cyrilzakka/clinical-trials huggingface dataset:
PAS 1ml Magtrace® for Sentinel Lymph Node Biopsy in Breast Cancer Patients

The purpose of this study is to provide prospective evidence in the US population of the frequency of skin discoloration and Sentinel Lymph Node detection rate in patients who have recevied Magtrace for Sentinel Lymph Node Biopsy (SLNB) and to evaluate the impact that skin discoloration has on patients when it does occur using patient reported outcome measures.

The purpose of this study is to provide prospective evidence in the US population of the frequency of skin discoloration and Sentinel Lymph Node (SLN) detection rate in patients who have received 1ml Magtrace for Sentinel Lymph Node Biopsy (SLNB) and to evaluate the impact that skin discoloration has on patients when it does occur using patient reported outcome measures utilising BREAST-Q.

Baseline assessment using BREAST-Q will performed. A key secondary objective is to demonstrate non-inferiority of sentinel lymph node (SLN) detection rate with Magtrace compared to the American Society of Breast Surgeons (ASBRS) performance standards.

All participants will undergo lymph node mapping with Magtrace, and Sentinel Lymph Node Biopsy undertaken and nodes localised with the Sentimag system, A sentimag count will be recorded for each node removed.

After completion of the surgery, at the postoperative visit the presence of Magtrace related discoloration will be assessed by the Investigator. Participants found to have no Magtrace related discoloration will be asked to complete the Post-Op BREAST-Q assessment and return at 12 months post-op for a follow-up visit. Those patients assessed as having the presence of Magtrace related skin discoloration will be asked complete the post-op BREAST-Q and will then undergo assessment of the size and severity of the discoloration. They will then be asked to return at 6, 12, 18 and 24 months for follow-up visits, or until the discoloration has resolved. At each of these visits the BREAST-Q will be completed, and the size and severity assessment will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Patient is willing and able to give informed consent for participation in the study
* Patient is aged 18 years or older at the time of consent
* Patients undergoing planned breast conserving surgery (for example, lumpectomy or partial mastectomy) and SLNB with Magtrace

Exclusion Criteria:

* The patient is pregnant or lactating
* The patient has had prior breast radiation to the ipsilateral breast
* The patient has clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes
* The patient has recevied a Feraheme (ferumoxytol) injection within the past 6 months
* The patient has intolerance or hypersensitivity to iron or dextran compounds or to Magtrace
* The patient has iron overload disease
* The patient has discoloration on the breast (such as tattoo, birthmark, tanning, rash etc.), that in the Investigator's opinion, could impact the clinical trial results, specifically the assessment of any skin discoloration, or plans to have a tattoo on the breast post-operatively.
Pilot Test of a Healthy Metabolic Behaviour Tool

This study aims to validate and pilot test the short-term intervention effect of a newly developed healthy metabolic behaviour tool, named as the 6P tool, on dietary attitude/ practice and body weight changes over one month among overweight and obese women. A total of 50 women, aged 21-40 years, BMI ≥25 kg/m2, who are attending the preconception clinic and planning for a pregnancy over the next one year, will be invited to participate in this pilot study. The recruitment period is estimated to take up to 10 weeks, with subsequent 1 month follow-up visit.

Preconception is a stage that could critically influence subsequent antenatal and postnatal health of mother and offspring. In Singapore, approximately one-third of women are overweight and obese during the preconception period. In the present pilot study, the investigators aim to introduce a simple, self-administered tool that can identify discrete components of an individual's diet, which would lead to self-awareness, self-evaluation and self-education, and over time, results in a positive change in eating habits and health. Specifically, the study aims i) to validate a newly developed tool that comprises six main dietary components (6P), namely Portion, Proportion, Pleasure, Phase, Physicality and Psychology in overweight and obese women during the preconception period; (ii) and to assess the short-term intervention effect of the 6P tool on dietary attitude/ practice and body weight changes over one month. The investigators hypothesise that intervention using this 6P tool in overweight and obese women will help them to promote healthy eating behaviours and reduce body weight. This study targets to recruit 50 overweight/ obese preconception women, from KK Women's and Children's Hospital, to evaluate the effectiveness of the tool over one month. Throughout the one month follow up period, nudges in the form of text messages/images related to the 6P goals will be sent to participants through mobile phone. This validated 6P tool is planned to be applied in a preconception targeted intervention cohort in order to build a positive mental model in healthy eating among overweight and obese women, enhancing awareness and belief towards weight management behaviour, and promoting a healthy life cycle.

