louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01390597: Biomarkers in Tumor Tissue Samples From Patients With Peripheral T-cell Lymphoma or Natural Killer Cell Neoplasms
Official title: The Molecular Mechanisms of Transformation in Peripheral T-cell and NK Lymphomas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma
Keywords: peripheral T-cell lymphoma
stage I adult T-cell leukemia/lymphoma
stage II adult T-cell leukemia/lymphoma
stage III adult T-cell leukemia/lymphoma
stage IV adult T-cell leukemia/lymphoma
anaplastic large cell lymphoma
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-07-11
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples from patient enrolled on E2404 from whom samples were submitted for research

Brief summary: RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors find better ways to treat the cancer.

PURPOSE: This research trial studies biomarkers in tumor tissue samples from patients with peripheral T-cell lymphoma or natural killer cell neoplasms.

Detailed description: OBJECTIVES:

* To identify mutations in oncogenes and tumor suppressors of peripheral T-cell lymphoma or natural killer (NK) cell neoplasm.
* To delineate the mechanisms that mediate oncogenic effects and their clinical prognostic significance in these diseases.
* To perform a comprehensive mutation analysis via whole exome resequencing in a panel of peripheral T-cell or NK lymphomas.

OUTLINE: Fixed paraffin-embedded tumor tissue samples are analyzed for mutations by the Illumina HiSeq platform. Sequencing reads are performed by GAPipeline version 1.5.1 and mapping on the human genome performed using the MAQ software version 0.7.1. Genes harboring validated somatic mutations are then amplified by PCR and analyzed by Sanger resequencing.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosed with peripheral T-cell lymphoma or natural killer cell neoplasms
* Available fresh tumor samples from patients treated on ECOG-E2404 and normal DNA (non-ECOG) samples

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: New somatically mutated genes in T-cell and NK lymphoma samples
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Herbert Irving Comprehensive Cancer Center
name: Adolfo A. Ferrando, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03883997: Accuracy of Anthropometric Equations for Estimating Body Fat in Professional Male Soccer Players Compared With DXA
Official title: Accuracy of Anthropometric Equations for Estimating Body Fat in Professional Male Soccer Players Compared With DXA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Body Composition
Keywords: Body fat
Soccer players
DXA
Lead sponsor: Centro Universitario de Ciencias de la Salud, Mexico
Sponsor class: OTHER
First posted: 2019-03-21
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Professional male soccer players hired into a second professional Mexican division team.

Brief summary: This study aimed to analyze the accuracy of different anthropometric equations to estimate body fat in professional male soccer players, setting DXA body fat as the reference.

Detailed description: The study consisted of evaluating anthropometric measurements and body composition with DXA in professional male soccer player aged 18 years and older. Standardized and certified personnel carried out anthropometric measurements and DXA whole body scan the same day.

Body fat was estimated with several anthropometric equations. These equations were divided into two groups: 1) Derived from non-athletic samples; and 2) Derived from athletic samples.

The body fat estimated from anthropometric equations was compared with DXA, and those with non-significant differences were further analyzed for calculating mean differences and 95% limits of agreement with DXA. This analysis was carried out for all equations.

Eligibility criteria: Inclusion Criteria:

* Signed contract with the team

Exclusion Criteria:

* Injured

Primary outcomes:
measure: Body fat by DXA
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Instituto de Ciencias Aplicadas a la Actividad Física y al Deporte
state: Jalisco
Study officials:
affiliation: University of Guadalajara
name: Juan R López-Taylor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05128097: Preventive Approach for the Management of the Main Geriatric Risks
Official title: Development of a Codified Preventive Approach for the Management of the Main Geriatric Risks
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Geriatric Syndromes
Keywords: Geriatric syndromes
psycho-behavioral pathologies
undernutrition,
diabetes
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-11-19
Enrollment: 107
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major subject (≥65 years old) hospitalized between June 17, 2019 to November 13, 2019, in the UF 3723 department, of the Medical Clinic B of the University Hospitals of Strasbourg

Brief summary: Nowadays, EHPAD residents are polypathological (cognitive and psycho-behavioral pathologies, undernutrition, IC, diabetes, COPD, IR, etc.) and multi-medicated. From a medical point of view, this implies the need for regular monitoring and a high level of medical or even multidisciplinary expertise for the healthcare team. The objective of the GER-e-TEC ™ project is to provide these complex patients with telemedicine tools allowing protocolized and personalized, non-intrusive monitoring. The GER-e-TEC ™ project more specifically takes into account the significant issues in nursing homes of aging residents with the main geriatric syndromes (fall, undernutrition, cognitive-behavioral disorders, iatropathogeny, etc.) The objective of the work undertaken is to develop a codified preventive approach for the management of the main geriatric risks, in order to avoid the occurrence of an acute decompensation factor in the elderly.


Eligibility criteria: Inclusion criteria:

* Major subject (≥65 years old)
* Subject hospitalized between June 17, 2019 to November 13, 2019, in the UF 3723 department, of the Medical Clinic B of the University Hospitals of Strasbourg
* Having not expressed his opposition, after information, to the reuse of his data for the purposes of this research.

Exclusion criteria:

* Subject having expressed opposition to participating in the study
* Impossibility of providing the subject with enlightened information (difficulties in understanding the subject, etc.)
* Subject under guardianship or guardianship
* Subject under safeguard of justice
* Subject in palliative / end of life situation
* Subject in acute emergency situation

Primary outcomes:
measure: Retrospective study of the management of the main geriatric risks in the University HÔptaux de Strasbourg
timeFrame: Files analysed retrospectively from from June 17, 2019 to November 13, 2019 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Médecine interne, Diabète, et Maladies Métaboliques - Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Médecine interne, Diabète, et Maladies Métaboliques - Hôpitaux Universitaires de Strasbourg
name: Emmanuel ANDRES, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04527497: Clinical Course and Treatment of COVID-19 Inpatients in Hospital
Official title: Clinical Course and Treatment of COVID-19 Inpatients in Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Lead sponsor: Wissenschaftliches Institut Bethanien e.V
Sponsor class: OTHER
First posted: 2020-08-26
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who are inpatients at Bethanien Hospital and have a proven COVID-19 infection and who agree to participate in the study during the period from 01.08.2020 - 30.05.2021.

Brief summary: The study is an epidemiological observational study. It serves to collect data from patients with positive COVID-19 test results who are hospitalized. All data describing the course of the inpatient stay are recorded (Length of stay, course of therapy, medication, X-ray and CT results,ventilation mode and duration, laboratory). Furthermore, anthropometric data and information on COVID-19 symptoms is recorded.

Detailed description: The aim of this study is to describe the course of disease and the treatment of patients suffering from COVID-19 who are hospitalized and treated as inpatients:

1. Are there common features (previous illnesses, medication, age, BMI, etc.), which may influence the course of disease?
2. Are there therapeutic procedures that have a positive or negative impact on the course of the disease or the length of stay in the intensive care unit/ the duration of ventilation (early/late intubation, CPAP, NIV, ECMO)?

Eligibility criteria: Inclusion Criteria:

* positive COVID-19 test result
* Age \> 18 years

Exclusion Criteria:

* Age \< 18 years
* negative COVID-19 test result
* lack of agreement
* Any medical, psychological or other condition, that restricts the ability of the person to be informed and to give the consent for voluntary participation in this trial

Primary outcomes:
measure: convalescence/death
timeFrame: through study completion, an average of 2 months
Secondary outcomes:
measure: length of stay in the intensive care unit
timeFrame: through study completion, an average of 2 months
measure: length of stay in hospital
timeFrame: through study completion, an average of 2 months
Other outcomes:
Locations:
city: Solingen
country: Germany
facility: Institut für Pneumologie an der Universität zu Köln / Wissenschaftliches Institut Bethanien für Pneumologie e.V.
state: Nordrhein-Westfalen
Study officials:
affiliation: Krankenhaus Bethanien Solingen
name: Winfried Randerath, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06465797: Observational Bronchoscopy Video Data Collection Study With Adult Patients
Official title: Collecting Imaging Data From Standard-of-care Bronchoscopies for AI-development: a Prospective, Non-interventional Study (Using CE-marked Bronchoscopes)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Diseases
Lung Neoplasms
Lung Cancer
Lung Transplantation
Lung Diseases, Obstructive
Lead sponsor: Ambu A/S
Sponsor class: INDUSTRY
Collaborators: name: Odense University Hospital
First posted: 2024-06-20
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adults indicated for a bronchoscopy above 18 year is part of the population.

Brief summary: The primary aim is to develop a software algorithm that has the capacity to detect the normal 18 anatomical structures of the lung by using the position of the scope during the bronchoscopy procedure and using existing bronchoscopy technology.

Detailed description: A data collection of bronchoscopy videos from 100-150 patients are enrolled for getting image material of different lung anatomies, captured with CE-marked and FDA-approved Ambu bronchoscopes (Ambu® aScope™ 5 Broncho HD). No intervention will take place, only standard of care. All types of indications are enrolled. All patients were given oral and written information prior to participating, and signed consent was provided. No patient identifiable information is stored.

Eligibility criteria: Inclusion Criteria:

* Patients indicated for bronchoscopy of central airways as per standard of care
* Patients of 18 years or above

Exclusion Criteria:

* Lack of patient cooperation for bronchoscopy (e.g. patients with mental disorders, dysgnosia, psychological disorder)
* Patients unable or unwilling to give informed consent

Primary outcomes:
measure: Number of bronchial segments accessed during bronchoscopy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
References:
Clinical trial NCT04977297: Move to Music Video Intervention for ICU Survivors
Official title: Move to Music Video Intervention - A Music and Video Guided Exercise Intervention for ICU Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Intensive Care Unit Syndrome
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Society of Critical Care Medicine
First posted: 2021-07-26
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 purpose of this study is to determine if exercising with a music video program will improve physical functions of patients who have been discharged from an Intensive Care Unit (ICU).


Eligibility criteria: Inclusion Criteria:

1. age ≥ 18 years old;
2. length of ICU stay \>5 days (excludes patients with less comorbidity);
3. recruitment within 48 hours of ICU discharge (standardizes time to begin intervention);
4. able to independently move upper and lower extremities (required to participate in intervention);
5. cognitively able to complete the assessments and comply with physical testing instructions;
6. able to speak English or Spanish; and
7. reside at home prior to ICU admission.

Exclusion Criteria:

1. documented mental incompetence;
2. dependent status pre-ICU admission (assessed by the Katz Index of Independence in Activities of Daily Living);
3. evidence of delirium assessed using the Confusion Assessment Method;
4. hearing impairment;
5. documented "comfort measures only" or impending death;
6. prior residence in a long-term care facility; and
7. unstable clinical measures defined as Heart Rate (\>140 beats/minute) or Respiratory Rate (\>35 breaths/minute), blood pressure (systolic blood pressure \>180 mmHg or \< 90mmHg), ventilation problems, agitation, or perspiration. We will not enroll adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, and prisoners.

Primary outcomes:
measure: Change in global health
timeFrame: baseline, up to 30 days
measure: Change in physical activity
timeFrame: baseline, day5
measure: Change in handgrip strength
timeFrame: baseline, up to 30 days
Secondary outcomes:
measure: Number of interventions completed
timeFrame: day 5
measure: Patient Satisfaction Survey Scores
timeFrame: day 5
measure: Exercise motivation as measured by the Physical Activity Enjoyment Scale
timeFrame: day 5
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Zhan Liang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01748097: Intravenous Bicarbonate To Verify The Correct Position of IV Catheters in Oncological Patients Oncological Patients Receiving Chemotherapy
Official title: Phase III Study to Assess the Utility of a New Innovative Technique Using Intravenous Bicarbonate to Verify the Correct Position of Patients Scheduled for Intravenous Bicarbonate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Detection of the Correct Position of Intravenous Line
Keywords: infiltration
extravasation
sodium bicarbonate
capnography
end tidal carbon dioxide
chemotherapy
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Netherlands: Ministry of Health, Welfare and Sports
First posted: 2012-12-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators use bicarbonate injected to an intravenous line and the changes in the exhaled end-tidal carbon dioxide to verify whether the IV line is in the vein or surrounding tissue

Detailed description: The method was proved useful in previous phase I, II studies. Now the investigators move on to assess the method in a phase III study in oncological patients.

each patients which will be subjected to intravenous chemotherapy will be eligible ( see also inclusion/exclusion criteria).

Once consent obtained the patient will have an IV line placed. each line placed will be categorized by the clinical team into 3 categories:

1. IV in place ready to use for chemotherapy ( good blood return)
2. Doubtful position ( no blood return/ little blood return bu flushes well).
3. IV not in place. Study design Category 1. IV bicarbonate 4.2% 20 cc and NS 20 cc in a randomized fashion Category 2. same as above Category 3. No injections

Eligibility criteria: Inclusion Criteria:

* age 18-80 oncological disease requires intravenous chemotherapy

Exclusion Criteria:

* 1. refusal to participate 2. lung disease acute or chronic sPo2 \< 92%, PaCO2 \> 50 3. renal failure Creatinine \> 2 mg% 4. metabolic alkalosis HCO3 \> 30 meq/L 5. medication that affect bicarbonate levels: Bicarbonate, Diamox, Fusid 6. obesity BMI \> 38 7. congestive heart failure EF \< 40 % or clinical signs of congestive heart failure

Primary outcomes:
measure: change in exhaled end tidal co2
timeFrame: 1-3 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Oncology Clinic
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center Oncology
Study officials:
References:
Clinical trial NCT05278897: Hyaluronic Acid for Soft Tissue Injuries
Official title: Soft Tissue Adapted Hyaluronic Acid Functional Evaluation (SAFE): A Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Elbow Tendinopathy
Ankle Sprains
Lead sponsor: Global Research Solutions
Sponsor class: INDUSTRY
Collaborators: name: Pendopharm
First posted: 2022-03-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Soft Tissue Adapted Biocompatible Hyaluronic Acid, or STABHA™, has demonstrated varying degrees efficacy in patients treated for common musculoskeletal tendinopathies and ligament injuries, such as ankle sprains, lateral elbow tendinopathy, and rotator cuff tendinopathies. Factors associated with prognosis following treatment remain largely unknown. Identifying appropriate patient populations for use of STABHA™ is a necessary first step to facilitate the design of future clinical trials in the management of acute and chronic musculoskeletal soft-tissue injuries.


Eligibility criteria: Inclusion Criteria:

1. Patients 18 years of age or older.
2. Having a STABHA™ injection for the treatment of:

   1. Acute first or second degree ankle sprain (e.g. occurred within the past 48 hours).
   2. Lateral epicondylitis (tennis elbow).
3. Informed consent obtained.

Exclusion Criteria:

1. Medical contraindication to STABHA™.
2. Previous treatment with STABHA™.
3. Ankle or foot fracture.
4. Bilateral ankle sprain.
5. Previous ankle sprain in the past 12 months.
6. Prior surgical management of the ankle or elbow.
7. Current or anticipated incarceration.
8. Terminal illness with expected survival less than 90 days.
9. Currently enrolled in a study that does not permit co-enrollment.
10. Unable to obtain informed consent due to language barriers.
11. Unable to comply with the protocol.
12. Problems, in the judgment of study personnel, with maintaining follow-up with the patient.
13. Prior enrollment in the study.
14. Other reason to exclude the patient, as approved by the Sponsor.

Primary outcomes:
measure: Visual Analog Scale (VAS) Pain
timeFrame: 12 months
Secondary outcomes:
measure: EuroQol-5 Dimensions (EQ-5D)
timeFrame: 12 months
measure: 12-Item Short Form Survey Version 1 (SF-12V1)
timeFrame: 12 months
measure: Pain medication use
timeFrame: 12 months
measure: Adverse Events
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Global Research Solutions
name: Mohit Bhandari
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01255397: Proposed Research Protocol For Male Infertility
Official title: Proposed Research Protocol For Male Infertility
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Male Infertility
Keywords: male infertility
natural cycle IVF
in-vitro fertilization
intrauterine inseminatio
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2010-12-07
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this experiment is to test the feasibility of a minimally interventionist protocol for young couples with male factor infertility, which addresses the cause of infertility for these couples which is the inability of the sperm to fertilize the egg.Ultrasound monitoring of natural follicular development utilizing rFSH, GnRH antagonist and rHCG only for the final maturation. Single follicle aspiration and IUI or IVF/ICSI based on sperm charcteristics on the day of fertilization. Fertilized eggs transfered to the uterus on the same day as the aspiration.


Eligibility criteria: Inclusion Criteria:

1. Couples with "pure" male factor infertility of six months or more, defined as not pregnant in spite of being desirous of pregnancy for at least six months with normal sexual activity and no birth control. Primary and Secondary infertility included.
2. Abnormality of any one of the sperm parameters according to WHO or Kruger for concentration, motility or morphology.
3. Women aged 18 to 30 with a BMI between 18 and 30
4. Women who testify that they are healthy with regular menstrual cycles between 25-35 days per cycle.

Exclusion Criteria:

1. Uterine fibroids or ovarian cysts or tumors or suspected hydrosalpinx on US on prior fertility workup. Paraovarian simple cysts, OK.
2. Prior PID, abdominal or pelvic surgery or abnormal HSG if done.
3. Known allergy to medications used in protocol
4. Diagnosed or suspected genetic or psychiatric disease in either patient.
5. Azoospermia
6. Female partner with a history of infertility with another partner
7. Elevated FSH (over 10 units/L) in female partner if done.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: