linjc16/ctgov huggingface dataset:
Molecular Determinants of Persistent Cancer Related Fatigue

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if inflammatory markers in blood as well as brain neurotransmitters (markers of in-brain activity and metabolism) are related to long-term or chronic fatigue.

Official Title
-----------------
Molecular Determinants of Persistent Cancer Related Fatigue

Conditions
-----------------
Fatigue, Pain, Poor Sleep Quality

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All Participants: - Women age 18 or older with no contraindication to magnetic resonance imaging(MRI); Fatigued BC Participants: Have a diagnosis of breast cancer; And have completed all cancer-related treatments (i.e., surgery, chemotherapy, radiotherapy, immunotherapy, etc.) except for hormonal therapy and or herceptin at least 12 weeks previously; and be apparently cancer-free. Age-Matched, Healthy Participants: Generally healthy; Matched in age ± 2.5 years to a Fatigued BC participant. No prior history of any cancer except for basal cell or squamous cell tumors of the skin that have been surgically excised; Have good sleep quality Have no chronic pain Have no chronic fatigue Exclusion Criteria: Pregnant, wanting to become pregnant or lactating women ; Diagnosed with anemia [defined as hemoglobin levels < 12 gm/dl] or receiving treatment for anemia ; Diagnosed with any comorbidities likely to cause significant fatigue (i.e., moderate to severe heart failure) Diagnosed with nutritional deficiencies; Have a diagnosis of untreated hypo- or hyper-thyroidism Have an initiation, a cessation or change of dose (up to three weeks prior to the study's start) of any chronic medications or dietary supplements or any planned change of chronic medications or dietary supplements during the study; Have implanted (e.g., surgical clips or staples) metal objects.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Healthy, Age-Matched<br> | |
| Fatigued<br> | |
| Not Fatigued<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare peripheral immune markers (cytokines), C-reactive protein levels and brain neurotransmitters (glutamate, GABA, myoinositol, and resting state intrinsic connectivity). |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare fatigue, pain, and sleep quality with peripheral immune markers, CRP, and brain markers. |  | 6 weeks |
Relationship Between Multi-exposure to Noise and Air Pollution and the Onset of Hypertension Disorders During Pregnancy

Study Overview
=================
Brief Summary
-----------------
This retrospective study aimed to analyse the relationship between multi-exposure to noise and air pollution the onset of hypertension disorders during pregnancy It will be conducted in 2650 mothers who gave birth at Dijon or Besançon CHU between 2005 and 2009 split into two groups: 530 cases (women who experienced hypertension disorders during pregnancy 2120 controls (women who did not experience a hypertension disorder during pregnancy)

Official Title
-----------------
Hypertension Disorders During Pregnancy and Multi-exposure to Environmental Noise and Atmospheric Pollution in an Urban Setting: Case-control Study in Women Who Gave Birth at Dijon and Besançon CHUs Between 2005 and 2009

Conditions
-----------------
Women Who Gave Birth at Dijon and Besançon CHUs Between 2005 and 2009

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women living in Besançon or one of the 15 communes of the Dijon conurbation Who gave birth at Dijon or Besançon CHU Between 1st January 2005 and 31st December 2009 Criterion for the inclusion of cases: Onset of a hypertension disorder during pregnancy defined according to expert recommendations Criterion for the inclusion of controls: No hypertension disorder during pregnancy Exclusion Criteria: Medical termination of pregnancy Opposition to the use of their data
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 |
| --- | --- |
| Cas<br>Onset of a hypertension disorder during pregnancy | |
| Controls<br>No hypertension disorder during pregnancy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset of a hypertension disorder during pregnancy |  | at baseline |
Exploration of microRNA and Metabolomics Biomarkers Predicting Drug Induced Liver Injury in Elderly People

Study Overview
=================
Brief Summary
-----------------
An open-label, one-sequence, multiple administration study for exploration of microRNA and metabolomics biomarkers to predict drug induced liver injury in healthy elderly Korean people.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Augmentin tab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects, as determined by medical history, physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations were eligible to participate in the study. Subjects had to be 65 to 84 years of age. Exclusion Criteria: Subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor Subject judged not eligible for study participation by investigator

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 84 Years

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

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

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: Augmentin tab<br> | Drug: Augmentin tab<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under Curve (AUC) |  | up to 35 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Elderly
Misoprostol For Nulliparous Women Before Hysteroscopy

Study Overview
=================
Brief Summary
-----------------
To compare the impact of 400-microgram self-administered vaginal versus self-administered oral misoprostol at home on preoperative cervical ripening in nulliparous women prior to outpatient hysteroscopy.

Detailed Description
-----------------
There is no consensus on the effect of misoprostol on cervical ripening for nulliparous women. The aim of the study is to compare the impact of 400-microgram self-administered vaginal versus self-administered oral misoprostol at home on preoperative cervical ripening in nulliparous women prior to outpatient hysteroscopy.

