louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05281081: Intraperitoneal Instillation of Levobupivacaine With Morphine Versus Levobupivacaine With Magnesium Sulfate for Postoperative Analgesia
Official title: Comparison of Intra-Peritoneal Instillation of Levobupivacaine With Morphine Hydrochloride Versus Levobupivacaine With Magnesium Sulfate for Post-Operative Pain Relief After Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post Operative Pain
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-03-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a prospective randomized study that included 60 patients and was divided into two equal groups of patients who were scheduled for LC, Ages 18 and 60 years, both sexes, ASA I-II and BMI 19 - 39. Group A received 30 ml levobupivacaine (0.25%) plus 3 mg morphine intraperitoneal at the site of surgery in the bed of the gallbladder via the navel port with the patient in a Trendelenburg position, Group B received 30 ml levobupivacaine (0.25%) plus 50 mg/kg magnesium sulfate in the same pattern as in the A group.


Eligibility criteria: Inclusion Criteria:

* Patients who were scheduled for L.C,
* Ages 18 and 60 years
* ASA I-II and
* BMI 19 - 39

Exclusion Criteria:

* Patients with hepatic or renal dysfunction
* use of opioids 24 hrs prior to the study
* treatment with steroids prior to surgery
* drug or alcohol abuse, allergy to any of the study drugs
* chronic pain syndrome as a result of neurological disease

Primary outcomes:
measure: reduction of postoperative pain
timeFrame: 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: ‪Khalid abdelal‬
Study officials:
References:
Clinical trial NCT02125981: The Study About the Efficacy of Oral Limaprost After Surgery for Cervical Myelopathy
Official title: A Prospective Randomized Double-blinded Clinical Trial About the Efficacy of Oral Limaprost Administration Following Surgery for Cervical Myelopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cervical Myelopathy
Keywords: limaprost alfadex
cervical myelopathy
surgery
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-04-29
Enrollment: 160
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The limaprost alfadex can improve the surgical outcomes in patients with cervical myelopathy.


Eligibility criteria: Inclusion Criteria:

* Older than 20 years old
* Compressive cervical myelopathy, confirmed by MRI, including C1-C2 instability, ossification of posterior longitudinal ligament
* Plan to undergo cervical surgery for myelopathy
* JOA score less than 15 points
* Signed informed consent of patient or legal guardian

Exclusion Criteria:

* Infection or malignancy
* Taking Limaprost before surgery
* Pregnancy or expected to be pregnant or breast feeding
* severe cardiovascular, pulmonary, renal disease or distress, brain pathology
* any related coagulopathy
* any drug to cause bleeding tendency
* severe pain from other disease
* any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study
* patient cannot follow study protocol, for any reason

Primary outcomes:
measure: Japanese Orthopedic Association (JOA) recovery rates
timeFrame: up to 12 months after operation
Secondary outcomes:
measure: Visual Analog Pain Scale for neck pain
timeFrame: up to 12 months after operation
measure: Neck disability index score
timeFrame: up to 12 months after operation
measure: Japanese orthopaedic association Cervical Myelopathy Evaluation Questionnaire score
timeFrame: up to 12 months after operation
measure: Questionnaire Short Form 12
timeFrame: up to 12 months after operation
measure: Japanese orthopaedic association score
timeFrame: up to 12 months after surgery
measure: assessment of the efficacy of positron emission tomography (PET)
timeFrame: up to 12 months after operation
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jin S. Yeom
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05450081: Association Between the Results of Specific Genetic Tests and the Efficacy of Targeted Therapies in Patients
Official title: Clinical Trials to Evaluate the Association Between the Results of Specific Genetic Tests and the Efficacy of Targeted Therapies in Patients With Non-small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Hunan Province Tumor Hospital
Sponsor class: OTHER
First posted: 2022-07-08
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with non-small cell lung cancer who have previously received single-agent K therapy

Brief summary: Our study aimed to evaluate the correlation between test reagent specific gene test results and the efficacy of relevant targeted drugs in patients with non-small cell lung cancer, and to support the continued registration of test reagents.


Eligibility criteria: Inclusion Criteria:

* 1)≥18，advanced non-small cell lung cancer confirmed by histopathology, and were previously or currently treated with gefitinib tablets (as the first-line treatment) or osimertinib (first-generation TKI resistance treatment) or crizotinib capsules monotherapy were evaluated for efficacy.
* 2) Able to provide FFPE samples with a storage life of 5 years: Large specimen 5 pieces in each case; 10 puncture specimens in each case

Exclusion Criteria:

* 1) Pathological evaluation of the tissue sample has too few tumor cells (total number of tumor cells \>20%);
* 2) Combination therapy with chemotherapy/radiotherapy/other targeted drugs/immunotherapy drugs;
* 3) Maintenance treatment when the disease does not progress after other anti-tumor treatments.

Primary outcomes:
measure: PFS
timeFrame: October 2022-December 2022
measure: ORR
timeFrame: October 2022-December 2022
measure: Consistency
timeFrame: October 2022-December 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Cancer hospital
state: Hunan
Study officials:
affiliation: Hunan Cancer Hospital
name: Yongchang Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06417281: Photodynamic Diagnosis for Malignant Brain Glioma With 5-Aminolevulinic Acid（5-ALA）
Official title: A Phase III Clinical Trial of Photodynamic Diagnosis for Malignant Brain Glioma With 5-Aminolevulinic Acid
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: 5-aminolevulinic Acid
Malignant Glioma of Brain
Lead sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-05-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This trial is an open-label, multicenter, phase III clinical study，conducted in patients with newly diagnosed or recurrent malignant high-grade (WHO grades 3\~4) glioma, to evaluate the efficacy and safety of a single oral dose of 5-aminolevulinic acid (5-ALA) oral solution powder for fluorescence-guided tumor resection and photodynamic diagnosis.


Eligibility criteria: Inclusion Criteria:

* Patient's written informed consent
* Age 18-75 years
* Radiological suspicion of a malignant glioma
* Indication for surgical tumour resection
* Karnofsky Performance Status (KPS) ≥ 70

Exclusion Criteria:

* Tumor located in the basal ganglia, thalamus, cerebellum, or brainstem
* Porphyria, hypersensitivity to porphyrins，history of cutaneous photosensitivity or photosensitive skin diseases；
* known hypersensitivity to the test drug ingredients
* Any other condition that, in the opinion of the investigator, makes participation in the trial inappropriate;

Primary outcomes:
measure: positive predictive rate of tissue fluorescence per biopsy sample taken from fluorescent sites
timeFrame: within 48 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University
Study officials:
References:
Clinical trial NCT05383781: Effect of Short Foot Exercise in Treatment of Patients With Patellofemoral Pain Syndrome
Official title: Effect of Adding Short Foot Exercise to Hip and Knee Focused Exercises in Treatment of Patients With Patellofemoral Pain Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patellofemoral Pain Syndrome
Keywords: Short foot exercise
Patellofemoral pain syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-05-20
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purposes of the study

To investigate the effect of adding Short foot exercise on patellofemoral pain syndrome on knee Pain, Function, Balance and abductors, quadriceps Muscle strength.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed as PFPS
* Pain elicited at least by two of the following four tests; (i) Isometric muscle contraction with slight bent knee,(ii) palpation of the patellofemoral joint line, (iii) patellar compression against the femoral bone (iv) active resisted knee extension.
* Psychological and mentally stable
* No previous knee surgery, except for diagnostic arthroscopy.
* No current knee pathologies (e.g. osteoarthritis)
* Navicular drop test more than 10 mm which indicated pronated foot

Exclusion Criteria:

- Subjects will be excluded if they don't meet the inclusion criteria.

Primary outcomes:
measure: assessment of knee pain
timeFrame: Change from baseline pain at 6th week
measure: assessment of knee function
timeFrame: Change from baseline function at 6th week
Secondary outcomes:
measure: Assessment of muscle strength
timeFrame: Change from baseline at 6th week
measure: Assessment of balance:
timeFrame: Change from baseline at 6th week
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Abdallah Ali
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01065610: Oxytocin Buffers Stress Response in Individuals With Impaired Coping Abilities
Official title: Oxytocin Buffers Cortisol Responses to Stress in Individuals With Impaired Coping Abilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coping Skills
Oxytocin
Stress
Lead sponsor: University of Osnabrueck
Sponsor class: OTHER
First posted: 2010-02-09
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes

Brief summary: This study investigated, if people with impaired coping abilities benefit from intranasal oxytocin application.


Eligibility criteria: Inclusion Criteria:

* male

Exclusion Criteria:

* psychological disorders
* drug abuse
* cigarette smoking
* coronary diseases
* nervous system diseases

Primary outcomes:
measure: Salivary Cortisol
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03244410: Lymphocyte Counts in Immune Thrombocytopenic Purpura
Official title: Initial Lymphocyte Counts Predictive Value in Immune Thrombocytopenic Purpura
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thrombocytopenic Purpura
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-08-09
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary immune Thrombocytopenic Purpura

Brief summary: * immune thrombocytopenic purpura is an acquired autoimmune disorder characterized by increased platelet destruction and decreased platelet number (cooper N et al 2006)
* recent studies have demonstrated that the pathogenesis of ITP envolves multifactorial autoimmune mechanisms of both humoral and cellular immunity and that acute and chronic forms may represent two distinct immunopathological disorders ( cooper N et al 2006) ( Gern Sheimer T 2009 )

Detailed description: Immune thrombocytopenic purpura is an acquired autoimmune disorder characterized by increased platelet destruction and decreased platelet number ( Cooper N et all 2006) platelet surface membrane proteins become antigenic for unknown reasons, leading to stimulation of the immune system, auto antibodies production and platelet destruction ( Gasbarrini A et all 2000) It is associated with the production of auto antibodies directed against platelet glycoprotein complex 2b/3a and/or 1b/1x , resulting in accelerated destruction of platelets by the reticular endothelial system via the activity of Fcc receptor bearing phagocytic cells ( Provan \& Newland et al 2002) Recent studies have demonstrated that the pathogenesis of ITP envolves multifactorial autoimmune mechanisms of both humoral and cellular immunity and that acute and chronic forms may represent two distinct immunopathological disorders ( Cooper N et al 2006) ( Gern Sheimer T 2009)

There are many phases of the disease:

1. Newly diagnosed ITP : for all cases at diagnosis.
2. persistent ITP: for patients with ITP between 3 to 12 months.
3. chronic ITP: for patients with ITP lasting more than one year ( blood journal 2009).

   * Although lymphocytopenia is a commonly reported feature of many chronic autoimmune disorders, differential white cell counts at presentation have seldom been evaluated as predictors for development of chronic ITP ( Deel MD et al 2013) (Ahmed et al 2010)

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed cases of primary ITP , adults and children.

Exclusion Criteria:

* Cases of secondary ITP

Primary outcomes:
measure: lymphocyte count in immune thrombocytopenic purpura
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00441610: An Extension Trial to a Phase I Dose Escalation Study of Gimatecan Administered Orally 5 Consecutive Days to Japanese Patients With Advanced Solid Tumor
Official title: An Extension Trial to a Phase I Dose Escalation Study of LBQ707 (Gimatecan) Administered Orally 5 Consecutive Days to Japanese Patients With Advanced Solid Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: Gimatecan
topoisomerase I inhibitor
advanced solid tumors
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-03-01
Enrollment: 4
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: CLBQ707A1101 assesses the tolerability, safety, efficacy and pharmacokinetics of gimatecan in Japanese patients.


Eligibility criteria: Inclusion criteria:

* Patients completing the core protocol (CLBQ707A1101, NCT00410358) exhibiting stable disease, or a partial or complete response as defined by the core protocol. If patients only have non-measurable lesions, he/she must not be exhibiting progressive disease

Exclusion criteria:

* Documented progressive disease as defined by the core protocol
* Patients with performance status of 3 or 4 on the ECOG scale

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Safety and tolerability assessed by Adverse Events
timeFrame: 2.8 years
measure: Anti-tumor activity assessed by RECIST criteria
timeFrame: 2.8 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chiba
country: Japan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT06746610: Screening and Molecular Diagnosis-based Individualized Precision Management of Monogenic Diabetes
Official title: Screening and Molecular Diagnosis-based Individualized Precision Management of Monogenic Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Monogenic Diabetes
Lead sponsor: Tianjin Medical University General Hospital
Sponsor class: OTHER
First posted: 2024-12-24
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The goal of this observational study is to establish a registry, screening, and individualized management platform for patients with monogenic diabetes mellitus(MDM) using internet-based and mobile application software. The main questions it aims to answer are:

* What are the genetic mutations causing MDM in China (genetic landscape)?
* How effective and safe is the individualized, molecular-diagnosis-based management platform for MDM in improving patient outcomes?

Participants will:

* Register in the MDM platform via mobile app or internet-based software
* Undergo genetic screening for MDM diagnosis
* Participate in follow-up visits for individualized management and monitoring of blood glucose control and outcomes


Eligibility criteria: Inclusion Criteria:

1. Diabetes patients who developed before 25 years old; Or they were diagnosed with diabetes before the age of 35, and two or more immediate relatives were diagnosed with diabetes before the age of 45;
2. Body mass index (BMI) at diagnosis \< 28 kg/m2;
3. Anti glutamic acid decarboxylase antibody (GAD Ab), anti islet cell antibody (ICA Ab), and anti insulin autoantibody (IAA Ab) were all negative;

Exclusion Criteria:

1. Secondary diabetes patients with other endocrine diseases, such as hyperthyroidism or hypothyroidism, hyperparathyroidism or hypothyroidism, acromegaly, Cushing's syndrome, autoimmune multiple endocrine diseases, etc.;
2. Systemic use of corticosteroids, immunosuppressants, and other drugs within the past 6 months;
3. Patients with malignant tumors.

Primary outcomes:
measure: Genetic landscape of monogenic diabetes mellitus in China
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
Study officials:
References:
Clinical trial NCT06614010: Effect of Different Administration Routes of Dexmedetomidine Combined with Ultrasound-Guided Fascia Iliaca Block on Emergence Agitation After Hip Replacement Surgery
Official title: Effect of Different Administration Routes of Dexmedetomidine Combined with Ultrasound-Guided Fascia Iliaca Block on Emergence Agitation After Hip Replacement Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Dexmedetomidine
Fascia Iliaca Block
Keywords: Fascia Iliaca Block
Dexmedetomidine
Emergence Agitation
Ropivacaine
Analgesic Mechanism
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2024-09-26
Enrollment: 207
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: To examine the impact of various administration routes of dexmedetomidine in conjunction with ultrasound-guided fascia iliaca block (FIB) on emergence agitation (EA) during the postoperative recovery period after hip replacement surgery.


Eligibility criteria: Inclusion Criteria:

1. age between 18 and 65 years, with no restriction on gender
2. diagnosis of hip joint disease necessitating hip arthroplasty
3. ASA grade I-II
4. no significant cardiopulmonary, hepatic, or renal dysfunction prior to the operation
5. no history of psychiatric disorders or long-term use of sedative medications prior to the operation
6. signing of an informed consent form to voluntarily participate in the study.

Exclusion Criteria:

1. patients allergic to or with contraindications to ropivacaine or dexmedetomidine
2. patients exhibiting symptoms of agitation or delirium prior to the procedure
3. patients with severe central or peripheral nervous system disorders
4. patients with coagulation disorders or receiving anticoagulant therapy
5. pregnant or breastfeeding women
6. patients who received other medications or treatments prior to the procedure that might affect the study results
7. patients unable to cooperate with the study or intolerant to ultrasound-guided iliofascial block

Primary outcomes:
measure: Incidence of awakening agitation
timeFrame: postoperative awakening period (1 min, 10 min, 20 min) and at the time of discharge from the PACU
Secondary outcomes:
measure: Analgesic effect
timeFrame: postoperative awakening period (1 min, 10 min, 20 min) and at the time of discharge from the PACU
measure: Ramesay score
timeFrame: postoperative awakening period (1 min, 10 min, 20 min) and at the time of discharge from the PACU
measure: Hemodynamic parameters
timeFrame: During operation
measure: Record of laryngeal mask removal time and adverse reactions
timeFrame: Within 24 hours after surgery
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qianfoshan Hospital
state: Shandong
Study officials:
References:
Clinical trial NCT04303910: An Analysis of Blood Management in Patients Having Hip or Knee Arthroplasty
Official title: An Analysis of Blood Management in Patients Having Hip or Knee Arthroplasty in Siriraj Hospital: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transfusion-dependent Anemia
Lead sponsor: Siriraj Hospital
Sponsor class: OTHER
First posted: 2020-03-11
Enrollment: 275
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients Having elective Hip or Knee Arthroplasty in Siriraj Hospital

Brief summary: The main objective of this study is to examine the transfusion rate and appropriateness in patients undergoing elective knee and hip replacement surgery at Siriraj Hospital

Detailed description: The main objective of this study is to examine the transfusion rate and appropriateness in patients undergoing elective knee and hip replacement surgery at Siriraj Hospita by reviewing data from previous medical records (retrospective chart review).

Eligibility criteria: Inclusion Criteria:

* Patients Having elective Hip or Knee Arthroplasty in Siriraj Hospital

Exclusion Criteria:

* none

Primary outcomes:
measure: Perioperative transfusion rate
timeFrame: 1 week
Secondary outcomes:
measure: Inappropriate transfusion rate
timeFrame: 1 week
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj hospital
Study officials:
affiliation: Siriraj Hospital
name: Mingkwan Wongyingsinn, MD
role: PRINCIPAL_INVESTIGATOR
References: