cyrilzakka/clinical-trials huggingface dataset:
Application of Left Colic Artery Preservation, Anastomotic Reinforcing Sutures and Transanal Tube in Robotic Low Anterior Resection

The purpose of this study is to evaluate the results of combined application of left colic artery preservation, anastomotic reinforcing sutures and postoperative transanal tube placement in robotic Low Anterior Resection for Rectal Cancer.

Combined application of left colic artery preservation, anastomotic reinforcing sutures and postoperative transanal tube placement in robotic low anterior resection for rectal cancer

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of low rectal cancer; Low rectal cancer was defined by the presence of the inferior pole of the tumor below the peritoneal reflection (in 11 cm from the anal margin)
* Primary tumor has undergone histologically comfirmed rectal adenocarcinoma
* Together with clinical or radiological evidence of Stage II (T3-4, N0, M0) or Stage III (T1-4, N1-2, M0) disease (according to the 2016 revision of the International Union Against Cancer primary tumor, regional nodes, metastasis (TNM) staging system)
* Performance status (ECOG) 0\~1
* Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; hemoglobin (Hb) ≥9g/dl (within 1 week prior to randomization)
* Adequate hepatic and renal function: Serum bilirubin≤1.5 x upper limit of normal (ULN), alkaline phosphatase ≤5x ULN, and serum transaminase (either primary tumor, regional nodes, metastasis (AST) or ALT) ≤ 5 x ULN(within 1 week prior to randomization);
* Written informed consent for participation in the trial.

Exclusion Criteria:

* Body mass index (BMI) more than 30 kg/m2
* Serious pre-operative comorbidity, including cardiovascular disease (coronary arteriosclerosis, arrhythmia, heart failure), pulmonary dysfunction (lung emphysema, obstructive lung disease), liver insufficiency (Child-Pugh B or C), renal insufficiency (serum creatinine \>2.0 mg/dl), and arterial circulation disturbance (occlusion of arterial vessels of limb in patient's history
* History of accepting abdominal surgery
Magnetic Resonance (MR) Enterography Assessment of Post Operative Small Bowel Length in Short Bowel Syndrome Patients

It is essential to know intestinal length and anastomotic type in post-operative short bowel syndrome patients. These parameters can help predict long-term intestinal failure with long-term parenteral nutrition usually needed for smallest lengths. Sometimes these parameters are unfortunately missing for lack of intraoperative measurement. Thus, it is necessary to develop non-invasive and reproducible techniques to assess small bowel length. This is the reason why the investigators will evaluate magnetic resonance (MR)-enterography and barium follow-through in this indication. There are at this time only two small studies evaluating barium follow-through for intestinal length measurement, and none evaluating MR-enterography. However, a major advantage of the latter is the lack of radiation exposure and possibility to perform 3D.

This will be an open labelled single center crossover study. Short bowel syndrome patients of the investigators center will be included after consent. The sequence of exams (MR enterography followed by barium follow-through or vice-versa) will be randomly assigned. Peroperative short bowel length measurement will be available for all patients. There will be one month between the two exams.

The main objective of this study is to assess the performance of MR-enterography in short bowel measurement in short bowel syndrome patients, the gold standard being peroperative length. Secondary objectives are to assess the performance of barium follow-through in short bowel measurement in these patients, and to show that barium follow-through does not perform better than MR-enterography. For that purpose the investigators will include 50 patients over 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Intraoperative small bowel length \< 200 cm
* Males and females between 18 and 85 years of age
* Patient with social insurance
* Signature of informed consent

Exclusion Criteria:

* Allergy to contrast product
* Enterostomy closure expected within 2 months after randomization
* Pregnancy or breast feeding woman
* Swallowing disorders
* Deprivation of liberty
* Contraindications to magnetic resonance imaging (pace-maker, metal implant, known allergy to gadolinium)
Semi-occluded Vocal Tract Exercise in Velopharyngeal Dysfunction in Patients With Cleft Palate

Analyze the effect of SOVTE (Semi-occluded Vocal Tract Exercise), with high resistance tube, on the velopharyngeal mechanism, for speech rehabilitation of twelve patients with cleft palate with vocal alterations, after four weeks. The study was developed in the city of Porto Alegre, southern Brazil. The hypothesis of the study is that after four weeks of exclusive therapy with exercise it will be improvement in the voice of patients with cleft palate.

The study is an uncompared before-after clinical trial. All patients were submitted to videonasoendoscopy and had their vocal emissions recorded before and after the four weeks of speech therapy. These individuals were submitted to multidimensional evaluation comprised of analysis of images generated by specialized videonasoendoscopy software, analysis of speech emissions by perceptual-auditory evaluation and acoustic analysis, and vocal self-assessment.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with surgically repaired CLP (Cleft lip and palate), regardless of gender and regardless of the type of clef palate.
* The sample only included patients aged 6+ because this is the ideal age to be submitted to videonasoendoscopy.
* These patients attended four speech therapy sessions.
* All individuals agreed to participate in this research voluntarily.

Exclusion Criteria:

* Individuals with cleft lip and palate associated with genetic syndromes or other congenital malformation
* Individuals who proved unable to do SOVTE (Semi-occluded Vocal Tract Exercise),
* No condition to be submitted to videonasoendoscopy examination,
* Patients who did not attend the four sessions of therapy or who did not do exercise at home were excluded from the sample.
Evaluation of Skin Irritation Potential With PF-06700841 Cream Formulation Using Negative Control in Adult Japanese Healthy Participants

This is a Phase 1, single center, randomized, vehicle and white petrolatum controlled, evaluator blinded study to assess the skin irritation potential with a range of concentrations of PF-06700841 cream including vehicle and empty patch with white petrolatum under occlusive conditions in adult Japanese healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants must be 20 to 55 years of age, inclusive, at the time of signing the informed consent document.
* Body mass index (BMI) of 17.5 to 25 kg/m2; and a total body weight \>50 kg (110 lb).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
* Participants who have any visible skin condition at the application site which, in the opinion of the investigative personnel, will interfere with the evaluation of the test site reaction.
* Participants who have psoriasis and/or active AD/eczema/urticaria.
* Participants who have a history of AD.
* Participants who have damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site.
* History of known or suspected intolerance to any of the ingredients of the investigational products, adhesive tape/plaster, or the test patches.
Real World Data Collection on the Synergy Disc

This is a real world data collection observational study at a single site. There are both prospective and retrospective cohorts. The study will examine the safety and effectiveness of the Synergy cervical disc system in patients with degenerative cervical disc disease.


Eligibility Criteria:
Inclusion Criteria:

Age 21 or above at the time of the surgery. Have had (retrospective cohort) or the decision has been made to have (prospective cohort) the Synergy Disc implanted Skeletally mature patients for reconstruction of the disc from C3-C7 following a single or multiple level discectomy for intractable radiculopathy

Intractable radiculopathy and/or myelopathy with at least one of the following producing symptomatic nerve root and/or spinal cord compression:

herniated disc and/or osteophyte formation Symptomatic nerve root and/or spinal cord compression documented by patient history (arm or neck pain and/or neurologic deficit) and imaging (CT, MRI, x-rays, etc.) Failed a minimum of 6 weeks conservative treatment Written informed consent given by subject.

Exclusion Criteria:

Moderate to advanced spondylosis Diagnosis of osteoporosis Active systemic infection or infection at the operative site Pregnancy Marked cervical instability on lateral, coronal, or flexion/extension radiographs Cervical spine condition other than symptomatic cervical disc disease requiring surgical treatment at the involved level Severe pathology of the facet joints of the involved vertebral bodies Previous diagnosis of osteopenia or osteomalacia More than one immobile vertebral level between C1 and T1 from any cause Morbid obesity Vulnerable person (pregnant patients, emergency cases, children, prisoners and people without mental capacity)-
Short-Term Recall and Reprocess Therapy for Post Traumatic Stress Disorder (PTSD)

The goal of this clinical trial is to learn if a short-term behavioral intervention, based on imaginal and in-vivo exposure and psychodynamic reprocessing, works on alleviating Post-Traumatic Stress Disorder (PTSD) symptoms in adults. The trial will also learn about patterns of recovery and relapse by following the patients for up to five years. The main questions it aims to answer are:

Does the reconsolidation-based short-term intervention help alleviate PTSD symptoms? How is it affecting other mental health issues (such as depression, sleep problems, and general functioning)? What is the long-term effect of the intervention? Researchers will compare this behavioral intervention to a waiting list, for up to three months. People on the waiting list will then be able to cross over to the treatment arm as well.

Participants will:

Be screened by a clinical psychologist Take the week-long intensive behavioral intervention (psychotherapy) Followed at the end of treatment (day 7), at 30 and 90 days, and every 6 months, up to five years.

Wearable devices will be used during the week before treatment, during treatment, and up to 30 days following the end of treatment.


Eligibility Criteria:
Inclusion Criteria:

* • Diagnosis of PTSD with a score of 25 or higher (i.e. severe PTSD) on the Clinician- Administered PTSD Scale (CAPS-5) at screening.

  * Subjects on FDA-approved antidepressants, trazodone, atypical neuroleptic, prazosin, or clonidine may enter the study if they have been on a stable treatment, as determined by the study clinician, for at least 4 weeks prior to randomization. Following randomization, small changes to doses may be allowable at the PI's discretion.
  * Able to provide written informed consent.
  * Able to read and write English/Hebrew.

Exclusion Criteria:

* • Patients with a diagnostic history of bipolar disorder, borderline personality disorder, obsessive-compulsive disorder, schizophrenia or schizoaffective disorder or currently exhibiting psychotic features as determined by the clinical interview; dementia or suspicion thereof, are excluded. Other DSM Axis I disorders are permitted as long as they are not considered primary disorders.

  * Patients with a history of antidepressant-induced hypomania or mania as determined by open-ended psychiatric interview.
  * Current, ongoing serious suicidal risk as assessed by evaluating.
  * Moderate severity or greater Substance Use Disorder (excepting Alcohol Use Disorder) during the 3 months prior to randomization, as determined by the SCID.
  * History of traumatic brain injury (TBI) with loss of consciousness for more than 24 hours or posttraumatic amnesia for more than 7 days may be considered if the trauma occurred more than 1 year ago, and no more than minimal symptoms have persisted over the past year.
  * Any significant history of neurological illness or heart disease.
  * Any signs of major medical or neurological illness on examination or as a result of ECG screening or laboratory studies.
  * Any history indicating learning disability or mental retardation.
Study of RAD001 in Patients With Relapsed/Refractory Hodgkin Lymphoma That Has Progressed After High-dose Chemotherapy and Autologous Stem Cell Transplant and/or After Gemcitabine- or Vinorelbine- or Vinblastine-based Treatment.

This study will assess RAD001 in patients with refractory or relapsed Hodgkin Lymphoma that has progressed after high-dose chemotherapy and Autologous Stem cell transplant and/or after gemcitabine- or vinorelbine- or vinblastine-based treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a history of classical Hodgkin's lymphoma that has progressed after high-dose chemotherapy and Autologous Stem cell transplant and/or after gemcitabine- or vinorelbine- or vinblastine-based treatment
* Patients with at least one site of measurable disease measuring ≥ 2.0cm confirmed by PET and CT Scan (or MRI)
* Patients with adequate bone marrow, liver and renal function (confirmed by laboratory values)
* Patients with fasting serum cholesterol ≤300 mg/dL OR ≤7.75 mmol/L AND fasting triglycerides ≤ 2.5 x ULN

Exclusion Criteria:

* Previous treatment with mTOR inhibitors
* Prior allogeneic stem cell transplant
* Chemotherapy, monoclonal antibody therapy, major surgery or treatment with other investigational drugs within 4 weeks of starting study treatment
* Another malignancy within 3 years of study entry (except adequately treated non-melanoma skin cancer and carcinoma in situ of the cervix)
* Severe and/or uncontrolled medical conditions that could affect participation in this study
* Female patients who are pregnant or breastfeeding; patients who are not willing to use adequate birth control during the study and for 8 weeks after the last study treatment Other protocol-defined inclusion/exclusion criteria may apply
A First-in-human Phase 1 Study of CP1050

This is a Phase I, first-in-human, double-blind, single-centre, randomised, placebo-controlled, single and multiple oral dose study in healthy subjects conducted in 4 parts (Part 1; Single-ascending dose, Part 2; Food-effect evaluation, Part 3; Gender-effect evaluation, Part 4; Multiple-ascending dose).


Eligibility Criteria:
Inclusion Criteria:

* Caucasian males or females between 18 and 55 years of age (inclusive).
* A body weight of ≥60 kg for males and ≥50 kg for females, with a body mass index (BMI) ranging from 18.0 to 30.0 kg/m2 (inclusive).
* Healthy and free from clinically significant illness or disease.

Exclusion Criteria:

* Presence or history of any clinically significant disease that could interfere with the objectives of the study or the safety of the subject in the opinion of the Investigator.
* Participation in more than 3 clinical studies involving administration of an IMP in the past one year, or any study within 12 weeks.
* Clinically significant abnormalities in ECG or laboratory tests.
Effect of Perioperative iv Dexmedetomidine vs. Lidocaine on Postoperative Pain, Analgesic Consumption and Recovery After Abdominal Gynaecological Surgery

Postoperative pain continues to be inadequately managed and is the most common reason for the delay in discharge and unplanned hospital admission after surgery. Opioids remain the mainstay for postoperative analgesia. However, there is a continuous search for adjuvant therapies to reduce the doses of opioids and their related adverse effects, and extend the use of non-opioid analgesia for acute pain after abdominal surgery, thereby improving patient recovery. Currently there are no clinical trials that investigate the effect of intravenous lidocaine vs dexmedetomidine on postoperative pain, analgesic consumption and bowel function of patients undergoing abdominal gynaecological surgery. Purpose of this prospective double blind randomised clinical trial is the investigation of the effect of perioperative intravenous infusion of lidocaine vs dexmedetomidine vs placebo (Normal Saline 0,9%) on analgesic parameters and functional recovery of patients undergoing abdominal gynaecological surgery.


Eligibility Criteria:
Inclusion Criteria:

* women
* ASA I-II
* 30-70 years
* abdominal gynaecological surgery

Exclusion Criteria:

* patient's refusal
* contraindication to the use of local anesthetics
* body mass index \>30 kg/m2
* history of cardiovascular diseases/ arrhythmias/ conduction abnormalities
* pregnant women
* significant renal or hepatic impairment
* insulin-dependent diabetes mellitus
* central nervous system disease or psychiatric diseases
* chronic use of opioids, steroids, clonidine (or other a2 agonist)
* use of drugs acting on the central nervous system or analgesics during the previous 2 weeks
* drug/alcohol abuse
* inability to comprehend the following pain assessment scale
First Trimester Risk Assessment Based on Ultrasound and Cell-free DNA vs Combined Screening

There is an ongoing debate regarding how cell-free DNA (cfDNA) screening can best be incorporated into current prenatal screening algorithms for chromosomal abnormalities.

Test performance of cfDNA has been shown to be better that first-trimester combined screening (FTCS). However, the cost of the cfDNA testing is considered too high to adopt as first line screening. Moreover, FTCS includes a detailed ultrasound examination of the fetus with nuchal translucency (NT) measurement that allows for early detection of fetal abnormalities.

An approach in which every woman are offered an early anatomy scan along with cfDNA may also be a reasonable option. Recently a randomized controlled trial, including 1,518 women with singleton pregnancy undergoing first-trimester screening, compared the screening performance of FTCS with an approach that uses the combination of a detailed ultrasound examination and cfDNA analysis. The trial showed that first-trimester risk assessment for trisomy 21 that includes a detailed ultrasound examination along cfDNA was associated with a significant reduction in the false-positive rate compared with FTCS. This approach obviates the need for maternal serum free beta-human chorionic gonadotropin and pregnancy-associated plasma protein-A in screening for fetal aneuploidy.

Despite robust evidence on the very high detection rate of cfDNA in detecting trisomy 21, literature is lacking on data regarding women's experience and emotional well-being and satisfaction after test-results of women offered cfDNA compared to those offered FTCS.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with singleton gestations
* ≤12 6/7 weeks of gestation
* Normal ultrasound examination at the time of randomization
* \>18 \<45 years
* Crown-rump length (CRL) \<84 mm at the time of randomization

Exclusion Criteria:

* Multiple gestations, including vanishing twins
* \>12 6/7 weeks of gestation
* Ectopic pregnancy
* Abnormal ultrasound examination at the time of first prenatal visit
* Women who are unconscious, severly ill, mentally handicapped, or under the age of 18 years.
* Women who have already planned for invasive prenatal testing, e.g. for a history of prior child or pregnancy with chromosomal or genetic abnormalities
* CRL \>84mm at the time of randomization
Intensified Insulin Therapy With Telemedicine

Investigation of the effect of a 3-month telemedicine-led lifestyle intervention in individuals requiring intensified insulin therapy.

The primary objective of this study was to evaluate the development of HbA1c levels in patients requiring 3 months of intensified insulin therapy using standard therapy and telemedicine devices currently in use.

The telemedicine system contains a mobile phone-based nutrition diary, bluetooth-related wrist activity meter, weight scale, blood pressure monitor, blood glucose meter, and IT system for transmitting and displaying data from these devices.

Eligibility Criteria:
Inclusion Criteria:

* Women or men between the ages of 18 and 75
* Patient with Diabetes who needs intensified insulin therapy HbA1c\> = 8%
* IT proficiency is at least basic for cell phones (answering / making a voice call).
* Signing a informed consent
* For women with childbearing potential, by definition, all women who who are physiologically able to conceive are twofold use of contraception
* The subject communicates well with the investigator and is able to perform the test to understand and help comply with the requirements of the protocol

Exclusion Criteria:

* informed refusal any time after the sign of the informed consent
* Planned invasive cardiac intervention (catheter vasodilation or surgical coronary artery bypass grafting, keyboard surgery or replacement)
* Tumor disease
* Pregnant or lactating women
* Any medical condition that does not allow participation
The Anesthetic Efficacy of Lidocaine and Articaine as Buccal Injection for Maxillary Premolar Teeth Extraction.

This study Is designed as a prospective randomized, single-blinded clinical trial. To evaluate The anesthetic efficacy of articaine as a buccal Injection for maxillary premolar teeth extraction, compared to lidocaine as a buccal and palatal injection.

In the current study, the sample size (200) patients were distributed into two groups, group (A), 100 patients extracted upper premolar teeth by using 1.8 mL cartridges of 4% articaine hydrochloride with 1:100,000 epinephrine (Artheek, Colombia) as a buccal injection without palatal injection, and Group (B), 100 patients were removed upper premolar teeth by using Injectable local anesthetic agents included; 1.8 mL cartridges of 2% lidocaine hydrochloride with 1:80,000 epinephrine (Huons, Korea) as a buccal and palatal injection, the pain assessment after extraction was assessed by using (vas) visual analog scale, comparison between the outcomes by the two groups were evaluated, according to many variables (age, gender, extracted tooth, type of anesthesia, extraction duration).

Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥ 16 years old, including both genders.
2. Patients indicated for extraction of one of the maxillary premolar's teeth.

Exclusion Criteria:

1. Patients who were allergic to the local anesthetic agents used in this study.
2. Patients who presented with acute periapical infections.
3. Patients who required surgical extraction that entails flap reflection and bone removal.
4. Pregnant patients.
5. Patients with uncontrolled systemic diseases.
6. Patients are taking medications affecting pain assessment, like opioids.