Official Title
-----------------
Comparison of Vaginal Versus Oral Misoprostol for Nulliparous Women Prior to Operative Hysteroscopy

Conditions
-----------------
Cervical Ripening

Intervention / Treatment
-----------------
* Drug: misoprostol
* Drug: oral misoprostol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: nulliparous women who are referred to outpatient hysteroscopy and who have given informed consent will be eligible for study recruitment. Exclusion Criteria: women with a known allergy to misoprostol.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: vaginal misoprostol<br>vaginal misoprostol was administered to this group of nulliparous women | Drug: misoprostol<br>* 400ug vaginally the day before surgery<br>|
| Experimental: oral misoprostol<br>oral misoprostol | Drug: oral misoprostol<br>* 400ug misoprostol orally the day before the surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cervical width |  | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| side effects |  | one day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
misoprostol, nulliparous, hysteroscopy
Efficacy of Ametop Cream in Reducing Pain of Local Anesthetic Infiltration

Study Overview
=================
Brief Summary
-----------------
Ametop is a numbing cream used to ease the pain of having blood drawn or an IV inserted. It is safe and virtually none enters the blood stream. It's effectiveness at reducing the pain of the freezing injection prior to epidural/ spinal anesthesia in pregnant women has not been studied.

Detailed Description
-----------------
We propose to randomize 70 women to have either the numbing cream or a similar looking moisturizing cream placed on their lower back before their anesthetic. They will rate the discomfort of the freezing injection allowing us to compare the two groups and determine if the numbing cream is effective.

Official Title
-----------------
The Efficacy of Topical Amethocaine Gel in Reducing the Pain of Local Anesthetic Infiltration Prior to Neuraxial Anesthesia in Non-labouring Pregnant Women: A Randomized Controlled Trial

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Ametop cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any pregnant subject undergoing an elective procedure under neuraxial anesthesia. Exclusion Criteria: Any contraindication to neuraxial anesthesia Subjects in labour

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ametop cream<br> | Drug: Ametop cream<br> <br> * Other names: amethocaine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | Patient will be asked to give a pain score | Within 5 minutes of spinal |
Response Based Treatment for Children With Unresectable Localized Soft Tissue Sarcoma

Study Overview
=================
Brief Summary
-----------------
To evaluate the treatment outcome of unresectable soft tissue sarcoma using response based treatment

Detailed Description
-----------------
Response after initial chemotherapy is one of the important prognostic factor in many cancers. In this study, treatment will be tailored according to the treatment responses which are assessed by tumor volume reduction, necrosis rate or residual fludeoxyglucose (FDG) uptake in positron emission tomography (PET) scan.

Official Title
-----------------
Response-based Treatment for Children With Unresectable Localized Soft Tissue Sarcomas

Conditions
-----------------
Unresectable Localized Soft Tissue Sarcoma

Intervention / Treatment
-----------------
* Drug: Cisplatin
* Drug: Etoposide
* Drug: Doxorubicin
* Drug: Cyclophosphamide
* Drug: Ifosfamide
* Drug: Carboplatin
* Radiation: Radiotherapy
* Drug: Thiotepa
* Drug: Melphalan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with unresectable localized high grade soft tissue sarcoma Exclusion Criteria: Patients with organ dysfunction (ejection fraction, liver function test, creatinine > CTCAE grade 2)

Ages Eligible for Study
-----------------
Maximum 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: Unresectable localized soft tissue sarcoma<br>Six cycles of chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen. Surgery, if possible Concurrent chemoradiotherapy according to the treatment response (necrosis rate, tumor volume reduction, and residual FDG uptake in PET scan) Tandem high dose chemotherapy (HDCT) and autologous stem cell transplantation, if there are still residual tumors after 9 cycle of chemotherapy, surgery, and radiotherapy. 1st HDCT: carboplatin, thiotepa, etoposide 2nd HDCT: cyclophosphamide, melphalan | Drug: Cisplatin<br> <br> Drug: Etoposide<br> <br> Drug: Doxorubicin<br> <br> Drug: Cyclophosphamide<br> <br> Drug: Ifosfamide<br> <br> Drug: Carboplatin<br> <br> Radiation: Radiotherapy<br> <br> Drug: Thiotepa<br> <br> Drug: Melphalan<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of event free survival |  | Up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adverse events |  | Up to 3 years |
Exercises Associated or Not With Manual Therapy Shoulder Impingement

Study Overview
=================
Brief Summary
-----------------
Manual therapy combined with a protocol of therapeutic exercises will increase the beneficial effects on scapular kinematics, myofascial pain and function in subjects with shoulder impingement when compared to exercises only.

