cyrilzakka/clinical-trials huggingface dataset:
Risk Factors for Psychiatric Disorders Associated With Adolescent Idiopathic Scoliosis

The purpose of this pilot study is to determine the presence, frequency, and severity of mental health disorders amongst adolescents undergoing spinal surgery for scoliosis.

This study is a cross-sectional pilot study investigating the prevalence of psychiatric illness at various time points in the course of treatment of AIS. Three independent sets of questionnaires will be administered during a single scheduled clinical visit. There will be no clinical visits for the exclusive purpose of completing questionnaires. The first questionnaire will be the SRS outcome instrument. The second questionnaire will be the Achenbach YSR, completed by the adolescents, and the parents will be asked to complete the CBCL. Finally, a generic outcome measure specific to children and adolescents, the Pediatric Outcome Data Collection Instrument, will be administered. The time requirement to complete these questionnaires is anticipated to be approximately 45 minutes. The Achenbach questionnaires will be scored promptly after each is completed using the provided scoring templates. This data will be used to identify those at risk and make appropriate resources available. This would provide appropriate care for adolescents at high risk of mental health disorder by identifying those at risk via a non-invasive screening tool.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with AIS between the ages of eleven and sixteen, scheduled to undergo surgical intervention
* The patient and one parent will be required to complete the questionnaires in their entirety at the predetermined time points.
* There are several different methods of surgical intervention for AIS, however there will be no selection on the basis of the type of intervention.
* Curve pattern and severity will, similarly, not be used as inclusion criteria.

Exclusion Criteria:

* All types of scoliosis besides AIS will be excluded. This includes neuromuscular, congenital, infantile idiopathic, and childhood idiopathic scoliosis.
* Children younger than eleven years or older than sixteen years will be excluded.
* Those with additional chronic disease will be excluded, due to the possibility of confounding.
* Those unable to complete the entire questionnaire, for any reason, or those unable to complete the questionnaires at each time point will be excluded.
* Existence of psychiatric disorder prior to treatment will not be cause for exclusion from the study.
Pretreatment With Electroacupuncture to Reduce Discomfort

The main hypothesis is that performance of electroacupuncture before colonoscopy reduces pain during the exam.

To assess the efficacy of pre-colonoscopic electroacupuncture in reducing discomfort during colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Adult Patients referred for their first colonoscopy in the department of GI in Sheba, Tel Hashomer

Exclusion Criteria:

1. Ages \<18y \>75y
2. Any prior gastrointestinal endoscopy.
3. History of colonic resection.
4. Known or suspected stenosis of the colon.
5. Pregnancy.
6. Inflammatory bowel disease
7. Neuropsychiatric disorders or receiving psychotropic drugs.
8. Prior knowledge or experience of acupuncture.
DX-8951f in Treating Previously Untreated Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of DX-8951f in treating patients who have previously untreated stage IIIB or stage IV non-small cell lung cancer.

OBJECTIVES: I. Determine the antitumor activity of DX-8951f in previously untreated patients with stage IIIB or IV non-small cell lung cancer. II. Evaluate the quantitative and qualitative toxic effects of this regimen in these patients. III. Evaluate the pharmacokinetics of this regimen in these patients. IV. Assess the time to progression and survival status of these patients.

OUTLINE: This is a multicenter study. Patients receive DX-8951f IV over 30 minutes daily for 5 days. Treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for survival.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed unresectable, metastatic, or recurrent non-small cell lung cancer Stage IIIB or IV Measurable disease No known brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT or SGPT no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present) Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No active congestive heart failure Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No concurrent serious infection No other malignancy within past 5 years except nonmelanomatous skin cancer No overt psychosis, mental disability, or incompetence No life threatening illness

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to greater than 25% of the bone marrow No concurrent radiotherapy Surgery: No concurrent surgery Other: At least 28 days since prior investigational drugs No other concurrent investigational drugs during or within 28 days after final dose of study drug No concurrent drugs that induce or inhibit CYP3A enzyme
Intraoperative Neuromuscular Monitoring and Its Impact on Pre- and Postoperative Acoustic Outcomes in Thyroid Surgery

This study examines the impact of intraoperative recurrent laryngeal nerve monitoring signal changes on the postoperative voice quality of thyroid surgery patients. By analyzing extensive surgical data and postoperative voice recordings, the investigation seeks to identify patterns in the variations of these signals and their correlation with voice quality outcomes. The goal is to enhance clinical understanding and surgical practices, allowing for more precise assessments of nerve function, informed surgical interventions, and improved postoperative patient well-being.

This research project conducts a detailed exploration into the fluctuations of intraoperative recurrent laryngeal nerve monitoring signals during thyroid surgery and their subsequent effects on the voice quality of patients after surgery. The study meticulously analyzes a comprehensive dataset comprised of surgical records and voice analyses conducted before and after the procedure. The primary objective is to pinpoint specific trends and changes in the nerve monitoring signals and to determine how these alterations correlate with the postoperative acoustic characteristics of patients' voices. By establishing a clear link between intraoperative signal dynamics and postoperative voice outcomes, the investigation aims to advance the field of thyroid surgery. This includes providing surgeons with critical insights for the precise evaluation of recurrent laryngeal nerve functionality, enabling targeted interventions during operations, and ultimately contributing to the enhancement of patients' quality of life following surgery. Through this rigorous analysis, the study seeks to contribute valuable knowledge to the surgical community, facilitating improved patient care and outcomes in thyroid surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-60 years old.
* Planned conventional unilateral thyroid lobectomy + isthmus resection + central compartment lymph node dissection.

Exclusion Criteria:

* History of past head and neck surgeries.
* Pronunciation system defect and disorder history.
* History of vocal cord polyps or nodules.
* History of upper respiratory tract infection in the 2 weeks before surgery or postoperative infection history.
* History of neurological disorders.
* Abnormalities in the throat.
* Preoperative damage to throat morphology or motor function.
* Preoperative functional voice or language disorders, noticeable hoarseness, or difficulty in pronunciation.
* Pre- and postoperative laryngoscopic examination showing vocal cord paralysis and arytenoid joint dislocation.
* Neurological disorders causing abnormal throat function.
* Patient unable to cooperate with VHI (Voice Handicap Index) assessment and voice spectrum examination.
Study in Healthy Adult Male Participants to Gather Information How the Human Body Absorbs, Distributes and Excretes the Study Drug Selitrectinib Including the Effect of the Interaction of Food With the Study Drug on the Human Body

The researchers in this study want to gather information in healthy adult male participants about how the human body absorbs, distributes and excretes the drug selitrectinib including the effect of the interaction of food with the study drug on the human body. Selitrectinib is a new drug under development for the treatment of patients with solid tumor caused by a genetic abnormality known as an NTRK gene fusion which cannot be cured by currently available treatment options or has spread to other parts of the body. The drug blocks the action of the NTRK gene fusion and prevents the activation of certain proteins (TRK fusion proteins), which can cause cancer cells to multiply and form a tumor. Researchers also want to find out if the participants have any medical problems during this study.

Participants in this study will receive the study drug twice with at least 6 days in between. The study drug will be taken orally as a liquid before or after meal. Observation will last for up to 8 weeks, and blood samples will be taken from the participants to measure the blood levels of the study drug.

The primary objectives of this study are to investigate the pharmacokinetics and the effect of food on the pharmacokinetics of selitrectinib after a single dose of the drug.

Secondary objective is to assess the safety of selitrectinib after a single dose.

Eligibility Criteria:
Inclusion Criteria:

* Participants who are overtly healthy as determined by the investigator or medically qualified designee based on medical evaluation including medical history, laboratory tests, physical, cardiac and neurologic examination
* Body mass index (BMI): ≥18.5 and ≤ 29.9 kg/m2, with body weight ≥50 kg
* Use of adequate contraception until 3 months after last study intervention

Exclusion Criteria:

* Existing relevant diseases of vital organs (e.g. liver diseases, heart diseases), central nervous system (e.g. seizures) or other organs (e.g. diabetes mellitus).
* Medical history of risk factors for Torsades de pointes (e.g. family history of Long QT Syndrome) or other arrhythmias
* Known severe allergies, allergies requiring therapy with corticosteroids, non-allergic drug reactions, or (multiple) drug allergies (excluding untreated asymptomatic seasonal allergies such as non-severe hay fever during the time of study conduct).
* Regular use of medicines
* Regular alcohol consumption
* Smoking more than 5 cigarettes daily
* History of COVID-19 or current SARS-CoV-2 infection
Evaluating the Impact of Basic Needs Assessment and Support to Improve Colposcopy Show Rates: The BASICS Trial

This randomized controlled, single-site study hopes to determine the effectiveness of a tailored phone call reminder to improve low-income patients' adherence to colposcopy.


Eligibility Criteria:
Inclusion Criteria:

* Female

  -≥ 21 years of age
* English speaking
* Able to provide verbal consent

Exclusion Criteria:

* Male
* Incarcerated
* Unable to consent
* Does not have access to a working contact phone number
Single and Multiple Ascending Dose Study of Aducanumab (BIIB037) in Japanese Participants With Alzheimer's Disease

The primary objective of the study is to evaluate the safety and tolerability of single and multiple intravenous (IV) infusions of Aducanumab in Japanese participants with mild to moderate Alzheimer's Disease (AD). The secondary objectives of this study are as follows: To evaluate the serum pharmacokinetics (PK) of Aducanumab after single and multiple intravenous (IV) infusions of Aducanumab; To evaluate the effect of single and multiple IV infusions of Aducanumab on immunogenicity.


