cyrilzakka/clinical-trials huggingface dataset:
Cognitive Strategies for Weight Loss

The goal of this clinical trial is to compare weight change and other related outcomes associated with three different behavioral weight loss interventions (STANDARD Behavioral, PREVENT, and PROMOTE) in adults with obesity. The main questions it aims to answer are:

* Which of the three Internet-delivered weight loss programs results in the greatest weight loss?
* How do key weight-related behaviors (e.g., adherence, diet, physical activity) differ across the arms?
* What individual characteristics predict success in each arm?
* What are the underlying mechanisms of each approach?
* Are there any potential adverse outcomes associated with any of the conditions (e.g., depression, weight stigmatization, increased body image concerns).

Participants will:

* signed informed consent
* complete a baseline assessment
* be randomized to 12 months of either Standard iBWL, PREVENT or PROMOTE
* complete a training workshop to learn arm-specific cognitive strategies
* complete a 12-month Internet-delivered weight loss program, requiring self-monitoring of intake and exercise and viewing of 12 weekly lessons followed by 9 monthly lessons
* complete an assessment at 3 months (during treatment)
* complete a refresher workshop on arm-specific cognitive strategies at 3 months
* complete an assessment at 6 months (during treatment), 12 months (at the conclusion of treatment), and 18 months (6 months after treatment


Eligibility Criteria:
Inclusion Criteria:

* Participants will be between the ages of 18 and 70, have a BMI between 25 and 45 kg/m2, and have regular (i.e., weekly) access to the Internet, defined as owning a smart phone with Internet capabilities, and/or having a broadband or Wi-Fi connection at home or work.

Exclusion Criteria:

* Exclusionary criteria include: 1) current enrollment in a weight loss program, 2) currently taking weight loss medications, 3) history of bariatric surgery or planned bariatric surgery in the next 18 months, 4) individuals who are pregnant, nursing, or have plans to become pregnant within the next 18 months, 5) individuals planning to relocate outside the area in the next 18 months, 6) any medical condition for which weight loss would be contraindicated, 7) neurological or psychiatric conditions including but not limited to schizophrenia and bipolar disorder, 8) inability to attend assessments at the Weight Control and Diabetes Research Center in Providence, RI.

Individuals with mobility issues, dizziness, or history of heart disease, diabetes, or cancer will be required to provide physician consent prior to enrolling.
Prevention of Periprosthetic Bone Loss After Total Hip Replacement by Annual Bisphosphonate Therapy

Periprosthetic bone loss caused by stress-shielding effect, a phenomenon of bone atrophy under mechanical unloading after THR implantation, further compromises the longevity of implant. The prospective randomized study is aimed to investigate the periprosthetic bone loss after primary total hip replacements.

This study is a prospective, randomized, open-label clinical trial. The study will be performed in patients after obtaining informed consent. Group assignment is by drawing a sealed envelops based on random table. (1) Group 1: Experimental group 30 cases, Aclasta® (Zoledronic acid 5mg/100ml) is given intravenously on the 4th postoperative day and one year after the total hip replacement, (2) Group 2: Control group, 30 cases, no bisphosphonate is given to the patients. Only the unilateral coxarthrosis will be recruited for the study. Patients will be analyzed with (1) DXA study (2) Clinical assessment (Harris hip score and SF-12) (3) X-ray (4) serum marker of bone turnover. Patients will be scheduled for specified examinations preoperatively, postoperatively 6 weeks, 3 months, 6 months, 12 months, and 24 months.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female,between 35 and 85 years of age
2. Indicated for Total hip replacement for various hip diseases
3. Has preoperative DXA study within 3 months before the total hip replacement procedure or willing to receive preoperative DXA study as a baseline comparison
4. Signed written informed consent
5. Standard transgluteal approach for total hip replacement using Zimmer Triology Cup and Versys Fiber Metal Taper Stem with metal to highly cross-linked polyethylene bearing surface

Exclusion Criteria:

1. Any prior use of intravenous bisphosphonate within the last 2 years
2. Uncontrolled seizure disorders associated with falls
3. A history of invasive malignancy of any organ system, treated or untreated, within the past five years; excluding, basal cell or squamous cell carcinoma of the skin, colonic polyps with non-invasive malignancy which have been removed
4. Carcinoma in situ of the uterine cervix
5. History of osteogenesis imperfecta, multiple myeloma, or Paget's disease
6. Active primary hyperparathyroidism
7. History of iritis or uveitis
8. Self-reported history of diabetic nephropathy or retinopathy
9. AST or ALT more than twice the upper limit of normal
10. Alkaline phosphatase more than twice the upper limit of normal
11. Serum calcium 2.75 mmol/L (11.0 mg/dL)
12. Baseline renal insufficiency (calculated creatinine clearance 35 ml/min)
13. History of hypersensitivity to bisphosphonates
14. Use of any investigational drug(s) and/or devices within 30 days prior to randomization
15. Any medical or psychiatric condition which, in the Investigator's opinion, would preclude the participant from adhering to the Protocol or completing the trial per protocol
16. Use of hip protectors
17. With implant or prosthesis on the contralateral hip joint
Study of GRN163L With Paclitaxel and Carboplatin in Patients With Advanced or Metastatic Non Small Cell Lung Cancer

The purpose of this study is to determine the safety and the maximum tolerated dose (MTD) of GRN163L when administered in combination with a standard paclitaxel/carboplatin regimen to patients with advanced or metastatic non-small cell lung cancer.

GRN163L is a telomerase template antagonist with in vitro and in vivo activity in a variety of tumor model systems. Telomerase is an enzyme that is active primarily in tumor cells and is crucial for the indefinite growth of tumor cells. Inhibition of telomerase may result in antineoplastic effects.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of NSCLC
* Stage IIIb with pleural effusion, Stage IV, or recurrent disease
* Measurable or evaluable disease by RECIST criteria
* ECOG performance status 0-1
* Adequate hepatic/renal function and platelet count
* If previously treated with an anthracycline, anthracenedione, or trastuzumab, must have left ventricular ejection fraction \> 50%

Exclusion Criteria:

* More than 2 prior chemotherapy regimens for metastatic disease (prior adjuvant chemotherapy is allowed)
* Tumor progression during treatment with paclitaxel (refractory to paclitaxel)
* Taxane-based regimen within 12 weeks
* Any systemic therapy for cancer within 4 weeks
* Anti-platelet therapy within 2 weeks, other than low dose aspirin prophylaxis therapy
* Therapeutic anticoagulation therapy except for low dose warfarin (eg, 1 mg by mouth per day)
* Radiation therapy within 3 weeks
* Major surgery within 4 weeks (central line placement is allowed)
* Prolongation of PT or aPTT \> the ULN or fibrinogen \< the LLN
* History of or active central nervous system metastatic disease
* Any other active malignancy
* Active or chronically recurrent bleeding (eg, active peptic ulcer disease)
* Clinically significant infection
* Active autoimmune disease requiring immunosuppressive therapy
* Clinically significant cardiovascular disease or condition
Visual Cue as Prevention of Pulmonary Infection Under Mechanical Ventilation

Nosocomial pneumonia is the third causes of nosocomial infection. In intensive care unit, their incidence is even higher, of the order of 10 to 30% in patients with invasive mechanical ventilation (IMV). One of the main mechanisms behind VAP (Ventilator-Associated Pneumonia) is the passage of germs colonizing the oropharynx to the subglottic airways. The presence of a nasogastric tube, immobilization, and strict dorsal decubitus increase the risk of colonization of the tracheobronchial tree and pneumonia in these patients. To reduce the incidence of VAP, several strategies have been developed in intensive care to try to control these different risk factors. These sets of measures, also called "bundle" systematically include the control of the elevation of the patient's head more than 30 °. Nevertheless, the strict and permanent control of the elevation of the patient's head is difficult to obtain. One of the reasons that may explain the difficulty of ensuring a correct elevation is the absence of visual cues that are easy to obtain on the beds of patients. An easily identifiable visual cue at the head of the bed would probably provide a satisfactory elevation (greater than 30 °) in patients intubated in intensive care. Our hypothesis is that the addition to the head of the patient's bed of a visible mark that is easily visible and easily interpretable by all the nurses will improve the elevation of the head of the patients in intensive care.


Eligibility Criteria:
Inclusion Criteria:

- Patient admitted to intensive care with invasive mechanical ventilation more than two days

Exclusion Criteria:

* Pregnancy
* Spinal trauma
* Brain trauma
Acceptance and Commitment Therapy Versus Cognitive Therapy for the Treatment of Major Depressive Disorder

The study will investigate the effectiveness of Cognitive Therapy and Acceptance and Commitment Therapy in a randomized controlled trial among patients with Major Depressive Disorder in routine clinical practice. Furthermore, the study will investigate whether each specific treatment approach is mediated by its proposed theoretical mechanism.

The current study aims at investigating the effectiveness of Cognitive Therapy and Acceptance and Commitment Therapy in a randomized controlled trial among patients with MDD in routine clinical practice. Further, the study will investigate whether each specific treatment approach is mediated by its proposed theoretical mechanism. Patients have to meet diagnostic criteria for nonpsychotic MDD as determined by the Structured Interview for DSM-IV. Each client will receive either Cognitive Therapy or Acceptance and Commitment Therapy that will last between 16 to 20 sessions. Based on previous results, it is expected that both treatment forms will prove beneficial for the patients.

Eligibility Criteria:
Inclusion Criteria:

1. Meeting DSM-IV criteria for MDD
2. Between the ages of 18 and 65-years-old
3. Having sufficient fluency in Dutch to complete treatment and research protocol

Exclusion Criteria:

1. DSM-IV criteria for bipolar disorder (past or present)
2. Psychotic disorders
3. Substance dependence disorders (current or within the past 6 months), or
4. Organic brain syndrome.
5. Borderline or antisocial personality disorder
2-cohort Study of Adult Patients With Severe Hemophilia A in Greece

This study is a prospective, single center, observational, 2-cohort study of adult patients with severe Hemophilia A. There is no randomization procedure and all patients will be treated as per usual clinical practice. Patients will be followed up for 18 months after enrolment.

The primary therapy for hemophilia is coagulation factor replacement, given either episodically on demand (OD) for the treatment of acute bleeds or prophylactically to prevent them.

The last years there has been an interest to study the comparative effectiveness of OD vs. SP (Secondary Prophylaxis) treatment strategies so as to create an evidence based platform to guide both clinical decision making and quantify the economic aspects of each treatment alternative. In Greece relevant information is lacking, thus it is imperative to study how patients on different treatment strategies are managed in a real-life setting in Greece, including the main factors associated with increased health care utilization, clinical success and patient well being.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with severe Hemophilia A.
* Age ≥18 years old
* Patients able to read and write
* Patients receiving Factor VIII substitute therapy, either on-demand or as secondary prophylaxis.
* Patients under the same therapeutic strategy (On Demand or Secondary Prophylaxis) for at least 6 months prior to enrolment.

Exclusion Criteria:

* Patients that have developed inhibitors against factor VIII.
* Patients participating in an investigational program with interventions outside of routine clinical practice.
Effects of Azithromycin on Airway Oxidative Stress Markers in Patients With Bronchiectasis

The mechanism by which macrolide antibiotics have immune modifying effects independent from its antibacterial activity has not been well established. In the present work, the investigators will analyze the effect of long-term treatment with azithromycin (250 mg three times per week during three months) on airway oxidative stress markers in exhaled breath condensate of adult patients with stable non-CF bronchiectasis.

The mechanism by which macrolide antibiotics have immune modifying effects independent from its antibacterial activity has not been well established. In the present work, we will analyze the effect of long-term treatment with azithromycin (AZ) on airway oxidative stress markers in exhaled breath condensate of adult patients with stable non-CF bronchiectasis. Patients will be randomized in an open label model to receive AZ 250 mg three times per week during three months or nothing.Dyspnea (Borg scale), exacerbations (Nº) in the last three months, sputum volume (cc), sputum colour (15-point scale), and health related quality of life (Questionnaire St.George) will be measured in both groups before and after treatment. Lung function, sputum culture, CT scan (Bhalla score) and inflammatory markers in blood (ESR, PCR),exhaled air (Nitric Oxide,) and exhaled condensed air (pH, nitrites, isoprostane) will be assessed before and after treatment. Relationships between clinical and inflammatory markers will be studied

Eligibility Criteria:
Inclusion Criteria:

* Previous diagnosis of bronchiectasis based on lung HRCT and clinical symptoms
* Clinically stable in previous four weeks without exacerbations
* Informed consent

Exclusion Criteria:

* Bronchiectasis secondary to Cystic fibrosis, pulmonary surgical processes, immune deficiency, emphysema, allergic bronchopulmonary aspergillosis or diffuse interstitial pulmonary diseases
* Intolerance to macrolides or severe liver disease.
A Multi-center, International Prospective Follow up Study

The study objective is to assess the safety and efficacy of iTind three to five years following treatment.

This study will recruit patients who participated in the MT-03 study in the iTind arm to assess the safety and efficacy of the iTind procedure at three to five years following treatment as demonstrated by reduction of symptoms measured by IPSS and QoL and improvement of functional parameters as measured by peak urinary flow and PVR. Sexual and erectile function will also be assessed alongside the incidence of any related late occurring adverse events.

Eligibility Criteria:
Inclusion Criteria:

1. Subject signed informed consent form (ICF)
2. Subject who had participated in the MT-03 study in the iTind arm
3. Subject able to comply with the study protocol.

Exclusion Criteria:

1. Any anatomical or physiological condition that in the opinion of the investigator likely to impede successful completion of the study
2. Patients that are known to have had undergone an alternative surgical procedure for BPH during MT-03 study.
Biologic Characterization of Patients With ITP

This is a no-profit, multicenter, biological, non-pharmacologic study aimed to characterize from a biological point of view previously untreated primary ITP patients. To this end, peripheral blood, fecal and bone marrow samples will be collected at baseline and at 30 days and 180 days after treatment initiation - for each line of therapy - and the results of the biological analysis performed at each time point will then be compared.

This is a no-profit, multicenter, biological, non-pharmacologic study aimed to characterize from a biological point of view ITP patients. Patients with previously untreated primary ITP who need first-line therapy will be included in the study.

To this end, peripheral blood, fecal and bone marrow samples will be collected at baseline and at 30 days and 180 days after treatment initiation. The same assessments will be repeated in case of any potential new line of therapy.

The results of the biological analysis performed at each time point will then be compared, in order to seek changes related to the natural history of the disease, the therapy administered and the response achieved.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with primary ITP, in need for first line treatment according to 2019 ITP consensus2.
2. Previously untreated patients. Patients who have already started first-line therapy because of life-threatening bleeding are admitted to the study if samples are collected within 24 hours of starting treatment. In such cases, as first-line treatment steroids and platelet transfusions would be preferable over high-dose IVIg. Treatment received before the collection of samples will be carefully documented.
3. Age ≥ 18 years
4. Signed written informed consent according to ICH/EU/GCP and national local laws.

Exclusion Criteria:

1. Secondary ITP. Patients with ANA positivity without a diagnosis of SLE are admitted to the study. As far as patients with ITP and antiphospholipid antibodies positivity, those with triple positivity (anti-beta2glicoprotein antibodies, anti-cardiolipin antibodies, lupus anticoagulans positivity) are excluded.
GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface in the Treatment of SFA Obstructive Disease (VIPER)

The objective of the study is collect data on the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface in the treatment of chronic Superficial Femoral Artery disease. Device patency at 12 months is the primary endpoint.


Eligibility Criteria:
Inclusion Criteria:\>

* lifestyle limiting claudication, rest pain or minor tissue loss\>
* ABI (ankle-brachial index) \< 0.9 or TBI (toe-brachial index) \< 0.5 if ABI is \>0.9
* Stenosis (\>50%) or occlusion of native SFA (superficial femoral artery) \>5cm
* Orifice and 1 cm of SFA are patent
* Popliteal artery is patent at the intercondylar fossa of the femur to the trifurcation
* At least 1 patent run off vessel
* Guidewire and deliver system successfully traversed the lesion

Exclusion Criteria:\>

* Untreated flow-limiting aortoiliac occlusive disease
* Any previous stenting or surgery in the target vessel
* Femoral or popliteal aneurysm of target vessel
* No patent tibial arteries
* Prior ipsilateral femoral artery bypass
* Major distal amputation (above the transmetatarsal) in either limb
* Patients with known sensitivity to Heparin
Transmission Electron Microscopy Images for Platelet Ultrastructural Criteria Before and After the Onset of an Antiplatelet Agent

The aim of the pilot study is to collect all the ultrastructural platelet characteristics by transmission electron microscopy before and after the onset of an antiplatelet treatment in patients hospitalized for an ischemic stroke ; and to assess recurrence of Ischemic Cerebral Accident (ICA) at 6 months in patients hospitalized for Ischemic stroke.

Ischaemic stroke is the leading cause of adult disability. Thus, a strategy based on an efficient antiplatelet therapy has been developed to prevent platelet activation occurring in the acute phase of non-cardioembolic ischemic stroke.

The biological monitoring of the antiplatelet therapy with available platelet function assays do not provide a global integrative approach considering all the mechanisms involved in platelet activation.

Platelet transmission electron microscopy recently validated for assessing distinct ultrastructural abnormalities is a reliable morphological platelet structural analysis tool.

Ultrastructural criteria could be identified and be useful for the assessment of the degree of platelet activation and thus the biological efficiency of antiplatelet agents. All the activation transduction signals are integrated and all antiplatelet agents can be assessed.

The aim of the pilot study is to collect all the ultrastructural platelet characteristics by transmission electron microscopy before and after the onset of an antiplatelet treatment in patients hospitalized for an ischemic stroke.

Investigators expect to identify ultrastructural characteristics that will be correlated with the platelet degree of activation to guide clinicians in decision-making regarding the antiplatelet therapy strategy.

Eligibility Criteria:
Inclusion Criteria:

* Social security affiliation
* Signed informed consent
* patients hospitalized for an non cardioembolic ischemic stroke requiring the onset of an antiplatelet therapy according to the usual guidelines recommendations

Exclusion Criteria:

Contraindications regarding antiplatelet agent(s) and/or at least one excipient according to Summary of Product Characteristics (SPC).
Comparison of Class II and Class III Hysterectomy in Early Stage Cervical Cancer Cervical Cancer

Based on the value-based medicine, a randomized clinical trial was conducted to compare the role of class II and class III hysterectomy in patients with low risk early staged cervical cancer (defined as tumor lesions less than 2cm with less than 50% stromal invasion).

This is a 1:1 multi-center randomized trial with class II hysterectomy plus node dissection as the experimental arm, and class III hysterectomy plus pelvic node dissection as the control arm. Primary endpoints are: (1). 3-year diseases-free survival (DFS) rate; (2) the rates of treatment-related toxicity; (3) post-operation QoL (including sexual function) and (4) treatment costs. Secondary endpoints are：(1) the rates of pelvic and/or extra-pelvic relapse; (2) overall survival(OS) rate; (3) the numbers of retroperitoneal node dissection, and (4) the rates of parametrial, margins and pelvic/para-aortic nodes involvement.

Eligibility Criteria:
Inclusion Criteria:

1. Stage IA2 and small IB1 \<2 cm
2. Less than 50% stromal invasion based on MRI OR 10mm stromal invasion based on the pathology measurement of the LEEP/cone specimen
3. Squamous OR adenocarcinoma OR adenosquamous
4. Grade 1, 2 and 3
5. Lymph-vascular space invasion (LVSI): presence or absence
6. Diagnosis confirmed by LEEP/cone/cervical biopsy
7. Pelvic MRI in patients with involved cone/LEEP margins and those who had cervical biopsy only
8. Abdomino-pelvic CT scan in patients with negative LEEP-cone margins
9. No contraindications to surgery
10. No desire to preserve fertility
11. Informed consent

Exclusion Criteria:

1. High-risk histology types (clear cell, small cell etc)
2. Evidence of lymph node metastasis on preoperative imaging
3. Stage 1A1
4. Neo-adjuvant chemotherapy
5. Pregnancy
6. Desire to preserve fertility
Platelet Inhibition and Bleeding in Patients Undergoing Emergent Cardiac Surgery

The aim of the study is to evaluate if there is an association between platelet inhibition and surgery-related bleeding in patients undergoing emergent cardiac surgery during dual antiplatelet therapy.

Blood for measuring platelet function is drawn before induction of anesthesia

Eligibility Criteria:
Inclusion Criteria:

* First time on-pump CABG with or without valve replacement

Exclusion Criteria:

* Redo surgery,
* Renal insufficiency needing dialysis,
* Concomitant medication with warfarin,
* Preoperative fibrinogen \< 150 mg%