linjc16/ctgov huggingface dataset:
Symptoms and Function During and After Pregnancy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to: describe degree of symptoms and disability during and after pregnancy to examine if women with pelvic girdle pain are able to correctly mark their pain location on a pain drawing to examine the responsiveness of The Pelvic Girdle Questionnaire

Official Title
-----------------
Symptoms and Function During and After Pregnancy

Conditions
-----------------
Pelvic Girdle Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnancy week 32-36 Understand and read/write a questionnaire in Norwegian or English Exclusion Criteria: Not able to understand and fill in a questionnaire

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>pregnant women | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the pelvic girdle questionnaire |  | 10 weeks postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity, Numeric rating scale |  | 10 weeks postpartum |
Botulinum Toxin Type A for Neuropathic Pain in Patients With Diabetic Peripheral Polyneuropathy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether botulinum toxin A is effective in the treatment of neuropathic pain in patients with diabetic peripheral polyneuropathy.

Official Title
-----------------
Botulinum Toxin Type A for Neuropathic Pain in Patients With Diabetic Peripheral Polyneuropathy

Conditions
-----------------
Neuralgia

Intervention / Treatment
-----------------
* Biological: Botulinum toxin type A
* Other: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • more than twenty years of age patients should have 4 or more items positive among the 10 items of the DN4 questionnaire. persistence of neuropathic pain for more than three months or remission and recurrence of neuropathic pain for more than six months a pain score of 4 or more on the numeric rating scale Exclusion Criteria: • neuropathic pain caused by confounding factors other than diabetic neuropathic pain contraindicated for botulinum toxin type A a change in pain medication one month prior to study enrollment a condition involving neuromuscular junction (Ex. Eaton Lambert disease, myasthenia gravis) person who received botulinum toxin type A within three months prior to study enrollment

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Normal saline<br>Normal saline | Other: Normal saline<br>* Placebo<br>|
| Active Comparator: Botulinum toxin type A 50U<br>Botulinum toxin 50U | Biological: Botulinum toxin type A<br> <br> |
| Active Comparator: Botulinum toxin type A 100U<br>Botulinum toxin 100U | Biological: Botulinum toxin type A<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity using numeric rating scale |  | 4 weeks after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity using numeric rating scale |  | 1, 8, 12, 24 weeks after intervention | 
| Quality of life using WHOQOL |  | 4,8,12 weeks after intervention |
A Study for the Treatment of Unresectable Stage III or Metastatic Stage IV Melanoma

Study Overview
=================
Brief Summary
-----------------
A study with YM155 for the treatment of unresectable stage III or metastatic stage IV melanoma.

Detailed Description
-----------------
A phase II, multicenter, open-label study in subjects with unresectable Stage III or metastatic (Stage IV) Melanoma to evaluate the efficacy and safety of YM155

Official Title
-----------------
A Phase II, Multicenter, Open-Label Study of YM155 in Subjects With Unresectable Stage III or Metastatic (Stage IV) Melanoma

Conditions
-----------------
Melanoma

Intervention / Treatment
-----------------
* Drug: YM155


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed unresectable stage III or IV malignant melanoma Life expectancy >12 weeks Exclusion Criteria: History of other malignancy in the last 5 years Major surgery within the past 21 days

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: YM155|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response rate |  | 6 cycles | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of response |  | 6 cycles | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety, Treatment Efficacy, Treatment Effectiveness, Disease Management, Treatment, Malignant Melanoma
Phase I Open-Label Dose Finding Study of SGN-35 for CD30 Positive Hematologic Malignancies

Study Overview
=================
Brief Summary
-----------------
Phase I study to define the safety profile and pharmacokinetic parameters of SGN-35 in patients with relapsed/refractory CD30-positive hematologic malignancies. This is a single-arm, open-label, Phase I dose escalation study designed to define the MTD, PK, immunogenicity and anti-tumor activity of SGN-35 in patients with relapsed/refractory CD30-positive hematologic malignancies.

Official Title
-----------------
A Phase I Dose Escalation Study of SGN-35 in Patients With Relapsed/Refractory CD30-Positive Hematologic Malignancies.

Conditions
-----------------
Lymphoma, Non-Hodgkin, Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic

Intervention / Treatment
-----------------
* Drug: SGN-35


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have histologically confirmed CD30-positive hematologic malignancy. Patients with HL must have failed systemic chemotherapy either as induction therapy for advanced stage disease or salvage therapy after initial radiotherapy for early stage disease and were ineligible for, refused treatment by, or previously received stem cell transplant. Patients must have measurable disease of at least 10mm as documented by radiographic technique. Must be at least 18 years of age. Exclusion Criteria: Patients with current diagnosis of pcALCL (systemic ALCL eligible). Patients with history of allogeneic stem cell transplant. Patients who have had previous treatment with any anti-CD30 antibody.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: SGN-35<br>* Every 21 days. Dose Escalating. 0.1 - 3.6 mg/kg<br>* Other names: brentuximab vedotin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events and laboratory abnormalities |  | 1 month after last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK profile |  | 2 months after last dose | 
| Immunogenicity (anti-SGN-35 antibodies) |  | 1 month after last dose | 
| Anti-tumor activity |  | 1 month after last dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antigens,CD30, Antibody-Drug Conjugate, Antibodies, Monoclonal, Lymphoma, Non-Hodgkin, Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Hematologic Diseases, Lymphoma
Lips and Tongue of Mouth Breathing Children

Study Overview
=================
Brief Summary
-----------------
Purpose: to characterize the posture, tone and mobility of lips and tongue of mouth breathing children. Methods: 40 mouth breathing children, 26 (65%) male and 14 (35%) female, aging between 7 and 10 years old, were involved in this research realized in São Paulo, SP, Brazil . It was used the MBGR protocol to evaluate the posture, tone and mobility of lips and tongue of mouth breathing children.

Official Title
-----------------
Posture, Tone and Mobility of Lips and Tongue of Mouth Breathing Children

Conditions
-----------------
Mouth Breathing

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mouth breathing children diagnosed by doctor. Exclusion Criteria: Children with mental, neurological or hearing diseases, or with cold or flu at the examination day.

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 10 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 |
| --- | --- |
| MOUTH BREATHING CHILDREN<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Comparison of Fluconazole and Amphotericin B in the Treatment of Fungal Infections

Study Overview
=================
Brief Summary
-----------------
To compare the safety, tolerance and efficacy of fluconazole and amphotericin B as treatment for biopsy proven fungal infections in major organs, disseminated infection, suspected fungal infection and fungemia in adult neutropenic and non-neutropenic patients without AIDS, AIDS related complex (ARC), or extensive burns. HIV seropositive patients are allowed only if they also have a malignancy.

Official Title
-----------------
Fluconazole Versus Amphotericin B: A Prospective, Randomized, Multicenter Study for Therapy of Fungal Infection

Conditions
-----------------
Mycoses, HIV Infections

Intervention / Treatment
-----------------
* Drug: Fluconazole
* Drug: Amphotericin B


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Concurrent Medication: Allowed: Immunostimulants under studies carried out under an IRB approved protocol. Treatments of intercurrent non-fungal infection. Allowed but requires monitoring during fluconazole therapy: Barbiturates. Phenytoin. Oral hypoglycemics. Coumarin-type anticoagulants. Patients must have the following: Diagnosis or presumption of fungal infection under defined conditions. Written informed consent either from the patient or the patient's legal guardian. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Burns > 30 percent of the body. Diagnosis of AIDS or AIDS related complex (ARC). HIV positive unless they have a malignancy. History of allergy to or intolerance of imidazoles or azoles. Moderate to severe liver disease as defined by specific lab values. Unlikely to survive more than 24 hours. Evidence of previous amphotericin B sensitivity. Concurrent Medication: Excluded: Concomitant antifungal agents other than the study drugs. Immunostimulants, except for studies carried out under an IRB approved protocol. Concurrent Treatment: Excluded: Lymphocyte replacements. Patients with the following are excluded: Defined disease conditions listed in Exclusion Co-Existing Conditions. Unlikely to survive more than 24 hours. Previous participation in this study; reentry for the same infection is not allowed. Known to be unable to take amphotericin B due to acute toxicities. Prior Medication: Excluded: Previous fluconazole therapy for this infection.

Ages Eligible for Study
-----------------
Minimum Age: 13 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fluconazole|nan|
|Drug: Amphotericin B|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
-----------------
Mycoses, Neoplasms, Neutropenia, Fluconazole, Amphotericin B
Taurine as an Anti-Manic Agent: A Double-Blind, Placebo-Controlled Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the amino acid taurine has effects on mood stability in bipolar disorder.

Detailed Description
-----------------
Taurine is an amino acid that has some actions similar to mood stabilizers. Taurine is widely sold as a component of over-the-counter mood enhancing agents. However, controlled studies examining the mood effects of taurine are limited. An initial study in this laboratory looked at taurine's mood effects in individuals with bipolar disorder. This follow-up study is designed to further examine taurine's effects on manic symptoms. Subjects in the current follow-up study will add taurine or placebo to their current treatment regimen. Both depressive and manic symptoms will be tracked for three months to determine whether the addition of taurine affects mood symptoms.

Official Title
-----------------
Taurine as an Anti-manic Agent: a Double-blind Placebo-controlled Study.

Conditions
-----------------
Bipolar Disorder, Mania, Bipolar Depression

Intervention / Treatment
-----------------
* Drug: taurine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: bipolar disorder, type I bipolar disorder, type II mania hypomania mixed manic symptoms Exclusion Criteria: significant medical or psychiatric co-morbidity pregnancy or planning pregnancy current substance abuse or dependence -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 68 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>cellulose | Drug: taurine<br>* taurine 2mg BID po<br>|
| Active Comparator: active drug<br>taurine | Drug: taurine<br>* taurine 2mg BID po<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores on standardized measures of manic and depressive symptoms (HAM-D, MADRS, YMRS) | MADRS and YMRS | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side-effect ratings, general health ratings | SF36 | 12 weeks | 
| Drop-outs due to medication changes | subjects leaving study before completion | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bipolar, mania, depression, taurine, alternative
PEG-rhG-CSF in Patients With Malignant Solid Tumors Receiving Chemotherapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to estimate the safety and efficacy of PEG-rhG-CSF in patients with lung cancer,head and neck cancer,colorectal cancer,and ovarian cancer receiving multi-cycle chemotherapy.

Official Title
-----------------
The Multi-center,Open-label,Single Arm Phase IV Clinical Trial of Efficacy and Safety of PEG-rhG-CSF in Patients With Lung Cancer,Head and Neck Cancer,Colorectal Cancer,Ovarian Cancer and the Other Cancer Receiving Chemotherapy

Conditions
-----------------
Malignant Solid Tumors

Intervention / Treatment
-----------------
* Drug: PEG-rhG-CSF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with age ≥ 18 years diagnosis of lung cancer,head and neck cancer,colorectal cancer,ovarian cancer Karnofsky Performance Status ≥ 70 life expectancy of at least 3 months Written informed consent are acquired Exclusion Criteria: uncontrolled infection,Temperature is 38.0 ℃ or higher pregnancy Other situations that investigators consider as contra-indication for this study

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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEG-rhG-CSF<br>patients received a single dose of 100 ug/kg of PEG-rhG-CSF(pegfilgrastim), on the basis of actual body weight, as a single subcutaneous injection on day 3 after chemotherapy. | Drug: PEG-rhG-CSF<br> <br> * Other names: pegfilgrastim;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence rate of adverse event during at least three consecutive cycles chemotherapy |  | up to 30 days after the patient study completion | 
| The severity of adverse event during at least three consecutive cycles chemotherapy |  | up to 30 days after the patient study completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the non-occurrence rate of grade IV neutropenia (ANC <0.5 x 10^9/L)during at least three consecutive cycles chemotherapy |  | through the study completion,an average of 5 months | 
| the duration of grade IV neutropenia(ANC <0.5 x 10^9/L) during at least three consecutive cycles chemotherapy |  | through the study completion,an average of 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PEG-rhG-CSF
Clinical Value and Efficacy Index of Lymphadenectomy for Thoracic Escc

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to to clarify the focus of lymph node dissection during esophagectomy.. The main question[s] it aims to answer is: provide a basis for accurate staging and the relationship between OS and lymph node dissection

Official Title
-----------------
Clinical Value and Efficacy Index of Lymphadenectomy for Thoracic Esophageal Squamous Cell Carcinoma

Conditions
-----------------
Esophageal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologic findings proved ESCC (8th AJCC/UICC stage T1b-4aN0-3M0) Underwent esophagecomy (two-field or three-field LN dissection) The primary tumor was thoracic ESCC Exclusion Criteria: Located outside the thoracic Patients underwent salvage or R1/R2 esophagecomy The number of resected lymph nodes (RLNs) less than 15 With neoadjuvant therapy(NT) or salvage chemoradiotherapy(SCRT)
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 |
| --- | --- | --- |
| 5-year survival rate of lymph nodes metastases (%) in patients | Surgical data were retrospectively collected | 2010.1.1-2017.12.30 |
Clinical Evaluation of the CARTO™ XP EP Navigation System v9 and Biosense Webster SOUNDSTAR 3D Diagnostic Ultrasound. A Feasibility Study

Study Overview
=================
Brief Summary
-----------------
Feasibility study to evaluate CARTO™ XP EP Navigation System V9 and SOUNDSTAR 3D Diagnostic Ultrasound Catheter.

Detailed Description
-----------------
To construct geometric representation of the heart chambers using intracardiac ultrasound.The Carto™ XP Electrophysiology (EP) Navigation System v9 is intended to acquire real-time catheter based cardiac electrophysiogical maps.

Official Title
-----------------
Clinical Evaluation of the CARTO™ XP EP Navigation System v9 and Biosense Webster SOUNDSTAR 3D Diagnostic Ultrasound. A Feasibility Study

Conditions
-----------------
Cardiac Arrhythmias

Intervention / Treatment
-----------------
* Procedure: Electrophysiology
* Device: CARTO™ XP EP Navigation System V9


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects undergoing any EPS study and or Ablation will be eligible for this study. Age 18 years or older Signed Patient Informed Consent Form Exclusion Criteria: Patients with inadequate vascular access Patients with any of the following criteria will be excluded: Women who are pregnant Age <18 years Any Contraindication to the clinical procedure Sepsis Major coagulation abnormalities Presence of any intracardiac thrombus Unstable angina Uncontrolled Heart failure Deep Vein Thrombosis Significant peripheral vascular 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

| Intervention/Treatment |
| --- |
|Procedure: Electrophysiology|nan|
|Device: CARTO™ XP EP Navigation System V9|nan|

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

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