linjc16/ctgov huggingface dataset:
Open-Label Study of Efficacy and Safety of Recombinant Human N-acetylgalactosamine 4-sulfatase in Patients With MPS VI

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is evaluate the efficacy, safety, and pharmacokinetics of weekly intravenous infusions of 1 mg/kg recombinant human N-acetylgalactosamine 4-sulfatase (rhASB) in patients diagnosed with Mucopolysaccharidosis VI (MPS VI)

Official Title
-----------------
Open-Label Study of Efficacy and Safety of Recombinant Human N-acetylgalactosamine 4-sulfatase in Patients With MPS VI

Conditions
-----------------
Mucopolysaccharidosis VI

Intervention / Treatment
-----------------
* Drug: N-acetylgalactosamine 4-sulfatase


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient consent Patient must be five years of age or older Patient must have documented biochemical or genetic proof of MPS VI Patient must walk at least 1 meter, but less than 250 meters, in the first 6 minutes of the baseline 12-minute walk test If female of childbearing potential, patient must have a negative pregnancy test Exclusion Criteria: Patient is under consideration for or has undergone a successful bone marrow transplant (BMT). Pregnant or lactating patient Patient has received an investigational drug within 30 days prior to study enrollment Patient has been previously treated with rhASB Patient has a medical condition, serious intercurrent illness, or other extenuating circumstance that may significantly confound study results or decrease study compliance Patient has a known hypersensitivity to rhASB or to components of the study drug History of cancer (except low grade and fully resolved skin malignancy)

Ages Eligible for Study
-----------------
Minimum Age: 5 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: N-acetylgalactosamine 4-sulfatase|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12-minute walk test |  | weeks 6, 12, 24, 48, 96 and 144 | 
| urinary glycoaminoglycan(uGAG)levels |  | weeks 1, 4, 6, 8, 12 |
Role of Low Inferior Mesenteric Artery Ligation During Laparoscopic Surgery for Rectosigmoid Cancer

Study Overview
=================
Brief Summary
-----------------
During sigmoid or rectal cancer surgery, dissection of lymphnodes at the origin of inferior mesenteric artery is mandatory. Nevertheless, ligation of the origin of IMA should compromise blood supply to left colon and affect anastomosis. The aim of this retrospective evaluation is to compare high and low IMA ligation with preservation of LCA, with or without skeletonization of the origin of IMA in laparoscopic colorectal resection.

Official Title
-----------------
Evaluation of the Role of Low Inferior Mesenteric Artery Ligation During Laparoscopic Surgery for Rectosigmoid Tumors

Conditions
-----------------
Rectosigmoid Adenocarcinoma

Intervention / Treatment
-----------------
* Procedure: Laparoscopic colorectal resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stage I-III carcinoma Exclusion Criteria: stage IV Urgent resection conversion to open surgery
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>High Ligation of Inferior mesenteric artery | Procedure: Laparoscopic colorectal resection<br>* Gruop 1: laparoscopic rectosigmoid resection with standard ligation of mesenteric artery at its origin Group 2: Laparoscopic rectosigmoid resection with low ligation of inferior mesenteric artery and its skeletonization with en bloc removal of all lymph nodes<br>|
| Group 2<br>Low ligation of inferior mesenteric artery with skeletonization at its origin | Procedure: Laparoscopic colorectal resection<br>* Gruop 1: laparoscopic rectosigmoid resection with standard ligation of mesenteric artery at its origin Group 2: Laparoscopic rectosigmoid resection with low ligation of inferior mesenteric artery and its skeletonization with en bloc removal of all lymph nodes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effectivenes of lymphnode dissection | number of dissected lymphnodes | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complication | incidence of anasthomotic leaks | 3 years |
Safety Follow-up Study for Subjects With Agitation Associated With Dementia of the Alzheimer's Type Who Previously Participated in a Double-blind Trial of Brexpiprazole or Placebo

Study Overview
=================
Brief Summary
-----------------
To follow-up on the safety of subjects who were previously treated in a double-blind trial of brexpiprazole.

Detailed Description
-----------------
Behavioral symptoms, such as agitation, are core features in subjects with Alzheimer's disease and related dementias, and develop in the majority of dementia subjects. The presence of agitation in subjects with Alzheimer's disease places a significant burden not only on subjects and their caregivers but also on the healthcare system. This is a trial designed to assess the ongoing safety of subjects with agitation associated with dementia of the Alzheimer's type after completing a 12-week double-blind trial of brexpiprazole or placebo; drug and placebo are discontinued prior to subjects enrolling in the safety follow-up trial. The trial consists of a continuous 2 month observation period. The trial population will include male and female subjects with a diagnosis of probable Alzheimer's disease.

Official Title
-----------------
A 2-Month, Observational, Rollover Trial to Evaluate the Safety of Subjects With Agitation Associated With Dementia of the Alzheimer's Type Who Were Previously Treated With Brexpiprazole (OPC 34712) or Placebo in a Phase 3, Double-blind Trial

Conditions
-----------------
Agitation Associated With Alzheimer's Disease, Alzheimer's Type, Mental Disorder, Nervous System Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The investigator must assess the capacity of the subject to provide informed consent prior to enrollment and throughout the trial. Male and female subjects who completed both the 12-week double-blind treatment period and the 30-day safety follow-up visit of the previous brexpiprazole trial. Subject has an identified caregiver who is usually assigned to care for the subject on a regular basis, has sufficient contact to describe the subject's symptoms, and has direct observation of the subject's behavior. Subject is able to comply with the protocol requirements. Exclusion Criterion: Subjects who, in the opinion of the investigator, medical monitor, or sponsor should not participate in the trial.
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 |
| --- | --- | --- |
| Adverse Events (AEs) |  | Baseline to Month 2/Early Termination | 
| Mini-Mental State Examination (MMSE) score |  | Baseline to Month 2/Early Termination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OPC-34712, brexpiprazole, Dementia, Alzheimer's Disease, Cognitive Disorders, Memory, Agitation
Tenoxicam for Intrapartum Analgesia

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess whether tenoxicam is as effective as pethidine for analgesia during the first stage of labor.

Official Title
-----------------
Efficacy of Intravenous Tenoxicam as an Analgesic During the First Stage of Labor: A Randomized Controlled Trial

Conditions
-----------------
Analgesia, Obstetrical

Intervention / Treatment
-----------------
* Drug: Tenoxicam
* Drug: Pethidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primiparity Active phase of labor (cervical dilatation of 3-5 cm, in the presence of adequate uterine contractions; lasting at least 40 seconds at intervals of 3-4 minutes) Maternal age between 20-30 years Singleton term pregnancy (37-42 weeks of gestation) Vertex-presenting fetus Exclusion Criteria: Clinical evidence of cephalopelvic disproportion Scarred uterus; previous cesarean section, hysterotomy or myomectomy Medical disorders associated with pregnancy, especially gastritis, peptic ulcer, bronchial asthma or renal impairment Fetal distress Receiving any regional or parenteral analgesia before recruitment in the study Known hypersensitivity to the drug family

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 30 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tenoxicam<br>Intravenous administration of tenoxicam, a lyophilisate with 20 mg to be dissolved and diluted in 10 mL of sterile water (single dose), as an analgesic during the first stage of labor, given by a member of the study team. | Drug: Tenoxicam<br> <br> |
| Active Comparator: Pethidine<br>Slow intravenous administration of pethidine, 50 mg to be diluted in 10 mL of sterile water (single dose), as an analgesic during the first stage of labor, given by a member of the study team. | Drug: Pethidine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy of intravenous tenoxicam to supply adequate analgesia as indicated by changes in the pain intensity score using the visual analog scale | Assessment is to be done and followed up by the investigator at ½, 1, 2, 3 and 4 hours from drug administration. Scores range from 0 [no pain] to 10 [worst possible pain]. | 4 hours |
Effect of Botulinum Toxin Type A on Swallowing in Patients With Cervical Dystonia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate swallowing efficiency in patients with cervical dystonia following treatment with botulinum toxin Type A.

Official Title
-----------------
Pilot Study of the Effect of Botulinum Toxin Type A Treatment on Swallowing in Patients With Cervical Dystonia

Conditions
-----------------
Torticollis

Intervention / Treatment
-----------------
* Biological: botulinum toxin Type A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with cervical dystonia Successfully completed Allergan study MedAff BTX-0616 with 16 weeks since last botulinum toxin Type A injection In need of additional botulinum toxin Type A injections Exclusion Criteria: Surgery or spinal cord stimulation for cervical dystonia Previous injections of phenol or alcohol for cervical dystonia

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>botulinum toxin Type A | Biological: botulinum toxin Type A<br>* 750 U at Visit 1<br>* Other names: Dysport®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Oropharyngeal Swallow Efficiency (OPSE) |  | Baseline, Week 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toronto Western Spasmodic Torticollis Scale (TWSTRS) Total Score |  | Week 4 | 
| Physician Assessment of Cervical Dystonia Severity |  | Week 4 | 
| Global Assessment of Benefit by Physician |  | Week 4 | 
| Global Assessment of Benefit by Patient |  | Week 4 | 
| Patient Visual Analog Assessment of Pain |  | Week 4 |
Multi-Center Study of ShuntCheck

Study Overview
=================
Brief Summary
-----------------
Multi-Center Study of ShuntCheck

Official Title
-----------------
Multi-Center Study of ShuntCheck

Conditions
-----------------
Blocked Ventricular Shunts

Intervention / Treatment
-----------------
* Device: ShuntCheck test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 19 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: ShuntCheck test|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
-----------------
Hydrocephalus, High Pressure, Shunt Blockage
Effect of Delayed vs Immediate Umbilical Cord Clamping on Maternal Blood Loss in Term Spontaneous Vaginal Delivery

Study Overview
=================
Brief Summary
-----------------
Policies for timing of cord clamping vary, with early cord clamping generally carried out in the first 60 seconds aLer birth, whereas latercord clamping usually involves clamping the umbilical cord greater than one minute after the birth or when cord pulsation has ceased

Official Title
-----------------
Effect of Delayed vs Immediate Umbilical Cord Clamping on Maternal Blood Loss in Term Spontaneous Vaginal Delivery

Conditions
-----------------
Post Partum Hemorrhage

Intervention / Treatment
-----------------
* Other: delayed cord clamping


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: singleton pregnancy at term cephalic presentation spontaneous labor spontaneous vaginal delivery Exclusion Criteria: multiple gestation preterm gestation induced labor operative delivery hypertension or preeclampsia fetal anomaly abnormal placentation planned cord blood banking maternal bleeding disorder
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Immediate cord clamping<br>Immediate cord clamping was defined as clampingwithin 15 seconds of birth | Other: delayed cord clamping<br>* delayed cord clamping<br>|
| Experimental: delayed cord clamping<br>when the cord stopped pulsing, or five minutes | Other: delayed cord clamping<br>* delayed cord clamping<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in maternal hemoglobin level on post delivery day 1 compared with the predelivery hemoglobin level | The primary outcome was an objective measure of maternal blood loss: the change in maternal hemoglobin level on postdelivery day 1 compared with the predelivery hemoglobin level. | day 1 after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postpartum hemorrhage | defined as estimated blood loss>500cc | at the time of delivery | 
| uterotonic administration |  | at the time of delivery | 
| need for blood transfusion |  | at the time of delivery | 
| jaundice | neonatal jaundice | day 10 of life |
Management Strategy of Polypoid Lesions of the Gallbladder

Study Overview
=================
Brief Summary
-----------------
We retrospectively review a single-center cohort of gallbladder polyps from January 2015 to May 2020. Univariate and multivariable analyses were performed to extract potential risky factors of neoplastic polyps. Also, a comparison was conducted between laparoscopic cholecystectomy (LC) and laparoscopic polypectomy (LP) to explore factors affecting surgeons' decision on LC or LP.

Official Title
-----------------
Management Strategy of Polypoid Lesions of the Gallbladder: a Single-center Retrospective Cohort Study

Conditions
-----------------
Polyp Gallbladder

Intervention / Treatment
-----------------
* Other: Non


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Surgical indications for LC included polyp diameter over 10 millimeters, or polyps accompanied by GB stones, or consideration of neoplastic polyps. Surgical indications for GB-preserving surgery included GB with normal emptying function and polyp diameter smaller than 10 millimeters, or consideration of benign non-neoplastic polyps, or asymptomatic polyps. Exclusion Criteria: Those do not fit for laparoscopic surgery.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-neoplastic group<br>Gallbladder polyps with pathological diagnosis of cholesterol polyps or inflammatory polyps are classified into Non-neoplastic group. | Other: Non<br>* This is a retrospective study, without intervention.<br>|
| Neoplastic group<br>Gallbladder polyps pathologically diagnosed as adenocarcinoma, adenoma, adenomyosis, or other malignancies are classified into Neoplastic group. | Other: Non<br>* This is a retrospective study, without intervention.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological diagnosis of polyps | Pathological diagnosis of polyps | Up to two weeks after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gallbladder polyp; laparoscopic cholecystectomy; polypectomy
We Talk About Our Hypertension

Study Overview
=================
Brief Summary
-----------------
The proposed pilot community-based research project will examine the feasibility, acceptability, and potential efficacy of the Storytelling intervention compared with usual care in hypertension control among rural residents in 4 communities in Vietnam. This is a major clinical and public health problem in this developing country.

Official Title
-----------------
Culturally Adaptive Storytelling Method to Improve Hypertension Control in Vietnam -We Talk About Our Hypertension: a Pilot Cluster Randomized Controlled Trial

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Behavioral: Storytelling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consenting adult men and women must fulfill each of the following criteria: be a resident of the selected commune; be aged 50 years or older; have a diagnosis of hypertension according to the 7th Joint National Commission of High Blood Pressure (JNC 7) not be cognitively impaired (as assessed by study physicians) not be a story teller used to develop the intervention; not be a family member of another participant in the study Exclusion Criteria:

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Storytelling intervention<br>Two communes will be assigned to intervention group. Within each commune, 25 adults with HTN will be enrolled. Patients will receive 2 DVDs with stories of patients who have successfully controlled their hypertension and Learn More section, which will be coordinated with specific patient stories and will fill in gaps not covered by the storytellers. | Behavioral: Storytelling<br>* The intervention will center on stories about living with hypertension, with patients speaking in their own words.<br>|
| No Intervention: Usual care<br>Two communes will be assigned to usual care group. Within each commune, 25 adults with HTN will be enrolled. Patients will receive 2 DVDs with only didactic material about common non-communicable diseases but without hypertension related stories. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recruitment rate |  | 3 months | 
| retention rate |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | systolic and diastolic BP and the proportion of participants with controlled BP defined as in JNC-8 | 3 months after randomization |