linjc16/ctgov huggingface dataset:
Allo-HSCT as First-line Consolidation in High-risk PTCL

Study Overview
=================
Brief Summary
-----------------
Results of conventional therapy in patients with peripheral T-cell lymphoma(PTCL) are poor. Allogeneic hematopoietic stem cell transplantation(allo-HSCT) gave excellent results in PTCL after failure of conventional therapy and in many cases also of HDT/ASCT. A disadvantage of allo-HSCT is high TRM rate, especially in refractory or relapsed patients. Another limitation to the use of allo-HSCT is the availability of a HLA matched donors. Haploidentical family donors have been successfully used in treatments of hematologic malignancies, including malignant lymphomas. Thus, allo-HSCT could be used as first-line consolidation following conventional chemotherapy in high-risk PTCL patients. The study hypothesis: Using allo-HSCT as consolidation following chemotherapy in high-risk PTCL exerts a strong anti-lymphoma effect and could increase response rate and improve long term survival.

Detailed Description
-----------------
After primary diagnosis eligible patients receive 2 to 3 courses of CHOEP-21 with formal restaging after course 2. Patients with CR, PR or no change proceed to allo-HSCT. Donor selection: Matched sibling donor(MSD) is the first choice. An unrelated donor or haploidentical family donor search is performed in patients without sibling donor. The primary end point was 1 year progression-free survival. The secondary end points were complete commission rate, transplant-related mortality, overall survival, relapse rate and graft-versus-host disease (GVHD) . Following time is 2 years

Official Title
-----------------
Allogeneic Hematopoietic Stem Cell Transplantation Following Conventional Chemotherapy in High Risk Peripheral T Cell Lymphoma

Conditions
-----------------
T Cell Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary diagnosis of mature T-cell lymphoma, stage 2-4, or stage 1 with aa IPI>=0 age <= 60 years KPS>=70 Exclusion Criteria: stage I with aaIPI 0, ALCL ALK positive, T-lymphoblastic lymphoma, cutaneous T-cell lymphoma HIV positivity major organ dysfunction pregnancy patient unable to give informed consent

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 60 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 |
| --- | --- | --- |
| 1 year PFS | progression free survival | participants will be follow for an expected average of 365 days |
Retrieval and Analysis of Orthopedic Implants at Revision Arthroplasty Surgery

Study Overview
=================
Brief Summary
-----------------
The goal of this is to improve durability of total joint replacements in patients, thereby improving clinical outcomes and implant performance. To reach this objective, our research program would like to assess the safety, efficacy, performance, and durability of FDA approved biomaterial and implant designs used in joint replacements.

Detailed Description
-----------------
The objective of the investigation will be to determine the mechanism of material failure and identify any design features that put the implant at risk for early failure. Normally all implants are discarded. The investigators will collect the implants indicated for removal and if there are impressive findings the investigators will perform research on the implants, otherwise the implants will be discarded. All patients will be followed prospectively after informed consent is signed. The implants that are chosen for research will be assessed for implant wear and failure at a lab appropriate for evaluating the particular concern.

Official Title
-----------------
Retrieval and Analysis of Orthopedic Implants at Revision Arthroplasty Surgery

Conditions
-----------------
Total Joint Revisions

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who will be undergoing revision total joint surgery will be asked to participate in this study. Exclusion Criteria: Patients who are not undergoing revision total joint surgery.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Total hip/knee joint revisions<br>All University of Utah orthopedic patients who have had total or partial joint arthroplasties at the time of revision surgery. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determine the mechanism of material failure |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| identify any design features that put the implant at risk for early failure. |  | 10 years |
Pimecrolimus Cream 1% in Adult Patients With Perioral Dermatitis

Study Overview
=================
Brief Summary
-----------------
An evaluation of the safety and efficacy of the calcineurin inhibitor, pimecrolimus cream 1%, in adult patients with perioral dermatitis. This study is not enrolling patients in the United States.

