cyrilzakka/clinical-trials huggingface dataset:
Development of an IT Tool Able to Identify Ocular Conditions

The aim of the study is to use machine learning to develop an IT tool able to differentiate between eye conditions analysing corneal biomechanical data.

Data will be collected using two different commercially available devices that are able to measure corneal biomechanics. Corneal biomechanics will be measured in participants with different conditions: glaucoma, ocular hypertension, corneal conditions, and healthy controls as it is well established that the above-mentioned conditions cause changes in corneal biomechanical properties.

Corneal biomechanics are the mechanical properties of the cornea, as rigidity, elasticity and it is possible to measure them using two devices: Ocular Response Analyzer (ORA) or Corneal Visualization Scheimpflug Technology (Corvis ST). Both devices use a puff of air to temporally flatten the cornea and derive the properties of the tissue.

Participants with ocular conditions will be recruited at Birmingham and Midlands Eye Centre (BMEC) at the Glaucoma and Anterior Eye clinics among patients attending for their routine clinical appointment. Healthy controls will be recruited at Aston University. This study requires only one visit and there is no need of follow up.

A portion of the data collected will be used to train machine learning algorithms to differentiate between conditions, the remaining data will be used to test the accuracy of newly created algorithms. The algorithm will be developed using Orange Data Mining.

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years old.
* Participants who are able to give informed consent.
* Study groups: Patients with diagnosis of glaucoma or corneal disease or ocular hypertension. Patients that are having a treatment (medications or surgery) for glaucoma or ocular hypertension or corneal conditions.
* Control group: people with no diagnosis or treatment of previous pathologies.

Exclusion Criteria:

* Age below 18.
* Participants who are not able to give informed consent.
* Patients with eye conditions not within the inclusion criteria.
* Patients with respiratory distress or significant head tremor.
* Patients who are in pain or unable to remain seated for duration of measurements.
* Participants that during the visit are wearing contact lenses. The wear of contact lenses can alter the measure of corneal biomechanics.
Effect of Different Oxygen Concentration on Postoperative Pulmonary Complications After Pulmonary Reexpansion

To evaluate the effect of 80% inspiratory oxygen fraction (FiO2) and 30% FiO2 on the incidence of pulmonary complications after pulmonary reexpansion following one-lung ventilation and 2-hour postoperative within the first 7 days after thoracic surgery, based on lung protective ventilation strategy.

Postoperative pulmonary complications (PPCs) account for the highest proportion (about 84%) among all the factors leading to death in thoracic surgery. High FiO2 was used in perioperative period. However, there is increasing evidence that high FiO2 in non-thoracic surgery can increase respiratory related adverse events and even mortality. The guideline also suggests that low FiO2 (30-50%) during surgery while ensuring moderate level of oxygenation would be more beneficial to the prognosis of patients. Whereas, the selection of oxygen concentration in thoracic surgery is still unclear, especially which oxygen concentration ventilation is more beneficial to reduce PPCs after pulmonary reexpansion. Strict randomized controlled clinical studies are urgently needed to verify the differences in the incidence of PPCs in patients with different oxygen concentration ventilation strategies. The study aim is to evaluate the effect of 80% FiO2 and 30% FiO2 on the incidence of pulmonary complications after pulmonary reexpansion following one-lung ventilation and 2-hour postoperative within the first 7 days after thoracic surgery, based on lung protective ventilation strategy, and to provide clinical basis for optimizing perioperative management of thoracic surgery and effectively reducing the occurrence of perioperative pulmonary complications

Eligibility Criteria:
Inclusion Criteria:1. Elective thoracic surgery: lung surgery, esophageal surgery, mediastinal surgery, etc.; 2. One-lung ventilation: double lumen bronchial cannula or occluder is used for isolation of one lung; 3, American Society of Anesthesiology (ASA) grade I \~ III; 4, 18 years ≤ age \< 80 years; 5. Estimated operation time ≥2 hours; 6. Agree to participate and sign the informed consent.

