louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01496729: Transversus Abdominis Plane (TAP) Block After Kidney Transplantation
Official title: Single Shot Transversus Abdominis Plane (TAP) Block Versus Sham Block for Analgesia in Donors and Recipients Following Kidney Transplantation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Transplantation, Kidney
Keywords: Kidney transplantation
Transversus abdominis plane (TAP) block
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2011-12-21
Enrollment: 0
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: Postoperative pain is a major problem in patients who either donate a kidney or undergo kidney transplantation. This pain is commonly treated with opioids, which can cause several side effects, ranging from pruritus, impaired vigilance, and most concerning to severe respiratory depression. This can be aggravated in the recipient by accumulation of opioid metabolites secondary to renal impairment and secretion.

Several studies have shown an opioid sparing effect of a transversus abdominis plane (TAP) block after surgery in the lower abdomen. In the proposed study, we plan to compare the impact of an ultrasound guided single shot transversus abdominis plane (TAP) block versus a ultrasound guided sham block with normal saline (placebo) on postoperative pain scores, postoperative opioid consumption, as well as patient's satisfaction.

The investigators hypothesize, that patients who receive a TAP block will have lower postoperative pain scores, lower postoperative opioid consumption as well as higher satisfaction scores.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years, English speaking, receiving a kidney transplant or donating a kidney as part of standard clinical care

Exclusion Criteria:

* Allergy to local anesthetics or opioids, coagulopathy or dementia. Patients with known history of IV drug abuse and with very high preoperative opioid requirements (defined as \> 120 mg oxycodone/ day, use of methadone or fentanyl patches) will also be excluded from this study.

Coagulopathy will be assessed by the patient's history and physical. Should there be concerns regarding "easy bleeding" or "easy bruising", further workup of the patient's coagulation will be ordered (PT, PTT, INR). Since we perform the TAP block after 3-4 hours of kidney surgery, any patient with coagulopathy will most likely have been canceled prior to surgery. Therefore, we would deem any patient, who was eligible for kidney surgery, eligible for a TAP block at the end of the surgical procedure.

Primary outcomes:
measure: Pain after kidney transplantation
timeFrame: 24 hours
Secondary outcomes:
measure: Use of opioids after kidney transplantation
timeFrame: 24 hours
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Medical Center at Parnassus
state: California
Study officials:
References:
Clinical trial NCT05578729: The Effect of Different Masks Used by Pregnant Women on Vital Signs and Non Stress Test During The COVID-19
Official title: The Effect of Different Masks Used by Pregnant Women on Vital Signs and Non Stress Test During The COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid-19
Pregnant
Fetus
Mask
Lead sponsor: Bozok University
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 91
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single surgical mask group (n=30) Double surgical mask group (n=30) N95 mask group (n=31)
Primary purpose: OTHER

Brief summary: This study was conducted to examine the effects of different masks used by pregnant women on vital signs and non stress test (NST) during the COVID-19. This study was conducted as a single-blind randomized controlled trial. Healthy pregnant women aged 19 years and older, who were followed up on an outpatient basis, and who were in the 37-40th week of pregnancy, were included in the study. The study consisted of a single surgical mask group (n=30), double surgical mask group (n=30), and N95 mask group (n=31). Masks were given to the resting pregnant women 30 minutes before the NST, and they were provided to wear masks. After 30 minutes, the vital signs of the pregnant women were measured just before and after the NST, and the images of the NST traces were taken.


Eligibility criteria: Inclusion Criteria:

1. Being 19 years or older
2. Being pregnant at 37-40 weeks of pregnancy and having healthy pregnancy
3. Being followed on an outpatient basis

Exclusion Criteria:

1. Having a multiple pregnancy
2. Having a systemic, psychiatric disease or psychological problem (thyroid, heart, schizophrenia, etc.)
3. Being in the category of risky pregnancies (Preeclampsia, gestational diabetes, etc.)
4. Smoking
5. Having alcohol and substance use
6. Never done NST before
7. Having an identified risk factor in the fetus
8. Having barriers to communication
9. Being a foreign national
10. Being in contact with, or having, or suspected of having COVID-19 and previously had COVID-19.

Primary outcomes:
measure: Vital signs
timeFrame: 30 minutes later, just before the NST was performed.
measure: Vital signs
timeFrame: 30 minutes later, just before the NST was performed.
measure: Vital signs
timeFrame: 30 minutes later, just before the NST was performed.
measure: Vital signs
timeFrame: 30 minutes later, just before the NST was performed.
measure: Non stress test
timeFrame: Just after the NST was finished (after 20 minutes)
Secondary outcomes:
measure: Vital signs
timeFrame: Just after the NST was finished (after 20 minutes)
measure: Vital signs
timeFrame: Just after the NST was finished (after 20 minutes)
measure: Vital signs
timeFrame: Just after the NST was finished (after 20 minutes)
measure: Vital signs
timeFrame: Just after the NST was finished (after 20 minutes)
Other outcomes:
Locations:
city: Yozgat
country: Turkey
facility: Yeter
Study officials:
References:
Clinical trial NCT01526629: Full Automaticity and Remote Follow-up
Official title: Identification of Implantable Cardioverter Defibrillator Patients With Remote Follow up That Requires an Onsite Visit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tachyarrhythmia
Keywords: ICD
Remote follow-up
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2012-02-06
Enrollment: 354
Sex: ALL
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: Patient implanted with a sigle- or dual-chamber ICD or a Cardiac Resynchronization-Defibrillator system (CRT-D) and remotely followed-up

Brief summary: With the expansion of Sudden Cardiac Death (SCD) primary prevention indications, the number of Implantable Cardioverter Defibrillators (ICD) implants has increased significantly in the recent years. This has resulted in an increase of the number of follow-up (FU) to be performed and a growing workload for centers. Remote FU system such as the Medtronic Carelink system allows to check remotely the proper functioning of self evaluating devices and give informations of some clinical events.

The objective of this study is to define which patients with a remote follow-up need additional onsite visit and to assess to which extent remote FU can be an alternative to onsite visit.


Eligibility criteria: Inclusion Criteria:

* Patient older than 18,
* Patient implanted with a fully automatic ICD and remotely followed-up,
* Patient geographically stable and able to attend FU at investigative site
* Patient who signed a data release authorization form,

Exclusion Criteria:

* Patient whose mental or physical capacity impedes to give an informed data release authorization,
* Patient already enrolled in a clinical study whose procedures may interfere with the results of the present study,
* Patients in New York Heart Association (NYHA) class IV

Primary outcomes:
measure: Remote Follow-up as an Alternative to Onsite Visit
timeFrame: 13 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montfermeil
country: France
facility: CH Montfermeil
Study officials:
affiliation: Centre Hospitalier de Montfermeil
name: Walid Amara, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02023229: Branched Chain Aminoacid Supplementation in Patients With Liver Cirrhosis
Official title: High-fiber High-fiber Diet and Branched Chain Aminoacids. Impact on Nutritional Status and Complications in Patients With Liver Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Liver Cirrhosis
Keywords: Branched chain aminoacids
Nutritional status
Hepatic encephalopathy
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2013-12-30
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Malnutrition is a frequent complication in patients with liver cirrhosis. Most patients have decreased dietary intake due to ascites, hepatic encephalopathy and pro-inflammatory cytokines.

We hypothesized that branched chain aminoacids can improve nutritional status and delay episodes of hepatic encephalopathy


Eligibility criteria: Inclusion Criteria:

Ambulatory patients Patients with confirmed diagnose of liver cirrhosis Patients classified as Child-Pugh A or Child Pugh B

Exclusion Criteria:

Acute or chronic renal failure Pregnancy Overt hepatic encephalopathy

Primary outcomes:
measure: Nutritional status
timeFrame: At time of recruitment
Secondary outcomes:
measure: Hepatic Encephalopathy
timeFrame: At time of recruitment
Other outcomes:
measure: Nutritional status
timeFrame: 3 months follow-up
measure: Nutritional status
timeFrame: 6 months follow-up
measure: Hepatic encephalopathy
timeFrame: 6 months follow-up
Locations:
city: Mexico city
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"
Study officials:
References:
Clinical trial NCT01886729: Effect of Time Shift of Transcranial Direct Current Stimulation (tDCS) for Treatment of Acute Tinnitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tinnitus
Keywords: transcranial direct current stimulation
time shift
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2013-06-26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Allocation: RANDOMIZED

Brief summary: The treatment for patients with acute tinnitus consists of Methylprednisolone and hyperbaric oxygen therapy. For this study transcranial direct current stimulation (tDCS) was added to the protocol. The purpose is to determine the effect of the time shift of tDCS. Two conditions will be compared: tDCS simultaneously with the hyperbaric oxygen therapy or tDCS 3 weeks after the start of the tinnitus.

An audiological testing will be performed at the day of admission, after 3 weeks, 6 weeks and 12 weeks.


Eligibility criteria: Inclusion Criteria:

* age between 18 and 50 years
* presence of acute tinnitus or worsening of tinnitus caused by otogenic disease
* registration in UZA within 48 hours after start tinnitus
* VAS-score ≥ 4
* ability to understand and sign informed consent

Exclusion Criteria:

* history of epileptic seizures
* severe organic comorbidity
* psychiatric disorders or a history of psychiatric disorders with psychotic symptoms
* Pace maker
* pregnancy

Primary outcomes:
measure: Improvement of tinnitus
timeFrame: 12 weeks
Secondary outcomes:
measure: Hearing
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University hospital of Antwerp
state: Antwerp
Study officials:
References:
Clinical trial NCT06482229: M-TAPA vs Intraperitoneal Bupivacain vs Intraperitoneal Bupivacain +Dexmedetomidin
Official title: Postoperative Analgesic Efficacy of Intraperitoneal Bupivacaine, Bupivacaine and Dexmedetomidine With Modified-Pericondrial Approach Thoracoabdominal Nerve Block (M-TAPA) in Laparoscopic Cholecystectomy Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Regional Anesthesia Morbidity
Lead sponsor: Sivas State Hospital
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Laparoscopic cholecystectomy is a common abdominal surgery in Western countries, favored for its minimal invasiveness, leading to less pain, smaller scars, and quicker recovery. Despite its benefits, it is contraindicated in cases of bleeding disorders, peritonitis, hemodynamic instability, severe heart failure, and advanced COPD. Effective postoperative pain management is crucial for faster recovery, shorter hospital stays, and lower costs, using techniques such as intravenous or intramuscular analgesics, epidural analgesia, and local anesthetic injections like TAP block or M-TAPA block. The TAPA block, introduced in 2019, involves applying local anesthetic to the costochondral junction, affecting thoracoabdominal nerves, with a modified version (M- TAPA) applying anesthetic to the lower surface only. Studies have shown M-TAPA's efficacy in reducing pain and analgesic use postoperatively. Postoperative pain from laparoscopic cholecystectomy mainly arises from inflammation in the gallbladder bed and pneumoperitoneum. This study aims to evaluate the postoperative analgesic efficacy of intraperitoneal bupivacaine, bupivacaine with dexmedetomidine, and M-TAPA block by assessing pain scores and analgesic consumption in a prospective, randomized, double- blind trial with 45 patients. Patients will be assigned to three groups: M- TAPA block, intraperitoneal bupivacaine, and intraperitoneal bupivacaine with dexmedetomidine, with an experienced anesthetist administering the blocks and evaluating outcomes to compare these pain management techniques.


Eligibility criteria: Inclusion Criteria:

* Laparoscopic cholecystectomy surgery planned
* ASA #-II-III classification
* Willingness to participate in the study

Exclusion Criteria:

* Bleeding disorders
* Signs of infection at the block application site
* Conversion to open surgery
* Allergy to local anesthetics
* Unstable hemodynamics
* Inability to provide informed consent

Primary outcomes:
measure: pain scores
timeFrame: Time Frame: 24 hours after the procedure
Secondary outcomes:
measure: total analgesic consumption
timeFrame: 24 hours after the procedure
Other outcomes:
Locations:
city: Sivas
country: Turkey
facility: Fatih Balci
Study officials:
References:
Clinical trial NCT05009329: A Study of JAB-21822 in Adult Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation in China
Official title: Multi-center, Open, Dose-escalation, and Expanded Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of JAB-21822 in Advanced Solid Tumors With KRAS p.G12C Mutation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: NSCLC
Solid Tumor
Keywords: KRAS p.G12C Mutant Advanced Solid Tumor; NSCLC
Lead sponsor: Allist Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-17
Enrollment: 311
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: To assess safety, tolerability, PK, efficacy and determine recommended phase 2 dose (RP2D) of JAB-21822 (glecirasib) administered in adult participants with KRAS p.G12C-mutant advanced solid tumors.


Eligibility criteria: Inclusion Criteria:

1. Written informed consent
2. Advanced (metastatic or unresectable) KRAS p.G12C mutant solid tumors, with failure or absence of standard treatment
3. Subject must be ≥18 years
4. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
5. Subjects with life expectancy ≥3 months.
6. Subjects must have at least one measurable lesion as defined by RECIST v1.1.
7. There was no serious organ dysfunction in the screening stage
8. Male or female subjects of reproductive age agree to use adequate contraception

Exclusion Criteria:

1. History of intestinal disease or major gastric surgery or inability to swallow oral medications
2. Other active cancer
3. Previously treated with KRAS G12C inhibitor
4. Active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV)
5. Impaired heart function or clinically significant heart disease
6. Pregnant or breast-feeding
7. Previous allogeneic bone marrow transplant or organ transplant
8. Intended study subjects who were unable to abstain from alcohol during medication
9. Other unqualified conditions judged by the investigators

Primary outcomes:
measure: Incidence of dose limiting toxicities (DLTs) in the dose escalation phase
timeFrame: first 21 days
measure: Number of participants with adverse events
timeFrame: up to 3 years
measure: Overall response rate (ORR) by IRC (independent review committee)
timeFrame: up to 3 years
Secondary outcomes:
measure: Overall response rate (ORR) by investigator
timeFrame: up to 3 years
measure: Duration of response ( DOR )
timeFrame: up to 3 years
measure: Disease Control Rate ( DCR )
timeFrame: up to 3 years
measure: Progression-free survival (PFS)
timeFrame: up to 3 years
measure: Time to response (TTR)
timeFrame: up to 3 years
measure: Peak Plasma Concentration (Cmax)
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT00256529: Prospective Analysis of Eosinophilic Esophagitis in Patients Presenting With Dysphagia
Official title: Prospective Analysis of Eosinophilic Esophagitis in Patients Presenting With Dysphagia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophagitis
Keywords: dysphagia
eosinophilic esophagitis
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2005-11-21
Enrollment: 483
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients presenting with dysphagia will be eligibile for enrollment into the study.

