cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Ranibizumab 0.5 mg Administered as Two Alternative Dosing Regimens in Chinese Patients With nAMD (Age Related Macular Degeneration)

The study evaluated the efficacy and safety of two different dosing regimens of ranibizumab (either monthly injections or injections as-needed based on the stability of a patient's vision) in Chinese patients with wet age-related macular degeneration (AMD) . This study was to provide long-term safety data in the treatment of Chinese patients with wet AMD.


Eligibility Criteria:
Key Inclusion criteria:

* Patients with visual impairment due to neovascular AMD
* A qualifying vision score at study entry Key Exclusion criteria
* Active infection or inflammation either eye at study entry
* Uncontrolled glaucoma in either eye
* Any disorder in the study eye which may affect vision
* Use of any systemic anti-vascular endothelial growth factor (VEGF)-drugs within 3 months prior to study entry
* Previous treatment of the study eye for wet AMD
* Any surgery in the study eye 3 months prior to or planned with 6 month after study entry
Assessment of Novel Intraocular Injection Guide

To determine if a novel intraocular injection guide (IIG) reduces patient discomfort during and after intravitreal injections.

This study is being conducted to assess the potential for an intraocular injection guide to increase comfort levels both during and after such injections. The hypothesis is that patients will feel increased comfort from a device which eliminates the need for a speculum while still keeping the eyelids apart, allowing a physician to deliver treatment. The results of this study will allow physicians to select the optimal device for patient comfort and well-being during intravitreal injections

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be receiving bilateral injections of the same dose of vascular endothelial growth factor (VEGF) inhibitor
* Injections in both eyes must be given on the same day
* Male or female age 18 years or older

Exclusion Criteria:

-Any condition or reason that precludes the subject's ability to comply with the study -
Expressive Helping for Stem Cell Transplant Patients

The Writing for Insight, Strength, and Ease (WISE) Study is a multisite Randomized Controlled Trial (RCT) testing the efficacy of the Expressive Helping (EH) intervention among adults receiving hematopoietic stem cell transplantation.

Use of stem cell transplant (mostly for hematologic cancers) is expected to increase 5-fold by 2030, when the number of survivors will reach 500,000. This highly toxic treatment causes a range of acute physical and psychological symptoms, which then persist for years for up to 45% of patients. To address gaps in existing symptom-focused behavioral interventions that can be added to standard patient care, the investigators developed Expressive Helping (EH), a low-cost, low-burden intervention that targets a range of physical and psychological symptoms in a broad group of transplant recipients. EH is completed in 4 brief structured writing sessions during and immediately after transplant, with instructions focused on having participants write about their transplant experience. Based on promising preliminary data, the investigators propose to determine whether EH can be used during and immediately after transplant to reduce common acute physical and psychological symptoms and prevent development of persistent physical and psychological symptoms. Assessments of physical symptoms and psychological symptoms will occur at baseline (prior to randomization), "nadir" (Day 7 post-transplant), "engraftment" (Day 14 post-transplant), 1 week post-intervention, 3-months post-intervention (primary endpoint, early post-transplant), 6-months post-intervention, and 12-months post-intervention (primary endpoint, later post-transplant). The investigators will also assess a select set of potential mediators and moderators of intervention effects. Participants will be adult cancer patients scheduled for allogeneic or autologous stem cell transplant at the study sites. After screening and consent, eligible patients will be enrolled in a parallel-group, 1:1 randomized controlled trial. Randomization will be stratified by study site (JTCC, Lombardi Comprehensive Cancer Center, LCCC, or Robert H. Lurie Comprehensive Cancer Center, RHLCCC); sex (linked with patient outcomes), age (18-59, ≥ 60), and transplant type (autologous, allogeneic). Staff performing assessments will be blind to study assignment. Participants cannot be blinded, but hypotheses will not be revealed to them until trial completion. They will be asked not to reveal their assignment to staff.

Eligibility Criteria:
Inclusion Criteria:

* Cancer patients
* Age ≥ 18
* English proficient
* Scheduled for allogeneic or autologous transplant at JTCC, LCCC, or RHLCC.

Exclusion Criteria:

* Current participation in a behavioral intervention targeting symptoms or quality of life
* Cognitive or psychiatric impairment precluding ability to complete informed consent or study procedures
* Literacy limitations precluding completion of a writing study
* Undergoing a tandem transplant where participant is now completing the first of two or more planned transplants
Recto-intercostal Facial Plane Block in Laparoscopic Hiatus Hernia Repair

The aim of this study is to evaluate the perioperative analgesic and intraoperative hemodynamic effects of ultrasound-guided bilateral recto-intercostal fascial plane block in patients undergoing laparoscopic Hiatus hernia repair.

Hiatus hernia is a prevalent condition in which the stomach or other abdominal organs protrude through the esophageal hiatus of the diaphragm into the thoracic cavity due to elevated pressure within the abdomen. Laparoscopic hernioplasty of hiatal hernia has been confirmed effective and safe in recent years and performed more due to its mini-invasive nature and intraperitoneal view and operating angle.

Although patients having laparoscopic hiatus hernia repair experience less pain than open surgery, postoperative pain can still be significant and lead to associated postoperative issues. These issues can include respiratory and other complications, delay in discharge and adverse effects from increasing requirements of systemic analgesia such as opioid. An important consideration in the potential multitude of problems associated with increased opioid use is respiratory depression, sedation, constipation and the propensity for vomiting. Postoperative vomiting can result in the repaired diaphragm enduring excessive pressure and subsequently early recurrence and failure of the procedure.

Recently, a novel block named "recto-intercostal fascial plane block" is performed between the recto abdominal muscle and costal cartilages of ribs 6-7 to block the anterior branches of the T6-T9 thoracic nerves, and laterally to the entire lower thorax. The investigators hypothesize that this block may provide perioperative analgesic benefits in patients undergoing Laparoscopic hiatus hernia repair under general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 65 years.
* American Society of Anesthesiology (ASA) physical status I-II.
* Both sexes.
* Scheduled for elective elective laparoscopic hiatus hernia repair under general anesthesia.

Exclusion Criteria:

* Patients with cardiovascular, pulmonary, or neurological diseases.
* History of chronic pain or Long-term or recent use of opioids.
* Coagulation disorders.
* History of allergy to local anesthetic drugs.
* History of previous abdominal surgery.
* Pregnancy.
Effectiveness of a Cell Phone-Based Program for Abstinence and HIV Risk Prevention

This study will develop and test the effectiveness of a cell phone-based text messaging program to encourage abstinence, monogamy, or condom use among black urban males in Philadelphia, Pennsylvania.

Sexually transmitted diseases (STDs), including HIV infections, are most commonly spread through unprotected sexual intercourse. STDs are a primary health issue, especially among young ethnic minorities in the United States. The rate of STDs is significantly greater in urban areas where ethnic minorities, particularly African-American males, are commonly represented. Despite this information, safe sexual practices, including correct condom use, are not commonly followed among minority males. It is believed that educational outreach designed to motivate and inform on the correct use of condoms will be effective in encouraging safer sex practices. A cell phone-based text messaging program designed to promote safer sex practices may provide an effective and easy means of delivery of treatment. This study will develop and test the effectiveness of a cell phone-based text messaging program to sustain abstinence, monogamy, or condom use among black urban males in Philadelphia, Pennsylvania.

Participation in this study will be divided into two phases. In the first study phase, participants will partake in a 90-minute focus group to help develop text message content and plans for treatment delivery. The next study phase will be a pilot test of the program developed in the first phase. Participants will be assigned to receive text messages concerning either HIV prevention or general nutrition. Participants receiving the HIV prevention text messages will be sent up to 90 text messages related to abstinence, monogamy, and condom use over a 3-month period. Participants will also be able to join interactive phone activities related to HIV. Participants receiving the nutritional text messages will be sent up to 30 messages about nutrition and healthy eating over the same period of time. Participants will complete telephone surveys at baseline and Months 3 and 6. The surveys will assess measures of abstinence, monogamy and condom use attitudes, norms, self-efficacy, and risk behaviors.

Eligibility Criteria:
Inclusion Criteria:

* Resident of Philadelphia
* Self-identified black or African American
* English-speaking
* Cell phone user
A Safety and Tolerability Study of ABT-126 in Elderly

The objectives of this study are to assess the safety, tolerability and pharmacokinetics of ABT-126 in elderly subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects 65 years or greater.
* Has a MMSE score of 27 or higher.

Exclusion Criteria:

* History of dementia including by not limited to Alzheimer's disease, Parkinson's disease and mult-infarct dementia.
* History of any significant neurological disease.
* Has an estimated creatinine clearance \< 30 mL/min
Cholecyst- Versus Cystic Duct Cholangiography During Laparoscopic Cholecystectomy

Standard cystic duct cholangiography (CDC) during laparoscopic cholecystectomy can be difficult, time consuming and bile duct injury may be caused by attempts to cannulate the cystic duct. Operative cholangiography performed by direct puncture of the gall bladder fundus or Cholecystocholangiography (CCC) is a valid and easier alternative.

This study was conducted on 60 patients with symptomatic gall bladder stones undergoing laparoscopic cholecystectomy. Patients were randomized into two groups: Group (1) was evaluated by cholecyst-cholangiography by puncture through the gall bladder fundus. Group (2) was evaluated for the standard cystic duct cholangiography.Cholangiography was considered successful if it could be performed with complete delineation of the biliary tree with flow of the dye through the duodenum occurred. It is to be noted that inability to cannulate the cystic duct for example, is considered a failure.

Eligibility Criteria:
Inclusion Criteria:

* patients with symptomatic gall bladder stones.

Exclusion Criteria:

* unfit Patients and/or had previous surgery
* history of obstructive jaundice and acute attacks or previous ERCP were excluded
Analysis of In-hospital Emergency Team Calls in a German Tertiary Care University Hospital From 2013 to 2016

A retrospective analysis of 1,664 emergency forms from MET activities, ranging from January 2013 to December 2016. Every MET activation call via the emergency telephone number ("5555") and following emergency treatment was recorded by a standardized documentation form.

Recent studies demonstrated that in-hospital emergencies are linked to a higher mortality in patients. In total, 1 out of 10 patients is suffering from an unexpected incident during the hospital stay. Therefore, establishing and developing medical emergency teams (MET) is getting more important in the future. Aim of the present study was an analysis of medical documentation, operational tactics and procedures taken by MET in a 4-year-period, ranging from 2013 to 2016. A retrospective analysis of 1,664 emergency forms from MET activities, ranging from January 2013 to December 2016. Every MET activation call via the emergency telephone number ("5555") and following emergency treatment was recorded by a standardized documentation form.

Eligibility Criteria:
Inclusion Criteria:

* all patients treated with emergencies

Exclusion Criteria:

* none
A Comparative Study Between Anterior and Posterior Pyelotomy in Transperitoneal Laparoscopic Pyelolithotomy

Large renal pelvic stones are frequently managed with percutaneous nephrolithotomy (PCNL) but laparoscopic pyelolithotomy (LPL) can be an alternative procedure when performed by skilled surgeons to achieve excellent outcomes in terms of stone free status, operative time, postoperative kidney function, hospitalization duration, and complications.

there are two methods for LPL surgery : Transperitoneal (TLP) and Retroperitoneal (RLP).

RLP associated with shorter mean time for oral intake, and mean hospital stay after surgery.

The surgical exposure in the transperitoneal route for LP is familiar to the majority of surgeons. Also, a much larger working space is available and there are various established anatomical landmarks for performing the surgery effectively. This study introduces a modified technique that creates application of posterior pyelotomy in TLP to achieve the advantages of RLP

This is a randomized controlled clinical trial that aims to collect a sample within two years from the date of approval of the Scientific Research Council at Damascus University.

The study will focus on a group of patients who will undergo a transperitoneal laparoscopic pyelolithotomy surgery.

The patients will be randomly divided into two groups. The first group will undergo a traditional transperitoneal laparoscopic pyelolithotomy, which involves application of anterior pyelotomy.

The second group will receive a modified transperitoneal laparoscopic pyelolithotomy, which involves application of posterior pyelotomy.

The data will be compared between the two groups in terms of the mean duration of surgery ,mean time for oral intake ,and mean hospital stay

Eligibility Criteria:
Inclusion Criteria:

* Patients with large renal pelvic stone \> 2 cm .
* failure of minimally invasive approaches such as PCNL or ESWL
* stones that were neither amenable to ESWL nor were ideally suitable for PCNL
* Patient's preference for a quick one-stage procedure.
* Negative urine culture

Exclusion Criteria:

* Patients refusing study participation.
* Contraindication to general anesthesia.
* Contraindication to laparoscopic surgery.
* Patients with an intrarenal pelvis.
* Previous surgical on the same kidney.
* Associated anatomical deformity.
Study on Baroreceptor Function in Relation to Orthostatic Blood Pressure Regulation After Hip Surgery

The purpose of this observational study is to evaluate the baroreceptor function in relation to surgical inflammation and orthostatic intolerance after elective hip arthroplasty.

The main hypothesis is that baroreceptor function is attenuated after surgery and related to surgical inflammation.

Orthostatic intolerance and hypotension is prevalent during early mobilization after major surgery.

This observational study aims to evaluate the baroreceptor function during using a standardized evaluation protocol before, 6- and 24 hours after elective primary unilateral hip-arthroplasty.

The study hypothesis is that baroreceptor function as expressed by the valsalva ratio is attenuated after surgery and related to surgical inflammation.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for unilateral hip arthroplasty
* 18 years or older
* Able to give informed consent

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) class 3 or higher
* Chronic arrythmia (Atrial fibrillation or other arrythmia)
* Incompensated ischaemic heart disease
* Mobilization restriction due to surgical reasons
* Medical complications during admission requiring transferral to other department
Long-Term Safety, Efficacy, and Durability of EN3835 in the Treatment and Retreatment of Plantar Fibromatosis

Assess the long-term safety and efficacy of EN3835 in participants who have participated in a parent placebo-controlled study of EN3835 (EN3835-222, NCT05152173) and assess the efficacy and safety of EN3835 in the treatment and retreatment of plantar fibromatosis.


Eligibility Criteria:
Inclusion Criteria:

1. Have been enrolled and completed a sponsored-clinical study of EN3835 (for the EN3835-222 study, participants who completed the study are those that completed the Day 57 visit, were assessed for safety and received at least 1 dose of study intervention).
2. Willing and able to comply with all protocol required visits and assessments.
3. Agree not to use opioids during the study period and has not used opioids 2 weeks prior to the Observational Day 1 Visit.
4. Agree to not initiate or change use of orthotics or inserts designed to relieve symptoms of plantar fibromatosis during the study period.
5. Willing and able to comply with all protocol required visits and assessments.
6. Be adequately informed and understand the nature and risks of the study and be able to provide consent
7. If female, be of non-childbearing potential (history of hysterectomy, bilateral oophorectomy, bilateral tubal ligation, or postmenopausal with no history of menstrual flow in the 12 months prior to the Day 1 Visit), or, if of childbearing potential, be nonpregnant, non-lactating and agree to use effective contraception when with a male partner for the duration of the study and for 28 days after any active treatment period.
8. Have no significant medical history or examination findings related to the participant's plantar nodules, which in the investigator's opinion, would make the participant unsuitable for EN3835 administration.

Exclusion Criteria:

1. Has any musculoskeletal, neuromuscular, neurosensory, or other neurological or related disorder that affects the participant's use of his or her feet and/or would impair his/her completion of study assessments as determined by the investigator.
2. Any other significant medical condition or had an SAE in the parent study which in the investigator's opinion, would make the participant unsuitable for enrollment in the study.
3. Received or plans to receive surgical or non-surgical treatments on the foot or nodules that were treated.
4. Has a known systemic allergy to collagenase or any other excipient of EN3835.
5. Has a known bleeding disorder that would make the participant unsuitable for treatment or retreatment in the study.
6. Has significant medical history or examination findings related to the participant's plantar nodules, which in the investigator's opinion, would make the participant unsuitable for EN3835 administration.
7. Has a known coagulation disorder or is taking any medications that would increase the risk of bleeding (except \<150mg of aspirin daily, 7 days prior to first injection and for the duration of the study.
Collection of Plasma and Serum Samples From Individuals Initiating Sofosbuvir for Chronic Hepatitis C for Testing

This non-interventional clinical study will be conducted to prospectively collect serial plasma and serum samples from treatment naïve subjects with chronic HCV infection who are initiating sofosbuvir-based therapy. These samples will be used to estimate clinical utility endpoints for the Aptima HCV Quant Dx assay which is used an aid in the management of HCV-infected patients undergoing HCV antiviral therapy.


Eligibility Criteria:
Inclusion Criteria:

* The subject is chronically infected with HCV genotypes 1, 2, 3, 4, 5, and/or 6 as documented in the subject's medical records and is naïve to HCV treatment (treatment naïve).
* Chronic HCV (with or without HIV \[human immunodeficiency virus\] co-infection) will be documented with historical record of:
* A positive HCV RNA test result (result generated at least 6 months before the baseline visit)
* A HCV genotype test result (result generated at least 6 months before the baseline visit)
* A liver biopsy report demonstrating chronic HCV

  ---The subject is initiating antiviral therapy with a sofosbuvir regimen as indicated below:
* Sofosbuvir plus peginterferon and ribavirin for 12 weeks (peginterferon eligible genotype 1, 4, 5, or 6)
* Sofosbuvir plus ribavirin for 12 weeks (genotype 2)
* Sofosbuvir plus ribavirin for 24 weeks (peginterferon ineligible or unwilling genotype 1 or genotype 3)
* The subject is at least 18 years of age at the time of enrollment
* Adequate medical records are available for collection of protocol-defined demographics, baseline patient characteristics, medical history, virology and specific laboratory results, and other information to verify enrollment criteria
* The subject and/or legally authorized representative is willing and able to provide consent prior to providing a specimen(s)

Exclusion Criteria:

* Subjects with history or evidence of decompensated liver disease
* Subjects with severe renal impairment or end stage renal disease
* Subjects who are not naïve to HCV therapy with prior exposure to an approved or experimental HCV antiviral therapy
* Subject has characteristics that are contraindicated in the FDA approved label for sofosbuvir (eg, subjects with contraindications applicable to peginterferon and/or ribavirin, pregnant woman or men whose female partners are pregnant; Sovaldi Package Insert 2013)
* Subject is receiving treatment pre- or post-transplant
* Subject is unsuitable for study participation based on the Investigator's decision (eg, unlikely to comply with study visit schedule, significant medical complication)
* Participating in another investigational study that the Investigator believes might interfere with the subject's participation in this study