linjc16/ctgov huggingface dataset:
Renal Nerve Denervation(RDN) and Renal Function

Study Overview
=================
Brief Summary
-----------------
Current studies have found the efficacy of RDN in the treatment of hypertension, however, the safety of RDN in renal function is still lacking. Therefore, the investigators are aimed to study the effect of RDN on renal function.

Official Title
-----------------
Effect of RDN on Renal Function

Conditions
-----------------
Effects of RDN on Renal Function

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.18<age≤75 years; 2.clinic blood pressure ≥ 140/90 mmHg or 24-hour ambulatory blood pressure monitoring average blood pressure ≥ 135/85 mmHg after taking 3 or more antihypertensive drugs for more than 4 weeks; 3.essential hypertension, renal parenchymal hypertension, or hypertension patients who are willing to receive RDN ; 4.who signed informed consent and were approved by the Ethics Committee of the First Affiliated Hospital of Xiamen University. Exclusion Criteria: pregnant women or lactating patients; identified secondary hypertension or Pseudo hypertension; whose renal arteries were unsuitable for ablation obvious bleeding tendency and blood system diseases; malignant tumors or end-stage diseases; ⑥Severe peripheral vascular disease, abdominal aortic aneurysm; ⑦A history of the acute coronary syndrome within two weeks; ⑧acute or severe systemic infection; ⑨drug or alcohol dependence or refusal to sign informed consent.

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of serum creatinine and urea nitrogen before and after RDN operation | Serum creatinine(umol/L, ammonia iminohydrolase assay)and urea nitrogen(umol/L, urease methods) were obtained by blood test. | Baseline,1week/1 month/6months after RDN operation | 
| Changes of glomerular filtration rate before and after RDN operation | Glomerular filtration rate(ml/min) were obtained by ECT | Baseline, 6months after RDN operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of RDN operation on renal artery | Renal arteries were observed by CT angiography. | Baseline, 6months after RDN operation | 
| Urinary protein/serum creatinine ratio change before and after RDN operation | Urinary protein (mg/L, PRM assay) were tested by urine test.Serum creatinine(umol/L, ammonia iminohydrolase assay) were obtained by blood test. | Baseline,1week/1 month/6months after RDN operation |
Dietary Quality and Subsequent Cardiovascular Disease

Study Overview
=================
Brief Summary
-----------------
To examine dietary quality and subsequent cardiovascular disease (CVD).

Detailed Description
-----------------
BACKGROUND: Although considerable evidence exists for associations between diet and subsequent cardiovascular disease (CVD) among younger and middle-aged adults, no comprehensive studies of these relationships have been conducted using a national sample of older Americans. National guidelines have recommended reductions of dietary fat, saturated fat, cholesterol and sodium as dietary practice to reduce CVD. However, it is possible that the focus on eliminating dietary components may obscure the advantages of consuming diets that are nutritionally adequate. Findings from this study could have important implications for setting research priorities to further study the effects of specific dietary variables on CVD, and for implementing national nutrition policies to assist Americans in selecting healthy diets. DESIGN NARRATIVE: Data from NHANES I and the three cycles of NHANES I Epidemiologic Followup Study (NHEFS) were used to 1) to examine the associations between several measures of dietary quality at baseline and subsequent 14-year morbidity and mortality from CVD for a national sample of 6109 United States adults aged 45 to 74 years at baseline; 2) to assess the relative importance of the associations of dietary quality and CVD for older adults compared to middle-aged adults. Dietary variables were based on responses to the 24-hour dietary recall and the food frequency questionnaire administered at baseline and included a composite measure of dietary quality, intakes of specific nutrients, and usual consumption of foods from 19 food groups. Baseline measures used as covariates included body mass index, blood pressure, serum cholesterol, sociodemographic variables (e.g., age, race, income, occupation), behavioral variables (e.g., smoking, alcohol consumption, activity level), and chronic health conditions. CVD outcomes were determined from medical history questionnaires, hospital records and death certificates. Change in blood pressure between baseline and 10-year followup were examined as an outcome variable as well as a covariate in the association between diet and CVD. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
A Comparison of Dapsone and Trimethoprim-Sulfamethoxazole in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS

Study Overview
=================
Brief Summary
-----------------
Evaluate the effectiveness rate of dapsone plus trimethoprim as a therapy for the first episode of Pneumocystis carinii pneumonia (PCP) in AIDS patients. Compare the rates and severity of adverse effects using dapsone versus trimethoprim - sulfamethoxazole (TMP / PurposeX). Establish relative toxicities with regard to suitability for outpatient treatment.

Official Title
-----------------
Randomized Prospective Study of Dapsone Versus Trimethoprim-Sulfamethoxazole in the Treatment of First Episode Pneumocystis Carinii Pneumonia in AIDS Patients

Conditions
-----------------
Pneumonia, Pneumocystis Carinii, HIV Infections

Intervention / Treatment
-----------------
* Drug: Trimethoprim
* Drug: Sulfamethoxazole
* Drug: Dapsone


Participation Criteria
=================
Eligibility Criteria
-----------------
Exclusion Criteria Concurrent Medication: Excluded: Requirement for other medications found to be effective in the treatment of Pneumocystis carinii pneumonia (PCP) (i.e., DFMO, pyrimethamine, and sulfadiazine). Patients with the following are excluded: History of allergic reaction to dapsone. Requirement for other medications found to be effective in the treatment of Pneumocystis carinii pneumonia (PCP) (i.e., DFMO, pyrimethamine, and sulfadiazine). Patients subsequently found to be glucose-6-phosphate dehydrogenase (G6PD) positive will be withdrawn from the study and treated with another regimen. Prior Medication: Excluded: Requirement for other medications found to be effective in the treatment of Pneumocystis carinii pneumonia (PCP) (i.e., DFMO, pyrimethamine, and sulfadiazine). Patients who are glucose-6-phosphate dehydrogenase (G6PD) positive will be withdrawn from the study and treated with another regimen. Hospitalized patients with first episode of Pneumocystis carinii pneumonia (PCP) documented by GIEMSA or methenamine stain. Patients must: Be willing and able to give informed consent. Be expected to survive 1 week without therapy. Have less than 48 hours of treatment for Pneumocystis carinii pneumonia (PCP) for this episode.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Trimethoprim|nan|
|Drug: Sulfamethoxazole|nan|
|Drug: Dapsone|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
-----------------
Dapsone, Trimethoprim-Sulfamethoxazole Combination, AIDS-Related Opportunistic Infections, Pneumonia, Pneumocystis carinii, Acquired Immunodeficiency Syndrome
Establishment of Optimal Transfusion Threshold After Major Orthopedic Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a higher threshold for transfusion with red blood cells improves the postoperative ambulation.

Official Title
-----------------
Establishment of Optimal Transfusion Threshold After Major Orthopedic Surgery

Conditions
-----------------
Hip, Anemia, Arthroplasty, Replacement

Intervention / Treatment
-----------------
* Other: Allowed drop in hemoglobin to 4.5-5.5 mmol/L
* Other: Allowed drop in hemoglobin to level between 5.6-6.5 mmol/L


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Patients undergoing replacement of hip arthroplasty Be legally competent Read and understand Danish Exclusion Criteria: Present malignant disease Known heart disease with functionality equivalent to NYHA II or CCS II or worse

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Allowed drop in hemoglobin to 4.5-5.5 mmol/L<br>Transfusion with red blood cells to level between 4.5-5.5 mmol/L | Other: Allowed drop in hemoglobin to 4.5-5.5 mmol/L<br>* Transfusion with red blood cells to hemoglobin between 4.5-5.5 mmol/L (Transfusion threshold of 4.5 mmol/L)<br>|
| Experimental: Allowed drop in hemoglobin to 5.6-6.5 mmol/L<br>Transfusion with red blood cells to level between 5.6-6.5 mmol/L | Other: Allowed drop in hemoglobin to level between 5.6-6.5 mmol/L<br>* Transfusion with red blood cells to between hemoglobin 5.6-6.5 mmol/L (Transfusion threshold of 5.5 mmol/L)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed Up and Go-test (TUG)in seconds. | Timed Up and Go-test is performed when the patient is able to undertake the test after surgery. This is judged by a physiotherapist. The test measures how long it takes the patient to rise, walk 3 meters, turn around, walk back and sit down again. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The postoperative day patients can walk ten meters |  | 30 days | 
| Length of stay at hospital |  | 30 days | 
| The day the patient is able to perform Timed Up and Go-test |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemoglobin, Ambulation
Double Blind Randomized Trial to Compare Gurmar (Gymnema Sylvestre) With Metformin in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The study plans to compare the glucose-lowering effect of gurmar, a herbal preparation, with metformin in patients with type 2 diabetes

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

Intervention / Treatment
-----------------
* Drug: Gurmar
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly detected type 2 diabetes Fasting plasma glucose >126mg/dl HbA1c > 7% Exclusion Criteria: Serious comorbid illnesss History of drug abuse History of recent weight loss

Ages Eligible for Study
-----------------
Minimum Age: 25 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gurmar|nan|
|Drug: Metformin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Expanded Access Program for Idebenone in Patients With Leber's Hereditary Optic Neuropathy Who Completed the LEROS Study

Study Overview
=================
Brief Summary
-----------------
Expanded Access Program for Idebenone in Patients with Leber's Hereditary Optic Neuropathy who completed the LEROS Study

Detailed Description
-----------------
see above

Official Title
-----------------
Expanded Access Program for Idebenone in Patients With Leber's Hereditary Optic Neuropathy Who Completed the LEROS Study

Conditions
-----------------
Leber's Hereditary Optic Neuropathy

Intervention / Treatment
-----------------
* Drug: Idebenone 150 MG Oral Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who completed the LEROS study, who attended the end of study visit in LEROS and who in the opinion of investigator could benefit from continuation of idebenone treatment. Signed and dated Informed Consent Form (to be obtained at the Enrollment Visit from patient or parent/legal guardian (if applicable) prior to dispensing idebenone to the patient). Exclusion Criteria: Patients who, in the opinion of the LEROS investigator, had unacceptable tolerability of idebenone treatment in LEROS trial. Patients who prematurely discontinued the LEROS study.
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Idebenone 150 MG Oral Tablet|idebenone 900 mg/day|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Efficacy, Safety, And Pharmacokinetics Of Rifaximin In Subjects With Severe Hepatic Impairment And Hepatic Encephalopathy

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the safety of Rifaximin or placebo in subjects with severe hepatic impairment and Hepatic Encephalopathy.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial To Evaluate The Efficacy, Safety, And Pharmacokinetics Of Rifaximin 550 Mg In Subjects With Severe Hepatic Impairment And Overt Hepatic Encephalopathy

Conditions
-----------------
Hepatic Encephalopathy

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or non-pregnant, non-breast feeding female ≥ 18 years old In remission from demonstrated overt HE Had ≥1 episode of overt HE associated with liver disease within the last 6 months MELD score of ≥ 19 Has a close family member or other personal contact who is familiar with the subject's HE, can provide continuing oversight to the subject and is willing to be available to the subject during the conduct of the trial Exclusion Criteria: HIV History of tuberculosis infection Chronic respiratory insufficiency Current infection and receiving antibiotics Renal insufficiency requiring dialysis Active spontaneous bacterial peritonitis infection Intestinal obstruction or has inflammatory bowel disease Active malignancy within the last 5 years Current GI bleeding or has had a GI hemorrhage within past 3 months Anemia

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: Rifaximin<br>Rifaximin, oral, 550 mg BID, 6 months of treatment | Drug: Rifaximin<br>* Rifaximin, oral, 550 mg BID, 6 months treatment<br>* Other names: XIFAXAN® Tablets;|
| Placebo Comparator: Placebo<br>Placebo, oral, 0 mg BID, 6 months of treatment | Drug: Placebo<br>* Placebo, oral, 0 mg BID, 6 months of treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first Hepatic Encephalopathy(HE) breakthrough episode |  | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first HE-related hospitalization |  | 6 Months | 
| All Cause Mortality |  | 6 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatic Encephalopathy, Liver Failure, Hepatic Insufficiency, Liver Diseases, Brain Diseases, Rifaximin, Cirrhosis
Safety, Effectiveness and Quality of Life of Trastuzumab Deruxtecan in Patients With HER2+ Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Collection of data in real life conditions on satefy, effectiveness and quality of life of trastuzumab deruxtecan in patients with metastatic or unresectable HER2-positive breast cancer.

Detailed Description
-----------------
The present observational study aims to collect data on long-term safety of trastuzumab deruxtecan, with a primary endpoint on trastuzumab deruxtecan related adverse drug reactions (ADRs) of interest. Data on patient profile, treatment history (before, during and after trastuzumab deruxtecan administration), effectiveness and health-related quality of life will also be collected in a real-life setting, to confirm and complement data from clinical trials. Patients will be recruited whether they have started trastuzumab deruxtecan treatment or will start it at the time of inclusion, whether they were prescribed compassionate trastuzumab deruxtecan or marketed Enhertu®, in order to rapidly collect a large set of data.

Official Title
-----------------
Real-world Study on Safety, Effectiveness and Quality of Life of Trastuzumab Deruxtecan in Patients With Metastatic or Unresectable HER2-positive Breast Cancer: a French Ambispective Multicentre 2 Year-follow-up Cohort Study

Conditions
-----------------
HER2-positive Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female adult patient (age ≥ 18 years); Unresectable or metastatic HER2+ breast cancer, previously treated with at least 2 lines of anti-HER2, and: previously treated by compassionate trastuzumab deruxtecan (ATU group), or previously treated or planned to be treated by trastuzumab deruxtecan (Enhertu®), upon the investigator's decision (Post-Marketing authorization group); Patient who expresses non-opposition to participate in the study, or deceased patient who did not express his/her opposition to the use of his/her personal data while alive. Exclusion Criteria: - Previous participation in an interventional clinical trial with trastuzumab deruxtecan

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

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

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 |
| --- | --- | --- |
| Percentage of patients with at least one Trastuzumab deruxtecan related Adverse Drug Reaction of interest | The primary endpoint is the percentage of patients with at least one Trastuzumab deruxtecan related Adverse Drug Reaction of interest | 2 years following the start of administration of Trastuzumab deruxtecan |
Evaluation of a Full Face Mask and Headgear for the Treatment of Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
Currently Fisher & Paykel Healthcare (FPH) is developing a new full face mask. The objective of this clinical investigation is to evaluate the usability and acceptance of the investigative mask, the effectiveness of the seal and headgear. The participant will be randomised to use either full face mask prototype 1 or 2 as according to the randomization log for 7 ± 3 days in home. The participant will then crossover to the other full face mask prototype to use in home for 7 ± 3 days. Neither the investigators or the participants will be blinded to the study.

Official Title
-----------------
Evaluation of a Full Face Mask and Headgear for the Treatment of Obstructive Sleep Apnea

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Device: Investigative Full Face Mask with Headgear


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AHI ≥ 5 from the diagnostic night ≥ 18 years of age Either prescribed APAP or CPAP or Bi level for OSA Existing full face users Exclusion Criteria: Inability to give informed consent Participant intolerance to PAP Anatomical or physiological conditions making PAP therapy inappropriate Current diagnosis of respiratory disease or CO2 retention Pregnant or think they may be pregnant

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Headgear 1<br>Full Face Mask with Headgear 1 | Device: Investigative Full Face Mask with Headgear<br> <br> |
| Experimental: Headgear 2<br>Full Face Mask with Headgear 2 | Device: Investigative Full Face Mask with Headgear<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mask is comfortable and is effective for the participant during in-home use | Performance in relations to leak and comfort of each prototype and how it compares to their usual mask, as measured by a custom questionnaire, daily participant feedback log and PAP device data. | 1 week for each mask prototype in-home | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of the Full Face mask prototypes | Preference for one of the Full Face Mask prototypes design through a custom questionnaire and a daily participant feedback log | 1 week for each mask prototype in-home |