linjc16/ctgov huggingface dataset:
Effect of Kinesiotaping Application in Preterm Infants Undergoing Noninvasive Ventilation

Study Overview
=================
Brief Summary
-----------------
Kinesiotaping (KT) applied to the thorax is believed to enhance breathing by supporting the respiratory muscles. Infants born premature usually have respiratory problems because of depletion of surfactant and respiratory muscle weakness. Therefore, we are going to use KT for premature infants in NICU who are undergoing non-invasive ventilation. Forty-two participants divided into two groups. The first group will be applied KT to chest wall, abdomen and diaphragm, and the other group will not receive any KT application during non-invasive ventilation. KT application will be going on as long as the infant underwent non-invasive ventilation. We are going to measure blood gas parameters (pH, pCO2, pO2, base excess), respiration rate, peak heart rate, percentage of Fio2, FiO2/pO2 rate, PEEP and PIP values before non-invasive ventilation, 2 hours after non-invasive ventilation, within 72 hours and shortly before weaning from non-invasive ventilation.

Official Title
-----------------
Effect of Kinesiotaping Applications on Diaphragm, Abdomen and Chest Wall in Preterm Infants Undergoing Noninvasive Ventilation

Conditions
-----------------
Preterm Infant

Intervention / Treatment
-----------------
* Device: kinesiotape application


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inpatient infants in NICU, born in Baskent University Ankara Hospital, undergoing non-invasive ventilation and age between 24-36.6 weeks. Exclusion Criteria: Infants with multiple kongenital anomaly, hypoxic ischemic encephalopathy, tracheoesophageal fistula, diaphragmatic hernia.

Ages Eligible for Study
-----------------
Minimum Age: 24 Weeks
Maximum Age: 36 Weeks

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kinesiotape<br>Kinesiotaping aplication to chest wall, abdomen and diaphragm in preterm infants. | Device: kinesiotape application<br>* kinesiotape application to diaphragm, chest wall and abdomen in preterm infants.<br>|
| No Intervention: Control<br>No kinesiotaping aplication to chest wall, abdomen and diaphragm in preterm infants. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| arterial blood gas | arterial blood gas | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
preterm infants, kinesiotape, ventilation, respiratory muscles
An Open-Label Extension Study of NGX-4010 for the Treatment of Neuropathic Pain

Study Overview
=================
Brief Summary
-----------------
This study is an open-label, multicenter, extension study for subjects who completed NeurogesX Study C111 and received treatment with NGX-4010 (Capsaicin Patch) within 12 weeks (up to +7days) before entry into Study C114

Official Title
-----------------
An Open-Label Extension Study of NGX-4010 for the Treatment of Neuropathic Pain

Conditions
-----------------
Neuralgia, Diabetes Mellitus, Herpes Zoster, Pain, HIV Infections, Peripheral Nervous System Diseases, Diabetic Neuropathies, Polyneuropathies

Intervention / Treatment
-----------------
* Drug: Capsaicin Dermal Patch


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Eligibility Criteria: Must have completed NeurogesX Study C111 and received treatment with NGX-4010 (Capsaicin Patch) within 12 weeks (up to +7 days) before entry into Study C114. Demonstrated adherence to protocol requirements during Study C111, and willing and able to comply with protocol requirements for the duration of the study participation. Must not have had any serious adverse experience since enrollment in Study C111, whether or not considered to be study drug-related. Must have intact skin at the treatment area. Must be prepared to remain on the same pain medications at the same doses as before the study for the entire duration of the study (36 weeks). Must not use topical pain medications on painful areas. Must be at least 18 years old, not pregnant, and able to take care of self independently, with only occasional assistance if needed. No history or current problem with substance abuse.

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Capsaicin Dermal Patch|nan|

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dermal assessment, Pain assessment, Diary, Analgesics, Capsaicin, Herpes zoster, Neuralgia, Pain, HIV Infections, Peripheral Nervous System Diseases, Diabetic Neuropathies, Diabetes Mellitus, Polyneuropathies, Complementary Therapies
Plasmapheresis Before Rituximab in Cryoglobulinemia

Study Overview
=================
Brief Summary
-----------------
Initial worsening following initiation of rituximab therapy in patients with cryoglobulinemic vasculitis was described in 3.6% of cases. This worsening is often a serious condition, with high levels of mortality. The objective of our study is to evaluate the efficacy of preventive plasmapheresis prior to the introduction of rituximab performed in Montpellier France since 2013 by assessing the frequency and severity of this flare effect in these patients compared to those reported in the literature.