Official Title
-----------------
Pimecrolimus Cream 1% in Adult Patients With Perioral Dermatitis

Conditions
-----------------
Perioral Dermatitis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinically diagnosed perioral dermatitis associated or not associated with topical steroid use (the periorbital area may also be involved in addition to the perioral region) minimum severity score (PODSI) ≥ 4 age 18 and older Exclusion Criteria: Ongoing use of the following treatments is NOT allowed after the start of study drug: Oral tetracyclines, oral erythromycin, oral steroids and oral calcineurin inhibitors. All topical treatments of the face, including steroids, calcineurin inhibitors, metronidazole, tetracyclines, erythromycin and emollients (exception: DAC Basiscreme). Systemic immunosuppression History of malignancy of any organ system, treated or untreated, within the past 5 years

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

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

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 |
| --- | --- |
| Experimental: 1<br>Pimecrolimus | Drug: Pimecrolimus<br>* Pimecrolimus cream 1 %<br>* Other names: Elidel;|
| Placebo Comparator: 2<br>Vehicle | Drug: Placebo<br>* Vehicle cream (placebo)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of the Perioral Dermatitis Severity Index |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to disease recurrence |  |  | 
| Response rates |  |  | 
| Patient's quality of life assessment |  |  | 
| Patient's disease severity assessment |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Perioral Dermatitis, pimecrolimus cream
Effectiveness of Convalescent Immune Plasma Therapy

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the safety, improvement of clinical symptoms and laboratory parameters of convalescent immune plasma treatment in severe Covid-19 patients with ARDS.

Detailed Description
-----------------
The aim of the study is to evaluate the safety, improvement of clinical symptoms with hypoxemia, metabolic and laboratory parameters of patients with convalescent immune plasma treatment in severe Covid-19 patients followed up in critical care unit.

Official Title
-----------------
Effectiveness of Convalescent Immune Plasma Therapy in Severe COVID-19 Patients With Acute Respiratory Distress Syndrome

Conditions
-----------------
Acute Respiratory Distress Syndrome

Intervention / Treatment
-----------------
* Other: Convalescent Immune Plasma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Clinical diagnosis of Covid-19 Exclusion Criteria Age lower than 18 Lower plasma IgA levels PaO2/FiO2 higher than 300 mmHg SpO2 higher than 90

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Convalescent Plasma Therapy Group<br>One dose of 200 mL of convalescent ımmune plasma derived from recently recovered donors with the neutralizing antibody titers above 1:640 was transfused to the patients as an addition to standart critical care treatment. | Other: Convalescent Immune Plasma<br>* One dose of 200 mL of convalescent ımmune plasma derived from recently recovered donors with the neutralizing antibody titers above 1:640 was transfused to the patients as an addition to standart critical care treatment.<br>|
| No Intervention: Non-Plasma Therapy Group<br>Standart critical care treatment group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma ferritin level | Acute phase reactant | 7. day | 
| Lymphocyte count | Infection markers | 7. day | 
| D-Dimer level | Hypercoagulability | 7. day | 
| C-Reactive protein level | Infection markers | 7. day | 
| Plasma procalcitonin level | Infection markers | 7. day | 
| Plasma fibrinogen level | Coagulopathy | 7. day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fractional Inspired Oxygen Level | Arterial oxygenation | 7. day | 
| Partial Oxygen Saturation level | Arterial oxygenation | 7. day | 
| Arterial Oxygen level | Arterial oxygenation | 7. day |
Pharmacogenetics of Acenocoumarol

Study Overview
=================
Brief Summary
-----------------
The use of oral anticoagulation is marked by an elevated risk of adverse drug events (ADE) due to a narrow therapeutic window leading to important medical and economical consequences. The risk of ADE is increased partly by drug interactions and recently identified genetic factors influencing the metabolism of coumarins (polymorphism of the cytochrome P450 CYP2C9) as well as the target enzyme of the coumarins (polymorphism of the vitamin K epoxide reductase complex subunit 1 (VKORC1). The objective is to determine the impact of several genotypes on acenocoumarol treatment and on vulnerability to drug-drug interactions.

Official Title
-----------------
Stabilization of Anticoagulation by Acenocoumarol: Role of Genetic Vulnerability and Risk of Drug Interactions

Conditions
-----------------
Thromboembolic Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Every patients with requiring acenocoumarol therapy for at least 4 weeks and a target INR in the low intensity range (INR range 2-3) Age ≥ 18 years Signed informed consent Exclusion Criteria: Severe cognitive impairment Previous or current treatment with any coumarin

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 |
| --- | --- | --- |
| Time to achieve stable dosing in days, since the beginning of the anticoagulation |  | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with INR > or = 4.0, which indicates overanticoagulation |  | 5 weeks | 
| Time to achieve two consecutive therapeutic INRs |  | 5 weeks | 
| Mean daily dosage of acenocoumarol |  | 5 weeks | 
| Major bleedings and minor bleedings |  | 5 weeks | 
| Thromboembolic events due to infratherapeutic anticoagulation |  | 5 weeks | 
| Length of hospitalisation in days |  | 5 weeks | 
| Potential of other drug interactions, linked to the observed genotype and phenotype of the patient |  | 5 weeks |
Prospective Outpatient Registry of Myocardial Infarction Patients

Study Overview
=================
Brief Summary
-----------------
The investigators enrolled 160 patients who visited Moscow state outpatient clinic №9 (and its two branches) within six months after acute myocardial infarction. The enrollment lasted from 01.03.2014 to 01.07.2015. The observation period is five years. During the first year after enrollment in the study, patients had follow-up visits every two months, from second-year every six months. Analysis of the prescribed therapy and its changes was carried out by the cardiologist in the clinic for the entire observation period, taking into account the concomitant diseases /indications/contraindications. Endpoints (the death, repeated cardiovascular complications (AMI, stroke), emergency hospitalization due to worsening of the main cardiovascular disease, the appearance of clinically significant cardiac arrhythmias, invasive interventions) were defined during out-patient visits and telephone contact

Official Title
-----------------
Prospective Outpatient Registry of Myocardial Infarction Patients

Conditions
-----------------
Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who have undergone AMI and applied no later than 6 months. after discharge from the hospital to the Moscow outpatient clinic № 9 from March 1, 2014, to December 31, 2015; availability of discharge summary with confirmed AMI; permanent residence on the territory of Moscow and the Moscow region; the signing of informed consent to the processing of personal data. Exclusion Criteria: patients with the absence of discharge summary from the hospital with a proven history of AMI; visit the clinic in a period exceeding six months from the AMI;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| time to death, recurrent cardiovascular events (AMI, stroke), emergency hospitalization, lifethreatening arrhythmias. | According to the results of monitoring will be determined a combined endpoint: the death, recurrent cardiovascular events, emergency hospitalization, lifethreatening arrhythmias | 01.03.2014 - through study completion, an average of 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total mortality | Determination of total mortality for any reason of patients enrolled in the Registry | 01.03.2014 - through study completion, an average of 5 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
myocardial infarction, registry
Safety and Tolerability of Omalizumab in Patients With Mild to Moderate Asthma

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and efficacy of omalizumab against asthma attacks in mild to moderate allergic asthma

Official Title
-----------------
Multi-center, Open-label, Multiple Dose Study in Mild to Moderate Asthmatics (With IgE/Body Weight Combinations Above That in the SmPC Dosing Table) to Determine Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Omalizumab

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Omalizumab
* Drug: Omalizumab
* Drug: Omalizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of allergic asthma >= 1 year duration and a history consistent with Step 2 or 3 clinical features from the Global Initiative for Asthma guidelines. Eligible baseline serum immunoglobulin E (IgE) levels value and body-weight combinations Exclusion Criteria: Documented medical history of anaphylaxis Lung disease other than mild to moderate allergic asthma such as chronic obstructive pulmonary disease (COPD) Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Omalizumab 900 mg | Drug: Omalizumab<br> <br> * Other names: Xolair, IGE025;|
| Experimental: 2<br>Omalizumab 1050 mg | Drug: Omalizumab<br> <br> * Other names: Xolair, IGE025;|
| Experimental: 3<br>Omalizumab 1200 mg | Drug: Omalizumab<br> <br> * Other names: Xolair, IGE025;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of omalizumab assessed by AEs and SAEs |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Pharmacokinetic/pharmacodynamic profile of multiple administrations of omalizumab to patients with mild to moderate allergic asthma - Pre-dose specific IgE levels |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, anti-immunoglobulin E, omalizumab
Biogeography of the Oral Microbiome

Study Overview
=================
Brief Summary
-----------------
A cross-sectional study to metatranscriptomically analyze and compare the oral microbiome in different environmental niches within the oral cavity.

Detailed Description
-----------------
This study will collect samples from participants meeting the eligibility criteria over the span of 3 months. Samples will be collected from multiple locations within the oral cavity and metatranscriptomically analyzed.

Official Title
-----------------
Biogeography of the Oral Microbiome Using Metatranscriptomic Analyses

Conditions
-----------------
Oral Microbiome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years old or older Exclusion Criteria: Positive SARS-CoV-2 test result, if performed Antibiotic use in the previous 30 days Mouthwash use in the previous 6 months

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Species richness in multiple oral locations | Number of species present in different areas swabbed in the oral cavity. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KO richness of multiple oral locations | KO richness of multiple areas swabbed in the oral cavity. | 3 months |
Red Cell Mass and Plasma Volume Measurements in Elderly Men and Women With Anemia

Study Overview
=================
Brief Summary
-----------------
On the basis that the clinical consequences of seemingly trivial levels of anemia are surprisingly severe, this study investigates if hemoglobin concentration accurately represents the underlying red cell mass in elderly patients with unresolved anemia.

Detailed Description
-----------------
For the study, the routine clinical measurement of hemoglobin will be compared to true red cell mass and plasma volume in elderly patients with anemia.

Official Title
-----------------
Red Cell Mass and Plasma Volume Measurements in Elderly Men and Women With Anemia

Conditions
-----------------
Anemia

Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: 65 and older Anemia (hemoglobin < 13 g/dL in men or < 12 g/dL in women) Outpatient at either the Stanford Health Care (SHC) Medical Center or VA Palo Alto Health Care System EXCLUSION CRITERIA: Body mass index (BMI): < 18.5 kg/m2 > 35 kg/m2 Palpable splenomegaly Contraindication to RBC mass/plasma volume testing On any experimental pharmacologic agent in the prior 2 months

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- | --- |
| Red blood cell mass |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma volume measurements |  | 1 day |
Expanded Access to Tipifarnib

Study Overview
=================
Brief Summary
-----------------
Requests for single patient expanded access to tipifarnib may be considered for adult patients with HRAS mutations or peripheral T Cell Lymphoma (PTCL). To request access, use Responsible Party contact information provided in this record. Expanded access for tipifarnib is only available in the United States.

Conditions
-----------------
HRAS Mutations or Peripheral T Cell Lymphoma (PTCL)

Intervention / Treatment
-----------------
* Drug: Tipifarnib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion/Exclusion Criteria: Diagnosed with HRAS-mutant carcinomas or peripheral T Cell Lymphoma (PTCL). Adult, ages 18+. Have exhausted appropriate standard treatments without success and no comparable or satisfactory alternative treatment is available or exists to treat the disease or condition. Is ineligible for participation in any ongoing clinical study of the investigational drug, which includes lack of access due to geographic limitations. Meets any other pertinent medical criteria for access to the investigational drug, as established by the Kura Oncology

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 |
| --- |
|Drug: Tipifarnib|nan|

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

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