linjc16/ctgov huggingface dataset:
A Study to Evaluate Safety and Efficacy of PHX1149T in Subjects With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
This study is to test the efficacy and safety of PHX1149T in combination with metformin, a glitazone, or metformin and a glitazone in subjects with Type 2 diabetes for 12 weeks. After completing the 12 week double blind part of the study, subjects can enter an open label extension study

Official Title
-----------------
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of PHX1149T in Subjects With Type 2 Diabetes Mellitus

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: PHX1149T


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Entry Criteria: Type 2 diabetes mellitus, diagnosed at least 4 months but not more than 12 years prior to screening. Male and non-pregnant, non-lactating (and not planning to become pregnant during the study) female subjects with a BMI of 25 to 48 kg/m2, inclusive. For India the BMI is 23 to 48 kg/m2, inclusive. Current treatment of Type 2 diabetes mellitus with a stable dose of metformin of 1500 mg or more (or the highest tolerated dose), or TZD (any labeled dose), or metformin + TZD at doses used in accordance with product labeling for at least 4 weeks (metformin) or 10 weeks (TZD) prior to screening (Visit 1). Fasting plasma glucose of 118 - 220 mg/dL (6.6 - 12.2 mmol/L), inclusive; HbA1c 7.3% - 11.0%, inclusive; and a fasting plasma C peptide greater than 0.26 nmol/L at screening. For Argentina the allowed upper limit of HbA1c is ≤ 10.5%. For Canada the upper limit will be 10.0% No Type 1 diabetes mellitus or marked diabetic long-term complications.

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: PHX1149T|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | 12 weeks |
Carbachols Headache-inducing Effect and Changes in Cerebral Blood Flow in Migraine Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test if carbachol infusion induces headache in migraine subjects as well as intra- and extra-cerebral vasodilatation.

Detailed Description
-----------------
To test if infusion of Carbachol induces headache in 12 migraine subjects as well as intra- and extra-cerebral vasodilatation in a double-blinded study

Official Title
-----------------
Experimental Study That Investigates the Effect of an Acetylcholine Analogue in Terms of Headache and Changes in Intra- and Extra-cerebral Vessels During and After Infusion of Carbachol

Conditions
-----------------
Headache

Intervention / Treatment
-----------------
* Drug: Carbachol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Migraine without aura Weight 50-100 kg Exclusion Criteria: Other significant diseases Migraine 5 days prior to experiment

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I<br> | Drug: Carbachol<br>* 3 microgram per kg bodyweight infused intravenously<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache response after Carbachol infusion |  | 1 day after infusion |
Rationale for New Topical Anthroponotic Cutaneous Leishmaniasis (ACL) Treatment in Kabul

Study Overview
=================
Brief Summary
-----------------
The aim of the randomized double blind trial with 134 patients presenting old world cutaneous leishmaniasis is: to evaluate the clinical efficacy of electro-thermo-cauterisation (ETC) followed by moist wound treatment versus ETC followed by moist wound treatment plus 0.05 % pharmaceutical chlorite that has been used in three European countries (Germany, Austria and Switzerland) in wound care management for more than 20 years; to judge whether early wound care management would present a viable improvement to the actual anti-parasitic treatments mostly neglecting the chronic wound problem and to evaluate its long-term effect on immunity through relapse control 6 months after wound healing.

Official Title
-----------------
Phase 2 Study Electrothermocauterisation of Afghan Patients With Anthroponotic Cutaneous Leishmaniasis With and Without Pharmaceutical Chlorite Listed in the German Drug Codex (DAC N-055)

Conditions
-----------------
Wound Healing

Intervention / Treatment
-----------------
* Other: Electro-thermo-coagulation
* Drug: DAC N-055
* Drug: saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least one suspected lesion positive in Giemsa smear Exclusion Criteria: patients previously treated for leishmania

Ages Eligible for Study
-----------------
Minimum Age: 5 Years

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ETC + DAC N-055<br> | Other: Electro-thermo-coagulation<br> <br> Drug: DAC N-055<br>* moist wound treatment plus 0.05 % pharmaceutical chlorite<br>|
| Active Comparator: ETC + physiological saline<br> | Other: Electro-thermo-coagulation<br> <br> Drug: saline<br>* physiological saline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound closure time |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leishmania load parasites per gram of tissue before and after treatment |  |  |
Influence of CPB and Mini CPB to the Absorption of the Metoprolol

Study Overview
=================
Brief Summary
-----------------
Influence of perfusion, miniperfusion and off pump coronary artery bypass grafting to the absorbtion of metoprolol postoperatively, hypothesis in that miniperfusion and off pump surgery does not decrease absorbtion of the metoprolol compared to conventional pefusion.

Detailed Description
-----------------
Influence of perfusion, miniperfusion and off pump coronary artery bypass grafting to the absorbtion of metoprolol postoperatively, hypothesis in that miniperfusion and off pump surgery does not decrease absorbtion of the metoprolol compared to conventional pefusion. Blood samples for concentration of metoprolol are taken preoperaively, 1. and 3. day after operation, before and 10 times after intake of 50 mg metoprolol. Sudy is randomized into 3 groups: 1. Miniperfusion n.15 2. Perfusion n.15 3. offpump n.15

Official Title
-----------------
Influence of CPB and Mini CPB to the Absorption of the Metoprolol After CABG

Conditions
-----------------
Drug Absorption

Intervention / Treatment
-----------------
* Drug: blood concentration of metoprolol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective CABG patient - Exclusion Criteria: contraindication to metoprolol -

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: blood concentration of metoprolol<br>how does off-pump miniperfusion and perfusion CABG influence the absorption of metoprolol after CABG | Drug: blood concentration of metoprolol<br>* measure blood concentration of metoprolol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| absorbtion of the metoprolol | absorbtion of the metoprolol, blood samples are taken centrifuged, frozed and analyzed | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| atrial fibrillation | is there correlation of incidence of the postopeative AF and absorbtion of the metoprolol | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
metoprolol, atrial fibrillation
Pilot Trial of the Robotic Uterine Manipulator

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test a robotic uterine manipulator system called the Barakat Automated Uterine Manipulator (BAUM), which will assist the surgeon in moving and positioning the uterus during a hysterectomy. This new device will allow the surgeon to control the movements of the robotic arm directly instead of giving verbal instructions to a staff member. The BAUM has never been used during surgeries before this trial. Overall, the study goal is to determine whether the use of this robotic uterine manipulator system can be safely used in the operating room while improving surgeon control during the procedure.

Official Title
-----------------
Pilot Trial of the Robotic Uterine Manipulator

Conditions
-----------------
Gynecologic Surgery

Intervention / Treatment
-----------------
* Device: BAUM device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female participant must be scheduled for a total laparoscopic or robotic-assisted hysterectomy for a gynecologic condition Female participants must be 18 years of age or older Exclusion Criteria: Female participant is not eligible if the surgeon does not plan to use a uterine manipulator

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: total laparoscopic or robotic-assisted hysterectomy<br>All patients who are consented for a total laparoscopic or robotic-assisted hysterectomy will be eligible for the trial, unless the surgeon does not plan to use a uterine manipulator. | Device: BAUM device<br>* The robotic manipulator will be placed at the start of each case. The manipulator will be cleaned and sanitized using the same process as other reusable OR devices. Feasibility will be determined by the rate of successful robotic manipulator docking and if the manipulation of the uterus was successful for the duration of the procedure. The V-Care is an FDA approved uterine manipulator which will attach to the investigational BAUM. Placement of a BAUM will be noted on the operative note.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of intraoperative complications attributed to the robotic manipulator. | will be assessed by reporting all intraoperative complications during the surgery. Complications might include vaginal tear or uterine perforation. | 25- 35 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Robotic Uterine Manipulator, 18-173
Extension Study of Long-term Safety and Efficacy of Myozyme in Patients With Pompe Disease Who Were Previously Enrolled in Genzyme Sponsored Enzyme Replacement Therapy (ERT) Studies

Study Overview
=================
Brief Summary
-----------------
This extension study was to monitor the long-term safety and efficacy of rhGAA treatment in patients with infantile-onset Pompe disease who were previously treated with rhGAA derived from the Synpac cell line

Official Title
-----------------
A Multicenter, Open-Label Extension Study of the Long-Term Safety and Efficacy of Recombinant Human Acid α-Glucosidase (rhGAA) in Patients With Pompe Disease (Glycogen Storage Disease Type II) Who Were Previously Enrolled in Genzyme-Sponsored Enzyme Replacement Therapy Studies

Conditions
-----------------
Pompe Disease Infantile-Onset, Glycogen Storage Disease Type II

Intervention / Treatment
-----------------
* Biological: Myozyme


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient was enrolled in Protocol AGLU-008-01, AGLU-009-02, or AGLU01502 The patient's legal guardian(s) provided written informed consent prior to any study related procedures being performed The patient and his/her guardian(s) were able to comply with the clinical protocol, which required extensive clinical evaluations for an extended period of time. Exclusion Criteria: Patients were excluded from this study if they did not meet the specific inclusion criteria, or if the patient experienced any unmanageable AE in Protocol AGLU-008-01, AGLU-009-02, or AGLU01502 (as determined and agreed upon by the Principal Investigator and Genzyme Corporation), due to Synpac rhGAA therapy, that would preclude continuing therapy

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: 1<br> | Biological: Myozyme<br>* 10 mg/kg or 20 mg/kg qw OR 20 mg/kg or 40 mg/kg qow<br>* Other names: Alglucosidase alfa;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The objective of this extension study was to monitor the long-term safety and efficacy |  | 3 years |
Quantitative Studies of Urinary Bladder Sensation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether more than one subpopulation exists of patients with the diagnosis of Interstitial Cystitis (IC) based on sensory testing and to determine if subjects with IC have normal counterirritation-related modulatory systems.

Detailed Description
-----------------
To determine whether more than one subpopulation exists of patients with the diagnosis of Interstitial Cystitis (IC) based on sensory testing and to determine if subjects with IC have normal counterirritation-related modulatory systems. Previous studies by the PI suggest that two populations of subjects are present in the IC population but a larger number of subjects with IC would need to be tested in order to determine if this were indeed true. Other studies have demonstrated that counterirritation-related effects are absent in several chronic pain populations including fibromyalgia and chronic headaches. Identification of a subset of IC patients or the identification of a failure of counterirritation-related effects may predict responses to therapeutic interventions.

Official Title
-----------------
Quantitative Studies of Urinary Bladder Sensation

Conditions
-----------------
Interstitial Cystitis

Intervention / Treatment
-----------------
* Other: Quantitative Sensory Testing and Stimulus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be able to read and speak English 19 years or older IC Diagnosis Exclusion Criteria: Over 65 years old Pregnant Children younger than 19 Significant cardiac disease

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Quantitative Sensory Testing and Stimulus|No therapeutic intervention will be given. Quantitative Sensory Testing, thermal/mechanical/ischemic stimulus will be performed.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The study proposes to examine the sensations that are produced by warming the skin, poking the skin, pressure on the muscles or by applying a blood pressure cuff. |  | One and a half to two hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cystitis, Urinary, Bladder
Urethrocutaneous Fistula Rate After Double Dartos and Single Dartos Tubularized Incised Plate Urethroplasty

Study Overview
=================
Brief Summary
-----------------
The subjects were divided into two groups. Each group comprised 30 children. Children were randomly allocated in two groups via computer generated tables. Children in group-A underwent single dartos tubularized incised plate urethroplasty while those in group-B underwent double dartos tubularized incised plate urethroplasty.

Detailed Description
-----------------
In group A dartos flap is raised from foreskin of the patient and applied as a single layer after tubularization in between neourethra and skin . In group B dartos flap is raised from the foreskin of patient and divided in two equal halves.Both flaps are placed as two layers in between skin and neourethra.After surgery patient is kept in ward for 10 days with stent.Patient is followed up in OPD on after 7th day after discharge for outcome.

Official Title
-----------------
To Compare the Frequency of Urethrocutaneous Fistula After Double Dartos Tubularized Incised Plate (TIP) Urethroplasty and Single Dartos Tubularized Incised

Conditions
-----------------
Hypospadias

Intervention / Treatment
-----------------
* Procedure: Group B
* Procedure: Group A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria All the patients above one year of age All patients having distal and mid penile hypospadias. - Exclusion Criteria Severe chordee Previously operated cases Patient with undescended testis Circumcised patient -

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 17 Years

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Dartos TIP<br>Single dartos tubularized incised plate urethroplasty | Procedure: Group A<br>* To release the pediatric hypospadias using Single Dartos Tubularized incised plate (TIP) Urethroplasty<br>* Other names: Single dartos TIP;|
| Experimental: Double Dartos TIP<br>Double dartos tubularized incised plate urethroplasty | Procedure: Group B<br>* To release the pediatric hypospadias using Double Dartos Tubularized incised plate (TIP) Urethroplasty<br>* Other names: Double dartos TIP;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of urethro-cutaneous fistula | Abnormal communication between urethra and penile skin after urethroplasty, presenting with complaints of two streams of micturition and noted on examination at 17th postoperative day. | 17 days |
Risk Factors for Recurrent Urinary Tract Infection in Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine clinical and urodynamic risk factors for recurrent urinary tract infection in 5-18 years old children.

Detailed Description
-----------------
It is known, that in the group of young children the most common reason of recurrent UTI is anatomic abnormalities, such as vesicoureteral reflux, hydronephrosis. However, not all recurrent UTI can be explained by anatomic abnormalities. The vast majority of school age children with recurrent UTI have anatomically normal urinary tract. Recent studies discuss about the role of behavioral and functional abnormalities (inadequate fluid intake, stool retention, infrequent voiding, etc.) that can predispose recurrent urinary tract infections. Influence of some these abnormalities for recurrent UTI is controversial. Family history, behavioral and functional abnormalities which predispose to urinary tract infections in children with normal urinary tract are neglected in most protocols of urinary tract infection. Children in this study receive a careful evaluation including complete history, voiding-drinking diary, bowel questionnaire, physical investigation, sonography, voiding cystourethrogram. Follow up time - 1 year. Urinalysis once a month and during each episode of fever.

Official Title
-----------------
Role of Clinical and Urodynamic Risk Factors for Recurrent Urinary Tract Infection in 5-18 Years Old Children

Conditions
-----------------
Urinary Tract Infection, Pyelonephritis, Cystitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 5-18 years old children, who were treated because of cystitis and pyelonephritis in Kaunas Medical University Hospital Exclusion Criteria: urinary tract malformations neurogenic bladder dysfunction patients, who received immunosuppressive drugs pregnant girls children with non bacterial urinary tract infection

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients, who were treated because of recurrent (2 or more urinary tract infections per year) pyelonephritis or cystitis. | |
| 2<br>Patients with nonrecurrent urinary tract infections (patients who had no history of more than one urinary tract infections in last year). | |

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
-----------------
pyelonephritis, cystitis, risk factor, children, urodynamics