Official Title
-----------------
Prevention of Rituximab Related Flare by Plasmapheresis in Cryoglobulinemic Vascularitis

Conditions
-----------------
Cryoglobulinemic Vasculitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: cryoglobulinemic vasculitis requiring rituximab treatment Patient ≥18 years old Exclusion Criteria: Patient who reject the study protocol Patient < 18 years old

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 |
| --- | --- | --- |
| comparison of frequency of occurrence of flare effects | comparison of frequency of occurrence of flare effects between patients who received plasmapheresis prior to rituximab compared to patients who did not. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of the severity of the flare effect | evaluation of the severity of the flare effect | 1 day | 
| impact of known risk factors | investigation of the impact of known risk factors for this effect | 1 day | 
| evaluation of the safety of plasmapheresis in this indication | evaluation of the safety of plasmapheresis in this indication | 1 day | 
| evaluation of the efficacy of plasmapheresis on biological parameters | evaluation of the efficacy of plasmapheresis on biological parameters | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cryoglobulinemic vasculitis requiring rituximab therapy
Determine the Effects of C-administration of AZD7325 and an Oral Contraceptive in Healthy Female Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of repeated doses of AZD7325 on the pharmacokinetics of ORTHO-CYCLEN, a monophasic oral contraceptive

Official Title
-----------------
A Randomized, Open-Label, Two-way Crossover Study to Determine the Effects of Co-administration of AZD7325 and a Monophasic Oral Contraceptive Containing Ethinyl Estradiol and Norgestimate in Healthy Female Subjects

Conditions
-----------------
Pharmacokinetics

Intervention / Treatment
-----------------
* Drug: monophasic oral contraceptive
* Drug: AZD7325


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: If previously pregnant, must be > 6 month post-partum at the time of randomization Body Mass Index (BMI) greater than or equal to 18 and less than or equal to 30 kg/m2 Exclusion Criteria: Use of any prescription medication within 14 days of screening current smoker or history of smoking within the last 3 months prior to enrollment Abnormal pap smear exam result within one year of enrollment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>monophasic oral contraceptive | Drug: monophasic oral contraceptive<br>* mg, oral dose<br>* Other names: ORTHO-CYCLEN;|
| Experimental: 2<br>AZD7325 | Drug: AZD7325<br>* mg, oral dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effect of repeated doses of AZD7325 on the pharmacokinetics of ORTHO-CYCLEN |  | weekly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize the pharmacokinetics of progesterone, luteinizing hormone, follicle-stimulating hormone, and sex hormone binding globulin following dosing with monophasic oral contraceptive (ORTH-CYCLEN) alone and following co-administration with AZD7325 |  | weekly | 
| To characterize the steady-state pharmacokinetics of AZD7325 |  | weekly | 
| To examine the safety and tolerability of AZD7325 in combination with the monophasic oral contraceptive (ORTHO-CYCLEN) |  | weekly | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oral contraceptive
Microcirculation in Patients With Leukemic Hyperleukocytosis

Study Overview
=================
Brief Summary
-----------------
Hyperleukocytosis in patients with acute leukemia impacts rheology and microvascularization, leading to severe symptoms or even death. The investigators investigated whether blood stream alterations induced by hyperleukocytosis can be detected by sidestream dark-field imaging and whether they correlate with the grade of symptoms.

Official Title
-----------------
Visualization of Microcirculation in Patients With Leukemic Hyperleukocytosis

Conditions
-----------------
Hyperleukocytic Syndrome

Intervention / Treatment
-----------------
* Diagnostic Test: intravital microscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute leukemia de-novo or relapsed stage able to give consent Exclusion Criteria: severe oral mucositis unable to give consent pregnant women patients hospitalized for psychiatric 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sublingual microscopy<br> | Diagnostic Test: intravital microscopy<br>* intravital microscopy with sidestream dark-field imaging<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| microvascular flow index (MFI) of sublingual microcirculation |  | 24 months |
Neo-adjuvant Chemotherapy Evluation in Gastric Cancer Patients Based on Circulating Exosomal LncRNA-GC1

Study Overview
=================
Brief Summary
-----------------
The investigators hope that through the analysis and research to find determine whether lncRNA-GC1 could serve as a non-invasive biomarker for monitoring the neo-adjuvant chemotherapy response for personalized medicine for gastric cancer.

Detailed Description
-----------------
The LncRNA-GC1could noninvasively track dynamics of tumor burden and has been proposed as a real-time biomarker that can provide both predictive and prognostic values. But the value in monitoring the neo-adjuvant chemotherapy response is unclear. The investigators hope that through the analysis and research to find determine whether lncRNA-GC1 could serve as a monitoring biomarker for patients with gastric cancer receiving neo-adjuvant chemotherapy.

Official Title
-----------------
Non-invasive Response Assessment of Neo-adjuvant Chemotherapy in Gastric Cancer Patients Based on Circulating Exosomal LncRNA-GC1

Conditions
-----------------
Gastric Cancer, Chemotherapy Effect

Intervention / Treatment
-----------------
* Diagnostic Test: Detection of levels of circulating EV-derived lncRNA-GC1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having signed informed consent Age≥ 18 years old Histologically confirmed gastric adenocarcinoma radiographically identified as advanced gastric cancer Exclusion Criteria: Other previous malignancy within 5 year Surgery (excluding diagnostic biopsy) within 4 weeks prior to study Pregnancy or lactation period Legal incapacity

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Detection of levels of circulating EV-derived lncRNA-GC1|For patients with gastric cancer receiving neo-adjuvant chemotherapy, the dynamic changes of EV-derived lncRNA-GC1 was detected to identify whether is can serve as a monitoring biomarker for treatment response.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of levels of circulating exosomal lncRNA-GC1 | Levels of circulating exosomal lncRNA-GC1 are detected by RT-PCR | Through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Circulating exosomal lncRNA-GC1, Advanced Gastric Carcinoma, treatment response
Neurokinin Receptor Antagonist Associated to Ondansetron in PONV

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether patients at high risk for postoperative nausea and vomiting can benefit from aprepitant, ondansetron and dexamethasone in the perioperative period.

Detailed Description
-----------------
High risk surgical patients for PONV, scheduled for laparoscopic surgery will be distributed in two groups: Group I will receive aprepitant 80 mg per os and Group II will receive placebo per os, one hour before surgery. In the operating room, patients will be submitted to combined intravenous general anesthesia plus spinal anesthesia. All patients will receive dexamethasone 4 mg and ondansetron 4 mg intravenously during the surgical procedure. After surgery, patients will be monitored for pain, nausea and vomiting during 24 hours.

Official Title
-----------------
Effect of the Association of Neurokinin-1 Receptor Antagonist Aprepitant to Dexamethasone/Ondansetron in the Incidence of Postoperative Nausea and Vomiting in High Risk Apfel Score Patients

Conditions
-----------------
Postoperative Nausea and Vomiting

Intervention / Treatment
-----------------
* Drug: Aprepitant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: high risk patients for nausea and vomiting Exclusion Criteria: cardiovascular disease, or hypersensibility to any of the drugs involved in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: aprepitant<br>aprepitant 80 mg one hour before surgery | Drug: Aprepitant<br>* Aprepitant or placebo will be administered to the patient before surgery<br>* Other names: Emend;|
| Placebo Comparator: placebo<br>oral placebo one hour before surgery | Drug: Aprepitant<br>* Aprepitant or placebo will be administered to the patient before surgery<br>* Other names: Emend;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of nausea and vomiting in postoperative period |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nausea, postoperative, postoperative nausea, postoperative vomiting, vomiting, postoperative
Characterization of Macroprolactinemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to clarify the nature of macroprolactin which has recently been highlighted because of the high prevalence and a diagnostic pitfall of hyperprolactinemia. The results of this study are beneficial for the patients to whom unnecessary medications and unnecessary radiological examinations have been performed. We used the remained serum samples taken for routine prolactin determination during the past several years. Since the blood was basically taken to examine the causes of hyperprolactinemia and only remained serum samples were used for this study, the Ethics Committee of Kobe City General Hospital judged that it was not required to obtain approval number.

Conditions
-----------------
Hyperprolactinemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of hyperprolactinemia
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hyperprolactinemia, autoantibody
Phase 2b Study of GC4711 in Combination With SBRT for Nonmetastatic Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
GTI-4711-201 is designed as a Phase 2b, multicenter, randomized, double-blind, placebo-controlled study to determine the effect to OS by adding GC4711 to SBRT following chemotherapy in patients with unresectable or borderline resectable nonmetastatic

Official Title
-----------------
GRECO-2: A Randomized, Phase 2b Study of GC4711 in Combination With Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Unresectable or Borderline Resectable Nonmetastatic Pancreatic Cancer

Conditions
-----------------
SBRT, Borderline Resectable Pancreatic Cancer, Unresectable Pancreatic Cancer

Intervention / Treatment
-----------------
* Drug: Drug GC4711
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological or biopsy proven adenocarcinoma of the pancreas. Cytology is acceptable if histology cannot be obtained. Newly diagnosed non-metastatic PC judged by tumor board to be feasible for SBRT Completed at least 6 weeks of chemotherapy consisting of FOLFIRINOX, mFOLFIRINOX, or a gemcitabine-based doublet regimen prior to start of SBRT Remain non-metastatic as confirmed by a CT scan at screening. Female or male subjects ≥ 18 years of age ECOG performance status of 0-2 Adequate end-organ function Exclusion Criteria: Subjects with documented metastatic disease First-line chemotherapy other than FOLFIRINOX, mFOLFIRINOX, and/or a gemcitabine-based doublet regimen Prior abdominal RT with substantial overlap in radiation fields Subjects not recovered/controlled from treatment-related toxicities Uncontrolled malignancy other than PC Uncontrolled gastric or duodenal ulcer disease within 30 days of dosing Visible invasion of bulky tumor into the lumen of the bowel or stomach on endoscopy

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A Active GC4711<br> | Drug: Drug GC4711<br>* 15 Minute IV Infusion<br>|
| Placebo Comparator: Arm B Placebo<br> | Drug: Placebo<br>* 15 Minute IV Infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Overall Survival after SBRT completion |  | From randomization up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Progression Free Survival after SBRT Completion per RESIST 1.1 |  | From randomization up to 3 years |