louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00030121: Carperitide in Acute Respiratory Distress Syndrome (ARDS)
Official title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Evaluation of the Safety and Efficacy of Carperitide Infusion in Patients With ARDS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Respiratory Distress Syndrome
Keywords: Acute Respiratory Distress
Acute Lung Injury
Lead sponsor: Suntory Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2002-02-01
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 whether Carperitide is safe and effective in the management of Acute Respiratory Distress Syndrome (ARDS).

Detailed description: Acute respiratory distress syndrome (ARDS is a severe form of acute lung injury. ARDS is characterized by an increase in pulmonary vascular permeability resulting from a non-cardiogenic cause, leading to an increased vascular water volume, pulmonary inflammation, and severe hypoxemia. Conventional therapy for ARDS is primarily respiratory management by mechanical ventilation using positive end-expiratory pressure (PEEP). Mechanical ventilation is the major management concern in patients with ARDS, due to its higher risk of infections and morbidity. Treatment with Carperitide may reduce time on the ventilator by reducing pulmonary edema and by improving gas exchange. The results of Carperitide studies in animals and humans support the idea that the hormone will be effective in managing the acute pulmonary complications and hypoxemia seen in ARDS.

Eligibility criteria: Inclusion:

In order to participate in the study, patients must:

* be 18 years or older
* have an acceptable PF ratio
* have adequate fluid volume
* be intubated less than 7 days

Exclusion:

In order to participate in the study, patients must not meet any of the following criteria:

* be moribund
* be immunocompromised
* have pneumonia (caused by Pneumocystis carinii)
* have recieved another investigational drug or device within the last 30 days
* have a Do not Resuscitate order

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06151821: Examining the Influence of Guided Meditation on Diabetes-related Distress and Glycemic Control
Official title: Examining the Influence of Guided Meditation on Diabetes-related Distress and Glycemic Control: A Randomized Controlled Trial Among Hospitalized Type 1 Adolescent Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: Type 1 diabetes mellitus
Guided meditation
Adolescents
Lead sponsor: Shifa International Hospital
Sponsor class: OTHER
First posted: 2023-11-30
Enrollment: 68
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study aims to investigate the effects of Guided Meditation on diabetes-related distress and glycemic control in hospitalized Type 1 adolescent diabetic patients. The study will employ a randomized controlled trial design, with participants randomly assigned to either the intervention group (receiving Guided Meditation sessions) or the control group (receiving standard care). The primary outcomes measured will be diabetes-related distress levels and glycemic control (HbA1c levels).

Detailed description: The researchers hypothesize that the intervention group will experience a reduction in diabetes-related distress and an improvement in glycemic control compared to the control group. The study's findings could suggest how guided meditation could help manage the emotional distress and enhance diabetes management in hospitalized Type 1 adolescent diabetic patients.

Eligibility criteria: Inclusion Criteria:

* Adolescent patients aged between 12 to 18 years.
* Confirmed diagnosis of Type 1 diabetes mellitus.
* Hospitalized in the participating medical facility.
* Capable of providing informed consent (for participants aged 18) or providing assent with parental/legal guardian consent (for participants aged 12 to 17).

Exclusion Criteria:

* Presence of severe psychiatric disorders or cognitive impairments that may hinder participation in the guided meditation sessions.
* Physical limitations or medical conditions that prevent the safe participation in the intervention or assessment procedures.
* Previously engaged in regular meditation or mindfulness practices, which may confound the results.
* Inability to communicate effectively in the language used for assessments and interventions.

Primary outcomes:
measure: Diabetes distress scale
timeFrame: Week 1 and Week 13
Secondary outcomes:
measure: HbA1c levels
timeFrame: Week 1 and Week 13
measure: Number of hypoglycemic and hyperglycemic episodes
timeFrame: Week 1, 4, 8 and 12
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Shifa Hospital
Study officials:
affiliation: Shifa hospital
name: Saima Abbass, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00002121: Diethylhomospermine (DEHSPM) for Refractory AIDS-Related Diarrhea
Official title: Diethylhomospermine (DEHSPM) for Refractory AIDS-Related Diarrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diarrhea
HIV Infections
Keywords: Antidiarrheals
Diarrhea
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
N(1),N(14)-bis(ethyl)homospermine
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To perform preliminary clinical testing of diethylhomospermine (DEHSPM), a polyamine analogue, for refractory AIDS-related diarrhea.

Possibly, DEHSPM will reduce stool volume and frequency in patients with refractory AIDS-related diarrhea.

Detailed description: Possibly, DEHSPM will reduce stool volume and frequency in patients with refractory AIDS-related diarrhea.

Patients are initially hydrated for 24 hours, followed by a 3-day baseline period. They then receive intravenous infusions of DEHSPM three times per day for 3 days, followed by observation for 3 days.

Eligibility criteria: Inclusion Criteria

Patients must have:

* ARC or AIDS by CDC criteria.
* Uncontrolled diarrhea unresponsive to high-dose, nonspecific antidiarrheal therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Known idiopathic ulcerative colitis or Crohn colitis.
* Acute stool-culture-positive bacterial colitis.
* Acute amoebic colitis.
* Pseudomembranous colitis with Clostridium difficile toxin positivity.
* Short-gut syndrome.
* Chronic pancreatitis.
* Ischemic bowel disease.
* Enteroenteric fistulae.
* Other gastrointestinal tract disorders known to cause diarrhea.
* Underlying evidence of immunosuppression other than that related to HIV infection.
* Unable or unwilling to have subcutaneous injections.
* Clinically significant CNS, hepatic, or renal disease.

Concurrent Medication:

Excluded:

* Other experimental antidiarrheal drugs.
* Antibiotic therapy.

Prior Medication:

Excluded:

* Other experimental drugs within 1 month prior to study entry.

Required:

* At least 2 weeks of prior high-dose, nonspecific antidiarrheal therapy (i.e., loperamide, diphenoxylate hydrochloride-atropine sulfate, or opiates) at maximally tolerable doses.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Gainesville Veterans Administration Med Ctr
state: Florida
Study officials:
References:
Clinical trial NCT05175521: Inhaled IAV vs Inhaled Eucalyptus for the Treatment of Nausea With Acute Migraine
Official title: Double Blind Randomized Control Trial of Inhaled Isopropyl Alcohol Vapors Versus Inhaled Eucalyptus Scent for the Treatment of Nausea Associated With Acute Migraine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Migraine
Keywords: Nausea
Isopropyl alcohol
Eucalyptus
Aromatherapy
Vapors
Lead sponsor: HonorHealth Research Institute
Sponsor class: OTHER
First posted: 2022-01-03
Enrollment: 50
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: SUPPORTIVE_CARE

Brief summary: The goal of this study is to compare the efficacy and adverse events of inhaled isopropyl alcohol vapor (IAV) versus placebo (inhaled eucalyptus scent (IES) (1:20 dilution in mineral oil) for treating nausea associated with acute migraine attacks.

Detailed description: The main goal of this study is to examine the efficacy of (nausea reduction and time to use of other anti-nausea medications) and side effects of inhaled isopropyl alcohol vapor (IAV) for treating nausea among migraine patients using a double blind randomized control methodology. IAV is being compared inhaled eucalyptus scent (IES) (1:20 dilution in mineral oil) which has not shown benefit for treating nausea or migraine and is therefore considered placebo in this study.

Eligibility criteria: Inclusion Criteria:

* Patients 18 to 65 years old with nausea associated migraines at least twice per month

Exclusion Criteria:

* Patients \<18 or \>65 years old
* Patients without a diagnosis of acute migraine

Primary outcomes:
measure: Change of Severity of Nausea on Nausea Scale
timeFrame: ½ hour or to the end of treatment
Secondary outcomes:
measure: Side effects associated with interventional substance
timeFrame: ½ hour, but likely less than 2 hours
measure: Use of anti-nausea medication/Time to use of anti-nausea medication
timeFrame: ½ hour or to the end of treatment
measure: Time to Clinically Relevant Nausea Change
timeFrame: ½ hour or to the end of treatment
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: HonorHealth Bob Bové Neuroscience Institute
state: Arizona
Study officials:
affiliation: HonorHealth Research Institute
name: Jill Rau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00583921: Ventricular Rate Regularization for Improved Quality of Life in Patients With CHF and AF
Official title: Randomized Study of Ventricular Rate Regularization for Improved Quality of Life in Patients With Congestive Heart Failure and Atrial Fibrillation.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Congestive Heart Failure
Atrial Fibrillation
Keywords: Atrial Fibrillation
ICD
BiV ICD
CHF
Congestive Heart Failure
AF
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Guidant Corporation
First posted: 2008-01-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients implanted with a new Guidant ICD/ CRT-D: Indication for CRT-D and ICD with history of atrial fibrillation. Patients with new implants will not be enrolled until their three month follow up visit in the pacemaker clinic.

Patients currenlty implanted with a Guidant ICD/ CRT-D: More than 20% atrial fibrillation burden as recorded by defibrillator follow up report or with history of atrial fibrillation.

Brief summary: Single center investigator initiated sponsored by Guidant Boston Scientific Corp. to evaluate the benefit of ventricular rate regularization (VRR) in patients with congestive heart failure (CHF) and significant atrial fibrillation (AF) burden.


Eligibility criteria: Inclusion Criteria:

* Be between 18-85 years old
* Be willing and able to give informed consent
* Patient currently has a CRT-D or ICD with \> 20% atrial fibrillation burden as recorded by defibrillator follow up report or a history of atrial fibrillation prior to implant.
* Patient has the ability to complete a Six minute walk test with the only limiting factors to be fatigue or shortness of breath.

Exclusion Criteria:

* Expected mortality less than 6 months due to non-cardiac causes.
* Pregnant women.
* Creatinine greater than or equal to 2.5 mg/dl.
* Anemia (HCT less than 30)
* COPD causing significant dyspnea
* Orthopedic problems affecting 6 minute walk.

Primary outcomes:
measure: Improved quality of life, reduced emergency room visits and hospitalization for congestive heart failure symptoms.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: U C Davis Medical Center
name: Uma Srivatsa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03914521: Pre-surgical CT Scan Assessment of Bone Mineral Density Before Resection of NHO of the Hip
Official title: Pre-surgical CT Scan Assessment of Femoral Head Bone Mineral Density Before Resection of Neurogenic Heterotopic Ossification (NHO) of the Hip
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Paraosteoarthropathies
Keywords: hip surgery
bone mineral density
femoral head
Pre-surgical prognostic
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients having surgery resection of surgery resection of Neurogenic heterotopic ossification of hip.

Their per-operative CT-scan and surgery report will be collected from the records of Nîmes and Montpellier University Hospital Center

Brief summary: Neurogenic heterotopic ossification (NHO) is defined as an ectopic ossification around proximal joints usually seen after traumatic brain injury, spinal cord injury or polytrauma.

NHO causes pain, partial or total joint ankylosis and vascular or nerve complications.

The osteopenia (low bone density) induced by ankylose increases the fracture risk of femoral neck during the hip surgery performed to remove the NHO.

The analyse of femoral head bone mineral density from hip pre-surgical CT scan could anticipate this kind of complication establishing a presurgical prognostic.

If as it turns out the bone density measured from hip pre-surgical CT scan is relevant fracture risk marker, a preventive osteosynthesis or femoral head and neck resection could be performed in the same time of NHO resection.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years and over
* Patients having surgery resection of surgery resection of Neurogenic heterotopic ossification of hip.
* Patients with pre-surgery CT-scan and surgery report available

Exclusion criteria:

* Minor patients
* Patients didn't have surgery surgery resection of Neurogenic heterotopic ossification of hip.
* Pre-surgery CT-scan and surgery report not available

Exclusion Criteria:

-

Primary outcomes:
measure: femoral head bone mineral density
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Florence BAUMANN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03157921: Prevalence of Pregnancy in Polycystic Ovary Syndrome
Official title: Prevalence of Spontaneous Ovulation and Pregnancy in Patients With Polycystic Ovary Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-05-17
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: infertile women with poly-cystic ovary syndrome

Brief summary: Polycystic ovary syndrome is the most common endocrine disorder in women of reproductive age, with a prevalence of approximately 5-10%. Polycystic ovary syndrome is diagnosed according to Rotterdam criteria by at least two of the following three key features: oligomenorrhea or amenorrhea; clinical and/or biochemical signs of hyperandrogenism; the presence of polycystic ovaries on ultrasound and exclusion of other endocrine disorders including hyperprolactinemia, thyroid dysfunction and congenital adrenal hyperplasia. Polycystic ovary syndrome is also associated with insulin resistance, obesity and disorders of lipid metabolism, as well as infertility, although these findings have not been addressed in the Rotterdam criteria. Polycystic ovary syndrome is the major cause of anovulatory infertility. The recent studies suggest that anovulation resulting from ovarian follicle abnormalities in Polycystic ovary syndrome patients are 2-fold of normal ovaries. Firstly, early follicular growth is excessive, thus women with Polycystic ovary syndrome are characterized by an excessive number of small antral follicles (2- to 3-fold of normal ovaries). Secondly, the selection of one follicle from the increased pool of selectable follicles and its further maturation to a dominant follicle does not occur. This second abnormality in the folliculogenesis can cause menstrual dysfunction presented as oligomenorrhea or amenorrhea. Historically, Polycystic ovary syndrome treatment has not been curative in nature, instead treatments focus on resolution of clinical manifestations of the disease.


Eligibility criteria: Inclusion Criteria:

* infertile women
* age from 18 to 40 years
* poly-cystic ovary syndrome
* Body mass index 18.5-35 kg/m2

Exclusion Criteria:

1. Endocrine disorders (cushing syndrome-congenital adrenal hyperplasia)
2. Systemic disease
3. Use of oral contraceptive,glucocorticoid and antiandrogen
4. Use of ovulation induction or dopaminergic agents
5. Use of antidiabetes, anti obesity drugs
6. history of tubal or ovarian surgery

Primary outcomes:
measure: Number of poly-cystic ovarian syndrome women who will be ovulated
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Women Health Hospital - Assiut university
Study officials:
References:
Clinical trial NCT06154421: Metacarpophalangeal Joint Prostheses in Hand Surgery.
Official title: Metacarpophalangeal Joint Prostheses in Hand Surgery. A Retrospective Investigation on Functional Outcome After Intervention.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteoarthritis Metacarpophalangeal Joint
Rheumatoid Arthritis Metacarpophalangeal Joint
Keywords: metacarpophalangeal joint prostheses
Swanson flexible finger joint implant
finger joint replacement
Osteoarthritis
Rheumatoid Arthritis
metacarpophalangeal joint arthroplasty
KeriFlex® finger joint prostheses
Lead sponsor: Waldfriede Hospital
Sponsor class: OTHER
First posted: 2023-12-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who have either suffered Metacarpophalangeal joint destruction due to rheumatiod arthritis inflammation, or individuals who have received joint implant due to post-traumatic osteoarthritis of the Metacarpophalangeal joint.

Brief summary: The primary working hypothesis of this study is whether KeriFlex® metacarpophalangeal joint prostheses provide an equivalent result to Swanson finger joint implants in patients with rheumatoid arthritis or post-traumatic osteoarthritis. Functional status will be measured by Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire no earlier than 1 year after surgery.


Eligibility criteria: Inclusion Criteria:

* Age 18-90
* Metacarpophalangeal Joint Prostheses between 2014 and 2022 using Swanson or KeriFlex implant system at Hospital Waldfriede

  * rheumatoid Arthritis or post-traumatic osteoarthritis of Metacarpophalangeal joint

Exclusion Criteria:

* post surgery bone fracture of the same limb
* Pregnancy, lactation
* active malignant tumor

Primary outcomes:
measure: Disabilities of the Arm, Shoulder and Hand questionnaire (DASH)
timeFrame: All patients who underwent surgery between 2014 to 2023
Secondary outcomes:
measure: Functional assessment: Goniometry
timeFrame: All patients who underwent surgery between 2014 to 2023
measure: Short-Form 36 (SF-36)
timeFrame: All patients who underwent surgery between 2014 to 2023
measure: Ultrasound Assessment
timeFrame: All patients who underwent surgery between 2014 to 2023
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Waldfriede Hospital
Study officials:
affiliation: Hospital Waldfriede, Argentinische Allee 40, 14163 Berlin
name: Martin Lautenbach, MD
role: STUDY_CHAIR
affiliation: Hospital Waldfriede, Argentinische Allee 40, 14163 Berlin
name: Markus Bock, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01267721: Macrophage Migration Inhibitory Factor (MIF)- Cardiac Surgery
Official title: Macrophage Migration Inhibitory Factor (MIF) as a Marker of Perioperative Inflammatory Reaction During Heart Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Surgery
Keywords: heart surgery
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2010-12-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing open heart surgery and use of heart lung device

Brief summary: It has been repeatedly demonstrated that cardiac surgery with the use of extracorporeal circulation elicits a systemic inflammatory response and provokes ischemia-reperfusion related oxidative stress which could further lead to the development of organ failure in critically ill patients. Perioperative levels of macrophage migration inhibitory factor (MIF) and other inflammatory mediators could be involved in adverse outcomes in cardiac surgery.

Detailed description: The trace element selenium (Se) serves as an essential co-factor for the antioxidant enzymes Thioredoxin - reductase (TRR) and many other antioxidant enzymes, which protect tissues from oxidative stress. In septic patients it has previously been shown that thioredoxin, a TRR regulated Redox Enzyme, has the ability to suppress the synthesis of MIF.

Aim of the present study is therefore to investigate the relation between perioperative selenium decrease and the reduction of TRR activity with a possible release of MIF during the inflammatory response after cardiac surgery.

Eligibility criteria: Inclusion Criteria:

* more than 18 years of age
* open heart surgery and use of heart-lung-device
* informed consent has been obtained

Exclusion Criteria:

* under 18 years of age
* emergency cases
* informed consent cannot be obtained
* pregnancy or patient is breast-feeding

Primary outcomes:
measure: Pilot study: correlation between clinical and lab parameters
timeFrame: two months
Secondary outcomes:
measure: Secondary Outcome
timeFrame: two months
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: RWTH Aachen University Hospital
state: NRW
Study officials:
affiliation: RWTH Aachen University Hospital
name: Steffen Rex, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: