linjc16/ctgov huggingface dataset:
Phase I Study of KRN330 Monoclonal Antibody in Patients With Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess the safety and tolerability of KRN330 in patients with relapsed or refractory advanced or metastatic colorectal cancer.

Official Title
-----------------
Phase I Study of KRN330 Monoclonal Antibody in Patients With Colorectal Cancer

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: KRN330


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have histologically confirmed colorectal cancer that is advanced or metastatic with measurable or assessable disease. Are not candidates for a surgically curative procedure. Have progressed despite, are intolerant of, or are not appropriate for current therapies. Exclusion Criteria: Have an active, uncontrolled infection. Have known or suspected cerebral metastasis. Have had a myocardial infarction (MI) or cerebrovascular accident (CVA) within the last 6 months; or meet the criteria for AHA class III or IV congestive heart failure (CHF). Have any significant concurrent disease or illness that would interfere with the interpretation of study results. Pregnant or breastfeeding women and male or female patients who do not agree to use effective contraceptive method(s) during the study. -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: KRN330|Open-label, dose-escalation study of KRN330 in patients with relapsed or refractory advanced or metastatic colorectal cancer|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this study is to assess the safety and tolerability of KRN330 in patients with relapsed or refractory advanced or metastatic colorectal cancer. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary objectives are to determine the degree of immunogenicity, gain information on the pharmacokinetic profile, assess the anti-tumor effects of KRN330 and determine the maximum tolerated dose (MTD). |  |  |
Comparison Between Two Methods of Throat Swabbing

Study Overview
=================
Brief Summary
-----------------
Throat swabbing is an important instrument in the diagnosis of strep pharyngitis and sometimes the main argument for antibiotic treatment. There is no firm knowledge about an appropriate method of the swabbing for receiving maximal sensitivity. We hypothesize that accurate swabbing from the pus will increase the sensitivity of the swabbing as compared to free swabbing. In order to check this hypothesis we will compare two swabs from the same throat. One that will be taken by a physician specifically from the pass and the second will be taken by a nurse as she used to do it. An increase of 10% of positive results will be accepted as a significant advantage.

Official Title
-----------------
Comparison Between Two Methods of Throat Swabbing

Conditions
-----------------
Pharyngitis

Intervention / Treatment
-----------------
* Other: additional swabbing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with sore throat, classified 2-3 according to Cantor's criteria Exclusion Criteria: patients on antibiotic treatment suspected carriers of streptococcus

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: nurse swabbing<br> | |
| Experimental: accurate swabbing by a physician<br> | Other: additional swabbing<br>* physician swabs patient's throat according to standard rules before referral of the patient to throat swabbing by nurse.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity of accurate swabbing versus sensitivity of habitual nurses' swabbing | Proportion of positive cultures obtained by accurate swabbing will be compared to the proportion of positive cultures obtained by nurses' habitual swabbing (as they do it usually). | 1 year |
Induction and Maintenance of Remission With Pentasa as Ulcerative Colitis Treatment

Study Overview
=================
Brief Summary
-----------------
For both induction of remission and in maintenance of remission, different doses and treatment durations are used in practice. The aim of this study is to assess how mesalazine is used in clinical practice, at which doses and for how long and how these differences impact the patient disease state and work productivity.

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Drug: mesalazine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with mild to moderate active ulcerative colitis with disease extension beyond the rectum (≥ 10 cm) who will receive oral Pentasa treatment (Compact sachets and/or tablets) for the treatment of the current active episode or in whom on oral Pentasa maintenance treatment induction of remission treatment will be initiated by dose escalation. Treatment combined with Pentasa enema (1g/100ml) is allowed. Informed consent Exclusion Criteria: Patients receiving treatment with one or more of the following: locally acting steroids (e.g. budesonide, beclomethasone), systemic steroids, immunosuppressants (e.g. thiopurines), biologicals (e.g. anti-Tumor Necrosis Factor-alpha)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pentasa<br>Treatment according to standard clinical practice. | Drug: mesalazine<br> <br> * Other names: Pentasa;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to dose reduction |  | From Day 1 up to one year |
Evaluation of Longterm Outcome of New York Heart Association Class III Heart Failure Patients Receiving Telemonitoring Using a Pulmonary Artery Pressure Sensor System (CardioMEMS)

Study Overview
=================
Brief Summary
-----------------
Invasive hemodynamic monitoring in advanced heart failure patients is a relative new option. In order to investigate the impact of remote telemonitoring of pulmonary artery pressures on mortality and morbidity in a routine clinical setting in Germany, the investigators initiated this multicenbtric registry.

Detailed Description
-----------------
All patients who receive invasive hemodynamic monitoring using a pulmonary artery pressure sensor (CardioMEMS device) are offered participation in the registry. Routine heart-failure parameters, lab values, medication and QoL as obtained on the regular outpatients visits in the department are entered into a registry-specific database. The investigators plan to asses the impact of telemonitoring on mortality, morbidity and QoL as well as on Guideline-recommended heart failure medication. In addition, it is planned to quantify the input in person time for telemonitoring.

Official Title
-----------------
CardioMEMS Registry of the Frankfurt Heart Failure Center

Conditions
-----------------
Chronic Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Implantation of CardioMEMS successful Telemonitoring according to the SOP of the Frankfurt Heart Failure Center (Goethe University) Exclusion Criteria: Unwillingness to participate in the registry

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morbidity measured as worsening heart failure requiring hospitalisation and / or increase in diuretic dose | morbidity | 5 years |
Usefulness of an Ultraportative Ultrasound Device in the Management of Intra Hospital Emergencies

Study Overview
=================
Brief Summary
-----------------
Estimate if the use of a portable cardiac echograph for intra-hospital Emergencie improves the performances diagnose in the bed of patient in department of conventional medicine. The concordance between the initial medical diagnosis (previous the utilsation of portable echograph) and the final diagnosis (after portable echograph utisation) will be evaluated. These evaluation will be performed after retrospective review of the medical files

Official Title
-----------------
Usefulness of an Ultraportative Ultrasound Device in the Management of Intra Hospital Emergencies

Conditions
-----------------
Respiratory Failure, Failure; Cardiac

Intervention / Treatment
-----------------
* Device: echography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: respiratory or cardiac distress Exclusion Criteria: pulmonary or cardiac patient transplant morphologic abnormalities Patient in rescucitation care unit

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| final diagnosis after portable echography<br>Experimental group: final diagnosis after portable cardiac echograph examination | Device: echography<br>* cardiac and pulmonary echography<br>|
| final diagnosis without portable echography<br>Group control: Final diagnosis for patient ( same medical condition and history) hospitalized in units without portable cardiac echograph examination avaible | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance between initial medecial diagnosis and final diagnosis | Concordance between the initial medical diagnosis at the bedside in ward and the definitive diagnosis after retrospective review of the medical files between two groups : one with an ultraportative echograph (POCUS group) and a control (without ultraportative group). The percentage of adequate initiale diagnosis at the bedside. | 1 day |
Prospective Study to Validate the Clinical Accuracy of Norbert Device to Measure Body Temperature

Study Overview
=================
Brief Summary
-----------------
The study will evaluate the clinical bias and clinical repeatability of measuring body temperature using the Norbert Device (ND).

Detailed Description
-----------------
The study design is based on the ISO 80601-2-56, Clause 201.102 for adjusted mode clinical thermometers. The study is designed to be a non-randomized, non-blinded single arm design to evaluate the clinical accuracy of the ND's temperature measurement compared to a standard FDA 510(k)-cleared reference clinical thermometer (RCT).

Official Title
-----------------
Prospective Study to Validate the Clinical Accuracy of Norbert Device to Measure Body Temperature

Conditions
-----------------
Healthy, Febrile Illness

Intervention / Treatment
-----------------
* Device: Norbert Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects over 22 years of age Ability to provide signed informed consent, and/or have a legally authorized representative (LAR) willing to provide informed consent on behalf of the subject ESI score of 3-5 Exclusion Criteria: Use of medications known to affect body temperature (for example, antipyretics, barbiturates, thyroid preparations, antipsychotics, etc.) within 3 hours of the study procedure Recent immunization within seven days of the study procedure Pregnancy ESI score of 1-2

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Norbert Device|The Norbert Device (ND) is a contactless, noninvasive device that provides measurements of body temperature, oxygen saturation (SpO2), and pulse rate.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Bias | Clinical Bias will be evaluated by comparing the first recorded measurement using ND with the corresponding measurement recorded by the RCT. The bias is calculated per IEC 80601-2-56, Clause 201.103.3. | Up to 1 hour | 
| Limits of Agreement | Limits of Agreement (LOA) will be calculated using all three measurements by the ND and the corresponding measurements by the RCT. The LOA is calculated per IEC 80601-2-56, Clause 201.103.4. | Up to 1 hour | 
| Clinical Repeatability | Clinical Repeatability is calculated by a pooled standard deviation of the triplicate measurements over the entire population of subjects. The method to calculate Clinical Repeatability is per IEC 80601-2-56, Clause 201.102.5. | Up to 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
medical device, validation, febrile, thermometer, body temperature, Norbert Device, Norbert Health
Correlation of Pupillary Diameter Changewith Age and Anterior Chamber Depth After Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
PURPOSE: To assess the correlation between the change in pupil diameter, age and depth of the anterior chamber after 3 months of cataract surgery both in photopic and mesopic conditions. And study the changes of the pupillary diameter at 3 months after surgery in the two light conditions

Detailed Description
-----------------
Healthy patients who are going to be operated on for cataracts are expected to take part in the study. If during the clinical study the minimum number of patients established in the protocol is exceeded, new samples will continue to be registered until the end of the established period. The sample selection mechanism is by consecutive recruitment during the study period (in order of arrival at the medical office). Patients are operated bilaterally in a period not exceeding 15 days and it will get the variables of both eyes. A simple random sampling will be used for the choice of single eye data per patient.

Official Title
-----------------
Correlation of Pupillary Diameter Change With Age and Anterior Chamber Depth After Cataract Surgery

Conditions
-----------------
Pupillary Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both sexes with age equal to or greater than 45 years Diagnosed cataract N1, C1, P1 or worse in some eye. Patients who will be operated on both eyes. Patients who have not been diagnosed with diabetes mellitus. Patients who have given their informed consent to take part in the study. Exclusion Criteria: Age under 45 years. Patients with anisocoria, neurological disorders, diagnosed with diabetes mellitus, glaucoma or another eye disease. Patients with complications during and after cataract surgery.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pupil diameter before/after cataract<br>The investigators measure the pupil diameter before and after (3 months) cataract. Mesopic and photopic conditions | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pupil diameter | It took measurements of pupil diameter in mesopic and photopic conditions using pupillometer software of the Topolyzer Vario (Wavelight Laser Technologie AG). | Preoperatively and 3-months postoperatively | 
| Anterior Chamber Depht | Anterior chamber depth was obtained with Pentacam® (Oculus Optikgeräte GmbH, Wetzlar, Germany). | Preoperatively | 
| Age | It took the patient's age at the time of surgery | Preoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cataract, Pupillary changes, Age, Anterior chamber depth
Managed Access Programs for LNP023, Iptacopan

Study Overview
=================
Brief Summary
-----------------
The purpose of this registration form is to list all Managed Access Programs (MAPs) related to LNP023, Iptacopan

Detailed Description
-----------------
CLNP023B12004M - Available - Managed Access Program (MAP) Cohort Treatment Plan CLNP023B12004M to Provide Access to Iptacopan (LNP023) for Complement 3 Glomerulopathy in Native and Transplanted Kidneys. CLNP023N12001M - Available - Managed Access Program (MAP) Cohort Treatment Plan CLNP023N12001M to provide access to Iptacopan for patients with paroxysmal nocturnal hemoglobinuria (PNH).

Official Title
-----------------
Managed Access Programs for LNP023, Iptacopan

Conditions
-----------------
C3 Glomerulopathy (C3G), Paroxysmal Nocturnal Hemoglobinuria (PNH)

Intervention / Treatment
-----------------
* Drug: Iptacopan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: An independent request should be received from a licensed physician (in some instances from Health Authorities, Institutions or Governments). The patient has a serious or life-threatening disease or condition and no comparable or satisfactory alternative therapy is available for diagnosis, monitoring or treatment; patient is not medically eligible for available treatment alternatives or has exhausted all available treatment options. The patient is not eligible or able to enroll in a Novartis clinical trial or continue participation in a Novartis clinical trial. There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated. The patient must meet any other medical criteria established by the medical experts responsible for the product or by the Health Authority in a country (as applicable). Provision of the product will not interfere with the initiation, conduct or completion of a Novartis clinical trial or overall development program. Managed access provision is allowed per local laws/regulations.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Iptacopan|Patients receive Iptacopan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
C3 glomerulopathy (C3G), Paroxysmal nocturnal hemoglobinuria (PNH), MAP, Manage access program, Iptacopan, LNP023
Effects of Live Music on the Perception of Noise in the SICU: A Patient, Caregiver, and Medical Staff Environmental Study

Study Overview
=================
Brief Summary
-----------------
The use of live music in SICU might affect the perception of noise, which may reduce staff's stress level and further decrease the possibility of clinical errors, reduce patient's anxiety and perception of pain as well as increase compliance from patient and family. Live music might also enhance the quality of stay and promote a holistic healing process for the patient.

Detailed Description
-----------------
In this study, the research team is looking at the effect of the live music provided by a trained music therapist, created through incorporating the noises in the SICU - such as the beeping of the machines as part of the elements in the music, to organize the sound environment as well as introducing familiar songs, chosen according to the cultures and ages of the patients, caregivers and staff, to increase a sense of familiarity and comfort. Through the intervention, the research team hope to ameliorate the effects of a noxious sound environment, which may reduce the stress level of the staff and increase their acuity level while decrease patients and caregivers' anxiety level and improve their mood state and the quality of hospitalization

Official Title
-----------------
Effects of an Integrative Music Therapy Program on the Perception of Noise in the SICU: A Patient, Caregiver, and Physician/Nursing Environmental Study

Conditions
-----------------
Pain, Anxiety, Stress

Intervention / Treatment
-----------------
* Other: Live music


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: SICU patients, caregivers, and physicians/nursing staff Exclusion Criteria: Non-medical Staff

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Live music<br>1-hour live music 5 days/week | Other: Live music<br>* Providing 1-hour live music 5 days/ week.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-report stress level from SICU staff | Environmental music therapy will reduce stress level for SICU staff. | 6 months | 
| Pre and Post-intervention score on the perception of SICU noises from SICU and Hospital Anxiety and Depression Scale for SICU patients | Environmental Music Therapy will ameliorate the perception of noises and decrease the anxiety level of SICU patients and caregivers | 1 week | 
| Pre and Post-intervention score on the perception of SICU noises from SICU patients, caregivers |  | 1 week |