louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05788367: Pericapsular Nerve Block Versus Interscalene Nerve Block for Acute Pain Management in Shoulder Arthroscopy
Official title: Pericapsular Nerve Block Versus Interscalene Nerve Block for Acute Pain Management in Shoulder Arthroscopy: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pericapsular Nerve Block
Interscalene Nerve Block
Shoulder Arthroscopy
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2023-03-28
Enrollment: 44
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 compare PENG and ISB after shoulder arthroscopy for postoperative pain management after shoulder arthroscopy.

Detailed description: Shoulder arthroscopy is a common procedure done is orthopedics for many surgical indications as rotator cuff tears, stiffness and instability. This procedure has a well - documented postoperative pain. To improve the outcome after surgery, effective pain control is needed.

Various methods are used for postoperative pain management. Intravenous opioid agents are among them, but they may cause undesirable side effects, such as respiratory depression, sedation, constipation, allergic reaction, nausea, and vomiting. Thus, alternative techniques are preferred.

Interscalene brachial plexus blocks (ISBPBs) are often used to provide perioperative analgesia and anesthesia for shoulder surgery. They target nerve roots C4-C6 and thereby provide regional analgesia to the shoulder and upper arm. Although ISBPBs are often performed in combination with general anesthesia (GA) to enhance postoperative analgesia, they are also sometimes used as a sole means of anesthesia.

The pericapsular nerve group (PENG) block is an ultrasound-guided approach, first described by Giron-Arango et al. for the blockade of the articular branches of the femoral, obturator and accessory obturator nerves that provide sensory innervation to the anterior hip capsule. It has been successfully used as an alternative regional anaesthesia technique for the management of acute pain after hip fracture, and for analgesia after elective hip surgery

Eligibility criteria: Inclusion Criteria:

* Body mass index \< 40 kg/m2
* American Society of Anesthesiologists (ASA) physical status I-II
* posted for elective shoulder arthroscopy

Exclusion Criteria:

* Known allergy to local anesthetics
* allergy to all opioid medications
* diagnostic shoulder arthroscopic procedures
* patients with chronic opioids use and coagulopathy

Primary outcomes:
measure: Asses The postoperative opioid consumption
timeFrame: 24 hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Mohammed Fouad Mohamed Algyar
state: Kafrelsheikh
Study officials:
affiliation: Lecturer of Anaesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Kafrelsheikh University
name: Mohammed F Algyar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02069067: Observational Study of Incidence of Breakthrough Cancer Pain and How it is Treated
Official title: Multicenter Observational Study of the Incidence and Treatment Modalities of Breakthrough Cancer Pain in Patients With Chronic Cancer Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Advanced Cancer
Keywords: breakthrough cancer pain
pain
neuropathic pain
intractable pain
cancer
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
First posted: 2014-02-21
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced cancer and chronic pain being controlled with opiods.

Brief summary: The purpose of this study is to describe how often advanced cancer patients experience breakthrough pain (BTcP), and to describe how this pain is treated, and how effective these treatments are.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of neoplasm in advanced stage
* Chronic pain controlled for at least one week with opioids 60 mg / day morphine equivalent
* 1-6 episodes of BTcP within any of 3 days previous to registration into study
* Signed Informed Consent

Exclusion Criteria:

· More than 6 episodes of BTcP within any of 3 days previous to registration into study

Primary outcomes:
measure: number of patients who experience BTcP
timeFrame: one year
measure: treatments used to treat BTcP
timeFrame: one year
Secondary outcomes:
measure: pain intensity
timeFrame: 4 weeks
measure: time to pain relief of BTcP
timeFrame: 4 weeks
measure: initial dose of therapy (in morphine equivalents) for BTcP
timeFrame: 4 weeks
measure: effective dose for BTcP
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Castellammare di Stabia
country: Italy
facility: Ospedale San Leonardo
city: Napoli
country: Italy
facility: Istituto Nazionale dei Tumori , Unita Terapia Antalgica
city: Nola
country: Italy
facility: S. Maria della Pietà
Study officials:
affiliation: NCI Naples, Division of Pain Therapy
name: Arturo Cuomo, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: NCI Naples, Clinical Trials Unit
name: Francesco Perrone, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00919867: A Drug Interaction Study of SPD503 and Vyvanse Administered Alone and In Combination in Normal Healthy Volunteers
Official title: A Phase 1, Open-label, Randomized, Three-period Crossover Drug Interaction Study Evaluating the Pharmacokinetic Profiles of SPD503 and VYVANSE, Administered Alone and in Combination in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Normal, healthy volunteers (for this Phase 1 study)
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2009-06-12
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Drug-drug interaction study; to examine the pharmacokinetics of SPD503 and VYVANSE (lisdexamfetamine dimesylate) when given alone, and in combination.


Eligibility criteria: Inclusion Criteria:

* Subjects must be normal healthy adult volunteers (with no significant abnormalities in medical history, physical exam, vital signs or lab evaluations at screening) in order to be eligible to participate.

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax) of Guanfacine
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
measure: Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Guanfacine
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
measure: Time of Maximum Plasma Concentration (Tmax) of Guanfacine
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
measure: Time of Plasma Half-Life(T 1/2) of Guanfacine
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
measure: Cmax of d-Amphetamine
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
measure: AUC of d-Amphetamine
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
measure: Tmax of d-Amphetamine
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
measure: T 1/2 of d-Amphetamine
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Advanced Biomedical Research, Inc.
state: New Jersey
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Roesch B, Corcoran ME, Fetterolf J, Haffey M, Martin P, Preston P, Purkayastha J, Wang P, Ermer J. Pharmacokinetics of coadministered guanfacine extended release and lisdexamfetamine dimesylate. Drugs R D. 2013 Jun;13(2):119-28. doi: 10.1007/s40268-013-0014-8.
Clinical trial NCT02391467: Validity of Elastography During Pregnancy
Official title: Validity of Non-invasive Liver Fibrosis Assessment by Ultrasound-based Elastography at the Third Trimester of Pregnancy: a Prospective Study
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Hepatitis B Virus Infection; Pregnant Women
Lead sponsor: Hopital Lariboisière
Sponsor class: OTHER
First posted: 2015-03-18
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women with HBV or HCV chronic hepatitis

Brief summary: Non invasive methods are the only available methods to stage liver fibrosis during pregnancy. The safety of elastometry - ultrasound based - is obvious, as medical supervision of pregnancy is based on ultrasonography, both methods using same wavelengths. Therefore, this method is sometimes used in pregnant women with recent diagnosis of chronic viral hepatitis infection, whereas its validity in pregnant women has never been studied. This lack of data justifies our study.

Detailed description: One measurement during the third trimester of pregnancy will be compared to a second measurement, 3 months after childbirth.

Eligibility criteria: Inclusion Criteria:

* Pregnant women
* Followed in Obstetrics Dpt
* HBV or HCV chronic hepatitis
* After information and written consent

Exclusion Criteria:

* None

Primary outcomes:
measure: Difference between the fibrosis score during and after pregnancy
timeFrame: 3 to 6 months after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Lariboisiere
Study officials:
affiliation: Hopital Lariboisiere, Paris, France
name: Pierre O SELLIER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06313567: Metronomic Capecitabine in Stage III Gastric Cancer
Official title: Metronomic Capecitabine as Adjuvant Therapy in Stage III Gastric Cancer: a Multicentre, Open-label, Parallel-group, Randomised, Controlled, Phase 3 Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Gastric Cancer
Keywords: Gastric Cancer
Metronomic capecitabine
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 722
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 find out whether treatment with metronomic capecitabine will improve the survival of gastric cancer patients with stage III who had received standard treatment.


Eligibility criteria: Inclusion Criteria:

1. Lower age limit of research subjects 18 years old and upper age limit of 80 years old.
2. Be proven to be primary adenocarcinoma of gastric cancer and staged III by pathological evidences
3. R0 gastrectomy with D2 lymphadenectomy
4. ECOG (ECOG score standard) performance status of 0 or 1 and expected to survive more than 6 months
5. No contraindications, including normal peripheral blood routine, liver and kidney function and electrocardiogram （WBC≥3.5 x 109 /L, NEU≥1.2 x 109 /L,PLT≥90 x 109 /L and HGB≥80g/L).

Exclusion Criteria:

1. History of chemotherapy, radiotherapy, immunotherapy or target therapy
2. Multiple primary tumors
3. Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases
4. Unavailable for R0 resection and D2 lymph node dissection.
5. Patients with stage IV gastric cancer

Primary outcomes:
measure: Disease-free survival
timeFrame: 3-year
Secondary outcomes:
measure: Overall survival
timeFrame: 3-year
measure: Side effects
timeFrame: 1-year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References:
Clinical trial NCT00577967: Gabapentin - A Solution to Uremic Pruritus?
Official title: Gabapentin - A Solution to Uremic Pruritus? A Prospective, Randomized, Placebo-controlled, Double-blind Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pruritus
Uremia
Keywords: Uremic pruritis
Lead sponsor: Hospital Authority, Hong Kong
Sponsor class: OTHER_GOV
Collaborators: name: Pfizer
First posted: 2007-12-20
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate using the drug gabapentin to relieve the intense pruritic sensation associated with chronic renal failure patients undergoing peritoneal dialysis.


Eligibility criteria: Inclusion Criteria:

* Adult Chinese male and female patients aged \> 18 undergoing CAPD for at least 3 months and able to read and understand Chinese
* Patients experiencing moderate to severe pruritis, defined as persistent, treatment-resistant pruritis considerably impairing sleep or daytime activity. Treatment resistance is defined as no or only partial resolvement of pruritis under current anti-pruritis treatment regimens such as anti-pruritis lotions and anti-histamines.
* Patients in stable clinical condition in terms of peritoneal dialysis and general health
* Patients able to understand and answer the SDS questionnaire
* Patients able to express the sensation of itchiness in the terms of the VAS and the SDS score
* Patients who are willing to give written informed consent and to participate in and comply with the study protocol

Exclusion Criteria:

* Patients with a known history of pruritis or dermatologic disease antedating renal failure.
* Patients with skin disease other than the usual cutaneous findings of uraemia such as xerosis or ecchymosis.
* Patients under current treatment with systemic steroids
* Known history of allergy to Gabapentin
* Those patients already put on anti-convulsants
* Unable to give written informed consent for the study
* Pregnancy or female patients of child-bearing age who are unwilling to use contraception
* Poor drug compliance
* Known HIV positivity
* Active neoplastic disease
* Those who do not want to participate the study

Primary outcomes:
measure: Subjective measurement of reduction in pruritus
timeFrame: 3 months
Secondary outcomes:
measure: Tolerability of Gabapentin in CAPD patients
timeFrame: 3 months
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Tuen Mun Hospital
Study officials:
affiliation: Medical and Geriatrics / Nephrology, Tuen Mun Hospital
name: Yui Pong Siu, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.
Clinical trial NCT00219167: A Clinical Study to Assess Efficacy and Safety of Aliskiren in the Elderly With High Blood Pressure
Official title: An 8-week, Randomized, Double-blind, Parallel-group, Multicenter Study Assessing the Efficacy and Safety of Aliskiren 75 mg, 150 mg, and 300 mg in Patients With at Least 65 Years of Age With Essential Hypertension, Using 24-hour ABPM, With Lisinopril 10 mg as a Reference
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: hypertension
aliskiren
age
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 355
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: After a wash-out (1 to 2 weeks), and 2 to 4 week single-blind placebo run-in period, eligible patients will be randomized to receive lisinopril 10 mg, aliskiren 75 mg, 150 mg or 300 mg for a period of 8 weeks


Eligibility criteria: Inclusion Criteria

* Patients with at least 65 years-old
* Patients with essential hypertension Exclusion Criteria
* Severe hypertension
* History or evidence of a secondary form of hypertension
* History of Hypertensive encephalopathy or cerebrovascular accident. Other protocol-defined inclusion exclusion criteria also apply.

Primary outcomes:
measure: Change from baseline in average 24 hour systolic ambulatory blood pressure after 8 weeks
Secondary outcomes:
measure: Change from baseline in average 24 hour diastolic ambulatory blood pressure after 8 weeks
measure: Change from baseline in sitting systolic and diastolic blood pressure after 8 weeks
measure: Change from baseline in daytime diastolic ambulatory blood pressure after 8 weeks
measure: Change from baseline in daytime systolic ambulatory blood pressure after 8 weeks
measure: Blood pressure control target of < 140/90 mmHg after 8 weeks
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis Pharmaceuticals
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Verdecchia P, Calvo C, Mockel V, Keeling L, Satlin A. Safety and efficacy of the oral direct renin inhibitor aliskiren in elderly patients with hypertension. Blood Press. 2007;16(6):381-91. doi: 10.1080/08037050701717014.
citation: Wang GM, Li LJ, Tang WL, Wright JM. Renin inhibitors versus angiotensin converting enzyme (ACE) inhibitors for primary hypertension. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD012569. doi: 10.1002/14651858.CD012569.pub2.
Clinical trial NCT03660267: >The Purpose of This Study Was to Determine Whether Consuming a 100-mL Cup of Coffee is Effective in Preventing or Reducing Postoperative Ileus After Laparotomy of Benign Gynecological Patients
Official title: The Effects of Coffee Ingestion on Recovery of Bowel Function in Patients Undergoing Benign Gynecologic Operation : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effects of Coffee Ingestion on Recovery of Bowel Function
Keywords: Benign Gynecologic Operation
Coffee Ingestion
Recovery of Bowel Function
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2018-09-06
Enrollment: 90
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of the effectiveness coffee (with or without caffeine) ingestion and water for reducing the duration of Postoperative ileus after Laparotomy of Benign Gynecological Patients

Detailed description: laparotomy benign gynecological surgery is the most common gynecologic operation worldwide because is major operation for surgery and can affect to bowel movement after operation and turn to postoperative ileus , clinically severe postoperative ileus affects up to 14% of patients after laparotomy for gynecologic surgery that leaded to more complication, slowly recovery , prolong length of hospitalized stay and consequently increase unnecessary cost of treatment.

Preclinical studies has considered to use preventative therapeutic options for prevent ileus including coffee

The investigators used the coffee reduces postoperative ileus However, no good quality of evidence base supports the effectiveness coffee (with or without caffeine) ingestion and water for reducing the duration of Postoperative ileus after Laparotomy of Benign Gynecological Patients

Eligibility criteria: Inclusion Criteria:

* Patients were asked to participate if they were scheduled to undergo laparotomy for a benign gynecologic condition
* Ever drink coffee before
* can speak or communication Thai language

Exclusion Criteria:

1 hypersensitivity or allergy to caffeine/ coffee 2.ever intraabdominal sugery before 3. had an active intra-abdominal malignancy, bowel perforation, pre-existing bowel disease, or a history of abdominal or pelvic irradiation.

4.pregnancy woman 5.thyroid disease 6 Inflammatory bowel disease 7.liver disease 8.cardiac arrhythmia 9.history of difficult to defecation ( feces only 2 times per week) 10.after operation need to stay in ICU more than 24 hr 11.need to put Ng tube after operation

Primary outcomes:
measure: time to flatus
timeFrame: ึ7 day
Secondary outcomes:
measure: time to toleration of a solid diet
timeFrame: 7 day
measure: time to defecation
timeFrame: 7 day
Other outcomes:
Locations:
city: Phaya Thai
country: Thailand
facility: Rajavithi Hospital
state: Bangkok
Study officials:
References:
Clinical trial NCT06097767: the Incidence of Necrotizing Enterocolitis in Preterm With Respiratory Distress Syndrome Undergoing Caffeine Therapy
Official title: Evaluation of the Incidence of Necrotizing Enterocolitis in Preterm Infants With Respiratory Distress Syndrome Undergoing Caffeine Therapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Pharmacological Action of Drug
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-10-24
Enrollment: 50
Sex: ALL
Minimum age (years): 32
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: It is a randomized, prospective study; it will be carried out in the NICU at Alzahraa University Hospital including 50 newborn babies diagnosed with respiratory distress syndrome.

The purpose of this study is to :

1. Investigate the protective caffeine on necrotizing enterocolitis in respiratory distress syndrome preterm infants.
2. Detect the impact of caffeine protocol treatment on the in-incidence of necrotizing enterocolitis in respiratory distress syndrome preterm infants in neonatal intensive care

1- Control group It includes preterm infants with respiratory distress syndrome aged 32 weeks-35 weeks.

2- Caffeine-treated group It includes preterm infants with respiratory distress syndrome who received caffeine treatment as intravenous caffeinospire (Caffeine citrate) 60 mg / 3 ml (20 mg /ml) 3 ml vial for injection.


Eligibility criteria: Inclusion Criteria:

* All preterm infants with respiratory distress syndrome.

Exclusion Criteria:

* Preterm admitted to NICU for other reasons rather than respiratory distress
* Major congenital anomalies
* spontaneous intestinal perforation
* Endocrinal Dysfunctions

Primary outcomes:
measure: decreasing NEC rates
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: NICU at Alzahraa University Hospital
Study officials:
References: