linjc16/ctgov huggingface dataset:
Effect of Progesterone Levels on 15th Day After Embryo Transfer in Early Miscarriage < 7 WG or Evolving Pregancy Rates

Study Overview
=================
Brief Summary
-----------------
Progesterone level has been studied at days before embryo transfert. But, progesterone blood level has not been studied 15 days after embryo transfert. The aim of this study is to study progesterone level impact at 15 days after embryo transfert on evolving pregnanies or early miscarriages.

Official Title
-----------------
Effect of Progesterone Levels on 15th Day After Embryo Transfer in Early Miscarriage < 7 WG or Evolving Pregancy Rates

Conditions
-----------------
ART

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: ART program in Montpellier hospital age >18 years old Blood progesterone level 15 days after embryo transfert Pregnancy development know Exclusion criteria: - non uterine pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 43 Years

Sexes Eligible for Study
-----------------
Female

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of blood progesterone | blood progesterone at day 15 after embryo transfert | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
betaHCG +, pregnancy development know, progesterone level, miscarriage
Ibuprofen Lozenge in Acute Sore Throat Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of repeated doses of a low dosage of oromucosal Ibuprofen form (lozenge) versus placebo in patients suffering from acute sore throat pain.

Official Title
-----------------
Study of Efficacy and Safety of V0498 Versus Placebo in Acute Sore Throat Pain.

Conditions
-----------------
Acute Sore Throat Pain

Intervention / Treatment
-----------------
* Drug: Ibuprofen 25 mg
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female aged at least 18 years old patient with an acute sore throat Exclusion Criteria: Severe respiratory tract infection (pneumonia, bronchitis or laryngitis) Oro-pharyngeal paresthesia or mycosis Severely traumatised and/or very severe oromucosal inflammation Tonsillopharyngectomy Peritonsillar abscess Hypersensitivity to ibuprofen or other NonSteroidal Anti-Inflammatory Drugs (NSAIDs) (including bronchospasm) or to excipients Long term use (≥ 3 times per week within the last month or regular intake within the last 3 months before randomisation) of antiinflammatory drugs- Any long-acting or slow release analgesic intake including NonSteroidal Anti-Inflammatory Drugs (NSAIDs)within 24 hours before randomisation (e.g. piroxicam or naproxen) Any anti-inflammatory drugs intake by systemic route within 12 hours before randomisation Any paracetamol intake within 6 hours before randomisation Any cold medication (decongestant, antihistamine, expectorant, antitussive) within 6 hours before randomisation Any topical throat medication intake containing or not a local oral anaesthetic such as lozenge, spray, mouth rinse within 4 hours before randomisation Heavy smokers (>20 cigarettes/day)

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug<br>V0498, Ibuprofen 25 mg | Drug: Ibuprofen 25 mg<br>* Lozenge, Oromucosal administration<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Lozenge matching V0498 lozenge, Oromucosal administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Pain relief over 2 hours | Total Pain Relief (TOTPAR) assessed on a 7-point rating scale called the Sore Throat Relief Scale (STRS) over 120min after the start of sucking of 1st study drug administered | 0-2 hours post-dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sore throat pain, tonsillopharyngitis, upper respiratory tract infection
Pharmacokinetic Interactions of Losartan and Hydrochlorothiazide

Study Overview
=================
Brief Summary
-----------------
This study was conducted to investigate any potential reaction between losartan and hydrochlorothiazide.

Conditions
-----------------
Healthy Normotensive Participants

Intervention / Treatment
-----------------
* Drug: Losartan/hydrochlorothiazide
* Drug: Losartan
* Drug: Hydrochlorothiazide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years old and not more than 45 healthy male volunteers Who had passed all the screening parameters Exclusion Criteria: A clinically significant abnormal physical exam, medical history, or laboratory studies If they showed a sitting SBP of >140 or <100 mmHg, DBP > 90 or <60mm Hg, or a pulse rate of > 95 or < 50 beats/min at screening The use of any prescription drug within the previous month or use of any over-the-counter medication within the past 14 days A history of blood dyscrasias A history of alcohol or drug abuse within the past year Donation of blood during the 8 weeks prior to the study or plans to donate blood during or within 8 weeks of completing the study Unable to tolerate vein puncture and multiple blood samplings Any surgical/medical condition that might alter drug absorption, distribution, metabolism, or excretion

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Losartan / Hydrochlorothiazide100 mg/25mg<br>Losartan / Hydrochlorothiazide100 mg/25mg fixed dose combination | Drug: Losartan/hydrochlorothiazide<br> <br> |
| Other: Losartan 100 mg<br>Losartan 100 mg alone | Drug: Losartan<br> <br> |
| Other: hydrochlorothiazide 25 mg<br>hydrochlorothiazide 25 mg alone | Drug: Hydrochlorothiazide<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate |  | Participants will be followed for the duration of study, an expected average of 5 weeks. | 
| Blood pressure |  | Participants will be monitored for the duration of study, an expected average of 5 weeks. | 
| Pharmacokinetic parameter such as Cmax of losartan and hydrochlorothiazide |  | At the end of the study, after collection of all blood samples, an expected average of 4 weeks | 
| Pharmacokinetic parameter such as AUC of losartan and hydrochlorothiazide |  | At the end of the study, after collection of all blood samples, an expected average of 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Normotensive Participants, Fixed dose combination, Pharmacokinetics, Losartan, Hydrochlorothiazide
Pulmicort Turbuhaler 100/200 Specific Clinical Experience Investigation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to confirm the safety profile for long term treatment in children aged 5 years and <15 years on bronchial asthma in daily clinical usage/Effect on growth rate. Effect on adrenal function. Development of infection diseases by diseases type.

Official Title
-----------------
Pulmicort Turbuhaler 100/200 Specific Clinical Experience Investigation for Long Term Use in Pediatrics

Conditions
-----------------
Bronchial Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients treated with Pulmicort Turbuhaler for the first time due to bronchial asthma and children of >= 5 years and < 15 years old age at the start of study treatment Exclusion Criteria: -None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pulmicort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event incidence. We will investigate, intensively, development of Adverse Drug Reactions, especially infections. Detection of Adverse Drug Reactions unexpected from the Precautions for use. |  | Two years | 
| Effects on growth rate and the adrenal cortical function, development of infections |  | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of the asthma control status (total of JPAC：Japanese Pediatric Asthma Control Program score) from the baseline score. |  | Two years | 
| Variation of the parental questionnaire (score by factor) from the baseline score. |  | Two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bronchial asthma, Pulmicort, long term use, pediatrics
Uses of Immunosuppression Therapy in Patients With Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
Conventionally, the outcome of liver transplantation is usually reported in terms of graft and patient survival, medical and surgical complications, but lack of health-related quality of life (HRQOL) that might be associated with immunosuppression complications (e.g., diabetes, hypertension, dyslipidemia, obesity, metabolic syndrome, cardiovascular disease, renal dysfunction, osteoporosis, and de novo malignancy), disease recurrence, and rejections after transplantation.

Detailed Description
-----------------
Specific aims are proposed to achieve in this study: To compare graft and patient survival rate, incidence of treatment-related adverse effects between different patterns of immunosuppression combination among patients received post-liver transplant care in Kaohsiung Chang Gung Memorial Hospital (KCGMH), Taiwan. To quantify the long-term health impacts of immunosuppressive regimens on quality-adjusted life expectancy (QALE), the loss-of-QALE relating to immunosuppression therapy, and types of transplantation.

Official Title
-----------------
Trends of Immunosuppression Therapy and Their Effectiveness in Patients With Liver Transplantation

Conditions
-----------------
Evidence of Liver Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Aim 1: Inclusion Criteria: age at liver transplantation is at least 20 years Aim 2: Inclusion Criteria: age at liver transplantation is at least 20 years Exclusion Criteria: deceased patient cannot obtain inform consent age <20 years

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| liver transplantation recipients<br>adult liver transplantation recipients (>=20 years at the date of surgery) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of graft and patient mortality, treatment-related complications | Patient will be followed from the date of liver transplantation to the occurence of outcome event for 5 years | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| health-related quality of life | health-related quality of life will be measured by EQ-5D-5L and 15D | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Agents, immunosuppressive agents, Liver transplantation/epidemiology, Liver transplantation/pharmacology, Health status/drug effects
Telehealth Could Mitigate Disease Progression Compared to Standard of Care in COPD - a Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
The objective of this randomised controlled trial is to test, whether telehealthcare can improve HRQOL and reduce emergency admissions and hospitalisations due to AECOPD. Different outcome parameters as described in the endpoints section will be analysed.

Official Title
-----------------
Telehealth Could Mitigate Disease Progression Compared to Standard of Care in COPD - a Randomized Controlled Trial

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Device: Telehealth care
* Diagnostic Test: Weekly CAT measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD GOLD B-D and age ≥ 40 years Exclusion Criteria: Inability to provide informed consent or to follow trial procedures

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br> | Device: Telehealth care<br>* Patients in the intervention group daily answer 6 questions, which are focused on the recognition of AECOPD, using the electronic healthcare platform Evita by Swisscom, which has been and continuously is developed by the study team and Swisscom. The study team daily analyses all patients online and reacts according to a pre-specified action plan.<br>Diagnostic Test: Weekly CAT measurement<br> <br> |
| Active Comparator: Control<br> | Diagnostic Test: Weekly CAT measurement<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of COPD assessment test (CAT) at 6 months (slope of the linear regression trend) |  | 1 year after inclusion |
Identify the Genes Polymorphisms Related to Non-familial Bradyarrhythmia

Study Overview
=================
Brief Summary
-----------------
Bradyarrhythmia, including sinus node dysfunction and atrioventricular block, is a major cause necessitating pacemaker implantation. In contrast to familial bradyarrhythmia known as by mutations at particular ion channels, limited information is available for the mechanistic study in non-familial bradyarrhythmia. Possible gene polymorphisms related to non-familial bradyarrhythmia were studied. Comparison of multi-locus analysis and single-locus analysis will be analyzed between the cases and controls. Functional studies will perform to clarify the results of association study.

Conditions
-----------------
Bradyarrhythmia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients with non-familial bradyarrhythmia Exclusion Criteria: Familial bradyarrhythmia Reversible bradyarrhythmia Bradyarrhythmia after open heart surgery and severe organic heart diseases
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| sinus node dysfunction<br> | |
| Atrioventricular block<br> | |
| control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Clinical Trial Assessing the Impact of Inhaled Insulin on Glucose Disposition

Study Overview
=================
Brief Summary
-----------------
To assess the impact of inhalation of insulin on glucose disposition in patients with type 1 diabetes

Detailed Description
-----------------
The study was terminated on Oct. 28, 2007. The protocol was undergoing implementation and methodological issues with major revisions that qualified this trial as a new trial. Pfizer decided to cancel new trials because of the decision to withdraw Exubera due to lack of market performance and not for safety reasons.

Official Title
-----------------
Open-Label Randomized Two-Way Crossover Pilot Study To Estimate The Effects Of Inhaled Versus IV Infusion Of Human Insulin With Regards To Glucose Disposal In Subjects With Type 1 Diabetes Mellitus

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Inhaled Human Insulin
* Drug: Regular Human Insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes mellitus Type 1 Exclusion Criteria: Asthma, COPD Smoking

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Inhaled Human Insulin|nan|
|Drug: Regular Human Insulin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 18F-labeled glucose uptake in muscle |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose turnover overnight Insulin pharmacokinetics |  |  |
A Study of Immediate and Delayed Closure of Type II and IIIa Open Tibia Fractures

Study Overview
=================
Brief Summary
-----------------
Delayed wound closure is considered by many to be the standard of care for the treatment of an open fracture. This study was conducted to determine the feasibility of a large multi-center prospective randomized clinical trial and collect the pilot data needed to compete for the funding for such a trial. The study was designed to compare immediate and delayed closure of Gustilo type II and IIIa tibia diaphyseal fractures. The primary outcomes were the infection rates and fracture related complications in patients treated with immediate or delayed wound closure strategies.

Official Title
-----------------
A Randomized Study of Immediate and Delayed Closure of Type II and IIIa Open Tibia Fractures: A Pilot Study

Conditions
-----------------
Type II and IIa Open Tibia Fractures

Intervention / Treatment
-----------------
* Procedure: delayed closure
* Procedure: immediate wound closure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gustilo type II-IIIa tibia fracture age greater than 15 years fractures amenable to intramedullary nailing Exclusion Criteria: excessive wound contamination patient cardio-pulmonary or hemodynamic instability preventing prompt surgical intervention impaired or absent consciousness refusal of consent

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: delayed closure<br>wounds packed open with normal saline wet to dry gauze dressings and were returned to the operating room 36 to 72 hours after initial procedure for debridement and definitive closure. | Procedure: delayed closure<br>* wounds packed open with normal saline wet to dry gauze dressings and were returned to the operating room 36 to 72 hours after initial procedure for a second debridement and definitive closure.<br>|
| Active Comparator: immediate wound closure<br>traumatic and surgical wounds closed at initial surgical intervention | Procedure: immediate wound closure<br>* traumatic and surgical wounds closed at the initial surgical intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| infection rate | defined as cases determined definitively by a positive culture or treated empirically based on tenderness, erythema, and heat at the wound site. |  | 
| hospital readmissions | need for additional procedures and hospital readmissions related to the index injury will be documented |  | 
| tibial fracture healing | evidence of bridging callus on three of four cortices assessed by biplanar radiograph |  |