cyrilzakka/clinical-trials huggingface dataset:
Safety Study of Alfalastin (Human Alpha-1 Antitrypsin) Administered at Home

The purpose of this study is to collect safety data on ALFALASTIN® infusions performed at home or in out-of hospital locations.

Non interventional, observational, longitudinal, prospective, multicenter, non comparative study.

Eligibility Criteria:
Participation Criteria:

* Patients above 18 y.o,
* suffering from severe forms of primary alpha-1 antitrypsin deficiency, phenotype PiZZ or PiSZ with pulmonary emphysema,
* currently treated as per routine practice, once a week, by ALFALASTIN® at home or in out-of-hospital location
* and having signed informed consent.
A 3-way Cross-over Study on the Effects of QRL-101 on Transcranial Magnetic Stimulation and Nerve Excitability in Healthy Participants

This is a phase I, prospective, single-center, randomized, double-blind, placebo-controlled, three-way cross-over study to evaluate the safety and tolerability of QRL-101 and investigate the pharmacodynamic effects of two dose levels of QRL-101 on transcranial magnetic stimulation (TMS) and nerve excitability threshold tracking (NETT) in healthy participants.

After screening and training, participants will be randomized to one of six treatment sequences of William's square balanced for first-order carry-over design consisting of two doses of QRL-101 or placebo, with at least seven days between each treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Males and postmenopausal women between the ages ≥ 18 and ≤ 55.
2. BMI ≥ 18.0 and ≤ 32.0 kg/m2, and body weight ≥ 50 kg, at screening.
3. Willing and able to practice effective contraception from the screening through at least 2 days after their last dose of study treatment.
4. Participants must be able to communicate effectively (in Dutch) with the study personnel and be willing to comply with the requirements of the study.

Exclusion Criteria:

1. Evidence of any acute or chronic disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study.
2. History or presence of conditions which, in the judgment of the investigator, are known to interfere with drug absorption, distribution, metabolism, or excretion.
3. History or presence of conditions which might increase the risk of performing TMS (e.g., epilepsy, febrile seizures, intracranial mass lesion, hydrocephalus, clinically significant head injury or trauma, metal objects in the brain or skull, cochlear implant or a deep brain stimulation device)
4. Any condition that could interfere with the quality of, or ability to perform, TMS (e.g., an abnormal sleeping pattern, unremovable dreadlocks or hairpieces, or a resting motor threshold (rMT) of more than 75%.

\*Other inclusion and exclusion criteria may apply\*
Phase 1 Study of Trastuzumab Administered as a Single Intravenous Infusion

The primary objective of this study was to demonstrate pharmacokinetic similarity of Mylan trastuzumab (Hercules) versus EU-approved Herceptin® and US-licensed Herceptin® and pharmacokinetic similarity of EU-approved Herceptin® versus US-licensed Herceptin® after 8 mg/kg as single dose administered as intravenous infusion over 90 minutes in healthy male subjects based on the equivalence criterion that AUC0-∞, AUC0-last, and Cmax least square mean ratios are bounded within the 90% confidence intervals, 80.00% - 125.00%. Three similarity assessments were performed, 1) Hercules vs. EU-approved Herceptin®, 2) Hercules vs. US-licensed Herceptin® and 3) EU-approved Herceptin® vs. US-licensed Herceptin®. Secondary objectives included further pharmacokinetic assessment of similarity of Hercules, EU-approved Herceptin® and US-licensed Herceptin® λz, tmax and t1/2 along with assessment of safety (including immunogenicity) and local tolerance.

All subjects checked into the clinical facility on the day prior to dosing. On study day 1, each subject received either a single i.v. infusion of 8 mg/kg BW in 250 mL normal saline over a 90 minute period of Mylan trastuzumab (Hercules), EU-approved Herceptin®, or US-licensed Herceptin®. Dosing occurred following an overnight fast of at least 8 hours. On the day of dosing, subjects fasted for the first 3 hours after the start of the infusion then received standard meals approximately 3, 6 and 9 hours post-dose. In each study period, blood samples were collected just immediately prior to dose administration (0 hour) and at 45 and 90 minutes (just prior to end of infusion). Blood samples were collected post-dose at 3, 6, 9, 24 and 48 hours, relative to the start of infusion. The subjects were allowed to leave the clinical facility after the 48-hour blood sample collection. Subjects returned to the clinical facility for the scheduled blood sample collections post-dose on Day 5, 8, 11, 15, 22, 29, 43, 57, and 71. Serum samples were stored at -80°C ± 15°C until shipment for analysis. Blood samples for anti-drug antibodies (ADA) were collected prior to dosing on Day 1 and on Day 71. Blood samples for C-reactive protein (CRP) were obtained at Screening, prior to dosing and at 3, 24 and 48 hours post-dose and on Day 8 and 71. Blood samples for analysis of immunoglobulins were collected prior to dosing on Day 1 and on Day 8 and 71.

Eligibility Criteria:
Inclusion Criteria:

* healthy adult subjects, age 18 to 55 years old
* able to understand procedures, agree to participate and willing to give informed consent

Exclusion Criteria:

* history of any significant disease
* use of any medication 7 days prior to start of study
* participation in a clinical trial within 30 days of start of study
Generic Substitution of Original Levetiracetam in Thai Epilepsy Patients

The retrospective pre-post observational study was conducted to evaluate the real-world evidence of efficacy and tolerability of generic levetiracetam (oral tablet) which was switched from original levetiracetam (oral tablet) in patients with epilepsy at the national hospital for neurology and neurosurgery in Thailand. Epilepsy patients who received generic substitution to original levetiracetam at the same dose and had stable conditions of seizure were only included. In the period of 6 months, the investigators assessed the change of seizure frequency, the incidence of hospitalization due to breakthrough seizure, the incidence of adverse events and the incidence of composite outcomes related to dosage adjustment of antiepileptic drugs.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of epilepsy for at least 6 months prior to generic levetiracetam substitution;
* Same dosage form and strength of generic substitution to original levetiracetam;
* Stable dose of original levetiracetam and stable seizure frequency prior to generic levetiracetam substitution;
* Stable dose of generic levetiracetam after generic levetiracetam substitution

Exclusion Criteria:

* Absence seizure with levetiracetam monotherapy;
* Original levetiracetam in dosage form of oral solution or intravenous solution prior to generic levetiracetam substitution;
* Poor compliance;
* Death or loss of follow up;
* Unavailable data for evaluation of outcomes
Evaluation of the Performance of the Motus Cleansing System (MCS)

The study is multi-center study ,planned as a single arm, open trial, aimed at evaluating the performance and safety of a colon cleansing device during a colonoscopy procedure in a poorly prepared colons.

Total of 47 subjects are planned to be enrolled at 3 clinical sites (1 in Germany and 2 in the Netherlands).

Subjects who meet the eligibility criteria will be screened for study participation at a baseline visit(visit 1). Subject who is eligible to the study will required to follow a specific reduced preparation instruction starting 2 days prior to the colonoscopy with the Motus Cleansing System (MCS) procedure.

Following the procedure a telephone follow-up will be conducted at 48 hours (± 24 hours) and 14 days (± 3 days) post MCS procedure to assess patient well-being and capture any Adverse Events (AE).

Eligibility Criteria:
Inclusion Criteria:

1. Subjects being considered for diagnostic, screening or surveillance colonoscopy
2. Subjects in the age range of 18-75 years inclusive
3. Subjects with BodyMass Index (BMI) within the range of 18.5-35 inclusive
4. Subject has signed the informed consent

Exclusion Criteria:

1. Subjects with known Inflammatory Bowel Disease
2. Subjects with known diverticulitis disease or with prior incomplete colonoscopy due to diverticular disease
3. Subjects with known or detected (during colonoscopy) bowel obstruction
4. History of prior surgery to colon and/or rectum
5. ASA≥IV
6. Renal insufficiency (Creatinine ≥ 1.5mg /dL) (based on medical history)
7. Abnormal Liver enzymes (ALT/AST ≥ 2 times upper limits of normal) (based on medical history)
8. Subjects taking anticoagulants drugs (excluding aspirin) or dual antiplatelet therapy
9. Subjects with known coagulation disorder (INR \>1.5).
10. Subjects treated with H2 receptor antagonists or proton pump inhibitors within the 72 hours prior to consuming the Bisacodyl
11. Subjects with active, ongoing lower GI bleeding with hemodynamic instability.
12. Subjects with known Mega Colon
13. Pregnancy (as stated by patient) or breast feeding
14. Subjects with altered mental status/inability to provide informed consent
15. Patients who have participated in another interventional clinical study in the last 2 months
General Anesthesia Exposure and Neurodevelopmental Outcome in Pediatrics

This study investigates the impact of different levels of anesthesia exposure on children's neurocognitive development and evaluates the concurrent validity of different methods that assess neurodevelopmental outcome.

The US Food and Drug Administration (FDA) recently released an official warning regarding the potentially harmful impact of repeated and prolonged (more than three hours) general anesthesia on the child's brain. The potential impact of anesthesia highlights the importance of remediating the need for repeated and prolonged surgery with accompanying anesthesia exposure in a time of cerebral vulnerability and if possible, delay exposure to avoid potentially preventable harm. Therefore, it is crucial to better understand the impact of (different durations and frequencies of) anesthesia exposure on neurodevelopment.

Eligibility Criteria:
Inclusion Criteria:

* Age 12 months (± four weeks) with a history of general anesthesia exposure (patient group) or without a history of general anesthesia (healthy controls)

Exclusion Criteria:

* Children with comorbid conditions affecting structure and/or function of the central nervous system (e.g. premature birth) will be excluded from participation in this study.
Long-term Results of Percutaneous Left Atrial Closure at Brest University Hospital (CLAPOT)

Atrial Fibrillation represents an important risk of cardioembolic stroke. In more than 90% of cases, thrombus originate in the left atrial appendage. Therefore guidelines recommend the anticoagulation of patients with atrial fibrillation and a significant cardioembolic risk, predicted by the CHA2DS2VASc score.

However, serious bleeding complications may definitively contraindicate the use of anticoagulants.

For those patients, percutaneous Left Atrial Appendage Occlusion (LAAO) has became a recommended alternative to prevent the thrombus formation and reduce the risk of cardioembolic events.

In the CHU of Brest, more than 120 patients have been treated with LAAO for the last 8 years with two different occluder devices : WATCHMAN®, Boston Scientifc and AMPLATZER Amulet®, Abbott Laboratories.

This retrospective longitudinal observational study named CLAPOT (CHU of Brest' Left Atrial Appendage Percutaneous Occlusion Treatment) aims to evaluate the long term results of this procedure for effectiveness and safety and to compare the results between the two devices (Watchman and Amplatzer).


Eligibility Criteria:
Inclusion Criteria:

* Major
* Non opposition
* All patients with non-valvular atrial fibrillation and a definitive contraindication to anticoagulants who underwent left atrial appendage occlusion in the CHU of Brest between December 2014 and August 2023

Exclusion Criteria:

* Minor
* Patients under tutorship or curatorship
* Formulated opposition
Evaluate the Efficacy and Security of Darunavir/Ritonavir 900/100 mg Once a Day as an Antiretroviral Treatment Simplification Strategy

Basing in studies which have related the darunavir (DRV) virtual inhibitory quotient (vIQ) with the virological response, it is possible to think in the possibility of simplifying the rescue treatment with DRV/ritonavir to 900/100 mg once a day in those patients who are being treated with DRV/ritonavir 600/100 mg twice a day and who, besides having undetectable viral load, have a vIQ over 2. This strategy would not jeopardize the efficacy of the antiretroviral treatment and would have less impact in the lipid profile of the patients as well as less pharmaceutical expenditure.

The probability of achieving viral replication suppression during the treatment with DRV has been related to both the extent of viral resistance to DRV (inhibitory concentration 50%, IC50) and the drug concentration. Moreover, the DRV virtual inhibitory quotient (vIQ) has been related significantly with the virological response to DRV treatment. So patients with a DRV vIQ \>= 1,5 had a 8-times higher probability of having viral load \< 50 copies/mL after 24 weeks of treatment than those having a vIQ \< 1,5.

Considering the previous arguments, it is possible to think in the possibility of simplifying the rescue treatment with DRV/ritonavir to 900/100 mg once a day in those patients who are being treated with DRV/ritonavir 600/100 mg twice a day and who, besides having undetectable viral load, have a DRV vIQ over 2. This strategy would not jeopardize the efficacy of the antiretroviral treatment and would have less impact in the lipid profile of the patients as well as less pharmaceutical expenditure.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>= 18 years.
2. HIV-infected patients.
3. Stable antiretroviral treatment including darunavir/ritonavir 600/100 every 12 hours for at least 4 weeks.
4. HIV viral load \< 50 copies/mL for at least 12 weeks.
5. Resistance test (Genotype or Virtual Phenotype) before starting tipranavir treatment.
6. Darunavir vIQ \>= 2.
7. Subject able to follow the treatment period.
8. In women, negative pregnancy test or not in fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or undertaking to use a barrier contraceptive method during the study.
9. Signature of the informed consent.

Exclusion Criteria:

1. AIDS-defining illness in the last 4 weeks.
2. Suspicion of unsuitable antiretroviral treatment compliance.
3. In women, pregnancy or breastfeeding.
4. Record or suspicion of incapability to cooperate as appropriate.
Correlation Between Optical Coherence Tomography Angiography and Photopic Negative Response in Patients With Glaucoma

Open angle glaucoma (OAG) is considered a common cause of irreversible vision loss worldwide. It is an optic neuropathy associated with progressive loss and degeneration of the retinal ganglion cell layer (RGC) and its axons (retinal nerve fiber layer; RNFL), which lead to neuroretinal rim excavation and corresponding visual field defects.

Open angle glaucoma (OAG) is considered a common cause of irreversible vision loss worldwide. It is an optic neuropathy associated with progressive loss and degeneration of the retinal ganglion cell layer (RGC) and its axons (retinal nerve fiber layer; RNFL), which lead to neuroretinal rim excavation and corresponding visual field defects.

OCT Angiography (OCTA) is a promising tool for diagnosing and monitoring glaucomatous patients. It can evaluate glaucomatous damage and assess the ganglion cells' health by measuring blood flow within the optic nerve and the retina Correlation between vascular , structural and functional changes of the peripapillary retinal nerve fiber (RNFL) and macular/ganglion cell complex (GCC) can lead to early detection of glaucomatous changes.

Eligibility Criteria:
Inclusion Criteria:

* Age of 30 years or older for both control and glaucoma groups.
* Spherical equivalent (SE) between -2 and +2 D.
* No history of previous eye surgery, trauma, or systemic diseases.

Exclusion Criteria:

* Spherical equivalent greater than +/- 2.00 diopters (D).
* Media opacity as (cataract or corneal scar).
* Any history of ocular surgeries or trauma.
* Optic nerve anomaly or other retinal diseases.
* Unreliable visual field tests (33% fixation losses, false positive, and false- negative results).
Comparison Levobupivacaine and Ropivacaine for TAP-block After Caesarean Section

Randomized, double-blind, controlled trial: a comparison of Levobupivacaine and Ropivacaine for postoperative analgesia using TAP-block

Objectives:

1. VAS score during the first 12 hours
2. Determine which drug is more effective for postoperative analgesia in the first 12 hours after surgery
3. Side effects

For TAP-block was used Hirokain® (Levobupivacaine) . Injectable solution 7.5 mg / ml; ampoule polypropylene 10 ml, a pack of cardboard 10; No. ЛП-003106, 2015-07-21 to 2020-07-21 from EbbVi Ltd. (Russia); manufacturer: Kurida AS (Norway); Packer: AbbVi S.r.l. (Italy), or Ropivacaine Kabi (Ropivacaine Kabi) (Ropivacaine) Solution for injection 7.5 mg / ml; ampoule polypropylene 1 10 ml, a pack of cardboard 5; EAN code: 4607085481524; No. ЛП-002897, 2015-03-04 to 2020-03-04 from Fresenius Kabi Deutschland GmbH (Germany); manufacturer: Fresenius Kabi Norge (Norway).

Both preparations were diluted to a volume of 50 ml, at a concentration of 3 mg / ml.

It was performed by TAP-block in-plain with a 22G needle Quincke, on both sides, and 25 ml on each side was injected.

The pain syndrome was assessed with admission, and every 2 hours during the first 12 hours after the operation, using a digital scale on the VAS.

All patients received NSAIDs (Ketorol 3 mg IV every 6 hours from admission)

Additionally:

Paracetamol IV infusion 100 ml with VAS = 4 score, lockout time 6 hours Tramadol 5% - 2 ml IM with VAS = or \> 5 score, lockout time 6 hours

Eligibility Criteria:
Inclusion Criteria:

* Cesarean section pfannenstiel incision under spinal anesthesia
* Spinal anesthesia with Bupivacaine heavy 0,5%
* Without any adjuvants

Exclusion Criteria:

* Any other anesthesia exept spinal
* Any other surgical incision
Kebele Elimination of Trachoma for Ocular Health

The investigators propose a cluster-randomized clinical trial to determine whether an intensive, targeted azithromycin distribution strategy is effective for elimination of trachoma at the kebele level compared to the World Health Organization (WHO) recommendation of annual azithromycin distribution.

The investigators propose to randomize at the kebele level, which consist of approximately 15 villages, 4,000 residents, and are served by a single primary school. Eighty kebeles will be randomized to one of four arms: 1) annual mass azithromycin distribution per WHO guidelines (Annual); 2) annual mass azithromycin distribution plus quarterly targeted treatment of all children aged 0-9 years (Core Group-Age); 3) annual mass azithromycin distribution plus quarterly targeted treatment of all children aged 0-9 years with a positive chlamydial PCR test (Core Group-PCR); or 4) annual mass azithromycin distribution plus quarterly targeted treatment of all children aged 0-9 years positive for conjunctival inflammation as assessed from annual photography (Core Group-TI). The primary outcome for the trial will be the ocular chlamydia prevalence at 12, 24, and 36 months. Secondary outcomes will include bacterial load of ocular chlamydia via quantitative PCR, the prevalence of clinically active trachoma assessed at 12, 24, and 36 months, and serology via dried blood spot at baseline and 36 months.

Eligibility Criteria:
Inclusion Criteria:

* All individuals in all communities will be eligible for annual mass azithromycin distribution per WHO guidelines.

Exclusion Criteria:

* Those who do not consent.
The KP Personal Shopper: A Pilot to Improve the Impact of Dietary Advice

Randomized trial of grocery-store based nutrition counseling visits for weight management vs. in-office visits. The investigators will test pre- and post-intervention individual-level dietary quality, knowledge, self-efficacy around dietary choice, and cost of shopping, measuring difference between intervention and control arms. At the study's end, the investigators will also conduct focus groups with a subset of 20 patients (10 from each arm) and do a structured interview with the dietitian to better understand the feasibility, strengths and shortcomings of this approach. Patients who complete the main portion of the trial will be randomly selected for recruitment into a focus group and consented separately for that focus group at the end of the study.

The investigators hypothesize that, compared to office-based visits, the KP Personal Shopper visits will result in higher member diet quality scores, better nutritional knowledge scores, higher self-efficacy and confidence around food purchasing decisions, and more favorable perception of the visit by both dietician and member. The KP Personal Shopper approach may also result in increased grocery store costs for some members. Long-term, the investigators hypothesize that improvements in member perception, knowledge and dietary quality will lead to improved health outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Employee population of a specific Southeastern U.S. County
* 18-64 years of age
* Body Mass Index greater than or equal to 30kg/m\^2 (Obese)
* Low rate of no-shows for office visits (\<10%)
* Saw PCP or other provider in past 12 months
* Does at least 50% of the food shopping and/or food preparation for their household

Exclusion Criteria:

* non-English speaking
* Currently being treated for cancer (other than non-melanoma skin cancer)
* Pregnant or planning pregnancy in the next 6 months
* Had or considering having bariatric surgery
* Currently participating in commercial weight loss program (e.g. Jenny Craig)
* Currently enrolled in another weight management or nutrition study
Comparing CO2 Laser and Electrosurgical Treatments for Perianal Condyloma

Perianal condyloma are skin- colored and fleshy lesions caused by various variants of Human Papilloma Virus (HPV), most commonly 6 and 11. The treatment modalities available include topical options like podophyllin, imiquimod cream, trichloroacetic acid and cryotherapy, injectable options like interferon and 5-fluoroucil, and surgical options like excision, fulguration, cryotherapy, and laser removal. However, the treatment is usually short-lived, and the patients are subjected to multiple repeat procedures because of high recurrence and low clearance rates. Surgical management has the highest clearance rate. There are several surgical modalities including excision, electrosurgical fulguration (ESF), and LASER vaporization. LASER techniques work directly to destroy/transect the lesion, cause necrosis of infected keratinocytes and induce local inflammation. LASER treatment is also reported to have minimal local surrounding tissue injury and sphincter injury, and less pain and discomfort. For this reason, LASER therapy has been increasingly used to remove anogenital warts, and is a standard of care treatment of condyloma. We hypothesize that LASER vaporization is effective to treat perianal condyloma and may have clinical benefits over ESF. We will compare postoperative outcomes such as pain, healing, cosmesis and recurrence following either treatment method.


Eligibility Criteria:
Inclusion Criteria: Adults (\>18) treated in our CRS department for perianal condyloma, not previously treated surgically, English speaking patients.

Exclusion Criteria: \<18, intra-anal condyloma, previously treated for condyloma, other skin diseases in the perianal region, limited English proficiency.

* Adults unable to consent- exclude
* Individuals who are not yet adults (infants, children, teenagers)- exclude
* Pregnant women- exclude
* Prisoners- exclude