linjc16/ctgov huggingface dataset:
CD INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to determine the incidence and pattern of serious and/or clinically significant infections, malignancies, and other serious adverse event (SAE) in participants with Crohn's Disease (CD) treated with natalizumab. The secondary objective of this study in this study population is to evaluate disease severity over time in participants with CD treated with natalizumab based on changes in the Harvey-Bradshaw Index (HBI).

Detailed Description
-----------------
This study was originally conducted by Elan Pharmaceuticals, Inc. (Elan) in collaboration with Biogen under a protocol written by Elan. Biogen is solely responsible for the study since April 2013.

Official Title
-----------------
INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Drug: natalizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Subjects with Crohn's Disease (CD) who are eligible for therapy according to US Tysabri label and who are enrolled in the Tysabri Outreach Unified Commitment to Health (TOUCH) Prescribing Program. Key Exclusion criteria: None Note: Other protocol defined Inclusion/ Exclusion criteria may apply.

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: natalizumab|Administered as specified in the TOUCH Prescribing Program|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of serious and/or clinically significant infections, malignancies, and other SAEs in participants with Crohn's Disease treated with natalizumab |  | Every 6 months for up to 5 years following the first Tysabri infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of disease severity over time as assessed by change in HBI |  | Every 6 months for up to 5 years following the first Tysabri infusion |
Intravenous Tedisamil in the Rapid Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm in Female Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the ability of tedisamil to convert atrial fibrillation or flutter into normal sinus rhythm (NSR) in female patients.

Official Title
-----------------
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety of Intravenous Tedisamil Sesquifumarate in the Rapid Conversion to Normal Sinus Rhythm in Female Subjects With Recent Onset Atrial Fibrillation

Conditions
-----------------
Atrial Fibrillation, Atrial Flutter

Intervention / Treatment
-----------------
* Drug: Tedisamil sesquifumarate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willing to sign informed consent before screening examinations are performed and before the study drug is administered Females > 18 years of age Subjects with documented (60 second rhythm strip) symptomatic atrial fibrillation or flutter (duration > 3 hours and < 45 days) at the time of randomization Subjects who are in no distress and hemodynamically stable (supine systolic blood pressure > 90 mmHg and diastolic blood pressure < 105 mmHg) Exclusion Criteria: Pregnancy and lactation Acute myocardial infarction and cerebrovascular accidents Coronary syndromes and congestive heart failure (CHF) New York Heart Association (NYHA) IV Life-threatening ventricular arrhythmias and electrocardiogram (ECG) abnormalities Concurrent antiarrhythmic treatments

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

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

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

| Intervention/Treatment |
| --- |
|Drug: Tedisamil sesquifumarate|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
-----------------
Atrial fibrillation, atrial flutter, anti-arrhythmic agents, conversion to normal sinus rhythm
Timing of Tracheostomy in COVID-19 - Impact on Mortality

Study Overview
=================
Brief Summary
-----------------
How timing of tracheostomy in COVID-19 patients changed and its impact on mortality in patients with severe COVID-19 ARDS

Official Title
-----------------
How Timing of Tracheostomy in COVID-19 Patients Changed and Its Impact on Mortality

Conditions
-----------------
Tracheostomy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Severe COVID-19 infection requiring endotracheal intubation and prolonged invasive ventilation as part of the treatment of severe to moderate acute respiratory distress syndrome. Exclusion Criteria: COVID-19 disease, without the need for endotracheal ventilation. COVID-19 disease with need for endotracheal intubation with anticipated short-term invasive ventilation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Early tracheostomy<br>Tracheostomy time before day 10 following endotracheal airway management and invasive ventilation. | |
| Late tracheostomy<br>Tracheostomy time after day 11 following endotracheal airway management and invasive ventilation. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Deaths in the course of treatment | During intensive care treatment (Usually within 8 weeks) |
BOND Study: the Benefit Of Night Splinting in Dupuytrens'

Study Overview
=================
Brief Summary
-----------------
The BOND study is a prospective, randomised single blinded controlled trial to assess the effect of night splinting in patients who have had collagenase injection and manipulation therapy for Dupuytren's Contracture.

Detailed Description
-----------------
This trial will assess the effectiveness of night splinting in Dupuytrens' contracture on functional and quality of life outcomes.

Official Title
-----------------
The Effectiveness of Night Splinting After Collagenase Injection for Dupuytren's Contracture

Conditions
-----------------
Dupuytren Contracture

Intervention / Treatment
-----------------
* Device: Thermoplastic Hand Splint


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Single digit contractures greater than 30 degrees No prior surgery for their contractures. Successful collagenase and manipulation therapy (contracture reduced to within 10 degrees of full extension). Exclusion Criteria: Multiple digit contractures Prior surgery for their contractures. Failure of collagenase and manipulation therapy (contracture not reduced to within 10 degrees of full extension). Inability to consent to treatment.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised Controlled Trial - Block Randomisation
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Splinted<br>Patients will be given Thermoplastic Hand Splint to wear overnight for 12 weeks. | Device: Thermoplastic Hand Splint<br>* Thermoplastic Night splint created and moulded to the individual patients hand in-house using generic thermoplastic.<br>|
| No Intervention: Un-Splinted<br>Patients will not wear a night splint | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of motion | To assess change in range of motion measured in degrees between pre-treatment, immediately post-treatment, 12 weeks post-treatment and 12 months post-treatment | At 0 weeks, 12 weeks and 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PEM Questionnaire | Patient Evaluation Measure to give disability score | At 0 weeks, 12 weeks and 52 weeks | 
| URAM Questionnaire | Hand specific outcome questionnaire to assess quality of life outcomes | At 0 weeks, 12 weeks and 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Collagenase, Night-splinting, Dupuytrens, Contracture
Organizing the Information Given to Parents of NICU Infants in Order to Reduce Their Anxiety

Study Overview
=================
Brief Summary
-----------------
Being a parent to a premature infant in NICU is an anxious state. Parents ask a lot of questions, and look for information all the time. Organizing the information given to parents could reduce their anxiety. The parents will be divided into two groups: one group will get organized information, by a lecture at the first week of their infant's life, and the other group will not. Of course, questions will be answered all the time. The parents will answer a questionnaire on the first week of the infant's life, and on the last week, just before releasing the infant home.

Detailed Description
-----------------
Being a parent to a premature infant in NICU is an anxious state. Parents ask a lot of questions, and look for information all the time. Organizing the information given to parents could reduce their anxiety. The parents will be divided into two groups: one group will get organized information, by a lecture at the first week of their infant's life, and the other group will not. Of course, questions will be answered all the time. The parents will answer a questionnaire on the first week of the infant's life, and on the last week, just before releasing the infant home.

Official Title
-----------------
Dose Organizing the Information Given to Parents of NICU Infants Reduce Their Anxiety?

Conditions
-----------------
Anxiety

Intervention / Treatment
-----------------
* Behavioral: Lecture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parents to premature infants, after releasing the mother Exclusion Criteria: Term infants Hospitalized mother

Ages Eligible for Study
-----------------
Maximum Age: 4 Months

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>The group that will have lecture of information regarding infants in NICU. | Behavioral: Lecture<br>* Lecture of information regarding prematurity, NICU hospitalization, etc.<br>|
| No Intervention: 2<br>The group that will not have lecture of information regarding NICU hospitalization | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between questionnaires at the first week and the last week to hospitalization. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anxiety, parents, NICU, prematurity, Anxiety of parents to NICU infants
Effect Of PRF Versus Xenograft In Closed Sinus Lift.

Study Overview
=================
Brief Summary
-----------------
Indirect sinus lift with used PRF as a graft material versus xenograft

Detailed Description
-----------------
Crestal incision and reflect the tissue until exposure of the bone, then use drilling to make osteotomy. Then use sutable osteotomes to elevate the sinus floor, then pack of Prf or bone graft in the osteotomy and implant placement . Then closed the flap and suturing.

Official Title
-----------------
Prf Controlled, Randamized Clinical Trial of THE EFFECT OF PLATELET RICH FIBRIN( PRF ) VERSUS XENOGRAFT IN CLOSED SINUS LIFT AND IMLANT PLACEMENT ON IMPLANT STABILITY IN PATIENTS WITH MISSING MAXILLARY PREMOLAR.

Conditions
-----------------
Implant or Graft; Rejection

Intervention / Treatment
-----------------
* Other: Prf


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Edentulous area and bone high at least 5-6 mm below the maxillary sinus at maxillary premolar. Good oral hygiene. Exclusion Criteria: bad oral hygiene. patient with systemic disease that may affect normal healing pregnant patients. patients with bone diseases and presence of periapical pathology affecting the neighboring teeth. Heavy smoker more than 20 cigarettes per day

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 45 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: Parallel Assignment
Interventional Model Description: Patallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Used of PRF in clsed sinus lifting<br>Used of PRF in closed sinus lifting with implant placement | Other: Prf<br>* Take 10 cc blood from patient and gain prf<br>|
| No Intervention: Closed sinus with xenograft<br>used of xenograft in closed sinus lift with implant placement. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary stability by ostell device | Implant stability will be mesured by ostell device, implant stability will be mesured intra operative at 0 ( time of implant placement ) and 2, 4, 6, 10 and 12 weeks after surgery | up to 3 months |
Psychostimulant Abuse - Novel Treatment Approaches - 1

Study Overview
=================
Brief Summary
-----------------
To determine if acute assessments of profasi and factrel affect plasma cocaine levels and cocaine-induced behavioral changes in men.

Official Title
-----------------
Psychostimulant Abuse - Novel Treatment Approaches

Conditions
-----------------
Cocaine-Related Disorders

Intervention / Treatment
-----------------
* Behavioral: Gonadorelin


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.
Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Gonadorelin|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
-----------------
cocaine dependence
Prevalence of Latent Tuberculosis (TB) Infection Diagnosed by Interferon-gamma Release Assay and Tuberculin Skin Tests in Patients With Old Healed TB

Study Overview
=================
Brief Summary
-----------------
We easily regard nodules and fibrosis in upper lobes of lung as TB sequelae. The aim of this study is to confirm the prevalence of latent TB infection diagnosed by interferon-gamma release assay and tuberculin skin tests in patients with old healed TB.

Conditions
-----------------
Tuberculosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 20 years Patients with TB sequelae in their CXR Exclusion Criteria: Patients on immune-suppressants

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with TB sequelae<br> | |
| People without TB sequelae<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of latent TB infection |  | At enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
People who have fibrosis or nodules in their upper lobe of the lung
Granulocyte Transfusion Study

Study Overview
=================
Brief Summary
-----------------
To evaluate granulocyte transfusion therapy with respect to its prophylactic and therapeutic effectiveness to prevent and aid recovery from infection. The study trials were conducted simultaneously.

Detailed Description
-----------------
BACKGROUND: Infection remains a major cause of death in patients receiving chemotherapy for malignant diseases. One approach to the problem of septicemia and high mortality in these patients was the therapeutic use of granulocyte transfusions. Improvements in collection techniques, employing continuous flow centrifugation, permitted the collection of granulocytes from a single, normal donor in sufficient numbers to study their application in the treatment of infections in granulocytopenic patients. Studies had demonstrated the efficacy of granulocyte transfusions as an adjunct in the therapy of septicemia due to gram negative microorganisms associated with granulocytopenia. The aims of the study were to determine (1) whether infections could be prevented in patients who received granulocytes prophylactically and (2) whether recovery from infection was aided in patients who received granulocytes therapeutically. Both trials utilized controls who received no granulocytes. Four contracts were awarded in September 1976. The protocol designed to evaluate the efficacy of prophylactic granulocyte transfusions was completed at the close of 1977. The protocol for the therapeutic trial was completed in April 1978. Approximately 90 patients were randomized in the prophylactic trial and 51 in the therapeutic trial. The Recruitment and Intervention Phase ended in February 1980. The trial has concluded. DESIGN NARRATIVE: Prophylactic Trial and Therapeutic Trial: randomized, non-blind, sequential. Eligible patients were randomized to daily granulocyte transfusions or no granulocyte transfusions. The study completion date listed in this record was inferred from the first publication listed in the Citations section of this study record.

Conditions
-----------------
Blood Transfusion, Infection

Intervention / Treatment
-----------------
* Procedure: leukocyte transfusions


Participation Criteria
=================
Eligibility Criteria
-----------------
Prophylactic Trial: males and females, 12 years or older, who were in the first induction phase of chemotherapy for acute leukemia, who had severe neutropenia, and who did not have documented infection. Therapeutic Trial: males and females, any

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: Prevention
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: leukocyte transfusions|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Comparison of Biphasic Insulin Aspart 70/30 With Anti-Diabetic Drugs in Subjects With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in the United States of America (USA). The purpose of this study is to test whether biphasic insulin aspart 70/30 is a safe and at least as effective alternative in combination with two oral anti-diabetics compared to the two oral anti-diabetics alone for the control of blood glucose.

Official Title
-----------------
A Multicenter, Open-Label, Randomised Trial to Compare the Efficacy and Safety of NovoLog Mix 70/30 BID in Combination With Metformin and Pioglitazone to Metformin and Pioglitazone Alone in Insulin Naïve Subjects With Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart
* Drug: pioglitazone
* Drug: metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with type 2 diabetes mellitus

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: biphasic insulin aspart|nan|
|Drug: pioglitazone|nan|
|Drug: metformin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | After 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables |  |  | 
| Other glycemic variables |  |  | 
| 8-point plasma glucose profiles |  |  |
Genetics of Periodontal Diseases in Chinese

Study Overview
=================
Brief Summary
-----------------
(A retrospective case control study to validate the association between Interleukin-1 gene variations and adult chronic periodontal disease in Chinese (Shanghai))

Conditions
-----------------
Periodontitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - To be included in this study, an individual needs to be Han Chinese of 35 years of age or older at time of enrollment. Exclusion Criteria: - 1) Age younger than 35 years old. 2) Patients with diagnosis of rheumatoid arthritis, psoriasis, inflammatory bowel disease, glomerulonephritis/kidney disease, cancer, or Sjogren's syndrome. 3) Organ transplant recipients.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic Periodontitis<br> | |
| Control<br> | |

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

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