cyrilzakka/clinical-trials huggingface dataset:
The Feasibility of a Novel Intervention for At Risk Mental State

Young people with At Risk Mental State (ARMS) may have changes in their thoughts and the way they see or hear things, which they might find odd and distressing. They may be feeling tense, worried and low in mood and may not feel like socialising. They may also experience difficulties with eating and sleeping. For many people these symptoms might not last for very long, but for a small number of people, they might last longer and could become worse (health professionals call this psychosis).

Psychological therapy, which involves talking to a therapist, can help to stop these symptoms from getting worse, stopping psychosis. It can also help to make the symptoms better. Cognitive Behavioural Therapy (CBT) is the treatment that is most recommended to help young people with ARMS. But, this is not always available, can take a long time and is quite expensive. Some research has shown that brief therapy with a therapist who is warm and understanding and helps the young person to make sense of their symptoms, may be as helpful as CBT, and is quicker and cheaper.

This study hopes to develop a treatment like this and to offer it to 12 young people, aged between 16 and 25, who are experiencing the symptoms outlined. Participants will be given four treatment sessions, and will be asked to complete some questionnaires. The study aims to see how they find it and whether it seems to help them. It will also ask professionals who work with these young people what they think about the new therapy. This is a feasibility study so the findings will help us to decide whether more research should be done on this treatment and whether it could be offered in the NHS in the future.


Eligibility Criteria:
For Service User Participants (Those receiving the intervention)

Inclusion Criteria:

* 16 - 25 Years Old
* Meeting criteria for attenuated psychosis on the Comprehensive Assessment of At Risk Mental State (CAARMS; Yung et al., 2005)
* Has an allocated lead care professional within the Central Norfolk Youth Team
* Identified by their care-coordinator as having capacity and being appropriate for therapy (including not being deemed at a high risk of being a danger to themselves or others).

Exclusion Criteria:

* Meeting criteria for psychosis on the CAARMS and/or a previous open referral to an Early Intervention in Psychosis team
* Change of psychiatric medication within the previous three months
* Currently receiving psychological therapy
* Previously had Cognitive Behavioural Therapy for At Risk Mental State
Study of the Pharmacokinetics and Safety of Carfilzomib in Patients With Multiple Myeloma and Renal Disease

The purpose of this study is to see how the body and the cancer react to carfilzomib, including measuring the amount of the study drug in the blood at certain times following dosing. This study is being done in people with normal kidney function and those with end-stage renal disease to see if they respond differently to the study drug.

Specifically, the purpose of this study is to assess the influence of end-stage renal disease (ESRD) on area under the curve (both area under the curve, from time 0 to the last concentration measured \[AUC0-last\] and area under the curve, from time 0 extrapolated to infinity \[AUC0-inf\]) of carfilzomib 56 mg/m² at Cycle 2 Day 1 (C2D1) in patients with relapsed multiple myeloma.

Eligibility Criteria:
Key Inclusion Criteria:

1. Relapsed multiple myeloma
2. Evaluable disease (serum protein electrophoresis \[SPEP\]/urine protein electrophoresis \[UPEP\]/serum free light chain \[SFLC\] criteria)
3. Received at least 1 prior treatment regimen or line of therapy for multiple myeloma
4. End-stage renal disease (ESRD) on hemodialysis or CrCl ≥ 75 mL/min
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
6. Adequate organ and bone marrow function
7. Active congestive heart failure (New York Heart Association \[NYHA\] Class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention or myocardial infarction within the protocol-specified period prior to enrollment

Key Exclusion Criteria:

1. Immunoglobulin M (IgM) multiple myeloma
2. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
3. Waldenström Macroglobulinemia
4. Active congestive heart failure (NYHA Class III-IV) ischemia, conduction abnormalities
5. Known human immunodeficiency virus (HIV), recent hepatitis B virus (HBV), hepatitis C virus (HCV)
6. Myelodysplastic Syndrome
7. Contraindication to test article, constituents, or required concomitant medications
8. Other investigational drugs
Efficacy and Safety of Grazax in Children

The purpose of this study is to investigate if immunotherapy with Grazax is safe and reduces the hayfever symptoms and the use of symptom relieving medications in children during the grass pollen season


Eligibility Criteria:
Inclusion Criteria:

* Boys and girls 5-16 years of age
* A clinical history of grass pollen induced hayfever
* Positive Skin Prick Test to Phleum pratense
* Positive specific IgE against Phleum pratense

Exclusion Criteria:

* History of seasonal hayfever symptoms (and/or asthma) caused by another allergen than Phleum pratense during or overlapping the grass pollen season
* History of perennial hayfever (and/or asthma) that needs medication due to an allergen to which the child is regularly exposed
* History of severe asthma
* Current severe atopic dermatitis
Urdu Version Of The Bournemouth Questionnaire For Neck Pain: A Reliability And Validity Study

The aim of study is to translate \& culturally adapt Neck Bournemouth Questionnaire into Urdu language along with investigation of the reliability \& validity of Neck Bournemouth Questionnaire in General Population of Pakistan and to correlate with Neck Disability Index, Visual Analogue Scale, Neck Pain and Disability Scale and Rand 36-Item Health Survey

The English version of the Bournemouth Questionnaire for Neck Pain will be translated and culturally adapted as per as previous recommendations. In the general population with neck pain, Urdu Version Of The Bournemouth Questionnaire For Neck Pain will be distributed among participants by choosing convenience sampling technique based on predefined inclusion and exclusion criteria. Test inter and intra- observer reliability of the final Urdu Version Of The Bournemouth Questionnaire For Neck Pain with Neck Disability Index, Neck Pain and Disability Scale, Visual Analogue Scale, and RAND will be filled with same day, by two observers and for the inter-observers assessment, with an interval of 45 minutes between the first and second application. Third assessment will be carried out after 7 days by Observer-1(re-intra-observers assessment. Data will be entered and analyzed by Cronbach alpha value. Test -retest reliability will be assessed using interclass correlation coefficient. The Urdu Version Of The Bournemouth Questionnaire For Neck Pain will be evaluated for content validity, construct validity, criterion validity and responsiveness.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years of age
* 3 months of neck pain
* Neck pain more than six moth
* Male female both genders
* Physician referral
* Not prescribed medicine
* Without deformity in neck
* Ability of reading and writing

Exclusion Criteria:

* Joint inflammation or infection
* Pathology of shoulder
* Fibromylgia
* Psychologically unstable or having neurological disorder
* Cancer history
* Cervical injury
* Took treatment of physical therapy in last 6 month
* Any disability
* Loss of memory
* Disease or any Red flag
* Using Neck immobilization device
Diode Laser 940 Nm Versus Electrosurgical Device During Second Stage Implant Surgery on Bone and Soft Tissue Healing

Background: Dental lasers and electrosurgical devices have been introduced a long time ago. However, limited studies are available concerning their use in the second stage of implant surgery, with the conventional surgical technique being the standard of care.

Aim of this study: To evaluate clinically and radiographically soft and hard tissue healing associated with the use of electrosurgical and laser devices and compare them with conventional surgical techniques during second-stage implant surgery.

Plan of the study: A randomized controlled clinical trial. The sample size will include patients who have an implant already placed and ready for second stage surgery recruited from the patient pool at the outpatient clinics.

Materials and Methods: Patients will be randomly allocated into the three groups. In Group (A) implant will be exposed using the conventional surgical exposure techniques with a tissue punch, the cover screw will be removed, and the healing abutment placed. In group (B) implant will be uncovered using a diode laser (940nm) in contact type with a continuous mode at a power of 1.5 watts, the laser tip will be used in a circular motion to create a small opening which will be increased till large enough to expose and remove the cover screw and place the healing abutments. In group (C) the monopolar electrosurgical device will be used in the same way as the laser tip with additional care avoiding contacting the implants during exposure.

The outcome: will be soft tissue healing and crestal marginal bone loss around implants.

Soft tissue healing will be assessed on the operative day, 2 weeks, and 4 weeks using Landry index. Crestal bone loss will be assessed using a standardized periapical x-ray at baseline and after 1 month with periapical x-ray.


Eligibility Criteria:
Inclusion Criteria:

* Adequate zone of keratinized mucosa.
* Osseointegrated Implants ready for second-stage surgery.

Exclusion Criteria:

* Heavy smokers due to increased risk of infection, delayed wound healing, and poor immune response.
* Medically compromised patients due to affection of the peri-implant health and tissue maintenance.
* Bad oral hygiene
* Patients with an exposed cover screw
* Evidence of bone loss in the preoperative peri-apical radiograph.
Pemetrexed as Salvage Treatment in Squamous Cell Carcinoma of Head and Neck

The aim of the study is to evaluate the efficacy and safety of pemetrexed monotherapy as salvage treatment in patients with relapsed or metastatic squamous cell carcinoma of head and neck.

The treatment option in patients with platinum-resistant relapsed or metastatic squamous cell carcinoma of head and neck is limited. Previous randomized phase III study showed a borderline benefit of pemetrexed added to cisplatin. Therefore, we aim to evaluate the efficacy of pemetrexed in salvage setting.

