cyrilzakka/clinical-trials huggingface dataset:
Quantification of the Airflow Into Sinuses Before and After ArchSinus Implantation

This is a single-center, single-arm, interventional case study designed to compare the sinonasal airflow and symptomatic status of four (4) chronic sinusitis patients, before and after the ArchSinus stent implantation.

This is a single-center, single-arm, interventional case study. This case study is designed to compare the sinonasal airflow and symptomatic status of four (4) chronic sinusitis patients who after undergoing primary FESS were seen to have symptomatic lateralization of the middle turbinate and underwent medialization of the middle turbinate accompanied by ArchSinus stent implantation.

Patient eligibility will be confirmed based on the endoscopic examination and SNOT-22 score.

Patient history will be taken, specifically which if any nasal spacer was used after the primary FESS.

4 chronic sinusitis patients that suffer from middle turbinate lateralization and symptomatic deterioration, 3-6 months after primary FESS, that met the inclusion / exclusion criteria, will undergo unilateral or bilateral in-office middle turbinate medialization and subsequent ArchSinus implantation. The stents will be removed 2-3 weeks after procedure.

CT scan will be performed at baseline and 12 weeks after the ArchSinus stent removal, and 3D sinonasal airways reconstruction of the maxillary, ethmoid, sphenoid \& frontal sinuses will be performed. Subsequently, airflow and particle deposition will be simulated in each reconstruction, and airflow rate and particle deposition will be quantified for different sinuses.

Symptomatic status will be analyzed at baseline and 1, 6 and 12 weeks after the ArchSinus stent removal using SNOT-22 and NOSE Questioners.

Debridement is disallowed during the ArchSinus implantation time period. Nasal decongestions are disallowed prior to CT scan examination.

Eligibility Criteria:
Inclusion Criteria:

* Male/female, 18 year or older
* Diagnosis of chronic rhinosinusitis defined as symptomatic inflammation of the sinuses of at least 12 consecutive weeks duration despite medical management
* ≥ 3 months post primary FESS
* Symptoms of chronic rhinosinusitis defined as ≥ 10 score on SNOT-22
* Middle turbinate lateralization defined as ˃ 2 score on MT lateralization scale

Exclusion Criteria:

* Polyp grade ˃ 4 bilaterally on Lildholdt's scale (1-3)
* Sinonasal tumors
* Known allergy to nickel
* Known polyurethane induced dermatitis
* History of immune deficiency
* Cystic fibrosis
* Pregnant or lactating female
* Acute sinus inflammation
* Coagulation disorders
Regional Hemodynamic Parameter Changes After Spinal Anesthesia

Spinal anesthesia is a regional anesthesia method used for surgical procedures generally involving the lower abdominal area, perineum, and lower extremities. Various tests are performed to evaluate the block level after spinal anesthesia, incluyding pinprick test, cold application, and motor examination. These tests are performed to check whether the pain, sympathetic and motor nerve fibers are affected, respectively, after the block; and good communication with the patient is important here. However, it is extremely difficult to evaluate these tests in pediatric, geriatric, mentally retarded or uncooperative patients.

Sympathectomy can be used as a criterion to evaluate the success of the block that occurs after the spinal anesthesia procedure. Sympathetic nerve fibers are the first to be affected by the block, and the success of the block can be evaluated with the revealed sympathectomy. Sympathectomy in the lower extremities after spinal block increases arterial blood flow. This increase in blood flow can be detected by the Pulsed Wave Doppler feature of USG.


Eligibility Criteria:
Inclusion Criteria:

* Elective surgery under spinal anesthesia
* American Society of Anesthesiologists (ASA) I-II physical status

Exclusion Criteria:

* Contraindication for spinal anesthesia
* ASA physical status \>II
* Vasoactive drug usage
Alternate Chemotherapy Regimens for the Clearance of W.Bancrofti Infection

Diethylcarbamazine (DEC) essentially a micro-filaricidal drug is given for 12 days as standard treatment for the clearance of W. bancrofti infection. It takes about one year for the individuals to completely clear the microfilaria from the blood. It takes another two to four years to clear the antigen. The aim of the present study is to shorten the time taken for clearing the Mf and antigen from the blood either by co-administration or sequential administration of a macrofilaricidal drug, Albendazole or doxycycline. This study is a randomized, double blind, controlled clinical trial to study the efficacy of these drug combinations in complete clearance the Mf and antigen from the blood in shorter span of 180 days and 365 days respectively.

Purpose:

Lymphatic dwelling parasite W. bancrofti is the most common cause of secondary lymphoedema. Till today, there is no effective treatment protocol for the complete clearance of W. bancrofti infection, in a short duration of time.

Methods:

The investigators conducted a double blind RCT under field conditions recruiting 146 asymptomatic W. bancrofti infected individuals. Participants were randomly assigned one of the four regimens for 12 days, DEC 300 mg + Doxycycline 100 mg co-administration or DEC 300 mg + Albendazole 400 mg co-administration or DEC 300 mg + Albendazole 400 mg sequential administration or control regimen DEC 300 mg. Participants were followed up at 13, 26 and 52 weeks post-treatment for the clearance of infection.

Eligibility Criteria:
Inclusion Criteria:

* Residing in or around Pondicherry and adjoining Tamilnadu areas
* Night blood microfilaria counts \> 10 mf/ml by membrane filtration
* No history of treatment for filarial infection for the last two years at least
* Willing for home visits by the staff of the center
* Willing to give written informed consent

Exclusion Criteria:

* Body weight less than 30 kg
* Hepatic or renal disease as evidenced by clinical or biochemical abnormalities. - concurrent illness like hypertension, diabetes mellitus, cardiac conditions and epilepsy requiring chronic medication
* Psychiatric illness
* Patients under tetracycline or doxycycline therapy
* History of de-worming by albendazole or other anti-helminthic during last one year
* Pregnancy or lactation
Safety and Efficacy of a New Transepithelial Photorefractive Keratectomy Treatment

This is a prospective, comparative, randomized, controlled, single-blind, single-surgeon, single-center PMCF clinical study whereby participants undergoing refractive surgery for correction of ametropia will receive a transepithelial PRK (tPRK) and conventional PRK treatment in the contralateral eye. To avoid bias in the clinical outcomes, the two PRK treatment options are randomized to the eyes of the patients based on ocular dominance. In addition, a 1:1 randomization is applied within the tPRK group to eyes with and without end-treatment laser polishing.

Both procedures, standard PRK and tPRK, are performed in a one-step procedure. The main difference between the procedures is, that in conventional PRK, the epithelium will be removed using alcohol, whereas in tPRK procedures, the epithelium will be removed by laser ablation.


Eligibility Criteria:
Inclusion Criteria:

* Ametropia
* Myopic subjects with refractive spherical equivalent (MRSE) between -1.5D and -9.0D
* Hyperopic subjects with refractive spherical equivalent (MRSE) between +1.5D and +5.25D
* Signed informed consent form

Exclusion Criteria:

* Ocular comorbidity
* Subject taking systemic medications likely to affect wound healing such as corticosteroids or antimetabolites.
* Subjects who are known to be pregnant, lactating, or who plans to become pregnant over the medications used for standard tPRK.
* Subjects participating in any other ophthalmic clinical trial during this clinical study.
* Subjects with cognitive impairments or other vulnerable persons
Efficacy and Safety Study of rhGM-CSF Gel to Treat Deep 2nd Thickness Burn

This was a multicenter, randomized, phase Ⅳ study, to investigate the extensive efficacy and safety of Recombinant Human Granulocyte/Macrophage Colony-stimulating Factor Hydro-gel for Topical Application (rhGM-CSF Gel) on deep 2nd burn.

There are two parts of the phase Ⅳstudy, the first part was a multicenter, randomized, reference controlled study, all the subjects were randomized into two groups, test group (rhGM-CSF Gel) and control group (iodophor gauze), totally 358 deep 2nd burned patients were enrolled in first part of the study, 177 cases were enrolled in test group and 181 cases were enrolled in reference control group. In the test group, after the patients were enrolled in the group, clean the wound surface regularly and wash with normal saline, spread the test drug on the wound surface, bandaging with sterilized vaseline gauze, change the drug product every two or one day according to the effusion. In the reference control group, after the patients were enrolled in the group, clean the wound surface regularly and wash with normal saline, bandaging with iodophor gauze, change the drug product every two or one day according to the effusion. Whole treatment were lasted till the wound surface was healing completely, if it is not recovered in 4 weeks, calculate and record the healing rate. The secondary part of the study was a multicenter, open study, to investigate the safety of rhGM-CSF on deep 2nd burn patients. Totally 2329 patients were enrolled in this part of the study.


Eligibility Criteria:
Inclusion Criteria:

* age is not less than 3 years old, any gender is ok.
* the subject who is diagnosed as deep 2nd thickness burn
* the subject who was not administrated with any other topical durg on wound surface before enrolled in the clinical study.
* the subject who sign the \<informed consent\>

Exclusion Criteria:

* age is less than 3 years old
* the subject who participated in any other clinical trial within 3 months
* the subject who was administrated with any other topical drug on wound surface before enrolled in the clinical study
* the female subject who is in lactation or pregnancy
* the subject who are allergic to rhGM-CSF, or has the allergic history to many drug products or has the allergic disease recently
* the subject who has serious heart disease, unstable angina pectoris break out, cardiac functional insufficiency, myocardial infarction or serious general infection.
* the subject who has serious renal inadequacy, creatinine(Cr) is more than 2.5 times of the upper limit
* aspartate aminotransferase or alanine transpeptidase is more than 2.5 times of the upper limit
* the subject who use immunosuppressant
Caregiver Burden and Wellbeing in Relatives of Intensive Care Unit Patients

The purpose of this study is to determine whether there is an association between adverse physical and/or psychological outcome in ICU survivors and the caregiver burden for their relatives.

We hypothesize that relatives to ICU survivors with an incomplete physical and/or psychological recovery three months after ICU stay report a higher caregiver burden.

This is a sub-study to the multicenter "PROGRESS study". Details of the PROGRESS study have been described elsewhere. Briefly, an observational study including 600-1000 adult ICU patients from ten European hospitals will be followed up during three months to identify potential risk factors for physical and psychological problems.

The sub-study is conducted in four Swedish hospitals (Karolinska University Hospital Solna, Södersjukhuset, Stockholm, Örebro University Hospital and Akademiska University Hospital in Uppsala). Relatives to patients included in the PROGRESS study, who give informed consent to participate are consecutively included in the study.

Consenting participants (relatives) will be approached after inclusion of the patient and asked to estimate their own health related quality of life (HRQOL) 2 weeks prior to the time point for patient ICU admission through a HRQOL questionnaire. This self-reported HRQOL data will be used as proxy for baseline data. Three months after ICU discharge, relatives to ICU survivors will receive the following questionnaires by postal mail; Caregiver Burden Index, HRQOL questionnaire, a questionnaire screening for symptoms of anxiety and depression and a questionnaire screening for symptoms of posttraumatic stress.

The relatives will also be asked to state the number of working days lost due to caretaking of the ICU survivor.

ICU survivors' physical and psychological outcome, assessed with BI, SF-36, PTSS-14 and HADS three months after ICU discharge, obtained in the main PROGRESS study, will be compared with relatives' reported caregiver burden.

Secondary outcomes are associations between caregiver burden and reported health-related quality of life between baseline and 3 months after ICU discharge, frequency of symptoms of anxiety, depression and posttraumatic stress 3 months post ICU discharge and number of working days lost because of their relative's critical illness.

Eligibility Criteria:
Inclusion Criteria:

1. Relatives are considered eligible if they are a) partner to the patient b) adult children, siblings, parents or close friend that share household with the ICU survivor

Exclusion Criteria:

1. Non-Swedish-speaking
2. Overt or documented cognitive impairment
Study of Talazoparib, a PARP Inhibitor, in Patients With Advanced or Recurrent Solid Tumors

This is a single-arm, open-label study to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of talazoparib in patients with advanced tumors with DNA-repair pathway deficiencies. There will be 2 parts to the study: a dose escalation phase in which the maximum tolerated dose will be defined, and a dose expansion phase.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically documented, unresectable, locally advanced or metastatic solid tumor
* Must have available archived tumor tissue (formalin-fixed paraffin-embedded) \[FFPE\].
* 18 years of age or older.
* Have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST, v1.1) or increased CA-125 (ovarian cancer) or PSA (prostate cancer) and/or CA 19-9 (pancreatic cancer).
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
* Have adequate organ function
* Able to take oral medications.
* Willing and able to provide informed consent.
* Sexually active patients must be willing to use an acceptable method of contraception.
* Females of childbearing potential must have a negative serum pregnancy test at screening.
* Willing and able to comply with all study procedures.

Part 2 Dose Expansion Tumor Types:

* Breast and ovarian cancer patients with deleterious or pathogenic BRCA mutations who have received no more than 4 prior regimens for metastatic disease.
* Prostate or pancreatic cancer patients with deleterious or pathogenic BRCA mutations who have received no more than 2 prior regimens for metastatic disease.
* Small cell lung cancer (SCLC) patients who have received no more than one prior regimen for SCLC.
* Ewing's sarcoma patients who have received no more than 3 prior regimens for metastatic disease.

Exclusion Criteria:

* Part 2 Expansion: Prior treatment with a PARP inhibitor.
* Has history of central nervous system (CNS) metastasis.

  \* Exception: In patients with SCLC, history of adequately treated brain metastasis who do not require corticosteroids for management of CNS symptoms.
* Has had major surgery within 28 days before Cycle 1, Day 1.
* Has active peptic ulcer disease.
* Active gastrointestinal tract disease with malabsorption syndrome.
* Pregnant or breastfeeding at screening or planning to become pregnant (in each case, either oneself or one's partner) at any time during the study.
Fluid Coloading and the Incidence of Hypotension

This study was conducted to evaluate the effects of rapid crystalloid (Lactated Ringer's solution) or colloid (hydroxyethyl starch; HES) cohydration with a second intravenous access line on the incidence of hypotension and ephedrine requirement during spinal anaesthesia for caesarean section.

Background: Spinal anaesthesia for caesarean delivery is often associated with hypotension. This study was conducted to evaluate the effects of rapid crystalloid (Lactated Ringer's solution) or colloid (hydroxyethyl starch; HES) cohydration with a second intravenous access line on the incidence of hypotension and ephedrine requirement during spinal anaesthesia for caesarean section.

Methods: We studied 90 women with uncomplicated pregnancies undergoing elective caesarean section under spinal anaesthesia. Intravenous access was established in all with two peripheral intravenous lines, the first being used for the baseline volume infusion. Immediately after induction of spinal anaesthesia, Lactated Ringer's solution (Group L) or HES (Group C) infusions were started at the maximal possible rate via the second line in groups L and C respectively. The third group (Group E) patients received lactated Ringer's solution at a 'keep vein open' rate to maintain the double-blind nature. The incidence of hypotension, ephedrine requirements, total amount of volume and side effects were recorded.

Eligibility Criteria:
Inclusion Criteria:

* elective caesarean section under spinal anaesthesia

Exclusion Criteria:

* Significant coexisting disease such as; pre-eclampsia and hepato-renal disease,
* Pregnancy preinduced hypertension,
* Being in active labour or requiring emergency caesarean section,
* Any contraindication to regional anaesthesia such as local infection or bleeding disorders.
FamilyLink Family-Centered Rounds

This study will be a pilot test of using FamilyLink software to bring parents of patients in the neonatal intensive care unit (NICU) virtually to the bedside during Family Centered Rounds.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the Blue Team in the NICU aged 0-365 days
* Parents/guardians of patients admitted to the Blue Team in the NICU aged ≥ 18 years
* Medical team members (physicians, nurse practitioners, fellows, residents, medical students, nurses) of patients admitted to the Blue Team in the NICU aged ≥ 18 years

Exclusion Criteria:

* Patients who are not discharged home from the NICU (e.g., transferred to another inpatient unit or another hospital)
* Parents/guardians of patients admitted to the Blue Team in the NICU who do not speak English, as a translator will not reliability be available to participate in rounds when the parent/guardian is not physically present
* Patients who have more than one admission to the Blue Team during our study period will only be included on their first admission
The Evaluation of the Ultrasound-guided Clinical Procedure Simulation Curriculum

Ultrasound is a non-radiated diagnostic tool that can be performed at the bedside in emergency departments and critical care settings. Traditionally, junior residents learn from patients by performing sonography on them. However, patient rights, patient safety, and medical quality are raising concerns.

How to enable junior doctors to be effectively familiar with ultrasound operations and to effectively integrate them into daily practice has become a major challenge in medical education. Also, the ultrasound-guided clinical procedure is included in the ultrasound core applications in the American College of Emergency Physicians statements.

This aim of this study is to establish an ultrasound-guided simulation curriculum and to evaluate the efficacy. The subjects of the study are junior doctors who are interested in clinical procedures in the emergency department or other relevant medical departments, and it is estimated that 200 people will be enrolled.


Eligibility Criteria:
Inclusion Criteria:

* participants attended the curriculum.

Exclusion Criteria:

* not attended the curriculum
Bone Remodeling Around HA-coated Acetabular Cups.

This study was designed to investigate the influence of HA-coating on bone remodeling around the cup in cementless THA.

100 patients gave informed consent to participate in a controlled randomized study between porous coated Trilogy® versus Trilogy Calcicoat®. The cup was inserted in press-fit fixation. The femoral component was a cementless porous coated titanium alloy stem (Bi-Metric®), with a modular 28 mm CrCo head. Effect parameters were Harris Hip Score (HHS) and Bone Mineral Density (BMD) determined by DEXA scanning.

Measurements revealed no difference between the two groups after 3 years, neither in clinical outcome nor in terms of periprosthetic bone density. Patients with Body Mass Index above normal regained more bone mineral than patients with normal weight. This finding supports the assumption that load is beneficial to bone remodeling. Advantages of better sealing of the bone-prosthesis interface, preventing polyethylene induced osteolysis, may still be anticipated for the 7 or 12 year follow-up examinations

This study was designed to investigate the influence of HA-coating on bone remodeling around the cup in cementless THA.

100 patients gave informed consent to participate in a controlled randomized study between porous coated Trilogy® versus Trilogy Calcicoat®. The cup was inserted in press-fit fixation. The femoral component was a cementless porous coated titanium alloy stem (Bi-Metric®), with a modular 28 mm CrCo head. Effect parameters were Harris Hip Score (HHS) and Bone Mineral Density (BMD) determined by DEXA scanning.

Measurements revealed no difference between the two groups after 3 years, neither in clinical outcome nor in terms of periprosthetic bone density. Patients with Body Mass Index above normal regained more bone mineral than patients with normal weight. This finding supports the assumption that load is beneficial to bone remodeling. Advantages of better sealing of the bone-prosthesis interface, preventing polyethylene induced osteolysis, may still be anticipated for the 7 or 12 year follow-up examinations

Eligibility Criteria:
Inclusion Criteria:

* Patients eligible for cementless THA

Exclusion Criteria:

* Medical conditions interfering with bone metabolism
Comparative Efficacy and Safety of Fenoverine

It is a randomized double-blind parallel phase IV study to compare Fenoverine and Trimebutine maleate in the efficacy and safety.

Study Hypothesis: Fenoverine is non-inferior to Trimebutine maleate in its efficacy and safety.

For subjects with IBS, Fenoverine and Trimebutine will be administered orally for 8 weeks; Fenoverine 100mg capsule three times a day and Trimebutine 150mg tablet three times a day. Because one is capsule and the other is tablet, double dummy design will be used. Efficacy is evaluated at the end of 8 weeks and safety will be followed for 4 more weeks after the end of the scheduled medication.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older and 60 years of age or younger
* Diagnosed as irritable bowel syndrome using Rome III Criteria
* Female subjects of child-bearing potential are confirmed to have a negative urine beta-hCG test within 7 days prior to administration of initial dose of investigational products.
* Female subjects of child-bearing potential must agree to use contraceptive measures during study period.

Exclusion Criteria:

* Known allergy or hypersensitivity to investigational products or components of the formulation
* Past or current diagnosis of chronic liver disease (e.g., liver cirrhosis, acute hepatitis, alcoholic hepatitis, chronic alcohol abuse and HCC)
* Past or current diagnosis of Myopathy
* Subject with serious renal disease
* Known medical condition assessed by investigators as inappropriate for the study
* Continuous use of NSAIDS, analgesics, steroids, or other immunosuppressants.
* Continuous use of HMG-CoA reductase inhibitors or fibrates to lower blood lipid level
* Pregnant, lactating, or planning to be pregnant women
* Evidence of abuse of drugs or alcohol within 6 months prior to screening
* Participation in other clinical trials within 3 months prior to enrollment or elapse of less than 5 half lives of previous investigational product after last dose of it.
* Unable to submit informed consent or comply with the requirements of the study