cyrilzakka/clinical-trials huggingface dataset:
Laparoscopic Versus Transvaginal Closure of the Vaginal Vault After Total Laparoscopic Hysterectomy

The goal of this clinical trial is to compare the laparoscopic and transvaginal closure techniques of the vaginal vault in patients who perform TLH, regarding the risk of vaginal vault hematoma and other complications as vaginal cuff infection and sexual dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* Adult females consenting to do TLH all age groups with diagnoses of benign uterine conditions.
* Women who are non-obese (normal or overweight women with BMI range 18-29.9).
* Sexually active female.

Exclusion Criteria:

* Diagnosed cases of pelvic malignancy
* Diagnosed patients with Cervical intraepithelial neoplasia (CIN) or bacterial vaginosis (any infection should be treated)
* Obese patients.
* Patients currently undergoing treatment for any type of cancer
* Patients with coagulopathy, bleeding/clotting disorders
* Patients with any condition can impair wound healing: diabetes mellites, anemia, steroids
* Patients with a previous history of radiation and allergy to sutures
* Patients with clinically evident prolapse
Preoperative Oral Carbohydrate Loading Versus Fasting in Patients Undergoing Major Abdominal Surgery

The aim of this study is to compare the effect of preoperative carbohydrate load versus the fasting protocol in patients undergoing major abdominal operations.

The surgical patients are influenced by many stressors during operation such as the prolonged fasting hours. Importantly, these stressors are iatrogenic and have been shown to disturb homeostasis with little benefit. Surgery itself, induces an endocrine and inflammatory stress response and contributes to postoperative insulin resistance (PIR) which increased also by Preoperative fasting.

Postoperative insulin resistance is a state of reduced insulin-mediated glucose uptake in skeletal muscles and adipose tissue, with an increased glucose release due to hepatic gluconeogenesis and hyperglycemia.

Strategies to reduce the postoperative stress response and postoperative insulin resistance include shortening the preoperative fasting time via preoperative carbohydrate oral drink administration (carbohydrate load). Preoperative fasting is the first step in postoperative insulin resistance development. The traditional fasting time of 6-8 h before elective surgery to prevent pulmonary aspiration usually extends up to 12 h in anesthetic practice. Overnight fasting is a physiological state of reduced insulin sensitivity due to the normal hormonal diurnal rhythm. If patients undergo surgery in the prolonged fasted state, insulin resistance may begin even before surgery.

A preoperative carbohydrate drink acts as a morning meal, may improve insulin sensitivity and propel the patient's metabolic state towards anabolism. The rationale of this study is to compare the differences between preoperative CHO loading and a conventional fasting protocol on the postoperative insulin resistance, Glasgow prognostic score (GPS), subjective patient well-being and surgical clinical outcome.

Eligibility Criteria:
Inclusion Criteria:

* Age from 21 and 70 years.
* Both sexes.
* American Society of Anesthesiologists (ASA) physical status l \& ll.
* Scheduled for elective major abdominal surgery

Exclusion Criteria:

* Disseminated malignant disease.
* Increased risk for gastric content aspiration.
* Body Mass Index (BMI) below 20 or above 30 kg/m2.
* Nutritional risk screening 2002 score above 3.
* Emergency surgery, diabetic patients, immunomodulatory therapy.
* Refusal of the patient.
30-Week Extension to an Initial Combination Study (24 Weeks in Duration) of Sitagliptin With Pioglitazone (0431-064)

A 30-week extension to a 24-week study assessing the hemoglobin A1c (HbA1c)- and fasting plasma glucose (FPG)-lowering efficacy of the combination of sitagliptin and pioglitazone in patients with type 2 diabetes mellitus (T2DM) with inadequate glycemic control.


Eligibility Criteria:
Inclusion Criteria:

* Patients must complete the double-blind base study (MK-0431-064-00)(NCT00397631) and have at least 75% compliance with study medication during the base study treatment period.
* Women of childbearing potential must continue to comply with the protocol-specified contraceptive methods
Triathlon Total Stabilizer (TS) Outcomes Study

This study will be a prospective, non-randomized evaluation of the change between preoperative and postoperative outcomes for those receiving the Triathlon® TS Total Knee System for a revision knee operation. The mean total Knee Society Score (for pain, motion and function) change is not 10% worse than, or is superior to, the expected change according to published revision total knee replacement data, for cases implanted with the Triathlon® TS Total Knee System as compared from preoperative to 2 years postoperative.


Eligibility Criteria:
Inclusion Criteria:

* Patient has signed an Institutional Review Board (IRB) approved, study specific Informed Patient Consent Form.
* Patient is a male or non-pregnant female age 18 years or older at time of study device implantation.
* Patient is a candidate for revision of all femoral and tibial components of a total knee replacement.
* Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria:

* Patient has a Body Mass Index (BMI) \> 40.
* Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation.
* Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
* Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.
* Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days).
* Patient has a failed unicondylar knee prosthesis.
* Patient has a known sensitivity to device materials.
* Patient is a prisoner.
Multiple-dose Regimen Study to Assess Effect of 12 Months of Secukinumab Treatment on Skin Response and Biomarkers in Psoriasis Patients

This study is designed to evaluate the proportion of patients achieving reversal of chronic plaque psoriasis at week 4 and 12 following multiple doses of secukinumab administered subcutaneously (sc) compared to placebo. Starting from week 13, all patients will receive multiple doses of secukinumab up to week 52 to study long term effects of secukinumab. Clinical endpoints including biomarker assessments, PASI, IGA and DLQI will be compared to better understand, why secukinumab may be effective in psoriasis patients.


Eligibility Criteria:
Inclusion criteria:

* Chronic plaque-type psoriasis diagnosed for at least 6 months
* Moderate to severe psoriasis as defined by: PASI score of ≥12, IGA score of ≥3, BSA (body surface area) affected by plaque-type psoriasis of ≥10%
* Chronic plaque-type psoriasis considered inadequately controlled by: topical treatment and/or; phototherapy and/or previous systemic therapy

Exclusion criteria:

* Forms of psoriasis other than chronic plaque-type
* Evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of the investigational product on psoriasis
* History or evidence of active tuberculosis or evidence of latent tuberculosis (or other infections like Hepatitis-C/B), malignancy; active or known use of other immunosuppressive drugs (for eg: AIDs, RA, organ rejection etc.) at the screening visit
* Pregnant or nursing (lactating) women
Randomized Controlled Trial of Subconjunctival Bevacizumab Injection in Impending Recurrent Pterygium

Hypothesis: Subconjunctival bevacizumab injection may potentially suppress neovascularization in pterygium, preventing or retarding the progression of recurrence.

1. Impending recurrent pterygium
2. Anti-VEGF therapy

   * Bevacizumab
   * Subconjunctival injection
   * Suppress neovascularization

Eligibility Criteria:
Inclusion Criteria:

1. Impending recurrent pterygium developed within 6 months following pterygium surgery either simple excision or excision with grafting.
2. Failure of conventional topical anti-inflammatory therapy for impending recurrent pterygium which was defined by the progression of fibrovascular tissue over the excised area despite receiving treatment.
3. No history of any adjunctive treatment such as MMC, 5-FU, periocular injection of corticosteroids and beta radiation.
4. No other ocular surface pathologies or coexisting ocular diseases.
5. No other ocular surgeries within the previous 6 months.
6. No history of allergy to the medications used in this study.
7. Good compliance with the study regimen and availability for the duration of the entire study period.

Exclusion Criteria:

1. Platelet disorders
2. Hypertension
3. Pregnant or lactating women
Feasibility of Radioisotope-guided Excision of Mediastinal Lymph Nodes in Patients With Non-small Cells Lung Carcinoma

Non-small cells lung carcinoma (NSCLC) represents one of the most common and lethal neoplasms. NSCLC is characterized by an early asymptomatic phase, which hinders the disease identification in its earliest stages. As a consequence, NSCLC is often diagnosed at a clinical stage when the potentially curative surgical approach is challenging. In general, NSCLC up to the TNM stage cT3N2M0 are considered operable; in particular, nodal localizations in the homolateral hilus (N1) and underneath the carina (N2) are considered surgically manageable. Identification of nodal disease on the pre-operative PET/CT does not guarantee that all disease-bearing lymph node will be retrieved in the course of the open operative procedure. Smaller nodes might be challenging to identify; moreover, the co-existence of macroscopic and microscopic disease might hinder the radicality of the surgical intervention. This process can be tracked using specific radioactive radiopharmaceuticals, such as radioisotope-labelled colloids, which can be injected in the immediate proximity of the primary and then travel toward the closest cluster of mediastinal lymph nodes. There, they are incorporated in the nodal structure and progress no farther. By employing a radioisotope probe during surgery, all of the first-line nodes (so-called sentinel lymph node, SLN), which receive the lymphatic flow from the tumor region directly, can be identified.

The hypothesis of the investigators is that, by performing a radioisotope SLN mapping intraoperatively, the surgeons will be able to detect the metastatization process more accurately than relying on pre-operative imaging alone.

The present study will be a prospective and monocentric trial. Clinical, histological, and imaging data collected from examinations performed according to the good clinical practice will be analyzed. The estimated duration of the study is 12 months. It will include the prospective inclusion of patients with a diagnosis of operable NSCLC, who will receive a surgical treatment with curative intent at the investigators' institution (ICH).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Newly diagnosis of stage I-IIIa NSCLC (higher stage could be considered, pending a multidisciplinary evaluation and approval).
* Baseline 18FFDG-PET-CT and ceCT
* Treatment according to good clinical practice

Exclusion criteria:

* Unavailability of baseline images
* Diagnosis other than NSCLC at definitive pathology
* Surgery carried without complete resection or with no curative intent
Analyzing Clinical Trial Experiences of Colon Cancer Patients

Participation in medical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups.

This trial will admit a wide range of data on the clinical trial experience of Colon Cancer patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.

It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future Colon Cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient has been diagnosed with colon cancer
* Patient has self-identified as planning to enroll in an observational clinical trial
* Patient is a minimum of 18 years or older

Exclusion Criteria:

* Pregnant or nursing patients
* Inability to perform regular electronic reporting
* Patient does not understand, sign, and return consent form
Phase II Study of Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma

This study is designed to test the safety and feasibility of the simultaneous administration of a biphosphonate with chemotherapy for the treatment of osteosarcoma in newly diagnosed patients.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed, previously untreated biopsy proven high-grade osteosarcoma. Patient who have undergone a definitive surgical resection as their primary surgery are still eligible for participation in this study.
* No prior chemotherapy or radiation therapy
* Adequate renal function: creatinine \< or = to 1.5 upper limit of normal
* Adequate liver function as defined by bilirubin \< or = to 1.5 X upper limit of normal and AST \< or = to 3 X upper limit of normal institutional range Adequate hematopoietic function as defined by platelet count \> or = to 100,000/ram3 an absolute neutrophil count \> or = to 1,000/mm3.
* Adequate cardiac function as defined by shortening fraction \> or = to 28% by echocardiogram OR ejection fraction \> or = to 50% by radionuclide angiogram
* Performance status \< or = to 2

Exclusion Criteria:

* Prior history of cancer
* Prior treatment for cancer
* Prior history of Paget's disease
* Prior history of pericarditis, myocarditis, symptomatic arrhythmia or symptomatic cardiac conduction abnormalities
* Pregnancy or breast feeding
Changes in Sensory Perception During Hypnotic Relaxation

Changes in sensory thresholds and pain thresholds will be measured with quantitative sensory testing (QST) before and during hypnotic relaxation in healthy volunteers. Hypnotic susceptibility will be assessed before QST.

QST data before and during hypnosis will be compared. Observed sensory changes will be evaluated in relation to the assessed hypnotic susceptibility

Healthy volunteers will be recruited and tested regarding their hypnotic susceptibility with Harvard Group Scale. In a second session QST will be performed on the right hand.Then hypnosis will be induced with the fixation method. After that the hypnotherapist will ask them to focus their attention on imagining an individual situation of well-being and calmness the volunteers had described before hypnosis. Then QST will be performed a second time on the same location. Results be compared using student's ttest.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* health conditions of any Kind
* inability to read and/ or sign informed consent
* previous hypnosis experience
Pancreaticogastrostomy Versus Pancreaticojejunostomy in Reconstruction After Cephalic Duodenopancreatectomy

Pancreaticoduodenectomy is the standards surgical procedure for various malignant and benign disease of the pancreas and periampullariy region. During the recent years, mortality rate of pancreaticoduodenectomy has decreased to 5% in specialized centers. Although, this procedure still carries considerable morbidity up to 40%, depending of definition of complications. Pancreatic fistula remains a common complication and the main cause of other morbidities and mortality. Pancreaticojejunal (PJ) anastomosis is the most often used method of reconstruction after pancreaticoduodenectomy. Several technique modifications such as placement of the stents, reinforcement of anasomosis with fibrin glue, pancreatic duct occlusion and pancreaticogastrostomy (PG) type of anastomosis was used in order to decrease pancreatic fistula rate. Since, some retrospective studies showed better results with some technique, several meta-analyses did not show any advantage of those various modifications. It was shown that the higher risk of pancreatic fistula was noticed in patients with soft residual pancreas and small diameter of pancreatic duct. There is only one randomized study in the literature dealing with this problem. This study did not reveal any significant differences between PG and PJ in patients with soft pancreas and small duct. In order to investigate once more this important issue, the researchers conducted randomized multicenter controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergone cephalic duodenopanceatectomy
* soft pancreas
* small diameter of the pancreatic remnant

Exclusion Criteria:

* Age bellow 18 and under 80
* prevous pancreatic surgery
* pregnancy
* Psychosis
DBT in Borderline Personality Disorder

Subjects will receive a 6-month course of DBT, consisting of one 90-minute group and one 60-minute individual session per week as well as telephone availability of the individual therapist.


Eligibility Criteria:
Inclusion Criteria: Is a male or female between 18 and 60 who meets criteria for Borderline Personality Disorder and has had at least 2 prior instances of suicidal or parasuicidal behavior. Either is off psychotropic drugs or is on a stable medication regimen. (During the study, psychotropic medications will be prescribed by a psychiatrist in the Mood and Personality Disorders Group.)

Exclusion Criteria: Meets criteria for Schizophrenia, Bipolar Disorder, Mental Retardation or current or recent Substance Dependence. Subjects also should not currently be in individual psychotherapy. (Case management and work therapy programs are allowed.)
A 2-year Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD) (LUCIA) Primary Efficacy Will be Determined at Week 56

This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.


Eligibility Criteria:
Inclusion Criteria:

* Previously treated or treatment naïve patients with a documented diagnosis of wAMD in the study eye, with onset of disease that began at any time prior to the Screening Visit.
* Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score between 78 to 35 letters (approximately 20/32 to 20/200 Snellen equivalent) in the study eye at the Screening Visit and on Baseline (Day 1).
* For previously-treated subjects, must have been treated with at least 2 anti-VEGF IVT injections (i.e., aflibercept 2 mg, aflibercept 8 mg, bevacizumab, ranibizumab, or faricimab) in the previous 6 months for wAMD per standard of care in the study eye prior to the Screening Visit.

Exclusion Criteria:

* Subfoveal fibrosis, atrophy, or scarring in the center subfield.
* BCVA using ETDRS charts \<20 letters (20/400 Snellen equivalent) in the fellow eye.
Health and Nutrition Status of Chinese Elderly

This study is aiming to understand the prevalence and risk factors related to malnutrition and sarcopenia in Chinese elderly.

The study objective is to understand the prevalence of malnutrition and sarcopenia in Chinese elderly with the cut-off points from the normal range of muscle mass and function in Chinese adults; to understand the risk factors related to malnutrition and sarcopenia in Chinese elderly; to set up a screening tool on malnutrition and sarcopenia risks in Chinese elderly.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female Chinese ages \>= 60 years.
2. Subject lives in the community for more than 12 months.
3. Subject has voluntarily signed and dated an informed consent form, approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) prior to any participation in the study.

Exclusion Criteria:

1. Subject who did/does heavy manual labor
2. Subject who was a professional or semi-professional athlete or game player
3. Subject who has physical disabilities such as loss of hand or foot or limbs or any other physical disability which may affect the muscle mass by the opinion of the study physician.
4. Subject has an implanted electronic device or orthopedic metal implantations, such as pacemaker, cardiac defibrillator, subcutaneous injection pump, or metal hip, metal knee joint, metal fracture internal fixation, etc.
5. Subject who has active hyperthyroidism or hypothyroidism and needs medication treatment as by self-report.
6. Subject who has severe heart dysfunction or renal dysfunction with significant sodium water retention or edema by the opinion of study physicians.
7. Subject who takes hormones except for external application of glucocorticoids.
8. Subject who takes diuretics except for using a stable dose for at least 3 weeks as a part of hypertension treatment.
9. Subject who has later stage of malignancies with cachexia by the opinion of study physicians.
10. Subject has any other disease or situation who should not to participate in the study by the opinion of study physicians.
11. Subject had hand/wrist or foot/leg surgery/injury within the past 3 months and the surgery/injury may affect the hand grip or gait speed test by study physician's opinion.
12. Subject is too frail by study physician's opinion
13. Subject is drug addicted or alcohol addicted
14. Subject is participating in other clinical trials which are not approved by AN
Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fasted Conditions

The objective of this study was to prove the bioequivalence of Roxane Laboratories' Oxcarbazepine Suspension 600 mg under fasted conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to oxcarbazepine or any comparable or similar product.