louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01623258: A Prospective Randomized Study Comparing Sentinel Lymph Node (SLN) Evaluation With Standard Pathological Evaluation for the Staging of Colon Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Cancer
Lead sponsor: Walter Reed Army Medical Center
Sponsor class: FED
First posted: 2012-06-19
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Up to 150 male or female military healthcare beneficiaries over the age of 18 years presenting at the Walter Reed Army Medical Center (WRAMC) General Surgery clinic with the diagnosis of biopsy-proven, primary, non-metastatic (Clinical Stage I,II or III) colon carcinoma will be enrolled. Subjects with colonic masses clinically consistent with colon cancer, and eventually confirmed by pathology, will also be enrolled.

Brief summary: The objective of this trial is to define the rate of upstaging of colon carcinoma lymph node metastasis with sentinel lymph node (SLN) mapping.

Null hypothesis: There is no difference in the rate of lymph node metastasis between conventional histopathological processing of lymph nodes and SLN mapping with detailed pathologic examination using immunohistochemistry (IHC) in patients undergoing resection of colon carcinoma.


Eligibility criteria: Inclusion Criteria:

1. 18 years of age
2. Primary, non-metastatic \[Stage I, II (localized, node negative), or III (localized, node positive)\] colon carcinoma confirmed by tissue biopsy or colon mass clinically consistent with cancer and eventually confirmed by pathology
3. Palpable mass at time of surgery
4. Capable of providing informed consent

Exclusion Criteria:

1. Prior radiation or chemotherapy
2. Non-palpable colon tumor
3. Recurrent or Stage IV (metastatic) colon cancer
4. Unable to give informed consent

Primary outcomes:
measure: Define the rate of upstaging of colon carcinoma lymph node metastasis with define the rate of upstaging of colon carcinoma lymph node metastasis with sentinel lymph node (SLN) mapping
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Washington DC
country: United States
facility: Walter Reed Army Medical Center
state: District of Columbia
Study officials:
affiliation: Walter Reed Army Medical Center
name: Alexander Stojadinovic
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nissan A, Protic M, Bilchik AJ, Howard RS, Peoples GE, Stojadinovic A. United States Military Cancer Institute Clinical Trials Group (USMCI GI-01) randomized controlled trial comparing targeted nodal assessment and ultrastaging with standard pathological evaluation for colon cancer. Ann Surg. 2012 Sep;256(3):412-27. doi: 10.1097/SLA.0b013e31826571c8.
Clinical trial NCT00151658: Sirolimus Eluting Stents in Complex Coronary Lesions (SCANDSTENT)
Official title: Randomized Multicenter Comparison of Sirolimus Versus Bare Metal Stent Implantation in Complex Coronary Lesions. Acronym: Scand Stent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischaemic Heart Disease
Keywords: Coronary complex lesions
Restenosis
Drug eluting stents
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2005-09-09
Enrollment: 322
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the clinical and angiographic outcome of implantation of stents eluting or not eluting Sirolimus in patients with complex coronary artery lesions suitable for percutaneous coronary intervention.


Eligibility criteria: Inclusion Criteria:

Stable, or unstable angina and/or objective signs of myocardial ischaemia Lesions should be de novo and located in native vessels with a diameter \> 2.25 mm.

Complex lesions to be included should have at least one of the following characteristics:

* Ostial in location (\< 5 mm from ostium)
* Total occlusions with a length ≥ 15 mm
* Bifurcational (side branch \> 1.75 mm in diameter)
* Angulated (\> 45° within lesion)

Exclusion Criteria:

Patients:

* Other severe disease with an expected survival \< 1 year
* Other significant cardiac disease
* Known allergy against paclitaxel, clopidogrel or stainless steel.
* Myocardial infarction within 3 days of the index procedure
* Linguistic difficulties needing an interpreter
* Renal insufficiency (p-creatinine \> 200 micromol/l)
* Gastrointestinal bleeding within 1 month
* Childbearing potential or pregnancy
* Participation in another study

Lesions:

* Unprotected left main disease
* Restenosis
* Lesions containing visible thrombus
* Treatment with other modality than balloon or stent (ablation, brachytherapy, ultrasound) in connection with the index procedure
* Diffuse coronary disease distal to the treated lesion
* Heavily calcification
* Lesion located in saphenous vein graft

Primary outcomes:
measure: Minimal lumen diameter
measure: Frequency of restenosis (>50%) at 6 months.
Secondary outcomes:
measure: Diameter stenosis, late loss and loss index at 6 months MACE: death, myocardial infarction, target lesion revascularisation within 12 months and 24 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Henning Kelbaek, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kelbaek H, Klovgaard L, Helqvist S, Lassen JF, Krusell LR, Engstrom T, Botker HE, Jorgensen E, Saunamaki K, Aljabbari S, Thayssen P, Galloe A, Jensen GV, Thuesen L. Long-term outcome in patients treated with sirolimus-eluting stents in complex coronary artery lesions: 3-year results of the SCANDSTENT (Stenting Coronary Arteries in Non-Stress/Benestent Disease) trial. J Am Coll Cardiol. 2008 May 27;51(21):2011-6. doi: 10.1016/j.jacc.2008.01.056.
Clinical trial NCT00038558: Prophylactic Use of Filgrastim SD/01 in Patients With Hodgkin's Disease Receiving ABVD Chemotherapy
Official title: Prophylactic Use of Filgrastim SD/01 In Patients With Hodgkin's Disease Receiving ABVD Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hodgkin Disease
Keywords: Hodgkin's lymphoma
Dacarbazine
DTIC
DTIC-Dome
Vinblastine
Velban
Bleomycin sulfate
Blenoxane
BLM
Doxorubicin Hydrochloride
Adriamycin
Filgrastim
G-CSF
Neupogen
Pegfilgrastim
granulocyte colony-stimulating factor
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2002-06-03
Enrollment: 25
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prophylactic use of Filgrastim SD/01 for patients with Hodgkin's lymphoma receiving ABVD chemotherapy.


Eligibility criteria: INCLUSION:

* Previously untreated Hodgkin's disease patients who are scheduled to receive standard ABVD chemo.
* Histologically proven diagnosis of Hodgkin's disease of any type.
* Bidimensionally measurable disease.
* Signed informed consent.
* Age \>/= 16 yrs.
* Adequate bone marrow reserve (ANC\>1000/uL, Platelet \>100,000/uL.
* LVEF\>/=50% by MUGA scan or echocardiogram.
* Serum creatinine \<2mg/dL; serum bilirubin\<2mg/dL.

EXCLUSION:

* HIV positive.
* Pregnant women and those of child bearing age who are not using adequate contraception.
* Prior chemotherapy.
* Severe pulmonary disease including COPD and asthma.
* History of prior sensitivity to E.coli derived products.

Primary outcomes:
measure: Number of Patients with Response to Prophylactic Filgrastim SD/01Chemotherapy
timeFrame: Following ABVD chemotherapy course
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: UT MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: UT MD Anderson Cancer Center
name: Anas Younes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04110158: Chronic Constipation in Children Among School Children is Assuit University Children Hospital
Official title: A Study on Chronic Constipation Etiology and Risk Factors Among School Age Children in Assuit University Children Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Constipation in Children
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 300
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children between 4:18 years old complain of constipation for a period long than 2 months

Brief summary: Aim of the work to show rate of constipation among school age children in Assuit University Children Hospital

Detailed description: Childhood constipation is a frequently overlooked global health problem, which is developing in a public health issue in many parts of the world.(1) Constipation is one of the commonest digestive complaints in children(2) Constipation has long been considered a symptom, rather than a disease(3)

It is often perceived as infrequent motions or passage of hard stools. Some defined constipation as less than 3 bowel motions per week)4(

or as difficulty in passing stools (5) Approximately 0.5% of school children have defecation frequency less than 3 per week and 0.3% have fecal incontinence(6) Furthermore, 20% of children also have at least 1 clinical feature of constipation.7 Therefore, it is important to use diagnostic criteria based on multiple symptoms to define constipation

Eligibility criteria: Inclusion Criteria:school age children 4:18 years old -

Exclusion Criteria: neonates and younger than 4years children

-

Primary outcomes:
measure: A.study on chronic Constipation Etiology and risk factors among school age children in Assuit University Children Hospital
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mustafa.tawfeek1@med.au.edu.eg
name: Mostafa Tawfeek
role: STUDY_DIRECTOR
References:
citation: Rajindrajith S, Devanarayana NM. Constipation in children: novel insight into epidemiology, pathophysiology and management. J Neurogastroenterol Motil. 2011 Jan;17(1):35-47. doi: 10.5056/jnm.2011.17.1.35. Epub 2011 Jan 26.
Clinical trial NCT01451658: A Trial of EVL\GVS Alone vs. EVL\GVS Combined Propranolol (S-HCC)
Official title: Endoscopic Treatment Alone Versus Combined Propranolol and Endoscopic Treatment of Acute Variceal Hemorrhage in Patients With Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Gastroesophageal Varices Hemorrhage
Hepatocellular Carcinoma
Keywords: Variceal bleeding
portal hypertension
hepatocellular carcinoma
endoscopic variceal ligation
non-selective beta-blocker
rebleeding
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2011-10-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with hepatocellular carcinoma and esophageal varices bleeding were randomized to undergo endoscopic ligation alone (group A) and additive propranolol treatment (group B) after stabilization of their first acute bleeding.

Detailed description: Esophageal variceal bleeding is characteristic of high rebleeding rate and mortality. Thanks to the recent advance of treatment for variceal bleeding such as non-selective beta blocker (NSBB) added to endoscopic ligation further reduce rebleeding in cirrhotic patients, the rebleeding rate and mortality has a marked reduction. However, hepatocellular carcinoma (HCC) is a distinct group characteristic of very poor prognosis in patients with portal hypertension when compared to those of liver cirrhosis only. Therefore, the investigators design a study to randomize patients with HCC and acute variceal bleeding to endoscopic treatment alone and combination with endoscopic treatment and NSBB. This is the two years study.

Eligibility criteria: Inclusion Criteria:

1. clinical diagnosis of HCC
2. endoscopically proven acute variceal bleeding
3. younger than 18 years old or older than 80 years old

Exclusion Criteria:

-Had a terminal illness of any major organ system,such as heart failure, kidney failure,COPD

Primary outcomes:
measure: Rebleeding
timeFrame: 2 year
Secondary outcomes:
measure: complication survival
timeFrame: 2 year
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Veteran General Hospital-Taipei
state: Ming-Chih Hou, MD
Study officials:
References:
Clinical trial NCT05359458: Emotional Freedom Liberation Technique, Surgical Fear and Anxiety
Official title: The Effect of Emotional Freedom Liberation Technique on Surgical Fear and Anxiety Applied to Patients Before Laparoscopic Cholecystectomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotional Distress
Keywords: surgery
anxiety
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2022-05-03
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Aim: In this study, the effect of Emotional Freedom Technique applied to patients before Laparoscopic Cholecystectomy on surgical fear and anxiety was investigated.

Design: This is a randomized controlled study. Method: A total of 112 patients who were going to have Laparoscopic Cholecystectomy were randomly divided into two groups each including 56 participants. The intervention group was provided with Emotional Freedom Technique. The control group received routine face-to-face education. Surgical fear and anxiety were examined.


Eligibility criteria: Inclusion Criteria:

* Clinical treatment for Laparoscopic Cholecystectomy
* 18 years of age or older
* Mentally healthy

Exclusion Criteria:

* Agree to participate in the study

Primary outcomes:
measure: Surgical Fear Scale
timeFrame: through study completion, an average of 5 month
Secondary outcomes:
measure: Anxiety Scale
timeFrame: through study completion, an average of 5 month
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
state: ABD Veya Kanada'da Lütfen Seçin ...
Study officials:
References:
Clinical trial NCT02665858: OCT Imaging of Papilledema in Pediatric Idiopathic Intracranial Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pediatric Idiopathic Intracranial Hypertension
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-01-28
Enrollment: 50
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Longitudinal clinical observation of optic nerve head, using slit lamp fundoscopy, guides therapy in pediatric idiopathic intracranial hypertension (IIH) patients; however, it remains a limited method of producing quantitative data in evaluating in patients with IIH.

In this study we intend to compare, by using spectral domain optical coherence tomography (OCT), the mean retinal nerve fiber layer thickness and total retinal thickness (RNFLT/TRT) of the optic nerve of newly diagnosed IIH children to a control group. This will provide a quantitative measure for follow-up and treatment of this patient group.


Eligibility criteria: Inclusion Criteria:

* Children with suspected IIH

Exclusion Criteria:

* Retinal disease
* High refractive error
* Unable to undergo OCT imaging

Primary outcomes:
measure: Comparison of RNFLT/TRT Thickness
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Yuval Cohen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04830358: Safety and Immunogenicity of the 'EuPCV15' in Healthy Korean Adults
Official title: A Single Center, Randomized, Single-blind, Active Comparator Phase 1 Clinical Trial to Assess the Safety and Immunogenicity of the 'EuPCV15' in Healthy Korean Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pneumococcal Disease
Lead sponsor: EuBiologics Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2021-04-05
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The safety and immunogenicity of EuPCV15 compared to Prevenar13 are assessed in healthy adults.


Eligibility criteria: Inclusion Criteria:

1. Healthy adults aged 19 to 50 years old
2. Participants willing to give written informed consent to participate in the trial

Exclusion Criteria:

1. History of invasive pneumococcal infection within 5 years at screening
2. Known hypersensitivity to any component of the study vaccine
3. Immune deficiency or immunosuppressive disorder
4. Immunized with any licensed vaccine within 4 weeks prior to screening
5. Pregnant, lactating women or women of childbearing age not using a reliable method of contraception
6. Participants who in the opinion of the investigator will not be able to comply with any of the protocol required procedure

Primary outcomes:
measure: Incidence of Solicited AEs (Local and Systemic)
timeFrame: within 14 days after vaccination
measure: Incidence of Unsolicited AEs
timeFrame: within 28 days after vaccination
measure: Incidence of SAEs
timeFrame: within 180 days after vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Seoul St.Mary's Hospital
Study officials:
References:
Clinical trial NCT00719758: Drug-Drug Interaction Study of TRK-100STP
Official title: TRK-100STP Pharmacokinetic Study in Healthy Volunteers - Evaluation of Pharmacokinetic Interaction Between TRK-100STP and Kremezin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: TRK-100STP,
beraprost sodium,
Careload LA
AST-120
Spherical carbon adsorbent
Drug-drug interaction
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Toray Industries, Inc
First posted: 2008-07-22
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of AST-120 on the PK of TRK-100STP, and to evaluate the safety and tolerability of TRK-100STP alone or in combination with AST-120

Detailed description: Non-blinded, randomized and crossover study to evaluate pharmacokinetic interaction between TRK-100STP and AST-120 in different administration condition. Nonelderly adult volunteers will receive TRK-100STP with or without AS-T120 after meal. Safety parameters will concurrently be measured.

Eligibility criteria: Inclusion Criteria:

* Provision of written informed consent
* Body Mass Index (BMI) of ≥17.6 to ≤26.4 kg/m2 and weight of ≥50 to ≤80 kg

Exclusion Criteria:

* Clinical abnormal physical findings, including BP, pulse rate, ECG and laboratory assessments
* Receives any investigational medicine within 120 days before screening
* Recent blood donor

Primary outcomes:
measure: Pharmacokinetic profile
timeFrame: 1 day
Secondary outcomes:
measure: Safety parameters (vital signs, ECG, laboratory tests)
timeFrame: 1 day
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT04580758: Fractional CO2 Laser Combined With PRP Fluid Versus Gel in Treatment of Acne Scars
Official title: Fractional CO2 Laser Combined With Platelet Rich Plasma Fluid Versus Gel Form in Treatment of Atrophic Acne Scars: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Atrophic Acne Scar
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to test the efficacy of fractional laser combined with either PRP fluid or PRP gel in the treatment of atrophic acne scars

Detailed description: The study will include 20 patients, treated with fractional CO2 laser plus PRP fluid on one side of the face and fractional CO2 laser plus PRP gel on the other side.

Choosing which side of the face will be injected with PRP fluid and which side will be injected with PRP gel will be chosen according to a randomization table for each patient.

Eligibility criteria: Inclusion Criteria:

* Age above 18
* Both genders
* Skin types III - V
* Willingness and ability to comply with the requirements of the protocol
* Atrophic acne scars

Exclusion Criteria:

* Patients with active acne
* Patients with herpes labialis, bacterial infections, other infections such as HBV. HCV or HIV.
* Oral isotretinoin use in the previous 6 months
* Pregnancy
* Tendency to keloid formation
* Patients with severe systemic illness or malignancy
* Patients with connective tissue diseases
* Patients with bleeding tendencies or any other hematological disease

Primary outcomes:
measure: Test which combination is more effective, fractional laser with PRP fluid or fractional laser with PRP gel
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Kasr Al Ainy Hospital
Study officials:
References:
Clinical trial NCT01022463: Effect of Ivabradine on Heart Rate & Effort Tolerance in Mitral Stenosis in Sinus Rhythm
Official title: Effect of Ivabradine vs Atenolol on Heart Rate and Effort Tolerance in Patients With Mild to Moderate Mitral Stenosis and Normal Sinus Rhythm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mitral Stenosis
Lead sponsor: Govind Ballabh Pant Hospital
Sponsor class: OTHER_GOV
First posted: 2009-12-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to study the effect of Ivabradine vs Atenolol on heart rate and effort tolerance in patients with mild to moderate mitral stenosis and normal sinus rhythm.


Eligibility criteria: Inclusion Criteria:

1. Mild to moderate mitral stenosis (Mitral valve area: 1.0 cm2 - 2.0 cm2 on echocardiography) with normal sinus rhythm
2. Age \>18 years
3. Need for rate control therapy for symptoms

Exclusion Criteria:

1. Atrial fibrillation
2. Other significant valvular lesions (More than mild AS/AR/MR)
3. Denial of consent
4. Unable to do TMT/Contraindication for TMT
5. Need for surgical treatment or BMV
6. Presence of significant non-cardiac co-morbidities
7. Pregnancy

Primary outcomes:
measure: Change in effort tolerance ( in minutes/Mets) from baseline with the study drugs at the end of stipulated 4 weeks
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Delhi
country: India
facility: G. B. Pant Hospital
state: Delhi
Study officials:
affiliation: G. B. Pant Hospital, New Delhi
name: Dr Neeraj Parakh, MD, DM
role: PRINCIPAL_INVESTIGATOR
References: