cyrilzakka/clinical-trials huggingface dataset:
A Study to Test Long-term Treatment With Spesolimab in People With Palmoplantar Pustulosis (PPP) Who Took Part in Previous Studies With Spesolimab

This study is open to people with palmoplantar pustulosis who took part in previous clinical studies of a medicine called spesolimab. Participants who benefited from spesolimab treatment in the previous studies can join this study.

The purpose of this study is to find out how safe spesolimab is and whether it helps people with palmoplantar pustulosis in the long-term. Participants are in this study for up to 5 years. During this time they visit the study site every month to get spesolimab injections under the skin.

At study visits, doctors check the severity of participants' palmoplantar pustulosis and collect information on any health problems of the participants.


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated written informed consent for the current trial 1368-0024, in accordance with ICH-GCP and local legislation prior to admission to the current trial
* Male or female patients who have completed the treatment period in one of the parent trials without premature discontinuation
* Patients who have obtained an individual health benefit, per investigator judgement (e.g. PPP PGA of 0 (clear) or 1 (almost clear) or other clinical improvement), from treatment in the parent trial
* Women of childbearing potential must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly

Exclusion Criteria:

* Women who are pregnant, nursing, or who plan to become pregnant while in the trial
* Patients who experienced study treatment-limiting adverse events during the parent trial
* Severe, progressive, or uncontrolled condition such as renal, hepatic, haematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof
* Patients with congestive heart disease, as assessed by the investigator
* Patient with a transplanted organ (with exception of a corneal transplant \> 12 weeks prior to screening in parent trial) or who have ever received stem cell therapy (e.g., Prochymal)
* Known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease (e.g. splenomegaly)
* Any documented active or suspected malignancy or history of malignancy at screening, except appropriately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix
* Patients who have developed active or severe infective disease and opportunistic infections/infective diseases
* Further exclusion criteria apply
Effect of Intranasal Administration of Orexine A on IL-6-System, Sleep-Wake-Regulation and Neurocognition

15 patients with narcolepsy and 15 healthy controls will be included in the study. According to a randomized, double-blind protocol they will receive intranasally at night first Orexine A and approximately two weeks later placebo or vice versa. Thereafter sleep will be recorded, the cytokine-system and neurocognition characterized.


Eligibility Criteria:
Inclusion Criteria:

* Narcolepsy
* Age \>18
* Informed consent
* GERMAN fluently spoken

Exclusion Criteria:

* Additional severe psychiatric or somatic disorders
* Pregnancy or nursing
* Anemia (Hb\<10g/dl)
Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2)

A Phase 3, randomized, blinded study comparing pelabresib (CPI-0610) and ruxolitinib with placebo and ruxolitinib in myelofibrosis (MF) patients that have not been previously treated with Janus kinase inhibitors (JAKi). Pelabresib is a small molecule inhibitor of bromodomain and extra-terminal (BET) proteins.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years
* Confirmed diagnosis of myelofibrosis (primary, post-polycythemia vera, or post essential thrombocythemia)
* Adequate hematologic, renal, and hepatic function
* Have at least 2 symptoms with an average score ≥ 3 or an average total score of ≥ 10 over the 7-day period prior to randomization using the MFSAF v4.0
* Prognostic risk-factor score of Intermediate-1 or higher per Dynamic International Prognostic Scoring System (DIPSS) scoring system
* Spleen volume of ≥ 450 cm\^3
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion Criteria:

* Splenectomy or splenic irradiation in the previous 6 months
* Chronic or active conditions and/or concomitant medication use that would prohibit treatment
* Had prior treatment with any JAKi or BET inhibitor for treatment of a myeloproliferative neoplasm
Induced Wound Healing by Application of Expanded Bone Marrow Stem Cells in Diabetic Patients With Critical Limb Ischemia

Diabetic foot patients with chronic limb ischemia and without the option for surgical or interventional revascularization were recruited and randomized to the transplant groups or the control group within this clinical trial. These patients are randomized to control or intervention group, whereas the intervention is divided into bone marrow cells administered intramuscular or intraarterial or expanded bone marrow cells administered intramuscular or intraarterial resulting in five distinct groups. To measure the therapeutic effects of the various treatment arms patients were evaluated for (ankle brachial index (ABI), transcutaneous oxygen partial pressure (TcPO2), and reactive hyperemia (Blood Oxygen Level Dependent \[BOLD\]). Patients also underwent imaging with angiographic methods.

Diabetic foot (DF) is a concomitant illness of diabetes mellitus. Diabetes is one of the main causes of non-traumatic amputation worldwide due to severe peripheral arterial occlusive disease with chronic critical limb ischemia being the most abundant problem. Ulceration occurs as failure of oxygenation, nutrient supply and progressive occlusion of larger blood vessels often exacerbates pre-existing microvascular abnormalities.

Purified bone marrow mononuclear cells or expanded bone marrow cells enriched in Cluster of Differentiation 90+ (CD90+) mesenchymal stem cells (named tissue repair cells, \[TRCs\]) are used in the treatment of diabetic ulcers in comparison to bone marrow derived stem cells to induce revascularization of the affected limb and to enhance local perfusion. Cells are administered intramuscular or intraarterial. A control group of patients treated according national guidelines without stem cells serves as comparator.

Diabetic foot patients with chronic limb ischemia and without the option for surgical or interventional revascularization were recruited and randomized to the transplant groups or the control group within this clinical trial. To measure the therapeutic effects of the various treatment arms patients were evaluated for (ankle brachial index (ABI), transcutaneous oxygen partial pressure (TcPO2), and reactive hyperemia (Blood Oxygen Level Dependent \[BOLD\]). Patients also underwent imaging with angiographic methods.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus Type 1 or 2
* Peripheral occlusive arterial disease stage III or IV (Fontaine) with chronical ischemia, chronic foot ulcer, degree of severity \<5 (Wagner), older than 6 weeks, without acute wound infection
* Ulcer size 1 - 30cm2, in case of osteomyelitis only one bone should be affected no trend towards healing in the ulcer after one week of standard treatment
* Angiopathic or angioneuropathic diabetic foot syndrome with no possible option of operative or interventional revascularisation
* Age 18 - 80 years
* Declaration of patient consent
RAPP- Systematic E-assessment of Postoperative Recovery in Patients Undergoing Day Surgery

Introduction Day surgery is a well-established practice in many European countries, but only limited information is available regarding postoperative recovery at home though there is a current lack of a standard procedure regarding postoperative follow-up. Furthermore, there is also a need for improvement of modern technology in assessing patient related outcomes such as native software applications. This article describes the RAPP study protocol, a mixed-methods study to evaluate if a systematic e-assessment follow-up in patients undergoing day surgery is cost effective and improves postoperative recovery, health and quality of life.

Methods and analysis This study is a mixed-methods study design that includes a multicenter, two-group, parallel, single-blind randomized controlled trial (RCT) and qualitative interview studies. One thousand patients \>17 years of age who are undergoing day surgery will be randomly assigned to either e-assessed postoperative recovery follow-up daily in 14 days measured via smartphone app including the Swedish web-version of Quality of Recovery (SwQoR) or to standard care (i.e. no follow up). The primary aim is cost effectiveness. Secondary aims are improvements on postoperative recovery, health-related quality of life (QoL) and overall health; (b) to determine whether differences in health literacy have a substantial and distinct effect on postoperative recovery, health, and QoL; and (c) to describe day-care patient and staff experiences with a systematic e-assessment follow-up after day surgery.The primary will be measured at 2 weeks postoperatively and secondary outcomes b) at 1 and 2 weeks and c) at 1 and 4 months.


Eligibility Criteria:
Inclusion Criteria:

* Understand the Swedish language in speech and writing, have an Android or iPhone OS smartphone, and give their informed consent to participate

Exclusion Criteria:

* Undergoing abortion, if their journal entries indicate alcohol and/or drug abuse or memory impairment, if they are participating in another clinical trial or suffering from visual impairment. .
The Prognostic Value of Post Thyroidectomy 99mTCpertechnetate Thyroid Scan in Patient With Differentiated Thyroid Cancer

The aim of this study is to evaluate the prognostic value of postoperative99mTc-pertechnetate scanning in patients with DTC.

The incidence of thyroid cancer in several affluent countries has markedly increased (1). Although mortality from thyroid cancer has remained relatively low and stable or has steadily declined in these and other countries (2).

Therefore, it is still important to identify markers for prognosis prediction and decision-making before radioactive iodine therapy (RIT). Various factors have been reported to be associated with the clinical outcome of RIT. These include preablative stimulated thyroglobulin (ps- Tg), tumor size, extrathyroidal invasiveness, cervical lymph node metastasis and TSH \[3,4\].

99mTc pertechnetate is a radiopharmaceutical used for thyroid scintigraphy. The photon energy of 140kev is ideally suited for use with gamma camera. It has short half life of about 6-hoursand no particulate emissions. 99mTc-pertechnetate scintigraphy is a simple, economic and RIT non-interfering technique to evaluate the volume of residual thyroid tissue(RTT). The 99m Tc-pertechnetate uptake of the thyroid bed can be used as a marker of RTT. Although negative uptake doesn't indicate the absence of RTT, it could suggest a small volume. On the other hand, positive uptake can be considered as a large volume of RTT. Several studies have reported that patients with negative 99mTc-pertechnetate uptake have a much higher chance of successful ablation\[5, 6\].

We hypothesized that negative 99mTc-pertechnetate scintigraphy is a significant predictor for excellent response (ER) to RIT in American Thyroid Association 2015(ATA) low- and intermediate risk DTC patient according to .

Eligibility Criteria:
Inclusion Criteria:

* • This study will include pathologically proved DTC patients in low and intermediate risk according to ATA who presented to nuclear medicine unit during the period from 2015 until the end of the study.

Exclusion Criteria:

* • High risk patient according to ATA

  * Pregnancy
Is Fat in the Liver a Marker of Post-Pregnancy Glycaemic Deterioration in Women With Gestational Diabetes?

The aim of this study is to utilise ultrasound, using an established method for detecting NAFLD, to determine whether the presence of NAFLD in women with GDM, detected during routine scanning, is a marker of deterioration in glycaemic status post-partum. We propose to assess the relationship between NAFLD and surrogates for insulin resistance as well as glycaemic status, insulin sensitivity and β-cell function, after delivery.

The study is not seeking to compare the incidence of T2DM between those with and without NAFLD. This would require a longer follow-up and larger cohort size. Instead, it aims to quantify the degree of early deterioration of glycaemic status in these groups using insulin resistance markers. This is a clinically important issue as a greater level of insulin resistance would in itself trigger clinical intervention, including vigilant follow-up and empowerment for proactive healthy life style changes, which have been shown to prevent diabetes development .


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 and over
* Pregnant women diagnosed with GDM based on OGTT

Exclusion Criteria:

* Women with known type 1 or type 2 diabetes prior to pregnancy
* Women with known history of liver disease including alcoholic liver disease
* Women unable or unwilling to consent to be part of the study
* Women with contraindication to MRI
Comparative Study Between (FC-SEMS) and (PC-SEMS) in the Palliation of Dysphagia Due to Malignant Neoplasm of Esophagus.

Esophageal cancer is the seventh most common type of cancer in the world, with an estimated global incidence of 604,100 new cases per year. The main symptom of esophageal cancer is dysphagia, associated or not with weight loss. Unfortunately, due to asymptomatic presentation in the early stages, more than half of patients are diagnosed in advanced stages of the disease, becoming ineligible for treatment with curative intent. In this sense, chemotherapy and radiotherapy are the pillars of palliative treatment, often regressing the injury and improving symptoms. However, some patients persist with dysphagia. In this scenario, esophageal prostheses are one of the main tools in the palliative treatment of esophageal cancer dysphagia, obtaining rapid and lasting relief of dysphagia. This study aims to compare fully covered (FC-SEMS) and partially covered (PC-SEMS) esophageal prostheses in this context, evaluating the number of reinterventions in each group, as well as the occurrence of adverse events. However, it is expected that with the data obtained it is possible to develop clearer and more effective protocols in the palliation of malignant dysphagia of esophageal stenosis.

STUDY DESIGN: Prospective and randomized study will be conducted.

PREPARATION AND TECHNICAL STEPS OF THE PROCEDURE: The placement of the esophageal prosthesis will be performed under sedation or general anesthesia supervised by the anesthesiologist at the endoscopy service of the Cancer Institute of the State of São Paulo (ICESP). The tests will be performed under radioscopic control. The tests will be performed on an outpatient basis, and hospitalization may occur in case of clinical need.

Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced malignant neoplasm of the esophagus, whether or not undergoing chemotherapy or radiotherapy;
* Dysphagia score greater than 2 or presence of malignant esophagorespiratory fistula;
* Indication of palliation of dysphagia through the placement of esophageal prostheses in a multidisciplinary meeting.

Exclusion Criteria:

* Patients under 18 years;
* Extraesophageal neoplasms;
* Lesions with longitudinal extension less than 30 mm;
* Previous treatment with esophageal prosthesis;
* Tumors easily transposed to standard endoscope (9.8mm).
Do we Prepare Patients for Their Digital Legacy? A Survey of Palliative Care Professionals in the West Midlands

Conduct a questionnaire survey of palliative care professionals including doctors, nurses and social workers currently working within the West Midlands to establish how much the palliative care community in the West Midlands engage in preparing patients for their digital legacy and find out if there is a further education need in this community about digital legacy.


Eligibility Criteria:
Inclusion Criteria:

* Palliative care professionals (medical, nursing and social worker) affiliated to a hospice in the West Midlands.

Exclusion Criteria:

* Medical, nursing or social worker not working in a hospice in the West Midlands.
Radon Asthma Intervention Trial

To determine if radon mitigation can improve asthma

We will conduct a randomized, double-blind, sham controlled trial to investigate the efficacy of radon mitigation in the homes of susceptible individuals to provide evidence for health benefits by improving indoor air quality. The trial will include 180 children with asthma. We will install a standard radon specific mitigation system in the participant's home. Health outcomes will be followed over 48 weeks to determine the outcomes of the intervention versus inactive (sham) control.

Eligibility Criteria:
1. Have physician-diagnosed asthma at least 1 year prior to the screening visit
2. Have evidence of uncontrolled disease as defined by at least one of the following:

Use of an asthma medication during the prior 12 months, report of asthma symptoms over the prior 12 months (wheezing/whistling in the chest)(3)

OR

One or more asthma-related hospitalization, emergency room visit

OR

Unscheduled clinic or urgent care facility visit resulting in a burst of systemic steroids (3 days or more of prednisone or equivalent; 1 or more doses of dexamethasone) in the previous 12 months

Exclusion Criteria

1. Not residing at the household for at least 5 days a week or family planning to move from the current home within the next twelve months, or homes with active radon mitigation systems (if home uses a HEPA filter air purifier, family must agree to disable the purifier for 28 days prior to randomization).
2. Lung disease, other than asthma, that requires daily medication (inflammatory diseases, chronic lung diseases aside from asthma, congenital cardiopulmonary conditions requiring medication or surgical treatment),
3. Homes with active HEPA filters will be excluded (even though the role of HEPA filters on radon and radon particles s is expected to be minimum and other exposures can be adjust for in the analysis)
4. Cardiovascular disease that requires daily medication, excluding hypertension
5. Taking a beta-blocker
6. Currently receiving unstable level of Immunotherapy (allergy shots)
7. Coordinator/PI judgment
8. Inability to perform lung function testing
9. Intake of abuse drugs or alcohol, have psychiatric disorders or severe mental disability that interferes with answering questions or following instructions.
PFC Sigma Fixed and Mobile Knee Study

The primary objective of this investigation is to evaluate the performance (in terms of post-operative active range of motion at one year) of the P.F.C. Sigma and P.F.C. Sigma Rotating Platform total knee systems in clinical practice.

The secondary objectives of this investigation are:To evaluate the performance of the P.F.C. Sigma and P.F.C. Sigma Rotating Platform total knee systems in clinical practice. To evaluate the impact of patellar resurfacing on the performance of the P.F.C. Sigma and the P.F.C. Sigma Rotating Platform total knee systems. To evaluate the impact of Posterior Cruciate Ligament (PCL) sacrifice or retention on the performance of the P.F.C. Sigma and the P.F.C. Sigma Rotating Platform total knee systems.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects may be recruited to the evaluation.
2. Age - there are no restrictions relating to age of the patient. The patient's age must be considered suitable by the clinical investigator for a bi-compartmental or tri-compartmental knee arthroplasty using either of the two systems available in the evaluation.
3. Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
4. Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
5. Subjects who require a bi-compartmental or tri-compartmental knee arthroplasty for primary surgical management of idiopathic osteoarthritis.
6. Patients who in the opinion of the Clinical Investigator are considered to be suitable for treatment with a fixed or mobile bearing knee system and who are suitable for patella resurfacing.

Exclusion Criteria:

1. Patients who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
2. Patients who require revision total knee arthroplasty surgery.
3. Patients with any tibial deformity requiring tibial component augmentation.
4. Patients whom, in the opinion of the Clinical Investigator, require a constrained prosthesis.
5. Patients with Rheumatoid Arthritis.
6. Patients with a pathology which, in the opinion of the Clinical Investigator, will adversely affect healing.
7. Patients with other disorders which, in the opinion of the Clinical Investigator, will / could impair rehabilitation.
8. Contra-indications for use of the device, as detailed in the package insert.
9. Women who are pregnant.
10. Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
11. Subjects who are currently involved in another clinical study with an investigational product.
12. Subjects who are currently involved in any injury litigation claims.
A Research Study to Evaluate the Effects of Repeated Intravitreal Injections on Bacteria Around the Eye

This is a research study to evaluate the effects of repeated intravitreal injections on bacteria around the eye.

The primary objective of this study is to determine whether conjunctival bacterial flora are altered and/or demonstrate increasing antibiotic resistance after serial intravitreal injections when a prophylactic topical antibiotic is used pre- and post-injection compared to when they are not used.

Eligibility Criteria:
Inclusion Criteria: Subjects will be eligible if the following criteria are met:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study.
* Have been diagnosed with neovascular AMD, CRVO or BRVO.
* Have been determined by the investigator to require intravitreal injections of bevacizumab or ranibizumab.

Exclusion Criteria: Subjects meeting any of the following criteria are ineligible for study entry:

* Prior intraocular injection in either eye.
* Chronic use of opthalmic medication.
* Contact lens wear.
* Ocular surgery within the past 6 months.
* Use of ophthalmic medications in either eye or ocular infection within the past 6 months.
* Use of systemic antibiotics within 6 months.
* Known allergy or contraindication to povidone iodine or fluoroquinolones.