linjc16/ctgov huggingface dataset:
Non -Interventional Study-Palliative Therapy of Multiple Myeloma With a Combination of Lenalidomide and Dexamethasone

Study Overview
=================
Brief Summary
-----------------
Purpose of this non-interventional study is the documentation of efficacy and safety data of multiple myeloma therapy with a combined treatment of Lenalidomide and Dexamethasone in daily routine practice.

Official Title
-----------------
Combined Application of Lenalidomide and Desamethasone in the Palliative Therapy of Patients With Multiple Myeloma

Conditions
-----------------
Multiple Myeloma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with multiple myeloma with at least one previous therapy. 18 years or older Signed, written informed consent Exclusion Criteria: Pregnancy or nursing All other exclusion criteria listed in SmPC (summary of product characteristics)

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 |
| --- | --- |
| Patients with multiple myeloma<br>Patients with multiple myeloma receiving second line therapy or higher. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression (TTP) |  | maximum 3 years per Patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate |  | maximum 3 years per Patient | 
| Time to Treatment Discontinuation (TTD) |  | maximum 3 years per Patient | 
| Overall Survival (OS) |  | maximum 3 years per Patient | 
| Safety Profile |  | maximum 3 years per Patient | 
| Dosage of Lenalidomide and Dexamethasone |  | maximum 3 years per Patient | 
| Kidney Function |  | maximum 3 years per Patient | 
| Neutropenia / Infection (Concomitant Medication) |  | maximum 3 years per Patient | 
| Thrombosis Prophylaxis |  | maximum 3 years per Patient | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Myeloma, Non-interventional study, Lenalidomide, Dexamethasone, Observational, Time to progression, Clinical routine, Germany, Plasmacytoma
Safety and Efficacy of Oral PTK787 in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration (AMD)

Study Overview
=================
Brief Summary
-----------------
This study evaluates the tolerability and safety of 3 months treatment with PTK787 tablets given daily. It also explores the efficacy of the compound in patients with wet age-related macular edema. In Cohort 1 verteporfin/PDT is the active control. The protocol was amended to reflect the current standard of care for AMD. As a result, ranibizumab is the active control for Cohort 2.

Official Title
-----------------
A Randomized, Double-Masked, Multicenter, Phase I/II Study of the Safety of PTK787 Administered to Patients With Predominantly Classic , Minimally Classic or Occult With no Classic Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration

Conditions
-----------------
Wet Age-Related Macular Degeneration

Intervention / Treatment
-----------------
* Drug: PTK787
* Drug: PTK787
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Male ≥ 65 years old or female ≥ 50 years old, with aged related macular degeneration Patients with subfoveal choroidal neovascularization secondary to AMD Exclusion criteria Eye disease that may result in visual loss during the study Uncontrolled high blood pressure, despite chronic stable treatment: systolic ≥ 140 mmHg, Diastolic ≥ 90 mmHg Chronic therapy with topical, local or systemic corticosteroids. Use of other investigational drugs within 30 days Pregnant or nursing (lactating) women. Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: PTK787<br>* Visudyne® + PTK787, 500 mg/day<br>|
| Experimental: 2<br> | Drug: PTK787<br>* Visudyne® + PTK787 1000 mg/day<br>|
| Placebo Comparator: 3<br> | Drug: Placebo<br>* Visudyne® + Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as assessed by visual acuity measurements, ophthalmic examinations, vital signs, laboratory assessments, and adverse events up to 12 months |  | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in macular edema from Baseline up to Month 3 Change in best-corrected visual acuity (BCVA) from Baseline up to Month 3 Change in size of fluorescein leakage Baseline up to Month 3 |  | from baseline up to 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wet Age-related macular degeneration, PTK787
Expanded Access to Nivolumab (Opdivo)

Study Overview
=================
Brief Summary
-----------------
At BMS, we work with physicians/investigators to make investigational products available to patients with life-threatening diseases that have exhausted other treatment options and where there is a reasonable expectation of benefit over risk. When contacted by a treating physician, BMS will consider requests for providing early patient access to Nivolumab in pediatric patients exhibiting a high mutational load.

Detailed Description
-----------------
Choosing to participate in an early patient access program is an important personal decision. Talk with your doctor and family members or friends about deciding to join an early patient access program. To learn more about early patient access programs, your doctor may contact BMS using the information provided below.

Official Title
-----------------
Expanded Access to Nivolumab (Opdivo)

Conditions
-----------------
Pediatric Cancer

Intervention / Treatment
-----------------
* Biological: Nivolumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Specific eligibility criteria must be met for access outside of a clinical trial. These inclusion criteria include: The illness must be serious or life threatening There are no other viable options (including approved products or active clinical trials) There is sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks based on what is known at the time Other defined inclusion/exclusion criteria could be applicable.

Ages Eligible for Study
-----------------
Maximum Age: 17 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Nivolumab|Opdivo (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody approved by the US Food and Drug Administration (FDA) on an accelerated basis for some types of cancer. Please contact your physician for more details.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Double-Blind Randomized Clinical Trial of a Rifabutin Regimen in the Treatment of Mycobacterium-Avium Complex (MAC) Bacteremia in Patients With AIDS

Study Overview
=================
Brief Summary
-----------------
To determine if a drug regimen containing rifabutin will eradicate or decrease the numbers of Mycobacterium avium complex (MAC) organisms in blood, improve the symptoms associated with MAC infection, and increase survival in patients with AIDS. To assess the safety of the drug regimen.

Official Title
-----------------
A Double-Blind Randomized Clinical Trial of a Rifabutin Regimen in the Treatment of Mycobacterium-Avium Complex (MAC) Bacteremia in Patients With AIDS

Conditions
-----------------
Mycobacterium Avium-Intracellulare Infection, HIV Infections

Intervention / Treatment
-----------------
* Drug: Rifabutin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Concurrent Medication: Allowed: Zidovudine (AZT). Didanosine (ddI). Patients must have the following: Diagnosis of AIDS as defined by the CDC. Blood cultures positive for Mycobacterium avium complex or for acid-fast bacilli (AFB). Provide written informed consent. Prior Medication: Allowed: If receiving zidovudine (AZT) or ddI must be taking the medication for at least 4 weeks prior to study entry. Required: Antipneumocystis prophylactic therapy for at least 4 weeks prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Known hypersensitivity to any of the study drugs. Concurrent Medication: Excluded: Other therapy for mycobacterial disease. Patients with the following are excluded: Known hypersensitivity to any of the study drugs. Prior Medication: Excluded within 4 weeks: Therapy for mycobacterial disease. Antiretroviral drugs, other than zidovudine (AZT) or ddI. Investigational drugs, other than ddI.

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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rifabutin|nan|

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
-----------------
Rifabutin, Mycobacterium avium-intracellulare Infection, Acquired Immunodeficiency Syndrome
Hematology Biobank : Invitro Study of Blood Disorders

Study Overview
=================
Brief Summary
-----------------
This is a bio repository of blood specimens from subjects with different Hematological disorders.

Detailed Description
-----------------
There has been a marked increase in our knowledge of Blood Disorders in the last decade. Much of this knowledge comes from examining blood specimens from patients and subjecting these samples to red cell, plasma, serum or DNA analyses. We propose to set up a Hematology biobank, which will include patient histories, their medical progress and a linked but de-identified bank of blood samples. This will enable us to have a large database, which can be used to learn more about these diseases. The Hematology biobank will use whole blood, red blood cells, plasma, serum and/or DNA.

Official Title
-----------------
Hematology Biobank : Invitro Study of Blood Disorders

Conditions
-----------------
Hematological Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Above 18 years of age and able to consent Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Biobank | To have specimens available for IRB approved studies | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hematology Biobank
Expanded Access Protocol (EAP) for Participants Receiving Idecabtagene Vicleucel That is Nonconforming for Commercial Release

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the safety and efficacy of nonconforming idecabtagene vicleucel (ide-cel) in participants with multiple myeloma per the approved prescribing information. This is an expanded access protocol (EAP) to be conducted at Risk Evaluation and Mitigation Strategies (REMS) qualified sites approved for commercial administration of idecabtagene vicleucel and where the EAP is authorized to be conducted for use of nonconforming idecabtagene vicleucel. Non-conforming idecabtagene vicluecel is idecabtagene vicleucel that does not meet commercial release specifications but may be acceptable for use as an investigational product in the Expanded Access Protocol setting.

Official Title
-----------------
Expanded Access Protocol (EAP) for Patients Receiving Idecabtagene Vicleucel That is Nonconforming for Commercial Release

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Biological: Nonconforming idecabtagene vicleucel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Had a participant-specific batch of Idecabtagene vicleucel (ide-cel) manufactured intended for commercial treatment; however, the final manufactured product was nonconforming and did not meet commercial release criteria Remanufacturing is deemed not feasible or clinically inappropriate per assessment of the treating physician in discussion with the participant Clinically stable Exclusion Criteria: Has a hypersensitivity to the active substance or to any of the excipients No experience of a significant worsening in clinical status that would, in the opinion of the treating physician, either increase the risk of Adverse Events associated with lymphodepleting chemotherapy, or exclude them from treatment with nonconforming Idecabtagene vicleucel (ide-cel) Has any condition and/or laboratory abnormality that places the participant at unacceptable risk if he/she were to participate in the Expanded Access Protocol based on the Investigator's judgement Other protocol-defined inclusion/exclusion criteria apply

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Nonconforming idecabtagene vicleucel|Nonconforming idecabtagene vicleucel is to be administered to participants after lymphodepleting chemotherapy|

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
-----------------
BB2121, Multiple Myeloma, Expanded Access, idecabtagene vicleucel, nonconforming, CAR T, EAP, Pre-Approval Access
Responsiveness and Validation Study of MFM-32 in SMA Patients Treated With Nusinersen

Study Overview
=================
Brief Summary
-----------------
The Motor Function Measure (MFM), a reliable tool assessing motor function and its progression in most neuromuscular diseases, is widely used in France in many teams. It can be used regardless of the severity of the motor impairment or the ambulatory status of the patient, allowing its use throughout the whole follow-up period of the patient, even in case of the loss of walking. Two versions of the MFM exist, one composed of 32 items originally validated for patients from 6 years old (MFM-32) and a shorter version composed of 20 items originally validated for patients between 2 and 6 years old (MFM-20). In order to prove the possible use of MFM-32 as early as the age of 2 years to validly and reliably monitor the evolution of the motor function of children treated with Nusinersen, we propose in this project to study the sensitivity to treatment-induced change of MFM-32 and the validity of the scale in this population.

Official Title
-----------------
Responsiveness and Validation Study of MFM-32 in SMA Patients Treated With Nusinersen: NusiMFM

Conditions
-----------------
Spinal Muscular Atrophy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Boys and girls with Type 1 or 2 Spinal Muscular Atrophy, genetically confirmed Aged 2 to 6 years old Treated by Nusinersen for at least two months With parental assent Exclusion Criteria: Patients with associated cognitive impairment making impossible evaluation of motor function Patients participating to a clinical study with a potential effect on their motor function.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 6 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 |
| --- | --- | --- |
| MFM-32 responsiveness | Responsiveness of MFM-32 in comparison to PGIC. The responsiveness sensitivity to change indexes considered will be the effect size (ES) amplitude and the Standardized Response Mean (SRM) | 1 Year after the first MFM-32 assessment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal Muscular Atrophy, Motor Function Measure,Nusinersen
Pilot Study to Evaluate A Novel Gastric Space Occupying Device

Study Overview
=================
Brief Summary
-----------------
This will be an observational, prospective, non-randomized, pilot study to gain initial device experience on a novel space-occupying device in persons who are overweight or obese. No formal hypothesis testing will be conducted.

Official Title
-----------------
A Single-Center 60-day Observational, Non-randomized Study to Evaluate Safety and Preliminary Efficacy of a Novel Gastric Space Occupying Device as an Aid for Weight Loss

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Device: Obalon Gastric Balloon(s)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 21-64 years BMI 27-40 Kg/m2 No history of weight reduction of more than 5% of total body weight in the past 6 months Exclusion Criteria: Have unstable angina, myocardial infarction within the past year, or heart disease classified within the New York Heart Association's Class III or IV functional capacity; Be taking chronic aspirin or other non steroidal anti-inflammatory agents, or other medications known to be gastric irritants, and unwillingness to discontinue the use of these concomitant medications, antiarrythmics, anti-anginal medications, anticoagulants or medications for congestive heart failure; Be taking blood pressure medications, unless their blood pressure is controlled and they have been at stable dose for at least 3 months; Have type 1 diabetes or type 2 diabetes requiring oral medications or insulin; History or symptoms of thyroid disease which is not controlled by medication; Have severe renal, hepatic, pulmonary disease or cancer; Past history of gastrointestinal surgery (excluding uncomplicated appendectomy); Have a history of adhesive peritonitis; History or symptoms of esophageal and/or gastric varices; Have history or congenital or acquired GI anomalies (e.g. atresias, stricture, and /or diverticula); History or symptoms of inflammatory bowel disease, such as Chron's disease; History of/ signs and /or symptoms of duodenal or gastric ulcer; Have gastroparesis; Pregnant or breastfeeding or intention of becoming pregnant during the study (if female of childbearing potential); Currently using pharmaceutical agents for weight loss;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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 |
| --- | --- |
| Obalon Gastric Balloon<br>One or two balloons administered to each patient | Device: Obalon Gastric Balloon(s)<br>* One or two balloons administered per patient<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Caffeinated Gum to Prevent Post-Operative Ileus: A Prospective, Randomized, Placebo-controlled Trial

Study Overview
=================
Brief Summary
-----------------
This is a randomized, three-arm, double-blind, placebo-controlled, Phase III clinical trial of caffeinated gum and sugar-less gum in adult patients after an abdominal procedure. Patients will be randomized to receive placebo, sugar-less gum or caffeinated gum three times daily for 30 minutes starting the day following surgery until discharge or 24 hours after attainment of the primary endpoint.

Official Title
-----------------
Caffeinated Gum to Prevent Post-Operative Ileus: A Prospective, Randomized, Placebo-controlled Trial

Conditions
-----------------
C.Surgical Procedure; Digestive System

Intervention / Treatment
-----------------
* Dietary Supplement: Caffeine
* Other: Gum
* Behavioral: wear silicone bracelet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Abdominal procedure (Laparoscopic or open, occurring electively), American Society of Anesthesiologists (ASA) physical status score ≤ 3, Glasgow Coma Score (GCS) ≥ 15. Exclusion Criteria: ASA physical status score of >3, GCS < 15, complete bowel obstruction, history of cardiac arrhythmia, history of phenylketonuria, alcohol abuse. substance abuse dentures

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Subjects will wear a silicone bracelet for 30 minutes 3 times daily at 8 am, 12 pm and 4 pm. | Behavioral: wear silicone bracelet<br>* Subjects will put on bracelet to correspond with times for chewing gum<br>|
| Sham Comparator: Sugar-less Gum<br>Subjects will chew one stick of sugar-less gum for 30 minutes 3 times daily at 8 am, 12 pm and 4 pm. | Other: Gum<br>* Chewing gum<br>|
| Experimental: Caffeinated Gum<br>Subjects will chew one stick of caffeinated gum (100mg caffeine per stick) for 30 minutes 3 times daily at 8 am, 12 pm and 4 pm. | Dietary Supplement: Caffeine<br>* caffeinated gum<br>Other: Gum<br>* Chewing gum<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean time to GI function recovery (GI-3) |  | An expected average of 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean length of postoperative hospitalization |  | Up to 30 days | 
| Rate of postoperative ileus |  | Up to 30 days | 
| Adverse event rates |  | Up to 30 days postoperative |