Exclusion Criteria:

1. Severe lung infection occurs within 1 month;
2. Coronary heart disease or heart failure occurs within 2 or 3 months;
3. Preoperative oxygen saturation is less than 94%; 4, Need continuous oxygen therapy; 5, BMI\>35 kg/m2;

6. Pregnant women; 7. Preoperative Hb\<70g/L or haematocrit\<30%.
Evaluation of the Cancer Tracking System (CATSystem)

Cervical cancer contributes to significant preventable mortality in Kenya where less than 20% of women are screened. The Cancer Tracking System (CATSystem) is a web-based, algorithm generated tool to promote guideline adherent cervical cancer screening and retention through treatment. The goal of this project is to rigorously evaluate the efficacy, implementation, and cost-effectiveness of the CATSystem to improve rates of screening, treatment, referral, and follow-up care in a matched, cluster randomized controlled trial in 10 Kenyan government hospitals (5 intervention, 5 standard of care).

To help address system level barriers to cervical cancer screening, treatment, and follow-up in Kenya, investigators worked with end-users (providers and patients) to develop the Cancer Tracking System (CATSystem), a web-based, algorithm generated tool to promote guideline adherent cervical cancer screening and retention through treatment. The goal of this project is to rigorously evaluate the efficacy, implementation, and cost-effectiveness of the CATSystem to improve rates of screening, treatment, referral, and follow-up care in a matched, cluster randomized controlled trial in 10 Kenyan government hospitals (5 intervention, 5 standard of care). Specific aims (SA) of the study are to (1) Implement and evaluate the efficacy of CATSystem to improve guideline adherent cervical cancer screening, treatment, referral and follow up, (2) Assess feasibility and acceptability of implementation of CATSystem in government run facilities using a human centered design approach, and (3) Calculate the costs and cost-effectiveness of the CATSystem to increase quality adjusted life years gained. Cervical cancer deaths can be prevented with early detection and treatment. This study will evaluate the public health impact of the CATSystem in improving cervical cancer screening, treatment, referral, follow-up, and the feasibility of scale up to other low resource settings.

Eligibility Criteria:
Inclusion Criteria:

* women above 16 years of age
* access to a cell phone,
* presenting for cervical cancer screening at a study hospital.

Exclusion Criteria:

* greater than 20 weeks gestation,
* incarcerated patients,
* women who study staff feel are unable to provide written informed consent due to impaired capacity.
Transplantation of Cultured Gut Microflora to Repeat Antibiotic-induced Diarrhea Due to Clostridium Difficile

Patients who have received antibiotics and thereafter developed diarrhea are investigated for presence of Clostridium difficile toxin. Primary treatment is given with oral metronidazole/vancomycin. In case of relapse, secondary treatment is given with either cultured gut microbiota rectally or oral vancomycin in sequence. In those cases where secondary treatment with vancomycin fails cultured gut microbiota is given as final treatment. As an extension treatment, all failures were treated with cluttered gut microbiota through the upper route. In both cases As an alternative cultured gut microbiota may be given via the duodenal route. Follow-up is carried out after 7, 30 and 90 days with interview and stool collection for analysis of Clostridium difficile.


Eligibility Criteria:
Inclusion Criteria:

* Antibiotic-induced diarrhea
* Positive fecal analysis for Clostridium difficile toxin

Exclusion Criteria:

* Antibiotic treatment
* Probiotic treatment
* Intestinal infection other than Clostridium difficile
* Inflammatory bowel disease (Ulcerative colitis, Crohn's disease
* Immunodeficiency (drug- och disease-related)
* Pregnancy
* Unable to accept endoscopic procedures
* Unable to give informed consent
Clinical Trial of Efficacy and Safety of the Combination of Reduced Duration Prophylaxis Followed by Immuno-guided Prophylaxis in Lung Transplant Recipients.

To assess the efficacy of reduced duration prophylaxis followed by immuno-guided prophylaxis to prevent cytomegalovirus disease.

Prolonged use of antivirals to prevent the development of cytomegalovirus (CMV) disease in lung transplant patients has been shown to have significant side effects, for which alternatives are being sought to reduce their use. The monitoring of cell immunity against CMV could be an alternative as it has shown to be useful in identifying transplant patients at low risk of infection, who could benefit from shorter prophylaxis. The aim of the CYTOCOR study is to demonstrate that the combination of a reduced prophylaxis strategy with subsequent CMV-specific immunological monitoring would allow CMV infection to be controlled in lung transplant patients as effectively as the usual strategy (prophylaxis followed by pre-emptive therapy), while reducing the side effects of antivirals due to the shorter duration of prophylaxis.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with cytomegalovirus positive serology who underwent lung transplantation.
* Subjects of 18 years of age or older.
* Expected valgancilovir prophylactic treatment of 6 months after transplantation.
* Patients who have signed the informed consent form.

Exclusion Criteria:

* HIV infected subjects.
* Subjects unable to comply with the protocolo follow-up visits.
* Subjects who underwent multivisceral transplant.
* Pregnant and/or lactating women.
* Intolerance to Valganciclovir/Ganciclovir treatment.
Romosozumab Versus Denosumab in GIOP: a 2-year Extension Study

The investigators conducted an open-label randomized controlled trial (RCT) in chronic glucocorticoid (GC) users with moderate/high risk of fracture to compare the efficacy and tolerability of romosozumab (ROMO) for 12 months followed by denosumab (DEN) for 12 more months vs DEN for 24 months throughout. Superiority of ROMO/DEN to DEN/DEN in raising the spine bone mineral density (BMD) was demonstrated at month 12 and month 24. The present study was to report the further BMD changes at 48 months (2 year extension) for those participants who were maintained on DEN treatment.

The investigators conducted a pilot open-label 24-month randomized controlled trial (RCT) comparing the efficacy of romosozumab (ROMO) with denosumab (DEN) in moderate/high risk adult patients using long-term GCs (defined as a daily prednisolone dose of ≥5mg/day for ≥12 months). All patients had moderate to high risk of osteoporotic fracture as evidenced by at least one of the following: (1) a personal history of fragility/vertebral fracture; (2) dual energy X-ray absorptiometry (DXA) T score ≤-2.5 \[age ≥40 years\] or Z scores ≤-3.0 \[age \<40 years\] at spine, hip or femoral neck; or (3) high risk of 10-year FRAX-estimated major fracture).

Of the 70 patients enrolled, 63 completed the study. At month 12, the spine bone mineral density (BMD) increased significantly in both the ROMO and DEN groups. The spine BMD gain from month 0-12 was significantly greater in ROMO-treated patients (p\<0.001). Although the hip BMD at month 12 also increased significantly in the ROMO and DEN groups, the BMD gain was not significantly different between the groups. At month 24, the spine BMD continued to increase in both the ROMO and DEN groups, and the BMD gain remained significantly greater in ROMO-treated patients.

As there are no long-term data on the sequential use of ROMO and DEN in patients with GIOP, the current 2-year extension study is planned to observe the BMD changes at the spine and the hip of patients in the two treatment groups at month 48.

Eligibility Criteria:
Inclusion Criteria:

1. patients who are continued on 6-monthly subcutaneous injection of DEN in either the ROMO or DEN arms after month 24 in our original RCT
2. Those who are willing to have a repeat DXA assessment at the end of 4 years.

Exclusion Criteria:

1. patients who refuse to be maintained on denosumab after month 24;
2. patients who are maintained on other anti-osteoporotic drugs after month 24; and
3. patients in whom prednisolone is planned to be tapered or discontinued after month 24.
Testing a Web-based Intervention for Radioactive Iodine Symptom Management (RAI Support) to Improve Health-related Quality of Life Among Differentiated Thyroid Cancer Patients

The goal of this clinical trial is to learn if adult patients diagnosed with differentiated thyroid cancer can easily use and benefit from an online tool aimed to provide patients with educational resources and symptom management strategies to improve their quality of life after radioactive iodine (RAI) treatment. The main questions it aims to answer are:

1. Can patients easily use and benefit from the RAI Support intervention?
2. Does RAI Support improve health-related quality of life (overall well-being) compared to usual care?

This research will help test better digital tools to support thyroid cancer survivors in managing their health after RAI treatment.

Researchers will compare RAI Support to treatment as usual (a publicly available informational website about thyroid cancer) to see if RAI Support works to improve patients' overall well-being.

Participants will:

1. Receive access to RAI Support or an informational website (treatment as usual) for four weeks.
2. Use the assigned website once a week for up to four weeks.
3. Complete two online questionnaires (an initial questionnaire and a final questionnaire after four weeks of using the assigned website) about symptoms related to RAI treatment, mood, and confidence in managing symptoms.
4. Complete an optional 60 minute virtual interview about your experiencing using the assigned website.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older (papillary or follicular carcinoma)
* Diagnosed with differentiated thyroid cancer
* Received radioactive iodine (RAI) treatment less than or equal to three years ago.
* Mild to moderate symptoms of RAI
* Able to provide informed consent in English
* Access to a computer, tablet, or smartphone with internet connectivity

Exclusion Criteria:

* A condition that precludes providing informed consent or completing study procedures (cognitive or psychiatric condition, hearing problems) as identified by the patient's physician or as assessed by a trained study team member.
ReDIAL: A Telephone Brief Intervention for Injured Emergency Department Patients

The goal of this study is to reduce impaired driving, risky driving and alcohol-related negative consequences among injured emergency department (ED) patients through a telephone brief intervention. This study will allow researchers to test a novel method of brief intervention that has the potential to be convenient and efficient mechanism to deliver an intervention to an at-risk population. Eligible patients will be consented in the ED, will receive an assessment and then will be randomized into one of two conditions: 1) telephone brief intervention or 2) a comparison control group with a home safety educational program. The participant will also receive an appointment for an initial telephone call. Both conditions will be provided over three telephone sessions: the initial call (immediately following randomization) and two booster calls at 2 weeks and 6 weeks after randomization. Participants will provide information about their alcohol use, alcohol-related injuries, impaired driving, and other driving related negative consequences at 4, 8, and 12 months post-randomization.


Eligibility Criteria:
Inclusion Criteria:

* English or Spanish speaking
* Age greater than 17 years
* ASSIST score \>=11
* Injured Emergency Department patient at time of consent

Exclusion Criteria:

* Medically unable to give consent
* Not English or Spanish speaking
* Homeless
* Cannot be contacted by telephone
Patient Performed Examination for Patients With Intra-articular Hip Pain

The primary objective of this study is evaluate the diagnostic accuracy of a patient self-administered clinical examination of the hip compared with a traditional clinical examination (i.e. index test).


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-80 years
* Seeking care for hip related pain and/or clicking, catching, giving way or stiffness
* Able to sign or verbalize study consent
* No other medical conditions (e.g. gynecological or urinary pathology) that may affect study results
* English speaking

Exclusion Criteria:

* Patients with primary lumbar spine, sacro-iliac or other non-hip related pain as determined with clinical examination
* Previous hip surgery
* Previous hip injury that would normally exclude from examination as standard practice
* Unable to sign or verbalize consent
* Other non-musculoskeletal pathology that may affect study results (e.g. gynecological or urinary pathology)
* Non-English speaking
Thiazide Diuretics for Hypertension in Kidney Transplant Recipients Using Tacrolimus

Background: Calcineurin inhibitors (CNIs) are the most commonly used immunosuppressive drugs to prevent rejection after kidney transplantation. However, the efficacy of preventing rejection comes at the cost of important side-effects. Among the most common side-effects is hypertension. Hypertension after kidney transplantation is clinically relevant, because it increases the risk of cardiovascular disease and is associated with increased graft loss and recipient mortality. The mechanism of CNI-induced hypertension is incompletely understood and, therefore, the treatment is currently empiric. These and other investigators recently showed that CNIs cause salt-sensitive hypertension by activating a sodium transporter in the kidney, namely the thiazide-sensitive sodium chloride cotransporter.

Hypothesis: The investigators hypothesize that thiazide diuretics are non-inferior to calcium channel blockers (CCBs) (currently usually the treatment of choice) for the treatment of CNI-induced hypertension.

Objective: To compare the blood pressure response to thiazide diuretics and CCBs in patients with CNI-induced hypertension.

Study design: Single-center, randomized cross-over trial.

Study population: Kidney transplant recipients with a good functioning allograft (eGFR \> 30 ml/min) who are hypertensive (daytime systolic blood pressure \> 140 mm Hg) and who do not have proteinuria (\< 1 g/day).

Intervention: Patients will be randomized to receive chlorthalidone (12.5 mg once daily, if needed titrated to 25 mg once daily) or amlodipine (5 mg once daily, if needed titrated to 10 mg once daily).

Main study parameters/endpoints: 24-hour blood pressure recording.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Both drugs have long been registered for the treatment of hypertension. The side-effect profile of both drugs is considered to be equal. The burden of the study for the patients are blood pressure measurements using 30-minute automated blood pressure measurement and 24-hour ambulatory blood pressure measurement.


Eligibility Criteria:
Inclusion Criteria:

* Kidney transplant recipients using tacrolimus
* Average daytime SBP \> 140 mm Hg (ABPM)
* eGFR \> 30 ml/min (MDRD)

Exclusion Criteria:

* Use of glucocorticoids, co-trimoxazole, diuretics
* Pregnancy
* Serum sodium \< 136, serum potassium \< 3.5
* Proteinuria \> 1 g/day
Double-blind Placebo Surgery Trial for Treatment of Parkinson's Disease

A double-blind sham surgery-controlled trial was developed to determine the effectiveness of implantation of human embryonic dopamine neurons into the putamen of patients with advanced Parkinson's disease (PD), with half the patients receiving the implant (n = 20) and half receiving sham surgery (n = 20). The blind was maintained for 12 months before participants were told which surgery they received, at which time those receiving sham surgery could request the implant surgery.

A double-blind sham surgery-controlled trial was conducted to determine the effectiveness of implantation of human embryonic dopamine neurons into the putamen of patients with advanced Parkinson's disease (PD), with half the patients receiving the implant (n = 20) and half receiving sham surgery (n = 20). The goals were to determine whether the cells survived and led to improvement of symptoms, and to examine the effect of age on results of the implantation. Quality of life of participants and care partners was also examined at each of the assessment periods (baseline, 4, 8 and 12 months). The blind was maintained for 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Parkinson's disease (PD) for more than 7 years, improvement in response to levodopa, Positive Emission Tomography scan compatible with presence of PD, improvement of at least 33% on UPDRS after first morning dose of levodopa

Exclusion Criteria:

* Mini-mental status exam score of less than 24, hallucinations during levodopa therapy, epilepsy, previous brain surgery, severe depression, another neurologic disorder, cardiovascular disease, and medical contraindication of surgery
Effect of Dabigatran on Coagulation parameters-an ex Vivo Study

Dabigatran represent a new class of promising anticoagulation agents. As an oral direct thrombin inhibitor it has been effective in preventing venous thromboembolism in patients undergoing elective orthopaedic surgery. This ex vivo study is undertaken to investigate the ex-vivo effects of Pradaxa® on different coagulation parameters.

This mono-centric, open-label study is undertaken to validate the effects of Dabigatran on coagulation parameters in plasma samples of 70 patients after hip or knee replacement surgery treated with Dabigatran 150-220 mg/d. Plasma samples are obtained by blood collection before, after 2 hours and after 12-14 hours after Dabigatran dosing in steady state (on 3rd - 5th day).

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 y

Exclusion Criteria:

* Hemorrhagic disorder
* Liver disease
* Anemia
* Severe renal impairment