linjc16/ctgov huggingface dataset:
Does Cold Provocation Increase Brown Adipose Tissue Volume?

Study Overview
=================
Brief Summary
-----------------
About 28 healthy subjects are randomized to 1 hour/day of coldprovocation or to the best of ability to avoid feeling cold, for 6 weeks. Basal metabolic rate and magnetic resonance (for determination of brown adipose tissue volume) imaging are performed before and after the study.

Official Title
-----------------
Study of the Effects of Temperature on Amount of Brown Adipose Tissue in Humans

Conditions
-----------------
Brown Adipose Tissue, Human

Intervention / Treatment
-----------------
* Procedure: cold arm
* Procedure: warm arm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subjects - Exclusion Criteria: any significant disease, ot other conditions that interferes with magnetic resonance imaging -

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: cold provocation<br>cold arm | Procedure: cold arm<br>* 1 hour/day of cold provocation of such an extent that it is unpleasant but does not cause shivering<br>|
| Active Comparator: to avoid feeling cold<br>warm arm | Procedure: warm arm<br>* To the best of ability avoid feeling cold during 6 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brown Adipose Tissue, Absolute Volume | Sub-clavicular brown adipose tissue volume by magnetic resonance imaging (liters) | Baseline and 6 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
brown adipose tissue, human
Assessing Costs & Cost-variability Among Enrollees of Health Insurance Programs Utilizing Charlson's Comorbidity Index and Administrative Databases

Study Overview
=================
Brief Summary
-----------------
This study will involve the evaluation of the cost profile of about approximately 241,000 patients (15,000 who are members of the Generations Plus/ Northern Manhattan Health Network AND 226,000 members of a large self insured union trust fund). We will test the hypothesis that as comorbidity scores exceed three-four, patients will have an exponential increase in average yearly cost with a parallel exponential increase in cost variability. We will examine the relationship between comorbidity and health insurance costs and variability in costs among patients enrolled in health plans.

Official Title
-----------------
Assessing Costs & Cost-variability Among Enrollees of Health Insurance Programs Utilizing Charlson's Comorbidity Index and Administrative Databases

Conditions
-----------------
Multiple Chronic Illnesses

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with different burdens of comorbidity who have at least two continuous years of enrollment in the Generations Plus/ Northern Manhattan Health Network between June 2007 to July 2009 and members of a large self insured union trust fund from 2007-2010
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Assessing costs & cost-variability<br>Data for the approximately 15,000 patients who were continuously enrolled during the calendar years 2006 and 2007 in the Generations Plus/ Northern Manhattan Health Network and 226,000 members of a large self insured union trust fund from 2007-2010 will be combined. The data will include age, gender, length of plan enrollment, whether or not the patient is disabled, their diagnoses, and their use of medical and social services. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing costs & cost-variability among enrollees of health insurance programs utilizing Charlson's comorbidity index and administrative databases | Data for approximately 241,000 patients (15,000 who are members of the Generations Plus/ Northern Manhattan Health Network and 226,000 members of a large self insured union trust fund) during the calendar years 2006 and 2010 will be assembled and will include age, gender, length of plan enrollment, whether or not the patient is disabled, and their diagnoses. The data within this dataset was collected between July 2006 and July 2010. | The data within this dataset was collected between July 2006 and July 2010. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
comorbidity, multiple chronic conditions, Medicaid, prediction of cost, Predictive models, cost containment, managed care
Application of Circulating Tumor DNA Test in the Diagnosis and Treatment of Patients With Advanced Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
Application of circulating tumor DNA detection in diagnosis and treatment of locally advanced rectal cancer. First, to explore the feasibility of ctDNA as a detection index for rectal cancer. Second, evaluate the accuracy of ctDNA detection in rectal cancer. Third, to explore whether ctDNA can be used in the evaluation of preoperative concurrent chemoradiotherapy, so as to provide guidance for subsequent treatment. Fourth, to explore the guidance value for the decision of postoperative adjuvant therapy and the frequency of reexamination. Fifth, search for possible recurrence related mutations.

Official Title
-----------------
Application of Circulating Tumor DNA Test in the Diagnosis and Treatment of Patients With Advanced Rectal Cancer

Conditions
-----------------
Rectal Neoplasms, Neoadjuvant Therapy, Circulating Tumor DNA

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed primary rectal cancer； First treatment； 18 years of age or older, male or female； According to the indications of operation, surgical treatment can be carried out； According to the indications of radiotherapy, radiotherapy can be carried out； The physical status score of ECOG was 0 1； Organ function is appropriate; Expected survival time more than 3 months； During the treatment period and 6 months after treatment, contraception was not in lactation； The patient volunteered and signed the informed consent. Exclusion Criteria: Poor compliance and failure to receive medication or follow up according to plan； There are other serious violations of the programme; At present, it has been included in other clinical trials, or at the same time, it has been included in other medical research which is judged to be incompatible with this research； It has a history of other cancers. Unless the cancer is completely relieved, the disease is not treated for more than 3 years.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival | Disease free survival | 3 year |
A Study of Single-Dose Gabapentin in Subjects With Transient Insomnia Induced by a Sleep Phase Advance

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effect of gabapentin as compared to placebo on sleep, using subjective sleep measurements, in subjects with transient insomnia induced by a sleep phase advance.

Official Title
-----------------
A Randomized, Double-Blind, Single-Dose, Placebo-Controlled, Multicenter Study Of Gabapentin 100 mg and 250 mg in Transient Insomnia Induced By A Sleep Phase Advance

Conditions
-----------------
Transient Insomnia

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged >/= 18 years Females of child-bearing potential using medically-acceptable method of birth control >/= 1 month prior to screening Exclusion Criteria: Current or recent history (within 2 years) of sleep disorder (excessive snoring, obstructive sleep apnea, chronic painful condition) Recreational drug use within past 30 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: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Gabapentin<br>* Gabapentin 100 mg oral capsule 30 minutes prior to bedtime<br>|
| Experimental: B<br> | Drug: Gabapentin<br>* Gabapentin 250 mg oral capsule 30 minutes prior to bedtime<br>|
| Placebo Comparator: C<br> | Drug: Placebo<br>* Matched placebo 30 minutes prior to bedtime<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective sleep latency |  | Hour +8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stanford Sleepiness Scale |  | Hour +13 | 
| Vital signs |  | Hour +8 | 
| Adverse events |  | Hour +13 | 
| Subjective number of awakenings |  | Hour +8 | 
| Subjective wake after sleep onset |  | Hour +8 | 
| Subjective total sleep time |  | Hour +8 | 
| Subjective assessment of sleep refreshment |  | Hour +8 | 
| Subjective assessment of sleep quality |  | Hour +8 | 
| Karolinska Sleep Diary-Sleep (KSD) Quality Index |  | Hour +8 | 
| KSD individual scores |  | Hour +8 | 
| Digit Symbol Substitution Test |  | Hour +8 | 
| Buschke Selective Reminding Test (immediate recall score, long term storage score, total number of intrusions, delayed recall score) |  | Hour +8 |
Effect of Iron Therapy as an Adjunct to Epoetin Alfa in the Anemia of Cancer Chemotherapy

Study Overview
=================
Brief Summary
-----------------
This study evaluates the safety and efficacy of Ferrlecit® (ferric gluconate; a form of intravenous iron) or ferrous sulfate (a form of oral iron) in improving the response to epoetin alfa among anemic cancer patients receiving chemotherapy.

Official Title
-----------------
A Multicenter, Randomized, Controlled Prospective Trial of the Safety and Efficacy of Ferrlecit® in Anemic Cancer Patients Who Are Receiving Acute Chemotherapy and Epoetin as Compared to Oral Iron and No Treatment

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: Sodium ferric gluconate, ferrous sulfate, standard of care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of nonmyeloid malignancy Moderate to severe anemia Adequate iron stores as measured by either TSAT or ferritin About to start cycle of chemotherapy Eligible for epoetin alfa therapy Exclusion Criteria: Highly elevated TSAT or ferritin Recent transfusion, epoetin alfa, darbepoetin or intravenous iron Medical conditions that would confound the efficacy evaluation

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

| Intervention/Treatment |
| --- |
|Drug: Sodium ferric gluconate, ferrous sulfate, standard of care|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hemoglobin |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in various iron indices |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Iron deficiency, Sodium ferric gluconate, anemia, cancer chemotherapy, epoetin alfa, Anemia/drug therapy, Anemia, Iron-Deficiency/drug therapy/etiology, Hematinics/administration & dosage/pharmacology, Antineoplastic Agents/adverse effects, Erythropoietin, Recombinant/therapeutic use/adverse effects
Utility and Cost-effectiveness of Microscopic Examination of the Neck Dissection.

Study Overview
=================
Brief Summary
-----------------
Most patients with cancer of the head and neck are offered surgical resection of the primary tumor. In order to determine how the tumor will eventually behave, along with the resection of the primary tumor, lymph nodes present in the neck are also dissected. Different institutes have different protocol on handling of the specimen that is received by the pathology labs after dissection of the neck. The investigators intend to analyze the protocol that they use to evaluate the neck dissection specimen.

Detailed Description
-----------------
This will be a retrospective study. All neck dissections received in the histology laboratory from Jan 2013 to December 2016 will be retrieved from the histopathology files by conducting a search through CoPath. The glass slides of all the neck dissections that fit the study criterion will be retrieved from the archives. The glass slides will be reviewed by the pathologist. At the time of review number of lymph nodes identified microscopically, presence or absence of metastasis and if the Lymph Nodes (LN) were palpable or not palpable will be documented. The data will be analyzed to see if the submission of extra fat yielded any additional positive lymph nodes or microscopic deposits. The cost analysis for additional slides will be also done.

Official Title
-----------------
Utility and Cost-effectiveness of Microscopic Examination of the Neck Dissection Specimen in Its Entirety.

Conditions
-----------------
Metastasis

Intervention / Treatment
-----------------
* Other: additional soft tissue in neck dissections


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neck dissection (unilateral and/or bilateral) Primary squamous cell carcinoma of head and neck Exclusion Criteria: 1. Any neck dissection performed outside UMMC and case received as a consult.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: additional soft tissue in neck dissections|Evaluation of submission of additional soft tissue in neck dissections for head and neck squamous cell carcinomas|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of additional lymph nodes obtained with additional sampling of soft tissue | Number of additional lymph nodes obtained with additional sampling of soft tissue | 3 years |
Evaluation of a Hybrid Prototype Strategy (Electrostimulation of Lower Limb Muscles Associated With Voluntary Strengthening of the Upper Limbs) in Reconditioning to Effort in Patients With Chronic Paraplegia.

Study Overview
=================
Brief Summary
-----------------
This single-centre study was carried out in collaboration with the Cardiovascular Research Laboratory of Harvard University (Boston, USA). This preliminary study does not include a control group. The aim of this study was to investigate the effect of a hybrid reconditioning programme (electrostimulation of the lower limb muscles associated with voluntary strengthening of the upper limbs) on a specially developed rowing machine in patients presenting stabilized paraplegia of a traumatic origin. This study will bear on the increase in maximal aerobic capacity (VO2max) between the start and end of the 9-month reconditioning programme.

Official Title
-----------------
Evaluation of a Hybrid Prototype Strategy (Electrostimulation of Lower Limb Muscles Associated With Voluntary Strengthening of the Upper Limbs) in Reconditioning to Effort in Patients With Chronic Paraplegia.

Conditions
-----------------
Chronic Paraplegia

Intervention / Treatment
-----------------
* Other: strengthening
* Other: hybrid training programme


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients with paraplegia, ageb between 18 and 45 years Body mass index (BMI) between 18.5 and 29.9 2 to 15 years after the accident, ASIA A or B, lesion situated between T3 and T12 Medically stable Able to follow instructions Persons who have provided written informed consent Exclusion Criteria: Persons without national health insurance cover Arterial blood pressure > 140/90 mmHg, arrythmia, heart disease, diabetes, impaired kidney function, cancer smoking-induced intoxication, Medical treatment for cardiovascular disease or antidepressants Orthostatic hypotension with a symptomatic fall in arterial pressure > 30 mmHg in the vertical position Grade 2 or more pressure sores Other associated neurological diseases (e.g. cerebrovascular accident, peripheral neuropathy, myopathy) Any disease affecting the shoulder that may compromise the ability to use the rowing machine. Coagulation disorders; Presence of an implanted electronic device Epilepsy

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paraplegic patients<br> | Other: strengthening<br> <br> Other: hybrid training programme<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal oxygen consumption (VO2max) measured during an incremental maximum effort test |  | Change from baseline in VO2max at 9 months |
COVID-19-associated Anxiety of Pregnant Women for Anomalies, Stillbirth and Preterm Labor-2

Study Overview
=================
Brief Summary
-----------------
Capture of anxiety for anomalies, stillbirth and preterm labor of pregnant women during COVID-19 pandemia

Official Title
-----------------
COVID-19-associated Anxiety of Pregnant Women for Anomalies, Stillbirth and Preterm Labor-2

Conditions
-----------------
Anxiety State

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: consenting ability Exclusion Criteria: language barrier uncompleted questionary

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anxiety for anomalies during COVID-19-pandemic and before (percentage difference in agreement to the items of the questionnaire) | Measurement of self-reported anxiety by a questionnaire and State-Trait Anxiety Inventory (STAI) and comparison (cut-off values) with different empiric studies of anxiety for anomalies in pandemics | 6 months | 
| anxiety for stillbirths during COVID-19-pandemic and before (percentage difference in agreement to the items of the questionnaire) | Measurement of self-reported anxiety by a questionnaire and State-Trait Anxiety Inventory (STAI) and comparison (cut-off values) with different empiric studies of anxiety for stillbirths in pandemics | 6 months | 
| anxiety for preterm labour during COVID-19-pandemic and before (percentage difference in agreement to the items of the questionnaire) | Measurement of self-reported anxiety by a questionnaire and State-Trait Anxiety Inventory (STAI) and comparison (cut-off values) with different empiric studies of anxiety for preterm labour in pandemics | 6 months |
Efficacy Study of Dysport® in the Treatment of Anal Fissure.

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect on healing rates of two different prognostic factors in patients treated with Dysport® for anal fissure: duration of fissure and dose of study drug

Official Title
-----------------
A Phase II, Multicentre, Open, Randomised, Parallel Group, Dose Ranging Study to Define the Efficacy of Dysport® in the Treatment of Anal Fissure.

Conditions
-----------------
Anal Fissure

Intervention / Treatment
-----------------
* Biological: Botulinum toxin type A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients having idiopathic anal fissure in the posterior anal midline Patients having anal fissure present for less than 6 months Patients having symptoms (pain) present for a minimum of 2 weeks and not responding after 2 weeks of standard therapy (diet, laxatives, sitz-bathes) Exclusion Criteria: Patients having anal fistulas or anal fissure of various causes such as Crohn disease, Behcet infectious ulceration, anal suppuration, subfissural infiltration, abscesses, acute haemorrhoidal attacks or inflammatory bowel disease Patients having idiopathic anal fissure in the anterior anal midline Patients having lateral or multiple fissures Patients having anal or perianal cancer Patients who underwent previous anal surgery or have cicatricial alterations or post-surgical cicatricial lesions Patients receiving drugs affecting neuromuscular transmission Patients who have received topical anaesthetic within 3 days of injection Patients receiving local treatment by myorelaxing agent Patients receiving prohibited analgesics Patients having bleeding disturbances or currently using coumarin derivates Patients having myasthenia or any genetic muscle disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Botulinum toxin type A|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing of the anal fissure by complete re-epithelisation of the anal canal mucosa. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of anal pain measured by the patients on Analogue Visual Pain Scale. |  |  |