cyrilzakka/clinical-trials huggingface dataset:
Evaluating the Pharmacokinetics and Pharmacodynamics of Romiplostim in Patients With Immune Thrombocytopenia (ITP)

The objective of evaluating the pharmacokinetics and pharmacodynamics of romiplostim in patients with immune thrombocytopenia.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with immune thrombocytopenia (ITP) for at least 6 months prior to signing the informed consent form (ICF).
* Subject is ≥ 18 years old and ≤ 70 years old while signing the ICF.
* Patients who have no response or relapsed after splenectomy. Or patients who have not been splenectomised and have completed at least 1 prior treatment for ITP. Excluded having previously received recombinant human thrombopoietin (rHuTPO) or any other thrombopoietin receptor agonist.
* The mean of 3 scheduled platelet counts taken during the screening period must be: \< 30 ×10\^9/L, with none \>35×10\^9/L.

Exclusion Criteria:

* Any known history of bone marrow stem cell disorder. Any abnormal bone marrow findings other than typical of ITP.
* Any active malignancy. If prior history of cancer other than basal cell carcinoma or cervical carcinoma in situ, no treatment or active disease within 5 years prior to signing the ICF.
* Had received Eltrombopag, recombinant human thrombopoietin (rHuTPO) or other myeloproliferative leukemia (MPL) stimulation product.
* Received hematopoietic growth factors (e.g., granulocyte colony-stimulating factor, macrophage colony-stimulating factor, erythropoietin, interleukin-11) for any reason within 4 weeks prior to signing the ICF.
* Received any anti-malignancy agents (e.g., cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, interferon-alfa) for any reason within 8 weeks prior to signing the ICF.
* Received any monoclonal antibody drugs (e.g., rituximab) for any reason within 14 weeks prior to signing the ICF.
* Less than 4 weeks since end of any clinical trials about therapeutic drug or device for any indication prior to signing the ICF.
* Pregnant or breast feeding.
* In the opinions of the principal investigator or investigators, the patients are not suitable for participation in this trial.
Study of ARO-HBV in Normal Adult Volunteers and Patients With Hepatitis B Virus (HBV)

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple-ascending doses of ARO-HBV in healthy adult volunteers and participants with hepatitis B virus (HBV).


Eligibility Criteria:
Inclusion Criteria for Parts A \& B:

* Women of childbearing potential must have a negative pregnancy test, cannot be breast feeding, and must be willing to use contraception.
* Willing to provide written informed consent and comply with study requirements

Additional Inclusion Criteria for Part B:

* Diagnosis of chronic HBV infection
* Hepatitis B surface antigen (HbsAg) at screening \> or = 50 IU/mL
* Liver Elastography score \< or = 10.5

Exclusion Criteria:

* Clinically significant health concerns (with the exception of HBV for Patients in Part B)
* Abnormal for any clinical safety laboratory result considered clinically significant
* Regular use of alcohol within 1 month prior to screening
* Recent use of illicit drugs
* Use of an investigational agent or device within 30 days prior to dosing or current participation in an investigational study

NOTE: additional inclusion/exclusion criteria may apply, per protocol
Efficacy and Safety of Org 25969 Administered After Zemuron® (MK-8616-042)

The primary objective of this study is to explore the dose-response relation of MK-8616 (Org 25969) given as a reversal agent of Zemuron® at 1 to 2 post tetanic counts (PTCs); both Zemuron® and MK-8616 are administered by intravenous (iv) infusion. Another goal of the study is to evaluate the safety of single doses of MK-8616 administered to participants of American Society of Anesthesiologists (ASA) Physical Status Class 1 (otherwise normal, healthy participant); Class 2 (participant with a mild systemic disease); or Class 3 (participant with a severe systemic disease that limits activity, but is not incapacitating).


Eligibility Criteria:
Inclusion Criteria:

* Has an ASA Class of 1 to 3
* Is scheduled for surgical procedures (excluding dental and neck surgeries) with an anticipated duration of anesthesia of ≥45 minutes with the use of Zemuron®

Exclusion Criteria:

* Is undergoing dental or neck surgery
* Has anatomical malformation that would impede intubation
* Has or is suspected to have neuromuscular disorders impairing neuromuscular block and/or significant renal dysfunction
* Is known or suspected to have a family history of malignant hyperthermia
* Is known or suspected to have an allergy to narcotics, muscle relaxants, or other medications used during general anesthesia
* Is pregnant
* Is a female of childbearing potential not using 1 of the following methods of birth control: condom or diaphragm with spermicide, vasectomized partner (\<6 months), intrauterine device (IUD), or abstinence
* Is breast-feeding
* Has already participated in the study
* Has participated in another clinical trial, not pre-approved by Organon Pharmaceuticals USA within 30 days of entering this study
A Phase 1 Study of an Investigational Drug, ALN-PCSSC, in Subjects With Elevated Low Density Lipoprotein Cholesterol (LDL-C)

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ALN-PCSSC in subjects with elevated LDL-C.


Eligibility Criteria:
Inclusion Criteria:

* Adequate complete blood counts, liver and renal function
* Female subjects must be of non-childbearing potential; e.g. post-menopausal or pre-menopausal with surgical sterilization
* Male subjects agree to use appropriate contraception
* Willing to provide written informed consent and willing to comply with study requirements.
* Non-smokers and non-nicotine users for at least 90 days before screening
* On stable statin co-medication \[for designated multiple dose cohorts only\]

Exclusion Criteria:

* Any uncontrolled or serious disease, or any medical or surgical condition, that may interfere with participation in the clinical study and/or put the subject at significant risk
* Received an investigational agent within 90 days before the first dose of study drug or are in follow-up of another clinical study
* History of multiple drug allergies or intolerance to subcutaneous injection
* Received any medication or nutraceutical to alter serum lipids within 30 days before screening (non-statin cohorts only)
Inferior Oblique Muscle Anteriorization Versus Anteriorization and Resection in DVD With IOOA

The goal of this clinical trial is to compare the results of two surgical modalities in patients with Dissociated vertical deviation with inferior oblique muscle overaction . The main questions it aims to answer are:

* How much does the magnitude of DVD improve after each modality?
* Is the IOOA eliminated? Participants will be divided into two equal groups; Researchers will compare the efficacy of symmetrical anteriorization of the inferior oblique and adding an additional rescetion to one eye in the second group to see which group had more signifcant reduction in the magnitude of DVD and IOOA.

A prospective study was performed on patients with bilateral symmterical dissociated vertical deviation(DVD) and bilateral inferior oblique muscle overaction (IOOA) in Cairo University hospitals starting from February 2018 through December 2021. Patients wetre included in the study if they had a minimum follow up period of 6 months. The study included 54 patients (108 eyes) with manifest DVD and IOOA in boths eyes. Patients were divided into two equal groups. The paitents in group 1 underwent symmetrical inferior oblique muscle anteriorization, while the patients in group 2 underwent ayymmetrical surgery , where inferior oblique anteriorization was performed in one eye the same manner is in group 1, and the eye with the larger deviation had an additional 3-5 mm rescetion of the inferior oblique muscle along with anteriorization according to the measured DVD difference between both eyes, whether less than or more than 5 prism diopters respectively.

Eligibility Criteria:
Inclusion Criteria:

* Manifest DVD decompensated to a tropia with free ocular motility
* Cases with or without horizontal misalignment
* Cases with or without previous horizontal muscle surgery

Exclusion Criteria:

* Incomitant, Paralytic or restrictive strabismus
* Eyes with previous inferior oblique muscle surgery
* Recurrent DVD after surgical treatment
* Eyes with previous scleral buckling for retinal deatchment
Crosslinking in Infectious Keratitis

Microbial keratitis is an infection of the cornea that is associated with risk of permanent visual impairment.

It can be caused by bacteria, virus, fungus, protozoa and parasites. The common risk factors for infectious keratitis include ocular trauma, contact lens wear, recent ocular surgery, preexisting ocular surface disease, dry eyes, lid deformity, corneal sensation impairment, chronic use of topical steroids and systemic immunosuppression .

The spectrum of bacterial keratitis can also be influenced by geographic and climatic factors.

The treatment usually consist of Topical administered antibiotics .the emergence of multidrug-resistant bacteria is a concern that might complicate the treatment and cure of infectious keratitis.

Collagen cross linking (CXL) using ultraviolet-A (UV-A) and riboflavin in a treatment that was developed to increase the biochemical strength of the cornea The procedure is based on using riboflavin as a photosensitizer, which generates reactive oxygen species when activated by UV-A at 365 or370 nm.

The standard technique (epi-off) also called Dresden Protocol includes removal of the epithelium in order to expose the underlying stroma to riboflavin, which is otherwise incompletely absorbed by the epithelium because of tight junctions. The area of corneal epithelium removed has a diameter of 6.0 to 8.5 mm. A crosslinking procedure without epithelial removal could also be performed (epi-on). It would likely be less painful compared to the standard procedure.

The crosslinking process generates reactive oxygen species that can damage the cell walls of pathogens. CXL induces formation of new covalent bonds thereby rendering the corneal stroma biomechanically stronger and more resistant to enzymatic digestion . This can potentially limit the spread of infection. Furthermore, CXL-induced apoptosis could contribute to the reduction of inflammatory response during corneal infection .

Eligibility Criteria:
Inclusion Criteria:

* Patients with proved bacterial, fungal, acanthamoeba microbial keratitis .
* Patient willing to comply with all study procedures .

Exclusion Criteria:

* Severe corneal scarring or opacification .
* Patients with viral infectious keratitis
* Prior herpetic infections .
* Patients with any coexisting ocular pathology,ocular surface disease .
* Patients with Autoimmune disease.
* Pregnant women .
* Corneal Thickness of less than 400 microns .
The Effect of Bronchodilator on Eosinophilic Bronchitis and Cough Variant Asthma

This study aim is to observe the response to Bambuterol Hydrochloride tablets treatment in subjects with eosinophilic bronchitis .

The investigators hypothesize:

A few of subjects with EB have some responses to Bambuterol Hydrochloride tablets therapy.

Most of subjects with CVA respond well to Bambuterol Hydrochloride tablets therapy

Study groups:

45 patients with chronic cough will be collected and two groups will formed based on diagnosis as follows:

Group 1: EB group The patients with eosinophilic bronchitis received Bambuterol Hydrochloride tablets 10mg Q24 for three days .

Group 2: CVA group The patients with cough variant asthma received Bambuterol Hydrochloride tablets 10mg Q24 for three days .

Observe the response to Bambuterol Hydrochloride tablets treatment three days later and compare the effective rate of patients with EB and CVA. Then the study will be over.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who have a history of cough as sole or main symptom lasting more than 8 weeks.
2. Patients whose chest x-ray outcome was normal or without any active focus.
3. Patients with eosinophilic bronchitis who were diagnosed with the result of sputum eosinophil percentage (Eos%) over 2.5%, and the negative result in bronchial provocation test by methacholine inhalation challenge.
4. Patients with cough variant asthma have positive result in bronchial provocation test.
5. Patients who was aged from 18 years old (≥ 18 years old ) to 75 years old (≤ 75 years old).

Exclusion Criteria:

1. Patients who is a smoker or ex-smoker and has smoked within the previous year or has a cumulative smoking history \>10 pack-years or equivalence.
2. Patients with concomitance of GERC (gastroesophageal reflux-related chronic cough), chronic bronchitis , bronchiectasis, bronchial tuberculosis, ACEI induced cough, bronchogenic carcinoma, psychologic cough, pulmonary fibrosis, bronchus foreign body, microlithiasis, tracheobroncheopathia osteochondroplastica, mediastinal tumor, left ventricular dysfunction.
3. Female subjects who are pregnant, breast-feeding or risk of becoming pregnant during the study.
4. Subjects who are diagnosed with past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease. e.g.nasal-sinus infection, lower respiratory tract infection, chronic bronchitis, emphysema, bronchiectasis, cystic fibrosis or bronchopulmonary dysplasia.
5. Subjects who demonstrate significant abnormality on biochemistry, hematology, ECG.
6. Patients who does not cooperate with us.
Adaptive Interventions for Emergency Department Patients With Opioid Use Disorder

The ADAPT-ED study is a two-stage, sequential multiple assignment randomized trial (SMART) to inform the development of an adaptive intervention that is optimally effective in increasing long-term buprenorphine use for adults presenting to the ED with probable opioid use disorder (OUD).

The ADAPT-ED study is a two-stage, sequential multiple assignment randomized trial (SMART) to inform the development of an adaptive intervention that is optimally effective in increasing long-term buprenorphine use for adults presenting to the ED with probable OUD. The trial includes (1) two first stage components: the CA Bridge Model with Substance Use Navigator assisted treatment initiation and linkage to care (SUN) or CA Bridge plus immediate telehealth connection to an outpatient provider (SUN+TeleBridge); (2) a dynamic tailoring variable describing (non) response to the first stage: whether the patient has not filled an outpatient buprenorphine prescription at 30 days or whether the patient returns to the ED with an OUD-related event or self-reports non-adherence to buprenorphine within the first 90 days; (3) two second-stage components for non-responders; either ongoing buprenorphine treatment by an ED-based interim treatment team (ED-ITT) or ED-ITT augmented with behavioral health support (ED-ITT+BHS). First-stage responders will receive no further active intervention unless the participant returns to the ED or notifies the SUN about no longer taking buprenorphine within 90 days of study enrollment.

Hypothesis 1: The investigators hypothesize that the most intensive Adaptive Treatment Strategy (ATS) will lead to (a) more days of buprenorphine use and (b) a longer time to overdose, self-harm, or death compared to the least intensive ATS.

Hypothesis 2: The investigators hypothesize that (a) SUN+TeleBridge in the first stage of the ATS and (b) ED-ITT+BHS in the second stage of the ATS will each lead to more days of buprenorphine use and a longer time to overdose, self-harm, or death within the first 12 months compared to SUN and ED-ITT, respectively, and (c) there is a synergistic positive effect of receiving both SUN+TeleBridge and ED-ITT+BHS on days of buprenorphine use.

Hypothesis 3: The investigators hypothesize that the effect of SUN+TeleBridge versus SUN and the effect of ED-ITT+BHS versus ED-ITT among first stage non-responders will be larger among those with (a) a history of overdose at baseline and (b) co-occurring depression or PTSD at baseline relative to those who do not have either or those conditions.

Eligibility Criteria:
Inclusion Criteria:

* Presented for ED care at ARMC
* Age 18 or older
* Probable OUD diagnosis
* Speak and understand English or Spanish
* Have capacity to give informed consent
* Provide a signed and dated informed consent form
Finnish Venous Ulcer Study (FINNULCER Study)

This multicenter randomized controlled trial evaluates the effect of first-visit foam sclerotherapy (including sub-ulcer foam sclerotherapy) in patients with venous leg ulcer.

To evaluate the effect of first-visit foam sclerotherapy, patients with venous leg ulcers are randomly assigned to either the first-visit foam sclerotherapy group or the scheduled treatment group. The scheduled treatment group represents the current standard of care. The primary outcome of this study is the time to ulcer healing.

In addition to the first-visit treatment in the study group, both groups receive endothermal ablation and/or foam sclerotherapy to (further) treat ulcer-related insufficient veins and truncal insufficiency in scheduled treatment visit(s).

Class 2 thigh-high compression or the best possible compression therapy tolerated by the patient is provided in both groups. The follow-up period for the primary outcome is one year.

For this study, based on Oulu University Hospital's retrospective data (partly published in Pihlaja et al 2020) of venous ulcer healing the investigators assumed Hazard Ratio 1.5 for venous ulcer to heal in first-visit foam sclerotherapy group compared to scheduled treatment group.

Assuming drop-out of 10% this study recruits total of 248 patients (a=0.05, b=0.2).

Eligibility Criteria:
Inclusion Criteria:

* Patient informed consent
* Venous ulcer, aged from one month to one year
* Duplex ultrasonography verified (vein reflux greater than \>0.5 second) superficial venous insufficiency
* Sufficient arterial circulation (at least on criterion met: Palpable distal pulses / ankle-brachial index \> 0,8 / Toe pressure \>60mmhg)

Exclusion Criteria:

* Leg ulcers other than venous etiology
* Ulcers requiring operation theater revision
* Patent foramen ovale
* Several times recurrent (over 3 recurrences) venous ulcer
* Body Mass Index over 40
* Pregnancy
Using a Wireless Controller to Deliver a Lighting Intervention to Persons With Dementia

To test the effect of a tailored lighting intervention controlled by the Readings At Desk (RAD) controller on sleep and mood in Alzheimer's disease participants.

Each participant will be enrolled for 22 weeks. Participants will be randomly assigned to receive either the active or control lighting condition. Each lighting condition will be 8 weeks in length. After a 4 week washout, each participant will crossover to the opposite condition. Assessments will be performed before and at the end of each lighting intervention.

Eligibility Criteria:
Inclusion criteria:

* Diagnosis of Alzheimer's disease with a Mini Mental Score Examination (MMSE) between 0 and 19
* a score \>5 on the PSQI.

Exclusion criteria:

- use of sleep medication
Comparison of Ergon Instruments-Assisted Soft Tissue Mobilization With Compressive Myofascial Release

The objective of this study is to investigate the effects of Virtual Reality and Motor Imagery along with Routine Physical Therapy in motor function and balance in patients with Parkinson disease.

This randomized control trial is the single blinded, single centered study. Standard Protocol Items: Recommendations for Interventional Trials guidelines are used as study protocol. Sixty three patients of Parkinson Disease (Modified Hoehn and Yahr stages I-III) will randomly allocate into three groups.

Group A will be given a 60 min session of Virtual Reality along with Routine Physical Therapy.

Group B will be given a 60 min session of Motor Imagery along with Routine Physical Therapy.

Group C will be given a 40 min session of Routine Physical Therapy and after a short period of rest,20 min for walking and cycling.

These treatment sessions will be given to each group at every alternative day (3 days per week) for 12 weeks.

Outcome measures are

1. Berg Balance Scale
2. Activities Specific Balance Confidence Scale
3. The Unified Parkinson Disease Rating Scale (part III) The Assessments will be recorded at baseline, at 6th and 12th weeks of therapy, and after one month of discontinuation of therapy.

Eligibility Criteria:
Inclusion Criteria:

* Inability to achieve 20 degrees of active dorsiflexion,
* Heel pain,
* Mid foot pain,
* Heal swelling,
* Mid foot swelling,
* Achilles' tendon tightness diagnosed on the base of Windlass test

Exclusion Criteria:

* Recent foot injury,
* Fracture,
* Infections,
* Surgical procedures,
* Tendon injury,
* Hypermobility,
* Neuromuscular disorders,
* Impaired sensation,
* Open sores,
* Skin disease,
* Active deep vein thrombosis or thrombophlebitis,
* Bruises,
* Varicose veins,
* Burn scars
Time-Restricted Feeding Plus Resistance Training in Active Females

The objective of this study is to examine the effects of time-restricted feeding (TRF; consuming all calories within an 8-hour period of time each day) and resistance training, with or without the addition of the dietary supplement HMB, on body composition, muscular performance and physiological outcomes in active females.


Eligibility Criteria:
Inclusion Criteria:

* Female between 18 and 30 years of age
* Current university affiliation
* Weighing at least 110 pounds
* Generally healthy
* Resistance-trained
* Schedule availability to complete supervised resistance training
* Body fat percentage between 15 and 29%

Exclusion Criteria:

* Pregnant or trying to become pregnant
* Currently breastfeeding
* Any disease, condition or orthopedic limitation that would prevent safe participation in resistance training or time-restricted feeding
* Current smoker
* Presence of pacemaker or other electrical implant
* Allergic to dairy proteins
Multimodal Recurrence Scoring System for Stratifying Stage III Clear Cell Renal Cell Carcinoma of Receiving Adjuvant Treatment

Whether patients with stage III clear cell renal cell carcinoma (ccRCC) should receive adjuvant targeted therapy or not is still on debate. The investigators invented a multimodal recurrence scoring system that was successfully categorise patients with stage III clear cell renal cell carcinoma into high-risk and low-risk groups with Hazard Ratio (HR) of 6.21. Here the investigators randomly assign assay-defined high risk patients of locally advanced ccRCC into adjuvant targeted therapy group and observation group. Disease free survival and overall survival are the end points of observation.


Eligibility Criteria:
Inclusion Criteria:

* The informed consent has been obtained from the patient.
* With confirmed diagnosis of stage III clear cell renal cell carcinoma
* With moderate/good Eastern Cooperative Oncology Group (ECOG) health rating (PS): 0-1 score.
* The patient receive no anti-cancer treatment before primary surgery.
* The patient receive radical operation for renal cancer with negative margin.

Exclusion Criteria:

* Patients who have previously received neoadjuvant therapy
* With severe comorbidities, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes mellitus, and chronic renal dysfunction.
* With bad compliance or contraindication to enrollment.
* Pregnant woman or lactating woman.
* With contraindication to receive adjuvant targeted therapy.