linjc16/ctgov huggingface dataset:
Impact of Therapist Change on Dropout in a Naturalistic Sample of Inpatients With Borderline Pathology Receiving DBT

Study Overview
=================
Brief Summary
-----------------
Participants with Borderline pathology (≥ 3 DSM-IV-criteria) receiving an inpatient Dialectical Behavior Therapy (DBT) program completed a quality assurance questionnaire set assessing demographic information and pretreatment psychopathology during the days of their inpatient stay. Beyond that, changes of therapists were documented.

Official Title
-----------------
Impact of Therapist Change After Initial Contact and Traumatic Burden on Dropout in a Naturalistic Sample of Inpatients With Borderline Pathology Receiving Dialectical Behavior Therapy

Conditions
-----------------
Borderline Personality Disorder, PostTraumatic Stress Disorder, Psychotherapy, Dropout

Intervention / Treatment
-----------------
* Behavioral: Dialectical Behavior Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: three or more criteria for BPD as defined by DSM-IV (Borderline Personality characteristics; BPC) Exclusion Criteria: inability to contract and consent, other severe mental disorders (bipolar disorder, acute psychosis), current alcohol, illicit or not prescribed drug use, simultaneous participation in other treatment studies, pregnancy or breastfeeding, an inability to negotiate a non-suicide agreement, ongoing traumatic contact with the perpetrator, and a Body Mass Index < 16.5.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Dialectical Behavior Therapy<br>The program's purpose is to help patients achieve the following therapeutic goals: (1) reduction of suicidal behaviors, (2) reduction of therapy-interfering behaviors, and (3) other risky or destabilizing behaviors. Standard DBT aims to achieve these goals by (1) conveying behavioral capabilities (skills), (2) motivation for applying these skills, (3) generalization of learned skills to the patient's natural environment, (4) structuring the treatment environment to reinforce functional behavior, and (5) conveying therapeutic resources and motivation to effectively treat patients with BPD. | Behavioral: Dialectical Behavior Therapy<br>* DBT is a cognitive-behavioral treatment program that was developed to treat suicidal Patients with BPD (Linehan, 1993).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dropout |  | 10 weeks |
Transcatheter Interventions for Tricuspid Insufficiency in Italy

Study Overview
=================
Brief Summary
-----------------
This is an observational, multi-center, retrospective and prospective study collecting data about patients undergoing transcatheter tricuspid valve interventions in a real world clinical environment. The aim is to report clinical characteristics, procedural results and short- and long-term outcomes of patients undergoing transcatheter tricuspid valve interventions in Italian centres.

Official Title
-----------------
TRans-catheter Interventions for triCuspid Valve Insufficiency: the iTalian Multicentre Study

Conditions
-----------------
Tricuspid Valve Insufficiency

Intervention / Treatment
-----------------
* Device: Transcatheter tricuspid valve interventions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing transcatheter treatment of tricuspid regurgitation (native valve -with or without previous surgical valve repair - or degenerated bioprosthesis) Patients who are willing and capable of providing informed consent, and participating in all follow-ups associated with this clinical investigation. Exclusion Criteria: Valve anatomy unsuitable for transcatheter tricuspid valve interventions. Subjects who are unable or not willing to complete follow-up visits and examination for the duration of the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Transcatheter tricuspid valve interventions|Transcatheter repair or replacement to treat tricuspid regurgitation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause death |  | 1-year | 
| Cardiovascular death or heart failure hospitalization |  | 1-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in tricuspid regurgitation degree |  | 30-day, 1-year and 5-year | 
| Changes in NYHA class |  | 30-day, 1-year and 5-year | 
| Changes in right ventricular dimensions and function |  | 30-day, 1-year and 5-year | 
| Changes in liver and kidney function |  | 30-day, 1-year and 5-year | 
| Changes in medical therapy (i.e. diuretic dose) |  | 30-day, 1-year and 5-year | 
| All-cause death |  | 30-day | 
| All-cause death |  | 5-year | 
| Cardiovascular death or heart failure hospitalization |  | 30-day | 
| Cardiovascular death or heart failure hospitalization |  | 5-year |
Placental Learning Model for Neurovascular Microsurgery for the Management of Intracranial Aneurysms

Study Overview
=================
Brief Summary
-----------------
Training in microsurgical techniques for the management of intracranial aneurysms is carried out during the practical training of the DES in Neurosurgery and during the continuous training of neurosurgeons according to the indications of the patients of the department. Currently, the recent increase in indications for endovascular treatment compared to surgical indications has led to a decrease in surgical indications and in the experience of neurosurgeons. However, there are still surgical indications that are often complex situations that neurosurgeons must overcome with a specific simulation approach. There are different simulation models for the treatment of intracranial aneurysms. The small animal (rodent) model has the disadvantage of being poorly suited to the reproduction of intracranial aneurysms (different extracranial vessel walls, too small intracerebral vessel caliber) and of being constraining to the establishment. The computerized stimulator model which has the advantage of being able to reproduce the anatomy of a patient but whose haptic sensitivity performance is difficult to reproduce for very fine movements, it is not very accessible because it is expensive. The placental model uses a fresh human placenta, the appearance of the vessels of which is very similar to those found intracerebrally, and dilations on their walls can be performed with a pediatric urinary catheter.

Official Title
-----------------
Placental Learning Model for Neurovascular Microsurgery for the Management of Intracranial Aneurysms

Conditions
-----------------
Intracranial Aneurysm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Woman over the age of 18; Placenta considered as surgical waste intended for incineration; with a negative infectious status verified during pregnancy follow-up Woman who did not express her opposition, after information, to the reuse of her placenta for educational purposes to improve the practical training of future neurosurgeons. Exclusion criteria: Subject who expressed their opposition to participating in the study Subject under guardianship or curatorship Subject under safeguard of justice

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 |
| --- | --- | --- |
| Evaluation of the practical training of neurosurgery students | Hands-on training will be assessed by the Brain Aneurysm Microsurgery Skills Rating Scale | 1 month after training students in microsurgery for brain aneurysms | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intracranial aneurysm, Placental learning model, Neurovascular microsurgery, Aneurysm
Vitamin D in Patients With Heart Failure

Study Overview
=================
Brief Summary
-----------------
To investigate the prevalence of vitamin D deficiency in patients with Heart Failure. To investigate if vitamin D levels are correlated to the degree of Heart Failure.

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient in the Heart Failure Clinic, Hvidovre Hospital Willing to participate and sign informed consent over 18 years of age

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Failure,, Vitamin D status,, NT-proBNP
Measurement of Noradrenaline Concentrations Using Different Dilution Methods

Study Overview
=================
Brief Summary
-----------------
Norepinephrine is the vasopressor of choice for the treatment of peri-anesthetic arterial hypotension. The use of this drug at significantly lower concentrations (dilution factor between 40 and 200) than the commercial preparation is increasingly common in the operating room (baby-noradrenaline). In addition, dilution errors are potentially serious for the patient (hypertensive peak) The preparation of precise dilutions is an important factor for the safe use of this medically In this study, the investigators wish to compare the dilution method of the protocol with another method of preparation (left to the free choice of the participant).

Official Title
-----------------
Measurement of Noradrenaline Concentrations Using Different Dilution Methods

Conditions
-----------------
Arterial Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Adult person, Employee of Strasbourg University Hospitals, Likely to have to prepare anesthesia drugs in the operating room (intern, hospital student, IADE, IADE student) Exclusion criteria: - Subject's refusal to participate in the study

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of noradrenaline concentrations using different dilution methods | Measurement methods: High performance liquid chromatography Measurement of the concentration of noradrenaline in the biochemical laboratory of the University Hospitals of Strasbourg | 1 hour after the preparation of the noradrenaline solutions | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vasopressor, Noradrenaline, Norepinephrine, Concentration of noradrenaline, Baby-noradrenaline, Dilution of Noradrenaline
Condylar Inclination Recorded With Modjaw® Device.

Study Overview
=================
Brief Summary
-----------------
In oral rehabilitation, the integration into the digital flow of mandibular movements and the patient's individual reference planes optimizes the functional adaptation of prosthetic elements whose design is computer aided. The innovative Modjaw® device allows you to record and then virtually simulate mandibular movements. This retrospective study aims to: 1) Test the reliability of the Modjaw® device; 2) Measure the condylar displacements of asymptomatic subjects for the arbitrary programming of simulators. Kinematic recordings of 22 healthy volunteers (15F / 7H; mean age: 22.2 years) were analyzed. Two recording sessions were carried out within one month of each other, by three different operators; each subject was followed by the same operator during the first (E1) and the second (E2) recording. The values of sagittal condylar inclination (SCI) obtained in opening, protrusion, right-left mediotrusion were calculated at 3 and 5 mm of condylar displacement. The transverse condylar inclination (TCI) was calculated at 4mm.

Official Title
-----------------
Analysis of Mandibular Kinematics of a Group of Asymptomatic Subjects Recorded With the Modjaw® Device

Conditions
-----------------
Temporomandibular Disorder

Intervention / Treatment
-----------------
* Device: Modjaw® device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria : adult ; Exclusion criteria : temporomandibular disorders (TMD symptom questionnaire)

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| healthy adult volunteers showing no signs of temporomandibular disorders<br> | Device: Modjaw® device<br>* Analysis of mandibular kinematics with Modjaw® device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reliability of recordings | The intra-class correlation coefficient (ICC) based on a one-way random-effects ANOVA was used to measure the repeatability of the recordings. | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mandibular motion | Sagittal and transversal condylar inclination mesured in degrees | 5 months |
Toxicity Attributed to Genetic Polymorphisms in Testicular Germ Cell Tumor Survivors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify genetic variations in survivors of testicular cancer and connect these variations to differences in risks of late effects.

Detailed Description
-----------------
Identification of late-effects through questionnaires and linkage to national registries. DNA samples will be gathered through buccal swabs or saliva kits and analysed with whole exome-sequencing.

Official Title
-----------------
Toxicity Attributed to Genetic Polymorphisms in Testicular Germ Cell Tumor Survivors

Conditions
-----------------
Germ Cell Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Danish citizen Diagnosed with germ cell cancer from 1984 to 2007 Treated initially at a Danish hospital Treated with standard treatment regimens. Exclusion Criteria: Treated initially at a foreign hospital

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Danish germ cell cancer patients<br>Danish patients with germ cell cancer diagnosed from 1984 to 2007. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal toxicity (Identify genetic variations predicting renal toxicity) | Identify genetic variations predicting renal toxicity. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Germ cell cancer, Late toxicity, Renal impairment, Cardiovascular disease
The Impact of Right Ventricular Pacing on Tricuspid Regurgitation

Study Overview
=================
Brief Summary
-----------------
1 To examine whether right ventricular pacing has an impact on tricuspid regurgitation grade that is related to pacing rather than to valve closure interference by the electrode.

Detailed Description
-----------------
1 Traditionally, tricuspid regurgitation in the presence of pacemaker is attributed to the physical interference of the valve closure by the electrode. 2 Right ventricular pacing may be associated with dyssynchrony in contraction of the right ventricular wall (i.e. septum and free wall. 3 The tricuspid sub-valvar apparatus is anchored to the septum and free wall, thus may be sensitive to dyssynchrony in those wals contraction. 4 The study hypothesis is that the dyssynchrony in right ventricular contraction, induced by pacing, may increase tricuspid regurgitation grade and that this is a mechanism is independent of the mechanical effect of the electrode on the valve closure.

Conditions
-----------------
Tricuspid Regurgitation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years Permanent pacemaker Exclusion Criteria: Epicardial pacing Left ventricular dysfunction Organic tricuspid regurgitation Bi-ventricular pacemaker Atrial fibrillation Complete pacemaker dependence

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pacemaker, Tricuspid regurgitation
Hemostasis in Sickle Cell Disease--Infancy to Adulthood

Study Overview
=================
Brief Summary
-----------------
To assess in older children and adults with sickle cell disease (SCD) whether intrinsic activation (relevant to the origin of pain and acute inflammation) occurs only during vasocclusive crisis (VOC).

Detailed Description
-----------------
BACKGROUND: Investigations into hemostatic abnormalities associated with sickle cell disease have been numerous. The data suggested that thrombin generation and fibrin formation were increased during steady state, with conflicting data whether further activation occurred in vaso-occlusive crisis. Platelet activation during VOC occurred, with variable findings during steady state. A selective, concomitant evaluation of the hemostatic pathways i.e. intrinsic, tissue factor (TF) or extrinsic activation, fibrinolysis, and platelet-endothelial activation had not been reported. Neither had a longitudinal evaluation been performed in infants during the unique transition period when HbF levels fall from 70 to 80 percent to less than 10 percent. The study was part of an initiative on Coagulation, Platelets and Thrombosis in Sickle Disease Pathophysiology. The Request for Applications was released in October 1994. DESIGN NARRATIVE: The studies used appropriate 'negative' and 'positive' control groups. Studies included intrinsic markers [kininogen profiling, high molecular weight kininogen (HK) and low molecular weight kininogen (LK) cleavages, western blotting of HK and LK, and kallikrein-alpha2 macroglobulin; extrinsic markers [TF and factor V11a]; other activation and fibrinolytic markers [prothrombin F1.2, FPA, TAT, tPA, PAI-I, D-dimer and plasma alpha2 antiplasmin]; platelet- endothelial markers [evaluation of activation dependent epitopes]. Unequivocal demonstration of contact pathway activation during VOC provided a crucial link between VOC and its accompanying phenomenon including pain, and inflammation. Finally, the studies provided a unique perspective on the continuum of hemostatic changes that unfolded during the course of SCD, and those that developed as vascular insufficiencies supervened in the adult. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Anemia, Sickle Cell, Blood Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
MOSAIC - Multicenter International Study of Oxaliplatin/ 5FU-LV in the Adjuvant Treatment of Colon Cancer

Study Overview
=================
Brief Summary
-----------------
To evaluate the FOLFOX regimen versus LV5FU2 in the adjuvant treatment of stage II and III colon cancer. Primary objective: Disease Free Survival (DFS) Secondary objective: Overall Survival (OS), safety (including long term toxicity)

Official Title
-----------------
Multicenter International Study of Oxaliplatin/ 5FU-LV in the Adjuvant Treatment of Colon Cancer

Conditions
-----------------
Colonic Neoplasms

Intervention / Treatment
-----------------
* Drug: Oxaliplatin (SR96669)


Participation Criteria
=================
Eligibility Criteria
-----------------
Main selection criteria: Histologically proven stage Dukes  B2  (stage II: T3-T4 N0 M0) and  C  (stage III: any T N1-2 M0) colon carcinoma. The inferior pole of the tumor must be above the peritoneal reflection (> 15 cm from the anal margin)· Complete resection of the primary tumor without gross or microscopic evidence of residual disease Treatment within 7 weeks following surgery Age 18-75 years old ECOG PS £ 2 No prior chemo, immuno or radiotherapy

Ages Eligible for Study
-----------------
Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Oxaliplatin (SR96669)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To to detect occurrence of relapse the following examinations have to be performed for 5 years: |  |  | 
| Every 6 months for ultrasound or abdominopelvic CT scan and CEA determination, |  |  | 
| Every year for chest X-ray and colonoscopy for non polyp free patient, |  |  | 
| Every 3 years colonoscopy for polyp free patient |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Every 2 weeks clinical and laboratory tests (hematological, creatinine and liver tests) for safety evaluation during treatment then every 6 months neurological examination Date of death for OS |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oxaliplatin, Chemotherapy,adjuvant, Colonic Neoplasms