cyrilzakka/clinical-trials huggingface dataset:
A Study to Learn About the Study Medicine Called Tafamidis 61mg in People Diagnosed With Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

The purpose of this clinical trial is to learn about the effects of the study medicine (called Tafamidis 61milligrams (mg)) for the potential treatment of Transthyretin amyloid cardiomyopathy (ATTR-CM).

This study is seeking participants who were prescribed Tafamidis 61mg after being diagnosed with ATTR-CM and have taken Tafamidis 61mg at least once.

We will examine the experiences of people receiving the study medicine. This will help us determine if the study medicine is safe and effective.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥19 years
* Patients diagnosed with ATTR-CM (ATTRwt and ATTRv) with tissue biopsy or nuclear scintigraphy
* Patients who was prescribed Tafamidis 61mg after being diagnosed with ATTR-CM and have taken Tafamidis 61mg at least once.

Exclusion Criteria:

* Presence of other amyloidosis
Cosmetic Fat Transplantation Using Expanded ASC Enriched Fat Grafts

The purpose of the present study is to examine whether enrichment of a fat graft with autologous ex vivo expanded ASC injected into the breast tissue or face, both for cosmetic use, will significantly improve the results of conventional lipofilling and synthetic facial fillers, thereby being able to offer a safer, more natural and long-lasting alternative to current artificial solutions for cosmetic patients.

The cosmetic breast augmentation design is a double-blind (surgeon and data assessor) randomized, prospective clinical study on healthy subjects.

The cosmetic facial filling design is a data assessor-blinded, randomized, prospective clinical study on healthy subjects.

Eligibility Criteria:
Criteria breast augmentation:

Inclusion criteria

1. Age 18 - 50 years
2. Healthy females
3. BMI 18 - 30 kg/m2
4. 1000 ml of fat (lipoaspirate) available for liposuction at the abdomen and/or thighs
5. Desire for breast augmentation
6. Speaks and reads Danish or English
7. Signed informed consent

Exclusion criteria

1. Smoking
2. Previous breast surgery
3. Previous cancer or predisposition to breast cancer
4. Pregnancy or planned pregnancy within one year after the procedure
5. Breastfeeding less than 6 months prior to inclusion
6. Weight gain or loss above 2 BMI point
7. Known chronic disease associated with metabolism malfunction or pour healing
8. Pacemaker or other implanted foreign objects
9. Allergy towards necessary anaesthesia
10. Intention of weight loss or weight gain within the trial period

Criteria fascial filling

Inclusion criteria

1. Age 25 - 65 years
2. Healthy females
3. BMI 18 - 30 kg/m2
4. 100 ml of fat (lipoaspirate) available for liposuction at the abdomen and/or thighs
5. Desire for facial wrinkle treatment and facial augmentation (rejuvenation)
6. Speaks and reads Danish or English
7. Signed informed consent

Exclusion criteria

1. Smoking
2. Previous facial surgery
3. Previous cancer
4. Pregnancy or planned pregnancy within one year after the procedure
5. Known chronic disease associated with metabolism malfunction or poor healing
6. Allergy towards necessary anaesthesia
7. Intention of weight loss or weight gain within the trial period
Effect of Multitarget tDCS for Neuropathic Pain

This study aims to conduct a randomized controlled trial to evaluate the effect of multitarget transcranial direct current stimulation (tDCS) on pain, depression, anxiety, quality of life and sleep, in patients with neuropathic pain.

The present multicenter, randomized, double-blind, sham-controlled, parallel-group trial aims to evaluate the effect of multitarget transcranial direct current stimulation (tDCS) in patients with neuropathic pain.

The patients will be randomized to receive one of 3 treatment arms: multitarget stimulation, single-target stimulation and sham stimulation. All patients received 20 minutes of active or sham tDCS once a day for 10 consecutive weekdays. In multitarget group, subjects will receive 2mA tDCS applied to M1 and DLPFC alternately, with each target stimulated for 5 sessions. In single-target group, 2mA tDCS will target M1 only. In sham group, subjects will receive sham tDCS. Ramps up and down will be applied for 15 seconds each at the beginning and end of the session. The current will be 0 mA during the interval between the initial and final ramps.

Eligibility Criteria:
Inclusion Criteria:

1. Female or males aged between 18 and 75 years.
2. Pain fulfilling the criteria for probable or definite neuropathic pain and scoring ≥4/10 at Douleur Neuropathique 4 Questions.
3. Pain duration of at least 3 months and average pain intensity scoring ≥4/10 at Numeric Rating Scale.
4. Stable pharmacological treatment for at least 4 weeks prior to the study and throughout the trial.
5. Informed consent obtained.

Exclusion Criteria:

1. Pregnancy or lactation.
2. Active central nervous system diseases including but not limited to brain tumour, intracranial hypertension, past or current epilepsy.
3. Unable to complete the questionnaire due to language abilities or reduced cognitive functioning.
4. Alcohol or substance abuse.
5. Common contraindications for transcranial direct current stimulation including but not limited to skull defect, implanted device or metal in the brain, severe cardiopulmonary, renal or hepatic diseases.
6. Unwilling to comply with the treatment or follow-up assessments.
7. Participating in another clinical trial within 3 months prior to enrollment of this clinical trial.
8. Any patient deemed unsuitable for enrollment by the investigators.
Dopamine and Muscle Function in the Heat

our goal is to study the effects of dopamine activity, using Ritalin ingestion, on neuromuscular function over the course of a progressive heating and cooling protocol developed in our lab. We hypothesize that Ritalin will minimize the previously reported progressive impairment in neuromuscular function with hyperthermia compared to placebo, suggesting that dopamine activity preserves neuromuscular capacity with hyperthermia.

Increased core temperature (hyperthermia) has been associated with impaired neuromuscular performance, with the majority of research suggesting that the observed fatigue is related to the central nervous system. Small doses of Ritalin has been used to study how changes in dopamine activity affects exercise capacity in the heat. This study found that 20 mg of Ritalin had no effect on exercise capacity in a thermoneutral environment of 18°C. However, when in a hot (30°C) environment, the Ritalin resulted in a 16% improvement in finishing time compared to the placebo trial. Interestingly, the higher output during the Ritalin-hot condition also resulted in higher rates of heat production and a higher (\~0.6°C) core temperature, suggesting that dopamine enabled greater voluntary tolerance of hyperthermia. This matches recent work from our own work showing that motivational skills training increased both exercise tolerance and final core temperature, and it is possible that dopamine activity played a role in this improvement.

Ultimately, fatigue is shown in an inability to sustain muscular force. However, the role of dopamine activity on neuromuscular function (e.g., central activation and recruitment of muscle) during hyperthermia is unknown. One study reported that 20 mg of Ritalin did not alter neuromuscular function, but this study was done without thermal stress.

Therefore, our goal is to study the effects of dopamine activity, using Ritalin ingestion, on neuromuscular function over the course of a progressive heating and cooling protocol developed in our lab. We hypothesize that Ritalin will minimize the previously reported progressive impairment in neuromuscular function with hyperthermia (5, 7) compared to placebo, suggesting that dopamine activity preserves neuromuscular capacity with hyperthermia.

Eligibility Criteria:
Inclusion Criteria:

* High aerobic fitness (\>55 mL/kg/min maximal aerobic capacity)

Exclusion Criteria:

* diagnosed cardiovascular, respiratory and/or neuromuscular disease, prescription of Ritalin or any drugs for hyperactivity within the past 1 year, any current prescription medication (except for asthma/allergy inhalers), any contraindications to Ritalin.
Dose Escalation Using Hypoxia-adjusted Radiotherapy

DE-HyART is a phase II clinical trial aimed at understanding the effects of escalating radiation doses to hypoxic sub-volumes inherent to squamous cell head and neck cancer. The study is aimed at assessing locoregional control, feasibility, and acceptable toxicity with such a strategy.

DE-HyART is a randomized, non-blinded study that assesses the effects of combining IMRT (using SIB-Sequential planning) with dose-escalation to hypoxic sub-volume delineated using \[18-F\] FMISO. The treatment protocol will also include concurrent chemotherapy with cisplatin at standard uniform dosing.

Patients with HNSCC whose cancer is determined to originate from the oral cavity, oropharynx, larynx, and hypopharynx will be selected. The included patients will be subjected to \[18F\] FMISO scan, labeled as baseline FMISO. Depending upon the result of the baseline FMISO, the patient will be either hypoxic or anoxic. Patients exhibiting no hypoxia in their tumor will be labeled as Arm 1 and act as an external cohort. Patients with hypoxia will be randomized (1:1) into two arms - Arms 2 and 3. Both arms will be subjected to chemoradiation by IMRT and concurrent chemotherapy with cisplatin at 40mg/m2. In Arm 3, the trial arm will receive an additional 10 Gy @ 2 Gy per fraction in phase II (total 80 Gy) to the HSV + 5mm isotropic margin.

One twenty-four patients will recruited in a 1:1 fashion between Arm 3 and Arm 2. The primary endpoint will be locoregional control and its possible increase in control.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 - 70 years
* Willingness to sign informed consent (written/video documentation)
* Performance status: ECOG 0 - 2
* Histology proved - squamous cell carcinoma
* Any grade, gender
* Tumour sites: Oral Cavity, Oropharynx, Hypopharynx and Larynx
* Sufficient bone marrow reserve within the last 14 days.

  * Hb: \> 10g/dl (corrected)
  * TLC: \> 4,000 per cumm
  * Platelet: \>1.5Lakh per cumm
* Liver functions and kidney functions within normal limits
* Nutritional and dental assessment before inclusion into the study

Exclusion Criteria:

* HPV (p16) positive tumours
* Prior surgery and/or radiation therapy given for any HNC
* T1/T2 Glottis
* Metastatic disease or disease not amenable for definitive locoregional treatment.
* Medical co-morbidity hampering the administration of radiation and/or chemotherapy (cisplatin)
* Pregnancy or lactation
Exploring the Optimal Timing of Minimally Invasive Surgery for Esophageal Squamous Cell Carcinoma

The optimal interval between neoadjuvant chemradiotherapy and esophagectomy is still a question that needs to be explored for patients with esophageal squamous cell carcinoma. In this study, based on previous studies, the investigators divided patients into two groups with a cutoff value of 50 days. By comparing the overall survival and disease-free survival of the entire population and non PCR population, the investigators ultimately obtained the optimal surgical timing suitable for clinical use

background：Neoadjuvant chemoradiotherapy has gradually become a first-line treatment for esophageal squamous cell carcinoma patients. After the completion of neoadjuvant chemoradiotherapy, patients usually undergo minimally invasive surgery to ensure complete removal of the tumor and lymphatic tissue. However, the optimal interval between neoadjuvant chemoradiotherapy and minimally invasive surgery is still an unknown factor, and whether it affects postoperative disease-free survival (DFS) and overall survival (OS) of patients remains unknown. Therefore, the main purpose of this study is to explore the specific impact of the interval between neoadjuvant chemoradiotherapy and minimally invasive surgery on patients, and to find the optimal interval time.

methods：Patients who underwent neoadjuvant chemoradiotherapy and minimally invasive surgery from two institutions between October 2010 and September 2019 were included in this study. The time interval is defined as the days between the last time a patient receives neoadjuvant chemoradiotherapy and the execution of surgery. Based on past research, the interval between the two groups was determined to be 50 days. The main research result is the OS and DFS of different interval groups in the overall population and non-PCR population. A multivariate Cox regression model was established to determine the main factors affecting Patient's OS and DFS.

Eligibility Criteria:
Inclusion Criteria:

* (I) thoracic ESCC
* (II) no history of concomitant or prior malignancy
* (III) Completed one cycle of nCRT
* (IV) Received endoscopic radical surgery for esophageal cancer

Exclusion Criteria:

* (I)other histological subtypes
* (II)Received ESD treatment
* (III) Radiation dose greater than 50Gy
* (IV) Metastatic esophageal squamous cell carcinoma
Neural Correlates of tVNS

Transcutaneous vagal nerve stimulation (tVNS) has been applied to a number of disease areas including visceral pain, depression, cluster headache and Alzheimer's disease. However, there is marked heterogeneity in these studies pertaining to i) the anatomical site of stimulation (neck, inner concha or tragus of ear), and ii) the waveform parameters of the stimulating impulse. This exploratory cross-sectional study will address these knowledge gaps by comparative functional neuroimaging of the neural correlates of tVNS with disparate anatomical sites and electrical waveform characteristics during rest in healthy participants.


Eligibility Criteria:
Inclusion criteria:

* Of female sex;
* Healthy participants (defined as those without a pre-existing medical comorbidity)
* Age between 18 and 40 years;
* BMI between 18 and 30 kg/m2;
* Women on oral contraceptives only
* All subjects should be right-handed.
* Inclusion will be determined on the basis of availability. Subjects should be able to attend for 2 scanning sessions.

Exclusion criteria

* Presence of metallic prostheses, pacemakers, metal clips on blood vessels, metal parts in the eye, an intrauterine device, metal braces, tattoos and/or other metal objects;
* History of major head trauma or head/brain surgery;
* History of claustrophobia;
* History of severe or chronic cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, haematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol;
* Use of regular medication, including vitamin and iron supplementation, except oral contraceptives, within 14 days prior to start of the study;
* Pregnancy, lactation, wish to become pregnant;
* High alcohol consumption (\>15 alcoholic units consumed per week);
* Using drugs of abuse;
* Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study;
* Participants unable to provide informed consent
* Participants with any systemic disease or medications that may influence the autonomic nervous system (e.g. beta-agonists or Parkinson's disease)
* Current smokers or current use of nicotine in any other way (including E-cigarettes and patches)
* History of clinical anxiety or depression, or a hospital anxiety or depression score \>8
* Participants whom score 8 or more on the HADS-questionnaire at study commencement
* Patient whom have cardiovascular conduction problems
* Patient with cochlear implants
* Not meeting any of the inclusion criteria above
* Any evidence of structural brain abnormalities examined by anatomical MRI will lead to exclusion
A Human Phase I Absolute Bioavailability Study of PRT054021 in Healthy Male Volunteers

This is a open label, single center, single oral dose, study of PRT054021, in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult men ages of 19 and 65 years old, inclusive
* BMI of 18-35 kg/m2

Exclusion Criteria:

* Clinically significant comorbid disease
* History of substance abuse
Evaluation of Intra Axial Brain Masses Based on Magnetic Resonance in Adults

Although the Magnetic resonance imaging with contrast is the gold standard for diagnosis of intra axial brain masses. The conventional Magnetic resonance imaging appearances of intra axial brain masses can be non-specific and even the use of contrast agent is of limited benefit.

Contrast enhancement reflects only disruption of blood brain barrier. One third of high-grade malignancies are non-enhanced and may non-neoplastic lesions show contrast enhancement.

Reliable differentiation of neoplastic from non-neoplastic brain masses, or of high grade from low grade tumor, is difficult with conventional Magnetic resonance imaging


Eligibility Criteria:
1. Inclusion criteria:

   \* An intra axial space occupying lesion/lesions detected on conventional structural imaging
2. Exclusion criteria:

   * MRI contraindications (as pace maker or claustrophobia).
   * Contrast hypersensitivity
   * Impaired renal function.
   * Pediatric age group
De Quervain's Disease in the Acute Phase:a Study Aimed at Evaluating the Effectiveness of Standard Physiotherapy Treatment (HANDGUIDE), Compared to Experimental Treatment After Performing Ultrasound-guided Infiltrative Therapy.

The objective of the study is to compare pain reduction and disability reduction in two groups of patients diagnosed with de Quervain syndrome who will undergo ultrasound-guided infiltrative treatment with corticosteroid as per normal clinical practice:

* the control group will subsequently be subjected to a standard treatment based on the European guidelines of the HANDGUIDE group,
* the experimental group will subsequently carry out a program of eccentric exercises.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes with a minimum age of 18 years;
* Medical diagnosis of de Quervain syndrome assessed through orthopedic clinical examination e confirmation by ultrasound;
* Signing of the informed consent and participation in the study.

Exclusion Criteria:

* Patients who are not self-sufficient or not able to understand and want;
* Presence of other pathologies in the hand affected by de Quervain pathology, such as intersection syndrome, neuropathies, fractures, rhizoarthrosis, arthrosis of the radio-carpal or intercarpal joint, intercarpal instability, cervical radiculopathy, rheumatic or metabolic pathologies;
* Pregnant or breastfeeding women.
Effect of Hyponatremia in Small Cell Lung Cancer

In this retrospective study, the investigators determined the frequency of hyponatremia in small cell lung cancer and the prognosis. 126 (27%) of 466 patients were hyponatremic. Hyponatremia could not be corrected in 50.8% (n=64) of hyponatremic patients. Survival was found to be better in the group of whom hyponatremia was corrected.


Eligibility Criteria:
Inclusion Criteria:

Patients diagnosed with SCLC between January 2012 and January 2017 in our hospital were retrospectively screened

Exclusion Criteria:

Over 18 age If data doesn't exist
Prognostic Value of Baseline Computed Tomography (CT) Perfusion Parameters of Pancreatic Cancer for Patients Undergoing Stereotactic Body Radiotherapy or Surgical Resection

The purpose of this study is first, to determine whether baseline perfusion characteristics of pancreatic cancer, as characterized by CT perfusion studies, can predict tumor response to treatment by stereotactic body radiotherapy (SBRT). The second goal of this study is to determine whether baseline perfusion characteristics in those patients with resectable pancreatic cancer correlate with immunohistologic markers of angiogenesis such as microvessel density and vascular endothelial growth factor (VEGF) expression.


Eligibility Criteria:
Inclusion Criteria:

1. suspected and/or biopsy-proven pancreatic adenocarcinoma, and
2. referral to Radiology for pre-treatment baseline pancreatic protocol CT.

Exclusion criteria:

1) are absolute contraindications to intravenous iodinated contrast or CT scan.
A Study on Predictive Models and Clinical Outcome of Radiation Pneumonitis

Radiation pneumonitis is the main dose-limiting toxicity of thoracic radiotherapy, which can affect life quality, survival, and the tumor-controlling effects of patients receiving thoracic radiotherapy.

The purpose of this study is to:

* Identify biomarkers including serum proteins, gene expression, genetic changes, and epigenetic modifications that determine radiation pneumonitis.
* Investigate the relationship between radiation pneumonitis and other toxicities induced by radiotherapy.
* Construct a predictive model for radiation pneumonitis.
* Evaluate survival and treatment outcome of patients with radiation pneumonitis.

1. Collect clinical information, CT images, and peripheral blood of the lung cancer patients treated with thoracic radiotherapy in Tongji Hospital, Hubei Cancer Hospital, and Jingjiang People's Hospital.
2. Follow up the enrolled patients. All patients enrolled in this study are examined during and one month after radiotherapy. Then, the patients are followed every three months for the first year and every six months thereafter. At each follow-up visits, all patients are asked to undergo a chest CT, and information including survival status, symptoms, CT images, and treatment is collected. Radiation pneumonitis and other toxicities induced by radiotherapy are graded by two radiation oncologists according to the Common Terminology Criteria for Adverse Events 4.0 (CTCAE4.0).
3. Detect serum proteins, gene expression profile, single-nucleotide polymorphisms, and epigenetic modifications that may be associated with radiation pneumonitis.
4. Screen biomarkers that are associated with radiation pneumonitis via univariate and multivariate Cox regression analysis.
5. Construct a predictive model of radiation pneumonitis based on clinical information, radiomics, and biomarkers via machine learning or Least absolute shrinkage and selection operator.
6. Use Kaplan-Meier and Cox model to analyze the association of radiation pneumonitis with survival and efficacy of antitumor treatment.
7. Identify biomarkers and predictors of other toxicities induced by radiotherapy including radiation esophagitis, cardiotoxicity and radiodermatitis.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of lung cancer by histology
2. Radiation dose at least 45 Gy
3. Karnofsky \>60
4. Age\>18
5. Life expectancy of at least 6 months

Exclusion Criteria:

1. Previous thoracic irradiation
2. Severe cardiopulmonary diseases