linjc16/ctgov huggingface dataset:
Nasopharyngeal Packing and Rhinologic Surgery.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy of three different pharyngeal packing during routine rhinologic surgery in the prevention of postoperative nausea and vomiting, and to evaluate the influence of pharyngeal packing on postoperative throat pain.

Official Title
-----------------
The Effectiveness of Three Different Nasopharyngeal Packing on the Prevention of Postoperative Nausea- Vomiting and Postoperative Throat Pain in Rhinologic Surgery.

Conditions
-----------------
Nasal Surgery, Tampons, PONV

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-60 years old adult patient nasal and/or paranasal sinus surgeries general anesthesia Exclusion Criteria: patients submitted to another intervention at the same time (adenoidectomy, tonsillectomy) patients with a serious systemic disease (acquired immunodeficiency syndrome,leukemia, lymphoma, or other neoplasias under chemotherapy treatment) patients presenting contraindications for using nonsteroid anti-inflammatory drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| nasal packing with dry packs<br> | |
| nasal packing with wet packs<br> | |
| nasal packing with Benzidamin-Clorhexsidin damped packs<br> | |
| no nasal packing<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative nausea vomiting |  | 3 months | 
| sore throat |  | 3 months |
Effect of Liraglutide on Weight and Appetite in Obese Subjects With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of the trial is to investigate the effect of NNC 90-1170 (liraglutide) on weight and appetite in obese subjects with type 2 diabetes treated with diet and/or sulphonylurea or repaglinide.

Official Title
-----------------
NNC 90-1170 Mechanism of Action: A Single-centre, Randomised, Double-blind, Parallel-group, Placebo-controlled Trial Evaluating the Effect of NNC 90-1170 on Weight and Appetite in Obese Subjects With Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Drug: liraglutide
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes mellitus Diet treated and/or subjects in monotherapy with sulphonylurea or repaglinide HbA1c for diet treated subjects 6.5-12%, both inclusive HbA1c for sulphonylurea or repaglinide treated subjects maximum 10% Body mass index (BMI) at least 27 kg/m^2 Euthyroid subjects Fasting blood glucose 7-14 mmol/l Exclusion Criteria: Impaired liver function Impaired renal function Cardiac problems Uncontrolled treated/untreated hypertension Recurrent severe hypoglycaemia as judged by the Investigator Known or suspected allergy to trial product or related products Use of any drug (except for OHAs (oral hypoglycaemic agents), which in the Investigator's opinion could interfere with the glucose level or body weight. Stable doses, for 3 months or greater, of thyroid hormone replacement are allowed

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NNC 90-1170<br> | Drug: liraglutide<br>* Once daily dosing of 0.6 mg for 8 weeks, injected subcutaneously<br>* Other names: NNC 90-1170;|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* Once daily dosing of 0.6 mg for 8 weeks, injected subcutaneously<br>|

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

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total fat mass (assessed by use of DEXA (dual energy X-ray absorptiometry) scan) |  |  | 
| Waist circumference |  |  | 
| Spontaneous energy intake assessed in connection to the ad libitum lunch meal |  |  | 
| Appetite assessed in connection with the fixed breakfast meal (assessed by the use of VAS (visual analogue scale)) |  |  | 
| Gastric emptying rate |  |  | 
| Energy expenditure |  |  | 
| HbA1c (Glycosylated Haemoglobin) |  |  | 
| Adverse events |  |  |
Pilot Study on the Use of the Matrix Radiofrequencyfor Treatment of Port Wine Stain Birthmarks

Study Overview
=================
Brief Summary
-----------------
Port wine stain, also called nevus flammeus, is a congenital, cutaneous vascular malformation involving post-capillary venules which produces a light pink to red to dark-red-violet discoloration of the skin. It is estimated that Port wine stain occurs in 3 children per 1,000 live births. Approximately 900,000 individuals in the United States and twenty million people worldwide have Port wine stain birthmarks .

Detailed Description
-----------------
The purpose of this research study is to improve port wine stain treatment after Matrix Radiofrequency device treatment. The Matrix Radiofrequency device energy generates fractional deep dermal heating in the region of the electrode matrix to induce skin injury, thus eliciting a wound healing response. Less affected tissue surrounding the matrix points may be stimulated by heat which helps accelerate the healing process, while at the same time minimizing adverse effects such as scarring or changes in the normal skin pigmentation. The researcher can determine Port wine stain areas treated with the Matrix Radiofrequency device will have improved Port wine stain blanching responses as compared to those areas treated by pulsed dye laser.

Official Title
-----------------
Pilot Study on the Use of the Matrix Radiofrequency for Treatment of Port Wine Stain Birthmarks

Conditions
-----------------
Port Wine Stain

Intervention / Treatment
-----------------
* Device: Matrix Radiofrequency


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Port Wine Stain Birthmarks suitable for comparison testing Age > 18 years of age Exclusion Criteria: Less than 18 years old Are pregnant or breastfeeding Other history assess by the investigator

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: Medical Tool<br>Matrix Radiofrequency Treatment of Port Wine Stain Birthmarks | Device: Matrix Radiofrequency<br>* Matrix Radiofrequency Treatment of Port Wine Stain Birthmarks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical Tool | Matrix Radiofrequency Treatment of Port Wine Stain Birthmarks | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Port Wine Stain blanching | Blanching responses on test site will be obtained from visible reflectance spectroscopy and Port Wine Stainblood volume fractions in the skin before and after laser treatment | 8 weeks |
Efficacy of Ginger as an Adjunctive Prophylaxis for Chemotherapy-induced Nausea and Vomiting

Study Overview
=================
Brief Summary
-----------------
Breast cancer patient receiving AC regimen chemotherapy (Doxorubicin + Cyclophosphamide) who has nausea score from 40/100 VAS or vomiting after the first or second cycle of chemotherapy is recruited. The patient who meets the eligibility criteria and provides informed consent is randomised to receive either Ginger capsule (500 mg) or placebo taking twice a day by mouth during the first 5 days of chemotherapy cycle. The study drug will be switched on the subsequent cycle (i.e. the patient who received Ginger capsule will receive placebo and vice versa). The primary outcome is the nausea score and vomiting during the first 5 days of each chemotherapy cycle when receiving the study drug.

Official Title
-----------------
Efficacy of Ginger as an Adjunctive Prophylaxis for Chemotherapy-induced Nausea and Vomiting: Randomised Double-blind Placebo-control Cross Over Study

Conditions
-----------------
Chemotherapy-induced Nausea and Vomiting

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed breast cancer patient Received AC regimen chemotherapy (Doxorubicin + Cyclophosphamide) and has nausea score at least 40/100 VAS or has vomiting Expect to receive at least 2 further cycles of AC regimen chemotherapy Provide informed consent Exclusion Criteria: Pregnancy or lactation Has nausea or vomiting during 24 hours before chemotherapy Has other causes of nausea or vomiting eg. brain metastasis, gut obstruction, hepatitis or recent abdominal or pelvic irradiation within 1 week before chemotherapy Received any chemotherapy regimen other than AC regimen Allergic or intolerance to ginger

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: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ginger<br>Ginger capsule (500 mg) taking twice a day by mouth during the first 5 days of chemotherapy cycle | Drug: Ginger<br>* Ginger capsule (500 mg) taking twice a day by mouth during the first 5 days of chemotherapy cycle<br>|
| Placebo Comparator: Placebo<br>Placebo capsule taking twice a day by mouth during the first 5 days of chemotherapy cycle | Drug: Placebo<br>* Placebo capsule taking twice a day by mouth during the first 5 days of chemotherapy cycle<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nausea score |  | The first 5 days of chemotherapy cycle |
Mindfulness Meditation

Study Overview
=================
Brief Summary
-----------------
To offer Roswell Park patients and caregivers a variety of options to reduce their stress and improve their psychological well-being amidst the difficulty of cancer

Official Title
-----------------
Mindfulness Meditation

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Behavioral: Mindfulness program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Being over 18 years old Cancer survivor or a caregiver of cancer patient/survivor. Exclusion Criteria: Unwilling or unable to complete the assessment in English. Are unwilling or unable to follow protocol requirements. Have any condition which in the Investigator's opinion deems the subject an unsuitable candidate to participate in this study including (based on criteria from the Mindfulness-based stress reduction (MBSR) authorized curriculum guide): Drug addiction (or recent recovery) Bereavement (recent loss) Mental health inpatient (recently discharged) Current depression or other major psychiatric diagnoses (including suicidality or suicidal ideation) that would interfere with participation

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindful based stress classes<br>6 week mindfulness program | Behavioral: Mindfulness program<br>* 6 week class designed to improve psychological well-being<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility - Enrollment rates | Number of participants enrolled in virtual classes vs in person classes | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability | Percentage of participants who choose in person classes vs. virtual classess | 6 weeks |
Thalidomide in Mucosa Associated Lymphoid Tissue (MALT) Lymphoma Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate Thalidomide for treatment of disseminated MALT Lymphoma or at relapse following helicobacter pylori (HP) - eradication or chemotherapy or radiation.

Detailed Description
-----------------
The objectives of this study are to evaluate the effectivity and the safety of thalidomide in patients with disseminated MALT lymphoma or at relapse following HP-eradication, or chemotherapy or radiation. It is a phase II prospective single arm study with a target sample size of 16 patients. Thalidomide is given orally at an initial dose of 100 mg for a maximum duration of 6 months.

Official Title
-----------------
Phase II Trial of Thalidomide (Thalidomide Pharmion) in Patients With Advanced or Relapsed Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)

Conditions
-----------------
MALT Lymphoma

Intervention / Treatment
-----------------
* Drug: Thalidomide, Pharmion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with histologically confirmed MALT lymphoma with measurable disease (Stage I-IV) With first or greater relapse after HP-eradication, radiation or chemotherapy Age > 18 Must be able to tolerate therapy and have adequate cardiac, renal and hepatic function ECOG status _< 2 Must be capable of understanding the purpose of the study and have given written informed consent

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: Thalidomide, Pharmion|200 mg p.o. daily|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the clinical potential of thalidomide to induce objective/histologic responses in patients with MALT lymphoma |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of thalidomide in this patient population and to evaluate |  | 6 months | 
| The impact of thalidomide on progression free survival |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MALT Lymphoma, thalidomide, disseminated MALT Lymphoma or at relapse following HP-eradication, or chemotherapy or radiation
Family-Centered Behavioral Preparation for Surgery

Study Overview
=================
Brief Summary
-----------------
Children experience significant anxiety and distress during the preoperative period. Currently available interventions are ineffective and/or associated with significant disadvantages. These interventions exclusively target the child and do not attempt to reduce parental anxiety. Based on an integration of the literature in both the anesthesia and psychological milieus, we developed ADVANCE, a behaviorally oriented anxiety reduction program for children undergoing surgery that targets the family as a whole.

Detailed Description
-----------------
Children and their parents (n=408) were randomly assigned to one of four groups: 1) Control: received standard of care, 2) PPIA: received standard parental presence during induction of anesthesia, 3) ADVANCE: received family-centered behavioral preparation, and 4) oral Midazolam. We assessed the effect of group assignment on anxiety levels and postoperative outcomes.

Official Title
-----------------
Study of the ADVANCE Behavioral Preparation Program for Children and Their Parents

Conditions
-----------------
Anxiety

Intervention / Treatment
-----------------
* Behavioral: ADVANCE
* Drug: Midazolam
* Procedure: Parental presence


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children 2-10 years old who were in good health (American Society of Anesthesiology physical status I-II) and who were undergoing general anesthesia and elective, outpatient surgery, and their parents. Exclusion Criteria: Children with a history of chronic illness, prematurity (fewer than 36 weeks gestation) or reported developmental delay

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 10 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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: ADVANCE|nan|
|Drug: Midazolam|nan|
|Procedure: Parental presence|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety in children: modified Yale Preoperative anxiety scale |  |  | 
| Anxiety in parents: STAI |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergence delirium |  |  | 
| Analgesic consumption |  |  | 
| Time to discharge from recovery room |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
children, anxiety, behavioral preparation, family, surgery, parents
Mindfulness to Reduce Post-cesarean Pain and Prevent Postpartum Depression

Study Overview
=================
Brief Summary
-----------------
This study will test the effect of a mobile mindfulness-based intervention on reducing post-cesarean delivery pain and preventing postpartum depression.

Detailed Description
-----------------
This clinical trial will test the effect of a mobile mindfulness-based intervention on reducing post-cesarean delivery pain and preventing postpartum depression.

Official Title
-----------------
Optimizing Mindfulness to Reduce Post-cesarean Pain and Prevent Postpartum Depression

Conditions
-----------------
Depression, Unipolar, Pain, Postoperative

Intervention / Treatment
-----------------
* Behavioral: Mindfulness


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-45 years of age, have a singleton pregnancy, score less than 10 on the Edinburgh Postnatal Depression Scale (EPDS; (Cox et al., 1987b), willing to participate in the eight-week intervention or be randomized to the TAUM condition, have no significant psychiatric disorders other than depression or anxiety (e.g., bipolar disorder, substance use disorder, etc.), have no chronic pain condition (e.g., fibromyalgia), and proficient in English or Spanish Exclusion Criteria: Women who screen 10 or higher on the EPDS

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness<br>Receiving mobile, self-guided mindfulness intervention | Behavioral: Mindfulness<br>* Meditation training to help reduce stress and reactivity to pain and other stressors.<br>* Other names: Mindfulness meditation;|
| No Intervention: Treatment as usual with monitoring<br>Receiving treatment as usual with monitoring by study PI and investigators. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postpartum depression | depressive symptoms EPDS 13 or higher | 4 weeks - 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain | Post-cesarean delivery pain | 4 weeks - 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postpartum, depression, pain, cesarean
Study Evaluating 3 New Formulations of SKI-606 in Healthy Adult Subjects

Study Overview
=================
Brief Summary
-----------------
To evaluate the comparative bioavailability of 3 new tablet formulations of SKI-606 with a reference capsule and an oral solution in healthy subjects.

Official Title
-----------------
A Single Dose Bioavailability Study of 3 New Formulations of SKI-606 (500 mg) Compared With a Reference Capsule and an Oral Solution in Healthy Adult Subjects

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

Intervention / Treatment
-----------------
* Drug: SKI-606


Participation Criteria
=================
Eligibility Criteria
-----------------
Criteria: Healthy male and female aged 18 to 50 years. Women of nonchildbearing potential (WONCBP).

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SKI-606|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The data from this study along with in vitro data will be used to explore in vitro/in vivo correlation for SKI-606 to support formulation development. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy subjects