louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03388671: Laparoscopic Guided Transversus Abdominis Plane Block for Postoperative Analgesia After Pediatric Laparoscopic Surgery.
Official title: Laparoscopic Guided Transversus Abdominis Plane Block for Postoperative Analgesia After Pediatric Laparoscopic Surgery.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Analgesia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-01-03
Enrollment: 44
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The aim of this study will be to investigate the safety and analgesic efficacy of Transversus Abdominis Plane (TAB) Block versus psoas blocks. Both blocks will be administered surgically and guided by the laparoscopy screen in children undergoing laparoscopic surgery.
Primary purpose: TREATMENT

Brief summary: The aim of this study will be to investigate the safety and analgesic efficacy of Transversus Abdominis Plane (TAB) Block versus psoas block blockade. Both blocks will be administered surgically and guided by the laparoscopy screen in children undergoing laparoscopic surgery.

Detailed description: Transversus abdominis plane (TAP) block is a promising effective method for postoperative pain control after major abdominal surgery. TAP block provides analgesia by inhibiting nerve conduction from the anterior abdominal wall arising from the intercostal nerves, subcostal nerves, and first lumbar nerve (T6-L1). Using a landmark technique, it is easily performed, but its popularity has decreased because of reduced efficacy due to inaccurate injection and the potential for intra-peritoneal organ damage. Ultrasound-guided TAP block provides better results and fewer complications, but it requires experienced operators. Surgically administered TAP (sTAP) block guided by the video camera of the laparoscope is a simple technique and may cause no complications. Also, under laparoscopic guidance, block of ilioinguinal, iliohypogastric, and genitofemoral nerves can be possible with anesthetic injection in the plane between psoas major and the fasciae covering its anterior aspects \[laparoscopic-assisted psoas (LAP) blockade\].

Eligibility criteria: Inclusion Criteria:

* Children (1-6 years) of both sexes undergoing elective laparoscopic surgeries that last \>30minutes (eg. undescended testis and inguinal hernia repair).
* Written consent, free and informed

Exclusion Criteria:

* Significant respiratory, cardiac or renal disease
* BMI \>95th percentile for age.

Primary outcomes:
measure: FLACC PAIN score
timeFrame: 36hours
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Pediatric hospital, faculty of medicine, Assiut university
state: Assiut Governorate
Study officials:
affiliation: Professor in anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt.
name: Hala S Abdelghaffar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01754571: CBT in Patients With Medication Overuse Headache
Official title: Cognitive Behavior Therapy in Patients With Medication Overuse
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Medication Overuse Headache
Keywords: medication overuse headache
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2012-12-21
Enrollment: 60
Sex: ALL
Minimum age (years): 20
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: According to the definition from International Headache Society, medication overuse headache (MOH) is diagnosed when patients takes painkillers for more than 10 or 15 days per month (depending on what kind of painkillers being used), for more than 3 months, which results in the deterioration of headache. The treatments of MOH include preventive medication of headache and withdrawal of the overused painkillers. Other than the simple oral advice, some researchers recommended non-pharmacological methods. Pryse-Phillips et al. (1998) reviewed the the treatment of migraine and suggested that biofeedback, relaxation, cognitive behavior therapy (CBT), psychological therapy, hypnosis and physical treatment are effective. Researches also point out CBT is effective on withdrawing medication in patients with MOH (Kroner-Herwig, 2009). Lake (2006) reported that behavioural therapy maybe an adjunct therapy to preventive medication to reduce the relapse rate of medication overuse.

The purpose of this study is to confirm the effect of CBT in patients with MOH. The target is to reduce the frequency of headache and use of painkillers. Patients could benefit from the education and relaxation training during CBT to cope with headache and reduce the use of painkillers.

The research will recruit 60 patients with MOH at Neurology Clinics, Far Eastern Memorial Hospital. They will be separated into two groups, 30 in control group and the other 30 in the experimental group. Education of MOH, relaxation and cognitive restructuring would be included in the four weeks training program. The training program is under the supervision of a neurologist from Far Eastern Memorial Hospital and a psychology professor from Fu Jen Catholic University. The control group will accept four weeks telephone interview to confirm their headache diary including the frequency of headache and use of painkillers. The frequency of headache and medication use will be used for analyzing the effect of CBT.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Medication overuse headache

Exclusion Criteria:

* other type headache

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
References:
Clinical trial NCT05966571: Ovarian Innervation Study in Patients With Polycystic Ovary Syndrome (PCOS)
Official title: Ovarian Innervation Study in Patients With Polycystic Ovary Syndrome (PCOS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Albanian University
Sponsor class: OTHER
First posted: 2023-07-28
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: PCOS Patients who meet the inclusion criteria will undergo a detailed medical history, physical examination, and laboratory investigations including hormonal evaluation as necessary (testosterone, sex hormone-binding globulin, luteinizing hormone, follicle-stimulating hormone, prolactin, thyroid-stimulating hormone, and cortisol).

Brief summary: Polycystic Ovary Syndrome (PCOS) is a complex endocrine disorder characterized by hyperandrogenism, insulin resistance, and ovulatory dysfunction. One of the diagnostic criteria for PCOS is the presence of polycystic ovaries, which are enlarged ovaries with multiple follicles on ultrasound. However, the mechanisms that lead to the development of polycystic ovaries in PCOS are not completely understood. One potential area of investigation is the role of ovarian innervation in the pathophysiology of PCOS. Therefore, the aim of this study is to evaluate the ovarian innervation in PCOS patients through ovarian biopsy sampling.

Detailed description: This is a cross-sectional study that will involve the recruitment of patients diagnosed with PCOS. The study will be conducted at a tertiary care center Koco Gliozheni Maternity, Faculty of Medicine of Tirana, Department of Obstetrics and Gynecology with expertise in gynecology and endocrinology and will then be examined with the aid of the department of Biology and Physiology of the University of Perugia. The study protocol will be approved by the institutional ethics committee, and written informed consent will be obtained from all participants.

Eligibility criteria: Inclusion criteria:

* Diagnosis of PCOS based on the Rotterdam criteria,
* No use of hormonal contraception or medications for at least 3 months prior to the study,
* No history of ovarian cancer.

Exclusion Criteria:

* History of pelvic inflammatory disease or other pelvic infections,
* Use of medications that may affect ovarian function or innervation, such as antipsychotics or antidepressants
* Presence of ovarian cysts \> 5 cm on ultrasound

Primary outcomes:
measure: Quantify nerve fibers
timeFrame: day 0
measure: Identifying nerual markers
timeFrame: day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Tirana
country: Albania
facility: University of medicine of Tirana
Study officials:
affiliation: University of Medicine
name: Elko Gliozheni, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00093171: Study Evaluating rFIX; BeneFIX® in Hemophilia B
Official title: An Open-label Safety and Efficacy Study of Recombinant Human Factor IX (rFIX; BeneFIX®) in Previously Treated Patients (PTPs) With Hemophilia B (FIX:C ≤2%)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hemophilia B
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2004-10-07
Enrollment: 23
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The primary objective of this clinical research study is to assess the safety and efficacy of rFIX for a minimum of 6 months in previously treated patients (PTPs) with hemophilia B (FIX:C ≤2%) during standard-of-care treatment (on-demand, prophylaxis, and through major and minor surgical procedures).


Eligibility criteria: Inclusion Criteria:

* Hemophilia B (FIX:C less than 2%)
* Previous treatment of at least 150 exposure days using any FIX product
* 12 years of age and older

Exclusion Criteria:

* The patient has a currently detectable factor IX inhibitor or a history of inhibitors. (A family history of inhibitors will not exclude the patient)
* Known hypersensitivity to protein pharmaceuticals or agents related to the test article, e.g. hamster proteins
* Patient has a genetic coagulation disorder other than hemophilia B

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Detroit
country: United States
state: Michigan
city: New Brunswick
country: United States
state: New Jersey
city: Chapel Hill
country: United States
state: North Carolina
city: Dayton
country: United States
state: Ohio
city: Houston
country: United States
state: Texas
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor, MD
role: STUDY_DIRECTOR
References:
citation: Rendo P, Smith L, Lee HY, Shafer F. Nonacog alfa: an analysis of safety data from six prospective clinical studies in different patient populations with haemophilia B treated with different therapeutic modalities. Blood Coagul Fibrinolysis. 2015 Dec;26(8):912-8. doi: 10.1097/MBC.0000000000000359.
Clinical trial NCT02860871: Use of Infrared Spectroscopy in Septic Arthritis Diagnosis
Official title: Use of Infrared Spectroscopy in Septic Arthritis Diagnosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Joint Effusion
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2016-08-09
Enrollment: 611
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients benefiting from joint fluid puncture for diagnostic purposes in the rheumatology hospitals participating in the study

Brief summary: The main objective of this study is to assess the ability of Fiber-optic Evanescent Wave Spectroscopy (FEWS) to discriminate synovial fluids samples of septic arthritis patients from other causes of joint effusion by analyzing ex vivo joint fluid samples collected during routine clinical care.


Eligibility criteria: Inclusion Criteria:

* patients benefiting from joint fluid puncture for diagnostic purposes in the rheumatology hospitals participating in the study
* patients over 18 year old,
* patients who received information about the protocol and have not expressed opposition to participate.

Exclusion Criteria:

* patients opposing the study,
* patients aged below 18 year old
* Protected major (safeguard justice , trusteeship and guardianship) and persons deprived of liberty

Primary outcomes:
measure: Diagnosis of the cause of joint effusion
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU de RENNES
Study officials:
References:
citation: Albert JD, Le Corvec M, Berthoud O, David C, Guennoc X, Hoppe E, Jousse-Joulin S, Le Goff B, Tariel H, Sire O, Jolivet-Gougeon A, Coiffier G, Loreal O. Ruling out septic arthritis risk in a few minutes using mid-infrared spectroscopy in synovial fluids. Rheumatology (Oxford). 2021 Mar 2;60(3):1158-1165. doi: 10.1093/rheumatology/keaa373.
Clinical trial NCT02625571: Tx for Child Sexual Behavior Problems
Official title: Development and Pilot Testing of a Treatment for Children With Sexual Behavior Problems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Behavior
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2015-12-09
Enrollment: 13
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A significant minority of children (ages 5-12) display problematic sexual behavior and the persistence of this behavior is oftentimes as stable as other child behavior problems, such as aggression and defiance. Unfortunately, the only tested intervention protocols for these concerns utilize a group treatment modality that is not feasible in most community treatment settings. This project will define and pilot test an intervention for child sexual behavior problems that is applicable in most settings and can be easily disseminated as a first step toward validation in larger clinical trials.


Eligibility criteria: Inclusion Criteria:

* A caregiver is willing to participate in treatment
* A clinically significant T-score on the Child Sexual Behavior Inventory
* Child is between the ages of 5 and 12, inclusive

Exclusion Criteria:

* Child and/or caregiver IQ below 70
* Active child and/or caregiver psychosis or suicidal/homicidal ideation
* Active substance use problems of the caregiver

Primary outcomes:
measure: Child Sexual Behavior on the Child Sexual Behavior Inventory (CSBI)
timeFrame: 4-6 months
Secondary outcomes:
measure: Child Sexual Concerns on the Trauma Symptom Checklist for Young Children (TSCYC)
timeFrame: 4-6 months
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01208571: The Effect of a Interdisciplinary Alcohol Cessation Intervention
Official title: The Effect of an Interdisciplinary "Booster" Session in Primary Care Following Brief Intervention in Hospitals - a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alcohol Use Disorders
Keywords: Harmful use
Hazardous use
Dependence
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
First posted: 2010-09-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The effect of alcohol interventions seems to be related to the intensity of the interventions. In this study the investigators will assess the effect of a interdisciplinary "booster session" in primary care, given to patients who were admitted to hospitals with alcohol related conditions, and who were given Brief Intervention before discharge. The booster session is based on a motivational interview.

Detailed description: The study is a randomized clinical trial, and aims to recruit 60 X 2 patients. Patients admitted to Stavanger University Hospital with an alcohol contributed condition, and who has been given a brief alcohol intervention may be recruited. Candidates for secondary healthcare related to alcohol misuse will be excluded. The interdisciplinary "booster" session will be given two weeks after discharge, and will be given in the facility of the primary care physician, facilitated by both the physician and an liaison alcohol nurse from Stavanger University Hospital. The intervention is based on motivational interview technique. The primary outcome will be assessed using the Alcohol Use Disorder Identification Test-C, six months after discharge. The outcome assessor will be blinded for the intervention. All outcomes will be collected by telephone interview.

The study aims to start recruiting candidates in October-November 2010, and will stoop recruiting in December 2012 at the latest.

The study was approved by the national ethical comite in August 2011. The results of the study wil be published in international referee based journals.

Eligibility criteria: Inclusion Criteria:

* Admission with an alcohol related disorder

Exclusion Criteria:

* Lack of ability to give informed consent

Primary outcomes:
measure: Alcohol Use Disorder Identification -C (AUDIT-C)
timeFrame: 6 months
Secondary outcomes:
measure: Timeline followback
timeFrame: 6 months
measure: Readmissions
timeFrame: 6 months
measure: Readiness to Change Questionaire (RTCQ)
timeFrame: 6 months
measure: Quality of Life
timeFrame: 6 months
Other outcomes:
Locations:
city: Stavanger
country: Norway
facility: Stavanger University Hospital
Study officials:
affiliation: Helse Stavanger HF
name: Kristian Oppedal, MD
role: STUDY_CHAIR
affiliation: Helse Stavanger HF
name: Sverre Nesvaag, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT06201871: Effect of Alcohol Consumption on the Success Rates
Official title: Effect of Alcohol Consumption on the Success Rates of Local Anesthesia in Patients With Symptomatic Irreversible Pulpitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulpitis - Irreversible
Lead sponsor: Jamia Millia Islamia
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This prospective, randomized, double-blind clinical trial will be carried out Conservative Dentistry, Faculty of Dentistry, Jamia Millia Islamia. Seventy adult patients (35 alcoholic and 35 non-alcoholics) with symptomatic irreversible pulpits in a mandibular first or second molar will receive an IANB with 2% lidocaine. In case of pain during treatment, the procedure will be stopped, and the patients will be asked to rate the pain on the Heft-Parker scale. The injection shall be considered as successful if the patient reports pain scores less than 55 on the HP scale.


Eligibility criteria: Inclusion Criteria:

* Symptomatic carious exposed mandibular first or second molars.
* Alcoholic patients: Patient with low-moderate drinking levels according to the US National Institute on Alcohol Abuse and Alcoholism
* Control patients: No history of alcohol consumption
* Positive and prolonged response to thermal sensitivity tests and electric pulp test.
* Vital coronal pulp on access cavity preparation.
* American Society of Anesthesiologists class I or II medical history.
* Ability to understand the use of pain scales.

Exclusion Criteria:

* Active pain in more than 1 teeth
* Teeth with fused roots.
* Radiographic evidence of an extra root.
* Large restorations with overhanging margins.
* Full crowns or deep periodontal pockets.
* Hypertension or cardiovascular diseases, compromised immunity, active infection or inflammation
* Known allergy or contraindications to any content of the local anesthetic solution or non-steroidal anti-inflammatory drugs (NSAIDs)
* History of known or suspected drug abuse.
* Taking any drugs which could affect the pain perception, e.g, opioids, antidepressants, anticonvulsants, muscle relaxants, anxiolytics, sedatives, nsaids. 23
* Pregnant or breastfeeding patients.
* Patients with asthma, gastric ulcers, bleeding disorders.

Primary outcomes:
measure: Anesthetic success
timeFrame: 15 minutes following the injection
Secondary outcomes:
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Faculty of Dentistry, Jamia MIliia Islamia
Study officials:
References:
Clinical trial NCT02261571: Impact on Quality of Life by Moxibustion in Chemotherapy for Cancer
Official title: A Pilot Study to Estimate the Efficacy of Moxibustion Stimulation at Abdominal Acupoints on Quality of Life in Cancer Patients Under Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Lead sponsor: The Comprehensive and Integrative Medicine Institute of South Korea
Sponsor class: OTHER
First posted: 2014-10-10
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Most cancer patients experience multiple symptoms related to chemotherapy and use CAM (complementary and alternative medicine) as an adjunct to conventional treatment. Moxibustion is traditional Korean medical therapeutic method and uses the heat generated by burning herbal preparations containing Artemisia vulgaris to stimulated acupoint.

Herein, the investigators propose an open-label pilot study investigating the effectiveness of moxibustion stimulation at abdominal acupoint on quality of life in cancer patients under chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Diagnostic histopathology of cancer
* Performance status of 0-2 on the European Cooperative Oncology Group (ECOG) performance scale.
* Patients on chemotherapy currently have plan to receive chemotherapy for more than 6 weeks.
* Follow-up possible during the clinical trial
* Informed signed consent

Exclusion Criteria:

* Patients with Severe Heart disease and hypertension that is not controlled (systolic blood pressure \>160 or Diastolic blood pressure \>100)
* Patients with diabetes that is not controlled (FBST \>180 or BST\>250)
* Patients with abdominal injury or severe ascites can't be received moxibustion therapy on abdomen.
* Hypersensitive section to moxibustion treatment
* Inability to comprehend or express oneself in the Korean language
* An Individual deemed to be ineligible by a physician
* Refusal to participate in this trial or to provide informed consent.

Primary outcomes:
measure: functional Assessment of Cancer Therapy: General (FACT-G)
timeFrame: change from baseline to 6 weeks
Secondary outcomes:
measure: Body mass index
timeFrame: change from baseline to 6 weeks
measure: immune function
timeFrame: change from baseline to 6 weeks
measure: M.D, Anderson symptom Inventory (MDASI)
timeFrame: change from baseline to 6 weeks
Other outcomes:
Locations:
city: Deagu
country: Korea, Republic of
facility: Deagu Hanny University Medical center
Study officials:
References:
citation: Lee MS, Kang JW, Ernst E. Does moxibustion work? An overview of systematic reviews. BMC Res Notes. 2010 Nov 5;3:284. doi: 10.1186/1756-0500-3-284.
citation: Lee MS, Choi TY, Park JE, Lee SS, Ernst E. Moxibustion for cancer care: a systematic review and meta-analysis. BMC Cancer. 2010 Apr 7;10:130. doi: 10.1186/1471-2407-10-130.