linjc16/ctgov huggingface dataset:
Randomized Trial of Mobilized Blood/Marrow Versus Blood Transplant

Study Overview
=================
Brief Summary
-----------------
The use of peripheral blood stem cells(PBSCs) is rapidly growing in the allogeneic transplantation setting as an alternative to bone marrow (BM).It was found that the use of PBSCs is associated with faster hematologic recovery but have yielded differing results regarding the incidence of graft-versus-host-disease (GVHD) and relapse. The study hypothesis: transplantation of mobilized PBSC to haploidentical donor with standard-risk leukemia had comparable engraftment and non-relapse mortality to mobilized BM combined with PBSCs

Detailed Description
-----------------
The donors were primed with granulocyte-colony stimulating factor (G-CSF) injected subcutaneously for five consecutive days. In the trial group, the PBSCs were harvested on the fourth and fifth day;in the control group, the bone marrow cells were harvested on the fourth day and the PBSCs were harvested on the fifth day.

Official Title
-----------------
Randomized Trial of Unmanipulated Mobilized Blood/Marrow Versus Blood Haploidentical Transplant With Standard-risk Leukemia

Conditions
-----------------
Leukemia

Intervention / Treatment
-----------------
* Procedure: transplant with PBSCs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Standard risk of Recipients of haploidentical stem cell transplantation with myeloablative conditioning regimens Exclusion Criteria: Active, uncontrolled infection

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: procedure/surgery<br>transplant with G-CSF mobilized PBSCs | Procedure: transplant with PBSCs<br>* mobilized PBSCs for 2 consecutive days<br>* Other names: G-CSF mobilized peripheral blood stem cells;|
| No Intervention: other<br>no intervention after transplant with mobilized BMPB | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of engraftment | number of participants with engraftment at 30d | paticipants will be followed for the duration of hospital stay,an expected average of 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of non-relapse mortality | number of participants with non-relapse mortality at 1 year | 1 year |
Are Newborns Conscious of the Placebo Effect? Result From an RCT in Osteopathy

Study Overview
=================
Brief Summary
-----------------
Results from previous studies suggest the association between Osteopathic Manipulative Treatment (OMT) and length of stay (LOS) reduction in a population of preterm infants. The primary objective of the present study is to evaluate the effectiveness of sham OMT in reducing LOS in a sample of preterm newborns, in order to investigate whether previous clinical results could be related to a hypothetical placebo effect.

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

Intervention / Treatment
-----------------
* Other: Sham Osteopathic Manipulative Treatment
* Other: Standard care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: preterm infants born at age between 29 and 37 weeks sham osteopathic treatment performed < 14 days after birth preterm infants born in the same hospital Exclusion Criteria: gestational age < 29, > 37 weeks; sham osteopathic treatment performed > 14 days after birth; newborn transferred to/from other hospital; newborn from to HIV seropositive and/or drug addict mother; newborn with genetic disorders, congenital abnormalities, cardiovascular abnormalities, neurological disorders, proven or suspected necrotizing enterocolitis with or without gastrointestinal perforation, proven or suspected abdominal obstruction, pre- and/or post-surgery patients, pneumoperitoneum and/or atelectasis.

Ages Eligible for Study
-----------------
Minimum Age: 29 Weeks
Maximum Age: 37 Weeks

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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sham OMT<br>patients under standard medical care plus sham OMT | Other: Sham Osteopathic Manipulative Treatment<br>* Patients from this group received sham osteopathic treatments twice a week for the entire length of stay in the unit.<br>|
| Other: Control<br>patients under standard medical care plus only osteopathic evaluation | Other: Standard care<br>* Patients from control group received standard care plus osteopathic evaluation only, according to the same schedule as the study group.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the effectiveness of sham OMT in reducing LOS |  | participants will be followed for the duration of hospital stay, an expected average of 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pre-post difference in weight gain |  | participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
PPI-Rebound-Trial. A Study of the Clinical Relevance of the Acid Rebound Phenomena

Study Overview
=================
Brief Summary
-----------------
The acid secretion in the stomach seems to increase after withdrawal of min. 8 wks of treatment with a PPI (protonpump inhibitor) It is unknown if this acid rebound phenomenon is of clinical significance. In a doubleblinded and placebocontrolled study healthy volunteers are randomized to treatment with placebo or PPI + placebo. Gastrointestinal symptoms are scored once a week and.

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

Intervention / Treatment
-----------------
* Drug: esomeprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years + Exclusion Criteria: Dyspepsia, heartburn og acid regurgitation within the preceeding 4 weeks Previous treatment with PPI og H2RA Previous contact to doctor or hospital because of dyspepsia or reflux Pregnancy or breast feeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: esomeprazole|40 mg od for 8 wks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom scores in the reflux part of the GSRS after withdrawal of active treatment in the actively treated group versus the placebo group |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Clinical significance of the acid rebound phenomenon after withdrawal of treatment with a PPI
Safety, Tolerability and Efficacy of BFH772 in Rosacea Patients

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety, tolerability and efficacy of BFH772 after 12 weeks of treatment as compared to an active control and vehicle in patients with erythemato-telangiectatic rosacea.

Official Title
-----------------
A Proof of Concept (PoC) Study to Evaluate the Safety, Tolerability, and Efficacy of 12 Week Administration of BFH772 Ointment in Rosacea Patients

Conditions
-----------------
Erythemato-telangiectatic Rosacea

Intervention / Treatment
-----------------
* Drug: BFH772 1% ointment
* Drug: Vehicle ointment
* Drug: Noritate® 1% cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have persistent facial erythema on the cheeks of at least moderate severity. Women must not be able to bear children Exclusion Criteria: Have more than 12 inflammatory lesions on the face Previous treatment of facial skin with lasers or electrocauterisation within 2 months prior to entering the study Have facial hair that makes it difficult to evaluate rosacea on the face Other protocol-defined inclusion/exclusion criteria may apply

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BFH772<br> | Drug: BFH772 1% ointment<br> <br> |
| Placebo Comparator: Vehicle<br> | Drug: Vehicle ointment<br> <br> |
| Active Comparator: Metronidazole<br> | Drug: Noritate® 1% cream<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the effect of BFH772 treatment compared to vehicle on non-transient facial erythema using the Investigator's assessment of facial erythema score |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate a patient's assessment of flushing frequency via patient reported episodes and facial redness via a patient reported score |  | 12 weeks | 
| To measure blood levels of BFH772 in patients |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BFH772, rosacea, erythemato-telangiectatic rosacea
Thoracoscopic Sympathectomy for Blushing

Study Overview
=================
Brief Summary
-----------------
To determine outcome and side effects following thoracoscopic sympathectomy in patients treated for disabling isolated facial blushing and investigate if there are any significant differences between two different routine procedures: T2 or T2-T3 sympathectomy.

Detailed Description
-----------------
To determine the outcome and side effects following thoracoscopic sympathectomy in patients treated for disabling isolated facial blushing. In addition, following randomization investigate if there are any significant differences between two different routine procedures: T2 or T2-T3 sympathectomy. Includes QoL before and 12 months after surgery

Official Title
-----------------
Thoracoscopic Sympathectomy for Blushing. A Prospective Randomised Trial.

Conditions
-----------------
Facial Blushing

Intervention / Treatment
-----------------
* Procedure: Level of sympathectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Isolated disabling facial blushing Over 18 years of age Willing to be randomized Exclusion Criteria: Primary hyperhidrosis in palms or axillae Previous lung surgery Bradycardia Arrythmias Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>T2 sympathectomy | Procedure: Level of sympathectomy<br>* T2 sympathectomy or T2-T3 sympathectomy<br>|
| Experimental: 2<br>T2-T3 sympathectomy | Procedure: Level of sympathectomy<br>* T2 sympathectomy or T2-T3 sympathectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of operation. Side effects: compensatory and gustatory sweating. |  | 12 months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Facial blushing, Sympathectomy
Incarceration Risk Factors in Inguinal Hernia.

Study Overview
=================
Brief Summary
-----------------
It is known that strangulation or necrosis of the intestine within the hernia sac of inguinal hernia increases mortality and morbidity in patients. However, the risks of incarceration in hernias have not been fully revealed.To better understand the factors associated with incarceration in inguinal hernia, the investigators will examine patients who will apply to our clinic for inguinal hernia and undergo elective and emergency inguinal hernia surgery.

Detailed Description
-----------------
A prospective study will be conducted for 2 years, involving all adult patients who have applied to the general surgery outpatient clinic of Bakırköy Dr Sadi Konuk Training and Research Hospital, diagnosed with inguinal hernia, and who have applied to the emergency diagnosed with incarcerated inguinal hernia and underwent hernia repair surgery.

Official Title
-----------------
Incarceration Risk Factors in Inguinal Hernia.Prospective Observational Clinical Trial.

Conditions
-----------------
Inguinal Hernia, Incarcerated Inguinal Hernia, Strangulated Inguinal Hernia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages between 18-80 Primary and recurrent inguinal hernias Incarcerated / strangulated inguinal hernias Exclusion Criteria: Younger than 18, older than 80 Pregnancy Mental retardation

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients who underwent elective inguinal hernia surgery<br>Patients who have applied to the general surgery outpatient clinic of Bakırköy Dr Sadi Konuk Training and Research Hospital, diagnosed with inguinal hernia and underwent hernia repair surgery. | |
| Patients who underwent emergency inguinal hernia surgery<br>Patients who have applied to the emergency clinic of Bakırköy Dr Sadi Konuk Training and Research Hospital, diagnosed with incarcerated inguinal hernia and underwent hernia repair surgery. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hernia defect size | Measurement of fascial defect causing the hernia, using USG or CT | 2 hours after physical examination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constipation | Frequent episodes without defecation lasting more than 3 days | 1 years | 
| Age | Patients age | up to 24 weeks | 
| Body Mass Index | Patients weight in kilograms divided by the square of height in meters. | up to 24 weeks |
Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of UB-221 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single dose of UB-221 in healthy volunteers.

Detailed Description
-----------------
This is a phase I, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics,and immunogenicity of a single dose of UB-221 in healthy volunteers.

Official Title
-----------------
A Phase I, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of a Single Dose of UB-221 in Healthy Volunteers

Conditions
-----------------
Chronic Spontaneous Urticaria

Intervention / Treatment
-----------------
* Biological: UB-221


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with age between 20 to 65 years old (inclusive). Subjects who are able and willing to provide the informed consent. Male subjects with body weight of 50 kilogram (kg) or above; female subjects body weight of 45 kilogram (kg) or above. Researchers based on medical history, physical examination, vital signs, clinical laboratory results and 12-lead electrocardiogram identified healthy subjects without clinically significant abnormalities Exclusion Criteria: • The investigator considered that the subjects were not suitable to participate in this study.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 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: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UB-221 (0.2 mg/kg)<br>Intravenous infusion | Biological: UB-221<br>* UB-221 (75 mg/ml)<br>|
| Experimental: UB-221 (0.6 mg/kg)<br>Intravenous infusion | Biological: UB-221<br>* UB-221 (75 mg/ml)<br>|
| Experimental: UB-221 (2 mg/kg)<br>Intravenous infusion | Biological: UB-221<br>* UB-221 (75 mg/ml)<br>|
| Experimental: UB-221 (6 mg/kg)<br>Intravenous infusion | Biological: UB-221<br>* UB-221 (75 mg/ml)<br>|
| Experimental: UB-221 (10 mg/kg)<br>Intravenous infusion | Biological: UB-221<br>* UB-221 (75 mg/ml)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1.Adverse event incidence | from the baseline to day 15 after IP infusion | 15 days |
Investigation of Correlation Between Concentrations of Glucose in Blood and Interstitial Fluid in Type 1 Diabetics

Study Overview
=================
Brief Summary
-----------------
This is a mono-centre trial performed at the Center for Clinical Research at the Medical University Graz. There will be a screening information and a study visit.In the study visit arterialized venous blood glucose values will be monitored and subcutaneous sampling of interstitial fluid (ISF) with microdialysis for glucose determination will be performed. Additionally to the laboratory analysis of the subcutaneous glucose samples, the glucose will be measured with extracorporeal on-line sensors and two marketed devices (Guardian RT and Glucoday S).The study visit will last 30 hours starting with the insertion of microdialysis catheters in the abdominal subcutaneous tissue and the insertion of the catheters for the Glucoday S system and Guardian RT system. The primary hypothesis of the study is: Interstitial fluid glucose concentration profiles correlate to the arterialized venous blood glucose concentration profile in type 1 diabetic subjects.

Official Title
-----------------
An Open, Mono-Centre Trial to Investigate the Correlation Between Concentrations of Glucose in Arterialized Venous Blood and Subcutaneous Interstitial Fluid Applying Different Extracorporeal Sensor Techniques in Type 1 Diabetics

Conditions
-----------------
Type 1 Diabetes

Intervention / Treatment
-----------------
* Procedure: Microdialysis
* Device: Guardian RT
* Device: Glucoday S


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent obtained before any trial-related activities. Skin fold thickness of minimally 5 mm Age of patients in the range from 19 to 60 years. Type 1 diabetes Exclusion Criteria: Severe acute and/or chronic diseases Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation. Taking of any vasoactive substances or anticoagulation medication. Diseases of the skin which could interfere with application of the catheters Pregnancy or breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Microdialysis|nan|
|Device: Guardian RT|nan|
|Device: Glucoday S|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
-----------------
microdialysis, subcutaneous adipose tissue, glucose sensor, glucose monitoring, type 1 diabetes, Guardian RT, Glucoday S
Population Pharmacokinetics and Pharmacodynamics Modeling to Optimize Dosage Regimen of Levofloxacin

Study Overview
=================
Brief Summary
-----------------
Levofloxacin, a fluoroquinolone antibiotic, is the optical S-(-) isomer of ofloxacin with a broad spectrum of activity. In common with other fluoroquinolones, the main pharmacokinetic/pharmacodynamic (PK/PD) index that correlates with its therapeutic efficacy is the area under the plasma time-concentration curve/the minimum inhibitory concentration ratios. The aims of the study were to: reveal the population pharmacokinetics, and assess the efficacy of various dosage regimens in achieving the probability of target attainment (PTA) and the cumulative fraction of response (CFR) of levofloxacin when oral levofloxacin was prescribed as the switching therapy after intravenous levofloxacin treatment. The study was conducted in 45 healthy volunteers. Each subject received one 500 mg tablet of levofloxacin, after which PK studies were carried out, using a Monte Carlo simulation to determine the PTA. By referral to the EUCAST MIC distributions database, the dosage regimens were predicted to achieve CFR greater than or equal to 90%.

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: Levofloxacin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: normal hematologic normal hepatic normal renal functions non-smoking non-alcoholic non-obese Exclusion: pregnant or lactating women any chronic medications

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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: levofloxacin in healthy<br> | Drug: Levofloxacin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| concentration of levofloxacin in plasma |  | up to 2 week after blood collection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
levofloxacin, population pharmacokinetics, pharmacodynamics