Eligibility Criteria:
Inclusion Criteria:

* age 21-40 years
* body mass index \>= 25 kg/m2
A Pilot Study of the Effectiveness of Intra-operative Ozurdex® in Vitrectomy Surgery for Epiretinal Membranes

To determine if an intravitreal sustained release dexamethasone implant (Ozurdex®) injected at the conclusion of surgery in patients undergoing vitrectomy and membrane peeling for idiopathic epiretinal membranes is safe and effective to decrease the macular edema, as demonstrated by a gain in vision and decreased in retinal thickness and volume.

We believe that the use of intravitreal corticosteroids post-operatively has the capacity to mitigate much of the residual swelling and retinal thickening that is seen after vitrectomy for epiretinal membranes. The unique pharmacokinetics of the sustained released dexamethasone implant (Ozurdex®) makes it an ideal delivery system to use post-vitrectomy for epiretinal membrane surgery. Its duration of action and its drug delivery characteristics over 6 months approximately match the post-operative time course of healing and remodeling in an edematous retina.

This is a prospective, multicentre, pilot study evaluating the efficacy of an intravitreal sustained release dexamethasone implant (Ozurdex®) injected at the conclusion of surgery in 15 patients undergoing vitrectomy and membrane peeling for idiopathic epiretinal membranes.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing vitrectomy surgery for a visually significant (≤ 20/50) idiopathic epiretinal membrane.
* Central retinal thickness ≥ 250 μm.
* Age more than 18 years old.
* Decision makers able to give informed consent.
* Females of child bearing potential must agree to use acceptable means of birth control for the duration of the study.

Exclusion Criteria:

* Secondary epiretinal membranes (ex: secondary to a retinal vein occlusion, etc.).
* Any other macular pathology that could affect anatomic or functional results.
* History of uveitis requiring intravitreal triamcinolone injection.
* History of steroid-responsive glaucoma.
* History of moderate or advanced glaucoma (cup to disc ratio ≥ 0.7).
* IOP \> 23 mm Hg if untreated, or \> 21 mm Hg if treated with medication.
* Pregnant or breast-feeding woman.
* Unable to attend the scheduled follow-up appointments.
* Patients with known hypersensitivity to any components of Ozurdex® or to other corticosteroids.
* Patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.
Cognitive Behavioral Therapy in Treating Anxiety in Patients With Stage IV Non-Small Cell Lung Cancer and Their Caregivers

This pilot clinical trial studies cognitive behavioral therapy in treating anxiety in patients with stage IV non-small cell lung cancer and their caregivers. Cognitive behavioral therapy may reduce anxiety and improve the well-being and quality of life of patients who have stage IV non-small cell lung cancer and their caregivers.

PRIMARY OBJECTIVES:

I. To identify, through both quantitative and qualitative methods, clinical correlates of anxiety and points of intervention to reduce anxiety in patients with late-stage lung cancer and their primary caregivers.

II. To apply these findings to develop a brief dyadic intervention based on Cognitive Behavioral Therapy (CBT) to reduce anxiety in late-stage lung cancer patients and their primary caregivers.

III. To evaluate the feasibility and acceptability of the pilot intervention through number of completed visits and assessment pre- and post- intervention.

OUTLINE:

Participants undergo cognitive behavioral therapy over 1 hour once weekly for a total of 6 sessions. Sessions are tailored to patient and caregiver cognitions and approach and avoidance behaviors.

After completion of study treatment, participants are followed up at 1 week.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of stage IV non-small cell lung cancer
* At least 6 weeks post-diagnosis
* Current symptoms of anxiety (e.g., Hamilton Rating Scale for Anxiety \[HAM-A\] \>=14)
* Ability to understand and the willingness to sign a written informed consent document
* CAREGIVER: Identified by patient as primary caregiver
* CAREGIVER: At least 14 hours/week spent caring for patient
* CAREGIVER: Current symptoms of anxiety (e.g., HAM-A \>= 14)
* CAREGIVER: Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* PATIENTS AND CAREGIVERS:
* Active, unstable, untreated serious mental illness
* Other cognitive inability to complete informed consent process or study procedures
Botulinum Toxin Type A (Dysport) Associated With Rehabilitation Treatment in Patients With Primary Myofascial Pain Syndrome

The main purpose of this study is to determine the effectiveness and safety of one dose of botulinum toxin type A (Dysport) associated with rehabilitation treatment on pain control in patients with a type of back pain called primary myofascial pain syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Patients with primary myofascial pain syndrome of cervical and dorsal localization, less than two years of length, who must have been diagnosed with the evidence of "trigger points" in which conventional treatment with oral analgesia, rehabilitation and local anesthesia has not been clinically successful for more than 15 days.
* Punctuation of 4cm or more in a 10cm visual analog scale.
* Previous positive response (self-limited reduction -less than 15 days- of pain) after an anaesthetic infiltration in the trigger point.

Exclusion Criteria:

* Patients diagnosed with fibromyalgia or with a spread pain.
* Patients having received previously botulinum toxin.
* Patients having received anesthetic injections at the trigger points within the month before the visit.
* Patients having received corticosteroids injections at the trigger points within three months before the selection visit.
Adductor Strength in Roller Hockey Athletes

Roller hockey athletes will be recruited along the season and will be examined for adductor strength and other potential groin pain risk factors.

Roller hockey athletes will be recruited and assess through the season. The assessment consist of an adductor, abductor strength measurement, Hip and Groin Outcome Score (HAGOS) completion and will be screened for other risk factors which are believed to cause groin pain (Age, previous injury)

Eligibility Criteria:
Inclusion Criteria:

* Participate in the roller hockey bronze division from spain

Exclusion Criteria:

* Deny participation
Electronic Brachytherapy for the Treatment of NMSC

The objective of this study is to record recurrence in patients treated for nonmelanoma (basal cell and squamous cell carcinomas) skin cancer using the Xoft Axxent Electronic Brachytherapy System. Additional objectives include evaluate the appearance of the treated area in patients treated for nonmelanoma skin cancer using the Xoft Axxent Electronic Brachytherapy System and record the occurrence of radiation therapy related skin changes in patients treated for nonmelanoma skin cancer.

The objective of this study is to record local recurrence in patients treated for nonmelanoma (basal cell and squamous cell carcinomas) skin cancer using the Xoft Axxent Electronic Brachytherapy System. Additional objectives include evaluate the cosmetic outcomes in patients treated for nonmelanoma skin cancer using the Xoft Axxent Electronic Brachytherapy System and record the occurrence of radiation therapy related skin toxicities in patients treated for nonmelanoma skin cancer using the Xoft Axxent Electronic Brachytherapy System.

Eligibility Criteria:
Inclusion Criteria:

* Patient has signed the informed consent form
* Pathological diagnosis confirmed of squamous cell or basal cell carcinoma
* Histopathological Grade: G1 (well differentiated), G2 (moderately differentiated), or Gx (Not assessed in report)
* Clinical Staging Tis, T1, or T2 (Must be ≤ 4 cm in diameter)
* One lesion is treated, or more than 1 lesion is treated with a minimum of a 5 mm gap between the edges of the lesion margins.

Exclusion Criteria:

* T2 \> 4 cm and T3 and T4
* American Joint Committee Staging for NMSC Stages III and IV
* Histopathologic Grade 3 (poorly differentiated) or higher grade
* Target area is adjacent to a burn scar
* Target area is on the lip
* Patient \< 50 years of age
* Any prior definitive surgical resection of the cancer
* Perineural invasion
* Lesion depth \> 5mm on clinical assessment or as assessed by ultrasound or CT.
* Patient is pregnant (pregnancy test required if standard of care).
* Target area is prone to trauma.
* Target area with compromised lymphatic or vascular drainage.
* Participation in another investigational device or drug study concurrently.
* Patient has undergone prior radiation therapy to this specific anatomic location.
* Patient is receiving pharmacologic agent(s) at or around the time of the Radiation therapy that is/are known to produce skin reactions that will influence cosmesis grading during study.
* Patient is receiving chemotherapeutic agent(s) Six (6) weeks before or six (6) weeks after radiation therapy.
* Life expectancy less than five (5) years.
Circulating Tumor DNA and Follow-up of BRCA1 Mutation Carriers (CirCa 01)

BRCA1 carriers who are at high risk of developing either a relapse and/or a new cancer growth will be included. These patients will be followed up during 30 months (2,5 years) with mutated TP53 mutation detection or during 42 months (3,5 years) with mutated TP53 mutation detection and circulating tumor cells detection (CTC) performed at each hospital visit (for technical reason only patients included at Institut Curie will be proposed to participate to the CTC substudy).


Eligibility Criteria:
Inclusion Criteria:

1. Patient with no evidence of any invasive tumor mass at inclusion (clinical and, if any, radiological exams)
2. Carriers of known germline BRCA1 deleterious mutation (a personal history of cancer is NOT mandatory).
3. Age ≥ 30 years for patient with personal previous history of cancer
4. Age ≥ 40 years for patient without personal previous history of cancer
5. Patient who a follow-up visit is scheduled in the including center at least once a year
6. Patient having health care insurance
7. Signed informed consent by patient

Exclusion Criteria:

1. Patient presenting with invasive tumor masses (e.g. stage IV cancer or localized cancer not yet surgically removed)
2. Carriers of germline BRCA1 variant of unknown significance
3. Carriers of germline BRCA2 deleterious mutation or variant
4. Individuals with a low risk of BRCA1-related tumor growth, i.e. women who underwent prophylactic bilateral mastectomy AND adnexectomy.
5. Any medical or other condition that in the Investigator's opinion rendered the patient unsuitable for this study
6. Patient deprived from ability to decide on her own.
7. Patient unable to have a regular follow up for geographical, social or psychological reasons.
BH4 in the Prevention and Treatment of Radiation-induced Skin Reactions for Head and Neck Squamous Cell Carcinoma (Including Nasopharyngeal Carcinoma)

Head and neck squamous cell carcinoma (include nasopharyngeal carcinoma) is one of the most common malignant tumor in China, and radiotherapy is the main treatment method. Radiation-induced dermatitis is one of the most common complications of head and neck squamous cell carcinoma patients during radiotherapy. Severe radiation dermatitis will cause secondary infection, severe pain, and even lead to the interruption of radiotherapy. On the one hand, it will affect the efficacy of tumor treatment, which may affect the long-term survival of patients, and on the other hand, it will also seriously affect the quality of life of patients. Tetrahydrobiopterin（BH4）, also known as sapropterin, has been shown not only to reduce the severity of acute radiation dermatitis but also to enhance the repair of skin injury in animal experiments. It may be a new approach and method for the prevention and treatment of radiation-induced dermatitis


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed diagnosis of head and neck squamous cell carcinoma (including nasopharyngeal carcinoma).
2. Age ≥ 18 years old, ≤ 80 years old.
3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
4. Head and neck radiotherapy alone or concurrent chemoradiotherapy, radiotherapy using intensity modulated radiotherapy.
5. Blood routine examination: hemoglobin ≥ 100g/L, platelet count ≥ 75×10\^9/L, white blood cell count ≥ 3.0×10\^9/L, absolute neutrophil count ≥ 1.5×10\^9/L. Blood biochemistry: total bilirubin≤1.5 upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5 ULN, serum creatinine ≤1.5 ULN or creatinine clearance rate \>=60ml/min.
6. Have signed informed consent form.

Exclusion Criteria:

1. Allergic to the components of Sapropterin dihydrochloride tablets or severe allergic constitution.
2. Poor compliance.
3. Pregnant or breastfeeding.
4. Any previous radiotherapy to the head and neck region.
5. Patients deemed unsuitable for the study by the investigator (concomitant with any other serious disease)
A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics of DW1809

Randomized, Open-label, Oral, Single-dose, two-Sequence, four-Period, crossover study


Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers who are ≥19 years old
* Body weight ≥50.0 kg and BMI between 18.0 and 30.0 kg/m2 and

Exclusion Criteria:

* Clinically significant Medical History
* In the case of women, pregnant(Urine-HCG positive) or lactating women
The Treatment of PD-1 Antibody Combined With Peg-IFNα in NAs-suppressed CHB Patients

This is a prospective, open-labled, randomized controlled study to assess efficacy and safety of treatment with Sintilimab (PD-1 antibody) combined Peg-IFNα-2b in CHB patients on stable NAs treatment.


Eligibility Criteria:
Inclusion Criteria:

1. 18 - 65 years old;
2. Chronic hepatitis B patients with clear diagnosis of hematology, etiology and clinical (for example: HBsAg positive for more than 6 months);
3. Treatment with NAs (ETV, TDF or TAF）at least 1 years and continue NAs therapy during screening;
4. HBV DNA and HBeAg turn negative after NAs treatment;
5. HBsAg ranged 200-1000 IU/ml.

Exclusion Criteria:

1. Cirrhosis;
2. platelet count \< 90×10\^9/L, WBC count \< 3.0×10\^9/L, neutrophil count \< 1.3×10\^9/L, ALT \> ULN（40U/L）, total bilirubin \> 2ULN;
3. History of or suspicion of hepatocellular carcinoma
4. Patients received interferon therapy within 12 months;
5. Patients received immunosuppressive therapy or other therapy influenced study within 12 months;
6. Hepatitis A, hepatitis C, hepatitis D, HIV infection or other active infections;
7. Alcohol or drug abuse/dependence;
8. Investigator judges that the participants are not suitable for this study.
Intravitreal Ranibizumab in Retinal Pigment Epithelial Detachments

The purpose of this study is to demonstrate the efficacy of ranibizumab in patients with retinal pigment epithelial detachment secondary to age-related macular degeneration (AMD).

Pigment epithelial detachments (PED) secondary to age-related macular degeneration (AMD) have been excluded from practically all study populations of ranibizumab studies so far. PED represents a special entity in AMD. As yet, no standard treatment has been established for this disease.The stimuli that induce PED are not very well known, but there is evidence suggesting that angiogenic factors such as vascular endothelial growth factor (VEGF) also play a role in the pathogenesis. Ranibizumab is an anti-VEGF antibody fragment that blocks VEGF activity in patients with neovascular AMD.

Eligibility Criteria:
Inclusion Criteria:

* patients with age-related macular degeneration and serous pigment epithelial detachment as determined by fluorescein and indocyanine green angiography and optical coherence tomography (OCT)
* patients who have a best-corrected visual acuity (BCVA) score between 73 and 24 ETDRS letters
* patients with pigment epithelial detachment (PED) ≥ 200 µm as determined by OCT
* male or female patients 50 years of age or greater
* patients willing and able to comply with all study procedures

Exclusion Criteria:

* patients with best-corrected visual acuity (BCVA) \< 24 or \>73 letters in the study eye
* patients previously treated by intravitreal injections of steroids or anti-VEGF agents, or patients previously treated by Verteporfin photodynamic therapy or focal laser photocoagulation
* history of uncontrolled glaucoma in the study eye