linjc16/ctgov huggingface dataset:
Spastic Cerebral Palsy and Slackline

Study Overview
=================
Brief Summary
-----------------
The aim of the present study was to assess whether supervised slackline training improves postural control in children and teenagers with spastic cerebral palsy (grade I and II of the Gross Motor Function Classification System).

Official Title
-----------------
The Slackline as a Rehabilitation Tool for Children and Teenagers With Spastic Cerebral Palsy: a Randomised Clinical Trial

Conditions
-----------------
Spastic Cerebral Palsy

Intervention / Treatment
-----------------
* Other: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis with any expression of spastic cerebral palsy and rated I-II on the Gross Motor Functional classification. Between 9 and 16 years of age. Ability to cooperate with simple instructions. Able to stand for at least 2 min without assistance. Able to walk at least 10 m without assistance. Exclusion Criteria: Individuals were excluded if they underwent neuro or orto surgery during or up to one year prior to the study, botulinum toxin injection or intrathecal pump during or up to six months prior to the study and/or rotational osteotomies, if they expressed gait deviations limited by musculoskeletal contracture, presented specific medical or orthopedic conditions that precluded exercising or if they did not meet the eligibility criteria.

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supervised Slackline Training<br>Supervised Slackline training in children and teenagers with spastic cerebral palsy (grade I and II of the Gross Motor Function Classification System). Intervention included 18 slackline rehabilitation sessions for 6 weeks: 3 sessions per week on non-consecutive days, 30 min each one. | Other: Exercise<br>* Intervention included 18 slackline rehabilitation sessions for 6 weeks: 3 sessions per week on non-consecutive days, 30 min each one.<br>|
| No Intervention: Physical Activity<br>The control group followed its usual weekly physical activity routine. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Static posturography (a composite measure). | The centre of pressure (CoP) parameters (these CoP parameters; Length, Xmean, Ymean, Xdeviation and Ydeviation in mm, Area in mm2 and Speed, Xspeed and Yspeed in m/s will be combined to report the static posturography). | 6 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myoelectrical activity. | Soles, Tibialis Anterior and Peroneus Longus (myoelectrical activity in microvolts). | 6 weeks. | 
| Jump Performance | Countermovement Jump Test and Abalakov´s Test (jump height in cm). | 6 weeks. |
Evaluation of Bioresorbable Sheet to Prevent Intra-Abdominal Adhesions in Colorectal Surgeries

Study Overview
=================
Brief Summary
-----------------
Study to investigate and determine the difference between the extent and severity of intra-abdominal adhesions in patients where SurgiWrap film was placed compared to patients with no adhesion barrier inserted. Hypothesis: Due to the preclinical safety data and clinical case reports in various indications it is anticipated that the surgical sites where the resorbable anti-adhesion barrier SurgiWrap was placed, there will be a reduction of adhesions compared to the control group with no treatment.

Official Title
-----------------
Evaluation of Intra-Abdominal Adhesions in Ileostomy Procedures When Using a Resorbable Polylactide Film (SurgiWrap) in Colorectal Surgeries

Conditions
-----------------
Adhesions

Intervention / Treatment
-----------------
* Device: Polylactic Acid Sheet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with rectal cancer, ulcerative colitis or other pathologies requiring a second surgery for ileostomy closure. Age between 18 and 78 years. Patient or his/her legal representative has read and signed the approved Informed Consent form before randomization. Exclusion Criteria: Previous abdominal operation through a midline approach Use of hernia mesh Use of any antiadhesive irrigants or irrigants containing corticosteroids, heparin, salicylates, nonsteroidal anti-inflammatory drugs. Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 78 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Colorectal Surgery without use of SurgiWrapTM | |
| Active Comparator: Test Group<br>Colorectal Surgery with use of SurgiWrapTM film secured directly below the abdominal incision | Device: Polylactic Acid Sheet<br>* SurgiWrapTM bioresorbable sheet will be secured directly below the abdominal incision.<br>* Other names: SurgiWrapTM;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the extent and severity of new formed adhesions having its source in the target region where the SurgiWrap film initially was placed: between the midline incision/scar and the omentum, and between the midline incision/scar and the small bowel |  | 6 to 8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Surgery, Colectomy, Proctocolectomy, Adhesions
Epidemiological EMESIS-Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this registry is to record information on reality of anti-emetic therapies of cancer-patients in Germany. The outcome of this study is the efficacy of anti-emetic therapies dependent on the rate complete and major control of nausea and emesis in moderately and highly emetogenic chemotherapies, consisting of platin-derivates (cisplatin, carboplatin and oxaliplatin), anthracyclines and/or cyclophosphamid.

Official Title
-----------------
Epidemiologic Registry for the Description of Antiemetic Strategies Under Real-life Conditions.

Conditions
-----------------
Antiemetic Therapy

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderately or highly emetogenic chemotherapy consisting of platin-derivates (cisplatin, carboplatin and oxaliplatin), anthracyclines and/or cyclophosphamid. start with the 1st cycle of the regimen (chemo naive patients). Inclusion of pretreated patients is also possible, if the last treatment cycle of a previous chemotherapy was given >= 24 months ago. Compliance with registry procedures Age >= 18 years WHO Performance Status of 0 or 1 (Karnofsky-Index >= 70%) Life expectancy of at least 12 weeks Signed and dated informed consent before the start of the registry Exclusion Criteria: Mentally incapable or incompliant patients Last chemotherapy <= 24 months (if pretreated) Known hypersensitivity to antiemetic medication unability of the patient to be treated with oral medication pregnancy or lactation period

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 |
| --- | --- |
| antiemetic treatment<br>epidemiological registry | Other: non-interventional<br>* non-interventional<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of anti-emetic therapies dependent on the rate complete and major control of nausea and emesis in moderately and highly emetogenic chemotherapy regimens. |  | 4 chemotherapy applications per patient | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
antiemetic therapy, emesis, vomiting, nausea, moderately and highly emetogenic chemotherapy, cisplatin, carboplatin, oxaliplatin, anthracycline, cyclophosphamid
The Prevalence of Group B Streptococcus Positive Pregnant Patients in an Inner City Tertiary Care Center

Study Overview
=================
Brief Summary
-----------------
A retrospective review of the prevalence of Group B Streptococcus Positive Pregnant Patients in an Inner City Tertiary Care Center

Detailed Description
-----------------
This is a retrospective chart review of the prevalence of Group B Streptococcus (GBS) positive patients

Official Title
-----------------
The Prevalence of Group B Streptococcus Positive Pregnant Patients in an Inner City Tertiary Care Center

Conditions
-----------------
Group B Streptococcus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: GBS positive pregnant women Exclusion Criteria: n/a
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- | --- |
Maximal Distance for Successful Supraclavicular Block

Study Overview
=================
Brief Summary
-----------------
The achievement of peripheral nerve block requires several needle passes, with each of them being at risk of causing nerve injury either by direct trauma or intraneural injection even with the use of the ultrasound. The ultrasound guided supraclavicular brachial plexus block is known to be at risk of pneumothorax and / or nerve injury. This study is designed to determine the maximal effective distance away from the nerve for the injection to be effective.

Official Title
-----------------
The Maximum Effective Needle-to-Nerve Distance for Anesthetic Ultrasound-Guided Supraclavicular Brachial Plexus Block

Conditions
-----------------
Regional Anesthesia, Ultrasound, Supraclavicular Block

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA physical status I-III 18-85 years of age, inclusive surgery less than 3 hours Exclusion Criteria: contraindications to brachial plexus block (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the area) existing neurological deficit in the area to be blocked pregnancy history of neck surgery or radiotherapy inability to understand the informed consent and demands of the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| Success of the ultrasound guided supraclavicular block at 30 minutes after injection at a specific distance of the needle tip from the outer sheeth of the nerve |  | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| •The onset time of sensory and motor block |  | the block success will be assessed for each patient every 5 min for 30 mins in the operating room beginning when the needle exits the skin | 
| The proportion of inadequate and failed blocks. |  | the block success will be assessed for each patient every 5 min for 30 mins in the operating room beginning when the needle exits the skin | 
| The presence of other complications such as hematoma, infection, pneumothorax. |  | up to 48 hours post operative. |
Work Productivity in Hyperventilation Syndrome

Study Overview
=================
Brief Summary
-----------------
Hyperventilation syndrome is associated with impaired quality of life. The aim of the study is to assess the relationship between work productivity, including absenteeism and presenteeism, and the severity of hyperventilation syndrome

Official Title
-----------------
Work Productivity in Hyperventilation Syndrome

Conditions
-----------------
Hyperventilation Syndrome

Intervention / Treatment
-----------------
* Other: questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Holders of employment contracts for at least 8 days Diagnosis of hyperventilation syndrome confirmed by: Compatible symptoms and at least two symptoms reproduced by the hyperventilation challenge test: Nijmegen's score> 23 ; Demonstration of alveolar hyperventilation ( Either on rest blood and / or at rest (PaCO2 at rest <36 mmHg and D (A-a) O2 normal; Either during the HV test (increased recovery time of the basic PETCO2 after voluntary hyperventilation (greater than 5 minutes) Exclusion Criteria: Existence of another chronic pulmonary disease (asthma, bronchial dilation, COPD, diffuse interstitial pneumonia, neuromuscular pathology ...) or cardiac (rhythm disorder, ischemic heart disease ...) which can participate in dyspnea Psychiatric illness / psychotropic treatment Pregnancy Patient already included in a clinical research protocol involving new therapeutics may not be included in this protocol Specific physiotherapy or previous training

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 |
| --- | --- |
| Hyperventilation syndrome<br> | Other: questionnaire<br>* Work Productivity and Activity Impairment (WPAI) Multidimensional Dyspnea Profile (MDP) Baseline Dyspnea Index (BDI), MOS-SF36, Hospital Anxiety Depression (HAD) Cognitive Failure Questionnaire (CFQ).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between the WPAI score and the Nijmegen score |  | At the time of diagnosis (Baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between the WPAI score and dyspnea scales |  | At the time of diagnosis (Baseline) | 
| Association between the WPAI score and quality of life scores |  | At the time of diagnosis (Baseline) | 
| Association between the WPAI score and PaCO2 |  | At the time of diagnosis (Baseline) | 
| Association between the WPAI score and the Cognitive Failure Questionnaire score |  | At the time of diagnosis (Baseline) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hyperventilation syndrome, Work productivity, Absenteeism, Presenteeism
Use of Point-of-care Ultrasound in High Risk Surgical Patients

Study Overview
=================
Brief Summary
-----------------
There is currently a lack of evidence to support the use of perioperative point-of-care ultrasound to assess the outcomes in high risk surgical patients. Thus, the purposes of this study were to evaluate whether perioperative use of point-of-care ultrasound can reduce the worse postoperative outcomes in high surgical patients.

Detailed Description
-----------------
Point-of-care ultrasound is increasingly established as a useful bedside tool when performed by the anesthesiologist for evaluation of cardiopulmonary dysfunction and other emergent situations. However, it remains unclear whether use of perioperative point-of-care ultrasound can reduce the worse postoperative outcomes in high surgical risk patients. Patients were randomly allocated to two groups. In the point-of-care ultrasound group, treatment was oriented by the findings of point-of-care ultrasound, while in the control group the decisions about the management of patients were made by the experience of the clinical team. The primary outcome measures were hospital mortality and 28-day mortality, and the secondary outcome measures were the complications and length of hospital stay.

Official Title
-----------------
Effects of Perioperative Point-of-care Ultrasound Assessment on Postoperative Outcomes in High Risk Surgical Patients

Conditions
-----------------
Ultrasonography, Outcomes, Cardiopulmonary

Intervention / Treatment
-----------------
* Device: Point-of-care Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have comprised cardiovascular，respiratory diseases，or other critical illness. Exclusion Criteria: Patients who decline to participate.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Point-of-care ultrasound group<br>High risk patients received point-of-care ultrasound assessment perioperatively, treatment was oriented by the findings of point-of-care ultrasound. | Device: Point-of-care Ultrasound<br>* Patients' management in the point-of-care ultrasound group will be adjusted according to the results of ultrasound, whereas patients in the control group the decisions about the management were made by the experience of clinical team.<br>|
| Control group<br>High risk patients received management by the experience of the clinical team. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypotension | Patients who have hypotension which is defined by mean arterial pressure less than 60 mmHg | Within 7 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
high risk, complication, Ultrasonography
Autologous Bone Marrow Derived Mesenchymal Stromal Cells (BM-MSCs) in Patients With Chronic Kidney Disease (CKD)

Study Overview
=================
Brief Summary
-----------------
This study was designed to provide confirmation of safety of mesenchymal stem cells (MSCs) therapy in chronic kidney disease (CKD).

Detailed Description
-----------------
We will assess the 18-month safety and potential efficacy of autologous MSCs as a therapy for CKD. A total of 10 patients with CKD IV injection of high doses 2×106/kg of autologous MSCs t, which will be derived from biopsies of their bone marrow. Assessments will be performed at 1, 3, 6, 12 and 18 months after cell injection. Changes in Glomerular Filtration Rate (GFR) were evaluated by scan isotope.

Official Title
-----------------
Administration of Autologous Bone Marrow Mesenchymal Stem Cells (BM-MSCs) in Patients With Chronic Kidney Disease (CKD)

Conditions
-----------------
Chronic Kidney Disease

Intervention / Treatment
-----------------
* Biological: Intravenous injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and Female CKD symptoms CKD confirmed with serum and urine analysis and GFR 25-60 mL/min/1.73 m2 Patient's age between 25 - 60 years Ability to understand and willingness to sign consent from Exclusion Criteria: Pregnant or lactating Basis disease such as diabetes, malignancy and autoimmune Unable to follow post-operative exercise regimen or return for evaluations

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MSC recipient<br>The patients with CKD who underwent intravenous injection of MSC. | Biological: Intravenous injection<br>* Intravenous injection of bone marrow derived MSC in patients with CKD.<br>* Other names: Intravenous transplantation;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mass formation | Evaluation the probability of mass formation due to MSC transplantation 6 months after cell injection. | 6months | 
| Creatinin | Evaluation the rise of creatinin 1 month after cell transplantation. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GFR | Evaluation the increase of GFR 6 months after cell transplantation with scan isotope . | 6months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
autologous bone marrow mesenchymal stem cells chronic kidney disease
Cervical Length Pre-induction as a Tool to Predict Vaginal Birth

Study Overview
=================
Brief Summary
-----------------
To evaluate the value of measuring cervical length as a predictor of vaginal birth after induction of labor with prostaglandins in pregnancies with 41 weeks of gestation.

Official Title
-----------------
Use of Cervical Length Previous to the Use of Prostaglandins as a Tool to Predict Vaginal Birth in Pregnancies With > 41 Weeks Gestation.

Conditions
-----------------
Cervical Length Measurement, Pregnancy, Prolonged

Intervention / Treatment
-----------------
* Procedure: Cervical length measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 41 weeks or more of gestational age Cervical length measured by a FMF certified physician Exclusion Criteria: Any condition that could interfere with a possible vaginal birth (previous cesarean section, hypertensive disorders of pregnancies).
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prolonged pregnancy<br>Pregnancies with 41 weeks or more of gestation determined by a reliable last menstrual period or early fetal ultrasound. | Procedure: Cervical length measurement<br>* Vaginal ultrasound to measure cervical length previous to use of prostaglandins.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal Birth | Number of vaginal births obtained after a measure of cervical length below 2,5 cms. | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Induction to delivery time | Time (hours) between the application of a prostaglandin and termination of pregnancy (vaginal or cesarean). | 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cervical length, Prolonged pregnancy, Vaginal birth