cyrilzakka/clinical-trials huggingface dataset:
rTMS for Aneroxia Nervosa in Youth

This study will examine the feasibility of off-label multilocus repetitive transcranial magnetic stimulation (rTMS) for symptoms of Anorexia Nervosa in participants between the ages of 14-24. rTMS is a non-invasive, brain-based intervention that uses magnets to deliver energy to the brain. The investigators will also see if patients receiving multilocus rTMS show any improvements in their eating disorder, mood, anxiety, and obsessions and compulsions (if present). Participants will receive daily intervention with off-label multilocus rTMS for 20 total treatments. Participants will also be asked to complete mental health and well-being surveys, physical measurements, and 2 brain imagining scans (MRIs) at baseline, and at study end. The investigators will also ask participants to complete surveys are 1-month and 3-months after the final rTMS session. The target enrollment for this study is 45 participants.


Eligibility Criteria:
Inclusion Criteria:

1. youth aged 14-24 with DSM-5 AN-restricting (ANR) or AN-binge-eating-purging (ANBP) type as determined by the MINI-KID/MINI and clinical interview;
2. YBC-EDS score≥16,
3. baseline CGI-S score ≥4,
4. English speaking (as this complement of questionnaires are available in English)
5. on stable psychotropic medication (if any) for the preceding 4 weeks (i.e., SSRIs, atypical antipsychotics and benzodiazepines of doses \<1 mg lorazepam equivalent daily),
6. medically stable, as determined by their treating clinician, and
7. not deemed to be at high risk of imminent suicidal behavior by initial study psychiatrist assessment and referring provider/team, and no endorsement of items 4 or 5 on the Severity of Ideation Subscale of the C-SSRS.
8. For women: not currently pregnant and on reliable birth control if sexually active (as the effects of rTMS on the unborn fetus are unknown).

Exclusion Criteria:

1. a lifetime history of psychosis, mania, or seizure disorder
2. active suicidality as determined by clinical assessment by MD or PhD, and endorsement of items 4 or 5 on the Severity of Ideation Subscale of the C-SSRS.
3. unstable neurological disorder,
4. metal in head/eye,
5. inability to tolerate MRI,
6. at high risk of alcohol withdrawal or substance intoxication,
7. diagnosis of pervasive development disorder,
8. medical instability as determined by primary care provider and/or referring clinician (i.e., unstable electrolytes in the setting of worsening binge-eating/purging, cardiac arrhythmias requiring Holter or other intensive monitoring),
9. For women: pregnant or not using a reliable form of birth control.
C1-inhibitor in Allergic ASThma Patients

The purpose of this proof-of-concept study is to determine the effect of Intestinal Microbiota Depletion or Intravenous Administration of C1-inhibitor on Inflammation and Coagulation after Bronchial Instillation of House Dust Mite Allergen and Lipopolysaccharide in Allergic Asthma Patients

Intravenous administration of C1-inhibitor (n=20) or vehicle (n=20). One group of patients (n=20) will receive broad spectrum antibiotics (vancomycin, ciprofloxacin, metronidazole) for 7 days (washout 36 hours before study day). This group will receive the same vehicle as the control group 2 hours prior to challenge. HDM will be administered together with the environmental pollutant LPS in a lung subsegment via a bronchoscope (mimicking environmental exposure to HDM); a contralateral lung subsegment will be administered with saline (control side). After 7 hours, bronchoalveolar lavage (BAL) fluid will be harvested by a second bronchoscopy. Blood samples will be collected before administration of C1-inhibitor or vehicle, and before both bronchoscopies. Faeces will be collected prior to antibiotic administration as well as prior to HDM+LPS challenge.

Eligibility Criteria:
Inclusion Criteria:

* Intermittent to mild asthma according to the Global Initiative for Asthma (GINA) criteria
* Allergy for HDM documented by a positive RAST and a positive skin prick test.
* No clinically significant findings during physical examination and hematological and biochemical screening
* At spirometry FEV1 more than 70% of predicted value
* A PC20 between 0.3 - 9.6 mg/ml (corresponding with increased airway hyperreactivity)
* Able to communicate well with the investigator and to comply with the requirements of the study
* Stable asthma without the use of asthma medication 2 weeks prior to the study day. As documented by the Juniper's Asthma control questionnaire (ACQ) score \< 1,2.
* Written informed consent
* No current smoking for at least 1 year and less than 10 pack years of smoking history

Exclusion Criteria:

* Relevant comorbidity, pregnancy and/or recent surgical procedures.
* A history of smoking within the last 12 months, or regular consumption of greater than three units of alcohol per day
* Exacerbation and/ or the use of asthma medication within 2 weeks before start
* Administration of any investigational drug within 30 days of study initiation
* Donation of blood within 60 days, or loss of greater than 400 ml of blood within 12 weeks of study initiation\]
* History of venous or arterial thromboembolic disease
* History of enhanced bleeding tendency or abnormal clotting test results.
* History of serious drug-related reactions, including hypersensitivity
* Inability to maintain stable without the use of asthma medication 2 weeks before start of the study
Reinforcing CP Robotic Training With Auditory Feedback

The purpose of this study is to create a platform to prolong the adaption obtained from the cable-actuated gait training and encourage the individuals with CP to provide self-care at home.

The experiment protocol involves a maximum of ten sessions and will take two or three hours for each session. Baseline data will be collected before the first session for both overground and treadmill walking. During this session, the sound level will be adjusted based on the feedback received from the users. The researcher will ask the comfortable sound level to the participant before starting the experiment. Training will be conducted on the treadmill with the cable-actuated device for about 20 minutes. When the cables were removed, participants walked on the treadmill for 4 minutes during the post-training session. During training and post-training, participants will be exposed to feedback while walking on the treadmill. After treadmill walking, CP participants will be asked to take a ten-minute break and then practice overground walking for two minutes with auditory feedback (type A) and without it (type B). Effects of 3 different types of auditory feedback will be explored namely, rhythmic sounds, movement sonification, and sound notifying erroneous gait. Group A participants will be further divided into groups depending on the type of auditory feedback that will be provided. Participants will participate in a maximum of 10 sessions, two or three times a week. Before the first and after the last training, participants will be evaluated for functional gait assessment, 6-min-walk, leg strength using a dynamometer, and Modified Ashworth test by a physical therapist.

Eligibility Criteria:
Inclusion Criteria:

* Adults with cerebral palsy (18-65 years old)
* Ambulation of a distance of 100 feet with or without the use of assistive devices.

Exclusion Criteria:

* Severe Equinovarus foot or Genu recurvatum of the knee
* Surgery within 6 months will be excluded.
* Individuals with pregnancy
* Lower limb prosthetics
* Severe respiratory problems such as chronic obstructive pulmonary disease, heart disease, a loss of sensation, uncontrolled blood pressure,
* Seizure disorder
* Severe arthritis
Sublobar Resection Versus Lobectomy for cT1N0M0 Non-small-cell Lung Cancer

The incidence rate of ground-glass opacity (GGO) has been increasing these years. A great number of retrospective studies suggested that sublobar resection was better for some GGO patients. However, no prospective clinical study supports the perspective. This study is prospective, multi-center, randomized-controlled. The aim of this study is to investigate whether sublobar resection is inferior to lobectomy for cT1N0M0 non-small-cell lung cancer or not.


Eligibility Criteria:
Inclusion Criteria:

* cT1N0M0 non-small-cell lung cancer
* ground-glass opacity, ≤2cm, GGO≥25%
* eligible for both lobectomy and sublobar resection
* intraoperative pathology is minimally-invasive adenocarcinoma or invasive adenocarcinoma
* intraoperative pathology of biopsied station 10 lymph node is negative

Exclusion Criteria:

* intraoperative pathology is benign nodule, atypical adenomatous hyperplasia, or adenocarcinoma in-situ
* intraoperative pathology of biopsied station 10 lymph node is positive
* multiple GGOs, lesions other than dominant lesion are malignant or \>5mm
* history of thoracic surgery
* history of malignancy in recent 5 years
* unstable systemic disease
* patients with psychiatric disorders
Effects of Berberine Ursodeoxycholate (HTD1801) Versus Dapagliflozin in Patients with Type 2 Diabetes Inadequately Controlled with Metformin

The goal of this clinical study is to evaluate the efficacy and safety of berberine ursodeoxycholate (HTD1801) compared to dapagliflozin in patients with type 2 diabetes inadequately controlled with metformin alone.

This Phase 3 randomized, double-blind, active-controlled, parallel-group study will evaluate the efficacy and safety of HTD1801 compared to dapagliflozin after 24 weeks of treatment. All patients will remain on a stable dose of metformin throughout the study.

To ensure stabilization of glycemic control, eligible patients will first participate in a 4-week single-blind run-in period where investigators will provide guidance on lifestyle modification, concomitant medications, and procedures for self-monitoring of blood glucose. Following this period, patient eligibility will be reassessed. Eligible patients will then be randomized 1:1 to receive HTD1801 1000 mg BID or dapagliflozin 10 mg QD.

Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed with type 2 diabetes
* Have received a stable dose of metformin monotherapy for at least 8 weeks prior to screening
* If used any glucose-lowering drugs other than metformin within the 8 weeks prior to screening such use was ≤7 days and was discontinued at least 4 weeks prior to screening
* Have HbA1c ≥7.5% to ≤11.0% (screening) and HbA1c ≥7.0% to ≤10.5% (pre-randomization)
* Have fasting plasma glucose ≤13.9 mmol/L (screening and pre-randomization)
* Have a body mass index ≥19.0 kg/m\^2 and ≤35.0 kg/m\^2

Exclusion Criteria:

* Have type 1 diabetes
* Have had any acute diabetic complications within 12 months prior to screening
* Have had any Grade 3 hypoglycemic event within 12 months prior to screening
* Have had proliferative retinopathy or macular degeneration, severe diabetic neuropathy, or diabetic foot
* Have been taking any weight loss medication or dietary supplement, have participated in a weight loss program, or have adhered to a special diet within 12 weeks prior to screening
* Have used insulin or an insulin analogue for more than 14 days within 12 months prior to screening
* Have used any hypoglycemic drug other than metformin during the 4-week run-in period prior to randomization
* Have had weight gain or loss ≥5% during the 4-week run-in period prior to randomization
* Have a history of refractory or recurrent urinary tract infections or genital infections
Remote Hearing Aid Adjustment for Experienced Hearing Aid Users

Many hearing aid users experience substantial communication difficulties that may affect their participation in daily life situations negatively. One of the reasons for experiencing remaining problems could be due to unrealistic expectations, another reason could be that the hearing aid is not well adjusted or that the hearing aid user didn't got sufficient support and follow-up from the audiologist.

The purpose of this project is to offer remote hearing aid adjustment as an additional support for experienced hearing aid users.


Eligibility Criteria:
Inclusion Criteria:

* \>18 yr of age
* experienced hearing aid user

Exclusion Criteria:

* \<18 yr of age
* new hearing aid users
Switching From Oral Antipsychotics to Long-Acting Risperidone in Participants With Schizophrenia

The purpose of this study is to evaluate efficacy, safety and tolerance of long-acting risperidone when switching from oral antipsychotics in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

This is an open-label (all people know the identity of the intervention), multi-centric (conducted in more than one center) and non-comparative study of long-acting risperidone in participants with schizophrenia who have a previous history (in the last 12 months) of bad adherence to the oral antipsychotic treatment of first or second generation. The duration of this study will be 24 weeks and will include following visits: Screening, Baseline, Week 2, 4, 8, 12, 16, 20, 24, 38 and 50 (End visit or early withdrawal). All the eligible participants (after risperidone intolerance test during screening) will receive a dose of 25 milligram risperidone every two weeks by intramuscular injection (injection of a substance into a muscle). Efficacy and safety of the participants will primarily be evaluated by Positive and Negative Syndromes Scale and Extrapyramidal Symptom Rating Scale, respectively. Participants' safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Have schizophrenia diagnosis by Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)
* Be on treatment with oral antipsychotic of first or second generation, for a minimum time of 12 months
* Previous history of bad adhesion to oral antipsychotic treatment in the last 12 months
* Total Positive and Negative Syndrome Scale score less than or equal to 90, the conceptual disorganization, hallucinatory behavior, suspicion and not usual content of thought must be less than or equal to 4
* Be not pregnant as showed on negative pregnancy serum test

Exclusion Criteria:

* Contraindication or known hypersensitivity to risperidone
* Previous history of unsatisfactory response to risperidone
* Previous history of refractivity to the other second generation antipsychotics
* Use of antipsychotic of intramuscular deposit in the last 12 months
* Other mental disturbances of DSM-IV axis
The Performance of the SOLTIVE Laser System for Laser Lithotripsy in Kidney or Ureteral Stones

The purpose of this study is to collect real-world evidence on the performance of the SOLTIVE™ Premium SuperPulsed Laser System for laser lithotripsy in ureteroscopy, percutaneous nephrolithotomy (PCNL) and mini PCNL for kidney and ureteral stones.


Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years of age
2. Medical indication for ureteroscopy, percutaneous nephrolithotomy (PCNL) or mini PCNL
3. Willing and able to provide informed consent
4. Female and of childbearing age with a negative pregnancy test

Exclusion Criteria:

1. Contraindicated for uteroscopy, PCNL or mini PCNL as determined by the physician
2. Inability to tolerate anesthesia for any reason
3. Unable or unwilling to provide informed consent
4. Concurrently participating in another competing clinical study
5. Known ureteral stricture
6. Unwilling or unable to return for follow-up
The Effects of Neuromuscular Electrical Stimulation in Older Patients With Asthma

The aim of the randomized controlled study is to investigate the effects of NMES superimposed on voluntary contraction combined with patient education and exercise training program in patients with chronic obstructive pulmonary disease.

When initial assessments will be completed, patients will be assigned to one of two possible sequences by simple randomization: Superimposed NMES group (SG) or control group (CG).

All volunteers will receive an COPD patient education program for once and conventional physiotherapy exercise program for COPD with the duration of 8 weeks. Additionally, superimposed NMES will be applied on quadriceps muscle of both limbs at the same time with voluntarily contraction of quadriceps muscle in SG.

All patients will be assessed in terms of functional capacity, pulmonary functions, quadriceps muscle endurance and strength, dyspnea, respiratory muscle strength and quality of life at the baseline and at the end of study. Data will be collected from all the patients at baseline and at the end of study (8 weeks) by the same physiotherapist who also will supervise the exercise sessions.

Eligibility Criteria:
Inclusion Criteria:

1. Having stable asthma
2. Participating to the study in a voluntary basis
3. Being 65 - 75 years old
4. Having 2 point or over score from "Modified Medical Research Council (MMRC)" Dyspnea Scale
5. Being motivated to participate and follow exercise program

Exclusion Criteria:

1. Having an asthma exacerbation in a last month
2. Other respiratory problems
3. Ischemic heart disease
4. Congestive heart disease
5. Pacemaker
6. Acute Cor Pulmonale
7. Neurological Diseases
8. Osteoporosis
9. Smoking
FAST (Focused Abbreviated Screening Technique)-MRI Study

The purpose of this study is to compare the diagnostic value of a reconstructed abbreviated Magnetic Resonance Imaging (MRI) from a full clinical exam, compared to ultrasound (US) for screening of liver cancer. Blood markers will be evaluated to determine their correlation to imaging. This study will help to determine whether abbreviated MRI is superior to ultrasound for diagnosis of liver cancer.

Hepatocellular carcinoma (HCC) is the fastest growing cause of cancer death in the United States and now kills over 30,000 Americans annually. To reduce the morbidity and mortality caused by this aggressive cancer, current practice guidelines recommend semi-annual abdominal ultrasound in adults with cirrhosis, the leading risk factor for HCC, to detect HCC nodules when they are small and treatable. Unfortunately, US has poor sensitivity for early-stage HCC in cirrhosis, failing to detect treatable cancer in over half of affected patients. Alternatives such as computed tomography (CT) or magnetic resonance imaging (MRI) are also not ideal due to ionizing radiation (CT), higher cost (MRI), or long exam time (\~30-45 min for MRI). An optimal and fast HCC screening method is urgently needed and should be more sensitive and cost-effective than US and avoid ionizing radiation.

This is a prospective cross-sectional single arm non randomized multicenter study enrolling in 4 American centers as follows: Icahn School of Medicine at Mount Sinai-ISMMS, University of California San Diego-UCSD, University of Wisconsin-UW, and Duke University. The composite reference standard will incorporate the clinical results of the full baseline MRI exam and of subsequent imaging and pathology data collected over the next 6 months. Routine clinical follow-up imaging at 6 months will be observed. Patients will then be classified as positive for HCC, negative for HCC, or excluded.

Eligibility Criteria:
Inclusion Criteria

* Liver cirrhosis of any etiology.
* 18 years of age and older.
* Enrolled in screening/surveillance program for HCC.
* Clinically indicated imaging-based screening for HCC.
* Willing and able to complete all study procedures within specified time windows.
* Patient is able to give informed consent for this study.

Exclusion Criteria

* Contra-indications to MRI.
* Age less than 18 years.
* Patients with chronic renal failure or inability to tolerate contrast.
* Inability to undergo MRI due to lack of insurance coverage.
* Prior negative screening exam less than 5 months prior to enrollment.
* Prior hepatic resection.
* Post liver transplantation.
* Previously treated HCC or other liver neoplasm.
* Any other condition or factor that in judgment of study investigator may interfere with study completion.
Maintenance Therapy of Hypomethylating Agent (HMA) in Favorable Risk Acute Myeloid Leukemia (AML) Patients

HMA maintenance therapy is expected to benefit overall survival (OS) and relapse free survival (RFS) in AML patients with favorable risk.

Applying hypomethylating agents, azacitidine or decitabine as maintenance therapy in favorable-risk AML may prolong the remission duration and further improve their long-term survival.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged ≥16 years;
2. Patients diagnosed with AML and categorized into favorable-risk group according to European LeukemiaNet (ELN) 2022;
3. Patients achieved remission after induction therapy and finished at least 3 cycles of high-dose Aar-C based consolidation therapy, remaining in minimal residual disease (MRD) negative remission status (For NPM1-mutated and core binding factor acute myeloid leukemia (CBF-AML), MRD negative is defined as \<2%, CEBPA-mutated AML, MRD negative is defined as \<0.1%).
4. Patients not receiving hematopoietic stem cell transplantation prior to enrollment;
5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
6. Expected survival time ≥ 3 months;
7. No serious heart, lung, liver or kidney disease;
8. Have the ability to understand and be willing to sign the informed consent form for this trial.

Exclusion Criteria:

1. Patients experienced hematologic relapse before recruitment.
2. Patients who are allergic to the study drug or drugs with similar chemical structures.
3. Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception.
4. Active infection.
5. Active bleeding.
6. Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment.
7. Patients with mental disorders or other conditions whereby informed consent cannot be obtained and where the requirements of the study treatment and procedures cannot be met.
8. Liver function abnormalities (total bilirubin \> 1.5 times the upper limit of the normal range, Alanine Aminotransferase (ALT) / Aspartate Aminotransferase (AST) \> 2.5 times the upper limit of the normal range or patients with liver involvement whose ALT/AST \> 1.5 times the upper limit of the normal range), or renal anomalies (serum creatinine \> 1.5 times the upper limit of the normal value).
9. Patients with a history of clinically significant Corrected QT Interval (QTc) prolongation (male \> 450 ms; female \> 470 ms), ventricular heart tachycardia and atrial fibrillation, II-degree heart block, myocardial infarction attack within one year before enrollment, and congestive heart failure, and patients with coronary heart disease who have clinical symptoms and requiring drug treatment.
10. Surgery on the main organs within the past six weeks.
11. Drug abuse or long-term alcohol abuse that would affect the evaluation results. Patients who have received organ transplants (excepting bone marrow transplantation).
12. Patients not suitable for the study according to the investigator's assessment.