cyrilzakka/clinical-trials huggingface dataset:
Comparison of ARPE Prosthesis With the Literature

This study is designed to document the objective and subjective measurements after trapeziometacarpal athroplasty with ARPE prosthesis and to compare those to literature values of outcome after trapeziectomy and trapeziectomy with ligament reconstruction and tendon interposition (LRTI), as published in a recent meta-analysis.

The primary objective is to compare functional outcome at 3 years after trapezio-metarcarpal arthroplasty with trapeziectomy and trapeziectomy with ligament reconstruction and tendon interposition. Literature values obtained by a recently published meta analysis will be used.

The secondary objectives are:

* to compare functional outcome at 1 and at 5 years after trapezio-metarcarpal arthroplasty with trapeziectomy and trapeziectomy with ligament reconstruction and tendon interposition
* to determine pre- and post-operative HR QOL
* Incidence of radiolucencies at each follow up time point. Literature values from the same meta analysis will be used,

Patients will be assessed at preoperatively, and at 1, 3 and 5 years postoperatively. Measured Outcomes: grip strength, tip pinch strength, key pinch strength, pain, occurrence of adverse events, hand function.

Eligibility Criteria:
Inclusion/exclusion criteria are identical to those indications and contraindications stated in the package insert of the implant.

Inclusion Criteria:

* patients with trapezio-metacarpal arthritis Eaton Stage of trapezio-metacarpal arthritis: Stage II - IV
* patients willing to return for follow up evaluation.

Exclusion Criteria:

* local or systemic infections
* severe muscular, neurological or vascular deficiencies of the extremity involved
* bone destruction or poor bone to affect implant stability
* allergy to any of the components of the implant
Analyzing Postural Parameters in Physiotherapy and Rehabilitation Students

In our study, with the voluntary participation of Term 3 and Term 4 students from the Hacettepe University Faculty of Physiotherapy and Rehabilitation, we examined the effect of physical workload on postural parameters based on students' standing and sitting times. Additionally, through surveys, we assessed the students' physical activity levels, quality of life, sleep, and burnout levels. The aim was to investigate the relationship between these components and postural alignment by measuring their levels. By identifying the factors that may affect students' postural alignment, the study aims to determine potential risks and provide valuable information for physiotherapists, physiotherapy students, and educators.

Volunteer individuals among Term 4 (senior year) intern physiotherapist students and Term 3 students studying at Hacettepe University Faculty of Physical Therapy and Rehabilitation will be included in the study. Individuals who will be included in the study will be informed face to face about the purpose of the research, the evaluation methods to be used in the research, and the results we foresee, as well as what benefits we will provide to the individuals at the end of the study. Participants will be reached via posters/brochures. Individuals participating in the study will be informed about the surveys and the parameters to be evaluated at the first meeting. Postural evaluations of individuals will be carried out 4 times, on Mondays and Fridays, in the morning and in the evening, for 1 week. Questionnaires will be asked to be answered after the first and last posture evaluation. The number of individuals to be included in our study was calculated using the G\*Power 3.1 program, taking the effect size as 0.74, alpha type error rate as 0.05 and the power of the test as 0.80, and the sample size for the period 4 and period 3 research groups was determined as 37/37. Taking into account situations such as inability to continue working, a total of 74 individuals were planned to be included in the study, with an excess of 10%.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who volunteer to participate in the study,
* Individuals who did not have pain according to the NORDIC Extended Musculoskeletal System questionnaire at the time of the evaluations,

Exclusion Criteria:

* Being diagnosed with scoliosis by a physician,
* Having spinal cord or extremity pain diagnosed by a physician in the last 3 months,
* Being diagnosed with any developmental disorder (Scheuermann's/Calve Disorder etc.),
* Having limb inequality, spine and pelvis etc. having serious deformities,
* Getting diagnosed with Infection (Spinal Tuberculosis etc.), Tumor (Multiple Myeloma),
* Having had spine surgery,
* Having a systemic inflammatory disease,
* Being diagnosed with a neurological and/or cognitive disease that may affect cognitive functions,
* Epilepsy, Antidepressant / Attention enhancing drug use,
* Being diagnosed with Cardiorespiratory Disease,
* Having menstrual irregularity,
Emotion Focused Internet Delivered Treatment for Adults with Eating Disorders

The goal of this clinical trial is to develop and test a new internet delivered treatment for adult patients with eating disorders, focused on developing normalized eating patterns and emotion regulation skills. The main focus is to investigate the additional effect of emotion regulation interventions, beyond the effect of other central tratment components normally included in evidence based eating disorder treatment.

The internet delivered treatment is divided into two phases, phase A and phase B. Phase A focus on establishing normalised eating patterns, and in phase B the emotion regulation interventions are added. Participants will get access to treatment modules every third day over a time period of 8.5 weeks, each module consist of psychopedagogical material, excercises and home work.

Data will be collected via the online research platform every third day during the treatment. Data is also collected at more comprehensive assessment points pre-treatment, post-treatment, and follow up 3 months after end of treatment.

This study uses an experimental single-case design, specifically a randomized replicated AB design.

The baseline lenght (i.e., phase A) is randomized for each participant. There is six possible assignments, as the randomization is restricted to give all participants minimum 8 and maximum 12 treatment modules in each phase, with minimum 9 and maximum 14 baseline assessment points.

Eligibility Criteria:
Inclusion Criteria:

* DSM5 eating disorder
* Minimum 18 years old
* Ongoing contact with a psychiatric clinic in sweden

Exclusion Criteria:

* Body mass index below 18,5
* Somatic instability due to eating disorder severeness
* High risk of suicide or severe self-harm
* Ongoing addiction or substance abuse
* Ongoing psychological treatment or psychotherapy
* New or changed mediciation for psychiatric disorders in the past 2 months
* Planned or ongoing pregnancy or recently gave birth
Acute Effects of Tocotrienols on Insulin Sensitivity and Metabolic Risk Markers in Individuals at Risk for Metabolic Syndrome

Objectives: To compare the acute effects of gamma delta rich tocotrienol fractions (gd-TRF) on insulin sensitivity, metabolic risk markers and postprandial lipemia in individuals at risk for metabolic syndrome.

Hypothesis: Gamma delta-rich TRF will improve insulin sensitivity, metabolic risk markers and postprandial lipemia in individuals at risk for metabolic syndrome.

A randomised, double-blind, crossover trial will be undertaken to test the acute effects of supplementation of 200 mg, 400 mg gd-TRF vs. placebo. There are 3 occasions for subjects to attend during postprandial period and these occasions will be separated by at least one week. On the day preceding the postprandial high fat meal challenge, subjects will be asked to avoid food high in fat, alcohol, caffeine and taking part in any strenuous exercise. Subjects will be provided with a standardised low fat meal (containing \< 10 g fat) on the day preceding the postprandial study days to consume as their evening meal. They will be asked to fast overnight and instructed to avoid eating or drinking anything, except water, after 10 pm. Fasting blood samples will be collected on the next day and subjects will then consume the test meal, containing 50 g test fat supplemented with gd-TRF. Further venous blood samples will be collected at regular intervals for up to 6 hours postprandially.

Eligibility Criteria:
Inclusion Criteria:

* Age: 20-60 years
* BMI ≥ 25 kg/m2
* Elevated triacylglycerols ≥ 1.70 mmol/L
* Low HDL cholesterol \< 1.04 mmol/L (men), \< 1.30 mmol/L (women)
* Elevated blood pressure ≥ 130/ ≥ 85 mmHg
* Fasting plasma glucose ≥ 5.60 - 7.00 mmol/L
* Increased waist circumference ≥ 90 cm (men), ≥ 80 cm (women)

Exclusion Criteria:

* BMI ≤ 18.5 kg/m2
* Current use of antihypertensive or lipid lowering, insulin/glucose modulating medication
* Lactose/milk intolerance
* Alcohol intake exceeding a moderate intake (\> 28 units per week)
* Smoker
* Pregnancy or lactation
* Fever, cold and infection during bleeding day
Sutent Maintenance After Response to Taxotere

The major goal is to determine whether the experimental agent has clinically promising activity that would merit progression to a formal phase III trial.

Patients with hormone refractory prostate cancer after docetaxel chemotherapy have limited treatment options and no systemic treatment has been proven to be effective. Because of its action, safety and simple administration SU011248 has potential for effectiveness in this disease setting. Promising activity in this study would provide the necessary proof-of-principle for a larger confirmatory study in this population, and potentially in earlier stages of this common disease.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological diagnosis of adenocarcinoma of the prostate
* Metastatic or locally recurrent disease not curable with standard therapy
* ECOG performance status 0, 1 or 2
* Prior single agent docetaxel or docetaxel combination chemotherapy with a documented PSA or imaging response, and no objective evidence of disease progression at study enrolment

Exclusion Criteria:

* Patients with a history of other invasive cancer, except adequately treated non
* melanoma skin cancer.
* Patients with known brain metastases.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to SU011248.
* Other serious intercurrent illness or medical condition that might be aggravated by protocol treatment.
Study for the Artificial Pancreas Project : Determination of a Tuning Strategy of Metabolic Profiles

The Artificial Pancreas Project developed by SUPELEC and the University Hospital of Rennes is focused on the evaluation of an original control algorithm that computes appropriate subcutaneous insulin infusion in response to continuous glucose measurements The results during a 24-hour closed-loop period will be compared with those of the open-loop. The implementation of this algorithm named Error Dynamics Shaping (EDS) requires as a preliminary a phase of identification of the parameters of the model (insulin pharmacokinetics and effect on glucose metabolism) followed by a phase of optimization i.e. a personalized adjustment of the damping parameters of EDS.

The present study aims to formalize this procedure of identification/optimization of the parameters of the model and controller EDS. They will be determined in type -1 diabetic patients using insulin therapy and under conditions free from disturbances such as those generated by the glucidic meals, i.e. during a period of glucidic fast. Three variables will determine this procedure: blood glucose, insulin concentration and insulin doses.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetic patients (age : 18-70)
* Diabetes duration higher than three years
* Insulin pump with Humalog®
* Hospitalized for a 24-hour glucidic fast test
* Written informed consent

Exclusion Criteria:

* Pregnancy or nursing
* Acute infectious disease
* Corticoid treatment
* Creatinine clearance \<40 ml/mn
* Patients using Apidra® or Novorapid®
* People major being the object of a legal protection (safeguard of justice, supervision, trusteeship)
Vertebral Osteosynthesis in Degenerative Lumbar Stenosis With Spondylolisthesis

Study to evaluate the superiority of the osteosynthesis associated with a decompressive surgery in comparison with a simple decompressive surgery in the treatment of lumbar degenerative stenosis with spondylolisthesis

Randomized, comparative study on 152 patients with degenerative spondylolisthesis L4-L5 confirmed by radiography with radicular pain for whom the antalgic and anti-inflammatory treatment are not efficient for at least 3 months.

Patients randomized in 2 parallel groups (each group with 76 patients)

* one group with decompressive surgery + osteosynthesis
* one group with decompressive surgery Study duration : 18 months, including a selection visit, an inclusion with the surgical intervention, 3, 12, 18 months' follow up visits and a follow up call at 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients with degenerative spondylolisthesis L4-L5 confirmed by radiography with radicular pain for whom the antalgic and anti-inflammatory treatment are not efficient for at least 3 months;
* Patients who agree to take part in the study and to sign an Informed Consent Form

Exclusion Criteria:

* Contre-indications to surgery or to vertebral isolated fixation L4-L5
* Previous lumbar surgery
* Work accidents
* Psychiatric troubles that may interfere with the clinical evaluation
* Pregnant women or women who could be pregnant during the study
* Patient under special supervision or trusteeship
* Refusal to sign the Informed Consent Form
* No Public Health Insurance cover
Microendoscopic Lumbar Discectomy: A Study of 100 Cases

Evaluate the outcome of micro endoscopic discectomy (MED) by tubular retractors on safety and efficacy of the technique.

Evaluate the outcome of micro endoscopic discectomy (MED) by tubular retractors on safety and efficacy of the technique.Patients who underwent surgery for herniated disc using the tubular retractors. The results were evaluated by using VAS (Visual Analog Scale 0-5) for back and leg pain and ODI (Oswestry Disability Index). Patients were followed up at intervals of 1 week, 6 weeks, 3 months, 6 months, 12 months and 2 years after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients with at least 6 weeks of conservative treatment with positive nerve root tension signs, radicular pain
* Patients are diagnosed with lumbar disc herniation by MRI
* Patients who underwent surgery for herniated disc using the tubular retractor

Exclusion Criteria:

* Patients with large central disc herniation, chronic discogenic pain, discitis, multi-level disease, presence of instability or history of lumbar surgery
Paclitaxel in Treating Patients With Recurrent or Progressive Advanced Ovarian Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with recurrent or progressive advanced epithelial ovarian cancer following previous paclitaxel.

OBJECTIVES: I. Evaluate the activity of paclitaxel when administered on a weekly schedule to patients with advanced ovarian cancer who have failed paclitaxel on a 3 or 24 hour infusion schedule. II. Evaluate the toxic effects of paclitaxel when administered on a weekly schedule in this patient population. III. Correlate response with quality of life outcomes, including symptom distress, performance status, and global quality of life.

OUTLINE: This is a single center, open label study. Paclitaxel is administered intravenously every week as a 1 hour infusion. Patients receive prophylactic anti-allergy premedication prior to paclitaxel.

PROJECTED ACCRUAL: 25-30 patients accrued per year.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed recurrent or progressive epithelial ovarian cancer defined as: A serial rise in CA 125 over a minimum of 3 samples to a level greater than 50% of the upper limit of normal OR Measurable or evaluable disease Disease progression following paclitaxel given by 3 or 24 hour infusion within the past 6 months

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky at least 60% Life expectancy: Not specified Hematopoietic: AGC at least 1500/uL Platelet count at least 100,000/uL Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Other: No active or uncontrolled infections No history of grade 3-4 peripheral neuropathy of any etiology No previously developed severe hypersensitivity reactions to paclitaxel Not pregnant or lactating Patients of childbearing potential must use effective method of contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior platinum based chemotherapy required Complete recovery from the myelosuppressive effects of prior chemotherapy for a minimum of 3 weeks At least one prior regimen of paclitaxel by 3 or 24 hour infusion within 6 months prior to study, with no intervening chemotherapy Endocrine therapy: No hormone therapy within 3 weeks of entry onto protocol Radiotherapy: No prior radiation therapy to major bone marrow ares within 4 weeks of entry onto protocol Surgery: Not specified
Study of Paclitaxel/Carboplatin With or Without Bavituximab in Previously Untreated Non Small-Cell Lung Cancer

This is a randomized, open-label, multicenter, phase 2 study comparing Paclitaxel/Carboplatin with or without bavituximab in patients that have previously untreated locally advanced or metastatic non-small cell lung cancer (NSCLC).


Eligibility Criteria:
Key Inclusion Criteria:

* Adults over 18 years of age with a life expectancy of at least 3 months.
* Histologically or cytologically confirmed stage IIIB or stage IV non-squamous NSCLC that has not been previously treated with systemic chemotherapy.
* Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.1).
* Adequate hematologic, renal and hepatic function.
* PT / INR ≤ 1.5 × ULN, aPTT ≤ 1.5 × ULN and D-dimer ≤ 3 × ULN.

Key Exclusion Criteria:

* Squamous cell, small cell, or mixed histology.
* Known history of bleeding diathesis or coagulopathy.
* Cavitary tumors or tumors abutting large blood vessels.
* Bleeding: Clinically significant bleeding, such as gross hematuria, GI bleeding and hemoptysis, within 12 months of Screening.
* Venous thromboembolic events (e.g., deep vein thrombosis or pulmonary thromboembolism) within 6 months of Screening.
* Ongoing therapy with oral or parenteral anticoagulants.
* Concurrent estrogens, anti-estrogens or progesterone compounds.
* Grade 2 or higher peripheral neuropathy.
* Radiotherapy within 2 weeks preceding Study Day 1.
* Symptomatic or clinically active brain metastases.
* Major surgery within 4 weeks of Study Day 1.
* Uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease).
* Symptomatic coronary artery disease, cerebrovascular accident,transient ischemic attack, myocardial infarction, or unstable angina pectoris within 6 months of Screening.
Effects of Sevoflurane and Desflurane on Treg

This prospective interventional study aims to compare sevoflurane and desflurane anesthetic agents on regulatory T cell (Treg) numbers and its cytokine production in patients undergoing Living Donor Kidney Transplant (LDKT).

All patients with end stage renal disease (ESRD) need renal replacement therapy, either dialysis or kidney transplantation. Dialysis, despite its effectiveness in prolonging ESRD patients' lives, is a burden. Successfulness in kidney transplantation will restore good quality of life in ESRD patients. However, one of the most important complications that lead to transplant failure is graft rejection. It is already known that the pathophysiology of the rejection is immune response. Recent evidence showed that regulatory T cell (Treg) plays a central role in preventing graft rejection by inhibiting recipient alloimmune response (1-3). Characterization of Treg numbers and/or functional changes under various conditions may lead to a new preventive measure and/or a novel therapeutic strategy for graft rejection.

Kidney transplantation is conducted under general anesthesia. Interestingly, several agents used in general anesthesia have also modulated immune functions (4-12). Although the effect of inhalation anesthetic agents on leukocyte count has been shown, the effect on Treg function has totally been unknown. Knowing the effects of inhalation agents on Treg numbers and functions will be beneficial to intraoperative management during transplant surgery, aiming toward reducing the risk of graft rejection in the future.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving 1st living donor kidney transplantation

Exclusion Criteria:

* Hyperacute graft rejection
* Pre-existing autoimmune or immunodeficiency diseases in recipients
* Receiving blood product during 24-h perioperative period
* Patient refuse to participate this study at any time point
Study to Evaluate the Safety and Pharmacokinetics of CKD-379

A study to compare the pharmacokinetics and safety between CKD-379 and D759, D745, D029, D150 combination

A randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-379 in healthy volunteers under fed conditions

Eligibility Criteria:
Inclusion Criteria:

* Between 19 aged and 50 aged in healthy adult
* 18.0kg/m2≤body mass index(BMI)≤27.0kg/m2 and 50.0kg≤Body weight≤90.0kg

Exclusion Criteria:

* Have clinical significant medical history or disease that blood, kidney(moderate nephropathy and etc.), endocrine system(type I or type II diabetes mellitus, diabetic ketoacidosis, diabetic coma and etc.), respiratory system, gastrointestinal system, urinary system, cardiovascular system(heart failure, Torsades de pointes and etc.), liver(moderate liver disorder and etc.), mental system, nervous system, immune system
* Have a gastrointestinal disease(Crohn's disease, ulcer etc.) history that can effect drug absorption or surgery
* Those who are pregnant or breastfeeding
* Those who are deemed inappropriate to participate in clinical trial by investigators
68Ga-grazytracer PET Assists in Diagnosing Pseudoprogression Following Immunotherapy in Lung Cancer.

Currently, there are limited methods available in clinical practice to distinguish pseudoprogression after immunotherapy. Most patients rely on follow-up observations to monitor the disease, which does not meet clinical needs. 68Ga-grazytracer is a novel imaging agent targeting granzyme B. By detecting the concentration of granzyme B, it reflects the localization of cytotoxic T cells in the tumor region and their potential ability to kill tumor cells. This study aims to leverage the simplicity, non-invasiveness, visualization, and semi-quantitative advantages of 68Ga-grazytracer PET imaging to evaluate its effectiveness and feasibility in diagnosing pseudoprogression.


Eligibility Criteria:
Inclusion Criteria:

1. Lung cancer patients who develope lesion enlargement and/or new lesions after treatment with immune checkpoint inhibitors;
2. Pseudoprogression cannot be ruled out in clinical practice;
3. Lung cancer confirmed by pathology or cytology, regardless of pathological type;
4. Fully-informed written consent obtained from patients;
5. Patient ability to comply with protocol requirements;
6. Age 18-75 years;
7. Life expectancy of at least 6 months.

Exclusion Criteria:

1. Patients with serious diseases that the investigator deems unsuitable for participation in the clinical study. Such as severe cardiopulmonary insufficiency, severe bone marrow suppression, severe hepatic or renal insufficiency, etc;
2. Intestinal perforation, complete intestinal obstruction;
3. Active phase of hepatitis B；
4. Pregnant women and women who are potentially pregnant, as well as nursing mothers;
5. Patients with poor compliance.