louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00002434: A Study of Neutrexin Plus Leucovorin in the Treatment of Pneumocystis Carinii Pneumonia (PCP)
Official title: A Study of Trimetrexate Glucuronate (Neutrexin) With Leucovorin Protection for Patients With Pneumocystis Carinii Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia, Pneumocystis Carinii
HIV Infections
Keywords: Trimetrexate
Pneumonia, Pneumocystis carinii
Leucovorin
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of trimetrexate glucuronate with leucovorin protection in patients with Pneumocystis carinii pneumonia (PCP) who are refractory to or have demonstrated severe or life-threatening toxicities to standard therapies (e.g., TMP/SMX or parenteral pentamidine).

Detailed description: Patients receive intravenous infusions of trimetrexate glucuronate and leucovorin for 21 days. Leucovorin is continued for 3 additional days after discontinuation of trimetrexate glucuronate. Patients are followed for 1 month.

Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Allowed:

* Myelosuppressive or nephrotoxic agents at the discretion of the treating physician.

Patients must have:

* Pneumocystis carinii pneumonia (PCP) confirmed within 15 days prior to study entry.
* Serious intolerance and/or resistance to standard therapies (such as trimethoprim/sulfamethoxazole and parenteral pentamidine) during the course of therapy for the current episode of PCP, or a documented history of such intolerance during a prior episode.
* Consent of parent or guardian if less than 18 years of age.

NOTE:

* Pregnant women may enroll after the physician and patient have discussed the potential benefit versus risk.

Exclusion Criteria

Patients with the following prior conditions are excluded:

History of Type I hypersensitivity (i.e., urticaria, angioedema, or anaphylaxis), exfoliative dermatitis, or other life-threatening reactions due to trimetrexate glucuronate.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: West Conshohocken
country: United States
facility: United States Bioscience Inc
state: Pennsylvania
Study officials:
name: Feinberg J
role: STUDY_CHAIR
References:
citation: Feinberg J, McDermott C, Nutter J. Trimetrexate (TMTX) salvage therapy for PCP in AIDS patients with limited therapeutic options. Int Conf AIDS. 1992 Jul 19-24;8(2):B136 (abstract no PoB 3297)
Clinical trial NCT05458934: Analysis of Exhaled Breath From Patients With Lung-/Airway Diseases (BigExBrESs)
Official title: Analysis of Exhaled Breath From Patients With Lung-/Airway Diseases (BigExBrESs)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung-/Airway Diseases
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Deep Breath Intelligence (DBI)
First posted: 2022-07-14
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: General population

Brief summary: Ananlyis of exhaled breath of patients with lung-/airway diseases to identify and distinguish respiratory diseases, and improve the disease manangament.

Detailed description: Breath analysis offers a unique opportunity to non-invasively retrieve unlimited samples of relevant information on the ongoing internal biochemical processes, as parts of the most volatile components in blood reach the gas phase and are subsequently exhaled (e.g. detection of ethanol in breath). Analysis of exhaled breath provides biochemical information about the metabolism and the pathophysiological state. Chemical analysis of exhaled breath with mass spectrometry identified numerous volatile organic compounds (VOCs) \[low molecular weightcomponents:\< 500 Dalton (Da)\]. Using Big Data analytics, specific patterns of diverse respiratory disease (e.g. for COPD and asthma) can be identified and the different diseases can be distinguished from each other. Specific Big Data Analytics might also improve the management of disease (e.g.avoiding of exacerbations) by identifying early signs of exacerbation risk.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Age ≥ 18 years at study entry

Exclusion Criteria:

* Physical or intellectual impairment precluding informed consent or protocol adherence
* Known pregnancy

Primary outcomes:
measure: Molecular breath pattern
timeFrame: at baseline
Secondary outcomes:
measure: Change in molecular breath pattern
timeFrame: over one year
measure: Symptoms
timeFrame: at baseline
measure: Inflammatory markers
timeFrame: at baseline
measure: Controls
timeFrame: at baseline
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Hospital Zurich
state: Zurich
Study officials:
References:
Clinical trial NCT05366634: A Single Ascending Dose Study to Evaluate MDK-703 in Healthy Adult Volunteers
Official title: A Phase 1, Randomized, Placebo-controlled, Single-Blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MDK-703 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Medikine, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Medikine Australia Pty Ltd.
First posted: 2022-05-09
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: MDK-703-101 is a single ascending dose study, to determine the safety, tolerability, and PK/PD of MDK-703 in healthy adult subjects.


Eligibility criteria: Inclusion Criteria:

1. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or ECGs.

Exclusion Criteria:

1. Significant history or clinical manifestation of any metabolic, autoimmune, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder.

Primary outcomes:
measure: Assessment of adverse events after single injection of MDK-703
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Herston
country: Australia
facility: Medikine Clinical Site
state: Queensland
Study officials:
References:
Clinical trial NCT03688334: Acute Effects of Oxygen Supplementation Among IPF Patients
Official title: Acute Effects of Oxygen Supplementation During Exercise Among Patients With Idiopathic Pulmonary Fibrosis Without Resting Hypoxemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: George Papanicolaou Hospital
Sponsor class: OTHER
First posted: 2018-09-28
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Idiopathic pulmonary fibrosis (IPF) is a disease characterised with significant morbidity and poor prognosis. Dyspnoea and impaired exercise capacity are very common manifestations of the disease, and result in significant impairment of patients' quality of life. Although hypoxemia is common among subjects with IPF, published data on the effects of supplementary oxygen therapy on specific clinical outcomes among these patients are currently few, while the existing data on the potential benefits of oxygen supplementation to treat exercise-induced hypoxemia, in this patient population, are even more controversial.

Based on the aforementioned, the purpose of this prospective, cross-over clinical trial is to investigate the acute effects of supplemental oxygen administration on the: a) exercise capacity, b) severity of dyspnea, c) cerebral oxygenation, b) muscle oxygenation, and e) hemodynamic profile, as compared to delivery of medical air (sham oxygen), in a group of patients with IPF, without resting hypoxemia, during steady state cardiopulmonary exercise testing (CPET).


Eligibility criteria: Inclusion Criteria:

Stable IPF patients with no hospitalization, exacerbation or change in regular IPF medication during the last month, who do not present with resting hypoxemia, but manifest exercise induced hypoxemia

Exclusion Criteria:

1. Major contraindications for CPET conduction
2. Not provision of informed consent -

Primary outcomes:
measure: Exercise duration
timeFrame: through study completion, an average of a year
Secondary outcomes:
measure: Dyspnea
timeFrame: through study completion, an average of a year
measure: Fatigue
timeFrame: through study completion, an average of a year
Other outcomes:
measure: Cerebral oxygenated hemoglobin
timeFrame: through study completion, an average of a year
measure: Cardiac output
timeFrame: through study completion, an average of a year
Locations:
city: Thessaloníki
country: Greece
facility: "G. Papanikolaou" General Hospital
Study officials:
affiliation: "G. Papanikolaou" General Hospital, Thessaloniki, Greece
name: Aikaterini Markopoulou, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00682734: Metoclopramide for Migraine: A Dose Finding Study
Official title: Metoclopramide for Acute Migraine: A Dose Finding Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2008-05-22
Enrollment: 349
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Metoclopramide is an effective intravenous treatment for acute migraine attacks, but we do not know the best dose to administer. This study compares three different doses of metoclorpamide.

Detailed description: Patients with acute migraine attacks are eligible for enrollment if they present to the emergency department of Montefiore Medical Center. Pain scores are assessed at baseline and every 30 minutes for two hours, and then again by telephone 48 hours after discharge

Eligibility criteria: Inclusion Criteria:

* acute migraine

Exclusion Criteria:

* secondary cause of headache
* lumbar puncture
* allergy or intolerance to study medication

Primary outcomes:
measure: Pain Intensity Score
timeFrame: Baseline, 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Benjamin W. Friedman, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05444634: The Pain and Anxiety in Children With Intramuscular Injection
Official title: The Effect of Distraction Cards and Stress Ball on Pain and Anxiety in Children With Intramuscular Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intramuscular Myxoma
Keywords: Children
Pain, Acute
Anxiety
Lead sponsor: Ataturk University
Sponsor class: OTHER
Collaborators: name: MSc Merve Eroğlu
First posted: 2022-07-06
Enrollment: 90
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was planned as a randomized controlled experimental study to determine the effect of distraction cards and stress ball on pain and anxiety in children with intramuscular injection.

Detailed description: Pharmacological and non-pharmacological methods are used in the management of pain and anxiety in children. Non-pharmacological methods are noninvasive, inexpensive, have no side effects and are independent functions of the nurse.This study was planned as a randomized controlled experimental study to determine the effect of distraction cards and stress ball on pain and anxiety in children with intramuscular injection. The study was conducted between May 2022 and August 2022. It will be done with children aged 3-6 years who come to the emergency unit of the State Hospital, who are given intramuscular injection.

"Descriptive Information Form", "Wong Baker Faces Pain Rating Scale", "Venham Anxiety Rating Picture Scale" will be used in data collection.

Eligibility criteria: Inclusion Criteria:

* 3-6 years old
* Intramuscular administration of ondansetron hcl active ingredient drug
* Mentally and physically handicapped
* Does not have a disease that causes chronic pain
* Open to communication
* Fluent in Turkish

Exclusion Criteria:

* Children of parents who did not give written consent
* Children who do not give verbal consent appropriate to the child's developmental level

Primary outcomes:
measure: Pain, acute
timeFrame: 12 week
measure: Anxiety, spitefulness
timeFrame: 12 week
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
state: Erzuum
Study officials:
References:
Clinical trial NCT02167334: Using Positive Pressure Ventilation for Preoxygenation During Panendoscopy.
Official title: Non Invasive Ventilation (NIV) Versus Spontaneous Breathing for Preoxygenation During Ear, Nose, and Throat (ENT) Panendoscopy. A Controlled, Prospective, Randomized Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ENT Cancer Screening
Keywords: panendoscopy
preoxygenation
non invasive ventilation
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2014-06-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: the aim of the study is to determine if Spontaneous Ventilation with Positive Pressure Ventilation (PPV) preoxygenation allows a longer non hypoxemic apnea time during panendoscopy compared to spontaneous breathing preoxygenation.

the hypothesis is PPV extends the residual functional capacity of lung so it provides more oxygen during apnea.


Eligibility criteria: Inclusion Criteria:

* patient going for scheduled panendoscopy under general anesthesia

Exclusion Criteria:

* BMI upper to 35 kg/m2
* pregnancy
* requirement of jet ventilation
* tracheostomy
* acute respiratory failure: pneumonia, pulmonary embolism
* health insurance careless

Primary outcomes:
measure: non hypoxemic apnea time
timeFrame: up to 5 minutes after stopping oxygenation
Secondary outcomes:
measure: surgical laryngoscopy frequency
timeFrame: up to 15 minutes after stopping oxygenation
measure: preoxygenation time
timeFrame: up to 10 min after the start of oxygenation
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Osama ABOU ARAB, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abou-Arab O, Guinot PG, Dimov E, Diouf M, de Broca B, Biet A, Zaatar R, Bernard E, Dupont H, Lorne E. Low-positive pressure ventilation improves non-hypoxaemic apnoea tolerance during ear, nose and throat pan-endoscopy: A randomised controlled trial. Eur J Anaesthesiol. 2016 Apr;33(4):269-74. doi: 10.1097/EJA.0000000000000394.
Clinical trial NCT01743534: Conservation of Praxis in the Food and Alzheimer Disease
Official title: Impact of the Shape of Plates on the Conservation of Praxis in the Food at the Old Persons Suffering From Severe Insanities of Chap Alzheimer or Mixed in Institution.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Disease
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2012-12-06
Enrollment: 32
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient achieves of the Alzheimer's disease

Brief summary: The insanities, priority of public health in 2008, have significant prevalency in Limousin, region in the ageing demography (1/3 of the population is more than 60 years old against 1/5th of average in France). To prevent the lack of therapeutic solutions, for these evolutionary diseases, the new plan Alzheimer 2008-2012 encourages the research.

The insanities deprive gradually the individual of their autonomy, their personality and their identity. The help of an institution is sometimes inevitable. In the middle of this stressful environment, the patient affected by severe insanity, need marks.

The aspect of their old objects, significant for them, has to be prioritized because the institutional universe, often depersonalized doesn't mean anything for them. In front of repeated failures, they're hurt in their self respect.

The prevention of the undernutrition, comes by a preservation of praxis and pleasure at table. The institutional plate used in certain hospital sectors, is unpersonal (rectangular, divided) and can be destabilizing for the mentally ill person.


Eligibility criteria: Inclusion Criteria:

* Men and women of more than 75 years
* Patients suffering from insanities of type Alzheimer
* Severe stage of the disease
* Residents in a Hospital for dependent old persons, with its own dining room
* Persons accommodated in the clinical service for more than 30 days
* EBS score \<16
* Information in the participation of the resident, their legal representative and their family
* Patients affiliated to the Social Security.
* Filled and signed form of participation
* Patient having a appointed reliable person or one helping known whose references are indicated in the patient file.

Exclusion Criteria:

* Patients presenting pathologies being able to interfere with the evaluation
* Participating patients in another research for type clinical trial.
* Undernutrition patients
* Patients presenting oral hurts
* Protected patient or having nobody helping.

Primary outcomes:
measure: Score of Blandford Scale
timeFrame: 2 days
Secondary outcomes:
measure: Score of Blandford scale
timeFrame: 2 days
Other outcomes:
Locations:
city: Limoges
country: France
facility: Limoges University hospital
Study officials:
References:
Clinical trial NCT03160534: Effect of Preoperative Exercise in Patients Undergoing Total Knee Arthroplasty
Official title: Effect of Preoperative Exercise in Patients Undergoing Total Knee Arthroplasty: A Randomized Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Arthroplasty
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
First posted: 2017-05-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomized Controlled Pilot Trial
Primary purpose: TREATMENT

Brief summary: This study evaluates the effect of preoperative exercise in patients undergoing a total knee arthroplasty.

Detailed description: The objectives of this study were to investigate the effects of a single (9 sessions) prescription community based preoperative physical therapy in patients awaiting a Total Knee Arthroplasty, taking prognostic factors into account.

The investigators will use different outcome measures to evaluate any possible effects.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing a Total Knee Arthroplasty
* Signed informed consent after being informed

Exclusion Criteria:

* Acute pain
* Weakness due to neurological problems
* Known or suspected non-compliance
* High BMI \> 28
* Patellar residual subluxation
* High patellar height

Primary outcomes:
measure: Stair climbing test
timeFrame: 5 minutes
Secondary outcomes:
measure: Knee - Range of Motion
timeFrame: 2 minutes
measure: Tegner Activity Scale and Lysholm Score
timeFrame: 10 minutes
measure: Patient Global Impression of Change
timeFrame: 2 minutes
measure: Risk of Discharge to a Rehabilitation Facility
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Balgrist University Hospital
Study officials:
affiliation: Balgrist University Hospital
name: Jaap Swanenburg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Granicher P, Stoggl T, Fucentese SF, Adelsberger R, Swanenburg J. Preoperative exercise in patients undergoing total knee arthroplasty: a pilot randomized controlled trial. Arch Physiother. 2020 Aug 5;10:13. doi: 10.1186/s40945-020-00085-9. eCollection 2020.
Clinical trial NCT05092334: Effect of Proprioceptive Exercises on Pain and Function in Non-specific Chronic Neck Pain
Official title: Effect of Proprioceptive Exercises on Pain and Function in Non-specific Chronic Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: Neck disability index,
Numerical pain rating scale
Proprioceptive exercise
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-10-25
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was conducted to see the effect of proprioceptive exercises on pain and function in Non-specific chronic neck pain.

Twenty participants with chronic Non-specific neck pain were enrolled in this study. During the final week of treatment, 14 patients were assessed at the end of the sixth treatment week. Participants were randomized into two groups treatment group and control group. Both groups were treated with conventional treatment which were strengthening exercises. Treatment group was also treated by proprioception exercises. For measurement of pain and disability NPRS and NDI scales were used. Exercise regime distributed in six weeks period one session per week exercise, 10-12 repetitions with 1-minute rest interval, lasted 45 minutes in both groups. pre-treatment and post-treatment measurements were taken.


Eligibility criteria: Inclusion Criteria:

* Patients with non-specific neck pain\>3 months
* Postural neck pain

Exclusion Criteria:

* Vascular neoplasia
* Fibromyalgia
* Rheumatoid arthritis
* Radiculopathy
* Neuropathy
* Tumor
* Cervical fractures
* Vestibular problems
* Congenital disorder of cervical spine

Primary outcomes:
measure: Numerical pain rating scale
timeFrame: 6 weeks
Secondary outcomes:
measure: NECK DISABILITY INDEX
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Qurat ul Ain
state: Punjab
Study officials:
affiliation: Riphah International University
name: Qurat ul Ain, Mphil
role: PRINCIPAL_INVESTIGATOR
References:
citation: Coulter ID, Crawford C, Vernon H, Hurwitz EL, Khorsan R, Booth MS, Herman PM. Manipulation and Mobilization for Treating Chronic Nonspecific Neck Pain: A Systematic Review and Meta-Analysis for an Appropriateness Panel. Pain Physician. 2019 Mar;22(2):E55-E70.