cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Alpha1-Proteinase Inhibitor (Human), Modified Process (Alpha-1 MP) in Subjects With Pulmonary Emphysema Due to Alpha1 Antitrypsin Deficiency (AATD)

This is a multi-center, randomized, placebo-controlled, double blind clinical study to assess the efficacy and safety of two separate dose regimens of Alpha-1 MP versus placebo for 156 weeks (i.e., 3 years) using computed tomography (CT) of the lungs as the main measure of efficacy. The two Alpha-1 MP doses to be tested are 60 mg/kg and 120 mg/kg administered weekly by IV infusion for 156 weeks. The study consists of an optional pre-screening phase, Screening Phase, a 156-week Treatment Phase, and an End of Study Visit at Week 160.


Eligibility Criteria:
Inclusion Criteria:

* Have a documented total alpha1-PI serum level \< 11 µM.
* Have a diagnosis of congenital AATD with an allelic combination of ZZ, SZ, Z(null), (null)(null), S(null), or "at-risk" alleles.
* At the Screening (Week -3) Visit, have a post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 30% and \< 80% of predicted and FEV1/forced vital capacity (FVC) \< 70% (Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] stage II or III).
* Have a carbon monoxide diffusing capacity (DLCO) ≤ 60% of predicted (corrected for HgB) within the past 2 years OR evidence of pulmonary emphysema on CT scan within the past 2 years per the Investigator's judgment.
* Have clinical evidence of pulmonary emphysema per the Investigator's judgment.

Exclusion Criteria:

* Has received alpha1-PI augmentation therapy for more than 1 month within the six months prior to the Screening Visit.
* Has received alpha1-PI augmentation therapy within one month of the Screening Visit.
* Has had a chronic obstructive pulmonary disease (COPD) exacerbation within the 5 weeks prior to the Screening Visit or during the Screening Phase.
* Unable to physically (e.g., unable to fit inside the CT scanner) or mentally (e.g., claustrophobic) undergo a CT scan.
* History of lung or liver transplant.
* Any lung surgery during the past 2 years (excluding lung biopsy).
* On the waiting list for lung surgery, including lung transplant.
* Smoking during the past 12 months or a positive urine cotinine test at screening that is due to smoking. Maybe on Nicotine replacement, including vapor cigarettes.
* History of anaphylaxis or severe systemic response to any plasma-derived alpha1-PI preparation or other blood product(s).
* Use of systemic steroids above a stable dose equivalent to 5 mg/day prednisone (i.e., 10 mg every 2 days) within the 5 weeks prior to the Screening Visit (inhaled steroids are not considered systemic steroids) or during the Screening Phase.
* Use of systemic or aerosolized antibiotics for a COPD exacerbation within the 5 weeks prior to the Screening Visit or during the Screening Phase.
* Known selective or severe Immunoglobulin A (IgA) deficiency.
Simultaneous CLE Guided Crybiopsy in Patients With Pulmonary Nodules

It is planned to use the CLE probe and cryoprobe simultaneously after detection of the round focus.

It is planned to include 5 patients with suspected central airway invading lung carcinoma and 15 patients with suspected peripheral lung carcinoma who have an indication for bronchoscopic histologic confirmation.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years
* Suspicion of lung carcinoma

Exclusion Criteria:

* Known allergy to fluorescin
* Pregnancy and/or lactation
* No discontinuation of ß-blocker 12 hours before intervention possible
TAF Switch Study in Hepatitis B Monoinfection

To evaluate various markers of renal function and bone density after the switch to Tenofovir alafenamide fumarate (TAF) in chronic hepatitis B patients who are currently treated with Tenofovir disoproxil fumarate (TDF) .

The investigators have previously reported the prevalence of abnormal renal tubular reabsorption of phosphate among CHB patients treated with more than 18 months of TDF to be 48%. Renal tubular dysfunction associated with TDF may be reversible when TDF is discontinued 4. Recently, TAF 25 mg daily was shown to have comparable efficacy to TDF 300 mg with respect to viral suppression in both HBeAg positive and HBeAg negative CHB patients (studies 110 and 108) at 48 weeks of therapy. As speculated, the systemic exposure to tenofovir was significantly less in patients exposed to TAF compared to those on TDF with strikingly less effects noted in a variety of renal and bone parameters for individuals receiving TAF. Notably, however, the question remains to what if any improvements may be seen in CHB patients switched from TDF to TAF.

The investigators propose a prospective open label study to evaluate various markers of renal function and bone density in 80 CHB patients who are currently treated with TDF who are switched to TAF.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic hepatitis B (who are either HBeAg reactive or non-reactive)
* Treated with TDF with unquantifiable Hepatitis B Virus (HBV) DNA by a sensitive Polymerase chain reaction (PCR) assay for a minimum of 6 months
* No prior nucleos(t)ide exposure prior to treatment with TDF
* Treatment with TDF for a minimum of 12 months

Exclusion Criteria:

* HIV Infection
The Aim of This Project is to Verify Whether a Depletion of B Cell Memory Subpopulation ("Marginal-zone-like") CD19 + IgD + CD27 + and CD19 + IgM + CD27 + is a Useful Indicator of Hyposplenism in Patients With Celiac Disease

This project is expected to confirm the hypothesis that hyposplenism in patients with celiac disease is not conditioned by a selective memory deficiency of B lymphocytes.

Other objectives of project are:

* determination of gliadin 33-mer in faecal and urine as indicators patient´s adherence to gluten-free diet
* determination of citrulline in plasma as an indicator of the overall functional capacity enterocytes

Ultrasound examination is focused to spleen size (spleen volumetry). Methodology of laboratory examinations is based on venous blood sampling for the determination of memory B-like marginal zone by flow cytometry; gliadin 33-mer (ELISA) determination in faecal and urine sample; blood plasma extraction for citrulline (high performance liquid chromatography, HPLC).

Eligibility Criteria:
Inclusion Criteria:

* diagnosed celiac disease
* age over 18 years

Exclusion Criteria:

* haematological diseases and cancer
* infectious and non-infectious inflammation of the small intestine
* congenital or acquired immunodeficiency
* autoimmune disease
* immunosuppressant treatment
* diabetes mellitus
* pregnancy and lactation
Study of Duloxetine in Elderly Patients With Major Depressive Disorder

A study of the safety and efficacy of duloxetine in elderly patients (greater than 65 years old) with major depressive disorder

Duloxetine 60 mg QD and placebo variable-duration, placebo lead-in period 9 weeks in the acute treatment phase

Eligibility Criteria:
Inclusion Criteria:

* You must be able to visit the doctor's office for clinic visits, tests, and procedures.
* You must have been diagnosed with major depression, and have had at least one other episode in the past.

Exclusion Criteria:

* You have a current or previous major psychiatric disorder other than depression, such as bipolar disorder, schizophrenia, or other psychotic disorder.
* You have taken a drug within the last 30 days that has not been approved for use by governmental authorities.
Tissue Characterization From Various Parts of the Gastrointestinal Tract in Healthy Volunteers

Tissue characterization will be performed, from different regions of the gastrointestinal tract in healthy volunteers.

During an endoscopic examination tissue samples will be taken from different regions of the gastrointestinal mucosa. The tissue samples will be used to characterize bacterial markers in the various intestinal segments.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers,
* Age: 20-60 years,
* Consent to perform endoscopic examination.

Exclusion Criteria:

* Antibiotics - a month prior to participation in the study,
* A chronic health condition.
Ultrasound Guided Rhomboid Intercostal Subserratus Plane Block vs Erector Spinae Plane Block in Open Nephrectomy

Our aim is to measure the efficacy of rhomboid intercostal subserratus plane block and erector spinae plane block in comparison to thoracic epidural block in patients undergoing open nephrectomy

Open nephrectomy incision is associated with a high incidence of intense immediate postoperative pain and chronic pain the months following surgery. Regional anesthesia techniques are commonly recommended for pain management in open nephrectomy as they decrease parenteral opioid requirements and improve patient satisfaction. Rhomboid intercostal subserratus plane block (RISS) is considered a novel approach for chest wall and upper abdominal analgesia, initially showed promising results, first reported in 2016. Erector Spinae Plane block (ESB), was initially described in 2016 for analgesia in thoracic neuropathic pain. It has also been widely used in both adults and children at different levels for different indications. Epidural analgesia is the gold standard for perioperative analgesia in open surgery. Epidural analgesia-related significant complications can include epidural hematoma, postoperative neurologic deficit, and post-dural puncture headache, and anesthesiologists are searching for alternative analgesic modalities that have adequate analgesia and a lower complication risk.

Eligibility Criteria:
Inclusion Criteria:

1. Type of surgery; open nephrectomy.
2. Physical status ASA II, III.
3. Body mass index (BMI): \> 20 kg/ m2 and \< 35 kg/ m2.

Exclusion Criteria:

1. Patient refusal.
2. Local infection at the puncture site.
3. Severe respiratory or cardiac disorders.
4. Advanced liver or kidney disease.
5. History of psychological disorders and/or chronic pain.
6. Contraindication to regional anesthesia e.g. local sepsis, pre- existing peripheral neuropathies and coagulopathy.
7. Patients with known sensitivity or contraindication to amide local anesthetics used in the study.
Rapid Diagnostic Tests for Assessment of Initial Clearance and Detection of Recurrent Malaria Infections

The aim of the study was to follow clearance of malaria infections and detection of new malaria episodes after initiation of antimalarial treatment in Tanzanian children. For this purpose the investigators used five diagnostic tools, 2 Rapid Diagnostic tests based on Histidine Rich Protein 2(HRP2) and Lactate dehydrogenase(LDH), 2 microscopical methods and one polymerase chain reaction (PCR). The investigators followed the 53 enrolled children during 42 days.


Eligibility Criteria:
Inclusion Criteria:

* children between 6-59 months
* fever (≤37.5 C) or history of fever during the preceding 24 hours
* confirmed P.falciparum monoinfection
* uncomplicated malaria
* parasite density between 2000-250.000/µL
* willing/able to comply with the 42 day follow up
* informed concent from patient/guardian

Exclusion Criteria:

* children with history of antimalaria drug intake within the last two weeks
* symptoms / signs of severe disease
Tranexamic Acid for The Treatment of Gastrointestinal Bleeding

Studies showed that in cases of gastrointestinal bleeding, injection tranexamic acid decreasing the risk of death and the need of surgical intervention. However, the quality of most clinical trials were not good and the results were not significant. Injection tranexamic acid does not become one of the treatment option in the international guidelines nor in national consensus, so the effectiveness and the safety of its use in the treatment of gastrointestinal bleeding remains unclear and not routinely used.

In Indonesia, injection tranexamic acid in gastrointestinal bleeding is limitedly used and recorded. Therefore, a clinical trial study of injection tranexamic acid is required to assess the effectiveness and the safety in the treatment of gastrointestinal bleeding.

This study is a randomized double-blind controlled trial study. Interventions were given in the form of tranexamic acid injection compared to placebo in patients with acute upper and lower gastrointestinal bleeding. Tranexamic acid were administered intravenously 1 gram loading dose, followed by 3 grams maintenance dose in infusion for 24 hours. Other routine and standardized drugs for gastrointestinal bleeding will still be given. Statistical analysis will use: Chi square test or Kolmogorov-Smirnov with alternative Fisher test for categorical dependent-variable; Independent T-Test with alternative Mann-Whitney test for two-group numerical dependent-variable; and one-way ANOVA with alternative Kruskal-Wallis for more than two-groups numerical dependent-variable.

Eligibility Criteria:
Inclusion Criteria:

* Adults
* Patients with acute lower and upper gastrointestinal bleeding (assessed clinically)
* Patients agreed to participate in the study and signed the informed consent

Exclusion Criteria:

* Allergy with tranexamic acid
* Patients considered by the clinician can not be randomized to participate in the study
* Patients with chronic kidney disease stage III - V
Initial Case Series With Exalt Single-Use Duodenoscope

To confirm procedural performance of the Exalt single-use duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) procedures.

This study is a prospective, multi-center case series of per standard of care ERCP procedures using a nonsignificant risk single-use duodenoscope. 35-70 cases will be included at up to 10 clinical sites. Patients who meet all eligibility criteria will be included and will have a clinically indicated ERCP procedure performed using the study device. Enrolled subjects will be followed for 7 days after their procedure.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
* Scheduled for a clinically indicated ERCP

Exclusion Criteria:

* Altered pancreaticobiliary anatomy
* Potentially vulnerable subjects, including, but not limited to pregnant women
* Subjects for whom endoscopic techniques are contraindicated
* Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor
* Investigator discretion
Anterior Cruciate Ligament Reconstruction With a Periosteal - Patellar Tendon - Bone Autograft - The Kocabey Press-Fit Technique

This study aims to evaluate the clinical and radiological outcomes of patients undergoing anatomical single-bundle anterior cruciate ligament reconstruction with periosteal-patellar tendon-bone autograft and press-fit tibial fixation technique. The study also aims to compare these outcomes with other reconstruction techniques in the literature. The research investigates the results of a novel surgical technique, providing a minimally invasive and faster rehabilitation for patients undergoing surgery due to anterior cruciate ligament rupture. The technique does not use any screws or staples for tibial fixation, but it carries similar risks as existing techniques. The technique, similar to the well-known bone-patellar tendon-bone (BPTB) autograft technique, creates minimal bone defect at the tibial tuberosity. Over time, the defect remodels and causes minimal clinical discomfort. Despite these limitations, the authors expect patients operated with the investigated new technique to experience less postoperative swelling, less pain, faster mobilization, and earlier rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* patients who underwent anatomical single-bundle anterior cruciate ligament reconstruction with periosteal - patellar tendon - bone autograft and press-fit tibial fixation technique after anterior cruciate ligament rupture
* patients with at least 1 year of clinical and radiological follow-up
* patients who did not undergo a revision

Exclusion Criteria:

* Patients who underwent a secondary arthroscopy for any reason after primary surgery
* Patients with a history of septic arthritis (before and after the surgery)
* Those with a history of trauma after primary surgery to the operated knee
* Patients who have not completed at least 1 year of follow-up
Climate Labels for Restaurant Menus Pilot

The aim of this study is to compare responses to 6 different types of labels for restaurant menus: 1) a QR code on all items (control); 2) High Climate Impact label; 3) High Climate Impact Warning label; 4) Climate Grade label; 5) Climate Grade label also displaying full range of possible grades; 6) Estimated Environmental Cost label. Participants will be randomized to 1 of these 6 labeling arms. Each participant will view a menu based on a real-world restaurant with one of the 6 labels shown on applicable menu items, select the menu item they would like, and then respond to survey questions about each label.

This is an online randomized controlled trial in which researchers will use a survey company to recruit participants to an online survey. In the study, participants will be randomized to 1 of 6 labeling arms: 1) a QR code on all items (control); 2) High Climate Impact label; 3) High Climate Impact Warning label; 4) Climate Grade label; 5) Climate Grade label also displaying full range of possible grades; 6) Estimated Environmental Cost label. Labels will only appear alongside main menu items and will be assigned using thresholds for greenhouse gas emissions set a priori in kilograms of CO2 equivalent per kilogram of food. Each participant will view a menu based on a real-world restaurant with one of the 6 labels shown on applicable menu items, select the menu item they would like, then respond to survey questions about each label.

For dichotomous outcomes, the investigators will directly estimate the probability ratio using Poisson regression with a robust error variance, regressing the outcome on indicators for experimental condition. For continuous outcomes, the investigators will use linear regression models, regressing the outcome on indicators for experimental condition. A critical alpha 0.05 will be used, and statistical tests will be two-tailed. Investigators will compare all experimental label conditions to the control label, then compare each experimental label to each other using pairwise comparisons.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* English-speaking
* U.S. residents
* Have eaten restaurant food at least once in the last month
* Participants will reflect the U.S. Census Bureau's American Community Survey estimates for sex, race/ethnicity, educational attainment, and age

Exclusion Criteria:

* Non-US resident
* Younger than 18 years old
* Failing the attention check question
* Completing the survey in less than 33% of the median completion time
Safety Study of the Switch From Oral Selexipag to Intravenous Selexipag in Subjects With Stable Pulmonary Arterial Hypertension

The development of selexipag for intravenous administration will be useful to avoid treatment interruptions in patients with pulmonary arterial hypertension (PAH) already treated with selexipag administered orally as tablets (Uptravi®). The target population for intravenous selexipag includes those PAH patients who are hospitalized and are unable to swallow tablets of Uptravi.

The primary objective of this study is to assess whether it is safe for patients with PAH to temporarily change from selexipag tablets (Uptravi®) to selexipag given directly into a vein (intravenous selexipag), and then switching back to the initial oral dose of selexipag.

After screening (Visit 1), each subject will participate in the following consecutive treatment periods: Period 1(treatment with oral selexipag at Visit 2/Day 1), Period 2 (treatment with intravenous selexipag at Visit 2/ Day 2 and Day 3), Period 3 (treatment with oral selexipag starting in the evening of Visit 2/Day 3 and ending 7 to 11 days later at Visit 3). Then a safety follow-up period is planned up to end of study visit (EOS), which occurs between Day 33 and Day 40.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form prior to any study-mandated procedure.
* Male and female subjects aged from 18 to 75 years (inclusive),
* Subjects with stable pulmonary arterial hypertension (PAH) defined as WHO Functional Class I-III at Visit 1 and Visit 2, and no change (i.e., introduction or dose change) in PAH-specific medication (i.e., ERA, PDE-5 inhibitor or sGC stimulator) and diuretics in the last 28 days prior to Visit 2.
* Subjects currently treated with Uptravi® at a stable dose (i.e. unchanged dose) for at least 28 days before Visit 2.
* Women of childbearing potential must have a negative pregnancy test at Visit 1 (screening) and Visit 2.

Exclusion Criteria:

* Pregnant, planning to become pregnant or lactating.
* Known and documented moderate or severe hepatic impairment.
* Subjects having received gemfibrozil at any time since initiation of Uptravi®.
* Treatment with any prostacyclin and prostacyclin analogs within 28 days prior to Visit 1.
* SBP \< 90 mmHg at Visit 1 or at Visit 2.
* Known or suspected uncontrolled hyperthyroidism.
* Severe renal failure and ongoing or planned dialysis.
* Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of the results.
* Known concomitant life-threatening disease with a life expectancy \< 12 months.
* Treatment with another investigational treatment within 3 months of Visit 1.
Foot and Lower Extremity Exercises in Adolescents With Pes Planovalgus

The study aims to determine and compare the effects of 8-week intrinsic foot muscle-strengthening exercises and lower extremity strengthening exercises in adolescents with pes planovalgus.


Eligibility Criteria:
Inclusion Criteria:

* Age between the 12-18 years,
* Foot posture index-6 score \> 6,
* Navicular drop test value \> 1 cm,
* Body mass index between 18.5 - 25 kg/m2,
* Children with flexible pes planovalgus

Exclusion Criteria:

* Presence of any pathology that prevents participation in exercises
* Diagnosis of any neurological, psychological, or metabolic disease
* History of orthopedic surgery
* Use of insoles in the last 1 year
* Leg length discrepancy and scoliosis