Conditions
-----------------
Shoulder Impingement

Intervention / Treatment
-----------------
* Other: Exercises
* Other: Exercises + Manual Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: history of non-traumatic onset of shoulder pain; painful arc during active elevation of the arm; one or more positive shoulder impingement tests (Neer, Hawkins and Jobe), or pain during passive or resisted external rotation of the arm at 90° of abduction; pain with palpation of the rotator cuff tendons; all subjects need also to be able to reach 150° of arm elevation as evaluated by visual observation. Exclusion Criteria: limitation of glenohumeral internal and external rotation as indicative of adhesive capsulitis; body mass index > 28kg/m2 as the amount of subcutaneous tissue can compromise the quality of the signal increasing soft tissue artifact; numbness or tingling of the upper limb reproduced by cervical compression test; history of clavicle, scapula or humerus fracture; history of rotator cuff surgery; systemic illnesses; positive sulcus or apprehension tests as indicative of instability; positive drop arm test as indicative of full thickness tear; corticosteroid injection within 3 months prior to intervention, or physiotherapy within 6 months prior to intervention; depressive symptoms as evaluated by the Beck Depression Inventory score ( > 9 points) due to its influence on myofascial pain; allergy to tape.

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercises and manual therapy<br> | Other: Exercises<br>* Strengthening and stretching<br>Other: Exercises + Manual Therapy<br>* Mobilization; massage; post-isometric relaxation; strengthening; stretching<br>|
| Active Comparator: Exercises<br> | Other: Exercises<br>* Strengthening and stretching<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scapular kinematics |  | up to 3 months from the initial interview |
Electrocardiography Versus Pulse Oximetry for Newborn Heart Rate Determination

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to compare the time required for accurate heart rate measurement of the preterm newborn when using pulse oximetry versus electrocardiography leads.

Official Title
-----------------
A Comparison of Electrocardiography Versus Pulse Oximetry for Determination of Initial Heart Rate in Preterm Newborns: A Pilot Study.

Conditions
-----------------
Prematurity

Intervention / Treatment
-----------------
* Device: Apparatuses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gestational age of 24-32 weeks Exclusion Criteria: Babies with open abdominal defects

Ages Eligible for Study
-----------------
Maximum Age: 20 Minutes

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Babies<br>Preterm newborn infants thought to be 24-32 weeks gestational age. | Device: Apparatuses<br>* Each baby will have both pulse oximetry leads (Massimo Radical 7) and electrocardiography leads (3M™ Red Dot™ Neonatal Limb Band Monitoring Electrodes, Pre-wired) applied. The time required for each modality to register a heart rate will be compared.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time until accurate heart rate. | The elapsed time (in seconds) between application of the specific measuring apparatus (pulse oximeter probe or electrocardiograph leads) and measurement of heart rate. | To be determined | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intermeasurement accuracy | Assessment of the level of accuracy between the two times to be measured. | To be determined | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Premature, baby, heart rate, resuscitation
DC-CIK Immunotherapy Plus Chemotherapy vs Chemotherapy Alone in the Adjuvant Treatment of Stage III Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
Stage III colorectal cancer constitutes more than half of the colorectal patients, and the prognosis does not improve much recently although varies of adjuvant drugs have been tried. DC-CIK immunotherapy has been proved to improve survival in cancer patients, but its role in stage III colorectal cancer patients stains unclear. The investigators study will focus on the efficacy and safety of DC-CIK immunotherapy plus chemotherapy in the adjuvant treatment of stage III colorectal cancer, compared with chemotherapy alone.

Official Title
-----------------
Randomized Controlled Trial Comparing DC-CIK Immunotherapy Combined With Adjuvant Chemotherapy and Adjuvant Chemotherapy Alone in Stage III Colorectal Cancer.

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: Fluorouracil
* Drug: Oxaliplatin
* Drug: Leucovorin
* Biological: DC-CIK


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage III colon cancer Undergone complete resection of primary tumor Completed standard adjuvant chemotherapy ECOG performancer status 0-2 Adequate hematologic, hepatic and renal functions Exclusion Criteria: HIV positive or other Immunodeficiency disease Uncontrolled hypertension History of recent cancers in the past 5 years Patients with previous or concurrent malignancy or any anti-cancer therapy Patients who were allergic to platinum drugs or fluorouracil Pregnant patients

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DC-CIK Immunotherapy Plus Chemotherapy<br>Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy will receive 12 cycles of DC-CIK therapy in this group | Drug: Fluorouracil<br> <br> * Other names: 5-FU;Drug: Oxaliplatin<br> <br> Drug: Leucovorin<br> <br> Biological: DC-CIK<br> <br> |
| Active Comparator: Chemotherapy Alone<br>Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy alone. | Drug: Fluorouracil<br> <br> * Other names: 5-FU;Drug: Oxaliplatin<br> <br> Drug: Leucovorin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 2 years | 
| Side Effect |  | 6 month |