cyrilzakka/clinical-trials huggingface dataset:
Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1940

The primary aim of this study is to investigate if AZD1940 can relieve the pain induced by the surgical removal of one lower wisdom-tooth. This will be done by comparing the effect of AZD1940 to placebo ("inactive substance") on pain. A number of patients will instead receive the common painkiller naproxen for comparison purposes. Rescue medication, acetaminophen, will be allowed if a need for additional painkillers would arise. A number of patients will receive Naproxen as control.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for surgical removal of one partial or complete impacted mandibular third molar.
* Provision of signed informed consent.
* Healthy males or non-fertile females.

Exclusion Criteria:

* History of somatic disease/condition, which may interfere with the objectives of the study, as judged by the investigator.
* History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder according to the criteria in the Diagnostic and Statistical Manual of Mental Disorder, 4th edition.
Characterization of Treatment Responses in Lymphedema

This study is designed to investigate the treatment response of lymphedema, of the upper or lower extremity, during clinical, pharmacologic treatment of lymphedema with oral ketoprofen. Correlation of clinical responses (changes in limb volume and skin thickness) with changes in the inflammasome will help to define the molecular substrate of treatment response.

Patients presenting to the Investigator's Clinic for evaluation and treatment of (upper or lower extremity) lymphedema, will be assessed for their suitability (of low risk) for medical treatment with ketoprofen. If there are no contra-indications to taking ketoprofen, after discussion of FDA warnings, including provision of a written copy of the FDA language to the patient, and with the recommendation to discuss with the primary physician-of-record, patients will be provided with a prescription for ketoprofen 200 mg daily (one capsule taken orally, once daily) or if obtained from a compound pharmacy, ketoprofen 210 mg daily (one capsule taken orally, once daily).

Participation in this study will be offered. Two study visits, at baseline and month 6 are required. Measurements (circumferential and skin thickness) and a blood sample will be taken at each study visit.

The investigators will try to determine how ketoprofen affects the body tissue by obtaining blood samples and measurements, before starting treatment and at month 6.

Eligibility Criteria:
Inclusion Criteria:

* Participants with a history of acquired lymphedema
* Stage 1, 2, or 3
* 18-75 years
* Clinical use of ketoprofen for lymphedema

Exclusion Criteria:

* Active cancer, infection, bleeding tendency, inflammatory disease and/or taking anti-inflammatory or anti-leukotriene medication will be excluded.
* Pregnant or lactating females
* Inability to take ketoprofen (contra-indicated, e.g patients with known CV, GI, renal, hepatic disease).
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation, may interfere with interpretation of study results, and in the judgement of the investigator, would make the participation inappropriate for entry into this study.
F 18 T807 Tau PET Imaging of Progressive Posterior Cortical Dysfunction (IND 123119, Protocol E)

This project will collect quantitative pilot data that will allow the characterization of uptake and binding of 18F-AV-1451 (also known as F 18 T807), a novel tau imaging compound, in individuals with Progressive Posterior Cortical Dysfunction (PPCD) and logopenic variant primary progressive aphasia (lvPPA). The primary goal is to develop tau imaging technique as an antecedent biomarker of cognitive decline. The investigators propose to obtain preliminary data that will support the possibility of detecting cognitive decline in its earliest stages, before the occurrence of dementia.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female participants, at least 45 years of age.
2. Clinical diagnosis of PPCD.
3. Participant is able and willing to undergo testing (MRI or CT, PET, radioactive tracer injection, LP; for those unable to undergo an MRI, CT will be used to generate regions-of-interest).
4. Pre-menopausal women will have a negative urine pregnancy test within 24 hours of T807 drug administration.

Exclusion Criteria:

1. Has any condition that, in the Investigator's opinion, could increase risk to the participant, limit the participant's ability to tolerate the experimental procedures, or interfere with the collection/analysis of the data (for example, participants with severe chronic back pain might not be able to lie still during the scanning procedures).
2. Is deemed likely unable to perform the imaging procedures for any reason.
3. Has a high risk for Torsades de Pointes or is taking medications known to prolong QT interval.
4. Has hypersensitivity to F 18 T807 or any of its excipients.
5. Contraindications to PET, PET-CT or MR (e.g. electronic medical devices, inability to lie still for long periods) that make it unsafe for the individual to participate.
6. Severe claustrophobia.
7. Currently pregnant or breast-feeding.
8. For those electing to undergo the optional lumbar puncture: on anticoagulant of any form prior to lumbar puncture.
Dose-finding Study of Novel Erythropoiesis Stimulating Protein (NESP) for the Treatment of Anaemia in Subjects With Solid Tumours Receiving Multicycle Chemotherapy

The purpose of this study is to assess the safety of NESP administered by SC injection in subjects with solid tumours and anaemia receiving multicycle chemotherapy.

Subjects in this study enter one of two schedules: Schedule 1 or Schedule 2. Schedule 1 is a sequential dose escalation study which consists of Parts A and B. Part A is the initial treatment phase, where the clinically effective dose (CED) of NESP administered every 3 weeks will be determined after 12 weeks of treatment. Part B is an optional 12-week, open-label, dose-maintenance phase that follows Part A.

Schedule 2 is a parallel dose-finding study and also consists of Parts A and B. Part A is the initial treatment phase, where the CED of NESP administered every 4 weeks will be determined after 12 weeks of treatment. Part B is an optional 12-week, open-label, dose-maintenance phase that follows Part A.


Eligibility Criteria:
Inclusion Criteria:

* Subject with solid tumour(s)
* Anaemia (hgb less than or equal to 11.0 g/dL
* Planned to receive cyclic chemotherapy
* At least 6-month life expectancy
* Eastern Cooperative Oncology Group (ECOG) status of 0 to 2
* Adequate renal and liver function
* At least 18 years of age

Exclusion Criteria:

* Central nervous system disease
* Iron deficiency
* Received more than 2 RBC transfusions within 4 weeks before randomisation or any RBC transfusion within 2 weeks before randomisation
* Received recombinant human erythropoietin (rHuEPO) therapy within 8 weeks before randomisation
* History of any seizure disorder
* Cardiac disease
* Active infection or inflammatory disease
* Known positive test for HIV infection
* Known primary haematologic disorder which could cause anaemia
* Use of other investigational agent(s)/device(s)
* Pregnant or breast feeding
* Known hypersensitivity to any recombinant mammalian derived product
Autologous BMMNC Combined With HA Therapy for PAOD

The purpose of this study is to evaluate the safety and efficacy of hyaluronan combined with autologous bone marrow mononuclear cells for the treatment of critical PAOD patients.

This is a multicenter, non-blinded and randomized study to evaluate the safety and efficacy of hyaluronan (HA) combined with autologous bone marrow mononuclear cells (BMMNC) therapy for critical peripheral arterial occlusive disease (PAOD) patients.

A total of 30 subjects will be recruited into the study. The subjects will be randomized into 3 different arms. During the Phase I study, 9 subjects recruited while another 21 additional subjects will be recruited in Phase II after the review of DSMB and consultation of Taiwan FDA on the results of the Phase I study.

Each subject will be administered 5\~10 injections of RV-P1501, the number of injections depends on the size of the subject's ischemic leg. Each subject will receive treatment once. Subjects will be assigned to the treatments in random order. Evaluations including ABI, PWT/PFWT, clinical status, EF, CTA, biochemistry and hematology checked during the inclusion and exclusion evaluation, and will be taken at baseline, 1 week, 2 weeks, 4 weeks, 12 weeks, and 24 weeks after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patient age ≥ 20
* Patients with severe PAOD and diagnosed with Rutherford category 3, 4, or 5
* Contraindication to angioplasty or bypass surgery, or post-angioplasty or bypass surgery for once but with limited or no effect.
* Patient without hypertension or hypertensive patient with adequate-controlled blood pressure.
* With signed informed consent

Exclusion Criteria:

* Patient undergone any organ transplantation
* Inability to undergo bone marrow aspiration
* Pregnant woman
* Life expectancy \< 1 year
* Cognitive impairment
* Active malignancy in 5 years prior to treatment
* Bleeding diathesis or pulmonary embolism
* Patient with active major cardiovascular diseases such as unstable angina, arrhythmia, heart failure, impaired cardiac function (ejection fraction \< 45%), or stroke
* Estimated Glomerular Filtration Rate (eGFR) \< 30
* Glutamic oxaloacetic transaminase (GOT) and glutamic pyruvic transaminase (GPT) values higher than 80 U/L
* Patient with severe diabetes mellitus (HbA1C \> 8%)
* Patient with alcohol addiction
* Patient with drug abuse
* Patient with infections or skin disease on the ischemic leg.
* Allergic to HA
* Patient whose blockage region only occurred in the femoral artery or at foot.
Written Exposure Therapy for Suicide Prevention

Military service members admitted to inpatient psychiatry for self-injurious thoughts and behaviors (SITBs) represent an at-risk group for continued SITBs and rehospitalizations in the post-discharge period. However, there is an absence of evidence-based interventions designed to be delivered on inpatient psychiatric units to reduce the risk of post-discharge SITBs. To address this gap, the investigator's research group developed Written Exposure Therapy for Suicide Prevention (WET-SP), a brief, scalable, suicide-specific psychotherapy based on the written disclosure paradigm. Written disclosure, in which an individual writes about a personally stressful experience and the related thoughts and feelings, yields improvements across physical and psychiatric domains. Pilot data suggest that written exposure also yields reductions in SITBs. Yet, no study has adapted the written exposure paradigm specifically to target the amelioration of distress associated with suicidal crises and examined whether implementing WET-SP reduces the risk of subsequent SITBs and suicide-related hospitalizations.

The primary objective of this randomized controlled trial (RCT) is to evaluate the efficacy of WET-SP, in reducing the incidence and severity of SITBs in active duty military service members following a psychiatric hospitalization due to suicidal ideation, suicide plans, or a suicide attempt. Secondary objectives are to evaluate a potential mechanism of change (i.e., decreases in thwarted belongingness \[cf. social disconnectedness\]) and moderator of outcomes (i.e., arc of narrative \[cf. linguistical parameters of the written narratives generated during treatment\]). Participants randomized to WET-SP + TAU will receive five sessions of WET-SP delivered by the study team during their psychiatric hospitalization plus treatment-as-usual (TAU). Participants randomized to TAU will receive daily contact and patient-centered care delivered by the acute psychiatric inpatient unit provider team (e.g., psychiatrists, therapists, case managers). TAU includes psychiatric assessment, initial stabilization, nurse case management, medication management, treatment of medical comorbidities, group and individual therapy, and discharge planning. Outcome assessments will be administered at pretreatment, posttreatment, and 10-, 20-, and 30-week follow-ups.


Eligibility Criteria:
Inclusion Criteria:

* Current active duty military service member, veteran, and beneficiaries
* Admitted to Carl R. Darnall Army Medical Center (CRDAMC) for suicidal thoughts, a suicide plan, or a suicide attempt
* Elevated levels of suicidal ideation severity in the past two weeks, as indicated by a score \>= 3 on the Depressive Symptom Index-Suicidality Subscale (DSI-SS)
* Ability to read, write, and speak English

Exclusion Criteria:

* Active psychosis as the priority of care for hospitalization
* Moderate or greater cognitive impairment (as determined by the inability to comprehend the baseline screening questionnaires)
* Unable to provide informed consent
Evolution of the 6-minute Walk Test in Patients Treated With ELEXACAFTOR / TEZACAFTOR / IVACAFTOR

The aim of the study is to identify a link between the new CFTR modulators and physical activity in cystic fibrosis patients.

The triple combination of CFTR modulators (ELEXACAFTOR / TEZACAFTOR/ IVACAFTOR) has recently changed the management of cystic fibrosis.

This treatment has been shown to rapidly improve patients' respiratory function, with a gain in FEV1 at 1 month ranging from 10.4% to 13.6%. It also reduces the number of respiratory exacerbations and improves the nutritional status and quality of life of treated patients.

To date, there is limited data on the impact of these new therapies on physical activity. Few studies have investigated changes in exercise or physical activity parameters under ELEXACAFTOR / TEZACAFTOR/ IVACAFTOR.

The 6-minute walk test is a validated field test used routinely to assess the exercise capacity of patients with chronic respiratory diseases, including cystic fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 12 years with cystic fibrosis, heterozygous for the F508del mutation of the CFTR gene, treated with ELEXACAFTOR/ TEZACAFTOR/ IVACAFTOR.
* Patients followed in the respiratory diseases department of the Renee Sabran Hospital
* 6-minute walked test performed in the year preceding initiation of ELEXACAFTOR / TEZACAFTOR/ IVACAFTOR
* 6-minute walked test performed after treatment initiation (between the 3rd month and the 14th month)
* No opposition to participation

Exclusion Criteria:

* - Age \< 12 years
* Pregnancy
* Discontinuation or reduction in dosage of ELEXACAFTOR/ TEZACAFTOR/ IVACAFTOR
* Patients objecting to the use of their data for research purposes
Reducing Alcohol Use in Depressed Patients

The purpose of this study is to determine whether a brief alcohol intervention reduces alcohol use and improves depression among depressed patients.

Heavy alcohol consumption is common among patients seeking treatment for depression. Heavy drinking is associated with a variety of medical and psychosocial problems. Heavy drinking is particularly problematic among depressed patients, increasing the likelihood of poor depression treatment outcomes. While methods for reducing alcohol use in this population have been unexplored to date, brief interventions to reduce heavy alcohol use have been well-validated in numerous patient populations and offer the promise to reduce heavy drinking among depressed patients and to improve depression treatment outcomes.

We hypothesize that adding a brief alcohol intervention to standard psychiatric care, relative to standard psychiatric care alone, will reduce overall drinking volume and heavy drinking days among heavy-drinking depressed patients. Furthermore, we expect patients who receive the brief alcohol intervention to have better depression outcomes than patients receiving standard psychiatric care alone. We also expect that reduced alcohol consumption will mediate the effect of the brief alcohol intervention on depression outcomes. In addition, we will examine individual difference variables as predictors of change in alcohol use.

The proposed study is a randomized, two-group design with repeated measures over time, comparing a brief, motivationally-focused alcohol intervention plus standard psychiatric care to standard psychiatric care alone. For this study, we will recruit a sample of 240 psychiatry clinic outpatients meeting structured diagnostic criteria for major depressive disorder who drink heavily but are not alcohol dependent.

We expect that the results of this study will improve depression treatment outcomes for the significant subpopulation of depression patients who drink heavily and are likely to do poorly in depression treatment in the absence of a change in their drinking behavior. The intervention proposed in this study represents a novel approach to reducing heavy drinking among depressed patients that, if effective, can be readily integrated into depression treatment in a variety of treatment settings. In addition, this study will provide valuable information on the association between alcohol use and depression outcomes and on the mechanisms of change in alcohol use among heavy-drinking depressed patients.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Meet criteria for current Major Depressive Disorder
* Have consumed more than 14 drinks per week or more than 5 drinks on one occasion in the past month for men or more than 7 drinks per week or more than 4 drinks on one occasion in the past month for females

Exclusion Criteria:

* Meet criteria for current alcohol dependence or current psychoactive substance dependence (excluding nicotine)
* Currently psychotic
Oxytocin Effects on Likeability After Being Liked or Disliked

The current study aimed to investigate oxytocin effect on the response after the experience of being liked or disliked.

In a double-blind, between-subject, placebo controlled design study, the researchers aimed to investigate the intranasal OXT (40IU) treatment on rating response after being liked or disliked in healthy male subjects. All subjects completed a range of questionnaires measuring personality and affective traits and levels of anxiety: Positive and Negative Affect Schedule (PANAS) , State-Trait Anxiety Inventory (STAI) , Beck Depression Inventory (BDI), Cheek and Buss shyness Scale (CBSS),Autism Spectrum Quotient (ASQ), Empathy Quotient(EQ) before self-administration.Study participants were led to believe that other participants had formed an opinion on their likability based on their appearance in a photograph and they passively viewed the responses (like or dislike) from 'other participants'. After that, they rated 'other participants' about likeability (how much do you like the person), accuracy (have you seen the person), feeling (how good do you feel), and tendency (how much would do like have him/her as a friend). Likeability, tendency, feeling and accuracy were included into analysis as dependent variables.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects without past or current psychiatric or neurological disorder

Exclusion Criteria:

* history of head injury;
* claustrophobia;
* medical or psychiatric illness.
Recurrence of Hereditary Hemorrhagic Telangiectasia (HHT) After Liver Transplantation

Liver transplantation (LT) has been proposed as a curative treatment in hereditary hemorrhagic telangiectasia (HHT) with severe hepatic involvement. The investigating team provides a long-term evaluation of graft status after LT for HHT with a focus on the risk of recurrence. The present study included all patients prospectively followed up after LT for HHT in the Lyon Liver Transplant Unit from 1993 to 2010 with a survival of more than 1 year.


Eligibility Criteria:
Inclusion Criteria:

* Hereditary Hemorrhagic Telangiectasia (HHT) patient who underwent liver transplant for HHT

Exclusion Criteria:

* Patient who died in the year following transplantation
Effects of Salt Intake on the Nervous Systems of Patients With Salt-Sensitive High Blood Pressure

Some patients with high blood pressure can experience an increase of blood pressure by 10 percent or more by taking in salt. These patients are referred to as having "salt-sensitive" (SS) hypertension.

Previous studies conducted on patients with salt sensitive hypertension suggest that their portion of the nervous system responsible for maintaining normal blood pressure (autonomic nervous system) may respond differently to salt than patients with non-salt sensitive (NSS) hypertension.

This study is designed to examine the response of the nervous system to high doses of salt in patients with salt-sensitive hypertension and patients with non-salt sensitive hypertension.

A subset of patients with idiopathic hypertension shows an increase in blood pressure of 10 percent or more in response to salt-loading and have been termed "salt-sensitive" (SS). Limited studies of adrenergic function in response to salt-loading suggest that the response of SS patients may differ from that of non-salt sensitive (NSS) patients. The present studies were designed to examine the response of the adrenergic and dopaminergic systems to salt-loading in SS and NSS patients with idiopathic hypertension.

Eligibility Criteria:
Eligibility criteria not identified in protocol.
A Prospective Study of Clinical Outcomes for the Pathwork Tissue of Origin Test

The study prospectively assesses the change in cancer-specific clinical decisions and outcomes before and after physicians received results from the Pathwork® Tissue of Origin (TOO) Test for patients whose primary site of cancer origin is uncertain.


Eligibility Criteria:
Inclusion Criteria:

* their physician ordered or intends to order a Pathwork® TOO Test between May 2012 and December 2013
* the patient is ≥ 18 years of age
* the patient has given informed consent (online or verbal)
* the patient is able to understand English.
Guided Bone Regeneration Versus Bone Block Grafting

The purpose of this study is to analyze the volumetric gain and stability of the newly formed bone tissue comparing guided bone regeneration with block graft.


Eligibility Criteria:
Inclusion Criteria:

* Patients in need of an implant-supported rehabilitation
* Patients requiring bone regeneration
* Healthy patients
* Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) ≤ 15%
* Sufficient mesiodistal and interocclusal space
* At least 6 months of follow-up

Exclusion Criteria:

* An American Society of Anesthesiologists physical status classification ≥ III
* General contraindications for surgical treatment or implant placement
* Untreated periodontitis
* Smoking
* Excessive alcohol consumption
* Any drug or medication known to affect oral status and bone turnover or contraindicate surgical treatment
* No residual keratinized tissue at the experimental area
* Unwillingness to return for follow-up examinations