cyrilzakka/clinical-trials huggingface dataset:
ROSA Robot Used in Total Knee Replacement Post Market Study

This is a prospective, multicenter clinical study designed to facilitate the collection and evaluation of workflow efficiency, patient pain and function, and adverse event data. This clinical study will include Persona, NexGen, and Vanguard product families using the ROSA Total Knee Robotic System or conventional instrumentation. The primary objective of this study is to collect and compare clinical and surgical data using the commercially available ROSA Total Knee robotic instrumentation and conventional instrumentation.

The primary objective of this study is to collect and compare clinical outcomes data using the commercially available ROSA Total Knee robotic instrumentation and conventional instrumentation.The assessments will include:Planned vs actual component positioning, workflow efficiency, patient safety based on incidence and frequency of adverse events, and clinical performance measured by overall pain and function, quality of life data, and radiographic parameters.

Eligibility Criteria:
Inclusion Criteria:

* Patient is a minimum of 18 years of age
* Independent of study participation, patient is a candidate for commercially available Persona, NexGen, and Vanguard knee components implanted in accordance with product labeling
* Patient has participated in this study-related Informed Consent process
* Patient is willing and able to provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent form
* Patient is willing and able to complete scheduled study procedures and follow-up evaluations

Exclusion Criteria:

* Patient is currently participating in any other surgical intervention studies or pain management studies
* Patient has underwent contralateral UKA or TKA within the last 18 months
* Hip pathology with significant bone loss (e.g. avascular necrosis of the femoral head with collapse, severe dysplasia of the femoral head or the acetabulum)
* Hip pathology severely limiting range of motion (e.g. arthrodesis, severe contracture, chronic severe dislocation)
* Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)
* Patient has previously received partial or total knee arthroplasty for the ipsilateral knee
A Phase II, Randomized Study of ACZONE™ (Dapsone) Gel, 5% for Papulopustular Rosacea.

The purpose of this study is to evaluate the safety and effectiveness of ACZONE™ gel compared to placebo (inactive substance), MetroGel® and a combination of ACZONE™ gel and MetroGel® for the treatment of rosacea.

ACZONE™ gel, 5% is a topical (applied to the skin) medication that is approved by the United States Food and Drug Administration (FDA) for the treatment of acne vulgaris in people 12 years and older. The use of ACZONE™ for the treatment of rosacea is investigational. An investigational use is one that is not approved by the FDA.

Subjects will apply the study treatment for 12 weeks. Efficacy assessments will be performed at baseline and Weeks 2, 4, 8, and 12. Laboratory assessments will be conducted at baseline and Week, 2, 4 and 12.

Study Objective:

•To evaluate the safety and preliminary efficacy of ACZONE in subjects with papulopustular rosacea

Study Population: Approximately 400 male and female subjects will be enrolled at 27 study centers in the United States.

Study Treatment: Subjects will be randomized to 1 of 5 treatment regimens. Subjects will receive study medication for 12 weeks. Study participation is 13 weeks (5 clinic visits and 1 telephone follow-up).

Eligibility Criteria:
Inclusion Criteria:

To be eligible for the study, subjects must fulfill all of the following criteria:

1. Men or women ≥18 years of age.
2. A diagnosis of papulopustular rosacea, with ≥10 inflammatory lesions (papules and/or pustules) above the mandibular line at baseline.
3. An Investigator Global Assessment (IGA) score ≥2
4. In good physical and mental health.
5. Signature of an approved informed consent form for the study and HIPAA authorization (if applicable).
6. Willingness to comply with the protocol.

Exclusion Criteria:

Subjects meeting any of the following criteria will be excluded from the study:

1. A skin examination reveals the presence of another skin disease and/or condition (excessive facial hair, excessive scarring, sunburn, or other disfigurement) located on the face that would confound the evaluation of the rosacea condition.
2. Current or past ocular rosacea, such as conjunctivitis, iritis, and keratitis, of sufficient severity to require topical or systemic antibiotics.
3. Treatment with topical antibiotics, topical steroids and other topical rosacea treatments on the face within 14 days of Baseline and throughout the study.
4. Treatment with systemic steroids within 30 days of Baseline and throughout the study.
5. Treatment with any systemic antibiotics within 30 days of Baseline and throughout the study.
6. Treatment with any systemic medication or therapy known to affect inflammatory responses within the 30 days prior to Baseline or throughout the study.
7. Treatment with topical retinoids within 30 days or systemic retinoids within 180 days of Baseline and throughout the study.
8. Treatment with physical modalities that could benefit rosacea are prohibited within 30 days of Baseline and throughout the study.
Assessment of AFP and PIVKA-II as Prognostic Indicators in Liver Transplantation for Hepatocellular Carcinoma

As key biomarkers in HCC, AFP and PIVKA-II reflects biological features of tumor and has been widely applied for clinical diagnosis. Previous studies reported preoperative AFP and PIVKA-II are related to HCC recipient long-term survival after liver transplantation. However, there is no prospective study supporting these conclusions. This study aims to prospective collect liver transplantation cases from multiple transplant centers and further evaluate the prognostic role of preoperative AFP and PIVKA-II in liver transplantation for HCC.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of HCC based on CT or MRI imaging or needle biopsy confirming a histologic diagnosis of HCC.
2. Patients undergoing deceased donor liver transplantation for the first time.

Exclusion Criteria:

(1) patients who received split LT or simultaneous transplantation, (2) patients who received re-transplantation, (3) patients with macroscopic portal vein tumor thrombosis or other macrovascular invasion, (4) patients with incomplete follow-up, (5) taking warfarin at the time of LT biomarker measurements
Detecting SARS-CoV-2 in Tears

Purpose:

* To determine the presence of SARS-CoV-2 in tears
* To determine SARS-CoV-2 receptors in tear production system

This is a prospective case series. NP swab and tear samples will be collected simultaneously from the confirmed or suspected COVID-19 patients. The samples will be transferred to the lab for SARS-CoV-2 testing. The presence of absence of SARS-CoV-2 will be compared in tears versus NP swabs.

The second part of the study is a histopathology examination series. Normal lacrimal gland and ocular surface tissue samples already stored at the UMN ocular pathology lab and Lion's Gift of Sight Eye Bank will be used for IHC staining for ACE2 and similar targets.

Eligibility Criteria:
Inclusion Criteria:

- Patients presenting at study sites with confirmed or suspected COVID-19

Exclusion Criteria:

* Pregnancy or nursing
* non-English speakers
* Those unable to read
* Those in other vulnerable study populations
Fecal Transplant for Crohn's Disease

To determine the efficacy and safety of serial FMT at inducing and maintaining clinical and endoscopic response in patients with mild to moderate Crohn's disease

Double blind study will randomize patients with mild to moderate Crohn's 1:1 (FMT : water) stratified by disease duration and current use of biologic therapy. First FMT/placebo at week 0 by colonoscopy plus weekly FMT/placebo by capsules for 7 weeks. At week 8, a repeat colonoscopy will be done and endoscopy score repeated.

Responders in FMT arm are eligible to enter open label phase to receive FMT by capsules q2 weeks.

Blood, stool and urine samples, colonic biopsies will be collected. Quality of Life as measured by Short Inflammatory Bowel Disease Questionnaire, EuroQol five dimensions, and Work Productivity and Activity Impairment Questionnaire: Crohns disease and dietary intake diary collected.

Colonoscopies recorded and reviewed by a central reader.

Eligibility Criteria:
Inclusion Criteria:

* mild to moderate ileal, ileo-colonic or colonic Crohns disease
* active ileal and/or colonic disease on endoscopy with or without elevated inflammatory markers i.e. C-reactive protein \>8mg/L, elevated fecal calprotectin \>250 ug/g
* If applicable, meds stable as follows: 5-ASA for 4 weeks, prednisone up to 20mg QD for 4 weeks, budesonide up to 6mg QD for 4 weeks, azathioprine, 6-MP and methotrexate for 12 weeks
* Use of effective contraception

Exclusion Criteria:

* Antibiotic exposure within 30 days and probiotic exposure within 14 days
* topical inflammatory bowel disease therapy within 2 weeks
* active perianal disease
* requirement for concurrent antibiotic therapy
* SES-CD score \<5
* severe CD HBI \>25 or need for hospitalization
* abdominal abscess
* extensive colonic resection, subtotal or total colectomy
* ileostomy, colostomy, known fixed symptomatic stenosis or complex fistulae
* evidence of or treatment for C. difficile or other intestinal pathogen including Cytomegalovirus within 28 days
* requiring or expected to require surgical intervention
* history or evidence of adenomatous colonic polyps not removed
* history of evidence of colonic dysplasia
* active substance abuse or psychiatric problems that may interfere with study
* chronic Hep B, C, or HIV infection
* pregnancy or planning to become pregnant
* upper CD
* history of adhesions preventing colonoscopy to cecum
* planned bowel resection within 3 mon of enrollment
Assessment of Metformin as Adjuvant Therapy in Patients With Ulcerative Colitis

Brief Summary:

This is a randomized, controlled study evaluating metformin tablets administered daily for 8 weeks. The purpose of the study is to evaluate the efficacy and safety of metformin in the treatment of mild to moderately active ulcerative colitis. Disease activity will be measured using Mayo score for ulcerative colitis activity. Calculation of the score requires patients to undergo colonoscopy at the start of the study and at week 8.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with mild or moderate ulcerative colitis newly diagnosed by colonoscopy and biopsy according to Mayo endoscopic scoring of ulcerative colitis.
2. Adults (males and/or females) with age range from 18 to 65 years old.
3. Patients on treatment with 5-aminosalisylic acid (5-ASA)

Exclusion Criteria:

1. Patients with severe ulcerative colitis according to Mayo endoscopic scoring of ulcerative colitis.
2. Treatment with systemic or rectal steroids.
3. Treatment with immunosuppressants.
4. Previously failed treatment with a sulphasalazine.
5. Known hypersensitivity to any of study drugs.
6. Hepatic and renal dysfunction.
7. Pregnancy and lactation.
8. History of colorectal carcinoma.
9. History of complete or partial colectomy.
10. Current or previous treatment with metformin for females with polycystic ovarian syndrome.
11. Patients with diabetes mellitus
12. Patients with history of lactic acidosis
13. Patients with disease states associated with hypoxemia including cardiorespiratory insufficiency
14. Positive stool culture for enteric pathogens, positive stool ova and parasite exam.
The Effects of Carperitide on Short and Long-term Prognosis in Patients With Both Cardiac and Renal Failure

Carperitide (alpha-human atrial natriuretic peptide) improves systemic hemodynamics in patients with heart failure through a vasodilatory action, a natriuretic action, and inhibition of the renin-angiotensin-aldosterone system and has been widely-used in Japan. However, a paucity of report is available on the effects of carperitide on short and long-term prognosis in patients with both cardiac and renal failure. The purpose of this study is to evaluate the effects of carperitide therapy on short and long-term prognosis in patients with both cardiac and renal failure, in comparison with standard therapy.


Eligibility Criteria:
Inclusion Criteria:

* Heart failure of any etiology, diagnosed according to Framingham criteria
* Estimated GFR \</= 60 ml/min/1.73 m2)

Exclusion Criteria:

* Severe heart failure required percutaneous cardiopulmonary bypass support (PCPS)
* End-stage renal failure on maintenance dialysis
* Severe hepatic dysfunction
* Severe anemia
* Allergic history of carperitide
* Pregnant women
Enhancing Exposure Therapy for Snake and Spider Phobias

This study tests whether exposure therapy for fear of snakes or spiders is enhanced by the addition of a brief fear retrieval trial prior to treatment, and the use of compound extinction during treatment. The goal of the study is to determine whether these behavioral techniques enhance the efficacy of exposure therapy, one of the most empirically supported treatments for anxiety disorders.

This study tests whether exposure therapy for fear of snakes or spiders is enhanced by the addition of a brief fear retrieval trial prior to treatment, and the use of compound extinction during treatment. The goal of the study is to determine whether these behavioral techniques enhance the efficacy of exposure therapy, one of the most empirically supported treatments for anxiety disorders. Individuals between the ages of 18-65 with elevated fear of spiders or fear of snakes are randomly assigned to one of four treatment conditions (1) standard exposure therapy, (2) exposure therapy with fear retrieval augmentation, (3) exposure therapy with compound extinction augmentation, and (4) exposure therapy with fear retrieval and compound extinction augmentations. All participants undergo an online prescreen and a face-to-face screening assessment to determine eligibility and baseline (pre-treatment) symptom severity. Participants additionally complete assessments directly after treatment (post-treatment), and approximately one week after treatment (follow-up). The pre-treatment assessment occurs 1-14 days prior to treatment, the post-treatment assessment occurs during the treatment visit as soon as the treatment procedure is complete, and the follow-up assessment occurs within a window of 6-14 days after the completion of treatment. Participants complete two behavioral approach tests (in the treatment context and in the generalization context) at pre-treatment, post-treatment, and follow-up. Participants complete a battery of self-report questionnaires at pre-treatment and follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 65.
2. Speaks English fluently.
3. A score of 70 or higher on the Fear of Snakes/Spiders Questionnaire.
4. Demonstrates avoidance during behavioral approach tests (defined as inability to put palm flat on the bottom of a tank containing a snake/spider, and inability to touch a snake/spider with a bare finger).

Exclusion Criteria:

1. Unstable dose of psychotropic medications during the 4 weeks prior to baseline assessment.
2. Currently receiving exposure-based treatment for snake/spider phobia.
3. Currently at risk for suicide.
Human Milk for Congenital Gastrointestinal Disorders

This study aims to identify whether an exclusive human milk diet (EHMD) would improve outcomes in neonates with congenital gastrointestinal disorders (CGD) and by facilitating an earlier transition off of parenteral nutrition (PN).

Infants born with congenital gastrointestinal disorders (CGD) can be very challenging to treat. The CGD require surgery shortly after birth to correct the problems and recovery can take a long time.

During the period of time the infant's intestines are sick or don't work properly, they rely on parenteral nutrition (IV fluids containing carbohydrates, proteins and fats) to meet their nutritional needs. Being on PN for a long time requires special intravenous lines, and increases the risk of blood stream infections and can make the liver sick.

Feeding babies who have these CGD is often very difficult, as the intestine needs to adapt. It needs to make appropriately formed stool to eliminate wastes, but not lose too much water or too many electrolytes. There is often a lot of starting and stopping of feeds. Human milk (HM) is considered the ideal source of nutrition for all infants.

This study aims to identify whether an exclusive human milk diet (EHMD) would improve outcomes in neonates with congenital gastrointestinal disorders (CGD) and by facilitating an earlier transition off of parenteral nutrition (PN).

Eligibility Criteria:
Inclusion Criteria:

1. Admission to participating NICU at less than 7 days of age
2. Birthweight \>1250g and/or gestational age at birth \>32 weeks
3. Less than 7 days of enteral feedings
4. Diagnosis of eligible primary "Congenital Gastointestinal Disorders" defined as: gastroschisis, omphalocele and intestinal atresias
5. Consent to the use of donor human milk products
6. Consent to participate in this study

Exclusion Criteria:

1. Admission to participating NICU at \>7 days of age
2. Birthweight \<1250g and/or gestational age \<32 weeks
3. Diagnosis of non-eligible gastrointestinal disorders: congenital diaphragmatic hernia, midgut volvulus, Hirschsprung's disease, esophageal atresia, imperforate anus
4. Evidence of significant liver dysfunction at time of enrollment (direct bilirubin \>4 and transaminases elevated more than 2 SD above upper limit of normal for age)
5. Liver malformations such as biliary atresia and choledochal cyst
6. Refusal of consent
A Multi-part Study of ALG-000184 to Evaluate Safety, Tolerability, Pharmacokinetics and Drug-drug Interaction Potential After Single and Multiple Doses in Healthy Volunteers

This Phase 1 study consists of two parts, all conducted in healthy volunteers (HVs).

In Part 1, the drug-drug interaction (DDI) potential of ALG-000184 will be explored with Itraconazole; participants will be assigned to receive multiple doses of ALG-000184 and Itraconazole over a two week period.

In Part 2, the drug-drug interaction (DDI) potential of ALG-000184 will be explored with Carbamazepine; participants will be assigned to receive multiple doses of ALG-000184 and ascending doses of Carbamazepine over an 18 day period.

The 2 parts may be conducted in parallel.


Eligibility Criteria:
Inclusion Criteria for All Participants:

1. Male or female between 18 and 55 years of age.
2. BMI 18.0 to 32.0 kg/m\^2
3. Female participants must have a negative serum pregnancy test at screening.
4. Subjects must have a 12-lead electrocardiogram (ECG) that meets the protocol criteria.

Exclusion Criteria for All Participants:

1. Participants with any current or previous illness that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject or that could prevent, limit, or confound the protocol specified assessments or study results' interpretation.
2. Participants with a past history of cardiac arrhythmias, risk factors for Torsade de Pointes syndrome (e.g., hypokalemia, family history of long QT Syndrome) or history or clinical evidence at screening of significant or unstable cardiac disease etc.
3. Participants with a history of clinically significant drug allergy.
4. Participants with excessive use of alcohol defined as regular consumption of ≥14 standard drinks/week (US CDC 2022)
5. Participants that are unwilling to abstain from alcohol use for 1 week prior to start of the study through end of study follow up.
6. Participants with positive results for urine drug screen, alcohol or cotinine test at screening and Day -1.
7. Participants with Hepatitis A, B, C, E or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection.
8. Participants with sensitivity to CYP3A4 or P-gp substrates, inhibitors/inducers.
9. Participants with clinically significant abnormal vital signs or physical examination.
10. Participants with renal dysfunction (e.g., estimated creatinine clearance \<90 mL/min/1.73 m\^2 at screening, calculated by the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula)
Spinal Stabilization Exercise Effects in Hypermobility

The aim of this study is to investigate the effects of an 8-week lumbar spinal stabilization exercise program on pain, trunk muscle endurance and postural stability in women with benign joint hypermobility syndrome


Eligibility Criteria:
Inclusion Criteria:

* volunteers in an age range of 18 to 30,
* being women,
* having benign joint hypermobility syndrome diagnosed according to the Brighton criteria,
* having no contraindication to join an exercise program.

Exclusion Criteria:

* having rheumatologic or neurologic diseases,
* any other pathology involving the musculoskeletal system-history of fractures, joint dislocations, sprains and strains,
* associated connective tissue disorders including Marfan syndrome, Ehlers-Danlos syndrome, osteogenesis imperfecta,
* severe psychological disorders,
* being pregnant,
* intervention including exercise or physical therapy in the last 3 months.
A Phase II Study of Docetaxel Plus Carboplatin in Chemonaive Hormone-Refractory Prostate Cancer (HRPC) Patients

The primary objective is to determine the efficacy of docetaxel plus carboplatin as first line treatment in patients with hormone refractory prostate cancer.

Docetaxel-prednisolone is the current standard in HRPC, based on 2 large randomized trials showing improved survival compared to mitoxantrone-prednisolone. Carboplatin has activity in prostate cancer and the combination of Docetaxel-carboplatin is known to be synergistic and is used with good effect in many cancers. The advantage of using this combination in prostate cancer is suported by clinical data: high response rates of docetaxel-carboplatin-estramustine (with G-CSF support) in a phase II trial (Oh, Halabi, Kelly et al. Cancer. 2003 Dec 15;98(12):2592-8), and additional effect of this combination in prior taxane failures (Oh, George, Tay. Clin Prostate Cancer. 2005 Jun;4(1):61-4). Carboplatin itself has activity and theoretically could target the more hormone resistant clones or neuroendocrine components of the tumor.(Di Sant' Agnese. J Urol. 1994 Nov;152(5 Pt 2):1927-31.) We are studying the combination of docetaxel-carboplatin both given in a weekly, low-dose fashion, without estramustine and without G-CSF. This is expected to be an effective and tolerable treatment for HRPC patients. We will be documenting (to our knowledge) for the first time in this trial the efficacy of the combination given in this particular dose and schedule.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed adenocarcinoma of the prostate.
2. At the time of enrollment, patients must have evidence of metastatic disease, with either measurable disease per RECIST criteria or non- measurable disease (i.e. positive bones scan) and PSA \> 5 ng/mm3.
3. Disease progression following androgen deprivation therapy.
4. Progression is defined according to the PSA Working Group criteria (see 6.1.3 and 6.3).
5. Serum testosterone levels \< 50 ng/mm3 (unless surgically castrate). Patients must continue androgen deprivation with an LHRH analogue if they have not undergone orchiectomy.
6. No use of an antiandrogen for at least 4 weeks.
7. Have not been treated with chemotherapy before.
8. ECOG performance status of \<= 2.
9. Laboratory criteria for entry:

   * White blood cell (WBC) =\> 3000/mm3
   * Platelets =\> 100,000/mm3
   * AST \< 2.5 x upper limit of normal
   * Calculated CCT of =\> 40 ml/min
10. Signed informed consent form.
11. Age: 30 years old and above

Exclusion Criteria:

1. Significant peripheral neuropathy defined as grade 2 or higher.
2. Within 4 weeks since completing external beam radiotherapy or 8 weeks since completing radiopharmaceutical therapy (strontium, samarium).
3. Concomitant chemotherapy or investigational agents.