cyrilzakka/clinical-trials huggingface dataset:
Cryospray Therapy for Benign Airway Stenosis

This is a clinical evaluation to assess the effectiveness of cryospray therapy used in addition to current standard of care endoscopic therapies in preventing short term recurrent airway stenosis with a multicentric outcome evaluation. The investigators hypothesize that the addition of SCT to standard endoscopic treatment of benign airway stenosis will result in decreased stenosis recurrence at 6 months as estimated by quantitative radiologic assessment of the stenotic volume.

Spray cryo treatment of tracheal stenosis has the potential for long-lasting endoscopic management of BCAS and is used as part of routine clinical care by many physicians, but there is a relative paucity of peer-reviewed data, and no randomized controlled trial has been performed. Thus, the study could potentially show that the use of spray cryo therapy could allow patients to undergo fewer procedures to treat this condition, or lengthen the amount of time required in between these procedures, or play a role in the resolution of this condition.

Eligibility Criteria:
Inclusion Criteria:

* Referral to interventional pulmonology or otorhinolaryngology or thoracic surgery for endoscopic management of suspected benign tracheal stenosis.
* Significant tracheal stenosis defined by stenosis ≥ 50% of tracheal lumen assessed on chest CT or previous bronchoscopy
* Able to provide informed consent.
* Age \> 18

Exclusion Criteria:

* Inability to provide informed consent
* Pregnancy
* Known or suspected malignant central airway stenosis
* Patient has already been enrolled in this study.
* Study subject has any disease or condition that interferes with safe completion of the study including:

  1. Hypoxemia with need for supplemental oxygen ≥ 2L/min by nasal canula
  2. Pneumothorax in the previous 12 months
  3. Severe COPD (defined as a FEV1/FVC \< 70% and FEV1 \<30% predicted) and/or severe persistent asthma.
  4. Hemodynamic instability with systolic blood pressure \<90 mmHg or heart rate \> 120 beats/min, unless deemed to be stable with these values by the attending physicians.
  5. Compromised tissue where significant ulceration or mucosal break is evident in the ablation area or adjacent organs.
  6. Significantly reduced tissue strength caused by prior procedure or pre-existing condition (e.g. PEG tube)
  7. Significantly reduced elasticity of the ablation area (e.g. Marfan's Syndrome)
* Prior complications with SCT (Spray cryotherapy)
* Contraindication to rigid bronchoscopy
* Significant tracheomalacia or alterations in cartilage integrity on CT (Computed Tomography) that would require stent placement or surgical referral.
* Greater than 1 BCAS intervention, excluding cricotracheal (tracheal surgery) resection, within 6 months before enrollment.
* Anatomical flow resistance (gas evacuation) where any procedure or anatomy proximal to the ablation site has significantly reduced or restricted the flow area of the lumen creating restriction where gas created from liquid nitrogen cannot adequately vent.
A Randomized Controlled Mindfulness Based Stress Reduction Intervention in Women With Breast Cancer

The purpose of this study is to evaluate the effect of mindfulness based stress reduction intervention in women with breast cancer


Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with breast cancer after completion of adjuvant chemotherapy or radiation therapy, with/or without endocrine therapy

Exclusion Criteria:

* patients with advanced illness at diagnosis
* patients previously used MBSR
Tolerance and Efficacy Nicotinamide (vitamin B3) in Dominant Optic Atrophy OPA1

Dominant Optic Atrophy (hereafter known as DOA) is a neurodegenerative pathology of the optic nerve inducing progressive loss of central visual field and visual acuity. There is currently no proven treatment for this disease. The metabolomics work of Pascal Reynier's team revealed a specific metabolomic signature of DOA in the plasma of patients. This metabolomic signature revealed a relative deficiency in nicotinamide compared to a control population, a vitamin compound (vitamin B3) known to be neuroprotective for the optic nerve and mitochondria. Note that the investigator have also identified this nicotinamide deficiency in primary open-angle glaucoma and Leber's hereditary optic neuropathy, the other most common cause of hereditary optic neuropathy, these three optic nerve conditions sharing a common pathophysiological mechanism of mitochondrial deficit. In addition, an American team demonstrated the high neuroprotective power on the optic nerve of nicotinamide in a mouse model of glaucoma. These arguments converge towards the potential therapeutic interest of this vitamin in degenerative pathologies of the optic nerve. This is encouraged by the fact that two randomized clinical trials have confirmed a benefit of nicotinamide in glaucoma. The objective of this pilot study is to test the tolerance and efficacy of nicotinamide in DOA and DOA+ patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Patients with DOA or DOA+ due to a heterozygous pathogenic variant in the OPA1 gene
* Naïve patients (\> 3 months) in terms of taking nicotinamide
* Patients able to take oral medication and comply with specific study procedures
* Patients affiliated or beneficiaries of a social security scheme
* Signature of voluntary, free and informed consent to participate in the study

Exclusion Criteria:

* Asymptomatic patients (= healthy carriers of an OPA1 mutation but not having developed optic neuropathy)
* Patients with another associated severe ophthalmological pathology (advanced glaucoma, retinal pathology, etc.)
* Patients treated with Idebenone
* Patients with a level of transaminase(s) (ASAT and/or ALAT) twice higher than the high normal value.
* Pregnant, breastfeeding or parturient women
* Patients with a contraindication to nicotinamide
* Persons deprived of liberty by administrative or judicial decision
* Patients subject to a legal protection measure
* Persons undergoing psychiatric treatment under duress
* Persons unable to express their consent
Skeletal Muscle Mass Used to Assess Frailty in Older Gastric Cancer Patients

The primary aim of this study was to quantify the diagnosis of pre-surgical skeletal muscle mass in elderly gastric cancer patients and to analyse its correlation with frailty. The second aim was to investigate whether skeletal muscle mass, or sarcopenia, is associated with mobility and nutritional status, and anxiety and depression. The main questions it aims to answer are whether skeletal muscle mass is significantly associated with frailty and whether it can be used as a brief screening tool for preoperative frailty.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with gastric cancer by endoscopy or pathology; age \>60 years old; radical gastrectomy was proposed; be able to communicate simply in writing and verbal.

Exclusion Criteria:

* received preoperative radiotherapy or chemotherapy; combined with other sites of malignant tumors; combined with severe heart, liver, lung and renal insufficiency; recent using hormones, immunosuppressants; with physical disabilities.
Regulatory T-cells After Subcutaneous Immunotherapy

The primary endpoint was the induction of T-regulatory cells under s specific subcutaneous immunotherapy (SCIT). Patients suffering from grass pollen allergy (relevant clinical symptomes during the pollen season, Skin Prick test diamter \>4mm or RAST class II or higher) were included. The patients were allocated to three study groups:

Group 1: during and directly after SCIT (after completion the 2nd or 3rd year of treatment) Group 2: completed SCIT more then three years ago Group 3: Patients with clinically relevant grass pollen allergy without SCIT.

The investigators analyzed the lung function parameters, exhaled NO (eNO) and asked the patients to record symptoms during the adjacent pollen season. A blood sample was drawn to analyze the amount of TH1 and TH2 and regulatory T-cells, inflammatory markers(IL-2, IL-5, IL-10, IL-12/23, TNF-alpha, IFN-gamma) and blocking antibodies (IgG, IgG4).


Eligibility Criteria:
Inclusion Criteria:

* informed consent,
* clinically relevant grass pollen allergy,
* age \> 6 and \< 28

Exclusion Criteria:

* severe unstable asthma,
* regular ingestion of antihistamine,
* systemic steroid therapy,
* lung funtcion VC \< 70%,
* FEV1 \< 65%
Exploratory Clinical Study on Fasting in Psoriasis and Psoriatic Arthritis (RiseFast)

The RiseFast pilot study will investigate the clinical, metabolic and immunological effects of fasting and plant-based diet (PBD) on patients with psoriasis (PsO) and psoriatic arthritis (PsA) on their gut microbiota. The project will combine clinical assessments, cytometric profiling, and gut microbiota analysis to explore the relationship between fasting, a plant-based diet, and psoriatic disease. The study includes a 7-day fasting period followed by 11 weeks of PBD, with the goal of improving disease activity, quality of life, and understanding the role of gut microbiota in these conditions. This approach could lead to low-cost, accessible therapeutic options with minimal side effects.

Psoriatic disease, encompassing psoriasis (PsO) and psoriatic arthritis (PsA) is a chronic inflammatory condition influenced by genetic, immune, and environmental factors, particularly diet and gut microbiota. While biologics and DMARDs have improved disease management, treatment responses vary, and long-term remission remains difficult. Continuous inflammation control often requires pharmacological treatment, highlighting the need for adjunctive therapies.

Emerging research links gut microbiota imbalances (dysbiosis) to chronic inflammation, suggesting that dietary interventions could offer therapeutic benefits. Fasting and plant-based diets (PBD) may help regulate immune responses and gut microbiota composition. Fasting has been shown to reduce oxidative stress, promote autophagy, and alter immune cell dynamics, while PBD is associated with anti-inflammatory effects and enhanced microbial diversity.

The RiseFast Pilot Study aims to investigate whether a seven-day fasting period followed by a structured PBD can improve disease activity, quality of life, and gut microbiota in PsO and PsA patients. While prior studies suggest potential benefits, their specific effects on psoriatic disease remain unclear. By integrating clinical, microbiome, and immune profiling, the study aims to clarify dietary impacts on inflammation.

Eligibility Criteria:
Inclusion Criteria:

* Active plaque psoriasis (PASI ≥3) or Psoriatic Arthritis fulfilling the Classification Criteria for Psoriatic Arthritis (CASPAR) and not meeting MDA criteria
* on stable baseline psoriatic treatment for 12 weeks before enrollment
* ≥ 18 years old

Exclusion Criteria:

* Pregnancy or breastfeeding
* underweight (BMI ≤18,5)
* eating disorder in the last 5 years
* severe internal diseases (e.g. renal insufficiency with creatinine \> 2mg/dl)
* current practice of vegan diet or fasting within the past 6 months
* use of antibiotics within the past 3 months
SPOT Vision Screening

The purpose of this protocol is to determine if the Welch-Allyn Spot Vision Screener (SPOT) is effective at detecting various risk factors for poor vision in developmentally delayed children. These children have a higher percentage of vision disorders than the average population. The SPOT screen itself takes about six seconds to complete. It produces a photograph of the eye and a print out with amount of hyperopia, myopia, astigmatism and pupil size. The subject will have three SPOT screens around the time of their standard of care eye exam. The data obtained from the three SPOT screens will be compared among themselves for accuracy and to the findings of the clinical eye exam.


Eligibility Criteria:
Inclusion Criteria:

child over 4 months of age social, behavioral, physical, or other handicap unable to complete age-appropriate vision screening

Exclusion Criteria:

glaucoma post intraocular surgery microphthalmia other serious eye disorder inability to complete SPOT screener
Vancomycin and Fecal Microbiota Transplant in a Single Patient With Autism Spectrum Disorder

Single patient with ASD will be treated with Vancomycin followed by FMT.

A single patient with profound ASD will be treated with Vancomycin. This will be followed by fecal microbiota transplant. The patient will be followed for one year.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Autism Spectrum Disorder
2. Parent or Legally Authorized Representative willing and able to provide informed consent
3. A reliable caregiver who can report side effects and communicate effectively with the research team
4. Stable medications in the two months prior to enrollment
5. Currently receiving interventions in the community/school for ASD
6. If female and of childbearing potential, must be willing to utilize at least one highly effective method of birth control for the duration of the study. This includes condoms with spermicide, oral birth control pills, contraceptive implants, intra-uterine devices, or diaphragms. Subjects not of reproductive potential will be exempt (e.g. post-menopausal, surgically sterilized)
7. If male, and partner is of childbearing potential, must be willing to utilize at least one highly effective method of birth control for the duration of the study. This includes condoms with spermicide, oral birth control pills, contraceptive implants, intra-uterine devices, or diaphragms. Subjects not of reproductive potential will be exempt (surgically sterilized)

Exclusion Criteria:

1. Female subjects who are pregnant, nursing, or intend to become pregnant during the study period.
2. Subjects whose caregivers are unable/unwilling to cooperate with the protocol requirements.
3. Subject will be excluded who are suffering with Rett syndrome and Childhood Disintegrative Disorder.
4. Other serious co-morbid medical disorders affecting brain function and behaviour, including uncontrolled seizures.
5. Subjects unable to refrain from taking non-study antibiotics for the period of the study.
6. Subjects diagnosed with cancer, except small localized basal cell carcinoma.
7. Subjects known to abuse alcohol or drugs.
8. Subjects who have undergone gastric bypass or total colectomy, or who are scheduled for these procedures.
9. Infection with HIV.
10. Infection with Hepatitis B or C.
11. Allergy to benzodiazepine.
12. Inability to stop loperamide, diphenoxylate/atropine, or cholestyramine before the study
13. Unable to stop opiate treatment unless on a stable dose including PRN dosing, and no dose increase planned for the duration of the study
14. Known positive stool cultures for enteropathogens including, but not limited to Shigella, Salmonella, and Campylobacter within 30 days before enrollment.
15. Known stool studies positive for ova and/or parasites in 30 days prior to enrollment.
16. Planned travel outside United States during study period.
17. Hypersensitivity to vancomycin
18. Renal insufficiency
19. Colitis
Efficacy and Safety of HD-6277 in Adult Patients with Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise

A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase 2 Study to Assess the Efficacy and Safety of HD-6277 in Adult Patients With Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of T2DM with HbA1c between 7.0% and 10.0% (inclusive) while on diet and exercise alone for at least 6 weeks prior to screening.

Exclusion Criteria:

* Type 1 diabetes or another immune-mediated diabetes syndrome
Spatial Epidemiology of HIV Infection

Data will be extracted from the National Taiwan University Hospital (NTUH) medical records database, geocoded according to the street address so that the case number, incidence, etc could be mapped. The spatial data would be used to detect the aggregation of HIV cases, existence of "hot spots" and then determine if they may merit further investigation or may have occurred by chance. The results from these GIS-based analyses would address local variations in HIV prevalence and transmission.

The transmission routes of human immunodeficiency virus (HIV) are well known and many control programs focusing on risk groups and behavior have been undertaken. However, the risk factors of HIV transmission are not only at individual level (eg: demographic, behavior, and genetic risk factors), socioeconomic and environmental factors also take important roles. In Taiwan, few researches explored the spatial distribution of HIV infection. Studies in other countries observed a significant geographic variation in HIV infection. To understand the spatial pattern of HIV infection in depth, the present study aims to retrospectively investigate the epidemiological and geographic characteristics of HIV infection using the medical records database of National Taiwan University Hospital. A Geographic information system (GIS) and spatial statistics will be used to analyze the geographic patterns to determine whether spatial dispersion or clustering. There are two aims of this study. One is to investigate the epidemiology of HIV infection in Taipei City. The second is to analyze the spatial characterizes of HIV infection, including disease mapping, geographic correlation studies, and identifying the presence of HIV clusters and their potential spatial risk factors. In addition, we want to examine whether there are different distributions between different classificatory groups. Finally, we hope that our findings would give some direction for local health and policy planners to improve the HIV intervention and prevention strategies

Eligibility Criteria:
Inclusion Criteria:

* HIV/AIDS patients of NTUH

Exclusion Criteria:

* HIV/AIDS patient whose address cannot be geocoded
A Study of Paravertebral Block in Thoracic Outlet Syndrome

This research is being done to evaluate the effects of receiving only a paravertebral block prior to first rib resection procedure versus receiving the block both pre and post procedure.


Eligibility Criteria:
Inclusion Criteria:

- All Thoracic Outlet Syndrome patients scheduled for first rib resection surgery.

Exclusion Criteria:

* Patients who are pregnant.
* Patients with prior first rib resection on side of presentation.
* Patients with complex regional pain syndrome (CRPS).
* Patients with brachial plexus disorder.
* Patients with cervical rib.
Post-Marketing Surveillance (PMS) Protocol of REKOVELLE Pre-Filled Pen (Follitropin Delta)

This post-marketing surveillance study was conducted in accordance with the regulations for re-examination of domestic new drugs (Standard for Re-Examination of New Drugs: Ministry of Food and Drug Safety \[MFDS\]: Notification No. 2017-95, 21 Nov, 2017).

It was important to monitor the pattern of drug use in general practice for a long term after marketing authorization, and to investigate and identify potential new adverse events (AEs) and their onset status that were not observed during the drug development phases and any potential factors that affect safety and effectiveness of the new drug.


Eligibility Criteria:
Inclusion Criteria:

* Participants who were prescribed with REKOVELLE (follitropin delta) for the first time according to the approved administration method and dose
* Participants who have consented to personal information use

Exclusion Criteria:

* Participants who are prohibited from use according to the special warnings and precautions for use of REKOVELLE (follitropin delta)
EEG Characteristics and Postoperative Delirium

The goal of this \[type of study: observational study \] is to \[compare Energy differences in various bands of intraoperative electroencephalogram in elderly patients with postoperative delirium and non delirium.\] in \[describe participant population selected 69 patients who underwent laparoscopic radical surgery for colorectal cancer on a selective basis\]. The main question\[s\] it aims to answer are:

• \[Is there any difference in the spectral range of EEG between POD patients and non POD patients\] Participants will \[Cognitive.•Postoperative delirium.•Preoperative weakness.\]

The goal of this \[type of study: observational study \] is to \[compare Correlation between EEG data and postoperative delirium in elderly patients undergoing colorectal cancer radical surgery under preoperative frailty monitoring.\] in \[describe participant population selected 69 patients who underwent laparoscopic radical surgery for colorectal cancer on a selective basis\]. The main question\[s\] it aims to answer are:

• \[Is there any difference in the spectral range of EEG between POD patients and non POD patients\] Participants will \[Sedline EEG monitoring electrodes were placed 1cm above the eyebrows on both sides of the patient and at the temples on both sides, and were continuously monitored from the start of anesthesia in the operating room until the end of the surgery.Pay close attention to the vital signs and wait for the patient to fully recover and the vital signs to basically return to the preoperative level before returning to the ward.•Assessment of cognitive function using the Mini Mental State Scale (MMSE) 1 day before surgery and 7 days after surgery.•Preoperative assessment of frailty using the frailty screening scale.•Assess delirium using the ICU Patient Ambiguity Assessment Form (CAM-ICU) 1 day, 2 days, 3 days, and 7 days after surgery.\].

Eligibility Criteria:
Inclusion Criteria:

* ASA I-III
* The preoperative Frailty Scale (FRAIL) assessed frailty
* The patient or his/her family is informed about the study and signs an informed consent form

Exclusion Criteria:

* Serious insufficiency of heart, liver, kidney and other functions
* Those with a history of psychiatric or neurological illness, long-term use of psychotropic drug
* History of cerebrovascular disease, brain trauma, or surgery
* The patient was allergic to coupler or unable to place electrodes on the head
* The patient was unable to complete the scale assessment as required.Patients with severe attention to hearing impairment were unable to complete the interview
* The patient was diagnosed with delirium before surgery