louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04910464: Early Tranexamic Acid and Modulating the Inflammatory Response in Sepsis
Official title: Could Early Tranexamic Acid Safely Serve as an Anti-inflammatory Treatment for Patients With Sepsis? A Randomized Double Blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Sepsis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-06-02
Enrollment: 80
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: TREATMENT

Brief summary: In this study, our aim is to investigate the role tranexamic acid in modulating inflammation in patients with sepsis.

Detailed description: A written informed consent will be taken from the patients or their relatives.Patients will be assigned randomly to two groups (40 subjects each) with qSOFA ≥2.

In (Group T) administer 1 gram of tranexamic acid (TXA) in 100 ml of 0.9% normal saline, intravenous over 10 minutes as soon as possible but no later than three hours after diagnosis, infuse a second gram of tranexamic acid (TXA) IV over 8 hours in 0.9% normal saline for the first 3 days. In (Group C) administer the same volume (100 ml normal saline)and same duration (first three days)for controlled patients.

Eligibility criteria: Inclusion Criteria:

* Adults (age 18-65 years) of American society of anesthesiologists (ASA) I-II who will be diagnosed with sepsis by qSOFA ≥2
* \& needed ICU admission.

Exclusion Criteria:

* Chronic renal failure
* Liver cirrhosis
* Bleeding disorders or current anticoagulant therapy
* Pregnancy or breastfeeding
* Impaired color vision
* Severe vascular ischemia, history of venous thrombosis \& pulmonary embolism
* Long term treatment with acetylsalicylic acid or non-steroidal anti-inflammatory drugs not discontinued before ICU admission
* Allergy to tranexamic acid (TXA)

Primary outcomes:
measure: ICU mortality
timeFrame: 7days
Secondary outcomes:
measure: Neutrophil/lymphocyte ratio (NLR)
timeFrame: 4 days
measure: Interleukin-6 (IL-6) serum level
timeFrame: 4 days
measure: Glasgow coma scale (GCS)
timeFrame: 5 days
measure: ICU stay
timeFrame: 7 days
measure: Length of hospitalization
timeFrame: 7 days
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospital
Study officials:
affiliation: Omar makram
name: Omar Soliman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04675164: Laser Assisted Sperm Selection of Viable Immotile Testicular Sperm in Azoospermic Infertile Men
Official title: Outcome of ICSI Using Laser Assisted Sperm Selection of Viable Immotile Testicular Sperm in Azoospermic Infertile Men: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Azoospermia
IVF
Keywords: Laser Assisted Immotile Sperm Selection
Hypo-osmotic swelling test
ICSI
Testicular sperm
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2020-12-19
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: (LAISS) group: viable immotile testicular sperms will be selected before ICSI using laser assisted immotile sperm selection (study group).

(HOST) group: viable immotile testicular sperms will be selected before ICSI using hypo-osmotic swelling test (control group).
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the outcome of ICSI after using LAISS for selection of viable immotile testicular sperm in azoospermic infertile men.

Patients will be randomly assigned to 2 groups. In (LAISS) group, viable immotile testicular sperms will be selected before ICSI using laser assisted immotile sperm selection (study group). In (HOST) group, viable immotile testicular sperms will be selected before ICSI using hypo-osmotic swelling test (control group).


Eligibility criteria: Inclusion Criteria:

* Eligible couples are those undergoing ICSI due to azoospermia with testicular biopsy positive for sperm (either fresh or cryopreserved) following testicular sperm extraction (TESE) or aspiration (TESA).

Exclusion Criteria:

* Cases with female factor infertility or woman age above 35 years will be excluded.

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 6- 7 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Ajyal Hospital, IVF Center
Study officials:
affiliation: Sohag Faculty of Medicine
name: Ramadan SA Saleh, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04750564: BreEStim for Motor Recovery in Chronic Stroke With Severe Impairment (Pilot)
Official title: BreEStim for Post-Stroke Motor Recovery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Motor Recovery
Keywords: Finger flexor spasticity
Motor Recovery
BreEStim
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2021-02-11
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall goal is to investigate the effectiveness of a novel intervention - Breathing-controlled electrical stimulation (BreEStim) on finger flexor spasticity reduction and hand function improvement in chronic stroke with severe impairment.


Eligibility criteria: Inclusion criteria:

* has post stroke ≥ 6 months , medically stable;
* Unilateral, single stroke (no restriction on type (ischemic or hemorrhagic) or volume (large or small) of stroke);
* MAS score ≥ 1, i.e., detectable finger flexor hypertonia;

Exclusion criteria include:

* Patients with visual deficit/neglect; hearing or cognitive impairment;
* Patients with history of pulmonary disease (Asthma, chronic obstruction pulmonary disease, COPD);
* Patients that are currently adjusting tone alternating medications (e.g., baclofen), or
* Patients received botulinum toxin injection to the arm/fingers \<4 months, or phenol injections \< 2 years;
* Patients with a pacemaker;
* Women who are pregnant.

Primary outcomes:
measure: Change in finger flexor spasticity measured by Modified Ashworth Scale (MAS)
timeFrame: Baseline, 5 minutes after intervention
Secondary outcomes:
measure: Change in finger extensors and hand function measured by Fugl Myer Assessment (FMA) Scale
timeFrame: Baseline, 5 minutes after intervention
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center
state: Texas
Study officials:
affiliation: University of Texas
name: Sheng Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05511064: CEFID-II (CEra Flow Improves DVT-II)
Official title: A Multiple Center, Clinical Trial to Evaluate the Efficacy and Safety of Blood Circulation Improvement Using an Investigational Device (Model Name CGM MB-1701) for the Risk Group of Deep Vein Thrombosis (DVT)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blood Circulation Disorder
Deep Vein Thrombosis
Lead sponsor: Ceragem Inc.
Sponsor class: INDUSTRY
First posted: 2022-08-22
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: For Deep Vein Thrombosis (DVT) risk groups, the effect and safety of blood circulation improvement before and after application are evaluated using an investigational device (model name CGM MB-1701).

Detailed description: The investigator applies the test device to the appropriate subjects for a total of 10 days (+1 days) at the institution and nursing hospital, and upon discharge for long-term follow-up investigation, the investigational device is applied at subjects' home according to the subject's consent for about 3 months.

Eligibility criteria: Inclusion Criteria:

1. Adult men and women over 19 years of age
2. Subjects who have not been diagnosed with deep vein thrombosis in the lower extremities through the following test results prior to the application of medical devices.

(1) Subjects diagnosed by Doppler ultrasonography as having no blood clots in the femoral vein and the vena poplitea (2) D-dimer negative test result (Even if D-dimer is tested positive, it can be selected through additional tests at the discretion of investigator.)

3. Subjects have 2 or more points of venous thromboembolism (hereinafter referred to as VTE) clinical prediction score (Two-level wells score) at the time of screening.

4. Subjects who fully understand the purpose and procedure of the study and wish to participate in clinical trials with voluntary consent

Exclusion Criteria:

1. Subjects complain of a decrease in the sensation of the lower extremities or is unable to feel the sensation of pain
2. Subjects have inflammation or trauma on the skin that directly touches the device

Primary outcomes:
measure: Peak Systolic Velocity (PSV) change
timeFrame: 10 days from the baseline
Secondary outcomes:
measure: Peak Systolic Velocity (PSV) change
timeFrame: 5 days from the baseline
measure: Anteroposterior (AP) diameter
timeFrame: 5 days (V3) and 10 days (V4) from the baseline
measure: Cross Sectional Area (CSA)
timeFrame: 5 days (V3) and 10 days (V4) from the baseline
measure: Leg volume (3D scanner)
timeFrame: 5 days (V3) and 10 days (V4) from the baseline
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Presbyterian Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Korea University Guro Hospital
name: Joon-shik Yoon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04365764: Effect of Treatments in Patients Hospitalized for Severe COVID-19 Pneumonia: a Multicenter Cohort Study
Official title: Effect of Treatments in Patients Hospitalized for Severe COVID-19 Pneumonia: a Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid-19
ARDS
Pneumonia
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Intercommunal Robert Ballanger
name: Centre Hospitalier Intercommunal Montfermeil-Le Raincy
name: CMC Ambroise Paré
First posted: 2020-04-28
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is cohort-base in routine care, in medical departments.

Brief summary: Several treatments have been used in during the Covid-19 pandemic of 2020. Using patients' registries from several hospitals in Paris, the investigators retrospectively analyzed associations between specific treatments, including but not limited to vaccines targeted against SARS-CoV-2, hydroxychloroquine, azithromycin, remdesivir, baricitinib, tocilizumab, sarilumab, lopinavir/ritonavir and oseltamivir; and clinical outcomes including, death and mechanical ventilation.

Detailed description: Several treatments have been used in during the Covid-19 pandemic of 2020. Using patients' registries from several hospitals in Paris, the investigators retrospectively analyzed associations between specific treatments, including but not limited to vaccines targeted against SARS-CoV-2, hydroxychloroquine, azithromycin, remdesivir, baricitinib, tocilizumab, sarilumab, lopinavir/ritonavir and oseltamivir; and clinical outcomes including, death and mechanical ventilation.

Other outcomes of interest include: acute kidney injury, encephalopathy, need for intensive care unit transfers.

Eligibility criteria: Inclusion Criteria:

* admitted for severe Covid-19 pneumonia (i.e. requiring O2-support more than 6L/min with SpO2\<96%)

Exclusion Criteria:

* patients who were previously in ICU
* patients already hospitalized prior to study start date
* patients in palliative care
* lack of consent

Primary outcomes:
measure: Composite of death and mechanical ventilation
timeFrame: 14-days follow-up
Secondary outcomes:
measure: Death
timeFrame: 14-days follow-up
measure: Mechanical ventilation
timeFrame: 14-days follow-up
measure: Composite of death and mechanical ventilation
timeFrame: 28-days follow-up
measure: World Health Organization score
timeFrame: 14-days follow-up
measure: World Health Organization score
timeFrame: 28-days follow-up
Other outcomes:
Locations:
city: Aulnay-sous-Bois
country: France
facility: Centre Hospitalier Intercommunal Robert Ballanger
city: Montfermeil
country: France
facility: Centre Hospitalier Intercommunal Le Raincy-Montfermeil
Study officials:
affiliation: APHP
name: Joe-Elie Salem, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00191490: A Randomized Study Evaluating the Feasibility and Activity of Three Different Combination With Gemcitabine as First Line Therapy for Non Small Cell Lung Cancer
Official title: A Multicenter Randomized Phase II Study Evaluating the Feasibility and Activity of Two Different Combinations of Docetaxel (RP56976, TAXOTERE *) and Gemcitabine and of Cisplatin/Gemcitabine Followed by Docetaxel as First Line Therapy for Locally Advanced Unresectable or Metastatic Non Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Aventis Pharmaceuticals
First posted: 2005-09-19
Enrollment: 162
Sex: ALL
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: Phase II study that will evaluate the activity of gemcitabine as intravesical therapy on the marker lesion in superficial bladder carcinoma at intermediate risk. Primary objective is the evaluation of the pathological complete response after 8 instillation of gemcitabine. 46 patients are requested.


Eligibility criteria: Inclusion criteria

* Histologically or cytologically confirmed diagnosis of NSCLC
* Patients must have a locoregionally advanced unresectable non metastatic NSCLC Stage IIIB (only N3 supraclavicular or T4 for pleural effusion) or Stage IV according to the revised International Staging System
* Patients must have at least one measurable lesion
* WHO Performance Status 0 or 1
* Adequate Organ Function

Exclusion criteria:

* Prior systemic chemotherapy or immunotherapy including neoadjuvant or adjuvant treatments
* Prior radiotherapy for NSCLC
* Patients with symptomatic brain metastases or with leptomeningeal disease. However, patients with symptomatic brain metastases who become asymptomatic under corticosteroids treatment can enter the study
* Current peripheral neuropathy NCI grade 2

Primary outcomes:
measure: To assess the antitumour activity as measured by response rate in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) of two different combinations of docetaxel and gemcitabine and of a sequential treatment of
measure: cisplatin /gemcitabine
Secondary outcomes:
measure: To determine time to progression, duration of response, time to treatment failure, and overall survival in each group.
measure: To evaluate changes from baseline in the Lung Cancer Symptom Scale of patients in each treatment arm
Other outcomes:
Locations:
city: Sesto Fiorentino
country: Italy
facility: For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Monday-Friday, 9:00 am to 5:00 pm Eastern time (UTC/GMT - 5 hours, EST) or speak with your physician
state: Florence
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) Monday-Friday 9am-5pm Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_CHAIR
References:
Clinical trial NCT03765190: Combination of Proton Therapy With Immunotherapy in Multiple Metastases Cancer
Official title: A Phase I/II Study of Combination of Proton Therapy With Immunotherapy in Multiple Metastases Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Proton Therapy
Immunotherapy
Neoplasm Metastasis
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: YiZhou International Cancer Hospital
First posted: 2018-12-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Proton Therapy+PD-1 Ab
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to compare the effects (good and bad) on subjects and their cancer using proton radiation therapy in combination with immunotherapy(ie. Programmed cell death protein 1, also known as PD-1 antibody) in multiple metastases.

Detailed description: As is known to all, the main treatment method for metastatic tumors is systemic chemotherapy and radiotherapy is merely for the purpose of palliative treatment. Recent studies have shown that tumors with no more than 5 metastatic sites can still achieve satisfactory overall survival by local treatments such as radiotherapy. However, for tumors with more metastatic lesions, side effect is pretty high for photon radiotherapy due to the wide range of irradiation. Protons might be a safe treatment means for multiple metastases cancer because of the Brag peak, when the normal tissue dose can be significantly reduced. Combination of proton therapy with immunotherapy can be a research direction for multiple metastatic tumors. This study intends to observe the safety and efficacy of proton technique combined with immunotherapy in improving the overall anti- tumor effect for metastatic tumors.

Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed Unspecified Adult Solid Tumor
* Multiple metastatic tumors
* Intending to be treated with proton beam and immunotherapy
* Age ≥ 18 years old
* KPS≥70
* Signed written informed consent.

Exclusion Criteria:

* Pregnant or breastfeeding woman
* Patient under guardianship or tutorship
* Patients or legal guardians who are unable to understand informed consent document

Primary outcomes:
measure: Adverse events
timeFrame: Through 1 years after completion of treatment
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Through 2 years after completion of treatment
measure: Overall survival (OS)
timeFrame: Through 2 years after completion of treatment
Other outcomes:
Locations:
Study officials:
affiliation: Peking University First Hospital
name: Xianshu Gao, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00521690: The Effect of Insulin Detemir on Blood Glucose Control in Taiwanese Patients With Type 2 Diabetes Failing on OAD
Official title: Safety and Therapeutic Effect of Insulin Detemir in Taiwanese Patients With Type 2 Diabetes Mellitus Not Achieving Glycaemic Targets With OAD With/Without Once-daily NPH Insulin Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2007-08-28
Enrollment: 25
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The trial is conducted in Asia. The aim of the trial is to evaluate the effect of insulin detemir on blood glucose control in Taiwanese patients with type 2 diabetes failing on OAD with/without once-daily NPH Insulin treatment.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* HbA1C: 7.0-11.0%
* Previous diabetes treatment for at least 6 months
* BMI max. 35 kg/m2
* Treatment with an oral anti-diabetic drug (OAD)

Exclusion Criteria:

* Type 1 diabetes
* Receipt of any investigational drug within the last three months prior to this trial

Primary outcomes:
measure: Incidence of serious adverse events, including major hypoglycaemic events
timeFrame: during 16 weeks of insulin detemir therapy
Secondary outcomes:
measure: Change in HbA1C
timeFrame: after 16 weeks
measure: Change in weight
measure: Change in fasting plasma glucose (FPG)
measure: Incidence of hypoglycaemic episodes
Other outcomes:
Locations:
city: Taipei
country: Taiwan
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00677690: Neuromuscular Electrical Stimulation in Chronic Obstructive Pulmonary Disease (COPD)
Official title: Combination of Pulmonary Rehabilitation and Neuromuscular Electrical Stimulation and in COPD Patients: a Randomized Clinical Trial of Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Lead sponsor: Fondazione Salvatore Maugeri
Sponsor class: OTHER
First posted: 2008-05-14
Enrollment: 83
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
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 elucidate whether combination of usual pulmonary rehabilitation and neuromuscular electrical stimulation of quadriceps may improve exercise capacity in patients affected by chronic obstructive pulmonary disease (COPD).

Detailed description: Neuromuscular electrical stimulation (NMES) has been extensively used as technique to improve muscle function in different areas of rehabilitation, however it seems to be more appropriate in critical care situation, while its use in more able patients is of uncertain benefit. In other words, NMES seems to be particularly effective in severely deconditioned and bed ridden patients. We therefore carried out a randomised trial to compare the efficacy of combination of NMES and PR (NM+PR) with combination of sham stimulation and PR (SS+PR) in a large population of moderately impaired COPD patients. Primary outcome was evaluation of effect of NMES on quadriceps strength and on exercise capacity. Secondary outcome was evaluation of effect of NMES on symptoms (dyspnoea) and quality of life.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of COPD
* Must be able to walk

Exclusion Criteria:

* Previous or current diagnosis of chronic respiratory failure
* A history of diseases other than COPD, in particular neurological disease
* Need for treatment with systemic steroids during the rehabilitation period

Primary outcomes:
measure: Exercise Capacity
timeFrame: 5 weeks
measure: Quadriceps Strength
timeFrame: 5 weeks
Secondary outcomes:
measure: Dyspnoea
timeFrame: 5 weeks
measure: Quality of Life
timeFrame: 5 weeks
measure: Respiratory Function
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Montescano
country: Italy
facility: Fondazione Salvatore Maugeri
state: Pavia
Study officials:
affiliation: Fondazione Maugeri
name: ercole zanotti, MD
role: PRINCIPAL_INVESTIGATOR
References: