cyrilzakka/clinical-trials huggingface dataset:
Single-dose to Evaluate the Pharmacokinetics of GTX-101 and Subcutaneous Injectable Bupivacaine in Healthy Subjects

This is a single-center, randomized, single-dose, active-controlled study in healthy male and female subjects.

The study will enroll subjects to evaluate the PK of 3 dose strengths (50 mg, 100 mg and 200 mg) of GTX-101 compared to Subcutaneous injection in healthy adult subjects.

Blood samples for PK assessments will be collect at specified time points. Safety assessments will also be performed throughout the study.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form (ICF)
* Healthy adult male or female, aged 18 to 55 years, inclusive, at Screening
* Body mass index (BMI) within 18.0 kg/m2 to 30.0 kg/m2, inclusively at Screening
* Have no clinically significant diseases captured in the medical/surgical history or evidence of clinically significant findings on the physical examination (including vital signs), weight and/or clinical laboratory tests and/or ECG, as determined by an Investigator

Exclusion Criteria:

* History of significant hypersensitivity to bupivacaine, local anesthetic agents of amide type, or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
* Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
* History of significant gastrointestinal, liver or kidney disease that may affect drug bioavailability
Comparison Between Dexamethasone and Ibuprofen on Pain Prevention and Control Following Surgical Implant Placement

Background and aim: Postoperative pain is an adverse effect of oral surgeries and may therefore be prevented or minimized. This study compares the efficacy of preemptive ibuprofen and dexamethasone protocols in pain prevention and control after surgical implant placement.

Methods: For this prospective, double-masked, parallel-group, placebo-controlled, randomized clinical trial, 117 dental implants were placed. The groups received three different protocols 1 hour before surgery:

1. 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose);
2. 4 mg dexamethasone (and another 4 mg 6 hours after the first dose) or
3. placebo.

Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary. Pain intensity was evaluated by a 101-point numeric rate scale and visual analogue scale, additionally discomfort was evaluated using a four-point verbal rate scale, hourly for the first 8 hours after surgery and three times a day on the following 3 days.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent for the described procedure
* Surgical placement of a single endosteal implant
* Age of at least 18 years

Exclusion Criteria:

* The need for bone grafting or sinus lift for implant placement
* Pregnant and lactating women
* Metabolic disorders
* Immunocompromised status
* Hemophilia or bleeding disorders
* Drug or alcohol abuse
* Treatment with steroids in the previous 6 months
* History of radiation therapy in the head and neck
* Psychiatric disorders
* Inability to understand the procedure described in the questionnaire
Anterior Capsulo-labral Reinsertion by Arthroscopic Approach Versus Immobilization

The risk of recurrence and chronic instability after an initial episode of anterior glenohumeral dislocation is high, the risk is higher the younger the patient is.

Most patients with recurrences develop this instability during the first 2 years.

Several studies have shown that an initial arthroscopic surgical treatment (Bankart intervention) decreased the risk of recurrence and therefore of chronic instability, but this attitude is not usual in France and none randomized study comparing intervention of arthroscopic Bankart and immobilization was published by a French team.

The primary objective was to evaluate at 2 years the efficacy on the rate of recurrent instability of the first-line arthroscopic repair of prior capsulo-labral lesions compared to conservative treatment by immobilization for patients under 25 years having an initial episode of anterior glenohumeral dislocation

Material and method : We conducted a randomized controlled, open-label, parallel-group study (conservative treatment group by immobilizing VS surgical treatment group) in patients aged 18 to 25 with anterior glenohumeral primo luxation. Patients were clinically reassessed at 2 years with functional scores (WOSI, DuplayWalch, DASH), mobility and instability recurrence.

Hypothesis: reduction of the recurrence rate in the surgically treated group


Eligibility Criteria:
Inclusion Criteria:

* Patients with inclusive on the day of dislocation.
* First episode of anterior glenohumeral dislocation without associated humeral fracture confirmed by a standard radiograph.

Exclusion Criteria:

* Dislocation without trauma, in a context of hyper laxity with a Beighton score ≥4 / 97.8. In these patients post-dislocation MRI was performed in the Robinson study, which found no capsulo-labral lesion.
* Bone glenoid defect\> 25% at the scanner (Bony Bankart).
* Delay greater than 15 days between luxation and surgical treatment
* Against indication to anesthesia
* Pregnant or nursing women
Acceptability and Feasibility of Combination Treatment for Cervical Precancer Among South African Women Living With HIV

The purpose of this study is to explore whether an anti-cancer medication (5-fluorouracil cream) placed in the vagina after a surgical excision procedure is an acceptable and useful form of treatment for cervical precancer among the woman with HIV infection.

There are currently no medical therapies recommended to promote the clearance of humanpapilloma virus (HPV) infection, regression of cervical dysplasia, or treatment of cervical intraepithelial neoplasia (CIN). Human immunodeficiency virus (HIV) -infected women are at higher risk of HPV infection, with rates as high as 45% - 90%. Despite being preventable, cytologic abnormalities, cervical precancer (high-grade cervical intraepithelial neoplasia \[CIN2/3\]), and invasive cervical cancer also occur more frequently in HIV infected women.

This study is testing whether topical 5-fluorouracil (5FU) can be used as a patient-controlled adjuvant treatment for cervical precancer (CIN2/3) to be self-administered after surgical excision to reduce the risk of persistent/recurrent CIN2/3 and progression to cervical cancer among HIV-infected women.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed HIV-1 infection
* On antiretroviral therapy (ART), for at least 90 days prior to enrollment
* Cervical biopsy demonstrating CIN2/3 within the preceding 120 days.

Exclusion Criteria:

* pregnancy,
* breastfeeding,
* intend to become pregnant within 180 days of enrollment
* have an active sexually transmitted infection (women may participate once treated)
* have a surgically absent cervix
* have a history of anogenital (cervical, vaginal, vulvar, or anal) cancer or a biopsy suspicious for cervical cancer
* have a medical comorbidity that would interfere with study participation.
Study of AMN107 With Imatinib in Gastrointestinal Stromal Tumors (GIST)

This study is an open-label, multicenter, Phase I dose-escalation study of the combination of AMN107 and imatinib (STI571) in patients with imatinib-resistant GIST. This study is designed to determine the Phase II dose of AMN107 and imatinib when administered together in patients with imatinib-resistant GIST, and to characterize the safety, tolerability and pharmacokinetic (PK) profile of this combination.


Eligibility Criteria:
Inclusion Criteria:

* Patients with gastrointestinal stromal tumor (GIST).
* Patients who have had disease progression during imatinib therapy with 800 mg.
* Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

* Patients with prior or concomitant malignancies other than GIST with the exception of previous or concomitant basal cell skin cancer or previous cervical carcinoma in situ.
* A history of impaired cardiac function or uncontrolled cardiovascular disease.
* Severe and/or uncontrolled concurrent disease that could cause unacceptable safety risks such as impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of AMN107.
* Currently taking certain medications that could affect an electrocardiogram result.
* Women who are pregnant or breast feeding.
* Patients unwilling or unable to comply with the protocol.

NOTE: Additional inclusion and/ or exclusion criteria may apply.
Intravenous Infusion of Lidocaine in Colonoscopy

intravenous infusion of lidocaine significantly reduce fatigue and pain and improve the patients satisfaction after sedation for colonoscopy.

This study divide patients into two groups, lidocaine group one will be given lidocaine intravenously; control group will be given saline . the difference between patients fatigue and pain will be compared. and the propofol consumption, pain after infusion of propofol, patients, endoscopists and anaesthesist satifaction, the incidence of hypotenstion, hypoxia, and bradycardia will aslo be compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria: patients aged \>18 years who were scheduled for colonscopy at Qilu hospital.

Exclusion Criteria:patients with ASA (American Society of Anesthesiologists) Class 4 or 5, pre-existing hypoxemia (SpO2 \<90%), hypotension (systolic blood pressure \<90 mm Hg), bradycardia (HR\<50 beats/min), uncontrolled hypertension (SBP \>170 mm Hg, diastolic blood pressure\>100 mm Hg), severe renal or liver failure, pregnancy or lactation, allergy to lidocaine, atrioventricular block, epilepsy, and inability to give informed consen

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Prevention of Post Operative Urinary Retention After Thoracic Surgery Trial

The objectives of this study are to determine the feasibility of conducting a full-scale randomized control trial comparing the efficacy of tamsulosin compared to placebo in reducing post-operative urinary retention in people undergoing elective thoracic surgery.

The objectives of this study are to determine the feasibility of conducting a full-scale randomized control trial comparing the efficacy of tamsulosin compared to placebo in reducing post-operative urinary retention in people undergoing elective thoracic surgery. Primary outcomes being measured are the enrollment rate, protocol adherence rate and participant drop out.

Eligibility Criteria:
Inclusion Criteria ( 2 or more of the following risk factors):

* Male Sex
* Age greater than or equal to 40 years
* History of Diabetes Mellitus
* Prior pelvic irradiation
* Use of indwelling Thoracic Epidural analgesia
* Prior history of urinary retention

AND

International Prostate Specific Score greater than or equal to 1.

Exclusion Criteria:

* Active treatment of Benign Prostatic Hyperplasia (BPH)
* Hypersensitivity or allergy to tamsulosin HCL
* Active treatment with tamsulosin or other alpha-blocker or uses of tamsulosin/ other alpha-blocker within 3 weeks of enrollment date
* Active urinary tract infection
* History of urological disorder specified as urethral stricture, BPH, bladder or prostate malignancy.
* History of urological surgery (Transurethral resection of the Prostate, Transurethral resection of the Bladder, Bladder suspension, prostatectomy)
* Underlying neurological disorders resulting in impaired bladder function
* Any known contraindication to the use of tamsulosin HCL
* Nursing/ Breastfeeding women
* Use of intraoperative bladder catheter
* patients for whom cataract and/or glaucoma surgery is scheduled.
* patients on strong inhibitors of CYP3A4 (e.g., ketoconazole), on moderate inhibitors of CYP3A4 (e.g., erythromycin), on strong (e.g. paroxetine), on moderate (e.g., terbinafine) inhibitors of CYP2D6 or in patients known to be CYP2D6 poor metabolizers.
* patients with a serious or life-threatening sulfa allergy
* patients with severe hepatic insufficiency
* patients with severe renal impairment (creatinine clearance of \<10 mL/min)
* patients with a serious or life-threatening sulfa allergy
Efficacy of Educating Physical Therapists in the Treatment of Patients With Nonspecific Chronic Low Back Pain

The aim of this trial is to investigate if patients treated by physical therapists who received an update on clinical practice guidelines and pain management have better outcomes than patients treated by physical therapists who did not received such training.

The training "Update on the treatment of patients with nonspecific chronic low back pain" will be announced in the social network by members of the study. Interested physical therapists will send an email to one of the study authors with their information regarding the inclusion criteria. After two months of notice, interested and eligible physiotherapists will be randomized into two groups of 15 participants each.

The study arms are: 1) control group (physical therapist who will not receive training) and 2) experimental group (physical therapist who will receive training). Before and after training, attitudes, beliefs and knowledge about low back pain guidelines will be evaluated.

Each physical therapist will recruit for the study a total of fifteen consecutive patients with chronic nonspecific low back pain (total sample=150 patients). All the patients will be assessed before the first session by a blinded examiner who will be unaware about the group allocation.

Clinical outcomes (pain, disability, fear avoidance beliefs and pain catastrophizing) will be collected at baseline and at 5 weeks, 3 and 6 months after randomization. All statistical analysis will be conducted following the principles of intention to treat analysis and the between-group differences will be performed using Mixed Linear Models.

Eligibility Criteria:
Inclusion Criteria:

* patients seeking care for chronic non-specific low back pain (defined as pain or discomfort between the costal margins and the inferior gluteal folds, with or without referred symptoms in the lower limbs, for at least 3 months), with a pain intensity of at least 3 points measured by a 0-10 pain numerical rating scale, aged between 18 and 65 years.
* physiotherapists who treat exclusively patients with musculoskeletal pain, duly accredited by the National Council of Physical Therapy, physiotherapists offering private or medical insurance treatment individually to their patients, lasting 50-60 minutes each session, physiotherapists from 2 to five years of graduation and / or working in the area for the same period, that treat at least 2 patients with low back pain per month, and who are willing to treat at least 10 patients for the study.

Exclusion Criteria:

* patients will be excluded if they have any contraindication to physical exercise or ultrasound or short wave therapy, evidence of nerve root compromise (i.e one or more of motor, reflex or sensation deficit), serious spinal pathology (such as fracture, tumor, inflammatory and infectious diseases), serious cardiovascular and metabolic diseases, previous back surgery and pregnancy.
* physiotherapists who want to stop the activities for some reason that prevents participation in the study
The Effects of Entrainment on Respiratory Stability and Cerebral Oxygenation in Preterm Infants

Infants born prematurely at will be asked to participate in this randomized controlled trial at a corrected gestational age of 24-37 weeks. Infants will be randomly selected to each of the two groups: intervention and control. Infants in the treatment group will receive six intervention days over a two-week period, 3 sessions per week. Each intervention day consists of each of the two interventions in a random sequence: no intervention/silence and live ocean disc instrument intervention. The sound decibel level will also be recorded and maintained at 40-65dB to prevent overstimulation. Each infant will thus receive control and ocean disc intervention on the same day in the NICU. Interventions will be given in a randomized order (i.e., first ocean disc or first silence, randomized to AM or PM), with observation occurring for 10 minutes before each intervention, 15 minutes during each intervention, and 10 minutes after each per session. There will be 3 sessions per week for a two-week randomized treatment schedule. For each infant, data on total apnea time, mean respiratory rate, heart rate, O2 levels and behavior rating during will be collected. The sound decibel level will also be recorded and maintained at 40-65dB to prevent overstimulation and hearing damage. Near-infrared light spectroscopy (NIRS) data on cerebral oxygenation will also be collected. Observations will be recorded on the infant's activity or when change occurs, such as a pacifier falling out. Parents and nurses will be asked to behave as they normally would during routine care.


Eligibility Criteria:
Inclusion Criteria:

* Newborns born at 24-37 weeks' gestation at Mount Sinai hospital
* Newborn is considered appropriate for clinically indicated music therapy

Exclusion Criteria:

* Infant not expected to survive 24 hours from the time of study entry (To be assessed by a member of the NICU Faculty other than the PI)
* Infant of uncertain viability (gestation \<23 weeks, birth weight \<500 grams)
* Known or suspected genetic disorder (e.g., Trisomy 21)
* Identified hearing disorder
Nanocrystalline Megestrol for First-line Treatment of Advanced Gastric or Colorectal Cancer With Cancer-related Fatigue

This study is a prospective, randomized, parallel-controlled clinical trial, with the primary objective to evaluate the efficacy and safety of nano-crystalline megestrol acetate combined with standard treatment compared to standard treatment alone for the first-line treatment of patients with cancer-related fatigue in gastric or colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years and ≤75 years.
* Eastern Cooperative Oncology Group (ECOG) physical status score of 0-2.
* Expected survival ≥ 6 months.
* Locally advanced or metastatic gastric/gastroesophageal junction (G/GEJ) adenocarcinoma or colorectal adenocarcinoma not amenable to radical treatment with histologic or cytologic confirmation.
* No prior systemic systemic antitumor therapy for gastric/gastroesophageal junction (G/GEJ) adenocarcinoma or colorectal cancer.
* Have at least one measurable tumor lesion according to RECIST v1.1.
* Compliance with a Fatigue Visual Analog Scale (VAS) score of ≥ 4 (consistent with moderate or severe fatigue).
* Complain of anorexia.
* Good organ function as determined by the following requirements.

Exclusion Criteria:

* Suffered significant surgery or traumatic injuries within the past 1month.
* Having any condition that affects gastrointestinal absorption, such as dysphagia, malabsorption, or uncontrollable vomiting.

currently undergoing tube feeding or parenteral nutrition.

* Suffering from anorexia due to neurosis, mental illness, or difficulty eating due to pain.
* Received erythropoietin or blood transfusion within the past 1month.
* Comorbidities such as serious cerebrovascular, heart, kidney, or liver disease.
* A history of hypersensitivity to the components of the trial medication.
* Other conditions that were considered inappropriate as determined by the investigators.
Effect of Amnioinfusion on External Cephalic Version Successful Rate

The aim of the study is to evaluate the effect of transabdominal amnioinfusion before second external cephalic version after initial failure.Patient with a single foetus, at term, in breech presentation and after a first cephalic version are included. The randomisation determines whether the patient is included in the group with amnioinfusion before second cephalic version or with usual second cephalic version only; The efficacy's evaluation is based on rate of cephalic presentation at birth.Success rate of cephalic version with or without transabdominal amnioinfusion, rates of cesarian section in the two groups,maternal and fetal morbidity, time between second cephalic version and birth will be studied.

Prospective interventional randomized sequential comparative multicentric study. A maximum of 240 patients will be included (120 in each group). As the study is sequential it will be over as soon as a significative difference is shown.

The purpose of the study is to evaluate the effect of transabdominal amnioinfusion before a second external cephalic version after initial failure. In case of success it could be an alternative to cesarian section. Without any other technique the foetus is in cephalic presentation after a first external cephalic version in 50%.

Patients with a single fetus, at term, in breech presentation are proposed to participate. The randomization is done at the inclusion and determines whether the patient is included in the group with amnioinfusion before second cephalic version or usual second cephalic version only. The only difference between the two groups is the realisation of an amnioinfusion, the cephalic version's technique is the same.

Efficacy's evaluation is based on rate of cephalic presentation at birth. Success rate of cephalic version, rates of cesarian section, maternal and fetal morbidity in the two groups, time between second cephalic version and birth will be studied.

Eligibility Criteria:
Inclusion Criteria:

* single fetal pregnancy
* breech presentation
* at term
* initial failure of external cephalic version
* structurally normal foetus

Exclusion Criteria:

* polyhydramnios
* anhydramnios
* abnormality of the fetal heart rhythm
* uterine congenital malformation
* cesarian section for a previous birth
* unability to understand study
Neural Predictors and Neural Changes Associated With Cognitive Behavior Therapy for Obssesive Compulsive Disorder

The goals of the project are 1) to understand what are the neural mechanisms involved in the psychological treatment of obsessive-compulsive disorder (OCD) in children/adolescents and adults, 2) to assess potential differences in the neural mechanisms involved in the psychological treatment of OCD between children/adolescents and adults, and 3) to assess the effectiveness of intensive CBT for children/adolescents and adults with OCD.

Obsessive-compulsive disorder (OCD) is a frequent and disabling disorder. Cognitive-behavior therapy (CBT) is the best treatment option available for OCD, although it achieves optimum results in less than half of the patients. The investigators will investigate the main neural circuits that predict CBT outcome in OCD and the neural changes associated with CBT in two separate randomized controlled trials (RCTs), one in an adult sample and another in a pediatric sample. In this two RCTs, OCD participants will be randomized to either intensive CBT (20 sessions in 1 month) by a experienced clinician or a waiting-list control (WLC) and will be assessed (by a blind assessor) and scanned before and after CBT. Patients will be offered CBT if they have been randomized to the WLC. At baseline, the investigators will also compare OCD patients with a group of healthy controls (HC). Secondary goals of the project include 1) assessing potential differences between children/adolescents and adults in the neural mechanisms involved in CBT for OCD; 2) assess the effectiveness of intensive CBT for children/adolescents and adults.

Eligibility Criteria:
Inclusion Criteria: (same for Study 1 and Study 2):

1. Principal diagnosis of OCD;
2. Y-BOCS or CYBOCS ≥ 16).
3. No current psychotropic medication (except benzodiacepines for sleep). 4 ) Age between 8 and 17 years (Study 1) and between 18 and 60 years (Study 2).

Exclusion Criteria: (same for Study 1 and Study 2

1. Current major depression or current/past psychosis, bipolar disorder or substance abuse.
2. Developmental disorders (including autistic spectrum disorders).
3. To be pregnant or during breastfeeding
4. Current CBT; nt.
5. Any severe medical disorder ;
6. Any contraindication for neuroimaging