linjc16/ctgov huggingface dataset:
Measuring Head Impacts in Sports

Study Overview
=================
Brief Summary
-----------------
Head impacts in sports can lead to brain injury even when the participant is wearing a helmet. The forces that contribute to brain injury from sports-related head impacts are not well understood. This study will test a new device to measure the speed of head impacts among football players.

Detailed Description
-----------------
Each year, 50 to 70 million people in the United States participate in helmeted and unhelmeted sports with the potential for head impacts. Such sports include football, soccer, hockey, basketball, and boxing. Participating in these sports carries the risk of mild traumatic brain injury (MTBI). The biomechanics of head impacts that result in concussions or other MTBIs are not well understood; however, it is thought that such impacts correlate with head accelerations. Currently, there is no system that allows researchers to measure head acceleration in a large number of individuals during actual play. This is a major obstacle in understanding the mechanism of MTBI and its prevention. This study will evaluate a newly designed miniature device that uses Head Impact Recording Technology (HIRT) to quantify head acceleration during impact in actual sports play. One hundred college football players will be enrolled in the study. Data from HIRT-instrumented helmets will be collected during normal team practice and games throughout a 5-month football season. Data collected will be assessed to determine the incidence, magnitude, and duration of head acceleration during impacts on the sports field.

Official Title
-----------------
Head Impact Recording Technology for Field Applications

Conditions
-----------------
Brain Injuries, Brain Concussion

Intervention / Treatment
-----------------
* Device: Head Impact Recording Technology (HIRT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria College football players

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 24 Years

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Head Impact Recording Technology (HIRT)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact Severity |  | Immediate | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mild traumatic brain injury
Therapeutic EUS Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this prospective registry is to assess long-term data on efficacy, safety and clinical outcome of Therapeutic Endoscopic ultrasound (T-EUS) . The registry will evaluate technical feasibility, clinical outcome, safety profile and overall clinical management through medical chart review. The procedures we are evaluating are all clinically indicated and will not be prescribed to someone to participate in this research study.

Detailed Description
-----------------
This study is a prospective, observational, medical chart review. There will be a retrospective chart review for patients who underwent endoscopic suturing procedures from October 2014 - May 2019. Those subjects will undergo no additional tests and procedures as part of this study. In order to validate these procedures and broaden its use beyond tertiary centers, it is crucial to understand its efficacy and success rate. The objective of the study is to evaluate retrospectively and prospectively the efficacy and safety of T-EUS procedures.

Official Title
-----------------
Therapeutic Endoscopic Ultrasound (EUS) Registry

Conditions
-----------------
Gastrointestinal Disease

Intervention / Treatment
-----------------
* Procedure: Therapeutic Endoscopic ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient who has undergone clinically indicated and/or standard of care T-EUS procedures from October 2014 - May 2019 Any patient who will undergo clinically indicated and/or standard of care T-EUS procedures from June 2019 - June 2022 Exclusion Criteria: Any patient who has not undergone endoscopic ultrasound would be excluded from the study. Below 18 years of age

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| T-EUS Patients<br>Any patient who has undergone clinically indicated and/or standard of care T-EUS procedures from October 2014 - June 2022. | Procedure: Therapeutic Endoscopic ultrasound<br>* A minimally invasive procedure to assess digestive (gastrointestinal) and lung diseases. Procedure allows detailed imaging of the regional anatomy by approximating the frequency transducer to the region of interest.<br>* Other names: T-EUS;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical success rates | Documentation of clinical success rates | October 2014 - June 2022 | 
| Documentation of Safety | Number of subjects with Adverse Events; Type, frequency and intensity of adverse events | October 2014 - June 2022 |
Descartes-25 in Relapsed/Refractory Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
This is a Phase I/IIa dose-escalation study to evaluate the safety, tolerability, and preliminary efficacy of an allogeneic Mesenchymal Stem Cell (Descartes-25) product secreting a bispecific protein and other proteins in patients with Relapsed/Refractory Multiple Myeloma.

Official Title
-----------------
Phase I/IIa Study of Descartes-25 in Patients With Relapsed/Refractory Multiple Myeloma

Conditions
-----------------
Multiple Myeloma, Relapse Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: Descartes-25


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years and older' diagnosed with active R/RMM, who have failed 2 lines of treatment have measurable disease Exclusion Criteria: - Patients with active plasma cell leukemia

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: Dose Level 1<br>Minimum of 3 patients per Dose Level will be treated sequentially with once weekly infusions for 3 weeks in a 28-day cycle until the Maximum Tolerated Dose (MTD) is reached. | Drug: Descartes-25<br>* allogeneic Mesenchymal Stem Cell product.<br>* Other names: DC-25;|
| Experimental: Arm 2: Dose Level 2<br>Minimum of 3 patients per Dose Level will be treated sequentially with once weekly infusions for 3 weeks in a 28-day cycle until the Maximum Tolerated Dose (MTD) is reached. | Drug: Descartes-25<br>* allogeneic Mesenchymal Stem Cell product.<br>* Other names: DC-25;|
| Experimental: Arm 3: Dose Level 3<br>Minimum of 3 patients per Dose Level will be treated sequentially with once weekly infusions for 3 weeks in a 28-day cycle until the Maximum Tolerated Dose (MTD) is reached. | Drug: Descartes-25<br>* allogeneic Mesenchymal Stem Cell product.<br>* Other names: DC-25;|
| Experimental: Arm 4: Dose Expansion<br>In Arm 2, the MTD established in Arm 1 will be administered for 3 28-day cycles to further evaluate the product's safety and preliminary efficacy. | Drug: Descartes-25<br>* allogeneic Mesenchymal Stem Cell product.<br>* Other names: DC-25;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Tolerated Dose | Dose Level at which no more than 20% of the patients treated have shown Dose-Limiting Toxicity. | 1 Year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
myeloma, multiple myeloma, Relapse Refactory multiple myeloma
Evaluation of the Renal Congestion, Perfusion and Function Before and After Diuretic Treatment in the ICU

Study Overview
=================
Brief Summary
-----------------
Renal congestion is a pathological state that can lead to acute kidney failure. Furosemide is known to lower renal congestion by its diuretic effect. The aim of this trial is to study the reversibility of kidney congestion under diuretic therapy and assess through echodoppler parameters if it can improve renal perfusion and function in congestive ICU patients. It could in fine lead to a better identification of patients that could benefit from diuretic therapy in the ICU.

Official Title
-----------------
Evaluation of the Renal Congestion, Perfusion and Function Before and After Diuretic Treatment in the ICU

Conditions
-----------------
Renal Congestion

Intervention / Treatment
-----------------
* Other: non applicable


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient hospitalized in ICU under furosemide treatment Exclusion Criteria: participation refusal uncontrolled shock (MAP<65mmHg) abdominal compartment syndrome diuretic administration in the 6 hours prior to inclusion renal replacement therapy or stage 4-5 chronic kidney disease atrial fibrillation no monitoring of CVP / invasive arterial pressure

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 renal congestion<br> | Other: non applicable<br>* non applicable<br>|
| Patients without renal congestion<br> | Other: non applicable<br>* non applicable<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of diuretics | Evaluation of renal perfusion diuretic treatment by measuring the renal resistance index and the renal venous impedance index. | 24 hours |
Cross-over Study to Evaluate the Effect on Trough Forced Expiratory Volume in One Second (FEV1) After 4 Weeks Treatment With CHF 5188 pMDI qd in Adult Patients With Persistent Asthma

Study Overview
=================
Brief Summary
-----------------
Cross-over study to evaluate the effect on trough FEV1 after 4 weeks treatment with CHF5188 pMDI qd in adult patients with persistent asthma

Detailed Description
-----------------
A randomised, double-blind, multinational, multicentre, active-controlled, 3-way cross-over study to evaluate the effect on trough FEV1 after 4 weeks treatment with CHF5188 pMDI qd in adult patients with moderate or severe persistent asthma

Official Title
-----------------
A Randomised, Double-blind, Active-controlled, 3 Way Cross-over Study to Evaluate the Effect on Trough FEV1 After 4 Weeks Treatment With CHF 5188 pMDI qd (Fixed Combination Budesonide / Carmoterol) in Adult Patients With Moderate or Severe Persistent Asthma

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

Intervention / Treatment
-----------------
* Drug: CHF 5188 pMDI
* Drug: Budesonide extrafine pMDI
* Drug: Seretide(r) Evohaler(r)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate or severe asthma partly controlled with ICS or ICS/LABA FEV1 ≥ 60% and ≤ 90% of predicted for the patient normal value Exclusion Criteria: Diagnosis of COPD History or current evidence of significant cardiovascular disease Uncontrolled concomitant disease

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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHF 5188 pMDI<br> | Drug: CHF 5188 pMDI<br>* CHF 5188: fixed combination budesonide/carmoterol<br>|
| Active Comparator: Budesonide extrafine pMDI<br> | Drug: Budesonide extrafine pMDI<br>* Budesonide extrafine pMDI<br>|
| Active Comparator: Seretide(r) Evohaler(r)<br> | Drug: Seretide(r) Evohaler(r)<br>* Seretide(r) Evohaler(r): fixed combination fluticasone/salmeterol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trough FEV1 (mean 23h-24h FEV1) |  | after day 28 dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trough FEV1 and forced vital capacity (FVC) (mean 23h-24h) |  | after day 1 dose | 
| Trough FVC (mean 23-24h) |  | after day 28 dose | 
| Peak FEV1 and FVC |  | on day 1 and day 28 | 
| FEV1 AUC0-24 |  | after day 1 and day 28 |
Use of Acupuncture for Stimulation of Labour

Study Overview
=================
Brief Summary
-----------------
Hypothesis:Acupuncture can be used as stimulation of labour in case of primary og secondary inertia. A randomized controlled trial including 150 pregnant women Acupuncture has become a natural part of the range of obstetric treatments offered in danish delivery wards, but there is only little evidence to the effect of the acupuncture. The women are randomized into to groups. Acupuncture, Acu.points: KI3, Ki6, SP6, BL60, LI4, BL67(acupressure) No treatment The women will be asked in case beginning signs of inertia, if they want to parcipitate in the trial. Inclusion criteria: Normal pregnancy In labour (orificium < 8 cm), 37th week or thereafter Ruptured membranes Primary or secondary inertia The women will just before randomization be vaginally explored and fetal heart monitored. The meassure of effect happens two hours after randomization. The midwife who measures the effect, is blinded to the treatment or lack of, and also on the including exploration. Secondary effect meassures: length of labour, use of oxytocin and number of contracions pr/min meassured twice: 1. before the randomization and again 1 hour after randomization.

Official Title
-----------------
Use of Acupuncture for Stimulation of Labour

Conditions
-----------------
Dystocia

Intervention / Treatment
-----------------
* Device: Acupuncture og acupressure when diagnosed with dystocia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal pregnancy In labour (orificium < 8 cm), 37th week or thereafter Ruptured membranes Primary or secondary inertia - Exclusion Criteria: Pathological pregnancy Pathological labour Medical diseases Women who do not speak and undrestand danish
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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Acupuncture og acupressure when diagnosed with dystocia|Acupuncture points: sp6 li4 ki3 ki6 bl60 Acupressure points: bl67|

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

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| use of oxytocin |  | additional need for oxytocin infusion in 1. stage and 2. stage | 
| number of contractions/30 minutes |  | number og contractions in 1st. stage and 2nd. stage | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dystocia, stimulation, acupuncture, oxytocin
Image Location and Performance of Left Bundle Branch Pacing

Study Overview
=================
Brief Summary
-----------------
This is a prospective, multi-site, non-randomized, data collection study. The purpose of this study is to investigate the correlation between pacing sites and ECG morphology or pacing parameters during left bundle branch pacing (LBBP) and perform the use condition analysis to assess the long-term performance of pacing lead during LBBP.

Detailed Description
-----------------
His bundle pacing (HBP) is a physiological pacing, but also has some limitations, including high and unstable pacing threshold in 5-10% patients, low R-wave amplitude causing inappropriate pacing management, damage to the His bundle during implantation. On the other hand, left bundle branch pacing (LBBP), achieved via trans-ventricular septal approach with the pacing lead tip at the left side of the ventricular septum, has recently initiated and been widely practiced in China because of easy implantation, relatively narrow paced QRS duration, low and stable pacing threshold, high R wave amplitude, and the LBBB correction by a low pacing output. As LBBP is in the early phase of clinical practice in China, in order to better conduct LBBP implantation and understand mechanisms of LBBP therapy, physicians often do imaging assessment of the pacing lead in patients implanted with LBBP based on clinical necessity. Additionally, there is no report of mid/long-term correlation between lead location and ventricular electrical activity, nor mid/long-term pacing lead performance assessment during LBBP.

Official Title
-----------------
Image Location and Performance of Left Bundle Branch Pacing

Conditions
-----------------
Cardiac Pacing, Pacing Therapy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged from 18 to 80 years old; Patients providing signed Informed Consent; Patients indicated for permanent pacing and implanted with LBBP for at least 3 months, with documentation of implantation records; Patients who plan to receive cardiac CT examination. Exclusion Criteria: Patients who have a history of allergy to contrast agent or refuse to use contrast agent in CT examination; Patients who are pregnant or have a plan for pregnancy during the study; Patients who are not willing to provide Informed Consent; Patients who have medical conditions that would limit study participation; Patients who were already enrolled in other clinical trial which would impact his/her participation.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QRS duration | The primary endpoint is QRS duration and morphology during LBBP | at least 3 months after implant |
Frequency of Xerostomia and Their Management in Upper Aerodigestive Tract Cancer Patients After the End of Radiotherapy

Study Overview
=================
Brief Summary
-----------------
The aim of this study is the evaluation of the frequency of xerostomia and their management after radiotherapy in head and neck cancer. The quality of life of these patients is also analysed with European Organization for Research and Treatment of Cancer Quality of life Questionnaire H&N35 (EORTC QLQ H&N35).

Official Title
-----------------
Assessment of Frequency of Xerostomia and Their Care Management in Upper Aerodigestive Tract Cancer Patients After the End of Radiotherapy

Conditions
-----------------
Head and Neck Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with head and neck cancer after radiotherapy treatment Exclusion Criteria: patient already treated for xerostomia for other reason : Sjögren's syndrome, medication, diabetes,...
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 |
| --- | --- | --- |
| Frequency of xerostomia and their management after radiotherapy in head and neck cancer | patients describe the severity of their xerostomia and their management in a standardized questionnaire | at enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life af patients after radiotherapy in head and neck cancer | patients describe their quality of life in a standardized questionnaire | at enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Xerostomia, Radiotherapy
Pilot Study of Biomarkers for Radiation Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether specific assays of DNA damage repair proteins can be used in patients undergoing radiation therapy. The ultimate goal of this research is to develop clinically useful biomarkers from blood samples that could be used to customize radiation treatment for individuals, leading to reduced side effects and improved outcomes.

Official Title
-----------------
Investigating Proteomic Biomarkers of Radiation Therapy Outcome: A Pilot Study

Conditions
-----------------
Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients > 18 years of age with primary lung, esophageal or rectal cancer receiving neo-adjuvant chemoradiotherapy before planned resection patients with clinically localized prostate cancer receiving definitive radiation therapy with external beam treatment. brachytherapy as a boost and/or hormonal therapy are allowed. patients with head and neck, lung, esophageal or cervical cancer who will receive definitive radiotherapy Exclusion Criteria: prior history of chemotherapy given within 6 months before enrollment. prior radiotherapy or radionuclide treatment and/or brachytherapy within 6 months prior to enrollment. unwillingness to comply with tests, protocol, or informed consent. concurrent enrollment on any protocol that would require non-compliance with treatment procedures. chemotherapy required within 2 hours following first dose of XRT. PET scan done within 48 hours of first blood draw. nuclear medicine exposure within 4 days prior to first draw.

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 |
| --- | --- |
| Radiation therapy patients<br>Individuals receiving radiation therapy as definitive or neo-adjuvant therapy for selected malignancies, including head and neck, lung, esophageal, rectal cervical and prostate cancers. | |

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
-----------------
proteome, biomarkers, radiotherapy, cancer