louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00185185: Olmesartan Medoxomil in Atherosclerosis
Official title: Multi-Centre Olmesartan Atherosclerosis Regression Evaluation (MORE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Essential Hypertension
Atherosclerotic Cardiovascular Disease
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 165
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study in hypertensive patients with atherosclerosis and increased cardiovascular risk. The efficacy of olmesartan medoxomil on atherosclerosis is measured.


Eligibility criteria: Inclusion Criteria:

* Mean sitting sBP and dBP prior to randomization of 140-180/90-105 mmHg
* Increased cardiovascular risk, e.g.: a) documented or clinical signs of peripheral atherosclerotic disease stage IIa or lower; b) diabetes mellitus type 2; c) left ventricular hypertrophy on echo; d) current smoking; e) old myocardial infarction, stroke or TIA
* Intima-media thickness of the common carotid artery greater than or equal to 0.8 and less than or equal to 1.6 mm (measured ultrasonographically) or the plaque volume of the carotid bulb greater than or equal to 4 μl and less than or equal to 500 μl

Exclusion Criteria:

* Body mass index \> 30
* Any type of known secondary hypertension
* Electrocardiographic evidence of 2nd or 3rd degree atrioventricular block, atrial fibrillation, cardiac arrhythmia requiring therapy or bradycardia at rest (\< 50/min)
* Obstructive pulmonary disease
* Claudicatio intermittens
* History or clinical evidence of any significant gastrointestinal, respiratory, hematological, metabolic, immunological or any other underlying disease which in the opinion of the investigator would interfere with the patient's participation in the trial
* Hypersensitivity or contraindication to ARBs, Beta-Blockers, HCTZ or any cross allergy
* Pre-treatment with ARBs or ACE inhibitors within 6 months prior to screening
* Treatment with disallowed medication
* Pregnant or breastfeeding females or females of childbearing potential without adequate contraception
* History of alcohol and/or drug abuse

Primary outcomes:
measure: Change of intima media thickness of the common carotid artery on the leading side of the neck.
Secondary outcomes:
measure: -Change in plaque volume in the common carotid artery or the carotid bulb.
measure: -Change of intima media thickness of the common carotid artery.
measure: -Changes of diastolic and systolic blood pressure.
measure: -Safety and tolerability
Other outcomes:
Locations:
city: Munich
country: Germany
Study officials:
affiliation: Medizinische Poliklinik der Friedrich-Wilhelms-Universitat, Bonn, Germany
name: Prof. Klaus O Stumpe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04499885: Potential Role of Gastric Lavage by Paraffin Oil in Acute Aluminum Phosphide Poisoning
Official title: Potential Role of Gastric Lavage by Paraffin Oil in Acute Aluminum Phosphide Poisoning: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Toxicity, Drug
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 62
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Potential Role of Gastric Lavage by Paraffin Oil in Acute Aluminum Phosphide Poisoning.

Detailed description: The study aims to investigate the Potential Role of Gastric Lavage by Paraffin Oil in Acute Aluminum Phosphide Poisoning: A Randomized Controlled Clinical Trial

Eligibility criteria: Inclusion Criteria:

* • Patients with symptomatic acute aluminum phosphide poisoning

Exclusion Criteria:

* • Pregnant and lactating women

  * Asymptomatic patients with history of acute aluminum phosphide exposure.
  * Patients with ingestion or exposure to other substances in addition to aluminum phosphide.
  * Patients with other major medical conditions (e.g. cardiovascular disease, renal or hepatic failure).
  * Patients with previous medical intervention (had gastric lavage in any medical center before admission).
  * Patients with disturbed consciousness level
  * Patients with post cardiac arrest cases

Primary outcomes:
measure: Number of deaths
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Sherief Abd-Elsalam
Study officials:
affiliation: Forensic medicine Department- Tanta University
name: Nadia Ezzat Helal, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Forensic medicine Department- Tanta University
name: Ayman Nagy, ass. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Forensic medicine Department- Tanta University
name: Ghada N. El-Sarnagawy, ass. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02322385: Clinical Implications of DNA Analysis on ADPKD
Official title: Mutational Types and Phenotypes Relationship in Autosomal Dominant Polycystic Kidney Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autosomal Dominant Polycystic Kidney Disease
Keywords: Autosomal Dominant Polycystic Kidney Disease
PKD 1 gene
PKD 2 gene
Truncational mutation
Hypomorphic mutation
Lead sponsor: Kyorin University
Sponsor class: OTHER
Collaborators: name: Otsuka Pharmaceutical Co., Ltd.
First posted: 2014-12-23
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients with ADPKD visiting Kyorin university hospital over two years. The patients whose clinical data including total kidney volume (TKV), eGFR, QOL data and other relevant clinical data are available will be enrolled.

Brief summary: Autosomal dominant polycystic kidney disease (ADPKD) is an inherited disease. We plan DNA analysis using the next generation sequencer (NGS) and examine the relationship between mutational types and clinical phenotypes. The accuracy of DNA analysis with NGS is tested by Sanger's method. The kidney and life survival curves will be compared between PKD1, PKD2 and non-ADPKD family members.

Detailed description: 80 unrelated patients with ADPKD attending to the Kyorin University Hospital whose clinical data are compiled. DNA analysis is performed at Otsuka Pharmaceutical Laboratory.

Clinical data include total kidney volume (TKV), TKV slope, eGFR, eGFR slope and other clinically relevant data.

Eligibility criteria: Inclusion Criteria:

* The unrelated patients with ADPKD.

Exclusion Criteria:

* The patients whose clinical data are not compiled.

Primary outcomes:
measure: The relationship between mutational types and phenotypes
timeFrame: Depends on the observational period at least more than one year.
Secondary outcomes:
measure: Identify the efficacy of next generation sequencing method
timeFrame: One year.
Other outcomes:
measure: The relationship between mutational types and phenotypes;
timeFrame: One year.
Locations:
city: Mitaka
country: Japan
facility: Department of Polycystic Kidney Research, Kyorin University School of Medicine
state: Tokyo
city: Mitaka
country: Japan
facility: Department of Urology, Kyorin University Hospital
state: Tokyo
Study officials:
affiliation: Department of Polycystic Kidney Research, Kyorin University School of Medicine
name: Eiji Higashihara, MD
role: STUDY_CHAIR
References:
citation: Higashihara E, Horie S, Kinoshita M, Harris PC, Okegawa T, Tanbo M, Hara H, Yamaguchi T, Shigemori K, Kawano H, Miyazaki I, Kaname S, Nutahara K. A potentially crucial role of the PKD1 C-terminal tail in renal prognosis. Clin Exp Nephrol. 2018 Apr;22(2):395-404. doi: 10.1007/s10157-017-1477-7. Epub 2017 Oct 5.
Clinical trial NCT01659385: Leptin Levels in Papillary Thyroid Cancer
Official title: Assessment of Serum Leptin Levels in Females With Papillary Thyroid Carcinoma, Benign Thyroid Nodules, and Normal Controls
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Cancer, Papillary
Leptin Levels
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2012-08-07
Enrollment: 18
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females with no prior history of thyroid disease and not on thyroid medications.

Active recruitment will be for normal controls only. They will be age and weight/height matched to females with prior diagnosis of thyroid cancer or thyroid nodules who are already part of another study.

Brief summary: The purpose of this study is to evaluate Leptin levels in females, in the setting of papillary thyroid cancer, benign thyroid nodules, and in normal females without thyroid disease.

Detailed description: There will be three groups in this study, but 2 of the groups are part of another study so will only recruit normal controls.

Eligibility criteria: Inclusion Criteria:

* Female
* Age\>/- 19
* Not currently pregnant or lactating
* Normal thyroid gland by history

Exclusion Criteria:

* Male Gender
* Pregnancy
* Lactation
* Age below 19
* Abnormal thyroid gland by history
* Abnormal thyroid gland by structure using ultrasound
* Abnormal thyroid gland by function using TSH, Free T4

Primary outcomes:
measure: evaluating Leptin level Evaluating Serum Leptin Levels Between 3 Groups. One Group with Papillary Thyroid Carcinoma. One Group With Benign Nodules. One Group with Normal Thyroid.
timeFrame: During Study
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Whitney Goldner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02695485: Sensory Reconstruction of the Digits
Official title: Sensory Reconstruction in Different Region of the Digits: A Review of 151 Cases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Soft Tissue Defect of Digit
Keywords: dorsal digital island flap
sensory reconstruction
Lead sponsor: The Second Hospital of Tangshan
Sponsor class: OTHER
Collaborators: name: Chinese PLA General Hospital
First posted: 2016-03-01
Enrollment: 151
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A retrospective study is conducted with 151 patients who has a soft tissue defect of digit treated with the sensate flaps from February 2005 to March 2014. Based on the different regions of soft tissue defects, the patients in the study are divided into four groups: (1) thumb group treated with the bilaterally innervated and traditional kite flaps; (2) distal finger group treated with the single- and dual-innervated dorsal digital flaps; (3) proximal finger group treated with heterodigital neurocutaneous island flap; and (4) awkward region group treated with Litter flap. The main outcomes are static 2-point discrimination and Semmes-Weinstein monofilament scores of the flap, and pain and patient satisfaction.

Detailed description: At final follow-up, sensory restoration of the flap is measured using the static 2PD test and Semmes-Weinstein monofilament test. Using the visual analogue scale (VAS) that consists of a 10 cm line, patients are asked to report pain sensations of the recipient site. Patients report their satisfaction with functional recovery of the injured finger according to the Michigan Hand Outcomes Questionnaire that is based on a 5-point response scale.

Eligibility criteria: Inclusion Criteria:

* thumbtip degloving injury with a projecting tip of exposed bone or/and pulp defect; the defect ≥2 cm in length associated with the transected digital nerves in both sides; necessity to preserve thumb length; patient at or younger than 55 years of age

Exclusion Criteria:

* injury to the dorsum of the proximal or/and middle phalanx of the index finger; injury to the course of the FDMA; thumb nail bed defect; radial or ulnar portion of thumbtip or pulp defect

Primary outcomes:
measure: Static 2PD test
timeFrame: 18 months to 24 months after surgery
measure: Pain sensation using the visual analogue scale
timeFrame: 18 months to 24 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Chen C, Tang P, Zhang X. The dorsal homodigital island flap based on the dorsal branch of the digital artery: a review of 166 cases. Plast Reconstr Surg. 2014 Apr;133(4):519e-529e. doi: 10.1097/PRS.0000000000000016.
Clinical trial NCT02597985: Prehabilitation to Improve Functional and Clinical Outcomes in Patients With Aortic Stenosis
Official title: Prehabilitation to Improve Functional and Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Replacement: TAVR-FRAILTY Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Stenosis
Keywords: Frailty
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-11-05
Enrollment: 13
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Transcatheter aortic valve replacement (TAVR) is a treatment alternative among high-risk elderly with aortic stenosis, however, mortality remains high. Fifty percent of patients undergoing TAVR exhibit frailty, a syndrome associated with poor survival. It is unknown whether interventions to improve frailty before TAVR (prehabilitation) will improve outcomes after TAVR. This study plans to evaluate whether simple cardiac exercise interventions to improve physical performance before TAVR improves outcomes after TAVR.


Eligibility criteria: Inclusion criteria:

* Eligibility for TAVR
* SPPB\<9
* Able to exercise
* Able to come for follow-up visits
* Able to give informed consent

Exclusion criteria:

* New York Heart Association (NYHA) Class III/IV congestive heart failure (CHF)
* Presyncope or syncope as presentation
* Acute coronary syndrome
* Unable to exercise
* Dementia
* Sustained ventricular arrhythmia
* Stroke with neurological deficit
* Advanced Parkinson's
* Participated in an exercise program

Primary outcomes:
measure: Change in Score on short physical performance battery (SPPB) test
timeFrame: Baseline, approximately 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Mandeep Singh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04354285: 24-hour Urinary Aldosterone And Endocrine System In Obesity
Official title: 24-hour Urinary Aldosterone And Endocrine System In Obesity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 230
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who came to the Outpatient Clinic of Nutrition at the National Institute of Gastroenterology "S. de Bellis," Research Hospital, Castellana Grotte, Italy.

Brief summary: The study was aimed at investigating the relationship between hormone parameters and urinary aldosterone levels in 24h within a cohort of overweight and obesity.

Detailed description: Subjects were enrolled at the first examination whether they were not taking any medication, including oral contraceptives or drugs for osteoporosis, and free of significant medical illnesses, except obesity. Exclusion criteria were history of endocrinological diseases (diabetes mellitus, hypo or hyperthyroidism, hypopituitarism, etc.), chronic inflammatory diseases, stable known hypertension, angina pectoris, stroke, transient ischemic attack, heart infarction, congenital heart disease, malignancies, chronic inflammatory diseases, renal and liver failure, angina pectoris, myocardial infarction, heart failure, congenital heart diseases, minor and major stroke, and inherited thrombocytopenias and other major malignancies. Subjects were examined by means of the medical history, hormonal, metabolic and routine hematochemical parameters. The investigators provided for a clinical baseline evaluation that included extemporaneous ambulatory blood pressure (BP) and a physical assessment of body weight, Body Mass Index (BMI) and Waist Circumference (WC) as anthropometric parameters.

Eligibility criteria: Inclusion Criteria:

* Overweight or obesity (BMI\> 25 Kg/m2)

Exclusion Criteria:

* Any kind of drug
* Hypertension
* Endocrine diseases (diabetes mellitus, hypo or hyperthyroidism, hypopituitarism, etc.),
* Chronic inflammatory diseases
* Renal failure
* Liver failure
* Angina pectoris
* Myocardial infarction and heart failure
* Genetic heart diseases
* Thrombocytopenias

Primary outcomes:
measure: Thyroid hormones (FT3, FT4)
timeFrame: Baseline
measure: TSH
timeFrame: Baseline
measure: Urinary Aldosterone
timeFrame: Baseline
measure: Prolactin
timeFrame: Baseline
measure: Insulin
timeFrame: Baseline
measure: Parathyroid Hormone
timeFrame: Baseline
Secondary outcomes:
measure: Total cholesterol
timeFrame: Baseline
measure: HDL cholesterol
timeFrame: Baseline
measure: LDL cholesterol
timeFrame: Baseline
measure: BMI
timeFrame: Baseline
measure: Height
timeFrame: Baseline
measure: Weight
timeFrame: Baseline
measure: Vitamin D
timeFrame: Baseline
Other outcomes:
Locations:
city: Castellana Grotte
country: Italy
facility: National Institute of Gastroenterology IRCCS S. de Bellis
state: Bari
Study officials:
References:
Clinical trial NCT00957385: Maintenance Therapy in Acute Myeloid Leukemia (AML) Patients
Official title: A Randomized Phase II Study of Lenalidomide Maintenance Therapy in AML Patients Aged > 60 Years in CR1 or Higher and < 60 Years in CR2 or Higher
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Keywords: Leukemia
Remission
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Celgene Corporation
First posted: 2009-08-12
Enrollment: 24
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 determine if Revlimid will help maintain patients with acute myeloid leukemia in remission.

Detailed description: At present, the majority of AML patients \>60 years of age that achieve CR and thereafter successfully complete further chemotherapy, are not candidates for allogeneic bone marrow transplantation (alloBMT) due to their age. Rather, this group of patients is simply observed until relapse occurs. In this age group, the median duration of CR is only \~10 months. The survival of patients \<60 years of age who are not candidates for transplantation (due to donor unavailability), and who are in CR2 or higher is also extremely poor. Several lines of evidence suggest that the immune system - and in particular AML specific CTLs and NK cells - is capable of recognizing and clearing AML cells.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Acute myeloid leukemia in remission.
* Able to take aspirin 81mgs daily.

Exclusion Criteria:

* Pregnant or breast feeding females.
* Known hypersensitivity to thalidomide.
* Any prior use of lenalidomide.

Primary outcomes:
measure: To assess the feasibility and assess the effect on relapse free survival by giving Revlimid in the post complete remission maintenance setting
timeFrame: The 1st interim analysis will be done once all subjects have completed 12 cycles, and the 2nd interim analysis will be done once all subjects have completed treatment.
Secondary outcomes:
measure: To determine the toxicity of Revlimid when given in the maintenance setting.
timeFrame: The 1st interim analysis will be done after all subjects have receieved 12 cycles and the 2nd when all subjects have completed treatment.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network, Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: University Health Network Princess Margaret Hospital
name: Andre Schuh, MD.FRCP(C)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01953185: MANUAL DIAPHRAGM RELEASE TECHNIQUE INCREASES TIDAL VOLUME IN ELDERLY
Official title: MANUAL DIAPHRAGM RELEASE TECHNIQUE INCREASES TIDAL VOLUME AND UPPER RIB CAGE CONTRIBUTION DURING QUIET BREATHING IN ELDERLY: A RANDOMIZED CONTROLLED TRIAL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: elderly
subjects
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2013-09-30
Enrollment: 17
Sex: ALL
Minimum age (years): 60
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Question: Does manual diaphragm release change kinematics and respiratory function of elderly subjects? Design: Randomized controlled trial with concealed allocation and double-blinding.

Participants: 17 volunteers over 60 years old randomized into two groups: 09 in the Control Group (CG) and 08 in the Intervention Group (IG).

Intervention: The manual diaphragm release technique was used on the IG, in two sets of ten deep breaths, with a one minute interval between them. The CG underwent a sham protocol (light touch), with same sets and time of interval.

Outcome measures: The groups were evaluated using spirometry, manovacuometry and optoelectronic plethysmography (OEP), in that order, before and immediately after the intervention.


Eligibility criteria: Inclusion Criteria:

* over 60 years of age;
* a body mass index (BMI) below 30 kg/m2
* non-smokers, self-declared sedentary;
* presenting a forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) greater than or equal to 80% of predicted;
* the ratio between these variables (FEV1/FVC) greater than 70% in spirometry

Exclusion Criteria:

* Showed the inability to understand verbal commands in the evaluation.

Primary outcomes:
measure: Compartmental chest wall volume
timeFrame: 1 day
Secondary outcomes:
measure: Pulmonary function
timeFrame: 1 day
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Universidade Federal de Pernambuco
state: Pernambuco
Study officials:
affiliation: Universidade Federal de Pernambuco
name: Taciano Rocha, Msc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aliverti A, Pedotti A. Opto-electronic plethysmography. Monaldi Arch Chest Dis. 2003 Jan-Mar;59(1):12-6.
citation: De Troyer A. Respiratory effect of the lower rib displacement produced by the diaphragm. J Appl Physiol (1985). 2012 Feb;112(4):529-34. doi: 10.1152/japplphysiol.01067.2011. Epub 2011 Dec 1.