigate the effects on airway lumen of talsaclidine in combination with propranolol and of talsaclidine and propranolol given as monosubstances


Eligibility Criteria:
Inclusion Criteria:

All participants in the study should be healthy males, range from 50 to 65 years of age and be within +- 20% of their normal weight (Broca-Index).

Exclusion Criteria:

* Volunteers will be excluded from the study if the result of the medical examination or laboratory tests (especially those which indicate liver malfunction) are judged by the clinical investigator to differ significantly from the normal clinical values
* Volunteers with blood pressure lower than 120/80 mm Hg or pulse rate below 60 beats/min
* Volunteers whose blood pressure dropped below 100/60 mm Hg in the pre-test within 80 mg propranolol
* Volunteers with Raw-values higher than their predicted normal upper limit
* Volunteers with known gastrointestinal, hepatic , renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Volunteers with disease of the central nervous system (such as epilepsy) or with psychiatric disorders
* Volunteers with known history of orthostatic hypotension, fainting spells or blackouts
* Volunteers with chronic or relevant acute infections
* Volunteers with history of allergy / hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Volunteers who have taken a drug with a long half life (\>=24 hours) within at least one month or less than ten half lives of the respective drug before enrolment in the study
* Volunteers who received any other drugs which might influence the results of the trial during the week prior the start of the study
* Volunteers who have participated in another study with an investigational drug within the last 2 month preceding this study
* Volunteers who are unable to refrain from smoking on the study days
* Volunteers who smoke more than 10 cigarettes (or 3 cigars or pipes) per day
* Volunteers who drink more than 40 g of alcohol per day
* Volunteers who are dependent on drugs
* Volunteers who have donated blood (\>=100ml) within the last 4 weeks
* Volunteers who participated in excessive physical activities (e.g. competitive sports) within the last week before the study
Pediatric Sleep Questionnaire: Use for Collection of Clinical Data

The purpose of this study is to develop a questionnaire that can be used for standardized patient information gathering in the clinical setting. This will serve as the information source for a pediatric sleep database.

A sleep questionnaire will be administered to patients who present to the Pediatric Neurology Clinic and the Pediatric Sleep Clinic in the DCAM as well as LaRabida Children's Hospital complaining of sleep problems. The questions asked are those routinely obtained in clinical practice of sleep medicine. Medical students, residents and faculty as part of their normal clinical responsibilities will administer the questionnaire. The database will be maintained in Filemaker Pro program for future research purposes. Collection of the data will require approximately 15 minutes. A database file number not related to the patient medical record number will be assigned to each patient. The investigator will keep a separate log linking patient database number and patient medical record number. The logbook will be kept under lock and key by the investigator.

Eligibility Criteria:
Inclusion Criteria:

* All patients seen in the Pediatric Neurology Clinic and at La Rabida Children's Hospital

Exclusion Criteria:

* Adults
Hydra Registry - UK

The study will evaluate the efficacy and safety of transcatheter aortic valve implantation (TAVI) using the Hydra transcatheter aortic heart valve (THV) series, in patients with severe aortic stenosis up to 1-year after the procedure. This will include an evaluation of the preservation of coronary access post implant by attempting to selectively engage both the right and left coronary arteries through standardised angiographic views.

The study will also examine the utility of 72 hours of post discharge remote ambulatory continuous electrocardiogram (ECG) monitoring using the novel Checkpoint Cardio System where it is clinically appropriate.

This is a prospective, observational, multi-centre study. The aim of this study is to collect clinical, procedural, and follow-up data in order to evaluate the efficacy and safety of the Hydra THV series (Vascular Innovations Co. Ltd., Nonthaburi, Thailand).

Additionally, the study will conduct the following evaluation:

1. The remote ambulatory cardiac monitoring (rACM) using the Checkpoint Cardio System, consisting of 72 hours of continuous electrocardiogram (ECG) monitoring, will be evaluated post hospital discharge where it is clinically appropriate.
2. Coronary access will be evaluated immediately post-TAVI by attempting to selectively engage both the right and left coronary arteries through standardised angiographic views. This will be done in a sub-set of patients who are either known to have coronary artery disease, did not have coronary angiogram prior to TAVI or where it is felt to be clinically appropriate for other reasons post implant.

Following discharge, clinical follow-ups are scheduled at 45 days (±14 days), and 1-year (±30 days).

Eligibility Criteria:
Inclusion Criteria:

1. Patients with severe aortic stenosis eligible for transfemoral TAVI procedure as per local Heart Team evaluation
2. Full understanding and willing to provide informed consent to study enrolment
3. Age ≥ 18 years

Exclusion Criteria:

1. Contraindications to TAVI (e.g., anatomically phenotypes, intracardiac mass, thrombus, vegetation, endocarditis)
2. Refusal to provide informed consent to study enrolment
3. Patients with severe aorta or peripheral artery disease precluding transfemoral approach of TAVI
4. Patients with significant calcification of the aortic annulus and in the Left Ventricular Outflow Tract (LVOT), or/and excess calcium within each cusp, or those who are deemed unsuitable for the Hydra THV series based on the clinical judgment of the Investigator.
Intrastromal Corneal Ring for High Astigmatism on Postkeratoplasty

To evaluate the clinical outcomes of Intrastromal Corneal Ring Segment (ICRS) implantation to correct high-degree astigmatism on eyes with prior penetrating keratoplasty (PK).

Eighteen eyes of 18 patients, 8 men and 10 women, with high levels (\> 5 diopters \[D\]) of postkeratoplasty astigmatism were studied in a nonrandomized, retrospective, observational case series. Mean age at the time of ICRS implantation was 38 years, range 22 to 49 years. PK was performed to treat keratoconus in 15 patients, corneal scar after trauma in 2 patients, and Fuchs endothelial dystrophy in 1 patient. All patients were spectacle and contact lens intolerant. There was no active corneal disease or problem apart from high astigmatism.

Minimum time of ICRS implantation was 2 years after PK and at least 6 months after sutures removal.

Preoperative examinations included personal medical ocular history, uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), refraction, keratometry, intraocular pressure (IOP) measurement by applanation tonometry, corneal astigmatism, surface regularity index, surface asymmetry index, tonometry, slit-lamp biomicroscopy, specular microscopy, and fundus examination.

Main outcome measures included UCVA, BSCVA, refraction, keratometry and computerized analysis of corneal topography.

All surgeries were performed by the same surgeon (BAN) at the Goiania Eye Institute, between July 2007 and January 2009. Corneal tunnels were created by means of mechanical dissection in all eyes. Intrastromal corneal ring segments implantation was indicated because of the existence of reduced best spectacle-corrected visual acuity (BSCVA) or contact lens intolerance. Intracorneal ring segments implantations were performed by the same surgeon following the same protocol. All eyes were implanted with the Cornealring (Visiontech Medical Optics, Belo Horizonte, MG, Brazil). Mean follow-up after ICRS implantation was 12 months (range, 09 to 22 months).

The procedure, its goals, and possible complications were explained and all patients signed an informed consent. The amount and axis of astigmatism to be corrected by ICRS was based on manifest refraction.

Eligibility Criteria:
Inclusion Criteria:

* \> 5 diopters of postkeratoplasty astigmatism
* Patients 21 to 50 years old
* Conventional treatments have failed

Exclusion Criteria:

* Diabetes
* Autoimmune diseases
Pin Site Infection Prevention for Open Tibial Fracture

This study aimed to compare the efficacy of pin-tract infection prevention between silversulfadiazine and dry dressing.

Methods: 30 patients with an open tibial fracture admitted to Songklanagarind hospital from September 2007 to June 2008 and treated by emergency debridement and external fixation were randomized into two groups, one treated with silversulfadiazine for infection prophylaxis (15) and a control group treated with dry dressing only (15). All patients were followed until the external fixator was removed. Pin-site infections were assessed and graded at each follow-up visit by an orthopaedist blinded to the mode of treatment. A culture from the pin site was done if an infection occurred.


Eligibility Criteria:
Inclusion Criteria:

* Open tibial fracture treated with external fixator age between 15-60 years

Exclusion Criteria:

* Immunocompromised patients (diabetes, HIV or malignancy)