cyrilzakka/clinical-trials huggingface dataset:
Repair Of Flexor Tendon In Zone II Using Minimal Incisions

Repair of the zone II flexor tendon of the hand using minimal incisions is successful with good results which will improve the outcome of the repair.

Flexor tendon laceration in the hand is a common injury with unique characteristics owing to the anatomy of flexor tendons contained within a flexor sheath, requiring good surgical technique as well as strict rehabilitation protocol for regaining function.

The hand is divided into 5 zones (Verdan's). Zone II is described by Bunnel as "No Man's Land" historically back to the 14th century (an area outside London used for executions) because it was previously believed that primary repair should not be done in this zone. After understanding flexor tendon anatomy, biomechanics, and healing new techniques of surgery and anesthesia repair is possible with good results.

Lacerated tendons in zone II can retract proximally to the PIP if the vinculum longus is intact or into the palm if it is disrupted. It will not retract to the level of the wrist because of the origin of the lumbrical insertion into the extensor mechanism.

The laceration can be extended in a Brunner incision or a mid-lateral exposure but it is better skin incisions are minimal to minimize postoperative finger edema, potential adhesions, and injury of any delicate structures.

There are a lot of techniques to retrieve the proximal tendon end as milking, using a hemostat or second incision proximal to the A1 pulley where the tendon is tied to a looped wire of silastic tube and pulled distally through the laceration in the tendon sheath. But little studies discuss the effect of minimal incision on functional outcomes post-operative.

Eligibility Criteria:
Inclusion Criteria:

Age: between 16-60 years.

* Flexor tendon injuries of zone II of any medial four digits in both genders.
* within two weeks.
* Sharp mechanism of injury.
* Single-level injury
* Minimal surgical incision.

Exclusion Criteria:

* Age less than sixteen years old or more than sixty years old.
* Amputation requiring replantation.
* Vascular injury requiring revascularization
* Associated fractures close to the tendon injury.
* Combined flexor and extensor tendon injury.
* Multiple-level injury
* Tendon substance loss
* Insufficient skin and soft tissue coverage.
* Surgical incision for whole tendon exposure.
Comparative Analysis of Cerebral Oximetry and Mean Arterial Pressures at the Cerebral Level in the Beach Chair Position

The purpose of this study is to compare the changes measured by Somanetics Invos cerebral oximeter to the mean arterial pressure at brain level in patients having elective shoulder replacement surgery. The Somanetics Invos System measures and monitors the oxygen saturation (rS02) of blood in the brain tissues to help prevent brain injury or other complications. The investigators hypothesize that maintaining normocarbia and systemic mean arterial pressure at or above 70mmHg during general anesthesia in the beach chair position will decrease the number of cerebral deoxygenation events during the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be undergoing elective shoulder replacement surgery
* Subjects must have an ASA class of I or II
* Subject is able and willing to sign the informed consent
* Subject is 18 years of age or older at time of consent
* Subject is not pregnant
* Subject is not a prisoner

Exclusion Criteria:

* Subject has a mental condition that may interfere with the subject's ability to give informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the subject cannot understand the informed consent process, global dementia, prior strokes that interfere with Subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
* Subject is younger than 18 years of age at consent
* Subject is pregnant
* Subject is a prisoner
Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy

The purpose of the present study is to evaluate the role of peripheral afferent input for spontaneous pain in painful diabetic polyneuropathy

Both peripheral and central changes in the nervous system contribute to the development of painful diabetic neuropathy, but how these changes contribute to the pain generation remains yet to be fully understood.

The purpose of this study is to evaluate if a peripheral regional nerve block relieves spontaneous pain in painful diabetic polyneuropathy.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older.
* Probably diabetic neuropathy confirmed using the Toronto criteria in a "conservative manner", i.e. three out of three symptoms/signs of neuropathy must be present (sensory neuropathy symptoms, distal reduced sensibility, reduced ankle reflexes) 7.
* Definite or probable neuropathic pain for minimum the last 6 months
* Mean pain intensity at \> 4 NRS the last week17.

Since we expect a large effect of the block it is not necessary to discontinue pain medication.

Exclusion Criteria:

* Other causes of pain in the same area or other pain that cannot be distinguished from the neuropathic pain.
* Unable to understand and speak Danish.
* Non-cooperative.
* Warfarin or other medication that contraindicate regional anesthesia.
* Infection in the injection area.
* Allergy to lidocaine.
* Pregnancy or lactating (fertile women must to show negative pregnancy test or use anticonception).
* Severe psychiatric disease e.g. severe depression during the last 6 months.
* Alcohol or drug abuse.
LESS Surgery Versus Conventional Multiport Laparoscopy in Ovarian Drilling

laparoendoscopic single-site surgery is compared to conventional multi-port laparoscopy for polycystic ovary syndrome in infertile women undergoing ovarian drilling as regards successful surgical procedure with less side effects

Laparoendoscopic single-site surgery; one of the most recent advances in the field of minimally invasive surgery, is the use of a single incision in the umbilicus for laparoscopic surgeries, is compared to the conventional multi-port laparoscopy for polycystic ovary syndrome in infertile women undergoing ovarian drilling as regards successful surgical procedure without conversion to laparotomy or use of an additional port in the single site group. in addition to operative time, intra- and post- operative complications and cosmetic outcome.

Eligibility Criteria:
Inclusion Criteria:

* PCOS according to Rotterdam Criteria (2 out of 3):
* polycystic ovaries (12 or more follicles in each ovary and/or increased ovarian volume \>10 cm3).
* oligo- or an-ovulation.
* clinical and/or biochemical hyperandrogenisim. After exclusion of other aetiologies for irregular cycles.
* Indications of laparoscopic ovarian drilling:
* clomiphene citrate- resistance or failure: failure to conceive after 6 to 9 cycles.
* other indications for laparoscopy.
* before gonadotropin administration to decrease risk of OHSS and multiple pregnancy.
* before ART to decrease risk of severe OHSS in women who previously had canceled IVF cycles due to OHSS risk or who suffered from OHSS in a previous treatment.

Exclusion Criteria:

* previous 2 or more laparotomies.
* chronic pelvic pain, endometriosis or pelvic inflammatory diseases to avoid pelvic adhesions and bias in the quantification of postoperative pain.
* High BMI (\>35kg/m2)
* do not possess a native umbilicus.
* advanced gynaecological surgeries or malignant disorders (TLH, ALVH, laparoscopic myomectomy).
* contraindication to any laparoscopy like any medical condition worsened by pneumoperitoneum or Trendelnburg position.
Newborn Pain and Stress Levels in Oxytocin Induction at Birth

The aim of the study is to compare pain and stress levels in the early neonatal period in newborns with and without oxytocin induction. The research was conducted in a case-control study design. The population of the study consisted of participants who gave birth vaginally (with or without oxytocin induction). The sample number of the study was calculated with the G\*Power 3.1.9.2 program, taking into account the mean and standard deviation values of the NIPS score in Cetinkaya et al., (2020). Effect size: 0.666, α= 0.05, power: 0.95, oxytocin induction group: 60, non-oxytocin induction group: 60. Anticipating possible data loss, 164 participants and their newborns were included, 85 in the oxytocin induction group and 79 in the non-oxytocin induction group. was included. The data of the study were collected using the Pregnant Information Form, Neonatal Follow-up Form and Newborn Pain and Stress Assessment Scale (ALPS-Neo). The research data were analyzed in SPSS 29.0 (IBM) program.

Purpose: To compare the pain and stress levels of painful stimuli in the early neonatal period in newborns with and without oxytocin induction.

H1: There is a statistical difference between the ALPS-Neo scores of the newborns of the group in which oxytocin induction was applied in labor and the group in which it was not applied.

H0: There is no statistical difference between the ALPS-Neo scores of the newborns of the group that underwent oxytocin induction in labor and the group that did not.

The data of the study were collected using the Pregnant Information Form, Neonatal Follow-up Form and Newborn Pain and Stress Assessment Scale (ALPS-Neo).

In the study, participants were divided into two groups: those with and without oxytocin induction, and the data were collected based on self-report. Newborn painful stimuli were discussed under 3 headings; drying process, first injection process and blood sugar measurement process. Before, during and after these procedures, data were confirmed and collected by one researcher and the other by an independent observer.

Statistical analysis was performed using IBM SPSS Statistic 29.0 (IBM Corp., Armonk, NY, USA). Descriptive statistical methods (number, percentage, mean, standard deviation) were used to evaluate socio-demographic data. It was used in comparative analysis of the data (chi square, t test, etc.). P value was considered significant at p\<0.05.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant at term,
* Giving birth vaginally,
* Birth weight ≥2500gr,
* Participants with a single and healthy fetus and their newborns

Exclusion Criteria:

* Mentally incompetent,
* Having a high-risk pregnancy,
* Those with risky newborns
To Determine the Maximum Tolerated Dose (MTD) of BIBF 1120 in Patients With Solid Tumours

The primary objective of this study was to determine the maximum tolerated dose (MTD) of BIBF 1120 in patients with solid tumours by the monitoring of drug-related adverse events. Secondary objectives were the evaluation of safety, efficacy, pharmacokinetics, and pharmacodynamics.


Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed diagnosis of advanced, non resectable and / or metastatic solid tumours, who have failed conventional treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment
* Evaluable tumour deposits by one or more techniques (X-ray, CT, MRI, ultrasound)
* Age 18 years or older
* Life expectancy of at least three months
* Patients had to give written informed consent (which must be consistent with International Conference on Harmonization Good Clinical Practice (ICH-GCP) and local legislation)
* Eastern Cooperative Oncology Group (ECOG) performance score \< 2
* Full recovery from all therapy-related toxicities from previous chemo-, hormone-,immuno-, or radiotherapy

Exclusion Criteria:

* History of relevant surgical procedures during the last four weeks prior to treatment with the trial drug, or active ulcers, or injuries with incomplete wound healing
* Pregnancy or breastfeeding
* Active infectious disease
* Brain metastases requiring therapy
* Absolute neutrophil count less than 1500 / mm3
* Platelet count less than 100 000 / mm3
* Bilirubin greater than 1.5 mg / dl (\> 26 μmol / L, International System of Units (SI unit) equivalent)
* Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than three times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal)
* Serum creatinine greater than 1.5 mg / dl (\> 132 μmol / L, SI unit equivalent)
* Uncontrolled, severe hypertension
* Gastrointestinal disorders anticipated to interfere with the resorption of the study drug
* Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol
* Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
* Treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial (except for present trial drug)
* Patients unable to comply with the protocol
* Active alcohol or drug abuse
Replaceability of Fluoroscopy and Ultrasound in the Evaluation of Hemidiaphragm Excursion

Precise measurement of diaphragm function is difficult. Several methods exist. No are sufficiently validated.

With this study, the investigators wish to investigate the validity of different ultrasound and radiological methods and compare them with inspiratory pressure measurements.

Fluoroscopy assessment of diaphragm motility is obtained and simultaneously correlated to sonographic assessments of motility.

Eligibility Criteria:
Inclusion Criteria:

* Completed informed consent
* one of the following conditions:

  * Healthy participants, control group
  * Lung disease group.

    * COPD or
    * Ideopatic pulmonary fibrosis.
  * Heart disease group.

Heart disease that lead to:

* heart transplantat or
* left ventricular assist device.

Exclusion Criteria:

* Known diaphragm dysfunction.
* Neuromuscular disease.
* Pleural effusion.
* Pneumothorax.
* In the healthy group: Significant comorbidity that affect heart og lung function (arterial hypertention, mild valve disease and COPD without symptoms are accepted).
* In the healthy group and in the lung disease group: Previous thorax surgery.
Treating Oxidative Stress in Children With Autism

An open label trial was undertaken in 40 autistic children to determine whether treatment with metabolic precursors methylcobalamin and folinic acid would improve plasma biomarkers of oxidative stress and measures of core behavior using the Vineland Adaptive Behavior Scales (VABS). Metabolites involved in methionine and glutathione synthesis and VABS behavior scores were measured before and after a three month intervention period.

The results indicated that pre-treatment metabolites in autistic children were significantly different from values in age-matched control children. The three month intervention resulted in significant increases in cysteine, cysteinylglycine, and glutathione (GSH, p \< 0.001). The oxidized disulfide form of glutathione (GSSG) was decreased (p \< 0.008) and the glutathione redox ratio (GSH/GSSG) was increased after treatment (p \< 0.001). Although significantly improved, these metabolites remained below control levels after intervention (p \> 0.01). Similarly, increases in VABS composite score and sub-scores for Socialization, Communication, and Daily Living Skills increased after treatment (p \< 0.007) but also remained below standard scores.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Autistic Disorder by DSM-IV 299.0 or CARS score \>30

Exclusion Criteria:

* Primary genetic disease with co-morbid autism
* frequent seizures
* recent surgery
* active infection with fever
* high dose vitamin/mineral supplements
* severe gastrointestinal symptoms
The Impact of Oral Contrast in Multidetector CT of the Abdomen and Pelvis on Radiologist Confidence

The investigators seek to demonstrate the non-superiority of oral contrast versus no oral contrast in intravenously enhanced CT in the outpatient setting. The investigators want to decrease preparation time for the patient and decrease delay in obtaining the study which will ultimately lead to faster results and an increased level of patient convenience.

The investigators hypothesis: Oral contrast does not significantly affect the diagnostic confidence of interpreting radiologists in intravenously enhanced abdominal CT scans.

This study will be a randomized controlled trial comparing radiologist confidence when faced with an intravenously enhanced study with and without oral contrast. At the time of making the appointment, the clerk will ask the patient if he/she wishes to participate in a research study about the impact of oral contrast. If the patient assents, he/she will receive a phone call from a research assistant to obtain informed consent. The first ten patients to call the office to schedule a scan using a 64 slice MDCT will be recruited and randomized if they consent.

Subjects will be randomized at the time of recruitment, which will be when he/she calls to make the appointment for the exam, in a 1:1 ratio between the control arm (contrast) and the experimental arm (no contrast). The control arm will either pick up their two bottles of oral contrast at a radiology office or have the bottles mailed to them as is currently the standard. They will drink the oral contrast two hours before the study. They will also ingest 300 mL of water immediately prior to imaging and be administered the standard intravenous contrast dose. The experimental group will not be mailed or given any oral contrast. They will arrive at their appointment and ingest 300 mL of water immediately prior to the exam as well as the standard intravenous contrast dose and be scanned. This design will eliminate the need to repeat scanning patients, thus decreasing radiation dose. A patient satisfaction survey will be given to each patient following the exam and handed to the technologist

Eligibility Criteria:
Inclusion Criteria:

* order for "Contrast Enhanced abdomen CT" or "Contrast Enhanced abdomen/pelvis CT"

  * age ≥21
  * able and willing to give consent

Exclusion Criteria:

* • allergy to IV contrast

  * order for non-contrast CT
  * \<21
  * pregnant woman
  * order for enterography or colonography
  * history of Crohn's Disease or Ulcerative Colitis
Comparison of Software-assisted Implantation of Elastic Spine Pad (TM) With Respect to Postoperative Change in Neck Disability Index (NDI) With the Conventional Disc Spacer Squale (TM) After Anterior Cervical Discectomy for Cervical Disc Prolapse

This is an investigator-initiated study. The primary goal is to evaluate the efficacy of two different cervical disc devices (prosthesis vs rigid spacer) with respect to postoperative change in neck disability index. The evaluation will include clinical and radiological parameters.


Eligibility Criteria:
Inclusion Criteria:

* Indication for monosegmental anterior cervical discectomy with implantation of a disc prosthesis

Exclusion Criteria:

* Radiologic signs of extensive bone degeneration in the affected segment
* Necessity of implantation of a device smaller in height than 5 mm (as predicted with teh use of the Vertaplan (TM) software
* Transversal spine cord lesion
* Cervical myelopathy
* Preceding surgery on the cervical spine
* Traumatic lesions of the cervical spine
* Radiographic instability in the affected segment: flexion / extension: shift sagittal plane\> 3.5 mm or 20% and rotation in the sagittal plane \> 20 °, OR in static X-ray examinations: shift in the sagittal plane 3.5 mm or 20% of the vertebral body width and relative sagittal plane angulation \> 11º
* signs of instability (Olisthesis) in another segment of the cervical spine
* Active systemic infection
* diseases of the rheumatic type and all autoimmune diseases
* bone metabolic diseases (for example, Paget's disease)
* skeletal metastases
* infections in the cervical spine
* Neurological seizure disorders or other serious neurological disease with risk of falls
* Severe heart failure (NYHA III-IV)
* Bleeding disorders or clopidogrel / coumarins - treatment
* Systemic use of corticosteroids for more than a month in the last 12 months
* Pregnancy
* Legally incompetent patient
* Lactation
* Deformity, anomalies, not fully developed skeleton
* Local tumor disease
* Pre-existing neurologic abnormalities or other shortcomings, such as a Parkinson's disease, diabetic neuropathy, multiple sclerosis, peripheral neuropathy
* Drug / drug or alcohol dependence
Evaluating the Effectiveness of Implementation Intentions to Strengthen Approach-avoidance Training

Approach Bias Modifcation corresponds to computerized interventions designed to change a cognitive bias (i.e., the approach bias) that may contribute to the maintenance of Alcohol Use Disorder. This study aims to compare the effectiveness of a classical Approach Bias Modification program, an Approach Bias Modification program integrating a planning strategy (i.e., implementation intentions) and a Sham-training to decrease the approach bias (from pre to post-test), and Alcohol Use Disorder symptomatology (from baseline to follow-up). 112 patients will be recruited for this study.

The Approach Bias is considered to be a maintenance factor of Alcohol Use Disorder. It correspond to the relative ease to approach alcohol rather than to avoid it. Approach Bias Modifcation correspond to computerized interventiond designed to change it by training participants to emit avoidance response (e.g., pull the joystick away) toward alcohol stimuli (e.g., alcohol pictures). Those programs have shown their effectiveness to promote abstinence among Alcohol Use Disorder patients. This study aims to compare the effectiveness of a classical Approach Bias Modification program to the one of a similar program integrating a planning add-on strategy named implementation intentions and to a Sham-training. 112 patients will be recruited for this study at Clinic de la Mitterie rehab center. During their hospitalization, participants will have to complete: a baseline that assess Alcohol Use Disorder symptomatology (i.e., alcohol consumption, alcohol consumption, and alcohol-related consequences) and other alcohol-related variables (e.g., motivation and self-efficacy), a pre-test that assess the approach bias, 6 sessions of one of the three experimental interventions {classical Approach Bias Modification, Approach Bias Modification with Implementation Intentions, Sham-training}, and a post-test that reassess the approach bias. After their hospitalization, they will have to complete a 2, 4 and 6-month online follow-up that reasses Alcohol Use Disorder symptomatology. It is expect that the Approach Bias Modification program with implementation intentions will decrease the approach bias and Alcohol Use Disorder symptomatology more than the classical program, that will also decrease it more than the Sham-training.

Eligibility Criteria:
Inclusion Criteria:

* care at the clinic for Alcohol Use Disorder,
* have an e-mail address,
* written and spoken French,
* signing informed consent.

Exclusion Criteria:

* not currently remissioned for the Alcohol Use Disorder,
* no other Substance Use Disorder (except tobaco one)