cyrilzakka/clinical-trials huggingface dataset:
A Study of Ametumumab in Combination With Anti-PD-1 Monoclonal Antibody and FOLFIRI in Patients With RAS Wild-type Advanced Colorectal Cancer

This is a multicenter, open-label, parallel-group, randomised, A phase IIb clinical trial of efficacy and safety of Ametumumab in combination with anti-PD-1 monoclonal antibody and FOLFIRI versus Ametumumab or Cetuximab in combination with FOLFIRI in patients with RAS wild-type advanced colorectal cancer.

This is a multicenter, open-label, parallel-group, randomised, phase IIb trial. This study is to evaluate and compare the efficacy and safety of Ametumumab (anti-EGFR monoclonal antibody) combined with anti-PD-1 monoclonal antibody in first-line treatment of RAS wild-type colorectal cancer patients, as well as to assess the immunogenicity and pharmacokinetic profile and recommend dosing regimen for phase III clinical trials.Conditions and keywords.

Eligibility Criteria:
Inclusion Criteria:

Voluntarily sign written informed consent; Age 18 \~ 85 years (inclusive), male or female;

•Patients requiring first-line treatment for locally advanced colorectal cancer with distant metastasis or unresectable disease; Histologically or cytologically confirmed adenocarcinoma of the colon or rectum; RAS (KRAS, NRAS) gene is wild-type and no BRAF V600E mutation has been identified; Presence of at least one measurable lesion (non-radiation field) confirmed by CT or MRI that meets RECIST 1.1 criteria; Performance status (ECOG) score 0 or 1.

Exclusion Criteria:

Previous chemotherapy for colorectal cancerPrevious treatment with anti-EGFR monoclonal antibodies Received systemic anti-tumor treatment approved or of other clinical studies within 4 weeks prior to the first dose.

Radiotherapy or surgery within 4 weeks prior to enrollment, except for diagnostic biopsy Participation in other clinical trials within 4 weeks prior to enrollment; Severe skin disease requiring systemic treatment. Presence of serious clinical infection.\\ Uncontrolled pleural effusion, pericardial effusion or peritoneal effusion after treatment.
An Open Label Study of Severe Sepsis in Adults

This trial is to obtain safety data in adult patients with severe sepsis and two sepsis-induced organ infections who receive an infusion of drotrecogin alfa (activated).

To collect safety data while providing drotrecogin alfa (activated) for the treatment of patients with severe sepsis with multiple organ dysfunctions. Patient access to drotrecogin alfa (activated) will be provided under this protocol prior to and during its review by the Authorities of Belgium and Luxemburg for commercial release.

Eligibility Criteria:
Inclusion Criteria:

* Patients greater than or equal 18 years of age may be included in this study only if they meet all of the following criteria:

  1. Must be 18 years.
  2. Suspected or proven infection
  3. Have or have had two or more sepsis-induced organ failures sepsis

Exclusion Criteria:

* Patients will be excluded from entry in this study for any of the following reasons:

  1. Documented first organ dysfunction greater than 48-hours prior to start of study drug.
  2. Patients greater than 135 kg in weight.
  3. Patients with a platelet count less than 30,000/mm3
  4. Active internal bleeding or at increased risk for bleeding
Efficacy and Safety of PT001 to Placebo and Open-label Spiriva® Respimat® in Subjects With Persistant Asthma

Study Comparing the Efficacy and Safety of PT001 to Placebo and Open-label Spiriva® Respimat® in Subjects With Persistent Asthma

A Randomized, Double-Blind, Parallel Group, Multi-Center 24-Week Study Comparing the Efficacy and Safety of Three Doses of PT001 to Placebo and Open-label Spiriva® Respimat® in Subjects With Persistent Asthma

Eligibility Criteria:
Inclusion Criteria:

* Have a documented history of physician-diagnosed asthma
* Require inhaled asthma maintenance therapy: has been regularly using an ICS/LABA on a stable regimen for at least 4 weeks
* Documented reversibility to albuterol
* A pre-bronchodilator FEV1 \>40% and \<85% of predicted normal value for subjects 18 to 80 years of age or \>40% and \<90% of predicted for subjects 12 to \<18 years of age
* Demonstrate acceptable spirometry performance
* Willing and, in the opinion of the Investigator, able to adjust current asthma therapy, as required by the protocol
* Compliance: must be willing to remain at the study center as required per protocol to complete all visit assessments

Exclusion Criteria:

* Oral corticosteroid use (any dose) within 4 weeks
* Current smokers, former smokers with \>10 pack-years history, or former smokers who stopped smoking \<6 months (including all forms of tobacco, e-cigarettes, and marijuana)
* Life-threatening asthma as defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s)
* Completed treatment for lower respiratory infection or asthma exacerbation within 4 weeks
* Hospitalizations for asthma within 3 months
* Historical or current evidence of a clinically significant disease
* Cancer not in complete remission for at least 5 years
* Treatment with investigational study drug (or device) in another clinical study within the last 30 days or 5 half-lives, whichever is longer
* Previously randomized in any PT001 study
Regional Citrate Anticoagulation in Plasma Exchange Treatment

The investigators want to compare the efficacy of plasma exchange treatment with using two different citrates ( 4% and 15% ) as anticoagulants in plasma exchange treatment.

The efficacy of plasma exchange treatment is better with using 15% trisodium citrate as anticoagulant during the plasma exchange procedure.

To compare the elimination rate of immunoglobulins in plasma exchange treatment by using two differently concentrated citrates for anticoagulation during plasma exchange procedure. At the same time we want to compare acid-base , electrolyte status and anticoagulation protocol in two citrate groups.

Eligibility Criteria:
Inclusion Criteria:

* patients who need plasma exchange treatment
* human albumins as a replacement fluid

Exclusion Criteria:

* anemia Hb less than 90
Investigation Of The Effect Of Proprioceptive Neuromuscular Fasilitation Tecniques in Scapular Dyskinesis

Scapular dyskinesis is defined as the loss of strength around the scapular muscle, tightness of the pectoralis minor and disruption of scapular movements. Scapular patterns of proprioceptive neuromuscular fasilition (PNF) techniques are often preferred in the rehabilitation of scapular dyskinesis. The main principals of PNF applications are defined as the autogenous inhibition, reciprocal inhibition, stress relaxation and gate control theory.The aim of this study was to investigate the effect of scapular PNF patterns on muscular strength and pectoralis minor tightness among individuals with unilateral scapular dyskinesis.

In order to standardize the measurements while evaluating individuals, the evaluation order will be as follows; The evaluation of minor pectoralis shortness, scapular dyskinesia by video analysis, scapular side shift test and then muscle strength evaluation will be done. The evaluation will be repeated before and 6 weeks after treatment and 12 weeks after treatment.

Proprioceptive Neuromuscular Facilitation Application:

Anterior elevation / posterior depression will be performed in the form of repetitive contractions using anterior depression / posterior elevation patterns. There will be 10 repetitions, with a 2-minute rest break between each technique. The treatment will be continued twice a week for a total of 6 weeks. Perceived Effort Scale, which is graded between 0-10, will be used to determine the level of perceived resistance to individuals before each treatment. In order to ensure standardization, the perceived effort level will be set to 5-6 (moderate).

Eligibility Criteria:
Inclusion Criteria:

* To be in the age range of 18-30,
* Being a sedentary,
* Having type 1 or type 2 scapular dyskinesia.

Exclusion Criteria:

* Has shoulder pain,
* Acute orthopedic injuries in the last 3 weeks, involving the upper extremity,
* Having had upper extremity surgery.
Effect of Patient-Centered Care (PCC) on Patient Satisfaction at Hospital Discharge

The purpose of this randomized clinical trial is to examine the effect of Patient-Centered Care (PCC) on a patient's level of satisfaction on discharge from an acute healthcare setting. Findings from this study will assist in determining if PCC, administered by nurses, should be instituted hospital wide.

SPECIFIC AIMS:

1. To examine the effect of Patient-Centered Care on patient satisfaction.
2. To examine the effect of Patient-Centered Care on the quality of patient care.
3. To examine the effect of patient's perception of nursing care on patient satisfaction.

Patient-Centered Care (PCC), also known as individualized patient care or negotiated care, focuses on the patient's right to have his/her values and beliefs respected as an individual.This respect is viewed as part of a commitment to build a deep understanding of the patient as a thinking and feeling individual with the ability to change and develop. A person-centered model of care requires a nurse to work with an individual's beliefs, values, wants, needs and desires.This adaptation to a patient's personal needs requires the nurse to be flexible, respectful, and reciprocal when providing patient care. If the patient's expectations are not appropriate to the type of care needed to heal or if the patient refuses or denies a specific type of treatment that is known as influencing ones quality of care, the nurse must negotiate with the patient. Negotiation incorporates education, which is believed to increase the patient's level of understanding. In addition, negotiation allows the nurse and patient to define a level of treatment that is specific to the patient's needs but still seen as a quality indicator.

The Institute of Medicine (IOM) has listed PCC as one of six national quality aims for improvement. The IOM's vision is that all health professionals will be educated to provide and deliver PCC as part of an interdisciplinary team. In 2001, the IOM report "Crossing the Quality Chasm: A New Health System for the 21st Century" recommends a mixture of approaches to achieve their vision . These approaches include an appropriate training environment, research, public reporting and leadership. At present, there is little evidence to support the critical role nurse clinicians' play in providing PCC and satisfying patient's needs.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Admitted to the service of Dr.RQ and scheduled for bariatric bypass surgery
* Expected length of hospital stay ≥ 2 days.

Exclusion Criteria:

* Any prior admission to the study unit
* Bariatric surgery performed by a surgeon other than Dr.RQ
* Scheduled to have a LAP Band procedure, as this procedure has a different postoperative course.
Study to Evaluate QR-110 in Leber's Congenital Amaurosis (LCA) Due to the c.2991+1655A>G Mutation (p.Cys998X) in the CEP290 Gene

The purpose of this study is to evaluate the safety and tolerability of QR-110 administered via intravitreal injection in subjects with LCA due to the CEP290 p.Cys998X mutation.

The purpose of this study is to evaluate the safety and tolerability of QR-110 administered via intravitreal injection in subjects with LCA due to the CEP290 p.Cys998X mutation. Subjects will receive QR-110 in one eye every 3 months, for a maximum of 4 doses. Up to 3 dose levels of QR-110 will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, ≥ 6 years of age at Screening with a clinical diagnosis of LCA and a molecular diagnosis of homozygosity or compound heterozygosity for the CEP290 p.Cys998X mutation.
* Best-corrected visual acuity greater than or equal to light perception in both eyes and equal to or worse than LogMAR +1.0 (Snellen notation 20/200) in the worse eye and equal to or worse than LogMAR +0.7 (Snellen notation 20/100) in the contralateral eye.
* Detectable outer nuclear layer (ONL) in the area of the macula.
* An electroretinogram (ERG) result consistent with LCA.
* Clear ocular media and adequate pupillary dilation to permit good quality retinal imaging.

Exclusion Criteria:

* Syndromic disease.
* Pregnant or breast-feeding female.
* Any clinically significant cardiac disease or defect.
* One or more coagulation parameters outside of the normal range.
* Any ocular disease or condition that could compromise treatment safety, visual acuity or interfere with assessment of efficacy and safety.
* Prior receipt of intraocular surgery or intravitreal injection within 3 months prior to study start or planned intraocular surgery or procedure during the course of the study.
* Use of any investigational drug or device within 90 days or 5 half-lives of Day 1, whichever is longer, or plans to participate in another study of a drug or device during the PQ-110-001 study period.
* Any prior receipt of genetic therapy for LCA
Radiofrequency Nerve Ablation Versus Sham to Treat Chronic Low Back Pain Caused by Sacroiliac Joint Dysfunction

Trial will enroll qualified subjects at a 2:1 ration to receive radiofrequency ablation or sham. At six weeks follow up they will be unblinded; sham subjects will then be given option to receive treatment.

Subjects will be followed after procedure for data collection for economic outcomes and efficacy of treatment.

Patients presenting with low back pain associated with SIJD for longer than 6 months, and who have not had positive responsive to the conservative treatments:

* Pharmacologic Management
* Therapies; physical, acupuncture, massage etc...
* Other alternative treatments

Enrollment, Treatment/Sham Procedure, Follow-up at 3 weeks, 6 weeks with unblinding, 4, 6, 9 months. Un-blinding occurring at 6 weeks with crossover option to receive treatment. Total visits 7 with enrollment approximately over a period of 9 months. Trial extension optional for phone contact at year 1, 2. Sham subjects receiving treatment will be followed at months 6 weeks, 4, and 6 months with phone calls at year 1, 2.

Patients who complete at least 50% of their patient diaries, and miss no more 2 consecutive office visits. Data will be used if patients have remained enrolled thru 4 month visit.

Eligibility Criteria:
Inclusion Criteria:

* 1. 18 years old, or older 2. Unilateral or Bilateral LBP or Buttocks Pain for greater than six months with a 3 day average VAS greater or equal to 4 on a 1-10 scale 3. Tenderness over the SI joint 4. 75% or greater relief of pain (with return to baseline) during the local anesthetic phase of two separate, one fluoroscopically guided intra-articular SI joint injection and one lateral branch block (see Appendix A) 5. Stable medications for pain for the last seven days 6. Have used at least 3 alternative treatments for pain without success (se 7. BMI less than 35.0

Exclusion Criteria:

1. Focal Neurologic Signs
2. Any component of pain related to Lumbar Z-joints at L4-5 and/or L5-S1 as determined by one set of medial branch blocks
3. Previous radiofrequency procedure within the last 6 months
4. Moderate or greater spinal stenosis
5. Greater than Grade 2 listhesis
6. Foraminal Stenosis; marked to severe
7. Previous Lumbar Spine Surgery
8. Unstable Medical or Psychological Conditions as determined by the investigator
9. Concomitant cervical or thoracic pain greater than 2/10 on VAS
10. Workers compensation, disability or litigation
11. Pregnancy, breast feeding or planning on becoming pregnant during the trial
12. Subject unwillingness to complete study related activities
13. Current Smoker; unless quit greater than 6 months -
Validity and Reliability of the Turkish Version of HAnDE

The aim of the present study was to translate and cross-culturally adapt The Hand Scleroderma Experienced Experience (HAnDE) Scale into the Turkish language and investigate its reliability and validity in Turkish-speaking patients with systemic sclerosis.

Objective: The aim of the present study was to translate and cross-culturally adapt The Hand Scleroderma Experienced Experience (HAnDE) Scale into the Turkish language and investigate its reliability and validity in Turkish-speaking patients with systemic sclerosis.

Methods: The HAnDE was cross-culturally adapted according to Beaton's guideline. Participants completed the Turkish version of HAnDE scale (HAnDE-T), The Mouth Handicap in Systemic Sclerosis Scale (MHISS), 36 Item Short Form Survey (SF-36), Health Assessment Questionnaire (HAQ). Internal consistency of the HAnDE-T questionnaire was evaluated by Cronbach's alpha coefficient. Convergent validity was tested using Pearson's correlation coefficient. The construct validity of the HAnDE-T questionnaire was assessed by factor analysis. The construct validity of the HAnDE-T was evaluated by correlating the scores between HAnDE-T and HAQ, SF-36 PCS, SF-36 MCS and MHISS scores.

Eligibility Criteria:
Inclusion Criteria:

* 1) being 18-65 years of age,
* 2) being diagnosed of SSc according to do 2013 American College of Rheumatology (ACR) criteria and/or European League Against Rheumatism (EULAR) criteria,
* 3) being literate in Turkish,
* 4) being agreed to participate in the research.

Exclusion Criteria:

* 1) being in a psychological or cognitive disorders that would prevent to answer questions.
A Clinical Trial About the Safety of Surgical Treatment in Severe Primary Pontine Hemorrhage

Primary pontine hemorrhage (PPH) is not common but is the most catastrophic subtype of intracerebral hemorrhage, with acute mortality between 30% and 60%. For severe PPH, defined as Glasgow Coma score (GCS) \<8 and hematoma volume≥5ml, the mortality rate is as high as 80-100%. Guidelines from the American Heart Association and European Stroke Organization do not make definite specifications. More than a century after Finkelnburg first explored the brainstem for hematoma, however, plenty of researches have shown surgery can save lives and improve the prognosis for selective patients and can be an effective and safe treatment. This study is proposed to validate the safety of surgical treatment in severe primary pontine hemorrhage.

The study is being conducted from Jan 2022 to Nov 2024 in 20 neurosurgical units. This STIPE trial is an investigator-initiated, parallel (3:1 to surgical HE or MT), multi-centre, randomized controlled open-label trial following the Consolidated Standards of Reporting Trials (CONSORT) guidelines and will be conducted from Jan 2022 to Nov 2024 in 20 Tertiary hospitals in China. The flow chart of the clinical trial is presented in Figure 1. Neurosurgeons involved in the study are senior investigators with good clinical experience in sPPH management. Moreover, all investigators are well trained centrally according to the requirements.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of PPH: patients have acute hemorrhage mainly in pons with a definite history of hypertension.
2. GCS 5\~7 and HV≥5ml on admission (the HV in intraventricular system being excluded).
3. Family members consenting to randomize and signing informed consent form (ICF).
4. Time from onset to admission less than 24 hours.
5. Age:18 years or older.

Exclusion Criteria:

1. Structural lesions such as brainstem cavernous malformation, arteriovenous malformation, aneurysm, tumor apoplexy.
2. GCS≥8 and HV\<5ml.
3. Time from onset to admission over 24 hours.
4. Patients with platelet count \< 100,000, International Normalized Ratio (INR)\> 1.4, or an elevated prothrombin time (PT) and activated partial thromboplastin time (APTT).
5. Multiple ICH.
6. Accompanying hydrocephalus that requires surgical management
7. Irreversible brainstem failure (bilateral fixed, dilated pupils and extensor motor posturing, GCS≤4).
8. A previous history of ICH.
9. Any serious concurrent illness that would interfere with the safety assessments including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease.
10. Pregnant patients.
11. Patients' family members refuse HE.
12. Any other condition that the investigator believes would present a significant hazard to the subject if the investigational therapy were initiated.
13. Participating in another simultaneous trial of ICH treatment.
Study of Stress and Life Quality of Patients Participating in Clinical Trials Versus Patients Non Participating

This study aims to assess anxiety/depression and life quality of patients included in clinical trials versus patients treated in a standard way.

This study aims to assess anxiety/depression and life quality of patients included in clinical trials versus patients treated in a standard way A case-control study

Eligibility Criteria:
Inclusion Criteria:

* patient with solid tumor or recurrent hematologic cancer, treated by chemotherapy or targeted therapy evaluated every 2 or 3 cycles; except for clinical trials associating non drug treatment (radiotherapy, surgery...)
* subject to a 1st, 2nd or 3rd line of antitumor treatment

  * a phase 2 open labeled study,
  * a phase 2 or 3 blind randomised study,
  * a phase 2 or 3 open randomised study,
  * a standard treatment non participating to a clinical trial
* male or female patients ≥ 18 years of age
* karnovsky ≥ 70 % or OMS ≤ 2
* recovered from prior toxicities
* social security covered
* written informed consent given

Exclusion Criteria:

* psychiatric disorders, receiving psychotropic treatment
* physical or psychological issues
* forbidden to be included in this study
A Single Blind Study to Evaluate the Safety, Tolerability and Explore the Efficacy of 8.0 mg ASM8 Inhaled Daily for 14 Days in Severe Asthma

The purpose of the study is to determine the safety and tolerability of 8.0 mg of ASM8 when given daily for 14 days by the Aeroneb® Go nebulizer to subjects with moderate to severe asthma.

The safety and tolerability of ASM8 will be assessed by performing a physical exam and vital signs, measuring the use of concomitant medication, routine laboratory tests, urinalysis, sputum analysis, serum IL-1 and TNF-α, lung carbon monoxide diffusion capacity, pulse oximetry and measuring AEs

There are 5 study phases: screening (phase 1), run-in (phase 2), treatment A (phase 3) with Active or Placebo, treatment B(phase 4) with Active or Placebo and end of study (phase 5) that includes a wash out period and a final visit.

Eligibility Criteria:
Inclusion Criteria:

* Be diagnosed with asthma for 3 or more months Have moderate to severe asthma as defined by ATS criteria

Exclusion Criteria:

* No history of pulmonary or health problems for which the Investigator considers that participation in this protocol is a risk for the subject