cyrilzakka/clinical-trials huggingface dataset:
A Study of the Effects of Itraconazole on the Plasma Levels of Nemtabrutinib (MK-1026-013)

The goal of this study is to learn what happens to levels of nemtabrutinib in a person's body over time. Researchers will compare what happens to nemtabrutinib in the body when it is given with or without another medicine called itraconazole.


Eligibility Criteria:
Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

* Is in good health based on medical history, physical examination, vital sign (VS) measurements, electrocardiograms (ECGs) and laboratory safety tests performed before allocation.
* Has a body mass index (BMI) of18 to 32 kg/m\^2 (inclusive)

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

* Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
* Has a history of cancer (malignancy).
Prevalence and Clinical Implications of HPV Infection in Male IBD Patients

The study aims at describing the prevalence of Human Papillomavirus (HPV) infection in anal and oral samples of men with Inflammatory Bowel Disease (IBD) and detecting risk factors for the infection.

Male IBD patients attending the IBD Clinic of Hospital de la Santa Creu i Sant Pau will be screened for eligibility. Informed consent will be obtained from all eligible patients. An anal and oral swab will be performed on all patients to look for HPV infection (HPV DNA test) and cytologic alterations. Patients will be inspected to rule out the presence of HPV-related lesions. Moreover, a self-administered questionnaire will be completed by all enrolled patients. Information regarding IBD characteristics and treatment will be obtained.

According to local practice, patients with anal or oral squamous intraepithelial lesions (ASIL) will be referred to a colorectal surgeon for further recommendations or treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed Crohn's disease or ulcerative colitis (at least 3 months before enrollment)
* Male
* Age from 18 to 79 years

Exclusion Criteria:

* Unclassified Inflammatory Bowel Disease
* Diarrhea (\> 3 bowel movements/day) with rectal bleeding at enrollment
* Prior full proctectomy
* Inability to collect the biological samples
* Inability to complete the questionnaire
* Refusal to sign the informed consent
Stroke Recovery Initiative - Registry for Stroke Research Studies

The Stroke Recovery Initiative is a nation-wide participant recruitment registry that connects people who have had a stroke with researchers who are working to develop new approaches to improve recovery after stroke.

The Stroke Recovery Initiative at UCSF is designed to help people who have had a stroke to connect with researchers who are applying the latest science and technology to develop new treatments for stroke recovery. Anyone who is 18 years of age or older and has had a stroke may submit a survey to join. The self-reported information on the survey will be used to match participants to current or future stroke research studies and study personnel for each specific study may contact participants for further screening. Some studies are recruiting participants nationally, not just in the San Francisco Bay Area.

Eligibility Criteria:
* 18 years of age or older
* Have suffered a stroke
* Have ongoing symptoms as a result of the stroke
Satisfaction Of Adult Patients With Gummy Smile Treated By Botulinum Toxin A Injection

The aim of the proposal study is to answer the question of how to manage gummy smiles due to hypermobile upper lip with less invasive and low risk level procedure . This trial will help the practitioners and the patients in taking the convenient decision to correct the gumminess to restore lip-gingival-dental harmony and enhance smile asthetics.

In this randomized clinical trial , two groups will be included to compare the effectiveness of a treatment modality of botulinum toxin-A injection , in the first group , on gingival display during smiling ,patient satisfaction , lower face esthetics ( upper lip length , upper lip vermillion length , interlabial gap , nasolabial angle) and the postoperative side effects . the comparator group will receive treatment by modified lip repositioning surgery ,to compare the results of the intervention group that can possibly obtained without undergoing surgery.

Eligibility Criteria:
Inclusion Criteria:

* Adults with age range from 18 - 30 years.
* Excessive gingival display more than 3 mm during smiling.
* Patients having hypermobile upper lip with or without (mild / moderate) vertical maxillary excess.
* Patients with normal morphology of clinical crowns.
* Normal lip separation (ILG) at rest
* Medically free subjects.

Exclusion Criteria:

* Patients with systemic diseases or neuromuscular disorders.
* Gummy smile with gingival display more than 8 mm during smiling.
* Severly long face (VME) patients.
* Patients with periodontal disease or gingival hyperplasia .
* Medically compromised patients contraindicated for surgery .
* Pregnant or lactating female patients.
* Patients with inadequate attached gingiva .
Mesalamine 4 g Sachet for the Induction of Remission in Active, Mild to Moderate Ulcerative Colitis (UC)

The purpose of this trial is to investigate the efficacy of mesalamine for the induction of clinical and endoscopic remission in subjects with active, mild to moderate UC. Subject will receive 4 g extended release granules (sachet) once daily.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged 18 to 75 years
* Mild to moderate UC

Exclusion Criteria:

* Disease limited to proctitis \<15 cm
* Short bowel syndrome
* Prior colon resection surgery
* History of severe/fulminant UC
* Evidence of other forms of inflammatory bowel disease
* Infectious disease (including human immunodeficiency virus \[HIV\], hepatitis B virus \[HBV\], or hepatitis C virus \[HCV\])
* Intolerant or allergic to aspirin or salicylate derivatives
* Use of rectal formulations (5-aminosalicylic acid \[5-ASA\], steroids) within ≤7 days
* Women who are pregnant or nursing
* History or known malignancy
* History of bleeding disorders, active gastric or active duodenal ulcers, autoimmune diseases, or mental/emotional disorders, that would interfere with their participation in the trial
Neo-adjuvant Short Course Chemo-radiation Therapy in Locally Advanced Rectal Cancer Patients

* The primary objective of this trial is to assess the safety and feasibility of 5-FU when given concurrently with5 Gy x 5 fractions IMRT.
* The secondary endpoint is to assess disease local control and the response rate after short course radiotherapy concurrent with dose escalation infusion 5-fu followed by mFOLFOX and delayed surgery.

Neo-adjuvant radiotherapy is associated with the improvement of local control for rectal cancer. For locally advanced stage II-III resectable rectal cancer, either preoperative short-course radiotherapy of 25 Gy in 5 consecutive days or long-course chemo-radiotherapy followed by radical Total Meso-rectal Excision is recommended. The Swedish Rectal Cancer Trial has demonstrated the lower rate of early toxicity of short course radiotherapy when compared to chemo-radiation. Short-course irradiation reduced the risk of local recurrence with evidence of overall survival improvement. Short-course regimen is less expensive and more convenient, especially in centers with long waiting lists. Two meta-analyses showed that short course is as effective as long course chemo-radiation in the management of locally advanced rectal cancer in the terms of sphincter preservation rates, down-staging, R0 resection, local control, and grade 3-4 toxicity. Despite reduction in local-regional recurrence risk with neo-adjuvant short course radiotherapy, distant disease recurrence remains a substantial risk for patients with locally advanced disease. In a controlled randomized trial, a short course radiotherapy followed by consolidation chemotherapy prior to surgery yielded superior overall survival outcomes compared to chemo-radiotherapy, without significant differences in disease-free survival, nor local or distant disease control rates. The phase III RAPIDO and STELLAR clinical trials are also evaluating short course radiotherapy and consolidation chemotherapy. The Stockholm III trial was a 3-arm trial that compared short-course RT with the standard 1-week delay to surgery, short-course RT with a 4- to 6-week delay to surgery, and long-course chemoradiation with a 4- to 6-week delay to surgery. The results show similar outcomes between the groups, but delaying the surgery after short-course RT decreased the rates of high-grade toxicity and allowed for an expedited treatment program.

Eligibility Criteria:
Inclusion Criteria:

* Pathological confirmed cancer rectum
* Age between 20-80
* Clinical T3\\4 or node positive disease by MRI

Exclusion Criteria:

* Early stage cancer rectum
* M1 disease confirmed by imaging or pathological
A Clinical Trial of TQB3909 Tablets in Patients With Breast Cancer

TQB3909 is an inhibitor targeting B-cell lymphoma (BCL)-2 protein. By binding to BCL-2 protein, TQB3909 releases Pro apoptotic proteins such as BCL-2-Anatagonist/Killer 1(BAK), BCL-2 associated X (BAX) protein and BCL-2 associated death (BAD) protein, promotes the release of cytochrome c from mitochondria, phosphatidylserine eversion, stimulates caspase 3/7 activity and caspase 3/9 cleavage, and induces apoptosis.


Eligibility Criteria:
Inclusion Criteria:

* Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
* Age: 18 to 75 years old; female patient, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
* Histopathologically confirmed HR positive and HER2 negative advanced or metastatic breast cancer.
* Patients who have been treated with endocrine therapy and have experienced disease progression.
* Patients previously treated with any CDK4/6 inhibitor and not treated with BCL-2 inhibitor.
* Has at least one measurable lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria
* The main organs function well;
* Female patient had no plans to become pregnant and voluntarily took effective contraceptive measures from agree with the study to at least 6 months after the last dose of study drug.

Exclusion Criteria:

* 1. Concomitant disease and medical history:

  1. There were other malignant tumors in 3 years before the first medication.
  2. Has multiple factors affecting oral medication;
  3. Unalleviated toxicity ≥ grade 1 due to any previous therapy;
  4. Major surgical treatment, open biopsy and obvious traumatic injury were performed within 28 days before the study; e．Arteriovenous thrombotic events occurred within 6 months before the first medication, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism; f．Have a history of psychotropic drug abuse and can not quit or have mental disorders; g．Subjects with any severe and / or uncontrolled disease included: Cirrhosis, active hepatitis, history of immunodeficiency;
* Tumor-related symptoms and treatment:

  1. Has central nervous system metastases (CNS) and/or cancerous meningitis or leptomeningeal carcinomatosis;
  2. have received radiotherapy, other antineoplastic therapy within 2 weeks prior to the first dose;
  3. Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
* Known hypersensitivity to TQB3909, LHRH agonists (e.g., goserelin), or any excipients.
* Subjects who have received the vaccine within 28 days prior to the first dose, or are planning to receive the vaccine during the study period.
* Has Participated in other clinical trials within 4 weeks before first dose.
* According to the judgement of the investigators, there are other factors that may lead to the termination of the study.
Sheffield Physical Activity Booster Trial

Adults that increase their physical activity can improve their health, and reduce future risks to health, but long-term changes are difficult to sustain. This study assesses whether it is worth providing further support, 3 months after giving initial advice, to those who have managed to do more physical activity. All participants will initially be given an interactive DVD. A researcher from Sheffield Hallam University will provide two telephone follow ups at one month intervals to assess physical activity levels. Only those that have increased their physical activity at this point will remain in the study. These participants will receive a "mini booster", a "full booster" or no booster. The "mini booster" consists of a two telephone calls one month apart to discuss physical activity and usage of the DVD. A "full booster" consists of a face-to-face meeting with the facilitator at the same intervals. The purpose of these booster sessions is to help the individual to maintain their increase in physical activity. The investigators will measure the differences in physical activity, quality of life and costs, associated with the booster interventions, 3 months and 9 months from randomisation. The research will be carried out in 20 of the most deprived neighbourhoods in Sheffield. These locations have large, ethnically diverse populations, high levels of economic deprivation, low levels of physical activity, poorer health and shorter life expectancy. Participants will be recruited through general practices and community groups, as well as by postal invitation to ensure the participation of minority ethnic groups and those with lower levels of literacy. Sheffield City Council and Primary Care Trust fund a range of facilities and activities to promote physical activity and variations in access to these between neighbourhoods will make it possible to examine whether the effectiveness of the intervention is modified by access to community facilities.


Eligibility Criteria:
Inclusion Criteria:

* Residents of the 20 most deprived neighbourhoods in the city of Sheffield
* Aged 40 to 64 years
* Not achieving the current recommended activity level (30 mins of moderate activity on at least 5 days) assessed using the SPAQ (Lowther, 1999) and wishing to have support to become more active

Exclusion Criteria:

* Have increased their physical activity level by at least 30 mins of moderate or vigorous activity per week (assessed using the SPAQ) since initial assessment of activity level
* Capacity to give written informed consent to trial participation
Outcome of High Dose Vitamin D on Prognosis of Sepsis Requiring Mechanical Ventilation

There is a high prevalence of vitamin D deficiency in the critically ill patient population, with approximately 60% of patients found to be vitamin D deficient, (25(OH)D concentrations \<20 ng/mL) and an additional 30% of patients being vitamin D insufficient, (25(OH)D = 20-30 ng/mL).Approximately 80% of sepsis/septic shock patients experience respiratory failure and require mechanical ventilation. Furthermore, several studies document that vitamin D deficiency could be associated with poor outcomes in critically ill patient.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with sepsis and required mechanical ventilation (MV) within 24 hours from ICU admission.
* Expected to require mechanical ventilation for at least 72 hours after study entry.

Exclusion Criteria:

* Age \<18 years.
* inability to obtain informed consent from the patient and/or legally authorized representative.
* BMI\> 40.
* Pregnant or breastfeeding.
* Chronic kidney diseases
* Pancreatitis.
* Hepatic insufficiency
* Cases with coagulopathy
* Moribund and not expected to survive 96 hours.
* Ongoing shock
* History of therapy with high dose vitamin D3 within previous 6 months.
* History of disorders associated with hypercalcemia
* Cancer as the cause of sepsis.
* Subjects undergoing chemotherapy.
* Immune compromised patients.
* Pneumonia developed \< 48 hours following intubation.
* Patients with history of aspiration before intubation.
* known allergy to vitamin D.
Efficacy of Intralesional Sodium Thiosulfate Versus Intralesional Saline for Dystrophic and Idiopathic Calcinosis Cutis

The purpose of our research is to compare the effectiveness of 125mg/50ml sodium thiosulfate (STS) solution to normal saline (0.9% sodium chloride) when injected intralesionally for the treatment of calcinosis cutis. Our specific aim is to assess the response of dystrophic and idiopathic calcinosis cutis to the injections of sodium thiosulfate in our patients.

Our specific aim is to assess the response of dystrophic and idiopathic calcinosis cutis to the injections of sodium thiosulfate in our patients.

Eligibility Criteria:
Inclusion Criteria:

* Male or female adult 18 years of age or older
* Must have health insurance will be eligible to participate
* Must have a current diagnosis of dystrophic or idiopathic calcinosis cutis
* Subjects must have at least 2 lesions of at least 2mm in size

Exclusion Criteria:

* Unable to read and speak English
* Allergy to any component of the sodium thiosulfate solution
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Women who are breastfeeding
* Prisoners
Delphi Consensus Excessive Daytime Sleepiness in OSA

The objective of this study is to generate expert consensus statements on the differential diagnosis, definition, and management of EDS in patients with OSA who are adequately treated with primary therapy.

A study will be performed using a modified Delphi process with an international expert panel to generate recommendation statements related to the differential diagnosis and management of patients with residual EDS in OSA (and relevant sub-topics) and to determine the level of agreement for each statement from the panel as a whole. The following topics will be covered:

1. EDS: definition, evaluation/assessment, and tools
2. Definitions of residual EDS in patients with OSA treated with primary OSA therapy
3. Practical recommendations
4. Management Consensus is achieved through iterative rounds of survey and revision to the statements until a pre-determined level of agreement is met (80% agreement).

Part 1: planning and evidence review

* Series of planning sessions with co-chairs and faculty leads
* Literature is reviewed/summarized
* Initial statements will be developed based on evidence Recommendation statements on EDS in OSA will be formulated and rated according to level of agreement on a 5-point Likert scale.

Part 2: Survey to achieve consensus

* Survey, based on the initial statements developed by faculty leads, will be developed to allow for vetting by full faculty group
* At least 3 rounds of review (2 remote and 1 live \[virtual\]) will be held to achieve consensus on each topic of interest and finalize consensus statements

Eligibility Criteria:
Inclusion Criteria:

* Members of the panel include experts in sleep and respiratory medicine in North American and Europe.

Exclusion Criteria:

* Panelists who were not able to commit to all rounds of the modified Delphi process will be excluded.
Randomized Trial of Two Antimalarial Treatments for Clearing Low Density P.Falciparum Parasitaemia in Sudan

In areas of seasonal malaria transmission, treatment of carriers of malaria parasites, whose parasitaemia persists at very low levels throughout the dry season, could be a useful strategy for malaria control in areas with a short transmission season. We did a randomized trial to compare two regimens for clearance of low level parasitaemia in the dry season.

104 individuals with low density Plasmodium falciparum infection detected by polymerase chain reaction (PCR) were randomized to receive sulfadoxine-pyrimethamine and three daily doses of artesunate (SP+AS) or SP+AS and a dose of primaquine (SP+AS+PQ), and were followed up for 14 days during the transmission-free season in Eastern Sudan. Subjects were visited on days 3, 7 and 14 after the start of treatment to record any adverse events and to detect P.falciparum using PCR. PCR positive samples were tested for gametocytes using RT-PCR. Packed cell volume was measured on days 7 and 14.

Eligibility Criteria:
Inclusion Criteria:

* infection with P.falciparum detected by PCR

Exclusion Criteria:

* pregnancy
* severe anaemia
* fever or other signs of illness
* history of allergy to sulfa drugs
* presence of other species of Plasmodium detected by microscopy
A Regulatory Requirement Non Interventional Study to Monitor Safety and Effectiveness of Trajenta Duo in Type 2 Diabetes Patients in Korea

The primary objective of this study is to monitor the safety profile of Trajenta Duo in Korean patients with type 2 diabetes mellitus (T2DM) in a routine clinical setting.

Study Design:

Post Marketed Study- Observational study

Eligibility Criteria:
Inclusion criteria:

Potential subjets must meet all of the following inclusion criteria to enter this trial:

1. No previous exposure to Trajenta, Trajenta Duo
2. Should have been started on Trajenta Duo in accordance with the approved label in Korea
3. No current participation in clinical trials
4. No metformin is inappropriate due to contraindications
5. Must sign on the data release consent form

Exclusion criteria:

Individuals with any of the following characteristics will not be able to enter this study:

1. Previous exposure to Trajenta, Trajenta Duo
2. Current participation in clinical trials
3. Patients for whom metformin is inappropriate due to contraindications