louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04709887: Appropriate Strategy of Surgical Treatment in Ischemic Diabetic Foot
Official title: Appropriate Strategy of Surgical Treatment in Ischemic Diabetic Foot
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Foot
Ischemic Diabetic Foot Ulcer
Popliteal Artery Stenosis
Keywords: Ischemic Diabetic Foot Ulcer
Surgical Strategy
Cohort study
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 332
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This cohort study aims to evaluate the outcomes of appropriate surgical treatment strategies in diabetic foot ulcers with different rate of popliteal artery stenosis(\<50% or ≥50%). In this study, patients with Texas university grade 2-4(stage C-D) ischemic diabetic foot ulcers will be included. Data of patients who underwent surgical treatment in the past will be retrospectively collected. The patients with follow-up time less than 12 months will continue to follow up. Also the postoperative patients will be prospectively collected. Effects of different surgical strategies, including wound healing therapy, interventional therapy and tibial transverse bone transport therapy will be measured by several indexes.


Eligibility criteria: Inclusion Criteria:

* Patients with diabetic foot, according to "Chinese Guidelines for Diagnosis and Treatment of Diabetic Foot (2017)".
* Texas university grade 2-4(stage C-D) ischemic diabetic foot ulcers.
* Have clear consciousness, not suffer from mental illness, can cooperate in research and treatment.
* Patients who are informed, participate in the research voluntarily, and have signed the informed consent.
* Have complete clinical data.

Exclusion Criteria:

* Patients with severe systemic infection, who need to be amputated immediately to save lives.
* Patients with mental illness, who cannot cooperate to complete the adjustment and nursing of the external fixator.
* Patients with severe cardiovascular and cerebrovascular diseases (such as severe cardiac insufficiency, severe sequelae of cerebrovascular disease), or with acute infectious diseases.
* Have used or using glucocorticoids systemically within 3 months before admission.
* Have participated in other medical clinical trials within 3 months before admission.
* Patients with severe liver or kidney function abnormalities
* Pregnant or lactating women.
* Patients who lost follow-up.

Primary outcomes:
measure: Healing rate of wound surface
timeFrame: 12 months after surgical operation
Secondary outcomes:
measure: Ankle-brachial index
timeFrame: 3 months after surgical operation
measure: Ankle-brachial index
timeFrame: 12 months after surgical operation
measure: Recurrence rate of foot ulcer
timeFrame: 12 months after surgical operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
Study officials:
affiliation: Peking University People's Hospital
name: Hailin Xu, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00752687: A Study of ABT-072 in Healthy and Hepatitis C Virus Genotype 1-Infected Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C
Keywords: Phase 1
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2008-09-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: To evaluate the safety, tolerability and pharmacokinetics of ABT-072 in healthy volunteers and its anti-viral activity in HCV infected subjects.

Detailed description: A blinded, randomized, placebo-controlled trial to study the safety, tolerability, antiviral activity and pharmacokinetic profiles of ABT-072 in healthy and HCV genotype-1 infected adults.

Eligibility criteria: Inclusion Criteria:

Criteria for Healthy Adults:

* Informed consent has been obtained
* Subject is in general good health
* If female, then postmenopausal
* If female, then not pregnant
* If male, must be surgically sterile or both he and the partner must use birth control
* Body Mass Index is 18 to 29, inclusive

Criteria for HCV-infected Adults:

* Infected with HCV for at least 6 months as shown by either detectable HCV RNA or reactive antibody, or liver biopsy with pathology indicative of HCV infection, or disclosure of a risk factor
* Subject is infected with HCV genotype 1 with detectable HCV RNA of \> 50,000 IU/mL

Exclusion Criteria:

Criteria for Healthy Adults:

* If female, then pregnant or breast feeding
* Positive HAV-IgM, HBs-Ag, HCV Ab or HIV Ab
* Within 6 months of start of study, drug or alcohol abuse and use of nicotine products
* Alcohol intake within 48 hours prior to study drug administration

Criteria for HCV-infected Adults:

* Need for prescription or over-the-counter medication
* Child Pugh score \> 5 or clinical evidence of cirrhosis
* No other cause for liver disease other than HCV infection
* ALT or AST \> 4 x ULN
* Creatinine \> ULN
* Clinically significant abnormal ECG
* HCV RNA levels above the level of assay quantification
* TSH values outside normal range

Primary outcomes:
measure: Analysis of pharmacokinetic variables and mean change in HCV RNA level from baseline.
timeFrame: 2 weeks
measure: Analysis of safety measures including but not limited to tabulation of adverse events, physical exam, clinical lab results (include chemistry, hematology and urine) and vital signs.
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Abbott Park
country: United States
facility: Global Medical Information
state: Illinois
Study officials:
References:
Clinical trial NCT04588987: Neoadjuvant Carilizumab and Apatinib for Recurrent High-Grade Glioma
Official title: A Study to Evaluate the Safety and Efficiency of Using the Neoadjuvant Therapy With Carilizumab and Apatinib in Patients With Recurrent High-Grade Glioma ：A Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Neoadjuvant Therapy
Carilizumab
Apatinib
Recurrent High-Grade Glioma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 60
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: GBM is the most common intracranial tumor in adults, accounting for about 40% of all primary intracranial tumors.Although surgery, radiotherapy and chemotherapy have been used, the prognosis of glioma patients is still very poor. The study aim to Evaluate the Safety and efficiency of Using the neoadjuvant therapy with Carilizumab and Apatinib in patients with Recurrent High-Grade Glioma.


Eligibility criteria: Inclusion Criteria:

1. Written informed consent.
2. Age 18-70 years old, both male and female.
3. After biopsy or surgery, the postoperative pathological diagnosis was WHO III-IV glioma.
4. Patients in whom surgery can be safely delayed for a minimum period of 2 weeks following the administration of the first dose of nivolumab, in the opinion of the investigator.
5. KPS score ≥60；
6. Life expectancy \>12 weeks.
7. Adequate organ function defined by:

   1. HGB≥110g/L；
   2. WBC≥3.0×109/L；NEUT≥1.5×109/L；
   3. PLT ≥75×109/L；

   <!-- -->

   1. BIL≤1.5ULN；
   2. ALT and AST≤2.0×ULN；
   3. creatinine \< 1.5 x ULN or estimated creatinine clearance≥50ml/min（using the Cockcroft-Gault formula）

Exclusion Criteria:

1. Presence of extracranial disease.
2. Previous treatment with a PD-1, PDL-1 or CTLA-4，VEGFR targeted therapy.
3. Pregnant or breastfeeding patients.
4. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). Routine testing is not required.
5. Positive tests for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating active or chronic infection.
6. History of allergy to study drug components or of severe hypersensitivity reactions to any monoclonal antibodies.
7. Known drug or alcohol abuse.

Primary outcomes:
measure: Overall survival (OS)
timeFrame: 3 years
Secondary outcomes:
measure: Progression-free survival(PFS)
timeFrame: 18 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer center of Sun Yat sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT06753487: "Effects of Facilitated Positional Release Technique( FPRT) Vs. Manual Myofascial Release Technique in Female Patients With Piriformis Syndrome
Official title: "Effects of Facilitated Postional Release Technique( FPRT) Vs Manual Myofascial Release Technique in Female Patients With Piriformis Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Piriformis Syndrome
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2024-12-31
Enrollment: 38
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial
Primary purpose: TREATMENT

Brief summary: This study is a randomised control trial and the purpose of this study is to determine the "Effects of Facilitated Postional Release Technique( FPRT) Vs Manual Myofascial Release Technique in Female Patients With Piriformis Syndrome.

Detailed description: The purpose of this study is to determine the "Effects of Facilitated positional release technique vs manual myofascial release technique in female patietns with piriformis syndrome.

we make 2 groups control and treatment group . we give FPRT technique to treatment group and manual release technique to control group in patients with piriformis syndrome.

first we take base line readings of HIP ROMS( abduction, adduction, internal rotation, external rotation),NPRS and LEFS(lower extremity functional scale)..

after 2 weeks of treatment again we take same readings and compare both readings.

Eligibility criteria: Inclusion Criteria:

* patients with Piriformis syndrome
* 25-50 years
* Only females
* Diagnosed piriformis syndromr
* Pain from 2 months

Exclusion criteria:

* Lumbar Radiculopathy
* Fracture
* trauma to lumbar spine
* surgery/ total hip relpacement
* hip OA

Primary outcomes:
measure: Change in ROM
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Foundation University College of Physical Therapy
state: Punjab
Study officials:
References:
Clinical trial NCT06574087: Determining the Frequency of Occurrence and Defining the Most Appropriate Screening Test for Anal Intraepithelial Neoplasia (AIN) in Patients With Human Papillomavirus (HPV) Related Gynecological Diseases.
Official title: Determining the Frequency of Occurrence and Defining the Most Appropriate Screening Test for Anal Intraepithelial Neoplasia (AIN) in Patients With Human Papillomavirus (HPV) Related Gynecological Diseases.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HPV-Related Carcinoma
HPV Infection
Keywords: anal cancer
HPV
anal intraepithelial neoplasia
Lead sponsor: PCK Marine Hospital in Gdynia
Sponsor class: OTHER
Collaborators: name: Medical University of Gdansk
First posted: 2024-08-27
Enrollment: 248
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The primary aim of the study is to determine the total risk of AIN in group of HPV-RGD survivors and additionally to establish an exact risk for each of HPV-related gynecological precancers/cancers. Moreover, the most appropriate screening test for HSIL(AIN) in this group of patients will be determined. It will be effectuated by performing two kinds of tests: hrHPV test for the 14 most common oncogenic HPV types and the liquid cytology from both the lower genital tract and anal canal with subsequent high resolution anoscopy (HRA) with potential biopsy/excision of suspected lesions and histopathological examination.


Eligibility criteria: Inclusion Criteria:

* HPV related gynecological disease confirmed in histo-pathological examination
* the posibility to obtain material from gynecological organ and from anal canal

Primary outcomes:
measure: HPV in the anal cancer
timeFrame: Just before surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Gdynia
country: Poland
facility: PCK Marine Hospital in Gdynia
state: Pomorskie
Study officials:
References:
Clinical trial NCT02978833: Platelet-rich Plasma vs. Whole Blood for Gluteus Medius Tendinopathy
Official title: Ultrasound-Guided Platelet Rich Plasma Versus Whole Blood Injection for the Treatment of Gluteus Medius Tendinopathy: A Double-Blind Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Tendinopathy
Hip Pain
Keywords: Gluteus Medius Tendinosis
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2016-12-01
Enrollment: 2
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Gluteus medius tendinopathy, which is often referred to as Greater Trochanteric Pain Syndrome, is characterized by pain in the lateral aspect of the hip that is aggravated by side lying, stair climbing, and walking. Treatment is currently limited to lifestyle modifications, corticosteroid injections, physical therapy, and open and endoscopic surgical repair. Platelet rich plasma (PRP) injections contain important growth factors that are essential in the healing and tissue formation processes. However, the extent to which PRP is more efficacious than whole blood in tendinopathy remains unclear. In this double-blind randomized trial, patients will be allocated to receive either a PRP or whole-blood injection. Post-procedure assessments will occur at 6 weeks, 3 months, 6 months, 9 months, and 1 year.


Eligibility criteria: Inclusion Criteria:

* Moderate to severe lateral hip pain for greater than 3 months
* Symptoms are refractory to conservative treatment, including at least 8 weeks of traditional physical therapy for this condition
* Moderate to severe gluteus medius tendinosis with or without partial tear \<1 cm
* Normal neurologic exam except for hip abductor weakness on the affected side

Exclusion Criteria:

* Severe (Tonnis grade \>1) hip osteoarthritis with active synovitis or bone edema
* Active lumbar radiculopathy with pain, numbness or weakness in a dermatomal distribution
* No evidence of fatty atrophy, denervation, or complete tears of gluteus medius seen on MRI
* Any condition that requires anti-platelet or anti-coagulation therapy, including aspirin therapy for cardiac conditions
* Non-English speaking

Primary outcomes:
measure: Improvement in Pain
timeFrame: Up to 1 year post-injection
measure: Improvement in Function
timeFrame: Up to 1 year post-injection
measure: Patient Satisfaction
timeFrame: Up to 1 year post-injection
Secondary outcomes:
measure: Quality of Movement During the Forward Step-down Test
timeFrame: Up to 1 year post-injection
measure: Pain During Side-lying Hip Abduction
timeFrame: Up to 1 year post-injection
measure: Pain During Forward Step-down Test
timeFrame: Up to 1 year post-injection
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Peter Moley, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04135833: A Phase I Study to Assess the Effect of Itraconazole and Rifampicin on Pharmacokinetics Profile of BPI-7711
Official title: A Phase I Study to Assess the Effect of Itraconazole and Rifampicin on Pharmacokinetics Profile of BPI-7711 in Chinese Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: NSCLC
Lead sponsor: Beta Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2019-10-23
Enrollment: 31
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a phase I study to assess the effect of itraconazole and rifampicin on the pharmacokinetic parameters of BPI-7711 in Chinese healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Male, aged from 18 to 45 years
* BMI from 18.5 to 28.0 kg/m2
* Medical history, vital signs, physical examination and lab tests are normal or abnormal without clinical significance

Exclusion Criteria:

* Subjects with clinical significant diseases
* Subjects with allergic disease history
* Subjects with gastrointestinal disease history that can affect study drug absorption
* Subjects with drug abuse history

Primary outcomes:
measure: Cmax
timeFrame: Blood samples collected on Day 1 and Day 20 (arm 1)/Day 25 (arm 2) at pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168 and 336 hours post BPI-7711 dose
measure: AUC(0-last)
timeFrame: Blood samples collected on Day 1 and Day 20 (arm 1)/Day 25 (arm 2) at pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168 and 336 hours post BPI-7711 dose
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Xuhui Central Hospital
Study officials:
affiliation: Shanghai Xuhui Central Hospital
name: Jingying Jia
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01104233: Pain Outcomes Following Video-Assisted Thoracic Surgery (VATS) With LAP Protector
Official title: Pain Outcomes Following Video-Assisted Thoracic Surgery (VATS) With Rigid Spreading Versus Soft Spreading (Using LAP Protector)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Keywords: Video-assisted Thoracoscopic Surgery
Soft spreading
LAP Protector
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2010-04-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with non-small cell lung cancer

Brief summary: The purpose of this study is to see if different types of spreading (rigid or soft) of Video-assisted Thoracoscopic Surgery (VATS) for lung cancer have different effects on pain.

Detailed description: The Lap-Protector (Hakko Co., Japan) is a device that consists of two flexible rings made of superelasticity alloys covered with polyurethane polyamide, and a thin silicone rubber membrane that is attached to the outer rim of the two rings. If the two rings are pulled apart, the device assumes a cylindrical shape. The outer diameter of each flexible ring is 12 cm, and this device can be used for minilaparotomy wounds between 5 and 9cm long.

Eligibility criteria: Inclusion Criteria:

* Non-small cell lung cancer stage IB - IIIA
* ECOG status 0-1

Exclusion Criteria:

* Prior chemotherapy and/or radiation therapy for lung cancer
* Peripheral neuropathy \> grade 1
* Concurrent other malignancies, other than basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
* Medical condition that will not permit treatment or follow up according to the protocol
* Pregnant or nursing women
* HIV-positive patients

Primary outcomes:
measure: Compare the level of postoperative pain between the rigid and soft spreading groups
timeFrame: 1 day
Secondary outcomes:
measure: Compare early postoperative analgesic requirements between the rigid and soft spreading groups
timeFrame: 1 week
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:
Clinical trial NCT02106533: Aerobic Exercise on Ventilatory Efficiency in CAD Patients
Official title: Effect of Aerobic Exercise Training on Ventilatory Efficiency in Patients With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Artery Disease
Exercise Addiction
Complication, Cardio-respiratory
Keywords: Coronary artery disease
Exercise
Ventilatory efficiency
Lead sponsor: Hospital TotalCor
Sponsor class: OTHER
First posted: 2014-04-08
Enrollment: 123
Sex: ALL
Minimum age (years): 48
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the present study was to test the hypothesis that patients with coronary artery disease with lower aerobic fitness exhibit greater responsiveness on improving ventilatory efficiency after aerobic exercise training.

Detailed description: Measurements of ventilatory efficiency during cardiorespiratory exercise testing typically expressed as the minute ventilation/ carbon dioxide production ratio have been validated to be useful in assessing the presence and severity of both heart and lung diseases. In this context, previous studies have showed ventilatory inefficiency in patients with coronary artery disease suggests abnormalities in the distribution of ventilation and perfusion in the lungs. In addition, a growing body of studies has demonstrated that lower ventilatory efficiency during exercise is considered an important predictor of risk mortality, hospitalization, and other outcomes than peak VO2.

Eligibility criteria: Inclusion Criteria:

* was stable coronary artery disease diagnosed by coronary angiography

Exclusion Criteria:

* unstable angina pectoris,
* complex ventricular arrhythmias,
* pulmonary congestion and
* orthopaedic or neurological limitations to exercise

Primary outcomes:
measure: Ventilatory efficiency in patients with coronary artery disease
timeFrame: up to 3 months of the interventions
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hospital TotalCor
name: Danilo ML Prado, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Prado DM, Rocco EA, Silva AG, Silva PF, Lazzari JM, Assumpcao GL, Thies SB, Suzaki CY, Puig RS, Furlan V. The influence of aerobic fitness status on ventilatory efficiency in patients with coronary artery disease. Clinics (Sao Paulo). 2015 Jan;70(1):46-51. doi: 10.6061/clinics/2015(01)09.