linjc16/ctgov huggingface dataset:
A Spinal Functional Magnetic Resonance Imagine (fMRI) Study of Resting-State, Motor Task and Acupoint Stimulation

Study Overview
=================
Brief Summary
-----------------
The spinal cord is a very important part of the central nervous system. fMRI can be applied to observe functional status of the human spinal cord. Under different conditions, the investigators will see different types of fMRI signals within the spinal cord. In resting state, the investigators might see active/inactive signals, too.

Official Title
-----------------
A Spinal fMRI Study of Resting-State, Motor Task and Acupoint Stimulation

Conditions
-----------------
Cerebral Infarction

Intervention / Treatment
-----------------
* Other: motor task, sensory stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (for healthy people): Chinese male residents right handed no history of psychological/psychotic problems no history of important diseases Exclusion Criteria (for healthy people): with factors which make subjects unsuitable to receive MR examination history of important diseases Inclusion Criteria (for patients): Chinese male patients with ischemic stroke (CT/MRI scan confirmed) right handed at least 1.5 months from onset of stroke ability to follow complex commands Exclusion Criteria (for patients): hemodynamic instability history of dementia inability to give consent because of impaired cognition or receptive aphasia diseases in spine/spinal cord with factors which make subjects unsuitable to receive MR examination

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>healthy people, male | Other: motor task, sensory stimulation<br>* motor task: finger tapping, simple type and complex type sensory stimulation: electric or tactile stimulation<br>* Other names: group 2:patients with cerebral infarction,chronic stage;|
| 2<br>male patients with cerebral infarction, chronic stage | Other: motor task, sensory stimulation<br>* motor task: finger tapping, simple type and complex type sensory stimulation: electric or tactile stimulation<br>* Other names: group 2:patients with cerebral infarction,chronic stage;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fMRI |  | one day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fMRI, spinal cord, human, health, cerebral infarction, healthy
Efficacy of a Scarf to Facilitate Mother-newborn Contact Designed to Facilitate Skin-to-skin Contact

Study Overview
=================
Brief Summary
-----------------
The skin-to-skin contact maneuver (kangaroo) has shown benefits in newborn babies. This is two-arm randomized open clinical trial to evaluate whether the use of a scarf specifically designed to facilitate the skin-to-skin method is effective in terms of increasing the skin-to-skin mother-neonate time, compared to traditional clinical practice. Mothers of full-term babies with expected delivery in the study centers will be included. Those mothers with a language barrier that prevents collaboration in the study procedures, cognitive impairment or morbid obesity will be excluded. The primary endpoint is the average daily skin-to-skin time during hospital admission days. A superiority analysis will be made in terms of the skin-to-skin time of the intervention arm, compared to the control arm.

Official Title
-----------------
Randomized Clinical Trial to Evaluate the Efficacy of a Scarf Designed to Facilitate Skin-to-skin Contact Between Parents and Healthy Term Neonates

Conditions
-----------------
Full-term Newborn Babies

Intervention / Treatment
-----------------
* Device: Scarf


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Moders attending the first hospital visit with the midwife, with delivery planned in either of the two study hospitals Exclusion Criteria: Language barrier that prevents collaboration in the study procedures Language barrier that prevents collaboration in the study procedures Language barrier that prevents collaboration in the study procedures

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Scarf<br> | Device: Scarf<br>* Scarf specifically designed to facilitate mother-neonate skin-to-skin contact<br>|
| No Intervention: Usual clinical practice<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mother-neonate skin-to-skin contact time | Number of daily hours of skin-to-skin contact maneuver (kangaroo) | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in arms or in physical contact of the neonate with the mother / father | Number of daily hours in arms or in physical contact of the neonate with the mother / father | 72 hours | 
| Time of crying | Number of daily hours crying | 72 hours | 
| Newborn weight loss | Weight change in grams | 72 hours | 
| Parents satisfaction with hospital care | Parents satisfaction (structured interview) | 72 hours |
Sems Placement With and Without Biliary Sphincterectomy in Patients With Malignant Biliary Obstruction

Study Overview
=================
Brief Summary
-----------------
Placement of biliary self expanding metal stent (SEMS) is indicated when malignant common bile duct obstruction is encountered [1]. Currently, there is still controversy regarding the use of endoscopic sphincterotomy (EST) before the placement of biliary stents [2-5]. The aim of this prospective randomized, multicenter study is to investigate the role of EST before fully covered SEMS placement in patients with neoplastic biliary obstruction.

Official Title
-----------------
A Prospective, Randomized, Multicenter Study Comparing Sems Placement With and Without Biliary Sphincterectomy in Patients With Malignant Biliary Obstruction

Conditions
-----------------
Malignant Bile Duct Obstruction

Intervention / Treatment
-----------------
* Procedure: ES before fully covered SEMS placement
* Procedure: no ES before fully covered SEMS placement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Patients referred for endoscopic retrograde cholangiopancreatography Malignant bile duct obstruction Signed written informed consent Age > 18 Exclusion criteria Inability to provide inform consent Pregnancy or lactation Suspected perforation of the GI tract Anatomical alterations due to previous surgery (Billroth surgery) Coagulation alterations

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 |
| --- | --- |
| Active Comparator: ES before SEMS placement<br>ERCP with ES before biliary fully covered SEMS placement. | Procedure: ES before fully covered SEMS placement<br> <br> |
| Active Comparator: no ES before SEMS placement<br>ERCP without ES before biliary fully covered SEMS placement. | Procedure: no ES before fully covered SEMS placement<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the need for ES before SEMS placement in patients with malignant bile duct obstruction. |  | During procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate immediate and delayed post ERCP complications including pancreatitis, SEMS migration, bleeding and perforation. |  | periprocedural and 30 days |
A 28 - 90 Days Study to Evaluate the Safety, Tolerability, and Efficacy of Caspofungin Injection as Empirical Therapy in Indian Adults With Persistent Fever and Neutropenia (0991-053)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety, tolerability and efficacy of ertapenem sodium as initial therapy for the treatment of complicated urinary tract infections, including pyelonephritis in indian adults.

Official Title
-----------------
A Noncomparative, Multicenter, Open-Label, Study to Evaluate the Safety, Tolerability and Efficacy of MK0991 as Empirical Therapy in Indian Adults With Persistent Fever and Neutropenia

Conditions
-----------------
Fungal Infection

Intervention / Treatment
-----------------
* Drug: caspofungin acetate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has a low white cell count (less than 500/mm3) for at least 96 hours Patient is indian and is greater than 18 years of age Patient received chemotherapy for blood disorders and blood cancers Exclusion Criteria: Patient has an invasive fungal infection Patient has a bacterial infection that is not controlled Patient has allergy to the class of antifungals of study drug Patient is not expected to survive at least 5 days Patient is pregnant or breast-feeding

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: caspofungin acetate|Cancidas 50 mg dose followed by 70 mg load on day 1 was administered in Indian adults with persistent fever and neutropenia for a maximum duration of empirical treatment from 28 days ((for patients without documented infection) to 90 days (for patients with documented baseline or emergent fungal infection). Patients were treated until the resolution of neutropenia (ANC>500/mm3), and for up to 72 hours later.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any clinical or laboratory serious drug-related adverse experience during the study drug therapy period plus 14 days posttherapy. |  | during the study drug therapy period plus 14 days posttherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival for at least 7 days following study therapy reduce fever during period of low white blood cell counts fungal infection no longer present following study therapy |  | 7 days following study therapy |
Safety and Efficacy Study of Intravenous Loading Dose of Ibandronate in Breast Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the efficacy and safety of a three time repeated loading dose of intravenous ibandronate (ibandronic acid), 6 mg, in breast cancer patients with painful skeletal metastases.

Detailed Description
-----------------
Painful skeletal metastases are a common site of advanced disease. For instance, in breast cancer, and despite cancer treatments (radiotherapy, cytotoxic treatment and adequate treatment of pain), the patients often need additional treatments that may relieve their symptoms. Bisphosphonates, such as ibandronic acid, have in pilot studies shown a significant decrease in pain scores, both after loading dose and after long-term treatment. In this study the safety and efficacy of an intravenous loading dose of three times 6 mg ibandronate during three consecutive days in breast cancer patients with painful skeletal metastases will be studied.

Official Title
-----------------
Phase II Open Label Study to Establish the Safety and Efficacy of Intravenous Loading Dose of Ibandronate 6 mg in 3 Consecutive Days in Breast Cancer Patients With Skeletal Metastases

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: Ibandronic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Breast cancer with presence of bone metastases Pain score over 4 on the VAS Exclusion Criteria: Patients with pathological fractures or medulla compression or neuropathic pain Patients with infection or corticosteroid treatment Pregnant or lactating patients
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: Ibandronic acid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Worst and average pain in movement and rest on the visual analogue scale (VAS) before the first dose, on days 2, 3, 7 and on day 28 |  |  | 
| Analgesic consumption during the same period will additionally be assessed |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone markers: serum 1CTP, serum P1NP, serum NTX on day 1 before dosing, and on days 7 and 28 |  |  | 
| World Health Organization (WHO) performance status |  |  | 
| Safety: serum cystatin C and serum creatinine, and reporting of adverse events |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, skeletal metastases, bisphosphonate therapy, Breast cancer with painful skeletal metastases
Therapeutic Efficacy of Phytosterols on Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
The objective is to evaluate therapeutic efficacy of 2 grams nano-phytosterols daily supplemention on diagnosis criteria of metabolic syndrome.

Official Title
-----------------
Double Blind, Randomized, Phase III, Parallel, Placebo-controled Study to Evaluate Therapeutic Efficacy of 2 Grams Phytosterols Daily Supplemention on Patients With Metabolic Syndrome

Conditions
-----------------
Metabolic Syndrome x

Intervention / Treatment
-----------------
* Dietary Supplement: Phytosterols
* Dietary Supplement: Titanium Dioxide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent written Available subjects to follow-up visits Subjects with diagnoses of metabolic syndrome 5 years ago or with current diagnoses criteria Subjects with health visits ongoing Subjects with arterial hypertension under control. Subjects with mellitus diabetes under control. Exclusion Criteria: Subjects with alcoholism history. Subjects with history of sitosterolemia. Subjects with familiar hypercholesterolemia Subjects who are consuming phytosterols Pregnancy women Breastfeeding period women Subjects with personal history of: acute miocardical infarction, stroke, hypertensive emergency, acute or chronic diabetes descompensation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phytosterol<br>Daily consumption of 2 grams (8 ml) nano-phytosterols per 180 days. | Dietary Supplement: Phytosterols<br>* Oral daily consumption of 2 grams of phytosterols (8 ml) per 180 days.<br>* Other names: Cardiosmile;|
| Placebo Comparator: Placebo<br>Daily consumption of 8 ml of a solution with Titanium Dioxide per 180 days. | Dietary Supplement: Titanium Dioxide<br>* Oral daily consumption of Titanium Dioxide (8 ml) per 180 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of proportion between study groups in the proportion of metabolic syndrome from baseline and the last visit (180 days). |  | 180 days |
Study of Eltrombopag in Platelet Refractory Thrombocytopenia

Study Overview
=================
Brief Summary
-----------------
This phase II trial is studying the effects of the drug eltrombopag has on thrombocytopenia (low platelet count). Eltrombopag is approved by the FDA for the treatment of thrombocytopenia (low platelet count) in adults who have had an insufficient response to medications such as corticosteroids and immunoglobulins. Eltrombopag is not approved by the FDA (Food and Drug Administration) for the treatment of thrombocytopenia refractory to platelet transfusion and so for this study is considered investigational.

Official Title
-----------------
A Phase II Study of Eltrombopag in Platelet Refractory Thrombocytopenia

Conditions
-----------------
Thrombocytopenia

Intervention / Treatment
-----------------
* Drug: Eltrombopag


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Laboratory diagnosis of platelet refractoriness Diagnosis of platelet dependence Adequate liver and renal laboratory screening tests Exclusion Criteria: Patients with thrombocytopenia that are responsive to platelet therapy Patients actively receiving intravenous immunoglobulin, plasmapheresis or cytotoxic medications for thrombocytopenia

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: Eltrombopag<br>Eltrombopag 75 mg per day. Possible escalation to 150 mg per day after day 15 lab results. Possible escalation to 300 mg per day after day 29 lab results. | Drug: Eltrombopag<br>* 75 mg per day with possible dose escalation to 150 mg per day and 300 mg per day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the likelihood of eltrombopag allowing platelet transfusion independence in patients with platelet refractoriness at doses of 75 mg, 150 mg, and 300 mg per day |  | 3 years average | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Platelet refractory thrombocytopenia
Brain Imaging of Psychotherapy for Depression

Study Overview
=================
Brief Summary
-----------------
The goal of the proposed research is to examine the neural correlates of depressive symptom reduction in individuals with major depressive disorder using functional magnetic resonance imaging (fMRI), and to compare results to those obtained from a nondepressed control group.

Official Title
-----------------
Brain Imaging of Psychotherapy for Depression (Includes, Reward System Recovery Following Behavioral Activation Therapy in Depression)

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Behavioral: Brief Behavioral Activation Treatment for Depression


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For group 1: Diagnosis of current depression and no other current Axis I psychiatric disorder For group 1: Hamilton Depression Rating Scale score of 15 or greater Exclusion Criteria: A history of serious head injury or neurological disease or psychosis Current use of psychoactive medications Factors that could affect MRI safety including current or planned pregnancy For group 2: current Axis I psychiatric disorder, as assessed by structured clinical interview

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 55 Years

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

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Individuals with major depressive disorder receiving therapy | Behavioral: Brief Behavioral Activation Treatment for Depression<br>* Weekly individual therapy sessions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Inventory |  | three times over 12 weeks | 
| Functional Magnetic Resonance Imaging |  | twice in 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Control participants