louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03667872: Efficacy and Safety of DBS in Patients With Treatment-Resistant Depression
Official title: Efficacy and Safety of MRI Compatible and Long-term LFP Recordable Deep Brain Stimulation in Patients With Treatment-Resistant Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Treatment Resistant Depressive Disorder
Keywords: Deep Brain Stimulation
Habenula
Functional magnetic resonance imaging
Lead sponsor: Beijing Pins Medical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2018-09-12
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The habenula (Hb) is an ancient structure, located at the center of the dorsal diencephalic conduction system, a pathway involved in linking forebrain to midbrain regions. An increasing number of studies indicated that the lateral habeluna (LHb) is overactivity during depressive behaviors in rats, where it could drive the changes in midbrain monoamine neurotransmitter linked to depression. However, the efficiency and mechanism of deep brain stimulation (DBS) of the LHb and/or its major afferent bundle (i.e., stria medullaris thalami) could treat treatment-resistant major depression (TRD) is still unclear. This research will investigate the effectiveness and mechanism of bilateral MRI Compatible and Long-term LFP Recordable DBS to habenula and/or its major afferent bundle for treatment TRD patients.


Eligibility criteria: Inclusion Criteria:

* Age 18-70 years old;
* DSM-IV diagnosis of Major depression disorder of psychiatrists;
* More than 3 year's history of depression and failure to respond to a minimum of three different antidepressant treatments;
* Failure or intolerance or unwilling of an adequate course of electroconvulsive therapy (ECT) during any episode;
* HAMD-17≥20;
* GAF≤50；
* Capacity to provide informed consent (understanding of the study purpose and methods);

Exclusion Criteria:

* Obvious medical and psychiatric comorbidities;
* Alcohol or substance abuse/dependence within 12 months;
* Antisocial personality disorder, dementia, current tic disorder;
* Subject has a history of 2 or more suicide attempts \< 12 months prior to the screening testing;
* Pregnancy and/or lactation;
* There are contraindications for DBS surgery and chronic stimulation.

Primary outcomes:
measure: Change in the Hamilton Anxiety Scale
timeFrame: Baseline（preoperative）,3 months, 6 months, 12months
Secondary outcomes:
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Habenula DBS
state: Shenzhen
Study officials:
References:
Clinical trial NCT06860672: Clinical Trial of the Dual Vector Base Editor for the Treatment of the CHD3-R1025W Mutation
Official title: Safety, Tolerability and Preliminary Efficacy Study of a Single Intrathecal Injection of the Dual Vector AAV-CHD3-R1025W Base Editor for the Treatment of Developmental Disorders Caused by the R1025W Mutation in the CHD3 Gene
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Developmental Delay Disorder
Intellectual Disability
Rare Diseases
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 1
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the safety, tolerability and preliminary efficacy study of a single intrathecal injection of the dual vector AAV-CHD3-R1025W base editor for the treatment of developmental disorders caused by the R1025W mutation in the CHD3 gene


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Snijders Blok-Campeau syndrome
* Heterozygous mutation of c.3073C\>T, p.(Arg1025Trp) in the CHD3 gene
* Normal liver, heart and immune function
* Normal coagulation and platelet counts

Exclusion Criteria:

* Brain tumor or intracranial space-occupying lesion
* Contraindications to administration of lumbar puncture or sheath injection administration
* Persistent status epilepticus or recurrent epileptic control instability
* Presence of unstable systemic disease including active bacterial, fungal or HIV, hepatitis A, hepatitis B infection
* Serum anti-AAV neutralizing antibody titer \>1:50 (ELISA immunoassay)
* Treatment with immunological agents other than protocol-specified prophylaxis within 3 months
* Prior gene therapy
* Participation in another clinical trial, or treatment with another investigational product within 30 days or 5 half-lives
* Known allergy to any investigational product

Primary outcomes:
measure: Incidence of drug-related serious adverse events
timeFrame: 0-26 weeks
Secondary outcomes:
measure: Evaluate the changes using the Clinical Global impression Scale -Overall improvement (CGI-I)
timeFrame: 0-26 weeks
measure: Evaluate the changes in the Patient's Global Impressions of Improvement (PGI-I) scale
timeFrame: 0-26 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Yongguo Yu, Dr, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Jiao Tong University School of Medicine Songjiang Research Institute
name: Zilong Qiu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06765772: Combined Ultrasound Guided Bilateral Rectus Sheath and Erector Spinae Plain Blocks Versus Erector Spinae Plain Block for Intra and Postoperative Analgesia in Elective Abdominoplastic Surgeries. a Randomized Controlled Double Blinded Trial.
Official title: Combined Ultrasound Guided Bilateral Rectus Sheath and Erector Spinae Plain Blocks Versus Erector Spinae Plain Block for Intra and Postoperative Analgesia in Elective Abdominoplastic Surgeries. a Randomized Controlled Double Blinded Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Abdominoplasty
Perioperative Analgesia
Keywords: Rectus sheath block
Erector spinae plane block
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 2 groups A\&B In Group A: GA along with combined Rectus sheath and Erector spinae plane blocks. In Group B: General anesthesia along with Erector spinae plane block alone.
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this clinical trail is to determine if bilateral erector spinae plane block alone can provide good perioperative analgesia for abdominoplastic surgery patients or it is better to give combined bilateral rectus sheath and erector spinae plane blocks to achieve effective intraoperative and postoperative analgesia with minimal morphine consumption in such operations in which there is an extensive surgical dissection and a high risk of respiratory problems.

Detailed description: This study is randomized controlled trail in which 40 adult patients (male or female) scheduled for elective abdominoplastic surgeries during the study duration will be randomized into to equal groups to investigate the efficacy of erector spinae plane block alone versus the efficacy of combine use of erector spinae and rectus sheath plane block for intra and postoperative analgesia in abdominoplastic surgery patients.

Eligibility criteria: Inclusion Criteria:

* patients Age from 21 to 60 years ,Male and female patients ,ASA I, II patients scheduled for elective abdominoplastic surgeries during the study duration.

Exclusion Criteria:

* Patient refusal, Age less than 21 and above 60 years old, ASA III, IV patients., Infection at the site of injection, Opioid addiction, Allergy to any used substances (lidocaine, bupivacaine)., Preexisting severe or uncontrolled respiratory, renal or cardiac disease. , INR more than 1.5 and platelets less than 100000.

Primary outcomes:
measure: Primary outcome
timeFrame: one hour
Secondary outcomes:
measure: Secondary Outcome
timeFrame: first 24 hours postoperative
measure: Secondary Outcome
timeFrame: During opration
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university hospital
Study officials:
affiliation: Professor of anesthesia Cairo university faculty of medicine
name: Hassan Mohamed Ali, Phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT02688972: The Accumulative Effect of Cold Water Immersion in Football Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Athletic Performance
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
First posted: 2016-02-23
Enrollment: 27
Sex: MALE
Minimum age (years): 17
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Football is a sport with congested calendars, which requires muscle recovery strategies such as cold water immersion (CWI). This recovery technique is well spread through football clubs, although it lacks a profound physiologic investigation to understand its effects on athlete's body. Objectives: The main objective of this study is to evaluate the effect of a long-term CWI exposure in football athlete's.

Study Hypothesis:

H0: The application of Cold water immersion doesn't amend the biomarkers, electromyograph signal, power and perceived of recover when compared with control sample.

H1: The application of Cold water immersion amends the biomarkers, electromyograph signal, power and perceived of recover when compared with control sample.

Detailed description: In order to answer this question, the investigators performed a randomized clinical trial in 23 sub-20 football athletes. All subjects were randomly divided into two groups; a control group (10 minutes seated rest) and a CWI group (10 minutes in a 10 degree C) during seven days in a row. The investigators evaluated creatine kinase (CK) and lactate dehydrogenase (LDH) as molecular biomarkers for muscle damage. The blood samples were collected on the first, second, ninth and tenth days. Yet, the investigators assessed the peak of muscle activity and isometric strength of the knee flexors and extensors, potency of lower limbs, perceived exertion (PE) and total quality recovery perceived (TQRPer) in order to understand the treatment physiological effect on the subjects on the first and last day of experiments (before and after training).

Eligibility criteria: Inclusion Criteria:

* Healthy subjects
* Soccer players

Exclusion Criteria:

* Neurological, vascular or systemic muscle disease

Primary outcomes:
measure: Biochemical Markers: Creatine Kinase
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02800772: Impact of Intraduodenal Acetic Acid Infusion on Pancreatic Duct Cannulation During Endoscopic Retrograde Cholangiopancreatography: a Double-blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Duct Cannulation During Endoscopic Retrograde Choledochopancreatography
Keywords: pancreatic duct
ERCP
acetic acid
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 210
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: TREATMENT

Brief summary: Intraduodenal acetic acid can stimulate secretion of water and bicarbonate from pancreatic ductal cells. In this study, acetic acid spraying to duodenal bulb was compared with saline solution for the facilitation of pancreatic duct cannulation in patients.The primary outcome was successful deep pancreatic duct cannulation. The secondary outcomes were the appearance of the major and minor papillary orifice, pancreatic juice flow from the papilla, time to achieve deep pancreatic duct cannulation, and fluoroscopy time for deep pancreatic duct cannulation in the acetic acid group versus saline group.


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria were(1)those with intact native papilla (2)who underwent endoscopic retrograde choledochopancreatography for pancreatic duct, (3)age≥18 years，≦80years,and (4)agreement to participate in the study.

Exclusion Criteria:

* Exclusion criteria were (1) a previous sphincterotomy, (2) previous attempted or unsuccessful endoscopic retrograde choledochopancreatography with papillary manipulation, (3) indwelling biliary or pancreatic stent(s), (4) active acute pancreatitis, (5) altered/postsurgical anatomy, (6) history of gastroparesis, and (7) endoscopic retrograde choledochopancreatography for sphincter of Oddi (SO) manometry.

Primary outcomes:
measure: cannulation time for deep pancreatic duct cannulation
timeFrame: 2 days
measure: fluoroscopy time for deep pancreatic duct cannulation
timeFrame: 2 days
Secondary outcomes:
measure: pancreatic juice flow from the major papilla
timeFrame: 2 days
measure: appearance of the major papillary orifice
timeFrame: 2 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
References:
citation: Fang J, Wang SL, Zhao SB, Hu LH, Yao J, Shen Z, Gu L, Xia T, Cai Q, Li ZS, Bai Y. Impact of intraduodenal acetic acid infusion on pancreatic duct cannulation during endoscopic retrograde cholangiopancreatography: A double-blind, randomized controlled trial. J Gastroenterol Hepatol. 2018 Oct;33(10):1804-1810. doi: 10.1111/jgh.14148. Epub 2018 May 4.
Clinical trial NCT05763472: Breast Cancer After Ovarian Cancer During and/or After Therapy: Genomic Evaluation
Official title: Molecular Landscape Involved in the Onset of Breast Cancer in Patients With Germline BRCA-1/2 Mutations, During or After Therapy With Platinum-based Agents and/or PARP-inhibitors for Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: BRCA-Associated Breast Carcinoma
Keywords: BRCA1/2
Breast cancer
Ovarian cancer
Platinum salts
PARP inhibitors
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with germline BRCA-1/2 mutations and breast cancer, arising during and / or after treatment with platinum-based chemotherapy and / or with PARP-inhibitors for ovarian cancer

Brief summary: This study will investigate, in patients with germline BRCA-1/2 mutations and breast cancer, arising during and / or after treatment with platinum-based chemotherapy and / or with PARP-inhibitors for ovarian cancer, the presence of molecular alterations potentially involved in the mechanisms of resistance to antineoplastic treatment on breast and ovarian tumor tissue.


Eligibility criteria: Inclusion Criteria:

* Written informed consent.
* Age older than 18 years.
* Germline BRCA1/2 mutation.
* Histologically confirmed ovarian cancer treated with platinum-based chemotherapy and/or PARP inhibitors.
* Histologically confirmed breast cancer occurred during or after therapy with platinum-based agents and/or PARP-inhibitors for ovarian cancer.
* Availability of FFPE breast and ovarian tumor samples.

Exclusion Criteria:

* Other malignancies in the last 2 years.
* Prior chemotherapy or radiation therapy for other malignancies.

Primary outcomes:
measure: Breast somatic mutations
timeFrame: 15 months
Secondary outcomes:
measure: Ovarian somatic mutations
timeFrame: 15 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
state: RM
Study officials:
References:
Clinical trial NCT06453772: How to Predict Post-Surgical Bleeding and Hemoglobin in Liposuction?
Official title: Effect of Using a Mathematical Model Based on pre-and Post-surgical Hemoglobin Differences to Determine the Volume to Aspirate in Primary Body Liposuction.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bleeding
Surgery
Keywords: bleeding
abdominoplasty
Liposuction
Hemoglobin
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2024-06-12
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing the first-time liposuction procedure, operated in the Plastic and Reconstructive Surgery Service

Brief summary: To evaluate the effect of using a mathematical model developed through pre- and post-surgical hemoglobins to predict the volume to aspirate in patients undergoing primary body liposuction.

Detailed description: Postoperative anemia is a significant risk associated with liposuction, yet the scientific literature lacks detailed data on blood loss relative to the volume of fat removed. To address this, the investigators aimed to develop a mathematical formula predicting the decrease in postoperative hemoglobin (Hb post) based on preoperative hemoglobin (Hb pre), Body Mass Index (BMI), and the volume of fat suctioned. An observational, analytical, non-experimental, prospective study was conducted on liposuction patients to validate this predictive formula. Statistical analysis using Spearman's test showed that the results were statistically significant (P \< 0.05).

Eligibility criteria: Inclusion Criteria:

* Patients of indistinct gender, operated on at the Centro Médico Nacional de Occidente for primary liposuction.
* Age between 18 to 60 years old
* Liposuction technique used: Super wet or Tumescent.
* Surgical procedure on any area of the body
* Large volume liposuction (\> 5 L)
* Use of regional anesthesia

Exclusion Criteria:

* Presence of any of the following comorbidities: Systemic Arterial Hypertension or Diabetes Mellitus type 2.
* Performance of 2 or more procedures
* Use of medications (NSAIDs and/or coadjuvants that modify coagulation times).

Primary outcomes:
measure: Bleeding Predicting Method
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: National Western Speciality Hospital, Mexican Social Security Institute
state: Jalisco
city: Guadalajara
country: Mexico
facility: Western Medical Center, Mexican Institute of Social Security
state: Jalisco
Study officials:
References:
Clinical trial NCT05155072: Clinical Trial to Evaluate the Safety and Pharmacokinetic/Pharmacodynamic Characteristics of DW1903
Official title: A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic/Pharmacodynamic Characteristics After Oral Administration of DW1903, DW1903-R1 and DW1903-R2 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gastritis
Lead sponsor: Daewon Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-12-13
Enrollment: 31
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A Randomized, Open-label, Oral in healthy male volunteers


Eligibility criteria: Inclusion Criteria:

* Healthy Volunteers who are ≥19 years old
* BMI between 18 and 30 kg/m2
* Body weight ≥50kg

Exclusion Criteria:

•Clinically significant Medical History

Primary outcomes:
measure: pH monitoring
timeFrame: up to day 5
Secondary outcomes:
Other outcomes:
Locations:
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
Study officials:
References:
Clinical trial NCT00044746: Study Evaluating the Safety and Efficacy of Piperacillin/Tazobactam and Ampicillin/Sulbactam in Patients With Diabetic Foot Infections
Official title: An Open-label, Randomized Study Comparing the Efficacy and Safety of Piperacillin/Tazobactam and Ampicillin/Sulbactam Administered Intravenously in the Empirical Treatment of Foot Infections in Diabetic Inpatients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Diabetic Foot
Keywords: Diabetes
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2002-09-06
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: Phase IV Open-Label Foot Infection Study is being conducted to generate comparative Efficacy and Safety data in Diabetic Inpatients.


Eligibility criteria: Inclusion Criteria

* Patients with diabetes mellitus
* Inpatient
* Have 1 or more infected ulcer(s) below the ankle

Exclusion Criteria

* Must not have gangrene or severely impaired arterial supply in your foot
* Must not have a bone infection in the area of your ulcer
* Must not have allergies to penicillins

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02393846: Topical Ketoprofen Versus Placebo in Patients With Ankle Sprain
Official title: Comparison of Topical Dexketoprofen Versus Placebo in Patients Presented With Ankle Sprain to the Emergency Department: A Randomised Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ankle Sprain
Keywords: ankle sprain
topical ketoprofen
non-steroidal anti-inflammatory drug
emergency department
Lead sponsor: Akdeniz University
Sponsor class: OTHER
Collaborators: name: Pamukkale University
First posted: 2015-03-20
Enrollment: 100
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: The aim of this study is to analyse the effect of ketoprofen gel in patients presented with ankle sprain to the emergency department.

Detailed description: Patients, 18-65 years old, presented with ankle sprain are enrolled into the study. Pain over 24 hours, pain intensity lower than 40 mm, allergy to the study drug, drug alcohol abuse and pregnancy or breastfeeding are the exclusion criteria. The study interventions are 2 gr of 2.5% ketoprofen gel versus placebo applied to the sprain area. The study drugs are identical in colour, form and smelling. After an eligible patient presented to the ED, the drug number from an opaque bag is determined by a nurse and then another nurse applies the study drug to the patient. Physicians, nurses and patients are blinded to the study drug. Pain intensity of patients is measured by visual analogue scale at baseline, 15th and 30th minutes after the administration.

Eligibility criteria: Inclusion Criteria:

* Patient presented with ankle sprain to the emergency department.
* Patients between 18-65 years old.

Exclusion Criteria:

* Pain over 24 hours,
* Pain intensity lower than 40 mm,
* allergy to the study drug,
* drug alcohol abuse
* pregnancy or breastfeeding are the exclusion criteria.

Primary outcomes:
measure: Visual analogue scale
timeFrame: 30 minutes
Secondary outcomes:
measure: Adverse effects
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
affiliation: Pamukkale University
name: Mustafa Serinken, MD
role: STUDY_CHAIR
References: