louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04436406: PD-L1 Expression in Cancer (PECan Study).
Official title: Measurement of PD-L1 Expression in Cancer to Monitor Treatment Response.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-small Cell Lung Cancer
Melanoma
Keywords: immunotherapy
checkpoint inhibitors
molecular imaging
non-small cell lung cancer
melanoma
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: NanoMab Technology (UK) Limited
First posted: 2020-06-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Measurement of PD-L1 expression in cancer to monitor treatment response.

A prospective non-blinded, single centre, single interventional arm diagnostic imaging study.

To determine the baseline level and variability within and between patients and tumour types of PD-L1 expression in melanoma and non-small cell lung cancer in immunotherapy naïve patients using \[99mTc\]-anti-PD-L1 SPECT/CT and immunohistochemistry.

Detailed description: Using \[99mTc\]-labeled anti-PD-L1 single-domain antibody, this study aims to prospectively measure changes in PD-L1 expression determined with SPECT/CT imaging and correlate these changes with response to anti-PD(L)1 immunotherapy.

Eligibility criteria: Inclusion Criteria:

* Aged 18 or above
* Patients with histologically confirmed NSCLC or melanoma scheduled for PD1/PDL1 immunotherapy alone or in combination with other systemic anti-cancer therapy.
* Willingness and ability to comply with scheduled study visits and tests.

Exclusion Criteria:

* Pregnant or lactating women
* Concomitant uncontrolled medical conditions
* Patients likely to require palliative radiotherapy within the first 12 weeks of treatment or radiotherapy to target lesion(s) received within preceding 42 days
* More than 3 months between IHC PDL1 and study recruitment
* Patients who have received other systemic anti-cancer therapy within preceding 14 days
* Prognosis less than 3 months
* Previous anticancer treatment with any checkpoint inhibitor or other immunotherapy, i.e. only immunotherapy naïve patients

Primary outcomes:
measure: Percentage change in PD-L1 expression (using [99mTc] SPECT) in NSCLC.
timeFrame: Up to 18 weeks
measure: Percentage change in PD-L1 expression (using [99mTc] SPECT) in melanoma lesions.
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Report PD-L1 tumour expression (using [99mTc] SPECT) of immunotherapy naive participants compared to PD-L1 expression determine by standard immunohistochemistry.
timeFrame: Baseline
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
Study officials:
affiliation: King's College London, London, UK
name: Gary JR Cook
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06183606: Interest of High-dose Gentamicin Cement Associated With Clindamycin in Changes of Hip and Knee Prostheses
Official title: Local Antibiotic Prophylaxis With Antibiotic Cement: Interest of High-dose Gentamicin Cement Associated With Clindamycin in Changes of Hip and Knee Prostheses
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hip or Knee Replacement
Keywords: Hip Replacement
knee Replacement
Local antibiotic prophylaxis
Antibiotic cement
Gentamicin cement
Clindamycin
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2023-12-27
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult subject (≥18 years old) operated on at the HUS between 01/02/2017 and 31/01/2019, for replacement of hip and knee prostheses.

Brief summary: A hip or knee prosthesis can be cemented or not. The team of orthopedic surgeons from the CCOM (Centre de Chirurgie Orthopédique et de la Main) has been cementing all hip and knee prosthesis poses for many years using gentamycin cement as recommended by the French Society of Orthopedic Surgery. and trauma (SOFCOT) (1). Data obtained from the Norwegian Register of Hip Prostheses show that the best survival curve for these prostheses is found for prostheses cemented with gentamycin cement (all causes combined). Independently of the risk of aseptic loosening, infection on the prosthesis is the second complication of arthroplasty. The defense mechanism against pathogens in contact with an implant is the formation of a biofilm. Biofilm bacteria are metabolically inactive and characterized by stationary growth. Due to their slower replication, bacteria in biofilm are up to 1000 times more resistant to antibiotics. Therefore, the optimization of local antibiotic prophylaxis is essential.


Eligibility criteria: Inclusion criteria:

* Adult subject (≥18 years old)
* Patient operated on at the HUS between 01/02/2017 and 31/01/2019, for replacement of hip and knee prostheses
* Patient having given their consent for the reuse of their data for the purposes of this research

Exclusion criteria:

- Patient who expressed their opposition to participating in the study

Primary outcomes:
measure: Retrospective study of surgical site infections (SSI) after changes of hip and knee prostheses
timeFrame: Through study completion, an average of 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie Orthopédique Septique - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT00687206: Efficacy and Safety of Valsartan Plus Hydrochlorothiazide in Patients With Slight Hypertension and Target Organ Damage
Official title: Efficacy and Safety of Valsartan 160 mg Plus Hydrochlorothiazide 25 mg Once a Day in Patients With Slight Hypertension and Target Organ Damage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Ventricular Remodeling
Erectile Dysfunctions
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2008-05-30
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with slight increase in blood pressure levels have an increased cardiovascular risk. In particular this has been demonstrated also in subjects with high-normal blood pressure in whom an exaggerated blood pressure increase, during exercise, and structural left ventricular abnormalities have been shown. On the other hand, the last American and European guidelines for management of hypertension recommend more aggressive treatment in young-middle aged subjects to achieve a better control of cardiovascular risk due to blood pressure increase. In agreement with these recommendations the investigators share the idea that a good blood pressure control should be achieved not only at rest, but also during psycho-physical stress conditions that frequently occur during daily life. On this basis, the investigators decided to evaluate the efficacy and tolerability of the association of valsartan and hydrochlorothiazide (160 an 25 mg daily, respectively) in patients with high-normal blood pressure and first degree arterial hypertension with evidence of organ damage.

The aim of this study is to assess if an early and adequate therapy could bring to a better pressure control (even during physical activity) and a regression of organ damage without interfering with metabolism and erectile function


Eligibility criteria: Inclusion Criteria:

* Aged 18-65
* Gender Males
* High-normal blood pressure (130-139 mmHg or 85-89 mmHg)
* First degree hypertension (140-159 mmHg or 90-99 mmHg)
* Cardiac remodeling (left ventricular concentric hypertrophy

Exclusion Criteria:

* Coronary artery disease
* Secondary hypertension
* Diabetes mellitus
* Incapacity to perform ergometry test
* Anemia (Hb \< 12.5g/dL)
* Cardiac valve disease
* Arrhythmia

Primary outcomes:
measure: The aim of this study is to assess if an early and adequate therapy could bring to a better pressure control (even during physical activity) and a regression of organ damage assessed by bicycle stress test and mono-bidimensional echocardiography.
timeFrame: 3 and 6 months
Secondary outcomes:
measure: Effects of Valsartan 160mg / HCT 25mg on metabolism and erectile function
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Department of internal medicine University Federico II
Study officials:
affiliation: Federico II University
name: Serafino Fazio, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01017406: Heel Cushion for Plantar Fasciitis
Official title: PSU Heel Cushion for Treatment of Plantar Fasciitis:A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Plantar Fasciitis
Keywords: plantar fasciitis
heel cushion
treatment
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2009-11-20
Enrollment: 160
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators study aim to evaluate the efficacy of PSU heel cushion in treatment of plantar fasciitis. The investigators will do a randomized controlled trial in patient with plantar fasciitis compared with stretching exercise alone. The outcome measurement include heel pain improvement, compliance, satisfaction, foot functional score at 6 months.


Eligibility criteria: Inclusion Criteria:

* Patient with plantar fasciitis

Exclusion Criteria:

* Rheumatologic problem such as rheumatoid arthritis
* Latex allergy
* Pregnancy
* Previous surgery around foot and ankle

Primary outcomes:
measure: VAS score
timeFrame: 2 years
Secondary outcomes:
measure: Compliance
timeFrame: 2 years
measure: Satisfaction score
timeFrame: 2 years
measure: Foot functional score : FHSQ score
timeFrame: 2 years
measure: Number of rescue pain killer
timeFrame: 2 years
Other outcomes:
Locations:
city: Hatyai
country: Thailand
facility: Prince of Songkla university
state: Songkhla
Study officials:
affiliation: Department of orthopedic surgery, faculty of medicine
name: Suntorn Wongsiri, MD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00909506: Efficacy and Safety of Adjuvant Metformin for Operable Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2009-05-28
Enrollment: 105
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators hypothesize that adjuvant metformin use in breast cancer patients with overweight or pre-diabetes mellitus (DM) may improve their body condition including weight loss.

In this study, the investigators aim to test the efficacy and safety of adjuvant metformin for operable breast cancer patients with overweight or pre-DM.


Eligibility criteria: Inclusion Criteria:

* Operable Breast cancer patients with BMI ≥ 23 or 100 ≤ FBS \< 126
* From 6 month to 2 years since breast cancer operation and at least 4 weeks since chemotherapy or radiotherapy
* No drug use except Tamoxifen
* Normal OTPT \& Serum creatinine (\<=ULN)
* ECOG performance status 0-2 or Karnofsky PS 60-100%
* Life expectancy \> 12
* Absolute neutrophil count ≥ 1.5 x 10\^9/L
* Platelets ≥ 100 x 10\^9/L
* Pregnancy(-) \& without plan for pregnancy
* Sign a written informed consent form

Exclusion Criteria:

* Type I or II DM or concurrent use of DM control agents
* Prior use of Metformin
* Hypoglycemia (FBS\< 70 with clinical symptom)
* Concurrent investigational or commercial agents
* Other diet or drug intervention for weight loss
* Concurrent use of steroid
* Abnormal liver and/or renal function
* Symptomatic congestive heart failure / Cardiac arrhythmia / Angina pectoris
* Ongoing or active infection
* lactic acidosis
* Pregnancy or ongoing breast feeding
* Anorexia, bulimia, nausea due to other disease for longer than 1 month
* Allergies or allergic reactions attributed to oral medications
* Inability to swallow or digest oral medications
* Physical or psychiatric illness that would limit compliance with study protocol
* Participants in other clinical trial

Primary outcomes:
measure: Weight loss
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Department of General Surgery, Seoul National University College of Medicine & Seoul National University Hospital
name: Wonshik Han, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00583206: Muscle Atrophy in Sepsis
Official title: Biochemical Pathways to Skeletal Muscle Atrophy in Human Sepsis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Atrophy
Sepsis
Weakness
Keywords: sepsis
atrophy
muscle
weakness
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2007-12-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Severe sepsis

Brief summary: Severe sepsis will provoke signals leading to muscle atrophy and weakness. Electrical stimulation will reduce the impact of sepsis.

Detailed description: Hypothesis 1: Severe sepsis will be associated with downregulation of anabolic signaling molecules and genes, upregulation of catabolic signaling molecules and genes, and the development of histologic and electrophysiologic abnormalities within skeletal muscle.

Hypothesis 2: Electrical stimulation will improve muscle strength in patients with sepsis.

Hypothesis 3: Electrical stimulation will be associated with upregulation of anabolic signaling molecules and genes, downregulation of catabolic signaling molecules and genes, and improvement of histologic and electrophysiologic parameters within skeletal muscle of patients with sepsis.

Hypothesis 4: The ratio of catabolic:anabolic gene expression on Day 3 will be positively correlated with the severity of clinical weakness on Day 7

Eligibility criteria: Inclusion Criteria:

* Severe sepsis for \< 72hr

Primary outcomes:
measure: Electrical stimulation will be associated with upregulation of anabolic signaling molecules and genes, downregulation of catabolic signaling molecules and genes within skeletal muscle of patients with sepsis
timeFrame: 3 days
Secondary outcomes:
measure: Electrical stimulation will be associated with improvement of histologic and electrophysiologic and strength parameters within skeletal muscle of patients with sepsis
timeFrame: 7 days
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals
state: Iowa
Study officials:
References:
Clinical trial NCT01732406: Acromegaly Treatment Quality of Life Study
Official title: Effect of Growth Hormone Receptor Antagonism and Somatostatin Analog Administration on Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acromegaly
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2012-11-22
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: There will be 3 groups/cohorts: 1) Patients with active acromegaly (n=35), 2) patients receiving pegvisomant monotherapy to treat acromegaly (n=31), and 3) patients receiving somatostatin analog monotherapy to treat acromegaly (n=60)

Brief summary: The investigators hypothesize that treatment of acromegaly will be associated with an improvement in quality of life compared to active acromegaly. At the same time, they will also be studying the effects of different acromegaly treatments on the quality of life.


Eligibility criteria: Inclusion Criteria:

* Age 18-90
* Active acromegaly or receiving pegvisomant monotherapy or receiving somatostatin analog monotherapy

Exclusion Criteria:

* Untreated thyroid or adrenal insufficiency. Subjects on replacement therapy must be stable for at least 3 months prior to entry into the study
* Initiation or discontinuation of testosterone or estrogen within 3 months of entry
* Pregnant and nursing women

Primary outcomes:
measure: Acromegaly Quality of Life (ACROQoL) Global Score
timeFrame: Cross-sectional at baseline
Secondary outcomes:
measure: The Gastrointestinal Quality of Life Index (GIQLI) Total Score
timeFrame: Cross-sectional at baseline
measure: 36-Item Short Form Survey Instrument (SF-36) Physical Health
timeFrame: Cross-sectional at baseline
measure: 36-Item Short Form Survey (SF-36) Mental Health Summary Score
timeFrame: Cross-sectional at baseline
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Karen Miller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00657306: Adrenal Insufficiency in Cirrhotics With Ascites. Effects of Hydrocortisone on Renal and Haemodynamic Function
Official title: Adrenal Insufficiency in Cirrhotics With Ascites. Effects of Stress Doses of Hydrocortisone on Renal Function and on Liver and Systemic Haemodynamics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cirrhosis With Ascites
Keywords: Cirrhosis
Ascites
Adrenal insufficiency
Hepatorenal syndrome
Portal hypertension
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2008-04-14
Enrollment: 50
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: Relative adrenal insufficiency (RAI) is an well known condition in patients with septic shock. Liver failure (including chronic liver failure)and sepsis are both characterized by hyperdynamic circulatory failure (with low arterial pressure) and high levels of pro-inflammatory cytokines.

Hydrocortisone has been shown to have a beneficial effect on clinical outcome. The aim of this study is to evaluate the incidence of RAI in the different settings of ascites in cirrhosis and the usefulness of hydrocortisone in this context.


Eligibility criteria: Inclusion Criteria:

* Cirrhosis with ascites, with or without hepatorenal syndrome

Exclusion Criteria:

* Age \< 18 and \> 75 years
* Shock or bacterial infection present at the inclusion or during the previous week
* Bleeding present at the inclusion or during the previous week
* Multifocal HCC
* Organic renal failure
* Hearth or pulmonary failure

Primary outcomes:
measure: renal function
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Turin
country: Italy
facility: San Giovanni Battista Hospital
Study officials:
affiliation: Division of gastroenterology and hepatology
name: Carlo Alessandria, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00373906: Velcade in MALT Lymphoma Patients
Official title: Phase II Trial pf Bortezomib in Patients With Advanced or Relapsed Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT) Type
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: MALT Lymphoma
Keywords: MALT Lymphoma, Bortezomib
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2006-09-08
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Bortezomib for treatment of disseminated MALT lymphoma or at relapse following HP -eradication,or chemotherapy or radiation.

Detailed description: The objectives of this study are to evaluate the effectivity and the safety of bortezomib in patients with disseminated MALT lymphoma or at relapse following HP-eradication, or chemotherapy or radiation.

It is a phase II prospective single arm study with a target sample of 16 patients. 1.5mg/m2 Bortezomib is given intravenously on day 1,4,8,11 every three week, for a maximum of 8cycles.

Eligibility criteria: Inclusion Criteria:

* patients with histologically confirmed MALT lymphoma with measurable disease (stage I-IV)
* with first or greater relapse after HP-eradication, radiation or chemotherapy ,
* age \> 18 years
* must be able to tolerate therapy and have adequate cardiac, renal and hepatic function
* ECOG status of \<_ 2
* must be capable of understanding the purpose of the study and given written informed consent

Primary outcomes:
measure: to evaluate the clinical potential of bortezomib
measure: to induce objective/histologic responses in patients with MALT-Lymphoma
Secondary outcomes:
measure: to evaluate the impact of bortezomib on progression free survival
Other outcomes:
Locations:
Study officials:
affiliation: Department of Internal Medicine I
name: Markus Raderer, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Troch M, Jonak C, Mullauer L, Puspok A, Formanek M, Hauff W, Zielinski CC, Chott A, Raderer M. A phase II study of bortezomib in patients with MALT lymphoma. Haematologica. 2009 May;94(5):738-42. doi: 10.3324/haematol.2008.001537. Epub 2009 Mar 31.