louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04367064: To Study the Clinical Characteristics and Treatment Outcome of COVID-19 Patients Admitted in Hospitals of Max Healthcare (SCOPe Study)
Official title: To Study the Clinical Characteristics and Treatment Outcome of COVID-19 Patients Admitted in Hospitals of Max Healthcare (SCOPe Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID
Lead sponsor: Max Healthcare Insititute Limited
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All the confirmed cases of COVID 19 getting treated at Max Super Speciality Hospital (DDF) as per the standard treatment protocol and policy for COVID 19.

Brief summary: This is an observational study for Corona virus disease by the Max Healthcare.Corona virus 2019 disease (COVID-19) is a respiratory tract infectious disease caused by a newly emergent corona virus. This virus is linked to the same family of viruses as Severe Acute Respiratory Syndrome (SARS) and some types of common cold.

Detailed description: In view of increasing cases in India and the possibility of the exponential rise of cases, study has been designed to observe the patient profile and outcomes for hospitalized positive Covid-19 patients that may help to understand the effectiveness of different treatment strategies. This is a retrospective and prospective, observational study based on collection of data related to COVID-19 admitted patients treated in the hospitals of Max Healthcare as per the standard treatment protocol and policy for COVID 19 at Max Healthcare.

Covid19 patients shall be approached at the time of admission for participation in this study. If the patient consents, the participating investigator or designated study personnel will collect the baseline demographic details of the patient, along with medical history; current disease status; current and previous treatment details; and the results of all the laboratory tests performed, as per the standard clinical practices. Daily follow up will be done on a structured case record form (CRF) till the discharge or death.

Eligibility criteria: Inclusion Criteria:

1. Patients of either sex aged ≥18 years
2. Patients who are Covid-19 positive
3. All patients with positive Corona virus infection admitted in the hospitals of Max Healthcare will be included in the study.

Exclusion Criteria:

-

Primary outcomes:
measure: we will compare the clinical outcome of the COVID 19 patients with their age and gender
timeFrame: 3-4 months
Secondary outcomes:
measure: we will compare the effect of different treatments given to the COVID 19 patients at Max Hospital
timeFrame: 3-4 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Max Super Speciality hospital, Saket (A unit of Devki Devi Foundation)
state: Delhi
Study officials:
affiliation: Max Healthcare
name: Sandeep Budhiraja, MRCP, FACP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03977064: Fertility and Cardiovascular Risk in Men With Metabolic Syndrome
Official title: Fertility and Cardiovascular Risk in Men With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: University of Giessen
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 70
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Men diagnosed with metabolic syndrome (MetS) including obesity, hypertension, dyslipidemia and infertility will be assessed for cardiovascular and diabetes risk. The eligible patient will be randomised to one-year life-style intervention program including nutritional, behavioural and exercise counselling or standard care by the general physician. The aim of the program is to reduce cardiovascular and diabetes risks and hypogonadism as well.


Eligibility criteria: Inclusion Criteria:

* Age\>18 years, wish for fatherhood in stable partnership, metabolic syndrome according to guidelines (minimum 3 out of 5 criteria), ready to participate in 1-yr lifestyle program

Exclusion Criteria:

* Not conforming to MetS diagnosis criteria, sterilisation, promiscuous behaviour, contraindications against established medical or surgical treatment of obesity, participation in another weight-loss program

Primary outcomes:
measure: Number of participants with normalisation of diabetes or cardiovascular risk or improvement of hypogonadism
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Gießen
country: Germany
facility: Justus Liebig University
Study officials:
References:
Clinical trial NCT06094764: S&B Heat Stress Pilot Protocols
Official title: Measuring the Effectiveness of a Personal Cooling Vest for the Prevention of Heat Strain in Construction Workers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thermal Discomfort
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institute for Occupational Safety and Health (NIOSH/CDC)
First posted: 2023-10-23
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to develop a heat stress program for the construction industry and evaluate its feasibility and appeal.


Eligibility criteria: Inclusion Criteria:

* employed at S\&B
* work more than 20 hours a week

Exclusion Criteria:

* severe chronic disease (e.g. severe pulmonary or cardiovascular disease
* history of severe heat stroke
* use of a pacemaker
* any medical issue which would render the participant unable to wear a chest monitor and cooling vest.

Primary outcomes:
measure: Thermal discomfort as assessed by the thermal comfort scale
timeFrame: end of study (about 2 hours after start)
Secondary outcomes:
measure: Change in Heart rate as assessed by the Zephyr BioHarness 3.0 device
timeFrame: from baseline to end of study (2 hours after baseline)
measure: Estimated core body temperature as assessed by the Zephyr BioHarness 3.0 device
timeFrame: from baseline to end of study (2 hours after baseline)
measure: Respiratory rate as assessed by the Zephyr BioHarness 3.0 device
timeFrame: from baseline to end of study (2 hours after baseline)
measure: Caloric burn as assessed by the Zephyr BioHarness 3.0 device
timeFrame: from baseline to end of study (2 hours after baseline)
measure: Hydration status as indicated by urine specific gravity as assessed by a clinical refractometer analysis of urine sample
timeFrame: from baseline to end of study (2 hours after baseline)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: William Perkison, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01404364: Use of Intravitreal Triamcinolone and Retrobulbar Chlorpromazine as Alternatives to the Management of Painful Blind Eye
Official title: Use of Intravitreal Triamcinolone and Retrobulbar Chlorpromazine as Alternatives to the Management of Painful Blind Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blind Painful Eye
Refractory Glaucoma
Control of Pain Through Drug Injection
Keywords: Triamcinolone
Chlorpromazine
Refractory glaucoma
Blind painful eye
Lead sponsor: Hospital Governador Celso Ramos
Sponsor class: OTHER
First posted: 2011-07-28
Enrollment: 36
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the efficacy of intravitreal triamcinolone and retrobulbar chlorpromazine as alternatives in the management of ocular pain in blind eyes.

Detailed description: The management of chronic eye pain is a constant challenge to ophthalmology. Treatment varies with the intensity of pain, and topical eye drops and contact lens therapy are effective in many patients. In refractory cases, and without vision, surgical removal of the eye through enucleation is considered classical therapy. As less invasive alternatives we have cyclodestruction and neurolytic drug injection in order to promote analgesia for a prolonged period.

The purpose of this study is to evaluate the efficacy of intravitreal triamcinolone and retrobulbar chlorpromazine as alternatives in the management of This is a prospective study of patients with blind painful eyes not responsive to topical treatment and with no indication for evisceration seen at the Department of Ophthalmology, Hospital Governador Celso Ramos (HGCR) in 2010.

Eligibility criteria: Inclusion Criteria:

* patients treated in the period at HGCR who wanted to be part of the protocol by signing the consent form

Exclusion Criteria:

* patients whose follow-up period was less than three months

Primary outcomes:
measure: Changes in Pain intensity
timeFrame: 0, 1 month, 3 months, 6 months after procedure
Secondary outcomes:
measure: Changes in Use of eyedrops before and after drug injection
timeFrame: 0, 1 month, 3 months, 6 months
measure: Changes in Intraocular pressure (IOP)
timeFrame: 0, 1 months, 3 months, 6 months
Other outcomes:
Locations:
city: Florianopolis
country: Brazil
facility: Hospital Governador Celso Ramos
state: Santa Catarina
Study officials:
affiliation: Hospital Governador Celso Ramos
name: Deborah C Ribas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03061864: The Periviable Birth Plan
Official title: The Periviable Birth Plan: A Randomized Control Trial Evaluating an Intervention to Decrease Maternal Anxiety and Stress
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy, High Risk
Parturition Complication as Antepartum Condition
Anxiety
PTSD
PreTerm Birth
Lead sponsor: Albany Medical College
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pregnant women who are at risk of delivering their infants in the periviable period can suffer a large amount of stress and anxiety. Moreover, many women feel a loss of control over their own pregnancy. There is some evidence that more counseling and planning can help reduce maternal stress and anxiety. Patients at risk of delivering in the periviable period will be randomized to either receive standard counselling or to complete the periviable birth plan.


Eligibility criteria: Inclusion Criteria:

* 18 years old.
* Currently Pregnant
* High risk of pre-term birth in the periviable period 20+0 to 25+6 wga

Exclusion Criteria:

* Intrauterine Fetal Demise (prior to admission)
* Inability to read or communicate in english

Primary outcomes:
measure: Change in Anxiety Scores
timeFrame: Time of Delivery and One Year
measure: Change in PTSD Scores
timeFrame: Time of Delivery and One Year
Secondary outcomes:
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical Center
state: New York
Study officials:
affiliation: Albany Medical College
name: Paul Burcher, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04458064: I-gel Versus Air-Q LMA for Pediatric Patients
Official title: I-gel Versus Air-Q LMA for Pediatric Patients Undergoing Short-duration Surgical Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Easy Insertion, Complications Ans Suitability of i Gel and Air Q LMA
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 120
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study targets to compare insertion facility, effect on hemodynamic parameters and effective ventilation using i-gel versus Air-Q LMA for pediatric patients undergoing short-duration surgical procedures.

Detailed description: The patient were divided into 2 groups. I gel group and Air Q group according to LMA type used to maintain airway ventilation.

The patients were compared according to insertion facility, effect on hemodynamic parameters and effective ventilation.

Eligibility criteria: Inclusion Criteria:

* ASA grade I-II
* operative time of ≤60 minutes

Exclusion Criteria:

* age \>10 years
* ASA grade ≥II
* current or recently resolved upper respiratory tract infection
* presence of oropharynx or laryngeal pathologies or congenital anomalies
* pathologies inducing reflux or increasing the possibility of aspiration
* allergy to anaesthetic or drugs to be used, renal, cardiac or hepatic diseases, or bronchial asthma

Primary outcomes:
measure: Supraglottic device success rate
timeFrame: 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT02840864: Comparison of Conventional With Sonography Assisted Breast Surgery
Official title: Comparison of Sonographically Assisted With Conventionally Breast Surgery - Prospective, Randomised, Multicenter, Parallel Group Study With Two Study Arms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Surgery
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2016-07-21
Enrollment: 374
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of the study is to test whether surgical removal of a tumor under sonographic control as compared to conventional method reduces the rate of resections and local relapse


Eligibility criteria: Inclusion Criteria:

* 18 to 70 years
* Female
* Presurgical validated breast cancer

Exclusion Criteria:

* Sonographically not defined report
* Lobular breast cancer
* Extensive ductal carcinoma in situ

Primary outcomes:
measure: Rate of second tumor resections
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Department for Women's Health
Study officials:
References:
Clinical trial NCT06135064: Ultrasonic Neuromodulation for Treatment of PTSD
Official title: Deep Brain Therapy With Low-intensity Ultrasound for Treatment of Post-traumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: PTSD
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will evaluate a new form of non-invasive deep brain therapy for individuals with post-traumatic stress disorder (PTSD). Low-intensity transcranial focused ultrasound stimulation will first be delivered using a range of stimulation parameters during psychophysical and physiological monitoring. A well-tolerated stimulation protocol will be selected for subsequent testing in a blinded randomized sham-controlled cross-over trial. The trial will evaluate brain target engagement using magnetic resonance imaging and numerical scales of PTSD, cognitive performance, and mood.


Eligibility criteria: Inclusion Criteria:

* Positive PTSD diagnosis; PCL-5 \> 20

Exclusion Criteria:

* Inability to complete MRI
* Suicidal ideation

Primary outcomes:
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Up to 3 months following study initiation
Secondary outcomes:
measure: National Institutes of Health Toolbox Cognitive Battery (NIHTB-CB)
timeFrame: Up to 3 months following study initiation
measure: California Verbal Learning Test, 3rd Edition (CVLT3)
timeFrame: Up to 3 months following study initiation
measure: PROMIS scale of Pain Intensity
timeFrame: Up to 3 months following study initiation
measure: Hamilton Depression Rating Scale (HDRS-17)
timeFrame: Up to 3 months following study initiation
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Up to 3 months following study initiation
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Jan Kubanek, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Utah
name: Elisabeth Wilde, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03428464: Bicarbonate Administration in Kidney Transplant Recipients
Official title: Bicarbonate Administration in Kidney Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplant; Complications
Metabolic Acidosis
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2018-02-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Metabolic acidosis is associated with vascular endothelial dysfunction and is a common complication in patients who have received a kidney transplant. Kidney transplant recipients (KTR) with lower serum bicarbonate levels, even within the normal range, have an increased risk of graft loss and mortality. The investigators propose a prospective, double-blind, randomized, placebo-controlled, 18-week crossover pilot study to examine the effects of sodium bicarbonate on vascular endothelial function, graft function, and cognitive function in 20 KTR patients.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Kidney transplant received at least 1 year ago
* Serum bicarbonate 20-26 mEq/L on 2 separate measurements (at least 1 day apart)
* eGFR \>45 ml/min/1.73m2
* Blood pressure \<140/90 mm Hg prior to randomization
* BMI \< 40 kg/m2 (FMD measurements can be inaccurate in severely obese patients).
* Able to provide consent
* Stable kidney transplant medication regimen for at least 1 month prior to randomization
* Stable anti-hypertensive regimen for at least one month prior to randomization
* Not taking medications that interact with agents administered during experimental sessions (e.g. sildenafil interacts with nitroglycerin).

Exclusion Criteria:

* Significant comorbid conditions that lead the investigator to conclude that life expectancy is less than 1 year
* Use of chronic daily oral alkali within the last 3 months (including sodium bicarbonate, calcium carbonate or baking soda)
* Uncontrolled hypertension
* Serum potassium \< 3.3 or ≥ 5.5 mEq/L at screening
* New York Heart Association Class 3 or 4 heart failure symptoms, known EF ≤30%, or hospital admission for heart failure within the past 3 months · Factors judged to limit adherence to interventions
* Current participation in another research study
* Pregnancy or planning to become pregnant or currently breastfeeding
* Chronic use of supplemental oxygen

Primary outcomes:
measure: Change in Brachial Artery Flow-Mediated Dilation
timeFrame: Baseline, 8, 10, and 18 weeks
Secondary outcomes:
measure: Change in Transforming Growth Factor Beta 1 (TGF-B1)
timeFrame: Baseline, 8, 10, and 18 weeks
measure: Change in Cognitive Function
timeFrame: Baseline, 8, 10, and 18 weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Jessica Kendrick, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01167764: Effect of Tranexamic Acid on Prevention of Recurrence of Hemoptysis
Official title: Effect of Tranexamic Acid on Prevention of Recurrence of Hemoptysis: Multicenter, Prospective, Randomized, Double-blind Phase 3 Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Hemoptysis
Keywords: hemoptysis
recurrence
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2010-07-22
Enrollment: 0
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hemoptysis is one of the serious complication of many pulmonary diseases. Upto now, there is no proven medical treatment in recurrence of hemoptysis. The investigators will conduct a randomized, placebo controlled trial of tranexamic acid, which can reduce the recurrence of hemoptysis.


Eligibility criteria: Inclusion Criteria:

* age: \>=20 and \<=75
* ER visit or admission for hemoptysis
* no evidence of hemoptysis on screening

Exclusion Criteria:

* anticoagulation treatment
* Cr \>= 2.0 mg/dL or urinary protein \>= 2+ or who received renal replacement treatment
* hepatic failure: total bilirubin \>= 1.5 mg/dL or AST or ALT \>= 1.5 of upper normal limit level
* hypersensitivity to tranexamic acid
* pregnant woman
* fertile female who don't use contraception

Primary outcomes:
measure: the proportion of recurrence of hemoptysis
timeFrame: 6 month: 1months medication + 5months observation
Secondary outcomes:
measure: time to recurrence
timeFrame: 6 month: 1months medication + 5months observation
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government Seoul National University Boramae Medical Center
Study officials:
affiliation: Seoul National University College of Medicine
name: Jae-Joon Yim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: