linjc16/ctgov huggingface dataset:
A Retrospective Study of Patients With Leukemia Relapse in the CNS Treated With CAR T Cells

Study Overview
=================
Brief Summary
-----------------
CAR T cells targeting CD19 have been approved for patients with relapsed or refractory ALL, failing two or more prior protocols. Several institutional-based studies with other CAR T cells targeting CD19 have demonstrated outstanding response rates in patients with refractory disease, and the ability of CAR T cells to clear CNS leukemia. Nevertheless, these cases are sparse and have never been reported collectively. Here, we aim to retrospectively assess toxicity and long term outcome of patients treated with CAR T cells for CNS relapse of ALL.

Official Title
-----------------
CARs for CNS-Leukemia Relapse: A Retrospective International Study

Conditions
-----------------
Acute Lymphoblastic Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prior diagnosis of B-cell acute lymphoblastic leukemia involving the central nervous system Treatment with CAR T cells (either on a clinical trial or commercial use) due to this indication
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CNS ALL at lymphodepletion<br>Patients with active CNS leukemia at the time of lymphodepletion | |
| CNS ALL at inclusion<br>Patients who were referred to CAR T-cells with CNS disease, which was cleared by the time of lymphodepletion | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Duration between CAR T-cell infusion and death or last follow-up, according to Kaplan-Meier analysis | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of CAR-related CRS or ICANS per ASCTC guidelines | Number of patients and average grade of cytokine-release syndrome and immune-effector cell associated neurotoxicity syndrome within 2 months after CAR treatment, according to ASCTC guidelines (Lee et al, BBMT 2019) | 2 months | 
| Leukemia-free survival | Duration between CAR T-cell infusion and leukemia relapse, according to Kaplan-Meier analysis | 6 months | 
| CNS-leukemia free survival | Duration between CAR T-cell infusion and CNS leukemia relapse, according to Kaplan-Meier analysis | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CAR T cells, CNS leukemia
Pilot Study of Cyclophosphamide in Patients With Life-Threatening Systemic Lupus Erythematosus or Antiphospholipid Antibody Syndrome

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine the induction of durable remission in patients with life-threatening systemic lupus erythematosus or antiphospholipid antibody syndrome treated with cyclophosphamide. II. Determine the toxicity of this drug in these patients.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients receive cyclophosphamide IV on days 1-4 and filgrastim (G-CSF) beginning on day 10 and continuing until blood counts recover. Patients are followed monthly for 6 months, and then every 3 months thereafter.

Conditions
-----------------
Systemic Lupus Erythematosus, Antiphospholipid Antibody Syndrome

Intervention / Treatment
-----------------
* Drug: Cyclophosphamide
* Drug: filgrastim


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of life-threatening systemic lupus erythematosus (SLE); must show at least 4 American College of Rheumatology criteria for SLE; must have severe organ damage in 1 or more organs; must have 1 or more of the following indications of ongoing disease activity: disease activity score (SLEDAI) at least 4, hospitalization for disease activity within 12 months, life-threatening disease not captured on SLEDAI OR Diagnosis of antiphospholipid antibody syndrome by the Hughes criteria; must show severity by ongoing symptoms or signs of hypercoagulability in spite of warfarin therapy --Patient Characteristics-- Hepatic: Bilirubin no greater than 2.0 mg/dL; transaminases no greater than 2.0 times normal Renal: Creatinine no greater than 3.0 mg/dL Cardiovascular: Ejection fraction at least 45% Pulmonary: FVC, FEV1, or DLCO at least 50% predicted Other: Not preterminal or moribund; not pregnant or nursing; fertile patients must use effective contraception

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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cyclophosphamide|nan|
|Drug: filgrastim|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
-----------------
antiphospholipid antibody syndrome, arthritis & connective tissue diseases, immunologic disorders and infectious disorders, rare disease, systemic lupus erythematosus
Local Infiltration Analgesia in Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
40 patients ASA I-III, undergoing total knee arthroplasty were randomly assigned, into one of two groups, namely group LIA (n=20), where local infiltration analgesia would be administered intraoperatively; and group sham LIA (n=20), where sham injections of normal saline would be administered. All patients received a standardized multimodal approach, including pregabalin, adductor canal peripheral nervous blockade, spinal anaesthesia, paracetamol, and PCA with morphine. Morphine consumption during the first 24 hours postoperatively was measured and additionally the investigators recorded: Time of morphine first dose administration, NRS scores in static and dynamic conditions in 6 hours, 12 hours, 18 hours and 24 hours postoperatively, complications, patient satisfaction and duration of hospitalization.

Official Title
-----------------
Local Infiltration Analgesia in Total Knee Arthroplasty: A Randomized, Prospective, Placebo Controlled, Double Blinded Study.

Conditions
-----------------
Total Knee Arthroplasty, Analgesia

Intervention / Treatment
-----------------
* Drug: Ropivacaine
* Other: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Physical status according to American Society of Anesthesiologists (ASA) I-III Patients scheduled for total knee arthroplasty Exclusion Criteria: Contraindication for central and/or peripheral nervous blockade Reoperation on previous total knee arthroplasty History of allergic or other adverse reactions on the agents used in the study Chronic opioid or gabapentinoid use Serious psychiatric, mental and cognitive disorders Language barrier Difficulty in understanding or using a patient controlled analgesia device
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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LIA<br>Local infiltration analgesia | Drug: Ropivacaine<br>* Large volume local anaesthetic intraarticularly<br>|
| Sham Comparator: sham LIA<br>Saline injections | Other: Saline<br>* sham injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine consumption |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS scores |  | 24 hours | 
| Complications |  | 24 hours | 
| Patient satisfaction | Patients asked whether they would choose the same anaesthetic management in a futue operaton: Yes / No | 24 hours | 
| Duration of hospitalization | Number of days patients remain in the hospital postoperatively | 1 month |
A Study of an Investigational Drug Sitagliptin for Type 2 Diabetes Mellitus (0431-044)

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to determine the efficacy and safety of an investigational drug in patients with type 2 diabetes mellitus.

Official Title
-----------------
Sitagliptin (MK0431) Late Phase II Double-Blind Dose-Response Study - Type 2 Diabetes Mellitus

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: sitagliptin phosphate
* Drug: Comparator: placebo (unspecified)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with type 2 diabetes mellitus Exclusion Criteria: Patients with type 1 diabetes mellitus

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo QD 12-week | Drug: Comparator: placebo (unspecified)<br>* placebo QD 12-weeks<br>|
| Experimental: 2<br>25 mg QD 12-week | Drug: sitagliptin phosphate<br>* sitagliptin phosphate 25 mg, 50 mg, 100 mg QD, or 200 mg QD 12-weeks.<br>* Other names: MK0431;|
| Experimental: 3<br>50 mg QD 12-week | Drug: sitagliptin phosphate<br>* sitagliptin phosphate 25 mg, 50 mg, 100 mg QD, or 200 mg QD 12-weeks.<br>* Other names: MK0431;|
| Experimental: 4<br>100 mg QD 12-week | Drug: sitagliptin phosphate<br>* sitagliptin phosphate 25 mg, 50 mg, 100 mg QD, or 200 mg QD 12-weeks.<br>* Other names: MK0431;|
| Experimental: 5<br>200 mg QD 12-week | Drug: sitagliptin phosphate<br>* sitagliptin phosphate 25 mg, 50 mg, 100 mg QD, or 200 mg QD 12-weeks.<br>* Other names: MK0431;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in HbA1c at Week 12 | HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent. | Baseline and Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Glycosylated Albumin at Week 12 | Change from baseline at Week 12 is defined as Week 12 minus Week 0. | Baseline and Week 12 | 
| Change From Baseline in Fasting Plasma Glucose at Week 12 | Change from baseline at Week 12 is defined as Week 12 minus Week 0. | Baseline and Week 12 |
Study Evaluating the Pharmacokinetics of the Potential Drug Interaction Between CYP2C9 Inhibitor and Substrate

Study Overview
=================
Brief Summary
-----------------
This is an open-label, randomized, 2-period crossover, inpatient study to be performed in healthy subjects. The study will consist of 2 treatment periods: There will be 2 parallel cohorts of 12 subjects each who will be enrolled to receive single doses of tolbutamide or AGG-523 plus tolbutamide in periods 1 and 2 in a crossover design. Doses of test article will be administered after an overnight fast of at least 10 hours.

Official Title
-----------------
A Randomized, Open Label, 2-Period Crossover Study to Determine the Pharmacokinetics of the Potential Drug Interaction Between CYP2C9 Inhibitor and Substrate.

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: pharmacokinetic (how the body absorbs and eliminates) interaction


Participation Criteria
=================
Eligibility Criteria
-----------------
Men and women, aged 18 to 50 years. Women of non-childbearing potential may be included. Body mass index in the range of 18 to 30 kg/meter squared and body weight equal to or greater than 50 kg. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12 lead electrocardiogram (graphic trace of the pattern of your heart beat). Non-smoker or smoker of fewer than 10 cigarettes (half a pack) per day as determined by history. Must abstain from smoking during inpatient stay. Have a high probability for compliance with and completion of the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: pharmacokinetic (how the body absorbs and eliminates) interaction|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effects of a single oral dose of AGG-523 on the pharmacokinetic profile of a single oral dose of tolbutamide in healthy subjects. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Health
Study Comparing Moxidectin And Ivermectin In Subjects With Onchocerca Volvulus Infection

Study Overview
=================
Brief Summary
-----------------
This is a Phase 3 study comparing the efficacy, safety and tolerability of moxidectin and ivermectin in subjects infected with Onchocerca volvulus, which is the parasite that causes river blindness. Subjects participating in the study will be randomly assigned (by a 2 to1 ratio) to receive one orally-administered dose of either moxidectin or ivermectin.

Official Title
-----------------
A Single-Dose, Ivermectin-Controlled, Double-Blind, Efficacy, Safety And Tolerability Study Of Orally Administered Moxidectin In Subjects Infected With Onchocerca Volvulus

Conditions
-----------------
Onchocerciasis

Intervention / Treatment
-----------------
* Drug: Moxidectin
* Drug: Ivermectin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects with Onchocerca volvulus infection Exclusion Criteria: Pregnant or breast feeding women; coincidental loiasis

Ages Eligible for Study
-----------------
Minimum Age: 12 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moxidectin<br>Moxidectin 8mg | Drug: Moxidectin<br>* Single dose of moxidectin 2 mg oral tablet x 4<br>|
| Active Comparator: Ivermectin<br>Ivermectin 150 mcg/kg | Drug: Ivermectin<br>* Single dose of ivermectin 3 mg oral tablet x 2, 3 or 4<br>* Other names: Ivermectin, Mectizan, Stromectol;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| skin microfilaria density (mf/mg) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| skin microfilaria density (mf/mg) |  | 1 month | 
| skin microfilaria density (mf/mg) |  | 6 months | 
| skin microfilaria density (mf/mg) |  | 18 months | 
| skin microfilaria reduction from baseline |  | 1 month | 
| skin microfilaria reduction from baseline |  | 6 months | 
| skin microfilaria reduction from baseline |  | 12 months | 
| skin microfilaria reduction from baseline |  | 18 months | 
| proportion of subjects with undetectable levels of skin microfilaria |  | 1 month | 
| proportion of subjects with undetectable levels of skin microfilaria |  | 6 months | 
| proportion of subjects with undetectable levels of skin microfilaria |  | 12 months | 
| proportion of subjects with undetectable levels of skin microfilaria |  | 18 months | 
| percent reduction in microfilaria levels in the anterior chamber of the eye |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
onchocerciasis, river blindness, onchocerca volvulus, moxidectin, ivermectin
A Non-Interventional Study to Document the Use of Straumann BLX Implants in Daily Dental Practice

Study Overview
=================
Brief Summary
-----------------
Prospective, multi-center, non-interventional observation to document the success and survival rates of Straumann BLX Implants used for tooth replacement in cleared indications up to 1 year after implant placement

Detailed Description
-----------------
Objective of the study is to confirm the safety and performance of Straumann BLX Implants used for tooth replacement in cleared indications up to 12 months after implant placement. Implants used are Straumann® BLX Implant Roxolid® SLActive®. Regular Base (3.5 mm): implant diameters 3.75 and 4.5mm, in lengths 6, 8, 10, 12,14, 16 and 18 mm Wide Base (4.5 mm): diameter 5.5 mm in lengths 6, 8, 10 and 12 mm

Official Title
-----------------
A Non-Interventional Study to Document the Use of Straumann BLX Implants in Daily Dental Practice

Conditions
-----------------
Surgical Operation With Implant of Artificial Internal Device

Intervention / Treatment
-----------------
* Procedure: surgical placement of an endosteal implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients seeking an implant supported restoration all patients with conditions that are in accordance with the IFU Patients must provide their informed consent for study participation and must be willing and able to attend control visits Patients need to be at least 18 years old Exclusion Criteria: -

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 |
| --- |
|Procedure: surgical placement of an endosteal implant|Subjects, male or female at least 18 years old, with the need of dental implant therapy and restoration according to the cleared indications for the implant|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant success rate at one year post implant placement | Measured in percent | 12 months follow-up period after implantation | 
| Implant survival rate at one year post implant placement | Measured in percent | 12 months follow-up period after implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prosthetic success at 12 months post implant placement | Measured in percent | 12 months follow-up period after implantation | 
| Prosthetic survival at 12 months post implant placement | Measured in percent | 12 months follow-up period after implantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Survival rate, Success rate, Straumann® BLX Implant Roxolid® SLActive®,
Comparison Between Two Fertility Protocols in Obese Polycystic Ovary Syndrome Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare two fertility protocols in obese women with Polycystic Ovarian Syndrome who are candidates for In Vitro Fertilization (IVF). These protocols carry less risk of ovarian hyperstimulation syndrome which these women may experience.

Detailed Description
-----------------
The purpose of this study is to compare two fertility protocols in obese women with Polycystic Ovarian Syndrome who are candidates for In Vitro Fertilization (IVF). These protocols carry less risk of ovarian hyperstimulation syndrome which these women may experience.The patients in the IVM group will not be exposeD to gonadotropin treatment for controlled ovarian hyperstimulation. In the antagonist group we will use GnRH agonist to induce ovulation which may reduce the risk for ovarian hyperstimulation.

Official Title
-----------------
Comparison Between Two Fertility Protocols in Obese Polycystic Ovary Syndrome

Conditions
-----------------
Obese, Infertility, Polycystic Ovary Syndrome

Intervention / Treatment
-----------------
* Procedure: IVM (In Vitro Maturation) Treatment
* Procedure: IVF (In Vitro Fertilization) Antagonist Protocol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI > 30 PCOS Failure of COH treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IVM Treatment<br> | Procedure: IVM (In Vitro Maturation) Treatment<br>* There will be no gonadotropin stimulation. There will be ovum pickup from antral follicles of immature oocyte which will be matured in the lab and fertilized by intracytoplasmic sperm injection (ICSI). Embryo transfer will take place on days 2 or 3.<br>* Other names: IVM;|
| Active Comparator: Antagonist Protocol<br> | Procedure: IVF (In Vitro Fertilization) Antagonist Protocol<br>* The first stage of the treatment will be stimulation with gonadotropins. Next GNRH Antagonist will be added. Ovulation induction will be performed with GNRH agonist. After ovulation there will be ovum pickup and fertilization in the lab. Embryo transfer will take place on days 2 or 3.<br>* Other names: IVF - antagonist protocol;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fertility results |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
(BMI > 30), best fertility protocol, women, PCOS