linjc16/ctgov huggingface dataset:
Retrospective Collection of Effectiveness and Safety Data From Patients Treated With Liraglutide or DPP-4 Inhibitor in Primary Care in Europe

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Europe. The aim of this study is to demonstrate the clinical effectiveness and safety of liraglutide and dipeptidyl peptidase-4 (DPP-4) inhibitor therapy in routine primary care in Europe.

Official Title
-----------------
Retrospective Collection of Effectiveness and Safety Data From Patients Treated With Liraglutide or DPP-4 Inhibitor in Primary Care in Europe

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients treated with liraglutide or DPP-4 inhibitors, according to license in respective participating country with data available for 12 (+/- 2) months Exclusion Criteria: Patients treated with liraglutide or DPP-4 inhibitors, outside of license in respective participating country
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Liraglutide<br> | Drug: liraglutide<br>* Anonymised patient level data will be collected by the patients' own general practitioner and electronic case report form (eCRF) will be used to capture the data.<br>|
| DPP-4<br> | Drug: liraglutide<br>* Anonymised patient level data will be collected by the patients' own general practitioner and electronic case report form (eCRF) will be used to capture the data.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c (glycosylated haemoglobin) |  | Baseline (anytime within 3 months before therapy initiation), month 12 (+/-2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight |  | Baseline (anytime within 3 months before therapy initiation), month 12 (+/-2) | 
| Change in systolic blood pressure |  | Baseline (anytime within 3 months before therapy initiation), month 12 (+/-2) |
Efficacy of Hyaluronic Acid and Platelet-rich Plasma Combination in Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of intra-articular injections of combined hyaluronic acid and platelet-rich plasma in knee degenerative joint disease in improving joint function and reducing pain.

Official Title
-----------------
Efficacy of Intra-articular Injection of Combined Hyaluronic Acid and Platelet-rich Plasma in Knee Degenerative Joint Disease

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Drug: hyaluronic Acid + platelet-rich plasma
* Drug: hyaluronic acid
* Drug: platelet-rich plasma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Knee pain for 4 months; Knee degenerative sign evaluated with X-ray with a Kellgren-Lawrence grade inferior to 3; Patients able to understand the study conditions and willing to participate for its entire duration; Patients who signed written informed consent. Exclusion criteria: Severe knee osteoarthritis of grade 4; Diabetes mellitus; Rheumatoid arthritis; Ongoing malignancies; Certified allergic reactions towards the administered drugs ; Malalignment of mechanical axis of the lower limb (varus > 10 °, valgus > 10 °); Coagulopathies; Severe cardiovascular diseases; Ongoing infections; Immunodepression; Anticoagulants or anti-platelet agents; Haemoglobin < 11 g/dl; Platelet count < 150,000/mm^3 Drug addiction; Alcoholism; Psychiatric disease; Pregnancy or breastfeeding.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 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: hyaluronic acid + platelet-rich plasma<br>Intra-articular injections of hyaluronic acid combined with platelet-rich plasma | Drug: hyaluronic Acid + platelet-rich plasma<br>* Intra-articular injections of hyaluronic acid combined with platelet-rich plasma<br>* Other names: Cellular Matrix/A-CP HA Kit;|
| Active Comparator: platelet-rich plasma<br>Intra-articular injections of platelet-rich plasma | Drug: platelet-rich plasma<br>* Intra-articular injections of platelet-rich plasma<br>* Other names: RegenKit-BCT-1;|
| Active Comparator: hyaluronic acid<br>Intra-articular injections of hyaluronic acid | Drug: hyaluronic acid<br>* Intra-articular injections of hyaluronic acid<br>* Other names: ArthroVisc40;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC score | Comparison of WOMAC total score among three treatment arms | 6 months after the first intra-articular injection |
Dynamic Position Change in Colonic Adenoma Detection

Study Overview
=================
Brief Summary
-----------------
There was an only single operator study reporting dynamic position change during colonoscopy withdrawal significantly improved polyp and adenoma detection. So we designed a prospective, randomized multicenter study to verify the effect of dynamic position change in colonic adenoma detection. We think position change improve luminal distension and has the potential to improve adenoma detection rate.

Official Title
-----------------
Dynamic Position Change in Colonic Adenoma Detection: a Prospective, Randomized, Multicenter Study

Conditions
-----------------
Adenoma, Position, Colonoscopy

Intervention / Treatment
-----------------
* Procedure: Position change
* Procedure: Left lateral


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient aged over 45 years who will be performed colonoscopy for the first time Exclusion Criteria: polyposis syndrome musculoskeletal problem Inflammatory bowel disease previous bowel operation

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Position change<br>Position change group | Procedure: Position change<br>* Patients change position (cecum to hepatic flexure, left lateral; transverse colon, supine; splenic flexure and descending colon , right lateral) during colonoscopy withdrawal.<br>|
| Active Comparator: Left lateral<br>Left lateral position | Procedure: Left lateral<br>* In left lateral position group patients are positioned left lateral decubitus during colonoscopy withdrawal.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma detection |  | 4 weeks |
MEV for Retroclavicular Approach to Infraclavicular Block

Study Overview
=================
Brief Summary
-----------------
In this study, the primary objective was to estimate the minimum effective volume of bupivacaine 0.5% resulting in successful block in 90% of patients (MEV90) for ultrasound-guided retroclavicular approach to infraclavicular brachial plexus block.

Detailed Description
-----------------
A biased coin up-and-down sequential design will be applied to assess the minimum effective volume in 90% of patients for the retroclavicular brachial plexus block. The first subject received 25 ml 0.5% bupivacaine . Each subsequent patient received a dose that depended on the response of the previous one. If the previous block is successful, the block will be performed either by a reduction of the volume by 2.5 ml with a probability ß = 0.11 or by a same dose of the previous one with a probability 1-ß = 0.89 in the next patient.

Official Title
-----------------
Minimum Effective Volume of Bupivacaine for Retroclavicular Approach Brachial Plexus Block

Conditions
-----------------
Bupivacaine

Intervention / Treatment
-----------------
* Other: minimum effective volume


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who received infraclavicular brachial plexus block for elective elbow, forearm, wrist, or hand surgery American Society of Anesthesiologists class I, II or III Exclusion Criteria: patients <18 years old >65 years old body mass index (BMI) <20 or >35 kg/m2 inability to provide written informed consent refusal of regional anesthesia pregnancy contraindication for regional anesthesia

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: minimum effective volume|The determination of MEV90 and its 95% confidence interval (CI) will be based on a biased coin up-and-down sequential design|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The minimum effective volume of bupivacaine 0.5% resulting in successful block in 90% of patients (MEV90) | The determination of MEV90 and its 95% confidence interval (CI) will be based on a biased coin up-and-down sequential design | 30 minutes |
MK2461 Phase I/II Study in Patients With Advanced Solid Tumors (MK-2461-002 AM1)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
The purposes of this phase I portion are; 1) to evaluate the safety and tolerability of MK2461 and 2) to determine the recommended phase 2 dose or doses of MK2461. The purpose of the phase II portion is to evaluate the anti-tumor efficacy of MK2461.

Official Title
-----------------
A Phase I/II Dose Escalation and Proof-of-Concept Study of MK2461 in Patients With Advanced Solid Tumors

Conditions
-----------------
Neoplasm

Intervention / Treatment
-----------------
* Drug: MK2461


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be at least 18 years of age, with adequate organ function, and an ecog performance of <2 Exclusion Criteria: No chemotherapy, radiotherapy, or biological therapy with 4 weeks of study participation Patients must not have primary central nervous system tumor

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK2461|MK2461 treatment, bid, 28-day|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of MK2461 by assessing incidence of toxicities. Pharmacokinetic and pharmacodynamic parameter will be evaluated. |  | 18 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the anti-tumor efficacy of MK2461 in patients with advanced solid tumor by assessing the response rate, progression- free survival, duration of response, time to response and time to progression. |  | 18 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neoplasm Malignant
Women and Children as the Focus for Control of Schistosomiasis Infections in the Irrigations Area of Burkina Faso

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the extent of schistosomasis infections in women and children, their daily activites that encumber contact with water and their knowledge and attitudes towards the prevention of schistosomiasis. The hypothesis that will be explored is that women and children spent more time with agricultural and household activities which bring them in contact with water and therefore give them an increased risk of being infected by schistosoma. Prevention and control of schistosomiasis has to be focusing on women and children.

Detailed Description
-----------------
The study will be carried out in and irrigation area of Burkina Faso where people relay on water. The study applies several methodes; Parasitological survey: From thre villages 200 women and children are randomly sampled to have their urin and stool examined for parasittes. Observations: At each village sites at the irrigation canals where people meet and have their activities observations of the kind and the duration of watercontact will be observed. Focus group interview: In each village 5 focus group interviews will be conducted with 6 to 12 participants in each group Individual interviews: for the participant in the focus group interview a total of 45 participants will be selected for indept individual interviews Questionnaire: a total of 360 questionnairs will be distributed to participants in the parasitological survey, the focus group interviews and to participants who did not participate in any of the above mentioned. Participants will be women and children from the three villages.

Official Title
-----------------
Women and Childres at the Focal Point for the Schistosomiasis Control and Sustainability and Effectiveness in the Hydro Agricultural Zone of Sourou, Burkina Faso

Conditions
-----------------
Schistosomiasis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women and children from three villages
Sexes Eligible for Study
-----------------
Female

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
schistosomiasis, gender perspectives
Human Metabolic Dynamics at Rest and During Aerobic Exercise Under Normobaric Normoxic and Moderate Hypoxic Conditions

Study Overview
=================
Brief Summary
-----------------
The aim is to define in detail metabolic pathways at rest and during aerobic exercise in normal and healthy men and women under normobaric normoxic and moderate hypoxic conditions, using metabolomics technologies based on minimally invasive sampling relying on gas chromatography and mass spectrometry.

Official Title
-----------------
MetaboDyn- Liquid-liquid Extraction of Single Drops of Whole Capillary Blood as a Reliable Method of Measuring Metabolic Effects of Exercise: A Pilot Study.

Conditions
-----------------
Energy Metabolism, Hypoxia, Metabolism and Nutrition Disorder

Intervention / Treatment
-----------------
* Behavioral: 30-minute movement activity
* Other: Hypoxia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: approval and written, informed consent healthy adults of varying fitness levels (age >18 years to 75 years) Exclusion criteria: chronic illness requiring any medication pregnancy limitations regarding functioning in the hypoxic chamber inability to follow simple instructions relevant or severe abnormalities in medical history, physical examination, ECG routine laboratory parameters from blood and urine

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: 30-minute movement activity|The subjects arrive in the CRU after a 12 hours overnight fast to perform a 30-minute movement activity with individually adapted exercise intensity on the treadmill.|
|Other: Hypoxia|The 30-minute movement activity on the treadmill will be completed by each subject once under normobaric normoxic and once under normobaric hypoxic conditions (equivalent to approximately 3000 meters above sea level) in a randomized episode.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coefficient of variation of relative quantities of metabolites and physiological parameters related to its dynamic during exercise under normoxic and hypoxic conditions, using GC-MS. | A drop of capillary blood (20 µl) will be collected from the hyperemic earlobe for metabolomic analysis at the times t = 0 min (before starting), 10 min, 20 min and 30 min during the activity, and t = 50 and 60 min taken in the recovery phase. The oxygen saturation and heart rate will be determined at the same time points by pulse oximetry and heart rate monitoring, as well as blood gas analyses and subjective self-perception of energy availability on a quantitative scale throughout exercise. | 6 months |
Non Cardiac Chest Pain and Benign Palpitations

Study Overview
=================
Brief Summary
-----------------
All Patients between 18 and 65 years are asked 6 month after investigation for chest pain or palpitation at Cardiological Out-patient Clinic, Molde Hospital, about if they still have symptoms of chest pain or palpitation. If they still have some of the symptoms they are invited to participate in a coping course to learn a better way to deal with their symptoms. The coping course consist of three sessions of cognitive behaviour therapy.

Official Title
-----------------
A Randomized Controlled Trial of Cognitive Behavioural Therapy for Non-cardiac Chest Pain and Palpitations.

Conditions
-----------------
Anxiety/Depression in Cardiological Unit

Intervention / Treatment
-----------------
* Behavioral: Cognitive behaviour therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: investigated for chest pain or palpitation 6 month ago at Cardiological Out-patient Clinic, Molde Hospital suffer of chest pain or palpitations Exclusion Criteria: do not speak norwegian properly mentally retarded psychosis last 6 month current alcohol or drug misuse

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Cognitive behaviour therapy|Three hours with cognitive therapy focusing on the chest pain and palpitations.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body sensation questionnaire (BSQ) |  | end of treatment, after 3 month and after 12 month | 
| Beck Depression Inventory (BDI) |  | end of treatment, after 3 and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anxiety, panic disorder, chest pain, palpitations
Correlation of Gene Status and Clinical Outcomes in ESCC

Study Overview
=================
Brief Summary
-----------------
The incidence of esophageal squamous cell carcinoma is highly regional and familial. The current treatment plan is based on the stage and location of the tumor.By studying the relationship between the status of different genes and prognosis, it can help doctors to develop precise and individualized treatment plans.

Official Title
-----------------
Retrospective Study of Gene Status and Clinical Outcome of Esophageal Squamous Cell Carcinoma(ESCC).

Conditions
-----------------
Prognosis of Patients With ESCC

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Esophageal cancer patients who underwent surgery treatment, and postoperative pathological diagnosis was squamous cell carcinoma. Patients with ESCC have complete clinical information. Exclusion Criteria: Patients who also suffering from other tumors.

Ages Eligible for Study
-----------------
Minimum Age: 30 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 |
| --- | --- |
| Lymph node metastasis Positive<br>good prognosis; without Lymph node metastasis. | |
| Lymph node metastasis Negative<br>poor prognosis; with Lymph node metastasis. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene test | 466 Tumor-associated gene test by next-generation sequencing(NGS) | 2019-2 to 2019-4 |