Brief summary: This is a prospective descriptive cross sectional study to determine the percentage of patients presenting with dysphagia who are found to have eosinophilic esophagitis (EoE) and to establish which presenting factors warrant esophageal biopsies. We hypothesize that a greater than expected percentage of patients who are biopsies will have histologic changes consistent with EE.

Detailed description: All patients presenting with dysphagia who do not already carry a previous diagnosis for their dysphagia will be asked to enroll. If patients have undergone previous work up for dysphagia such as manometry, 24-hour probe, or barium swallow they can still participate in this study. Informed consent will take place prior to enrollment. After patients present with dysphagia they will fill-out a questionnaire regarding their dysphagia symptoms. An EGD with biopsies will then be performed. Biopsies will be taken from 4 quadrants in the proximal and distal esophagus. The distal esophagus biopsies will be taken 5 cm proximal to the Z-line. Proximal biopsies will be taken anywhere proximal to 30 cm from the incisors.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-90 presenting with dysphagia or food impaction
* Ability to undergo esophagogastroduodenoscopy and biopsies
* No significant cardiopulmonary disease, or other contraindication to EGD

Exclusion Criteria:

* Contradiction to EGD and/or biopsies such as Boerhaave's syndrome, or history or bleeding disorder or elevated INR
* Inability to provide informed consent
* Esophageal varices

Primary outcomes:
measure: To assess the percentage of patients who present with dysphagia who have EE by histologic criteria
timeFrame: December 2010
Secondary outcomes:
measure: To assess the demographics of the EE patients with dysphagia
timeFrame: December 2010
measure: To measure the frequency, severity, and time course of dysphagia in patients with EE
timeFrame: December 2010
measure: To assess percentage of EE patients with recurrent, versus acute dysphagia
timeFrame: December 2010
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Department of Veterans Affairs
state: Utah
Study officials:
affiliation: University of Utah
name: Kathryn Byrne, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01815229: Role of Neutrophil Activation
Official title: Sore Throat Secondary to Endotracheal Intubation: the Role of Neutrophil Activation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients Requiring Endotracheal Intubation
Keywords: endotracheal
intubation
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2013-03-20
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Patients will undergo placement of an endotracheal tube (ETT) as standard of care. Tracheal lavage will be conducted using 5 mL of sterile saline solution by a push/suction technique. Specimen samples obtained by wall suction will be collected at 2 time points following intubation.

Blood samples will be obtained at 2 time points, simultaneous with the collection of the tracheal specimens.


Eligibility criteria: Inclusion Criteria

1. Ages 18 to 65
2. American Society of Anesthesiologists Physical Status Classification (ASA) I and II
3. Required to have endotracheal intubation
4. Scheduled for short admission (\<23 hrs), or ambulatory orthopedic surgery (ankle, shoulder, or extremity surgery); general surgery (exploratory laparotomy, cholecystectomy, ventral or inguinal hernia repair); obstetric/gynecological surgery(total abdominal hysterectomy, bilateral salpingo-oophorectomy); urologic surgery (nephrectomy, prostatectomy), lumbar spine surgery( discectomy, one or two level lumbar fusion) procedures.
5. Estimated duration of surgery 3 to 4 hours.
6. Provide informed consent

Exclusion Criteria

1. Active pulmonary disease within 5 days prior to enrollment
2. On immunosuppressive medications
3. Previous tracheal surgery
4. On azithromycin
5. Diabetes
6. Pregnancy
7. Smoking history of less than 6 weeks prior to surgery
8. Surgery or intubation within 5 days of surgery
9. Planned surgical procedure involving neck or thoracic regions
10. Active pulmonary disease
11. Autoimmune disease (HIV, AIDS, Rheumatoid Arthritis
12. Hepatitis
13. Cancer

Primary outcomes:
measure: Neutrophil Cell Counts in Tracheal Lavages
timeFrame: average of 3.2 hours of exposure to an ETT
Secondary outcomes:
measure: Intubation Time in Minutes
timeFrame: Up to 363 minutes for intubation time
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Carlos Puyo, MD
role: PRINCIPAL_INVESTIGATOR
References: