cyrilzakka/clinical-trials huggingface dataset:
Multiple Ascending-Dose Study of XmAb®27564 in Patients With Psoriasis or Atopic Dermatitis

The purpose of this study is to evaluate the safety and tolerability of XmAb27564 following multiple doses among participants with plaque psoriasis and atopic dermatitis.

This is a phase 1b, randomized, double-blind, placebo-controlled, multiple ascending dose (MAD) study of XmAb27564. It is planned to enroll approximately 48 adult patients with mild-to-severe plaque psoriasis and 80 adult patients with moderate-to-severe atopic dermatitis. All patients will receive a total of 4 doses of study drug or placebo, administered subcutaneously every 2 weeks. A one year, open-label extension is available to qualifying patients.

Eligibility Criteria:
Inclusion Criteria:

The main inclusion and exclusion criteria include, but are not limited to, the following:

* Have active mild-to-severe plaque psoriasis or moderate-to-severe atopic dermatitis according to study-specific criteria
* Weight between 40 to 150 kg, inclusive
* No topical treatments for psoriasis or atopic dermatitis for 2 weeks before randomization
* No phototherapy for psoriasis for 4 weeks before randomization
* Washout of oral treatments for psoriasis or atopic dermatitis for 4 weeks before randomization
* Washout of biologic treatments for psoriasis or atopic dermatitis for 12 weeks before randomization
* Stated willingness to comply with all study procedures (including skin biopsies) and availability for the duration of the study

Exclusion Criteria:

* Patients with a history of active asthma within 5 years of screening, except those that have well controlled asthma symptoms at screening visit.
* Patients who have had any prior investigational treatment with IL-2 therapies
Behavioral Treatment for Nightmares in REM Sleep Behavior Disorder

The purpose of this clinical trial is learn whether a behavioral (non-medication) treatment can reduce nightmares in adults with Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD). People with RBD will be enrolled in the study along with their romantic partners. All participants will receive the treatment via videoconference and will complete 2 assessments. Participants with RBD will attend 7 sessions, and their partners will attend 2 of those sessions with them.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of isolated RBD or RBD secondary to neurodegenerative disease
* Age 18 or older
* Speak, read, and write English
* Live in the United States
* Nightmare frequency ≥3 times per week
* Disturbing Dream and Nightmare Severity Index score indicative of nightmare disorder
* Sleep, neurological, and psychiatric medications stable for at least 1 month and willing to keep medications stable through the course of the study
* Live with a romantic partner who is willing to participate in the study

Exclusion Criteria:

* Possible dementia
* Narcolepsy
* Posttraumatic stress disorder
* Previous behavioral treatment for nightmares
* Currently engaged in sleep- or trauma-focused psychotherapy
* Taking a medication that could cause RBD, if the medication was started prior to onset of RBD symptoms

Inclusion Criteria (Partners):

* Live with a romantic partner who meets all of the above criteria
* Age 18 or older
* Speak, read, and write English
* Live in the United States
Effects of Morphine Added to Bupivacaine in Transversus Abdominis Plane Block for Inguinal Hernia Repair

This study is conducted to determine whether morphine added to bupivacaine in ultrasound guided (USG) transversus abdominis plane (TAP) block has beneficial effects than bupivacaine alone in providing postoperative analgesia for inguinal hernia surgery.

Total of forty adult patients of American Society of Anaesthesiologists (ASA) physical status ( PS) I - II scheduled for elective inguinal hernia surgery under spinal anaesthesia were recruited in this study after getting written informed consent. They were randomized to undergo ipsilateral USG TAP block with 20 ml of 0.25 % bupivacaine (group B) versus 20 ml of 0.25 % bupivacaine with 3 mg morphine (group BM). Patients were followed postoperatively for the 24 hours by a blinded investigator for monitoring of number of rescue analgesic consumed, duration of analgesia, numerical rating scale (NRS) at rest and on cough and any adverse effects.

Eligibility Criteria:
Inclusion Criteria:

ASA I to III Elective surgery

Exclusion Criteria:

* Patient's refusal
* BMI \> 35 kg/m2 or \< 18 kg/m2
* Allergic or contraindication to drugs used in study
* Coagulopathy
* Local site infection
* Spine deformity
* Uncooperative or psychological illness
* Inability to comprehend pain scale
* Drugs not injected in target area
Hyperbaric Oxygen Therapy for Antibiotic Refractory Pouchitis

The aim of current study is to evaluate the effect of hyperbaric oxygen therapy for the treatment of chronic antibiotic-refractory pouchitis.

Pouch ischemia plays an important role in the pathogenesis of pouchitis after IPAA surgery for ulcerative colitis. Obese Male patients are at high risk for pouchitis because of mesenteric tension. Excessive weight gain is associated with an increased risk for pouch failure in patients with restorative proctocolectomy. Also, patients with an 'S' pouch hardly ever develop chronic pouchitis, owing to the additional length of bowel loop along with mesentery when attached to the anal transitional zone. The treatment of chronic antibiotic-refractory pouchitis(CARP) is difficult.

Hyperbaric oxygen therapy(HBOT) have been proven effecitve in the treatment of inflammatory bowel diseases(IBD). Meta-analysis revealed that the overall response rate was 86% (85% CD, 88% UC), and of the endoscopic response rate to HBOT is 100%. The possible mechanism might be due to the prmoted wound healing by increasing oxygen delivery to hypooxic tissues and changes in inflammatory and immunological mediators.

Therefore, the aim of current study is to examine the therapeutic effect of HBOT for chronic antibiotic-refractory pouchitis(CARP).

Eligibility Criteria:
Inclusion Criteria:

* IPAA performed for ulcerative colitis;
* Pouchitis Disease Activity Index (PDAI) scores ≥7;
* Antibiotic refractory pouchitis(CARP), defined as patients who do not respond to conventional 2-week, single-agent antibiotic therapy including metronidazole,ornidazole,tinidazole, or ciprofloxacin
* 18-75years
* Informed consent given
* Able and willing to comply with all trial procedures
* Including prepouch ileitis

Exclusion Criteria:

* Crohn's disease of the pouch
* Pouchitis after IPAA for FAP
* Isolated cuffitis
* with cocomttant Primary sclerosing cholangitis (PSC)
* Pouch strictures
* Abscess/Sinuses
* Perianal disease
* Active malignancy
* Uncontrolled systemic diseases
* History of noninfammatory disease of the pouch
* Decreased pouch compliance
* Irritable pouch syndrome
* Afferent or efferent limb obstruction
* Needing oral or topical steroid or 5-ASA
* Major physical or psychiatric illness within the last 6m
* Active use of cholestyramine, NSAIDs or aspirin
* Pregnant, breast feeding
* Clinically significant co-morbidities causing untolerant or unsuitable for hyperbaric oxygen therapy.
Comparison of Two Liraglutide Formulations in Healthy Subjects

This trial is conducted in Europe. The aim of this trial is to test for bioequivalence of the phase 3a formulation of liraglutide at pH 8.15 (formulation 4) and liraglutide at pH 7.7 (formulation 3).


Eligibility Criteria:
Inclusion Criteria:

* Good general health as judged by the investigator, based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs and blood and urinary laboratory assessments
* BMI (Body Mass Index) of 18.0-27.0 kg/m\^2, both inclusive

Exclusion Criteria:

* History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders that may interfere with the objectives of the trial, as judged by the Investigator
* Impaired renal function
* Any clinically significant abnormal ECG, as judged by the Investigator
* Active hepatitis B and/or active hepatitis C
* Positive human immunodeficiency virus (HIV) antibodies
* Known or suspected allergy to trial product(s) or related products
* Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures
* Use of any prescription or non-prescription medication, except for paracetamol and vitamins, as judged by the Investigator
Randomized Trial of Transcranial Theta-burst Stimulation and Transcranial Direct Current Stimulation

Background: Stroke is a leading cause of adult disability. Non-invasive brain stimulation can induce significant and sustained improvements in functional outcome. However the effect is inconsistent and difficult to predict, in particular in the subacute phase after stroke. Although several different stimulation techniques are available, it is unknown which is suitable for which patient.

Objectives: This study has three main objectives:

1. To compare the effects of two techniques of non-invasive brain stimulation (cTBC, continuous theta-burst stimulation; tDCS, direct current transcranial stimulation) on clinical recovery in patients with subacute stroke.
2. To assess the effect of these brain stimulation techniques on brain organization with non-invasive imaging.
3. To find clinical and neural predictors of responsiveness to brain stimulation therapy.

Method: 45 patients with ischemic or hemorrhagic stroke will be randomly assigned to one of 3 groups: cTBS, tDCS, or sham stimulation. Each group will receive the corresponding stimulation therapy 3 times per week for 3 weeks, immediately before intensive physical therapy. Before and after the treatment period, standardized assessments of sensorimotor function areas are obtained together with electroencephalography and functional magnetic resonance recordings. These recordings will be used to analyze and compare the neural effects of each treatment modality.

Clinical Implication: The results of this study might help optimize and individualize stimulation treatment for patients with subacute stroke. It may hence facilitate the transfer of brain stimulation therapy to routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* ischemic or hemorrhagic stroke leading to unilateral deficits in motor function with significant impact on independence and daily activities at the beginning of rehabilitation
* less than 10 weeks after stroke onset.

Exclusion Criteria:

* epileptic seizures
* metallic objects in the brain
* presence of implants or neural stimulators
* pregnancy
* sleep deprivation
* recent traumatic brain injury
* delirium or disturbed vigilance
* inability to participate in 1h treatment sessions
* severe language comprehension deficits
* skull breach
* new stroke lesions during rehabilitation
* medical complications
Treatment With Topical Eflornithin After Laser Treatment in Women With Facial Hirsutism

Split-face investigation of the efficacy of applying Eflornithin cream twice daily for six months after a period with six laser treatments for hair removal.

Background: Unwanted facial hair growth is a serious problem for 5-15% of all women winch affects their quality of life. In Denmark patients are offered six laser treatments covered by the public health insurance. There is a lack of good follow-up treatments to this regime that can extent the efficacy of the laser treatment. Eflornithin cream is an approved treatment for reduction of facial hair growth which has proved to give an additional efficiency when used in combination with laser treatments.The efficacy when used after laser hair removal is not known.

Aim: To investigate whether an extended efficacy of laser hair removal can be achieved with application of Eflornithin cream twice daily for six months after completion of laser treatments.

Method: in a split-face trial to apply Eflornithin cream twice daily for six months. Outcome measures are investigator evaluation, blinded on-site evaluation, patient's assessment score and clinical photos.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* habile, understands Danish
* moderate to severe hirsutism prior to laser treatments
* succeeded minimum five laser treatments
* intact skin with no severe adverse events to laser treatments
* record of current medication and androgen hormone blood profile available
* Use of safe anti-conception (fertile women)

Exclusion Criteria:

* Pregnant or lactating
* allergy toward the content of Eflornithin cream
* Concomitant use of immunosuppressive therapy
* Dementia, psychiatric disease, alcoholic
The Efficacy of Intravenous Iron for the Treatment of Anemia in Cancer Patients

* Multifactorial pathogenesis is involved in anemia of cancer patients and defining the causes of anemia is not always simple.
* Currently, treatment options available for anemia in cancer patients include red blood cell (RBC) transfusion, erythropoietin stimulating agent (ESA), and iron supplementation, accompanying considerable pros and cons for each treatment.
* Previous studies have demonstrated benefit when treating with IV iron in combination with ESA and, more recently, evidence is emerging to suggest a role for IV iron alone.
* In this study, investigator will assess the efficacy of intravenous iron for the treatment of anemia in cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who diagnosed with solid cancer or lymphoma
* Subjects who are under anti-cancer therapy at enrollment or has finished anti-cancer therapy within 2 months before enrollment

  * anticancer therapy: "chemotherapy", and/or "chemotherapy + radiotherapy", and/or "target agent"
* Subjects whose Hb level is 8.0-10.5g/dL, or who experienced a drop of Hb by 2g/dL or more during anti-cancer treatment

Exclusion Criteria:

* Subjects who received iron (oral or iv), ESA, dialysis within 4 weeks before enrollment
* Subjects with uncontrolled infection
* Subjects with ongoing bleeding
* Deteriorated organ function
* poor performance state (ECOG 3-4)
* Subjects whose disease involves bone marrow
* Ferritin \> 800 ng/ml and Transferrin saturation(TSAT) ≥ 50%
Effect of Tenofovir on Genital Herpes Simplex Virus (HSV) Shedding

The investigators propose a randomized, double blind, placebo-controlled, cross-over trial to evaluate the effect of oral and topical (vaginal gel) tenofovir on genital herpes simplex virus (HSV) shedding among herpes simplex virus type-2 (HSV-2) seropositive, human immunodeficiency virus (HIV) seronegative women. The investigators hypothesize that tenofovir will reduce genital HSV shedding compared to placebo.

The investigators propose a randomized, double-blind, placebo-controlled, cross-over study of 55 adult, healthy women who are HSV-2 seropositive and HIV-1 seronegative. Women will first participate in a run-in phase with twice daily swabbing. Following 4 weeks of swabbing, participants will be randomized 2:2:1 to one of three groups: 1) oral tenofovir and placebo gel, 2) oral placebo and tenofovir gel, or 3) oral placebo and placebo gel. Participants will begin treatment and swab the genital region twice daily for 5 more weeks. Study drug will be administered daily.

Eligibility Criteria:
Inclusion Criteria:

* Women age 18-50
* HSV-2 seropositive by the University of Washington (UW) Western blot
* History of recurrent genital herpes, with more than 4 recurrences but less than 10 in the last year or, if currently on suppressive therapy, with more than 4 recurrences but less than 10 in the year prior to starting suppressive therapy
* HIV negative
* General good health
* Willing to not use antiviral therapy (other than the study drug) for the duration of the study
* Willing to obtain a swab from genital secretions twice daily for the duration of the study
* Willing to use effective birth control
* Able to provide written informed consent at screening and enrollment

Exclusion Criteria:

* HIV positive or at high risk for HIV acquisition (intravenous drug user or HIV+ sex partner)
* Hepatitis B (HepB) antigen (Ag) positive, or at high risk for HepB acquisition and not vaccinated
* Have a history of adverse reaction to tenofovir and/or adefovir
* Immunosuppressive medications, except for intranasal or topical (not high potency) steroids.
* Any kidney disease, or renal insufficiency, defined as serum creatinine \>1.5 mg/dl. Participants with a prior history of a single episode of pyelonephritis will be eligible.
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 times upper limit of normal
* Pregnancy, as confirmed by a urine pregnancy test, planning to become pregnant during the course of the trial, or breast-feeding.
* Serious medical conditions or active infections
* Any other conditions that in the judgment of the investigator would preclude successful completion of the clinical trial.
Anticoagulation and Activation - Comparison in Continuous Renal Replacement Therapy

Actual clinical practice predominantly makes use of heparin (systemically) or citrate regionally as anticoagulation in the extracorporeal circulation for renal replacement therapy. We aim to find out if different anticoagulation strategies may lead to different levels of platelet activation and whole blood coagulation. Regarding coagulation activation, it remains uncertain if there is an advantage for one of these methods. However, it is of major interest to minimize the risk of any additional clotting activation via extracorporeal circulation in these usually critically ill patients.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years, acute renal failure with need for continuous veno-venous renal replacement therapy

Exclusion Criteria:

* Age \< 18 years, pregnancy, contraindications for one of the two anticoagulation methods, missing informed consent or disagreement in the progress of the study
Influence of the Brownie Breast Shield on the Dynamics of Milk Removal

The purpose of this study is to investigate the efficacy of breast drainage of the healthy breast with the new Medela pump set breast shield (Brownie).

The objective of the study is to verify the Brownie breast shield to be non-inferior to the current PersonalFit breast shield in emptying the healthy lactating breast.

In this study we could show that the Brownie shield is non-inferior to the PersonalFit shield in all four endpoints, superior to the PersonalFit shield in terms of PAMR and expressed milk volume, and is more comfortable than the PersonalFit shield according to participant surveys.

Eligibility Criteria:
Inclusion Criteria:

1. Subject ≥ 18 years old
2. Infant is ≥1 and ≤6 month old
3. Subject is predominantly breastfeeding (80% of all feeds, i.e. ≤150 ml formula/day or equal representative amount of solid food)
4. The subject agrees to pump or feed the last time a minimum of 3 hours before the start of the pumping session at the study site
5. The subject agrees to photographs of the breast and upper body (no face)
6. The subject agrees to perform a 24 hour milk production at home, inclusive weighing the Infant before and after each feeding
7. The subject agrees to collect \~2 ml of milk before and after each feeding for fat analysis
8. The subject signed the Informed Consent Form

Exclusion Criteria:

1. Mastitis (any breast within two weeks prior enrolment)
2. Engorgement (any breast within two weeks prior enrolment)
Subthreshold Laser Treatment for Reticular Pseudodrusen Secondary to Age-related Macular Degeneration

Prospective, randomized, controlled, longitudinal, interventional multicentric study involving patients with reticular pseudodrusen secondary to AMD.

The objective of this study is to establish the effectiveness of subthreshold laser treatment in increase/prevent the decrease of the retinal sensibility in patients with reticular pseudodrusen, and to reduce the progression of RPD to atrophy.

Approximately 50 naïve patients with reticular pseudodrusen who underwent subthreshold laser treatment in perifoveal area. These patients should be randomized in the 2 study arms of the study. Patients will be evaluated at Screening/Baseline and then revaluated and retreated at month 3, 6 and 9. At month 12, all patients will be evaluated with a full ocular examination, visual acuity measurement (VA), optical coherence tomography (OCT) with autofluorescence, OCT-angiography and microperimetry.

The rationale of the study is to prevent the evolution of reticular pseudodrusen to atrophic degeneration.


Eligibility Criteria:
Inclusion Criteria:

* 50 years or older
* Presence of RPD secondary to AMD
* Best-corrected visual acuity (BCVA) between 20/20 and 20/400 inclusive
* Clear ocular media
* Ability to provide informed consent and attend all study visits

Exclusion Criteria:

* Presence of Geographic Atrophy (GA)
* Evidence of choroidal neovascularization in either eye
* Any prior treatment for AMD, aside from antioxidants
* Any corneal opacity, cataract formation and hemorrhage in the vitreous body, which may interfere with viewing by the laser surgeon of the target structures
* Aphakic eye with vitreous in the anterior chamber
* Neovascular Glaucoma
* Glaucoma caused by congenital angle anomalies
* Open angle of less than 90º or extensive peripheral anterior and low synechia, present circumferentially around the corner
* Significant corneal edema or reduced water clarity that obscures the view angle in detail
* Glaucoma secondary to active uveitis
* Any other ocular condition that would progress in the study period and confound visual acuity assessment
* Any ocular or systemic medication known to be toxic to the lens, retina or optic nerve Presence of idiopathic or autoimmune-associated uveitis
* Any intraocular surgery 3 months of entry
* Any prior thermal laser in the macula
* History of vitrectomy, filtering surgery, corneal transplant or retinal detachment surgery
* Previous therapeutic radiation in the ocular region in either eye
* Any treatment with an investigational agent in the previous 60 days before study entry
* Women of child-bearing potential, defined as all women less than 1 year postmenopausal or less than 6 weeks since sterilization (further definition can be found in Section 12.7) at Baseline, unless they are using highly effective methods of contraception during dosing of study treatment.
* Participation in an investigational drug, biologic, or device study within 6 Months prior to Baseline \[Note: observational clinical studies solely involving over-the-counter vitamins, supplements, or diets are not exclusionary
A Safety and Efficacy Study of Vitreosolve® for Non-Proliferative Diabetic Retinopathy Subjects

The purpose of this study is to determine the safety and efficacy of Vitreosolve® in diabetic retinopathy patients.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a history of systemic diabetes(type I,or II)
* Subject with a documented history of Non- proliferative Diabetic Retinopathy(NPDR)
* Subjects with no or partial PVD at baseline exam in study eye.

Exclusion Criteria:

* Subjects with retinal pathology in the study eye other then (NPDR)
* Subjects with high myopia in the study eye
* Subjects who have monocular vision or central lateral vision of 20/200 or worse BCVA in the non-study eye.
* Subjects with an aphakic study eye or if pseudophakic, cataract extraction surgery less then 6 months prior to study enrollment.
* Subjects that have either vitrectomy surgery, intavitreal injections, or laser treatments in the study eye.