cyrilzakka/clinical-trials huggingface dataset:
RT001 in Amyotrophic Lateral Sclerosis

RT001-014 is a Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Assess Efficacy, Long Term Safety and Tolerability of RT001 in Subjects with Amyotrophic Lateral Sclerosis

Forty subjects at 4 EU sites will undergo baseline examination, and then be randomized 1:1 to receive either RT001 or placebo. Repeat visits will occur every 2 months. The final visit will be at 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subject with age 20 years to 75 years at the time of signed consent
2. Patients who are defined as "definite ALS," "probable ALS" or "probable-laboratory-supported ALS," met diagnostic criteria revised EL Escorial for Airlie House.
3. ALSFRS-R \> 20
4. Patients who can eat a meal, excrete, or move with oneself alone, and do not need assistance in everyday life
5. Patients of less than 3 years after the onset of ALS
6. Subject has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend)
7. If patients are duly capable of study consent but are unable to sign by themselves due to aggravation of disease condition, written informed consent can be obtained from a legally authorized representative who can sign on behalf of the patients after confirming the patients' agreement to study participation

Exclusion Criteria:

1. Received treatment with other experimental therapies within the last 30 days prior to the first dose
2. Previously received treatment with RT001
3. Refusal to discontinue fish oils or other oil-based supplements for the duration of the study (Screening till last study procedure completed)
4. SVC \< 70 at screening
5. Subject has a feeding tube or the need for a feeding tube is anticipated within the first 24 weeks after enrollment
6. Subject resides at a skilled nursing or dementia care facility, or admission to such a facility is planned during the study period
7. Evidence of any clinically significant neurological disorder other than ALS
8. The subject has a history of or currently has schizophrenia, schizoaffective disorder or bipolar disorder according to DSM-V or ICD-10 criteria
9. The subject has a significant pulmonary disorder not attributed to ALS or who require treatments that might complicate the evaluation of the effect of ALS on respiratory function
10. Subject has had a significant illness or infection requiring medical intervention in the past 30 days
11. Female who is breastfeeding or has a positive pregnancy test
12. Male participant or female participant of childbearing potential, who is sexually active and unwilling/unable to use a medically acceptable and effective double barrier birth control method throughout the study
13. Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to return for visits as scheduled
14. History, within the last 2 years, of alcohol abuse or physical opioid dependence
A Clinical Study of Xenetix 300 in Multislice Computed Tomography (CT) Pediatric Indications

This is a clinical study of Xenetix 300 in Multislice Computed Tomography (MSCT) in pediatric indications.


Eligibility Criteria:
Inclusion Criteria:

* Child aged 1 year or above and 16 years or under
* Patients with normal renal function (creatinine clearance \> 60 ml/min/1.73 m2)
* Patient requiring MSCT with contrast medium injection for diagnosis
* Patient who has a blood sample planned in the 24 hours preceding the MSCT scan
* Female patient with childbearing potential must have effective contraception (contraceptive pill or intrauterine device), be surgically sterilized or blood beta human chorionic gonadotropin (ßHCG) will be tested prior to product injection.
* Parent(s) of the patient (and child with sufficient intellectual maturity) provided his/her/their written informed consent for their child to participate in the trial.
* Patient with national health insurance

Exclusion Criteria:

* Patients who have received diuretic or biguanide treatment during the 48 hours preceding the MSCT scan.
* Patient with known allergy to iodinated contrast agent.
* Patient treated with nephrotoxic drugs within one week before first blood sample
* Patients planned to either undergo surgery or receive chemotherapy within 72 hours post injection (ie: before the blood test 72 hours post injection)
* Patient received or planned to receive an iodinated contrast agent during 48 hours preceding the MSCT scan.
* Breast feeding patient.
* Pregnant patient.
* Patient already included in this trial
* Patient included in another clinical trial involving an investigational drug.
* Patients whose degree of cooperation is incompatible with carrying out the study
ABCB4 Gene Mutations in Intrahepatic Cholestasis of Pregnancy and Controls

Mutations of the ATP binding cassette subfamily B member 4 (ABCB4) gene, a gene involved in a subtype of progressive familial intrahepatic cholestasis, have been reported in women suffering from intrahepatic cholestasis of pregnancy. The true incidence and the role of these ABCB4 gene mutations in patients suffering from intrahepatic cholestasis of pregnancy have not been clearly established.

The aim of the present study is to describe the nature and frequency of these mutations in a series of patients with intrahepatic cholestasis of pregnancy and to compare with a control group of pregnant women without intrahepatic cholestasis of pregnancy.

Intrahepatic cholestasis of pregnancy was defined by pruritus and elevated serum alanine aminotransferase activity or bile acid concentration, with recovery after delivery. Patients with intercurrent liver disease were excluded.

The entire ABCB4 gene coding sequence and the promoter region were analyzed, during the routine medical management, by single strand conformation polymorphism and/or sequencing in 50 unrelated Caucasian patients with intrahepatic cholestasis of pregnancy.

The genomic variants detected in these patients with intrahepatic cholestasis of pregnancy will be sought in 100 control women from Caucasian origin recruited in the same hospital.

Eligibility Criteria:
For the control group :

Inclusion Criteria:

* pregnant woman (age \> 18 years) during the third trimester
* caucasian and born in France
* multiparous (with at least 2 full term pregnancies)
* with informed written consent

Exclusion Criteria:

* generalized pruritus and/or liver disease during pregnancy
* liver disease secondary to oral contraception
* Chronic liver disease
* disease during current pregnancy
Hydros Joint Therapy and Hydros-TA Joint Therapy for Pain Associated With Knee Osteoarthritis (OA)

The purpose of this study is to evaluate the safety and performance of Hydros Joint Therapy (Hydros) and Hydros-TA Joint Therapy (Hydros-TA) for treatment of pain from osteoarthritis of the knee, in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics.

The objective of the study is to evaluate Hydros and Hydros-TA treated subject for reduction of osteoarthritis symptoms, compared to a commercial control, as assessed by the WOMAC Osteoarthritis Index.

The WOMAC Osteoarthritis Index is a validated assessment instrument that is self-administered and designed to subjectively elicit patient symptoms of osteoarthritis in the knee in the areas of pain, stiffness, and physical function. The WOMAC Osteoarthritis Index with its Pain Subscale has been used extensively as an effectiveness endpoint in clinical trials of viscosupplements.

Eligibility Criteria:
Inclusion Criteria:

- Osteoarthritis grade 2 or 3 in one knee using Kellgren-Lawrence Grading for OA radiologically and verified within the prior 6 months.

Exclusion Criteria:

* Secondary OA resulting from rheumatoid arthritis, chondrocalcinosis, osteonecrosis, chronic fibromyalgia or other autoimmune disease.
* Generalized symptomatic OA in lower extremity joints other than the knees.
* Active infection in either knee joint or adjacent tissues.
* Any contraindications for intra-articular injection or aspiration.
* Knee surgery or trauma within 3 months prior to enrollment.
* Intra-articular steroid injection in the knee and/or use of systemic (oral) corticosteroids within 3 months prior to enrollment.
* Intra-articular hyaluronan injection in the treatment knee within 6 months prior to enrollment.
* Body Mass Index (BMI) greater than 35.
Clinical-immunological Features of Anti-NMDAR Encephalitis

Using a retrospective cohort of 501 patients with anti-NMDAR encephalitis to assess clinical and immunological prognostic biomarkers


Eligibility Criteria:
Inclusion Criteria:

* Patient with neurological disorder
* Patient with NMDAR antibodies in sera or CSF

Exclusion Criteria:

* - No available clinical data
* Patient without NMDAR antibodies or neurological disorder
The Efficacy of Chlorhexidine Gluconate Pre - Disinfection Scrubbing in Preventing Surgical Site Infections for Hepatectomy Patients

To test whether pre - disinfection skin scrub with 4% chlorhexidine gluconate is more effective on the reduction of surgical site microbial colonization and subsequent infection than is normal saline.

Surgical site infections (SSIs) following elective surgical procedures occur most commonly as a result of colonization by the patient's native skin flora . The most common pathogens causing SSIs are Staphylococcus aureus and coagulase-negative Staphylococci , components of normal skin flora . Therefore, preoperative disinfection of the surgical site with an antiseptic skin preparation is standard practice before any surgical intervention to decrease skin microbial counts before incision . It is considered an important step in limiting surgical wound contamination and preventing infection.

A variety of skin-preparation agents and methods are available for preventing surgical site infections and the techniques for preoperative cleansing of the skin vary among hospitals and surgeons. There is a pressing need to elucidate the effect of cutaneous disinfection with chlorhexidine gluconate ( CHG ) in prevention of surgical site infections.

Many studies demonstrated that comparisons with cutaneous disinfection with povidone-iodine, disinfection with CHG before insertion of an intravascular device and for post-infection site care can substantially reduce the incidence of device-related infection .

Hence, this study aimed to test whether an additional chlorhexidine gluconate scrub followed by a routine disinfection would lower the incidence of surgical site culture and subsequent infection after hepatic resection. This data will show the originality and clinical importance of a cutaneous pre-disinfection scrubbing solution for such risk patients with hepatectomy.

Eligibility Criteria:
Inclusion Criteria:

* patient who received elective hepatectomy for liver tumors

Exclusion Criteria:

* patients who were younger than 18 years of age
* patients who had a history of radiation to the operative sites
* patients who received repeat hepatectomy
* patients who had a history of allergy to CHG, ethyl alcohol or povidone - iodine
* patients whose tumors were metastatic cancers
* patients who had a preoperative active remote infection
Medical Assistance for the Procreation and Risk of Thrombosis.

This study aims at evaluating clincal practice regarding prevention of arterial and venous thrombosis following ovarian stimulation.

Secondary outcomes are : 1) to describe the incidence and risk factors of arterial and venous thrombosis in women undergoing assisted reproductive technology and 2)to identify the incidence and risk factors for ovarian hyperstimulation syndrome in these women

All women undergoing an assisted reproductive tecnology in order to receive an in vitro fertilization in French centers will be included in the study. These women will be followed up until 12 months after ovarian stimulation if they get pregnant or until 3 months if the stimulation does not lead to pregnancy. Risk factors for thrombosis and ovarian hyperstimulation syndrome will be collected in each woman. At each visit, women will be asked whether arterial and/or venous thrombosis had occured.

Eligibility Criteria:
Inclusion Criteria:

* All women undergoing ovarian stimulation in order to receive in vitro fertilization

Exclusion Criteria:

* Age\<18 years
* Women refusing to particpate in the study
* No health coverage
* Women under guardianship
* Women receiving therapeutic doses of anticoagulation
A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection

The purpose of this study is to assess the safety and tolerability of subcutaneous nivolumab vs intravenous nivolumab in participants with completely resected Stage IIIA/B/C/D or Stage IV melanoma.


Eligibility Criteria:
Inclusion Criteria:

* Stage IIIA/B/C/D or Stage IV melanoma and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins
* Complete resection performed within 12 weeks prior to randomization or treatment assignment
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1

Exclusion Criteria:

* History of uveal or mucosal melanoma
* Untreated/unresected CNS metastases or leptomeningeal metastases
* Active, known or suspected autoimmune disease
* Serious or uncontrolled medical disorder 4 weeks prior to screening
* Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to randomization or treatment assignment. Participants with history of prior early stage basal/squamous cell skin cancer or non-invasive or in situ cancers that have undergone definitive treatment at any time are eligible
* Prior immunotherapy treatments for any prior malignancies are not permitted

Other protocol-defined inclusion/exclusion criteria apply
PCR-Based Detection of Bacterial Agents in Platelet Concentrates and Whole Blood

Using methods of molecular biology bacteria can be detected in blood. In comparison to conventional blood cultures "bacterial DNA" is isolated using a new sample preparation system in platelet apheresis concentrates and in the predonation whole blood of donors.

Bacterial contamination of platelet concentrates is discussed worldwide and according to literature occuring in 1:1000 to 1:5000 concentrates. Bacterial contaminated concentrates can in fact cause severe infections in patients. therefore this study initially intends to detect contamination with "bacterial DNA" in platelet aphereses concentrates. All sample donations are also examined by blood culture for contamination. To exclude already existing "infection" of the donor one tube of whole blood is taken in addition to the other legally required samples for the production of pharmaceutical medicine. All samples are anonymised before passed on for analysing.

Eligibility Criteria:
Inclusion Criteria:

* healthy platelet apheresis donor

Exclusion Criteria:

* Missing health clearance for blood donation
A Multi-Modal Remote Monitoring Platform for Frontotemporal Lobar Degeneration (FTLD) Syndromes

The primary objective of this study is to enroll an observational cohort of approximately 60 patients with PSP over the course of 24 months using a multicenter study design and to follow each of them for 12 months.

The secondary objective of this study is to develop a robust solution for multi-modal remote monitoring of motor symptoms and function in PSP that can be applied to other Frontotemporal lobar degeneration (FTLD) syndromes.

The goal of this project is to develop a robust multi-modal platform for remote monitoring of motor symptoms and cognitive function in FTLD syndromes using wearable sensors and mobile health technology to assess speech, motor, and cognitive functions. The solution will be validated in Progressive Supranuclear Palsy (PSP) by collecting longitudinal data from 60 PSP individuals with PSP. Enrollment will take place over a period of 24 months, though each participant will only be followed for 12 months for data collection. The participants will consist of adult volunteers from two leading CurePSP Centers of Care located at the Atypical Parkinsonism Center at Johns Hopkins Hospital in Baltimore, MD and Massachusetts General Hospital (MGH) in Boston, MA.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of possible or probable PSP as defined by the 2017 MDS criteria
* Fluent in reading and speaking English and capable of providing informed consent based on the principal investigator's judgement
* Able to walk 10 feet unassisted at the time of initial enrollment
* Must have a caregiver or study partner who is willing and able to assist with all study-related procedures

Exclusion Criteria:

* Any neurological, medical, or psychiatric condition that would preclude participation in study activities based on the investigator's judgment.
* A history of frequent falls defined as more than 5 falls per month, or who require a walker to ambulate safely at baseline will not be eligible to participate in the study.
Spironolactone in Preventing Rash in Patients With Advanced Cancer Receiving Panitumumab and Cetuximab

This randomized phase II trial studies how well giving spironolactone works in preventing rash in patients with cancer that has spread to other places in the body and are receiving panitumumab and cetuximab. Spironolactone may prevent endothelial growth factor receptor (EGFR) inhibitor-induced skin rash.

PRIMARY OBJECTIVES:

I. To determine feasibility of the administration of topical spironolactone versus placebo in this patient population. (Study I) II. To further explore the efficacy of the topical spironolactone to prevent/attenuate rash from EGFR inhibitors. (Study II)

SECONDARY OBJECTIVES:

I. To explore efficacy of the spironolactone versus placebo. (Study I) II. To describe the efficacy of a Modified Preemptive Therapy Regimen intervention. (Study II) III. To explore the adverse event profile of spironolactone and the Modified Preemptive Therapy Regimen intervention. (Study II) IV. To explore patient reported outcomes of patients using spironolactone and a Modified Preemptive Therapy Regimen intervention. (Study II) V. To explore long term (8 week) effect of the 4 week treatment of spironolactone and a Modified Preemptive Therapy Regimen intervention on EFGR induced rash. (Study II)

OUTLINE:

STUDY I: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients apply spironolactone topically to face twice daily (BID) for 4 weeks.

ARM II: Patients apply placebo topically to face BID for 4 weeks.

STUDY II: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients apply spironolactone topically to face and body BID for 4 weeks

ARM II: Patients undergo modified preemptive therapy regimen consisting of skin moisturizer topically BID, sunscreen topically before going outside, hydrocortisone topically once daily (QD), and doxycycline orally (PO) BID for 4 weeks.

After completion of study, patients are followed up for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled to start panitumumab or cetuximab; patients must not have been on the EGFR agent prior to randomization
* Ability to reliably apply topical spironolactone/placebo twice a day to the face
* Ability to complete questionnaire(s) by themselves or with assistance
* For study 2 only, patients must be willing to avoid sun exposure for one month from registration
* Creatinine =\< 1.5 x upper limit of normal (UNL)
* For Study 2 only, ability to apply topical creams to the entire face and body

Exclusion Criteria:

* Prior allergic reaction or severe intolerance to spironolactone
* Any rash at the time of randomization
* Cutaneous metastases
* Any other disorder that may predispose to hyperkalemia in the opinion of the treating oncologist
* Use of topical corticosteroids at the time of study or their anticipated use in the next 8 weeks; (it is acknowledged that patients may be starting these agents pre-emptively as part of this protocol)
* For study 2 only, previous intolerance of sunscreen or any of the other components of the Modified Preemptive Therapy Regimen (a moisturizer or oral doxycycline)
The Effects of Lumbar Stabilization Exercise on Transversus Abdominis Muscle Activation Capacity and Function in Chronic Low Back Pain Patients

Purpose: The purpose of this study is to investigate the effects of lumbar stabilization exercises on pain intensity, transversus abdominis muscle (TrA) activation capacity, functional disability, and TrA thickness in patients with chronic low back pain (CLBP). Subjects: The subjects of this study were 30 CLBP patients. Methods: The experimental group performed diverse lumbar stabilization exercises in different postures, and the control group conducted an ordinary trunk muscle strengthening exercise. Results: There were significant differences in pain intensity, TrA activation capacity, functional disability, and TrA thickness between before and after the intervention in both groups. Significant differences between the two groups were shown in the pain intensity, TrA activation capacity, and functional disability after the intervention. However, there were no significant differences between the two groups in TrA thickness. Conclusion: Lumbar stabilization exercises in different postures could reduce pain, functional disability, and increase TrA activation capacity and thickness in CLBP patients.


Eligibility Criteria:
Inclusion Criteria:

* patients who felt low back pain

Exclusion Criteria:

* Orthopedic surgery within 6 months
Surgical Treatment of Refractory Open Angle Glaucoma

The primary objective of this study is to evaluate the safety, efficacy, and performance of the Suprachoroidal Dissection Instrument in creating a fistula between Schlemm's canal and the suprachoroidal space in refractory, open angle glaucoma subjects.

The Suprachoroidal Dissection Instrument (SDI) is a manually operated surgical instrument designed for use within Schlemm's canal. The instrument can access Schlemm's canal through a small ab-externo dissection, allowing use in eyes with scarring due to previous surgery or trauma.

Eligibility Criteria:
Inclusion Criteria:

* Available for up to 3 years follow-up.
* Diagnosed with primary open-angle, pseudoexfoliative, or pigmentary glaucoma or more than one glaucoma diagnosis of these types.
* Subject scheduled to undergo glaucoma surgery with the Suprachoroidal Dissection Instrument involving creation of fistula between Schlemm's canal and the suprachoroidal space without combined cataract surgery.
* Subject has failed at least one incisional glaucoma surgery (trabeculectomy, tube shunt, deep sclerectomy, viscocanalostomy, canaloplasty) or angle surgery (Trabectome) OR Is not a candidate for conventional glaucoma surgery due to reasons such as the presence of scleral buckle or compromised conjunctiva.
* Subject has IOP ≥ 16 mm Hg on maximally tolerated medications within the six week (-42 days) period prior to surgery.
* Visual field defect defined as mean deviation (MD) score worse than or equal to -10 dB on the Swedish Interactive Threshold Algorithm \[SITA\] Standard 24-2 Humphrey Analysis during the 6 month period prior to surgery. OR Subject has vertical cup-to-disk ratio ≥ 0.75 during the 6 month period prior to surgery.

Exclusion Criteria:

* Significant lens opacities or patient is candidate for cataract surgery during the duration of the study.
* The patient had developmental glaucoma or a secondary glaucoma including steroid-induced, uveitic, or neovascular glaucoma (with the exception of pigmentary and pseudoexfoliative glaucoma).
* The patient has narrow angle component possibly associated with glaucoma in the operative eye.
* The subject has angle recession in the operative eye.
* Significant ocular disease other than glaucoma affecting the assessment of visual function.