Eligibility Criteria:
Inclusion Criteria:

* Age range: 18-65 years old
* Histological confirmed incurable relapsed or metastatic squamous cell carcinoma of head and neck
* Prior exposure of at least one line of platinum-containing regimen
* At least one site of measurable disease according to RECIST criteria
* ECOG performance status 0-1
* Life expectancy of more than 3 months
* Bone marrow function: ANC≧1.5×109/L, PLT≧100×109/L, Hb≧80g/L
* Liver function: total bilirubin, ALT and AST \<1.5×UNL
* Renal function: Cr\<1.5×UNL, CCR≧45ml/min

Exclusion Criteria:

* With curable treatment option
* Prior platinum exposure only in neo-adjuvant/adjuvant setting or concurrently used with radiotherapy
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* Significant active infection
* Pregnant or lactating women
The WISER Study: Web Based Methods for Enhancing Resilience

This is a research study to find out if web-based resilience tools can increase well-being.

Enrolled participants will try out one or more brief positive psychology tools. The tools ask participants to reflect on positive experiences or to do an activity (e.g., write a letter of gratitude). The study is entirely online and participants will be prompted to participate via email or text messages.

The study team is interested in the effects of the tools on stress, depression, and burnout in adults. A set of brief surveys are administered before and after using the tool, and again at follow-up periods (e.g., 1, 3, 6 and 12 months). Surveys are collected electronically using the secure, HIPAA-compliant survey software.

There is no direct benefit to participants for participating in this research study aside from the potential to experience improvements in well-being. Risks are minimal and include the potential to feel emotional or psychological distress when asked questions related to burnout.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 and over are considered eligible for the study. A sub-sample will include employees (including but not limited to frontline caregivers, support staff and management) of the Duke University Health System, as well as external health systems. All participants will be invited to participate in one or more of the online tools. The investigators will allow the participation of any clinical areas/healthcare worker groups whose leaders express interest in building resilience. The investigators are targeting healthcare workers for recruitment in the study, but adults 18+ are eligible to participate in any of these tools. Identification as a healthcare worker or not is part of data collection in every tool.

Exclusion Criteria:

* Adults who are not proficient in English, do not have basic computer skills, or who have prohibitive vision or hearing disabilities will be excluded from this study as they will be incapable of full participation in the intervention and/or the survey process.
Dry Eye Management With 3% Diquafosol Before and After Cataract Surgery

The objective of this study is to evaluate the efficacy of Diquafosol 3% in the management of dry eyes before and after cataract surgery. Patients with pre-existing dry eyes and planned for cataract surgery will be started on Diquafosol eyedrops prior to surgery and treatment will be continued after cataract surgery. Eligible patients will undergo evaluation of dry eye at baseline and subsequently started on treatment with Diquafosol for the duration of 4 weeks before surgery. Further evaluations will be conducted on the day of surgery and at designated time points during and up to 12 weeks after surgery.

Title: Dry Eye Management with 3% Diquafosol Before and After Cataract Surgery

Setting: LEC Eye Centre, Ipoh, Malaysia

Background: Dry eye disease and cataract are two conditions which have been known to increase in incidence with age. Dry eye disease can also be further exacerbated by cataract surgery. Diquafosol (Diquas) is a P2Y2 receptor agonist which improves mucin and tear secretion and is a 'first in class' therapeutic option which has been shown repeatedly to be efficacious in dry eye management.

Objective: To evaluate the efficacy of Diquafosol for dry eye management in patients with pre-existing dry eye disease before and after cataract surgery

Design: Observational case series in a private ophthalmic health facility

Study Plan: Eligible patients will have treatment with Diquas for 4 weeks prior to undergoing cataract surgery. Preoperative clinical evaluation will include documentation of severity of signs and symptoms of dry eye and this will be carried out at baseline, immediately before surgery and subsequently at Week 4 and Week 12.

Eligibility Criteria:
Inclusion Criteria:

1. Eyes with pre-existing dry eye and visually significant cataract planned for phacoemulsification
2. Patients aged18years or older and in good general health
3. Mild to moderate dry eye; non-visually significant ocular surface disease (NVS-OSD) defined as Corneal Fluorescein Staining (CFS) score of \<3 on the Oxford scale
4. Tear break-up time (TBUT) \<10 seconds

Exclusion Criteria:

1. Eyes with complications after cataract surgery which require a prolonged course of topical medication
2. Eyes with history of contact lens wear in the previous 3 months
3. Eyes with history of regular use of topical eye drops(except artificial tears) in the previous 6 months
4. Treatment history of dry eye beyond artificial tears
5. Eyes with significant ocular surface disease (defined as CFS score of ≥3 on the Oxford scale)
6. Eyes with lacrimal or eyelid disease or ocular surface infections
7. Any ocular surgery within the prior 6 months
8. Using medications that could affect the dry eye condition (eg, antihistamines, antidepressants, decongestants, anticholinergic drugs or hormone treatment)
9. Allergies to Diquafosol
A Feasibility Study to Assess Pre Admission Status and Six Month Outcomes After Major Trauma

This study aims to assess the feasibility of obtaining details about a patients previous level of function from the patient of friend/relative, after they have been admitted an intensive care unit (ICU). It will also assess the feasibility of re-assessing level of function at 6 months after the patient has been discharged from ICU.

Currently there is no standardised way of obtaining details about a patients pre-admission level of function. the process of gaining this history is often done by several different people with no standard questions asked.

There is also a need to be able to measure what happens to patients after they leave ICU, and compare their abilities to preadmission status.

This feasibility study will aim to investigate:

* the time taken to train the physiotherapy team in the use of the outcome measure
* the ability to obtain pre admission functional status from patients/friend/relative on admission to ICU
* the ability to follow patients up at 6 months post discharge with re-assessment of the outcome measure

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study
* Participants relative or friend (consultee) is willing and able to give informed consent for participation in the study (where the patient is unable to give informed consent)
* Male or Female, aged 18 years or above
* Injury Severity Score greater than 9
* Admitted as an emergency to AICU
* Experienced at least 24 hours level three care during their admission

Exclusion Criteria:

* Non UK resident (due to potential loss to follow up)
* Unwilling to consent
* No GP details available
* Patients with a palliative diagnosis or established on a palliative treatment pathway
A Multi-center Study to Investigate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of R7103 Following Repeated Inhalation in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease

This study will assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of RO5024118 following repeated inhalation in patients with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD). Patients will be randomized to receive multiple inhaled doses of R7103, as compared with placebo. The target sample size is approximately 30 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients 40-70 years of age, inclusive.
* Body Mass Index 18-32 kg/m2, inclusive.
* Female patients must be surgically sterile or post menopausal for the past year confirmed by a negative hormone panel. Male patients and their partners of childbearing potential must use two methods of contraception, one of which must be a barrier method for the duration of the study and for 7 days after last dose.
* Diagnosis of moderate-to-severe COPD (GOLD Stage II-III).

Exclusion Criteria:

* Current smoker or history of smoking in the last three months.
* Use of continuous daily long term oxygen therapy or requirement for oxygen therapy during exercise.
* History of cardiac conduction abnormalities or ventricular tachyarrhythmias.
* Exacerbation of COPD within 8 weeks before first dosing.
Pilot Simplification Study to Lopinavir/Ritonavir 800/200 mg Monotherapy Regimen Once Daily

Lopinavir/ritonavir monotherapy is currently a well known and widely used strategy, while Lopinavir/ritonavir 800/200 mg once a day in a triple-therapy was approved a few years ago. The purpose of this study is to evaluate efficacy and safety of Lopinavir/ritonavir 800/200 mg monotherapy once a day.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18, HIV positive
* Patients receiving a monotherapy regimen (Lopinavir/ritonavir twice daily)during the last 6 months
* Undetectable viral load (\<40 copies/ml) during the last 6 months
* Patients that accept participation in the study and sign the Informed Consent Form
* Childbearing females with negative pregnancy tests and using appropriate contraceptive measures

Exclusion Criteria:

* Opportunistic disease, cancer or any other active disease with specific treatment
* Active addiction to illegal drugs or active use of psychotropic drugs
* Mental retardation diagnosis, or mental dementia or severe psychiatric disorder (excluding major depression disorder solved \> 3 months)
* Females who are breastfeeding or pregnant
A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics With Asthma

A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics with Asthma


Eligibility Criteria:
Inclusion Criteria:

* Diabetes Mellitus (Type 1 or Type 2) currently controlled with injected insulin
* Mild intermittent or mild to moderate persistent asthma

Exclusion Criteria:

* Poorly controlled, unstable or steroid-dependent asthma, insulin pump therapy, smoking
P. Gingivalis IgG Titer Test for Periodontitis

This study was performed to evaluate prospectively the diagnostic utility of a blood IgG antibody titer test against periodontal pathogens.

Background: Periodontitis is a prevalent silent infectious disease worldwide, and affects lifestyle-related diseases such as diabetes. Therefore, efficient screening of patients is essential for general health. This study was performed to evaluate prospectively the diagnostic utility of a blood IgG antibody titer test against periodontal pathogens.

Methods: Oral examination was performed and blood IgG antibody titers against periodontal pathogens were measured by ELISA, in 1387 subjects. The cut-off value of IgG titer was determined in receiver operating characteristic curve analysis, and changes in periodontal clinical parameters and IgG titers by periodontal treatment were evaluated. The relationships between IgG titers and severity of periodontitis were analyzed.

Eligibility Criteria:
Inclusion Criteria:

* periodontal patients
* adults

Exclusion Criteria:

* difficulty of communication
* received periodontal therapy within 3 months
* with other diseases, i.e., hypertension, diabetes (self reported)