cyrilzakka/clinical-trials huggingface dataset:
Detection of ARv7 in the Plasma of Men With Advanced Metastatic Castrate Resistant Prostate Cancer (MCRP)

Demonstrate detection of ARv7 splice variant transcripts from exosomes in the circulation of MCRPC patients pre and post treatment with selective Androgen pathway inhibitors (i.e. abiraterone and enzalutamide)

Primary Objective

-Demonstrate detection of ARv7 splice variant transcripts from exosomes in the circulation of MCRPC patients pre and post treatment with selective Androgen pathway inhibitors (i.e. abiraterone and enzalutamide)

Secondary and Exploratory Objectives

* Correlate ARv7 status with PSA response (\>/=50% decline in PSA level from baseline, maintained for \>/=4 weeks) at any time after the initiation of therapy.
* Comparison of median progression free survival (PFS) and overall survival (OS).
* Determine additional molecular lesions in exoRNA and cfDNA in MCRPC patients post-treatment with androgen pathway inhibitors.
* Correlate other AR-variants (non ARv7) with clinical outcomes including PSA response.

Eligibility Criteria:
Inclusion Criteria:

1. Participants must have histologically confirmed diagnosis of adenocarcinoma of the prostate.
2. Clinical or radiographic evidence of metastatic disease.
3. Planned therapy with either enzalutamide or abiraterone acetate within the coming 6 weeks.
4. Evidence of disease progression on or following most recent therapy as evidenced by the following:

   * Radiographic evidence of disease progression as defined by one or more new bone scan lesions.
   * Growth of soft tissue / visceral metastases to greater than one centimeter in longest diameter.
   * Progressive disease despite 'castration levels' of serum testosterone (\<50ng/dL with continued androgen deprivation therapy.
5. At least two of the following high risk features during screening for rapid disease progression:

   * Anemia with a hemoglobin \<12.0 g/dL
   * Elevated alkaline phosphatase
   * High lactate dehydrogenase (LDH)
   * Presence of visceral metastasis on imaging
   * Presence of clinically significant pain requiring opioid analgesics.
   * PSA doubling time under 3 months on most recent therapy
   * PSA values obtained 2 or more weeks apart, with last value being 2.0ng/mL or higher.
6. Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

1. Receiving or intend to receive concurrent chemotherapy
2. Hepatitis (all types) in patient's medical record
3. HIV documented in patient's medical record
4. History of intercurrent or past medical history or psychiatric illness that would make participation in a blood drawing protocol difficult or not feasible.
A Preventive Behavioral Intervention for Young Adults With Psychotic Experiences

This is a randomized controlled trial testing the efficacy of Resilience Training in college students with elevated transdiagnostic risk for developing a serious mental illness.


Eligibility Criteria:
Inclusion criteria:

1. 18-30 years old
2. Enrolled as a first or second year student (i.e., freshman or sophomore) in an undergraduate program at the college or university where the intervention takes place
3. Students who endorse some psychotic experiences (Peter's et al. Delusion Inventory (PDI) score \> 3)

Exclusion criteria:

1. Inability to provide informed consent
2. Not proficient in English
3. Current self-reported Diagnostic Statistical Manual 5 (DSM-5) diagnosis with active symptoms (such as active psychotic symptoms, current suicidality, serious active alcohol or substance use, marked deterioration in functioning over the prior month) determined by clinical interview with participant, or self-report of a psychiatric diagnosis that necessitates close monitoring or individual therapy and/or inpatient or partial hospitalization
4. Current enrollment in psychological or behavioral health treatment.
5. Current use of psychotropic medications (other than stimulants) prescribed by a physician.
6. A diagnosis of a serious, chronic mental illness as determined by the Mini-International Neuropsychiatric Interview (MINI)
State of Coagulation in Pre-eclampsia: Comparing Sonoclot Signature Analysis With Conventional and Specific Haemostasis Assays

* Detection of the presence or absence of coagulopathy in cases with pre-eclampsia.
* Investigate the value of global hemostasis studies (Sonoclot signature analysis) in cases of pre-eclampsia and if there a correlation between it and the specific traditional assays of hemostasis.

Pre-eclampsia remains a major cause of morbidity and mortality in pregnant women, as well in their newborns (1). Despite intense study, preeclampsia remains poorly understood and a major cause of maternal and foetal morbidity and mortality. It's clear that vascular endothelial dysfunction, which may lead to hypertension by imbalance between vasoactive, and vasodilator agents, is an important component of this disorder. The induction of endothelial dysfunction is probably multifactorial (2). Some researchers suggested that hereditary and acquired thrombophilia has been associated with recurrent pregnancy loss and gestational vascular complications, such as early-onset pre-eclampsia and placental abruption (3). Despite it is widely known that pregnancy induces a state of hypercoagulability (4), publications failed to demonstrate a uniform pattern of pathology that can carry the association between thrombophilia and adverse pregnancy outcomes, as between factor V Leiden mutation, MTHFR C677T mutation, G20210A Prothrombin gene mutation, Anti-thrombin III deficiency, Protein C,S deficiency and other causes of thrombophilia, different researchers claimed different causes of the previously mentioned as the one responsible for maternal thrombophilia (2, 3, 5). Others claimed racial variations were associated with the state of thrombophilia (6).

Other than standard routine and specific tests, various other methods are used to record coagulation profile. One of them is estimation by sonoclot, which is a viscoelastic hemostatic assays device (7). Sonoclot have practical advantages as point-of-care device for monitoring major hemorrhage including a set of parameters that assesses a global coagulation profile and can indicate the presence of hypercoagulable state (8). Establishing correlations between Sonoclot parameters and conventional hemostasis assays could open a path of better monitoring of patients with suspected coagulopathies, and can be helpful in guiding management of preeclampsia and preventing severe maternal outcomes (7).

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant pre-eclamptic patients with blood pressure \> 140/90 mm hg and proteinuria \> 0.39/24 hrs., with gestational age between 20-42 weeks (second \& third trimester).
2. Pregnant normotensive females with no pregnancy complications and gestational age 20-42 weeks to act as controls.

Exclusion Criteria:

1. Patients with gestational age \< 20 weeks (First trimester).
2. Patients in labour.
3. Patients with foetal malformations, history of chronic hypertension, diabetes mellitus, renal diseases, collagen vascular disease, anaemia, cardiovascular diseases and patients known to be thrombophilic before pregnancy (acquired or inherited).
Effect of Intense Sport Practice in Athletes With Non-ischemic Scar

The prognostic relevance of isolated non-ischemic LGE (i.e. with no underlying "labelled" cardiomyopathy) is unclear, and current guidelines to not state on the clearance of athlete with this type of findings as regards to competitive or intense sport practice.

The principal objective of the study is to evaluate during a five-years follow up, the clinical outcome of athletes with this kind of findings. The secondary objective is the determination of prognostic factors. The management and follow-up of the athletes will be let at the appraisal of each center.

The presence of a scar, assessed by late gadolinium enhancement (LGE) on cardiac resonance imaging (CMR), is associated with a poor prognosis in patients with ischemic heart disease or cardiomyopathy. But the prognostic relevance of isolated non-ischemic LGE (i.e. with no underlying "labelled" cardiomyopathy) is unclear, and current guidelines do not state on the clearance of athlete with this type of findings as regards to competitive or intense sport practice.

The objective of the study is to evaluate the clinical outcome of athletes with isolated non-ischemic LGE with no underlying "labelled" cardiomyopathy during a five-years follow-up. The secondary objective is the determination of prognostic factors based on the baseline inclusion data: indication of CMR (i.e. symptoms, abnormal ECG, presence and morphology of arrhythmias, abnormal echocardiography); localization and amount of LGE, left and right ventricular geometry and function, characteristics of sport practice (amount, type, competition).

The management of the athletes will be let at the appraisal of each centre, as regards to the initial assessment, the follow-up and the medical clearance for competitive sports participation. Nevertheless, due to the absence of consensus, we propose that the patient should at least undergo clinical examination, ECG, echocardiography, cardiopulmonary exercise test (CPET) and holter ECG each year. A CMR should be performed at one and five years.

Eligibility Criteria:
Inclusion Criteria:

* Any athlete, aged of more than 15 years, symptomatic or not,
* in whom non-ischemic LGE with no underlying "labelled" cardiomyopathy is detected on CMR. Scare of an acute myocarditis will also be included.

Athletes will be defined by a practice of ≥4 hours/week of sport activity and/or competitive sport activity at the time of the assessment which triggered the realization of the 1st CMR.

Exclusion Criteria:

* Athletes with any unequivocal cardiac disease that might explain the LGE (i.e. hypertrophic cardiomyopathy, ischemic cardiac disease). In case of borderline or doubtful diagnosis the athlete can still be included (for example an athlete with a dilated LV and borderline function, or with borderline wall thickness).
* Patients who refuse their participation in the study.
* Patients under legal protection or deprived of their liberty.
The Efficacy of Polidocanol Injections as a Treatment of Chronic Achilles. Tendinopathy

Chronic achilles tendinopathy is a common disease especially in adults. The golden standard in treatment has up to now been excentric exercises but with varying success. A new hypothesis is that this chronic pain is due to neo vascularisation. In a pilot study sclerosing injections with polidocanol have had a successful efficacy. Our aim is to study the efficacy of polidocanol as a treatment in a randomised controlled setting on a larger scale.

48 patients with chronic achilles tendinopathy for more than 3 months who have tried excentric exercises without success will be randomised to either polidocanol or lidocaine injections if having ultrasound verified neo-vascularisation.

Eligibility Criteria:
Inclusion Criteria:

* 18 year old, Ultrasound verified Achilles tendinopathy with neo-vascularisation, pain duration more than three months, excentric exercises for at least three months, women: negative pregnancy test, safe anticonceptive

Exclusion Criteria:

* Dementia, mental disease or other illness incompatible with participation, no ultrasound verified neo-vascularisation, any illness which contraindicate the use of Polidocanol or Lidocaine, granulation tissue of more than 50 % of the Achilles tendon, ability of lying in prone position, women: pregnancy or breastfeeding,
Blue Light Imaging (BLI) for Optical Diagnosis of Colorectal Polyps

Several imaging technologies have been developed in order to enable the endoscopists to differentiate neoplastic from non-neoplastic lesions. The real-time prediction of polyps histology is clinically relevant as diminutive polyps represent the majority of polyps detected during colonoscopy and have a very low risk of harboring advanced histology or invasive carcinoma. Thus, an optical diagnosis would allow diminutive polyps to be resected and discarded without pathological assessment or left in place without resection, with an enormous cost-saving potential. Recently, the American Society of Gastrointestinal Endoscopy (ASGE) has set the Preservation and Incorporation of Valuable endoscopic Innovation (PIVI) which defined accuracy threshold to be met, in order to consider a new technology ready to be incorporate into clinical practice. Blue Light Imaging (BLI) is a new chromoendoscopy technology integrated in the latest generation ELUXEOTM 7000 endoscopy platform (Fujifilm Co, Tokyo, Japan), based on the direct (i.e. not filtered) emission of blue light with short wavelength (410nm), that enhances visibility of both microvascular and superficial mucosal pattern. In a recent randomized trial BLI was superior to high-definition white light (HDWL) in the real time characterization of subcentimetric and diminutive colonic polyps. Nevertheless, in this study the paucity of diminutive rectosigmoid polyps analyzed does not allow to draw definite conclusions as the meeting of PIVI thresholds are concerned. Similarly, the low numbers of patients evaluated limited the per-patient analysis. Therefore further studies adequately powered to this clinically end-point were advocated. Additionally, when the study was performed a BLI dedicated classification for optical diagnosis of colonic polyps was not available, whereas recently a specific classification (the BLI Adenoma Serrated International Classification-BASIC) has been developed and a specific training set has been settled.

In the present study the investigators prospectively evaluate whether the use of BLI-assisted optical characterization of diminutive polyps using BASIC classification by specifically trained endoscopists may met PIVI thresholds and particularly if it allow the endoscopists to achieve \> 90% correct assignment of post-polypectomy surveillance intervals when combined with the histopathology assessment of polyps \>5 mm in size.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive adult (18-80 yrs) outpatients undergoing colonoscopy in the frame of the FOBT based screening program or for CRC primary prevention, in which at least one diminutive (\<5 mm) rectosigmoid polyp is detected.

Exclusion Criteria:

* patients with CRC history or hereditary polyposis syndromes or hereditary non-polyposis colorectal cancer
* patients with inadequate bowel preparation
* patients in which caecal intubation was not achieved or scheduled for partial examinations
* polyps could not be resected due to ongoing anticoagulation preventing resection and pathologic assessment
Single Versus Combined Antibiotic Therapy for Bacterial Peritonitis in CAPD Patients

To compare the efficacy of single versus combined antibiotic therapy for bacterial peritonitis in CAPD patients.

To compare relapse and recurrent rate of peritonitis between single and combined antibiotic regimens for bacterial peritonitis in CAPD patients.

Eligibility Criteria:
Inclusion Criteria:

* age \>/= 18 years old
* ESRD patients on continuous ambulatory peritoneal dialysis more than 4 weeks
* presence of symptom or sign of peritonitis
* presence of WBC \>100cell/mm3 with PMN \>50% in peritoneal dialysate or gram stain positive for gram positive or gram negative bacteria

Exclusion Criteria:

* presence of polymicrobial organism, non-fermentative gram negative organism, fungus, mycobacteria in peritoneal fluid or culture-negative
* peritonitis from the organisms that required combined antibiotic therapy according to ISPD guideline 2010
* hospital-acquired peritonitis
* presence of catheter-related infection
* history of peritonitis within 4 weeks
* currently taking antibiotic
* allergic to the antibiotic that used in the study(penicillin or cephalosporin or quinolone or aminoglycoside)
WSI Based DL for Diagnosing the IASLC Grading System of Lung Adenocarcinoma

The purpose of this study is to evaluate the performance of a whole slide image based deep learning model for diagnosing the IASLC grading system in resected lung adenocarcinoma based on a multicenter prospective cohort.


Eligibility Criteria:
Inclusion Criteria:

1. Age ranging from 18-85 years old;
2. Pathological confirmation of primary lung adenocarcinoma after surgery;
3. Obtained written informed consent.

Exclusion Criteria:

1. Multiple lung lesions;
2. Poor quality of whole slide images;
3. Mucinous adenocarcinomas and variants;
4. Participants who have received neoadjuvant therapy.
Bioactive Glass as Bone Graft Substitute in Operative Treatment of Bone - a 10 Years Follow-up Study

The main aim is to evaluate the long-term safety and bone healing in the operated area and to compare bioactive glass granules with autogenous bone as a filler material.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained; Participation of previous clinical investigation with bioactive glass

Exclusion Criteria:

* The subject is unlikely to adhere to study procedures
* Concurrent disease or condition that in the opinion of the investigator is contraindicating participation
* Simultaneous participation in another medical device or investigational drug trial
Male Involvement in Antenatal Care and the Prevention Programme of Mother-to-child Transmission of HIV in Uganda

HIV /AIDS is a major public health problem in Uganda. The prevention of mother to child transmission of HIV/ AIDS (PMTCT) was launched in Uganda in November 2001 and in Mbale Hospital in May 2002. Currently, PMTCT services have been integrated into mainstream antenatal care services throughout the country.

Though engaging men as partners is a critical component in the PMTCT programme, their involvement has been low. Measures to increase male partner involvement in the PMTCT programmes have not been explored in Uganda.

Objectives: To determine the effect of a written invitation letter to the spouses of women, attending their first antenatal visit on: (a) couple attendance at subsequent antenatal clinic visits; and (b) couple acceptance of HIV testing.

Study site: The study will be carried out at Mbale Regional Referral Hospital in eastern Uganda

Study design: A randomised clinical trial among 1060 (530 intervention and 530 control) new antenatal attendees. The intervention will be a written invitation letter to their spouses.

Outcome measures: The main outcome measure is the proportion of pregnant women who come with their partners for ANC at the subsequent antenatal visit.

Utility: The results of this study will be utilised in re-orienting the ANC services to encourage male participation and hopefully improve the uptake of the PMTCT services at Mbale Regional Referral Hospital.


Eligibility Criteria:
Inclusion Criteria:

* New antenatal mothers (attendees) at Mbale regional referral hospital
* Acceptance to attend at least two subsequent antenatal visits at Mbale hospital

Exclusion Criteria:

* Women attending with their spouses at the first ANC visit
* Refusal to take the letter to her spouse
* Women with inaccessible spouses
Effect of Anterioposterior Weight Shifting Training With Visual Biofeedback in Patients With Step Length Asymmetry After Stroke

To investigate the effect of anteroposterior weight shifting training with visual biofeedback on step length asymmetry. Reduced speed and asymmetry of stepping is a specific characteristic of hemiplegic gait. Asymmetry of stepping is characterized by shorter step length of the unaffected limb compared to the affected limb. Causes of this phenomenon are difficulty in weight bearing at the affected limb, weak propulsive force of the affected limb, and decreased strength of hip extensors. To correct these factors. we have developed an anteroposterior weight shifting training system with visual feedback and studied its effects.


Eligibility Criteria:
Inclusion Criteria:

1. Independent standing
2. Ability to walk 10m without manual assistance
3. Asymmetric ratio of step length \> 1.1
4. No severe perceptual, cognitive or cardiovascular impairments that could affect walking

Exclusion Criteria:

1. Quadriplegia or double hemiplegia
2. Orthopedic or neurologic conditions in addition to the stroke
3. Had more than 1 cerebrovascular accident
Ultrasound Guided Autologous Blood Injection in Temporomandibular Joint Dislocation

The aim of this study is To compare the accuracy and effectiveness of ultrasound (US) guided autologous blood injection (ABI) versus non- guided technique for the treatment of chronic recurrent temporomandibular joint dislocation

All patients involved in this study will be divided randomly to two different groups and injected with autologous blood into joint space and pericapsular tissue.

Study group (group A) will be injected with autologous blood with ultrasound guidance.

control group (group B) will be injected with autologous blood without US guidance. Anatomical landmarks and tactical sense will be followed only.

The operation will be done under local anesthesia ( Auriculotemporal nerve block ) the skin overlying the temporomandibular joint will be scrubbed by an antiseptic solution and the area will be isolated with sterile towels. External auditory canal will be blocked with cotton.

About 3 ml of blood will be withdrawn from patient's antecubital fossa, of which 2 ml injected intra-articular and 1 ml in the pericapsular tissue (PT) The procedure should be repeated on the opposite side in case of bilateral involvement.

Eligibility Criteria:
Inclusion Criteria:

* Patient with at least 3 episodes of temporomandibular joint dislocation in the past 6 months.
* Necessitating a visit to the emergency room or trained professional to reduce the dislocation.
* Radiological evidence of displacement of condylar head beyond the articular eminence on wide mouth opening.
* Maximum mouth opening (MMO) more than 40 mm.
* Unilateral or bilateral.
* Over 18 years of age.
* Both gender Males or females.

Exclusion Criteria:

* Patient having inflammatory temporomandibular joint disease like tuberculous arthritis, rheumatoid arthritis.
* Patients with bleeding disorders, pregnancy or bony pathology of temporomandibular joint .
* Allergy to local anesthetic.
* Severe epilepsy or Parkinson's disease.
* Patient on anti-depressants or anti-psychotics.
* Inability to follow-up the patient during the entire follow-up period.
* Patients who had recent fracture at temporomandibular joint level or who had previous surgical interference to temporomandibular joint .
* Refused to sign the written informed consent were also excluded.
* Dystonia