louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00608868: SELINE: Second-Line Iressa Phase IV Study in NSCLC Patients
Official title: A Phase IV, Multicenter, Non-randomized, Open-labeled Study to Evaluate the Efficacy of Gefitinib (IRESSA®) as a Second-line Therapy in NSCLC Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non Small Cell Lung Carcinoma
Keywords: Carcinoma
Non Small Cell Lung
EGFR mutation
Gefitinib
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-02-06
Enrollment: 156
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate ORR (Objective Response Rate) of gefitinib as a second-line therapy for NSCLC patients based on RECIST (Response Evaluation Criteria in Solid Tumors Group) and check up ORR difference by EGFR mutation, gender, smoking history, and type of tumor.


Eligibility criteria: Inclusion Criteria:

* Pathological Diagnosis of local advanced/metastatic Non Small Cell Lung Carcinoma
* Previously failed the first-line chemotherapy
* Patient who can provide sample for EGFR mutation test

Exclusion Criteria:

* Central Nervous System metastasis or spinal cord compression that has not yet been definitively treated with surgery and/or radiation
* Any evidence of clinically active interstitial lung disease

Primary outcomes:
measure: Objective Response Rate(ORR)
timeFrame: Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009)
Secondary outcomes:
measure: Period of Progression-Free Survival
timeFrame: Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009)
measure: Quality of Life and Symptom Improvement Based on Functional Assessment of Cancer Therapy-Lung (FACT-L)
timeFrame: Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009)
measure: Overall Survival
timeFrame: Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) and every 12 weeks after progression until death or death.
measure: Adverse Event
timeFrame: Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009)
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Research Site
Study officials:
References:
Clinical trial NCT00879268: Vasosol Organ Perfusion Solution and Medtronic Portable Bypass System
Official title: Phase 1 Study of Liver Machine Preservation With Vasosol Solution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Liver Transplantation
Organ Preservation
Keywords: Liver Transplantation
Organ Preservation
Liver Preservation
Machine Perfusion
Vasosol
Machine Preservation
Lead sponsor: Polyak, Maximilian
Sponsor class: INDIV
Collaborators: name: Health Resources and Services Administration (HRSA)
First posted: 2009-04-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a pilot trial of centrifugal machine preservation of donor livers for transplantation using a novel preservation solution.


Eligibility criteria: Inclusion Criteria:

* Primary/ Solitary Liver Transplant
* Lab MELD\<35
* Donor age \<65

Exclusion Criteria:

* Donor Liver \> 30% Macrosteatosis
* DCD donor liver
* Multi-organ Recipient
* Recipient in ICU
* Retransplant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Columbia University
name: James V. Guarrera, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02831868: Safety, Tolerability and Efficacy of HAVAI, for Correction of Inter-metatarsal Angle
Official title: Multi Center, Open-label, Single Arm, Study Designed to Evaluate Safety, Tolerability and Efficacy of HAVAI, a Minimally Invasive Implant Composed of Spring, Double Anchor and Suture, Versus Standard of Care 1st Metatarsal Osteotomy, for Correction of Inter-metatarsal Angle in Subjects Suffering From Hallux Valgus Deformity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hallux Valgus
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2016-07-13
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A non-inferiority study to demonstrate efficacy of the HAVAI minimally invasive device compared to standard of surgical care 1st metatarsal osteotomy (SSOC)


Eligibility criteria: Inclusion Criteria:

1. Adult males and female subjects, aged 20 to 75 years old, inclusive, at screening visit.
2. Subject weighing \<100 kg and body mass index (BMI) \<32 kg/m2.
3. Subjects with confirmed diagnosis of HV deformity based on radiography assessment of IMA 12°-15°.
4. Able and willing to comply with the requirements of the protocol.
5. Able to understand and sign written informed consent to participate in the study.

Exclusion Criteria:

1. Patients who need or may need to have 2nd MT osteotomy as part of their index surgery (e.g. instability or subluxation of 2nd MTPJ)
2. History of:

   a. Severe Diabetes mellitus (defined as existence of: i. More than 10 years duration ii. HbA1C 8.0 \< iii. any known complications of diabetes (PVD, Nephropathy \[CR\>1.3\], retinopathy, IHD)) b. Claudication, known peripheral vascular disease or no palpable pulses (DP or TP).

   c. Known rheumatoid or inflammatory disease. d. X-ray evidence of moderate osteoarthritis of MTPJ-1 or TMTJ-1. e. neurological conditions associated with spasticity or lower limb paralysis. f. Prior operation on MT1 or MT2. g. Fracture (past or present) of MT1 or MT2.
3. Aseptic necrosis or any deformity of MT2 head.
4. Aseptic necrosis of the MT1 head
5. Pregnant women or women with childbearing potential who are not obliged to take any contraception measures
6. Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s)
7. ASA grade above 2

Primary outcomes:
measure: A change in IMA angle
timeFrame: 50 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Hospital
city: Jerusalem
country: Israel
facility: Bonfix Ltd
Study officials:
affiliation: Rabin MC
name: Eyal Heller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04350268: Adult Social Interaction
Official title: Exploratory Study of Wireless, Wearable Sensors at Assessing Social Interaction in Healthy Adults
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Adults
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy normal adults

Brief summary: This study will collect vocalization data from healthy adults during regular daily activity.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years old
* Subjects willing and able to comply with requirements of the protocol
* Healthy

Exclusion Criteria:

* Age \<18 years old
* Subjects unwilling and able to comply with requirements of the protocol
* History of skin allergy to medical adhesive tape
* Non-English speaking subjects

Primary outcomes:
measure: Speech detection
timeFrame: 2 years
measure: Administration UCLA Loneliness scale.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Evanston
country: United States
facility: Northwestern University Feinberg School of Medicine, Department of Dermatology
state: Illinois
Study officials:
References:
Clinical trial NCT01366768: Gut Hormones After Oral Versus Intravenous Amino Acids
Official title: Release of Gut Hormones After Oral Versus Intravenous Amino Acids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Normal Non-fluency
Keywords: Gut hormones
Insulin secretion
Normal physiology
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2011-06-06
Enrollment: 12
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The study hypothesis is that gut hormones are released after oral but not intravenous amino acids which result in stimulation of insulin secretion.

Detailed description: Amino acid mixture is given orally or intravenously to match total concentrations of amino acids in healthy subjects. Samples are taken regularly for 300 min after administrations. Plasma levels of the gut hormones glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1)and determined and related to plasma levels of insulin and glucagon.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects

Exclusion Criteria:

* Diabetes
* Liver disease
* Kidney disease
* Thyroid disease

Primary outcomes:
measure: Gut hormone secretion
timeFrame: 300 min
Secondary outcomes:
measure: Insulin secretion
timeFrame: 300 min
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Department of Clinical Sciences Lund, Lund University
Study officials:
affiliation: Lund University
name: Bo Ahrén, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03549468: The Effect of Low LEVel TrAgus STimulation on the Electrophysiological Substrate of Patients With Ischemic CardioMyopathy Substrate of Subjects With Ischemic CardioMyopathy
Official title: The Effect of Low LEVel TrAgus STimulation on the Electrophysiological Substrate of Patients With Ischemic CardioMyopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Cardiomyopathy
Keywords: ischemic cardiomyopathy; neuromodulation; repolarization alternans
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
First posted: 2018-06-08
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with ischemic cardiomyopathy (left ventricular ejection fraction \<35%) and heart failure who already have an implantable device with an atrial lead (dual chamber defibrillator or biventricular defibrillator) will undergo sequentially 1. Sham low level tragus stimulation (LLTS) (5min), 2. Active LLTS at 5Hz (15min) and 20Hz (15min) and 3. Active LLTS group with atrial pacing at 100bpm at 5Hz (15min) and 20Hz (15min). The latter is required to examine the effect of LLTS on RA independent of heart rate. Repolarization alternans will be measured by analyzing a regular 12-lead ECG using a custom-made software.


Eligibility criteria: Inclusion Criteria:

1. Ischemic cardiomyopathy (LVEF \<35%) and heart failure
2. Implantable device with an atrial lead (dual chamber ICD or CRT-D)
3. Sinus rhythm at the time of the study

Exclusion Criteria:

1. Recent (\<6 months) stroke or myocardial infarction
2. Persistent atrial fibrillation
3. Recurrent vaso-vagal syncopal episodes
4. Unilateral or bilateral vagotomy
5. Pregnancy or breast feeding
6. Uncontrolled diabetes or hypertension
7. Sick sinus syndrome and 2nd or 3rd degree AV block (without a pacemaker)
8. Bifascicular block or prolonged first degree block
9. Hypotension due to autonomic dysfunction
10. Inability or unwillingness to understand and/or sign informed consent

Primary outcomes:
measure: Repolarization alternans, an ECG measure for susceptibility to VT/VF
timeFrame: during acute stimulation procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
References:
Clinical trial NCT03650868: The Effect of Thoracal Paravertebral Block on Seroma Reduction in Breast Surgery
Official title: The Effect of Thoracal Paravertebral Block on Seroma Reduction in Breast Surgery, a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Seroma
Breast Cancer
Keywords: Thoracal Paravertebral Block
Breast Surgery
Seroma Reduction
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Thoracal paravertebral block (TPVB) is a commonly prefferred regional anesthesia technique to provide postoperative analgesia. In addition, the successful use of TPVB is reported for some seroma related pain cases. Postoperative analgesia in breast surgery is a difficult and overworked issue due to etensive surgery and complex innervation of the breast and in addition to this complex mechanisms, seroma accumulation has a negative effect for patients postoperatively. With this study, the investigators aimed to study the effect of TPVB on seroma reduction for breast cancer surgery.


Eligibility criteria: Inclusion Criteria:

* 18-70 years of agge
* ASA I-II
* Undergoing elective breast cancer surgery

Exclusion Criteria:

* obesity (body mass index \>35 kg/m2)
* infection of the skin at the site of needle puncture area
* patients with known allergies to any of the study drugs
* coagulopathy

Primary outcomes:
measure: Seroma quantitiy
timeFrame: 24 hour postoperatively.
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University
Study officials:
affiliation: Kocaeli Üniversitesi Tıp Fakültesi
name: Alparslan Kus
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01278368: Effect Of Preoperative Chemotherapy On Short-Term Outcome After Pancreatic Resection
Official title: PREOPERATIVE CHEMOTHERAPY DOES NOT ADVERSELY AFFECT SHORT-TERM OUTCOME AFTER PANCREATIC RESECTION.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Locally Advanced Pancreatic Adenocarcinoma
Keywords: pancreatic cancer, neoadjuvant chemotherapy
Lead sponsor: Università Vita-Salute San Raffaele
Sponsor class: OTHER
First posted: 2011-01-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: No comparative trial investigating the effect of preoperative chemotherapy for locally advanced pancreatic cancer on short-term postoperative outcome has been published so far. The aim of the present study is to assess the potential impact of preoperative chemotherapy on short-term postoperative outcome after pancreatic resection in a case-matched series of cancer patients.

Detailed description: Between 2003 and 2011, patients with locally advanced (stage III) pancreatic cancer who were treated with preoperative chemotherapy (PCHT) underwent surgical resection. Each patient was matched with the closest two patients with pancreatic cancer ( control group ) selected from our prospective electronic database who met the following match criteria: age (+/- 3 years), gender, ASA score, type of resection, pancreatic duct diameter (+/- 1 mm), and tumour size (+/- 5 mm).

Eligibility criteria: Inclusion Criteria:

* Diagnosis of pancreatic cancer
* Preoperative chemotherapy
* Pancreatic resection

Exclusion Criteria:

* Metastatic disease
* ASA score 4

Primary outcomes:
measure: Postoperative morbidity rate
timeFrame: Postoperative. From 0 to 30 days after discharge
Secondary outcomes:
measure: Postoperative mortality
timeFrame: Postoperative. From 0 to 30 days after discharge
measure: Length of hospital stay (LOS)
timeFrame: Postoperative. From 0 to 30 days after discharge
Other outcomes:
Locations:
city: Milan
country: Italy
facility: San Raffaele Hospital
Study officials:
affiliation: Università Vita-Salute San Raffaele
name: Marco Braga, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05950568: Quadratus Lumborum Block Type III Versus Type II Versus Transversus Abdominis Plane Block in Cesarean Section
Official title: Efficacy of Quadratus Lumborum Block Type III Versus Type II Versus Transversus Abdominis Plane Block in Cesarean Section: A Randomized Controlled Multicenter Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Quadratus Lumborum Block
Transversus Abdominis Plane Block
Lead sponsor: The General Authority for Teaching Hospitals and Institutes
Sponsor class: NETWORK
First posted: 2023-07-18
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Compare the type III and type II quadratus lumborum block (QLB) to transversus abdominis plane block (TAPB) regarding efficacy in CS

Detailed description: The transversus abdominis plane block (TAPB) is administered between the internal oblique muscle and the transversus abdominis muscle in the fascial plane, directly pointing to the somatic nerves T6-L1 that run in this plane. In addition, meta-analyses demonstrate that it is an effective analgesic for somatic pain and diminishes opiate intake. It has been reported that TAPB is an efficient analgesic approach following cesarean section .

The quadratus lumborum (QL) muscle block (QLB) is a fascial plane block as local anesthetic (LA) is introduced nearby to the QL muscle to numb the thoracolumbar nerves. QLB is categorized into four types according to drug administration location, I (lateral), II (posterior), III (anterior/transmuscular), and Intravenous, (intramuscular). QLB can effectively decrease both visceral and somatic pain by LA distribution to the thoracic paravertebral space (TPVS), as this block ensures effective pain control from the T7 to L1 dermatomes. QLB is one of the regional techniques that provides the greatest benefit in post-CS pain control, as it is progressively applied in obstetric anesthetic precise to improve analgesic results.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status II
* aged 18 to 40 years old
* presenting for elective Cesarean section

Exclusion Criteria:

* body mass index (BMI) ≥40 kg/m2
* weight \< 50kg
* height \< 150 cm
* contraindications for the use of active labor, spinal anesthesia
* recent opiate intake
* hypersensitivity to any used medication
* substantial cardiovascular diseases
* renal diseases
* hepatic, diseases.

Primary outcomes:
measure: Total postoperative consumed pethidine
timeFrame: 24 hour postoperatively
Secondary outcomes:
measure: Time of the first analgesic request
timeFrame: 24 hour postoperatively
measure: Patient satisfaction
timeFrame: 24 hour postoperatively
measure: The degree of postoperative pain
timeFrame: 24 hour postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: The General Authority for Teaching Hospitals and Institutes
Study officials:
References:
Clinical trial NCT02905968: Transanual Tube Placement in Low Anterior Resection (LAR) for Rectal Cancer
Official title: The Safety and Effect of Transanual Tube Placement in Low Anterior Resection (LAR) for Rectal Cancer to Prevent Anastomotic Leak: Randomized Control Trial Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Rectal Cancer
Keywords: Anastomotic leak
Low rectal cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2016-09-19
Enrollment: 520
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 purpose of this study is to evaluate the effectiveness of transanual tube placement in low anterior resection (LAR) for rectal cancer in preventing anastomotic leakage.

Detailed description: Transanual tube placement after anastomosis in low anterior resection for rectal cancer.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 and ≤ 75 years;
2. Primary tumor has undergone histologically confirmed rectal adenocarcinoma; Low rectal cancer was defined by the presence of the inferior pole of the tumor below the peritoneal reflection (in 11 cm from the anal margin).
3. Together with clinical or radiological evidence of Stage II (T3-4, N0, M0) or Stage III (T1-4, N1-2, M0) disease (according to the 2010 revision of the International Union Against Cancer primary tumor, regional nodes, metastasis (TNM) staging system).
4. Performance status (ECOG) 0\~1
5. Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; hemoglobin (Hb) ≥9g/dl (within 1 week prior to randomization)
6. Adequate hepatic and renal function: Serum bilirubin≤1.5 x upper limit of normal (ULN), alkaline phosphatase ≤5x ULN, and serum transaminase (either primary tumor, regional nodes, metastasis (AST) or ALT) ≤ 5 x ULN(within 1 week prior to randomization);
7. Written informed consent for participation in the trial.

Exclusion Criteria:

1. Body mass index (BMI) more than 30 kg/m2.
2. Serious pre-operative comorbidity, including cardiovascular disease (coronary arteriosclerosis, arrhythmia, heart failure), pulmonary dysfunction (lung emphysema, obstructive lung disease), liver insufficiency (Child-Pugh B or C), renal insufficiency (serum creatinine \>2.0 mg/dl), and arterial circulation disturbance (occlusion of arterial vessels of limb in patient's history.
3. History of accepting abdominal surgery.

Primary outcomes:
measure: anastomotic leak rate
timeFrame: 30 days post operatively
Secondary outcomes:
measure: Time Frame: Reoperation rate after anastomotic leak
timeFrame: 30 days post operatively
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of General Surgery, Zhongshan Hospital, Fudan University
Study officials:
affiliation: Fudan University
name: Tuo Yi, MD
role: PRINCIPAL_INVESTIGATOR
References: