cyrilzakka/clinical-trials huggingface dataset:
Application of Rectus Sheath Block based-on Incision in Upper Abdominal Surgery

General anesthesia combined subcostal transversus abdominis plane (TAP)or rectus sheath block (RSB)can significantly reduce the use of opiates in minimally invasive surgery.However, similar reduction was not observed in open abdominal surgery during perioperative period.Therefore, the investigators should try to improve the blocking methods to reduce the side effects of a large number of opiates. Based on the range and its analgesic effect of various nerve block is obviously related to the injection site of local anesthetics, this randomized controlled study hypothesized that modified RSB under the guidance of surgical incision may be more effective in inhibiting the harmful stimulation of surgery.

For abdominal cancer surgery with midline incision, subcostal transversus abdominis plane or rectus sheath block combined with general anesthesia was more effective in reducing pain scores and opioid consumption compared with general anesthesia alone. However, there was no statistically significant difference in supplementary fentanyl during operation. Besides adequate pain relief around incisions, blunting visceral traction response has also an important role in hemodynamic stability.With the evidences for a potential mechanism for the antinociceptive effects of propofol on visceral nociception and dexmedetomidine combined with oxycodone can provide good visceral analgesia, the investigators supposed that visceral nociception was well suppressed by adequate antinociceptive drugs. The propofol combination with dexmedetomidine may had significant effect on the reduction of the sympathoadrenergic tone with decrease of blood pressure and heart rate.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-85 years
* Anesthesiologists (ASA) risk classification I to IV
* Scheduled to undergo midline incision of upper abdomen (From xiphoid to navel )

Exclusion Criteria:

* Patient refusal
* Any contraindications to regional techniques (allergy to local anesthetics, infection around the site of the block, and coagulation disorder)
* History of analgesics dependence
* Any difficulty with communication
* Allergy to the study drugs
* Heat rate \< 50 beats/minutes or II-III Atrioventricular block
* Previous open surgery
* Previous definite history of malignant tumor
* Who had an estimated intraoperative blood loss of more than 500 mL
HIV/STI Risk Reduction for Incarcerated Women With Interpersonal Violence

The pilot study aims to conduct a randomized pilot trial in a sample of 40 incarcerated women with lifetime interpersonal violence who are 6-10 weeks away from release to demonstrate the feasibility and acceptability of the proposed recruitment methods and research design, of the intervention training methods, of delivering the enhanced Women's Coop and nutrition control interventions. Per recent guidance from NIMH, the investigators will also examine 95% confidence intervals around differences between the proposed intervention and a dose-matched control condition (Nutrition Program), for the following outcomes through 8 months post prison release: reduced unprotected vaginal or anal sex occasions and fewer cases of vaginal trichomoniasis (primary); reduced interpersonal violence episodes, symptoms of PTSD and depression, and drug using/heavy drinking days (secondary); and increased affect management and social support (including effectiveness in obtaining substance use, mental health treatment and other resources) (tertiary).


Eligibility Criteria:
Inclusion Criteria:

* Females in prison
* Experienced lifetime interpersonal violence (includes physical or sexual assault or abuse)
* At least one unprotected sexual occasion with a male partner within the 90 days prior to incarceration
* Approximately 6-10 weeks before release
* Expect to be released to locations within RI or MA

Exclusion criteria:

* Cannot complete intake interview due to problems with reality testing, brain impairment, or language barrier
Volume Flow-guided Angioplasty of Dysfunctional Dialysis Access

This is a pilot study investigating a new concept of intra-procedural percutaneous duplex ultrasound (DUS) volume flow-guided balloon angioplasty for the quantification and optimization of endovascular treatment outcomes of dysfunctional autologous arteriovenous fistulae (AVF).

This is a prospective, single-center, single-arm clinical trial introducing a new functional index of clinical success of endovascular treatment and investigating the feasibility of volume flow-guided balloon angioplasty of dysfunctional AVF assessed with intraprocedural percutaneous DUS. The study will include consecutive patients undergoing fluoroscopically-guided percutaneous balloon angioplasty due to dysfunctional AVF in the investigator's center. Exclusion criteria will be: (i) not available volume flow values at the time of AVF maturation, (ii) patients with arteriovenous synthetic grafts. Patients' demographical data, dialysis access history, and procedural details will be recorded. Intraprocedural volume flow measurements will be obtained just prior to the procedure and after each balloon dilation. Volume flow measurements will be correlated with digital subtraction angiography quantitative vessel analysis (QVA) performed by an independent investigator blinded to the volume flow analysis outcomes. Follow up DUS imaging including volume-flow assessment will be set at 24h, 6, and 12 months after the index procedure, while fistulograms with QVA analysis will be performed at 6 and 12 months. All DUS measurements will be performed using the same imaging protocol and the same operator. The study's primary endpoints will be (i) the quantification of angioplasty outcome using sequential DUS volume flow analysis following each balloon catheter dilation and (ii) to assess the correlation between volume flow and clinical success defined as high-quality dialysis for a period of at least one month. Secondary endpoints will be (i) re-intervention-free interval defined as the time interval between endovascular treatment and reintervention due to dysfunction recurrence of the treated AVF and (ii) correlation between volume flow and QVA measurements.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients undergoing fluoroscopically-guided percutaneous balloon angioplasty due to dysfunctional AVF
* Signed consent form
* Agree to the imaging protocol

Exclusion Criteria:

* not available volume flow values at the time of AVF maturation
* patients with arteriovenous synthetic grafts.
Antazoline in Rapid Cardioversion of Paroxysmal Atrial Fibrillation

The purpose of this randomized, double blind, placebo-controlled, superiority clinical trial was to assess clinical efficacy of antazoline in rapid conversion of atrial fibrillation during observation sinus rhythm.

Antazoline is a first generation antihistaminic agent with chinidin-like properties. When administered intravenously, antazoline exerts a strong antiarrhythmic effect on supraventricular arrhythmia especially on atrial fibrillation (AF) facilitating rapid conversion to sinus rhythm. Despite relative lack of published data antazoline is marketed in Poland and widely used in cardiology wards and emergency rooms due to its efficacy, safety and rapid onset of action within minutes of administration.

To show superiority of antazoline over placebo a sample size of 80 patients was calculated based on following assumptions: two-tailed test, a type I error of 0.01, a power of 90%, efficacy of placebo 5%, efficacy of antazoline 50% and 20% drop-out rate to fulfill the criteria of intention-to-treat analysis. Due to presumed lack of statistical power the secondary end points and safety endpoints will be considered exploratory.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent for participating in the study and written standard version of informed consent for cardioversion accepted in Institute of Cardiology, Warsaw, Poland
* Age above 18 and good general condition
* Potassium level over 3.5 mmol/l
* Stable cardio-pulmonary state on enrollment
* In case of unclear history of heart failure or suspicion of impaired left ventricle function echocardiography is indicated prior to enrollment
* A long-term antiarrhythmic drug therapy is allowed

Exclusion Criteria:

* Lack of written informed consent
* Antazoline allergy
* AF related to significant valvular disease
* Clinically significant heart failure or ejection fraction \< 55%
* Diastolic blood pressure (BP) \< 100mmHg
* History of significant bradyarrhythmia not treated with permanent pacemaker
* QT prolongation over 440ms or QTc (Bazett's formula) over population norm
* Tachycardia \> 160'
* Advanced liver or kidney failure
* Acute coronary syndrome, coronary artery by-pass graft, stroke or transient ischemic attack within 30 days before enrollment
* Preexcitation in ECG not treated by radiofrequency ablation of accessory pathway
* Signs and symptoms of ischemia related to AF
* An investigational drug used within 30 days before enrollment
* Pregnancy or breast feeding
A Safety Trial of GEN1042 in Japanese Subjects With Malignant Solid Tumors

This study evaluating GEN1042 will include multiple parts. In this study, GEN1042 alone (phase 1a) or GEN1042 in combination with other anticancer drug(s) (phase 1b) will be evaluated in Japanese participants. The main purpose is to assess the safety and tolerability of GEN1042 monotherapy or GEN1042 in combination in Japanese study participants with cancer.

This is an open-label, trial to evaluate the safety and tolerability, pharmacokinetics (PK), pharmacodynamics, and antitumor activity of GEN1042 in Japanese participants with malignant solid tumors. The trial consists of 2 parts: a GEN1042 Monotherapy Dose Escalation Part (phase 1a); and a Combination Therapy Part (phase 1b).

The purpose of Dose Escalation Part (phase 1a) is to evaluate GEN1042 as monotherapy in participants with non-central nervous system (non-CNS) malignant solid tumors.

The Combination Therapy Part (phase 1b) will evaluate GEN1042 in combination with pembrolizumab (pembro) or pembro along with the standard of care (SOC) chemotherapy in participants with head and neck squamous cell carcinoma (HNSCC) and non-small-cell lung cancer (NSCLC).

Eligibility Criteria:
Key Inclusion Criteria:

1. Must have measurable disease according to RECIST v1.1.
2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
3. Acceptable organ and bone marrow function.
4. Participant must have a life expectancy of at least 3 months.

Key Exclusion Criteria:

1. Has clinically significant toxicities from previous anticancer therapies.
2. Has rapidly progressing disease.
3. Has a history of noninfectious pneumonitis/interstitial lung disease.
4. Has a history of liver disease.
5. Has had an allogeneic tissue/solid organ transplant or autologous or allogeneic bone marrow transplant, or stem cell rescue within 3 months prior to the first dose of GEN1042.
6. Has any history of intracerebral arteriovenous malformation, cerebral aneurysm, or progressive brain metastases or stroke.
7. Has had major surgery within 4 weeks before Screening.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Gravitas Feeding Tube System Placement Validation in Neonates

The purpose of this study is to validate the Gravitas Feeding Tube System Placement Algorithm for NICU patients and to evaluate the safety and effectiveness of the Gravitas Feeding Tube in the neonate population for the administration of nutrition, fluids and medications.


Eligibility Criteria:
Inclusion Criteria:

* Infants in the Newborn Intensive Care Unit or on the general medical floor requiring a 5-8 Fr NG tube. The desired size of the feeding tube should be determined clinically, and the Gravitas 5-8 Fr Feeding Tube should only be placed if that size is appropriate.
* Age at enrollment: 0 to 18 weeks post-partum. Can be up to 12 weeks preterm (gestational age ≥ 28 weeks).
* Suitable to start enteral (gastric but not post-pyloric) feeding
* Anticipated to receive enteral feeding (either bolus or continuous feeds) for more than 6 hours. If enteral nutrition has already been initiated, indicated for replacement of an orogastric/nasogastric feeding tube.
* Ability to have a legally authorized representative provide informed consent Both neonates on a ventilator (non-invasive or invasive ventilation) or not requiring a ventilator are eligible for this study.

Exclusion Criteria:

* Known major upper airway malformation (e.g. tracheoesophageal fistula)
* Known major GI malformation (e.g. malrotation)
* NPO status - neonate expected to remain NPO/NPG for the following 72 hours
* Has a medical condition that drastically affects gastric acid-secretion (e.g. Zollinger-Ellison Syndrome, congenital achlorhydria, gastrointestinal perforation/leak/obstruction);
* Has had removal of part of the stomach
* Critically ill, facing imminent death
* Neonate on ECMO
* Deemed unsuitable for enrollment in study by the site principal investigator based on the patients' medical history
* Infant needs an MRI in the immediate future (e.g. 6-12h)
* Infant needs post-pyloric feeds (distal to stomach)
* Infant has a basilar skull fracture
Effects of and Exploring the Processes of Free Movement Dance as a Physical Therapy Intervention for Female Patients Diagnosed With Chronic Widespread Pain (Including Fibromyalgia).

The study has three parts:

Part 1: To evaluate, for adult female patients diagnosed with chronic widespread pain (including fibromyalgia), the effects of Free Movement Dance as an add-on intervention after interdisciplinary pain management/rehabilitation at a specialist pain clinic versus modified person-centered progressive resistance exercise. The cognitive-behavioural conceptualization of pain, effects on pain intensity, physical function, self-efficacy, pain catastrophizing, health related quality of life, anxiety and depression symptoms and quality of sleep will be evaluated.

Part 2: To explore, for adult female patients diagnosed with chronic widespread pain (including fibromyalgia), the processes of Free Movement Dance, as an add-on intervention after interdisciplinary pain management/rehabilitation at a specialist pain clinic, to generate a substantive theory useful for clinical praxis.

Part 3: To explore and describe why participants who agreed and signed consent choose to withdraw from participating in the interventions of the study's part 1.


Eligibility Criteria:
Inclusion Criteria:

* Female Patients Diagnosed With Chronic Widespread Pain (Including Fibromyalgia) participating in an interdisciplinary pain management and rehabilitation for three months on a specialist pain clinic in south-west of Sweden.
* Age over 18 years and to be able to read and write Swedish. -

Exclusion Criteria:

* Red flag disorders such as malignancy/cancer, acute traumas such as fracture (less than six months ago) or infection.
* Pregnancy, severe mental illness, and ongoing substance abuse.
* Yellow flags as issues with compensation system or unsolved insurance issues with insurance company or the Swedish Social Insurance Agency. -
Oxytocin vs. Prostaglandin for Induction of Labor in Primiparas With Prelabor Rupture of Membrane and Low Bishop

The purpose of the study is to compare between oxytocin to prostaglandin (PGE2), regarding time from induction of labor (IOL) to delivery among primiparas at term with prelabor rupture of membrane (PROM) and an unfavorable cervix.

The purpose of the study is to compare between oxytocin to prostaglandin (PGE2), regarding time from induction of labor (IOL) to delivery among primiparas at term with prelabor rupture of membrane (PROM) and an unfavorable cervix.

Our secondary outcome is to compare between the groups regarding obstetric complications including: cesarean delivery, operative vaginal delivery, maternal intrapartum fever, postpartum hemorrhage, Apgar score at 5 minutes ≤ 7, PH, admission to NICU and the time from initiation of induction to active labor.

The study population will include primiparous at term with PROM and unfavorable bishop score (≤3). Subsequent to confirming inclusion criteria and after receiving informed consent parturients will be randomly allocated to receive oxytocin or PGE2.

Induction with oxytocin (group 1) will be initiated by infusion of intravenous oxytocin: 2.5 mIU per minute with increments of 2.5 mIU every 20 minutes until achieving 4-5 contractions during 10 minutes. Then after continuous infusion without increasing oxytocin dose will be continued. In case of lack of painful contraction/active labor after 24 hours with oxytocin a trial with PGE2 will be initiated (as described for group 2) Induction with PGE2 (group 2) will be initiated by inserting to the posterior fornix PGE2 2 mg, this will be repeated every 6 hours until achieving painful contractions or up to 4 doses (24 hours). In case of lack of painful contraction/active labor after the fourth dose of PGE2 a trial with oxytocin will be initiated (as described for group1).

Failed induction will be defined for parturients who failed to develop active labor after 48 hours from initiation of induction.

Decisions regarding management of labor including all aspects of labor (augmentation, delivery, postpartum) will be made by the physician in charge and will be based on standards of our labor room.

Eligibility Criteria:
Inclusion Criteria:

Age 18-38 years Primiparas Term (37-42) EFW 2500-4000 PROM \< 12 hours Confirmed PROM No painful contractions Vertex presentation Willing to be induced Bishop score: (3 or less) cervix: elongated, posterior, closed, firm-medium, head SP-1 or higher

Exclusion Criteria:

Intrauterine growth retardation preterm\<37 weeks painful contraction Other reasons for induction aside from PROM as: severe PIH, uncontrolled GDM Medical conditions that the researcher thinks will affect the outcome

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Hypnosis for Treating Xerostomia Following Radiotherapy in Head & Neck Cancer Patients

xerostomia develops in all patients with head and neck cancer following radiotherapy. it consists one of the main side effects which affects quality of life. currently, there is no standard of care for treating this condition. parasympathomimetic drugs may help but carry significant side effects.

hypnosis may affect autonomic function such as salivation, in healthy people.in this study we will explore the efficacy of hypnosis in improving salivation, in the patient population.

10 head and neck cancer patients with xerostomia following radiotherapy will be assessed for severity of xerostomia using questionnares and quantitative salivation tests. patients responsive to citric acid will receive a hypnotic session with specific suggestion for salivation. saliva volume will be assessed pre and post hypnosis. patients will receive a CD with recorded hypnotic session to use freely at home. xerostomia will be assessed using a questionnare one week following hypnosis.

Eligibility Criteria:
Inclusion Criteria:

* radiotherapy for head and neck cancer
* xerostomia

Exclusion Criteria:

* psychiatric illness (present or past)
Prophylactic Use of Cranberries in Recurrent Bacterial Cystitis in Women

To investigate if oral administration of 240mg PAC of cranberries can reduce the number of episodes of acute bacterial cystitis and improve general QoL in women with recurrent bacterial cystitis. In addition, the effect on vagina and rectal flora will studied and the adverse effect profile of the drug will be reported.

Women with ≥3 symptomatic episodes of lower UTIs at the previous year will be recruited from the outpatient population who present to their family physician or specialist with symptomatic recurrent UTI. Informed consent will be obtained from all patients and they will be divided in groups according to their age. Urinary culture, vaginal and rectal swab will be taken from all the patients. Antibiotic treatment will be prescribed (using the drug of choice according to the urine culture and the treating physician choice). Subsequently, they will be randomized to receive combined antibiotic treatment with one capsule of Cysticlean 240mg PAC two times per day or antibiotic treatment with placebo. At 14th day post treatment and after a negative urinary culture patients will continue to receive per os, daily, one capsule of Cysticlean 240mg at bed time for 12 months or placebo respectively.

Study visits will occur at 3rd, 6th , 9th and 12th month treatment phase. A urine collection, vaginal swabs and rectal swab will be taken at study entry and at the month 3, 6, 9 and 12 visits.

Participants will be asked about medication usage, any side effects they may be experiencing at each study visit. If participants develop a UTI at any time during the study, they will be asked to visit the study site within 24 hours.


Eligibility Criteria:
Inclusion Criteria:

* Negative urine culture
* At least 3 UTI's within 12 months prior to study entry

Exclusion Criteria:

* Anatomic abnormalities of the urinary tract
* Use of investigational drugs within 30 days prior to study entry
* Current use of warfarin
* Allergy or intolerance of cranberry products
* \> 50 ml of residual urine (measured by US)
* Use of indwelling catheter
* uncontrolled diabetes
* creatinine \> 250 mmol/l,
* Symptomatic vaginitis
* Pregnant or breastfeeding
Exercise and Nutrition Recommendations for Patients Using Glucocorticoids (ENRG)

This parallel-group randomized, controlled, clinical trial aims to investigate the influence of a 6-month home-based, remotely-monitored, exercise training intervention on musculoskeletal health in patients with Systemic Lupus Erythematosus who have undergone glucocorticoid pulse therapy.

Glucocorticoid treatment is a frequently prescribed to individuals with autoimmune diseases, such as Systemic Lupus Erythematosus, due to its anti-inflammatory effects. This treatment strategy has proven clinical benefits, but it can also adversely influence musculoskeletal health. Glucocorticoid pulse therapy is a particularly intensive treatment strategy, commonly used when the disease state is at its most active. Patients who undergo pulse therapy have a high risk of muscle and bone loss, and exercise training is a promising adjunct therapy to potentially ameliorate these adverse effects, but the feasibility and efficacy of this approach has yet to be investigated. The aim of this study, therefore, is to conduct a parallel-group, controlled, randomized clinical trial, to investigate the feasibility and efficacy of a home-based, remotely-monitored, exercise training intervention on musculoskeletal health in patients with Systemic Lupus Erythematosus who have undergone glucocorticoid pulse therapy.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women aged 18 to 45 diagnosed with Systemic Lupus Erythematosus according to SLICC criteria;
* Medical indication and prescription for glucocorticoid pulse therapy;
* Access to Internet and any device that allows for participation in exercise training online lessons (such as smart phone, laptop or personal computer);
* Willingness to participate in an exercise training program.

Exclusion Criteria:

* Any physical, mental, neurological or musculoskeletal health impairment that contra-indicates exercise training.
* Use of medical therapy that alters bone metabolism, such as bisphosphonates, teriparatide and denosumab;
* Receiving prescription for multiple glucocorticoid pulse therapies mid-intervention;
* Being currently enrolled or having enrolled in a structured exercise training program in the last 6 months (defined as at least 2 planned, structures sessions of exercise training per week);
* Having a vertebral fracture at the moment of enrollment (identified by Vertical Fracture Assessment), or high risk for fracture (defined as low hip or spine bone mass \[z-score \< -3\] or history of fragility fractures).