louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04648631: Hidradenitis Suppurativa (HS) Tunneling Wounds
Official title: The Microbiome of Hidradenitis Suppurativa (HS) Tunneling Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hidradenitis Suppurativa
Keywords: tunneling wound
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Next Science LLC
First posted: 2020-12-01
Enrollment: 15
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: The purpose of this study is to look at the change in the microbiome (bacterial composition) of an HS tunneling wound and examine if treatment with an antibiofilm surfactant wound gel (ABWG) (a topical medication that will fight bacteria attached to the surface of those tunnels) changes the bacterial composition of the wounds.


Eligibility criteria: Inclusion Criteria:

1. Adults 18 years old and older
2. Have diagnosis of HS confirmed by a dermatologist
3. Have at least one HS related tunneling wound that is at least 2 centimeters in length
4. Able to provide informed consent

Exclusion Criteria:

1. Individuals who are not yet adults
2. Women known to be pregnant
3. Prisoners
4. Subjects, who in the opinion of the PI, cannot comply with home application of the treatment.

Primary outcomes:
measure: Change in Microbiome
timeFrame: Baseline, 4 weeks
Secondary outcomes:
measure: Change in Lesion Severity as Measured by HS-PGA
timeFrame: Baseline, 4 week
measure: Change in Lesion Severity as Measured by the Hurley Stage
timeFrame: Baseline, 4 weeks
measure: Change in Pain as Measured by VAS
timeFrame: Baseline, 4 weeks
measure: Change HS Lesion Erythema
timeFrame: Baseline, 4 weeks
measure: Change in Exudate
timeFrame: Baseline, 4 weeks
measure: Change in Range of Motion
timeFrame: Baseline, 4 weeks
measure: Number of Participants With Decreased Pain Medication Use
timeFrame: 4 weeks
measure: Number of Participants With Escalated Pain Medication Use
timeFrame: 4 weeks
measure: Change in Number of Days of Work/School Lost
timeFrame: Baseline, 4 weeks
measure: Number of Dressings Used
timeFrame: 4 weeks
measure: Change in Quality of Life as Measured by HiSQOL
timeFrame: Baseline, 4 weeks
measure: Change in Quality of Life as Measured by DLQI
timeFrame: Baseline, 4 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Hadar Lev-Tov, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00800631: The Biomarker and Cardiac Function in Sepsis
Official title: The Biomarker and Associated Cardiac Function in the Patients With Sepsis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2008-12-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: sepsis

Brief summary: The development and severity of sepsis induced myocardial dysfunction can be monitored from the serum biomarker.


Eligibility criteria: Inclusion Criteria:

* Sepsis patients with 2 of the followings when arrival ER and treated \> 6 hours:

  * BT \>38℃ or\<36℃
  * HR \>90/min
  * RR \>20/min or PaCO2 \< 32 mmHg
  * WBC count \>12×109/L or \<4×109/L or immature form \>10％

Exclusion Criteria:

* Age \< 18
* Major trauma patients
* Pregnancy
* Willing to do not aggressive treatment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: ER of National Taiwan Univeristy Hospital
Study officials:
References:
Clinical trial NCT02540031: The Impact of Additional Oral Preparation on the Quality of Bowel Preparation for Colonoscopy
Official title: The Impact of Additional Oral Preparation on the Quality of Bowel Preparation for Colonoscopy in Patients Showing Brown Effluents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bowel Preparation Quality
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2015-09-03
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Although adequate bowel preparation is essential for successful colonoscopy, the 23% of patients had shown inadequate bowel preparation. Inadequate bowel preparation may results in incomplete examination, increased patient's discomfort, decreased polyp detection rates, ultimately leading to repeated colonoscopies. One prior study showed that patients reporting their last rectal effluents as brown color or solid stool had a 54% chance of having fair or poor preparation. Thus, recent consensus guideline suggested consideration of additional oral preparation in patients presenting brown effluents on the day of colonoscopy. However, the data supporting additional oral preparation is still spares. Therefore, the investigators aimed to examine the impact of additional oral preparation on the quality of bowel preparation for colonoscopy in patients showing brown effluents on the day of colonoscopy.


Eligibility criteria: Inclusion Criteria:

* patients who reporting their last rectal effluents as brown color or solid stool on the day colonoscopy

Exclusion Criteria:

* known hypersensitivity to polyethylene glycol
* severe congestive heart failure \[New York Heart Association (NYHA) grade III or grade IV\]
* severe renal insufficiency (creatinine clearance \<30 ml/min)
* hemodynamic instability
* suspected intestinal obstruction or perforation
* compromised swallowing reflex or altered mental status
* pregnancy or lactating woman
* patients who declined to participate

Primary outcomes:
measure: Quality of bowel preparation
timeFrame: Day 1
Secondary outcomes:
measure: Adenoma detection rate
timeFrame: Day 1
measure: Patient compliance
timeFrame: Baseline
measure: Patient satisfaction
timeFrame: Baseline
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
Study officials:
affiliation: Keimyung University Dongsan Medical Center
name: Eun Soo Kim
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fatima H, Johnson CS, Rex DK. Patients' description of rectal effluent and quality of bowel preparation at colonoscopy. Gastrointest Endosc. 2010 Jun;71(7):1244-1252.e2. doi: 10.1016/j.gie.2009.11.053. Epub 2010 Apr 1.
Clinical trial NCT01145131: Dietary Interventions for Muscle Mass
Official title: Dietary Interventions for Muscle Mass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: muscle
FSR
protein
meat
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2010-06-16
Enrollment: 12
Sex: MALE
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Dietary intervention to prevent sarcopenia in elderly people. The objective of this study is to test whether meat structure plays an important role in protein digestion, to maximise the amino acid availability and to stimulate the muscle protein growth in elderly people.


Eligibility criteria: Inclusion Criteria:

* Non-obese male subjects (BMI\<30) between the age of 65-85 years.

Exclusion Criteria:

* Type II diabetes or other known diseases, use of medication, female, other ages or BMI than indicated above, participation in any regular exercise program.

Primary outcomes:
measure: Muscle protein synthesis
timeFrame: 6 h postprandial period
Secondary outcomes:
measure: Dietary amino acid plasma availability
timeFrame: 6h postprandial period
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Universiteit Maastricht, Bewegingswetenschappen
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: B Pennings, Ir
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mioche L, Bourdiol P, Monier S, Martin JF, Cormier D. Changes in jaw muscles activity with age: effects on food bolus properties. Physiol Behav. 2004 Sep 30;82(4):621-7. doi: 10.1016/j.physbeh.2004.05.012.
citation: Mioche L, Bourdiol P, Monier S. Chewing behaviour and bolus formation during mastication of meat with different textures. Arch Oral Biol. 2003 Mar;48(3):193-200. doi: 10.1016/s0003-9969(03)00002-5.
citation: Pennings B, Groen BB, van Dijk JW, de Lange A, Kiskini A, Kuklinski M, Senden JM, van Loon LJ. Minced beef is more rapidly digested and absorbed than beef steak, resulting in greater postprandial protein retention in older men. Am J Clin Nutr. 2013 Jul;98(1):121-8. doi: 10.3945/ajcn.112.051201. Epub 2013 May 1.
Clinical trial NCT06377982: Human Umbilical Cord Blood Infusion in Patients with Cerebral Palsy
Official title: A Phase I, Randomized, Double-blind, Placebo-controlled Clinical Study to Assess the Safety and Efficacy of Allogeneic Human Umbilical Cord Blood Infusion in Children with Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Cerebral Palsy
Lead sponsor: StemCyte International, Ltd.
Sponsor class: INDUSTRY
First posted: 2024-04-22
Enrollment: 12
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A phase I, randomized, double-blind, placebo-controlled clinical study to assess the safety and efficacy of allogeneic human umbilical cord blood infusion in children with cerebral palsy

Detailed description: This is a phase I study to evaluate the safety and efficacy in hUCB treatment on the patients with cerebral palsy (CP).

Eligibility criteria: Inclusion Criteria:

* Male or female underage at the time of screening.
* With a confirmed diagnosis of CP
* non-progressive motor disability
* brain dysfunction

Exclusion Criteria:

* Judged by the Investigator to be not suitable/eligible for study participation.

Primary outcomes:
measure: safety-TEAE
timeFrame: From screening to 56 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06190782: Local Therapy for Oligometastatic ESCC Patients Treated With PD-1 Inhibitor
Official title: Phase III Randomized-controlled Study of PD-1 Inhibitor Combined With Local Therapy in Patients With Oligometastatic Esophageal Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Esophageal Squamous Cell Carcinoma
Oligometastatic Disease
Radiotherapy
Keywords: esophageal squamous cell carcinom
Oligometastatic
Radiotherapy
pd-1 inhibitor
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 354
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: Patients with oligometastatic squamous cell carcinoma were enrolled and randomly assigned to receive either PD-1 inhibitor +/- chemotherapy combined with local therapy or PD-1 inhibitor +/- chemotherapy alone.

The primary end point was progression-free survival (PFS). The secondary end points included overall survival, side effects and local control.

Detailed description: Patients with oligometastatic squamous cell carcinoma were enrolled and 2:1 randomly assigned to receive either PD-1 inhibitor +/- chemotherapy combined with local therapy (radiotherapy, surgery, radiofrequency/microwave ablation, etc.) or PD-1 inhibitor +/- chemotherapy alone. Different local therapy techniques are allowed to be used on different lesions in the same patient.All suspected malignant lesion should be included in local treatment planning in principle.

The primary end point was progression-free survival (PFS). The second end points included overall survival, side effects and local control.

Eligibility criteria: Inclusion Criteria:

* 1. ≥18 years old; 2. ECOG 0-1; 3. Esophageal squamous cell carcinoma 4. ASTRO/ESTRO defined genuine oligometastatic disease and consistent with: i. ≤4 distant metastases, ii. ≤3 metastatic lesions within a single organ, iii. maximum diameter of each metastatic lesion ≤5cm; 5. ≥1 pathologically diagnosed metastases

Exclusion Criteria:

* 1. History of disseminated metastases or ASTRO/ESTRO defined induced oligometastatic disease 2.Esophageal perforation/hemorrhage 3.Progression disease after PD-1 inhibitor treatment 4.In-field recurrence 5.Intolerance to chemotherapy or immunotherapy 6.lung V20\>25%

Primary outcomes:
measure: Progression-free survival difference of PD-1 inhibitor+radiotherapy and PD-1 inhibitor alone
timeFrame: 3-year
Secondary outcomes:
measure: overall survival difference of PD-1 inhibitor+radiotherapy and PD-1 inhibitor alone
timeFrame: 3-year
measure: treatment related side effect
timeFrame: acute side effects within 3 months, late side effects for 3 months later
measure: local control rate
timeFrame: 1-year, 3-year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai cancer center
Study officials:
affiliation: Fudan University
name: Kuaile Zhao, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06627582: A Study on Pain After Breast Reconstruction
Official title: Persistent Postmastectomy Pain: Defining the Burden of Disease and the Role of Surgical Reinnervation in Patients With Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mastectomy
Mastectomy Patient
Mastectomy and Breast Reconstruction
Breast Reconstruction
Breast Reconstruction After Mastectomy
Postmastectomy Pain
Keywords: Postmastectomy Pain
breast reconstruction after mastectomy
breast reconstruction
mastectomy and breast reconstruction
mastectomy
mastectomy patient
24-271
Memorial Sloan Kettering Cancer Center
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out how common persistent postmastectomy pain (PPMP) is among people who have had a mastectomy and breast reconstruction surgery for their breast cancer. The study will also look at how effective regenerative peripheral nerve interface (RPNI) surgery is for reducing pain from neuropathic PPMP after breast reconstruction.


Eligibility criteria: Inclusion Criteria:

* Female
* Age ≥18 years
* History of mastectomy for breast cancer or genetic predisposition to breast cancer
* History of breast reconstruction with implants and/or autologous tissue
* At least 6 months of follow-up after reconstruction
* Patient treated at MSK

Exclusion Criteria:

* Exchange or revision surgery within 6 months
* Active medical reason for pain (e.g., infectious, neoplastic, wound related)
* Greater than 15 years post-reconstruction

Primary outcomes:
measure: Number of participants with Persistent Postmastectomy Pain
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memoral Sloan Kettering Basking Ridge (Limited Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memoral Sloan Kettering Monmouth (Limited protocol activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All protocol activites)
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Nassau (Limited Protocol Activites)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Danielle Rochlin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04998682: Prospective Evaluation of Targeted Axillary Dissection (TAD)
Official title: TAD: Prospective Evaluation of Targeted Axillary Dissection After Neoadjuvant Systemic Therapy in Patients With Breast Cancer With Advanced Nodal Disease at Diagnosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Targeted Axillary Dissection
Advanced Nodal Disease
Axillary Lymph Node
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2021-08-10
Enrollment: 45
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: The purpose of this research is to evaluate how to manage the axillary lymph nodes in patients with breast cancer. The investigators will determine if a sampling of the lymph nodes under the arm will give the information necessary to determine if fewer lymph nodes can be removed.


Eligibility criteria: Inclusion Criteria:

* Women or men greater than or equal to 18 years.
* Histologically confirmed invasive adenocarcinoma of the breast.
* Clinical T0-4 N2-3 M0 at diagnosis (American Joint Committee on Cancer, 7th Edition)

  * Assessment for cN2 disease will be performed by clinical exam and imaging. Patients should have pathologic level 1 and/or 2 axillary lymph nodes which are fixed/matted on physical exam.
  * Cross-sectional imaging will be used to identify advanced nodal disease involving the axilla, infraclavicular, supraclavicular, and internal mammary regions, cN3 disease.
* Patients must have biopsy proven involvement of the axillary lymph nodes.
* Receipt of standard multiagent chemotherapy +/- targeted therapy based on tumor subtype.
* Candidate for surgical management of breast cancer.
* Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

* History of allergic reactions or hypersensitivity to radioactive lymph node mapping agents or blue dye.
* Pregnancy.

Primary outcomes:
measure: False Negative Rate
timeFrame: Up to 2 weeks
Secondary outcomes:
measure: Sentinel Lymph Node Identification Rate
timeFrame: Day 1 (Day of Surgery)
measure: Clipped Lymph Node Identification Rate
timeFrame: Day 1 (Day of Surgery)
measure: Accuracy Rate of Imaging Studies
timeFrame: Up to 2 weeks
measure: Pathologic Complete Response (pCR)
timeFrame: Up to 2 weeks
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Up to 3 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Susan Kesmodel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01054482: Pre-operative Chemotherapy Versus Concurrent Chemoradiotherapy in Locally Advanced Non-small Cell Lung Cancer
Official title: A Randomized Phase II Study Preoperative Chemotherapy Versus Preoperative Concurrent Chemoradiotherapy for Patients With Locally Advanced Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: Neoadjuvant chemotherapy
neoadjuvant chemoradiotherapy
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2010-01-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This phase II trial is to compare neoadjuvant chemotherapy with concurrent chemoradiotherapy in patients with locally advanced non-small cell lung cancer (NSCLC) to address optimal induction strategy.

Detailed description: Management of locally advanced non-small cell lung cancer (NSCLC) remains a challenge. Both local relapses and distant metastases are frequent, with 5-year survival of 3-17% for inoperable disease. Staging has historically subdivided stage III disease into clinical stage IIIA, thought to be potentially amenable to surgery, and stage IIIB, treated by defi nitive radiotherapy or radiochemotherapy. This phase II trial is to compare neoadjuvant chemotherapy with concurrent chemoradiotherapy in patients with locally advanced NSCLC to address optimal induction strategy.

Eligibility criteria: Inclusion Criteria:

* Histopathologic diagnosis of non small-cell lung cancer
* Clinical stage IIIA and/or IIIB without pleural effusion
* ECOG functional status 0 or 1
* No renal function alteration (GFR \>50%)
* No hepatic function alteration (ALT and AST less than 2 times its normal value)
* Leucocytes more than 2,000/mcl
* Hemoglobin more than 10mg/dL
* Platelets more than 100,000/mcl

Exclusion Criteria:

* Active uncontrolled infection.
* Serious concomitant disorders that would compromise the safety of patient or compromise the patient's ability to tolerate therapy.
* MI within preceding 6 months or symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmia.
* Significant neurological or mental disorder.
* Second primary malignancy.
* Pregnant or nursing.

Primary outcomes:
measure: To estimate the time to recurrence
timeFrame: Every 3 months
Secondary outcomes:
measure: To assess the pathologic complete response rate and the complete resection rate
timeFrame: Every 4 weeks
measure: To estimate toxicities
timeFrame: Every 4 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical College
state: Guangdong
Study officials:
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: Jianxing He, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References: