cyrilzakka/clinical-trials huggingface dataset:
Open Label Extension Study of 1 mg/kg Pegunigalsidase Alfa Every 2 Weeks in Patients With Fabry Disease

The objective of CLI-06657AA1-04 (formerly PB-102-F60) is to evaluate the long-term safety, tolerability, and efficacy parameters of 1 mg/kg pegunigalsidase alfa administered intravenously every other week in adult Fabry patients who have successfully completed studies PB-102-F03, PB-102-F20 or PB-102-F30.

This is an open-label study. Patients will be enrolled to receive 1 mg/kg pegunigalsidase alfa as intravenous infusions every 2 weeks (±3 days). The duration of treatment is until pegunigalsidase alfa is commercially available to the patient, or at the discretion of the Sponsor. For the analysis, available efficacy and safety parameters will be summarized using descriptive statistics.

Eligibility Criteria:
Inclusion Criteria:

1. Completion of study PB-102-F20, PB-102-F03, or PB-102-F30
2. The patient signs informed consent
3. Female patients and male patients whose co-partners are of child-bearing potential agree to use a medically acceptable method of contraception. These include combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal) supplemented with a barrier method (preferably male condom), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable) supplemented with a barrier method (preferably male condom), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner, or sexual abstinence. Contraception should be used for 2 weeks after treatment termination.

Exclusion Criteria:

Presence of any medical, emotional, behavioral or psychological condition that, in the judgment of the Investigator, would interfere with patient compliance with the requirements of the study.
Edinburgh Cognitive and Behavioural Amyotrophic Lateral Sclerosis Screen in Norway: A Validation Study

Cognitive impairment is present in about 30-50% of the patients with amyotrophic lateral sclerosis (ALS). Suitable screening tools are available, but none of these are evaluated in a Norwegian population.

Screening of cognitive and behavioral impairment is a distinct recommendation in ALS-specific health-care. Thus, a rapid screening tool valid for use in Norway is urgent. However, cognitive assessment for patients with ALS can be difficult due to the complexity of cognitive impairment, as well as motor challenges with writing, drawing and speaking. Therefore, only ALS-specific, multi domain screening instruments with integrated behavioral sections should be used. Internationally, the Edinburgh cognitive and behavioral amyotrophic lateral sclerosis screen (ECAS), is recommended for the purpose. Besides being quick and easy to administer, the ECAS is shown to be sensitive and have high specificity to ALS-specific dysfunction and behavioral changes. The introduction of ECAS has probably contributed to a more nuanced picture of cognitive impairment in ALS than previously assumed. Therefore the ECAS has been translated and culturally adapted into Norwegian (ECAS-N). Based on scores from healthy people, Norwegian age- and educational-adjusted norms for verbal fluency (n=277) and cut-off-scores (n=85) for abnormal findings are established. However, further investigation of psychometric properties of the ECAS-N is needed. The objectives of the study are: 1. To investigate if the ECAS-N reflect cognitive impairment (internal consistency), and is robust to measurement errors due to different times of testing (test-retest reliability) and different raters (interrater reliability) 2. To investigate if the ECAS-N can be used to distinguish between people with ALS-specific cognitive impairment, and those who do not have cognitive impairment, and those who have cognitive impairment due to other disorders (construct validity).

Eligibility Criteria:
Inclusion Criteria:

* voluntary informed consent
* native Norwegian speaker
* aged between 35 and 85 years old (only for Controls)

Exclusion Criteria:

* great difficulties in writing og Reading
* comorbid Medical history
* neurological disorders others than ALS
* psychiatric history of importance to cognitive function
Sentinel Node Mapping in Women With Cervical and Endometrial Cancer

This study aims to evaluate the effect of SLN mapping on the incidence and severity of lymphedema in women with early stage cervical and endometrial cancer.


Eligibility Criteria:
Inclusion Criteria:

* Study IA: Cervical carcinoma, FIGO stage IB1, cervical tumour size \< 2 cm
* Study IB: Endometrial adenocarcinoma, presumed FIGO stage I, low- and intermediate risk: Type 1 grade 1 + 2, \> 50% myometrial invasion

Exclusion Criteria:

* Prior PL
* Known allergy towards ICG and/or iodine (ICG contains 5% sodium iodine)
* Women included in other studies affecting outcome-measures of the present study
Phase II Study of Immunization With a Hepatitis C Virus (HCV) Antigen Peptide Vaccine

The objectives are

1. to determine the immunological profile (CD4+, CD8+ cells, DTH) induced by immunization with HCV antigen peptide vaccine with polyarginine.
2. to document virological (HCV-RNA) and biochemical (ALT) responses following immunization with HCV antigen peptide vaccine with polyarginine.
3. to assess the safety of immunization with HCV antigen peptide vaccine with polyarginine.

This is a double blind, randomized, parallel group, controlled, multicenter phase II study.

60 patients will be enrolled and assigned to one of the 5 dose or control groups. Each study group will include 8 patients.

Each patient will receive a total of 6 injections according to the dose of the assigned study group. The injections will be administered subcutaneously in the upper arm once every four weeks for 5 months, i.e. at days 1, 29, 57, 85, 113 and 141.

The volume of each injection will be 0.5 ml in all groups.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic hepatitis C
* Non-response to or relapse from primary standard HCV therapy
* HLA A2 positive
* HCV-RNA positive
* HCV antibodies positive
* Liver biopsy within 30 months prior to inclusion
* Hematology and biochemistry laboratory results within the limits normally expected for the patient population (liver values maximal 5 times the upper limit of normal)
* Male and female
* From 18 to 65 years
* Written informed consent obtained prior to study entry

Exclusion Criteria:

* Any degree of liver cirrhosis or fibrosis of Ishak score ≥ 4 (for grading table, see APPENDIX 2: The Ishak Modified Hepatic Activity Index (HAI))
* Any liver disease other than hepatitis C
* History of autoimmune disease
* Immunodeficiency including post-organ-transplantation
* HIV infection
* Immunosuppressive therapy
* Any acute infections within 4 weeks prior to inclusion
* History of severe hypersensitivity reactions, anaphylaxis or atopy
* Diabetes mellitus, severe cardiopulmonary disorders, history of malignancy in the past 5 years
* Active or passive vaccination within 2 months prior to enrolment, and concomitant vaccination throughout the study period
* Pregnancy or lactation
* Unreliable contraception
* Alcohol consumption
* Drug abuse or addiction within 12 months prior to inclusion
* Participation in a methadone program
* Participation in another study within 1 month prior to enrolment
Quality Improvement Project for Maternal Health and Family Planning Services in Kenya

Evaluation of a quality improvement (QI) collaborative aimed at improving person-centered care (PCC) for maternal health (MH) and family planning (FP) services

Evaluation of a quality improvement (QI) collaborative in public facilities in Nairobi and Kiambu Counties in Kenya aimed at improving person-centered care (PCC) for maternal health (MH) and family planning (FP) services.

Eligibility Criteria:
Inclusion Criteria for Women:

* Women aged 15-49 years old
* Agreed/consented to participate
* Delivered at the facility within the last 7 days OR adopted a family planning method at their visit on day of survey
* Has a working mobile phone and specified service provider (airtel/safaricom)

Exclusion Criteria for Women:

* Not a women aged 15-49 years old
* Did no agreed/consented to participate
* Did not deliver at the facility within the last 7 days OR adopted a family planning method at their visit on day of survey
* Does not have a working mobile phone or specified service provider (airtel/safaricom)

Inclusion Criteria for Providers:

* Agreed/consented to participate
* Staff at facility

Exclusion Criteria for Providers

* Did no agreed/consent to participate
* Not staff at facility
Thyroid Dysfunction Induced by Anti-PD-1 Therapy in Patients With Advanced Carcinoma

In this study, we monitored patients with advanced malignant tumors who received anti-PD-1 therapy to observe the characteristic of anti-PD-1 therapy-induced thyroid dysfunction and its correlation with prognosis.


Eligibility Criteria:
Inclusion Criteria:

* Eighteen years or older
* Confirmed diagnosis of malignancy
* Received anti-PD-1 therapy

Exclusion Criteria:

* Thyroid malignancy or history of thyroid malignancy
* Thyroid dysfunction before anti-PD-1 therapies
* Previous ICIs treatment
* Less than 2 cycles of anti-PD-1 treatment
* No thyroid function monitoring during treatment
* Known pituitary disease
* Pregnancy.
Pelvic Drain After Rectal Resection for Mid-low Rectal Cancer

This RCT aims at assessing the effects of a pelvic drain after total mesorectal excision for mid-low rectal cancer on the rates of pelvic sepsis and anastomotic leaks.

This is a 2-arm, non-inferiority RCT. Patients undergoing total mesorectal excision for mid-low rectal cancer will be randomly assigned into two groups:

* pelvic drain
* no pelvic drain. Patients will be followed-up to assess the rates of anastomotic leaks, pelvic sepsis and secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female, 18 year-of-age or above
* Mid or low rectal cancer
* Anastomosis below the peritoneal reflection
* Total mesorectal excision (TME)
* Capability to understand the study
* Informed consent

Exclusion Criteria:

* For women, pregnancy
* Chronic kidney failure or hepatic failure, immunodepression, malnoutrition
* Life expectancy \< 6 months
* Partial mesorectal excision
* Abdominoperineal excision
* Multivisceral resections
* Emergency surgery
Influence of Calcium Pattern on Plaque Modification Achieved With Intracoronary Lithotripsy

Calcified coronary artery disease is a frequently encountered problem that can lead to poorer outcomes for patients undergoing PCI. Recently, intravascular lithotripsy has become available for the treatment of callcified coronary artery disease. The effect of intravascular lithotripsy on varying calcium patterns has not been adequately explored.

This is an investigator initiated, open label, non-blinded, observational study involving a number of centers in Spain examining the effect of intravasuclar lithotripsy in varying calcium patterns. 100 patients wll be enrolled. Optical coherence tomography will be used to assess the effect of intravascular lithotripsy on varying calcium patterns (concentric, eccentric and nodular).

Calcified coronary artery disease continues to present a challenge for Interventional Cardiologists. Moderate calcification is found in over 25% of coronary artery lesions planned for percutaneous coronary intervention (PCI). Outcomes for patients undergoing PCI to calcified lesions have been shown to be consistently poorer than in non-calcified lesions. Recently, intravascular lithotripsy has become available for the treatment of calcified coronary artery disease. The effect of intravascular lithotripsy on varying calcium patterns has not been adequately explored.

This is an investigator initiated, open label, non-blinded, observational study involving a number of centers in Spain. Patients with an indication of PCI and with a significant calcium burden requiring modification will be invited to participate. PCI procedures will be performed via either radial or femoral access as deemed appropriate by the operator and in accordance with local protocols. Intravascular imaging using OCT will be performed prior to calcium modification to define the pattern of calcium, after calcium modification to assess the effectiveness of IVL therapy and after stent implantation to assess stent expansion.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years of age
* Patients with an indication for PCI (ischemic symptoms or evidence of myocardial ischemia (inducible or spontaneous) in the presence of \>50% de novo severely calcified coronary stenosis that requires IVL treatment.

Exclusion Criteria:

* Patients unwilling or unable to sign informed consent for the procedure
* Patients with severe peripheral vascular disease limiting vascular access to the extent that it is unsafe to perform the procedure
* Patients with severe renal dysfunction (eGFR \<15mls/min and not receiving dialysis)
* Treatment of vessels \< 2.5mm diameter which are not amenable to IVL treatment or OCT assessment.
* Treatment of lesions located very distally in the coronary vessel where the OCT catheter may not reach.
* Inability to cross the lesion with the OCT catheter due to very severe stenosis or severe vessel tortuosity.
* Ostial left main stem or right coronary artery lesions which may be difficult to visualise by OCT
* Patients requiring concomitant use of rotational or orbital atherectomy of LASER.
Gentamicin Versus Clindamycin Versus Normal Saline Lavage in Axilla

The patients undergoing axillary lymph node dissection were randomized into 3 groups: patients undergoing lavages with normal saline (Group 1), patients undergoing lavage gentamicin solution (Group 2) and patients undergoing lavage with a clindamycin solution (Group 3). Drainage volume discharge is investigated

The patients undergoing axillary lymph node dissection were randomized into 3 groups: patients undergoing 2 lavages with 500 ml normal saline (Group 1), patients first undergoing lavage with 500 ml normal saline followed by a second lavage with a 500 ml of a gentamicin (240 mg) solution (Group 2) and patients first undergoing lavage with 500 ml normal saline followed by a second lavage with 500ml of a clindamycin (600mg) solution (Group 3). Drainage volume discharge is investigated

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of breast neoplasms
* plans to undergo an elective ALND of Berg's levels I and II due to axillary metastasis determined preoperatively by core biopsy or evidence of metastasis in the SLNB in the intraoperative or in the differed analysis.

Exclusion Criteria:

* allergy to any of the antibiotic drugs used
* chronic renal failure due to possible toxicity of gentamicin
* patients undergoing a modified radical mastectomy.
Effects of Glycopyrrolate on Heart Rate and Heart Rate Variability in Patients With Different Basic Heart Rate

Glycopyrrolate is an anticholinergic medication commonly used in respiratory medicine for treating chronic obstructive pulmonary disease (COPD), bronchial asthma, and other conditions . In the perioperative period, it is often administered before anesthesia to reduce secretions in the salivary glands, bronchi, and pharynx . It is used during the recovery period to counteract the muscarinic effects of anticholinesterase inhibitors and can also be employed to prevent/treat vagal reflexes and related arrhythmias induced by surgery or medications .

Heart rate (HR) is influenced by both the sympathetic and parasympathetic nervous systems. The baseline HR of different patients may vary due to differing levels of sympathetic and parasympathetic nerve activity within the body. It remains unclear whether patients with different baseline HRs exhibit varying degrees of HR elevation after the administration of glycopyrrolate(i.e.,the parasympathetic activity in vivo is antagonized). The primary aim of this study is to explore the impact of glycopyrrolate administration on HR in patients with different baseline HRs. The secondary objective is to investigate the effects of glycopyrrolate on heart rate variability (HRV) in patients with different baseline HR.


Eligibility Criteria:
Inclusion Criteria:

* 1.Weight not restricted; 2.American Society of Anesthesiologists (ASA) status I or II; 3.The operative time≥1 h; 4.Undergoing orthopedic or urological surgery.

Exclusion Criteria:

* 1.allergy to glycopyrrolate; 2.laparoscopic surgery; 3.liver or kidney dysfunction; 4.pre-existing abnormal electrocardiogram such as bradycardia; 5.concomitant glaucoma; 6.patients refusal to participate.
Clinical Study of 68Ga Labeled HER2 Affibody Analogues

The purpose of this study is to assess the dosimetric properties of the positron emission tomography (PET) imaging probe 68Ga labeled HER2 Affibody analogues and preliminarily evaluate its diagnosis value in patients with breast or gastric tumors.

6 healthy volunteers with whole-body PET/CT scans at 0-1.0, 2.0, 3.0 and 4.0 hours after tracer injection (mean dose, 4.93 ± 0.10 mCi) will be performed. During the imaging period, 1 mL blood samples will be obtained specifically at 1, 3, 5, 10, 30,60, 90, 120, 150, 180 and 240 minutes after the injection, for time-activity curve calculations. The estimated radiation doses will be calculated by using OLINDA/EXM software.

50 patients with breast or gastric tumors will be enrolled for the clinical study, they will be performed with both 68Ga-HER2 Affibody PET/CT and18F-FDG PET/CT scans before surgery. The preoperative images are compared and correlated with the pathologically report. Next, the expression of HER2 will be determined by immunohistochemical staining of the resected brain tumor tissues.

Eligibility Criteria:
Inclusion Criteria:

* patients with breast or gastric cancers: diagnosed by MR and ready for surgery

Exclusion Criteria:

* refuse or cannot endure surgery pregnant women
A Clinical Registry to Collect Patient Outcome Date for the BIOMET® Stimulator Systems

The purpose of this clinical registry is to capture data on an ongoing basis from a population of patients who will use Biomet's BHS, OrthoPak and SpinalPak devices.

The purpose of this clinical registry is to capture current, real-world, bone specific healing data from the medical records of patients being treated with a Biomet® EBI Bone Healing System (BHS), the Biomet® OrthoPak® Non-Invasive Bone Growth Stimulator System, or the Biomet® SpinalPak® Non-Invasive Spine Fusion Stimulator System. This study will provide current data on the effectiveness of these electrical stimulation devices.

Eligibility Criteria:
Inclusion Criteria:

1. Subject has agreed to undergo electrical stimulation therapy as prescribed by their physician.
2. Subject has agreed to return to the physician for their physician required follow up visits.
3. Subject will undergo treatment with Biomet's BHS, OrthoPak or SpinalPak devices.
4. Subject has agreed to complete QoL questionnaires prior to starting treatment and at the follow up visit when the physician has determined the subject to be either healed or failed.

Exclusion Criteria:

1. Any subject not willing to comply with the physician prescribed treatment program and follow up visit schedule.
2. Any subject not willing to complete the QoL questionnaires.
Development of an Intervention to Enhance Cancer Pain Management

This research study is being done to understand how patients with chronic cancer pain take their long-acting opioid medications, and to develop an intervention to enhance cancer pain management.

Long-acting opioids are a common treatment for cancer pain. The purpose of this study is to develop a program for patients who are taking a prescribed long-acting opioid for their cancer pain. Participants will be enrolled in this study at the Massachusetts General Hospital Cancer Center. This 14-week study involves completing a set of questionnaires at three different times during the study period. . During the study period, participants will use electronic pill caps to monitor their pain medication taking. They also will attend a series of three visits with one of the nurse practitioners on their care cancer team. The visits will focus on learning and practicing skills for managing cancer pain. The information that the investigators collect will help identify whether the sessions are feasible and useful to patients during the course of treatment for cancer pain.

This trial will consist of two parts:

Part 1: This is a single-group prospective observational study. Investigators will use quantitative and qualitative methods to examine rates, predictors and outcomes of adherence to LA opioids over a period of approximately eight weeks. This information will be used to inform Part 2 intervention development and testing.

Part 2: Investigators will test the behavioral intervention in a non-randomized open pilot, over a period of approximately six weeks. Intervention process data, psychosocial and medical data, and post-intervention feedback will be collected to assess feasibility and acceptability. In an iterative process, ongoing data from exit interviews and therapist experience will be used to modify the intervention protocol.

Eligibility Criteria:
Inclusion Criteria:

* Age 21 or older
* Currently prescribed a long-acting (LA) opioid for nociceptive cancer pain (extended release oxycodone, extended-release morphine, transdermal fentanyl patches, methadone tablets)
* Ability to comprehend study materials in English
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* In charge of administering own pain medications
* Part 2 study only: within 4 months of current prescription of LA opioid for nociceptive cancer pain

Exclusion Criteria:

* Impaired cognition, active substance disorder, or other active, unstable mental health disorder
* Current long-acting opioid treatment for pre-existing condition
* Part 2 study only: Prior enrollment in the Part 1 study\*\*