Eligibility Criteria:
Key Inclusion Criteria:

* Must be ambulatory
* Must have a clinical diagnosis of mild to moderate AD
* Must be in good health as determined by the Investigator, based on medical history and Screening assessments
* Must have a caregiver who, understands the study and assents to accompany the subject to all study site visits, provide information to the Investigator/study site staff, specifically about cognitive abilities and AEs/SAEs and return for per-protocol follow-up visits and procedures
* Must consent to blood sample collection for deoxyribonucleic acid (DNA; genotyping) and ribonucleic acid (RNA; for potential future analysis).

Key Exclusion Criteria:

* Any medical or neurological condition (other than AD) that in the opinion of the Investigator could be a contributing cause of the subject's dementia
* Transient ischemic attack or stroke or any unexplained loss of consciousness within 1 year prior to Screening
* Poorly controlled diabetes mellitus, as defined by having dosage adjustment of diabetic medication within the 3 months prior to Day 1
* History of unstable angina, myocardial infarction, chronic heart failure
* Chronic, uncontrolled hypertension
* History of seizure within 3 years prior to Screening
* History within the past 6 months or evidence of clinically significant psychiatric illness
* History of severe allergic or anaphylactic reactions, or history of hypersensitivity to any of the inactive ingredients in the drug product

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Anecortave Acetate Versus Placebo in AMD Patients Following PDT

The purpose of this study was to evaluate the efficacy of anecortave acetate for depot suspension (30 mg and 15 mg) plus PDT versus PDT alone with respect to maintenance of visual acuity in patients with wet AMD.


Eligibility Criteria:
Inclusion Criteria:

* AMD disease

Exclusion Criteria:

* Age
ESWT vs Cryo-US Therapy in the Treatment of Chronic Lateral Epicondylitis: One Year Follow up Study

Chronic lateral epicondylitis is usually managed conservatively. The purpose of this single-blinded, randomized, controlled study is to compare the clinical therapeutic effects of extracorporeal shock wave therapy (ESWT) in comparison with cryoultrasound (Cryo-US) therapy in chronic lateral epicondylitis (LE) during a period of 12 months.

Eighty participants with chronic LE were randomly assigned to receive 3 ESWT sessions at 48/72-hours intervals -2400 impulses at energy flux density 0.14-0.20 mJ/mm2 at each session- (ESWT Group, n=40) or 12 Cryo-US therapy sessions (4 daily sessions per week) in a continuous modality at 1.8 Watt/cm2 and -2˚C at each session- (Cryo-US Group, n=40). Visual Analogue Scale (VAS) and satisfactory results, considered as the sum of the excellent and good scores in the Roles and Maudsley score, were used as outcome measures at baseline and 3, 6, and 12 months post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* an age range from 18 to 75 years
* clinical or instrumental diagnosis of chronic lateral epicondylitis, present for at least three months
* intensity of pain of more than 5 on the Visual Analogue Scale (VAS) performing a maximum voluntary resisted isometric wrist extension with the elbow in extension (Cozen test)
* the failure of conservative treatments previously made
* a wash-out period of at least 12 weeks since the last conservative therapy carried out before inclusion in the study
* capability of filling in the questionnaires and signing the consent form

Exclusion Criteria:

* Previous treatment with Cryo-US, ultrasound therapy, ESWT
* The conjoint presence of bilateral or lateral and medial epicondylitis
* Acute infection of the soft tissues or the bones adjacent to the area of treatment
* Local bleedings or skin lesions, pathologies of the blood coagulation, or use of anticoagulant drugs
* Pacemaker, pregnancy
* Neoplastic disease
* Raynaud's disease, altered thermal and pain sensitivity, or cold intolerance
* Evidence of elbow bursitis, or articular or synovial pathologies; signs of elbow laxity or instability
* Cervicobrachialgia; syndrome of ulnar, radial, or posterior interosseous nerve entrapment
Goal Directed Fluid Therapy

Intraoperative fluid demand will be monitored by Esophageal Doppler in lean and obese patients.

To our knowledge no data are available on the effect of goal-directed fluid therapy on hemodynamics in lean patients and obese patients, respectively. Consequently, we want to compare lean patients (BMI \<25) vs. obese patients (BMI \>25) in regard of their respective needs for intraoperative fluid therapy, and the impact of the goal-directed fluid regimen on tissue oxygenation.

Eligibility Criteria:
Inclusion Criteria:

* female patients (18 - 80 years) undergoing elective gynecological open surgery (hysterectomy, ovarian cysts and tumors, myomectomy, endometriosis)

Exclusion Criteria:

* cardiac insufficiency (EF\< 35%)
* renal insufficiency (creatinin clearance \<30ml/min, dialysis)
* insulin dependant diabetes mellitus
* coagulopathy
* NYHA IV
* infection
* sepsis
* history of suspect malignant hyperthermia
* porphyria
A Low Interventional Study to Monitor Activity Using Wearable Sensors in Duchenne Muscular Dystrophy

The purpose of this low interventional study is to collect data on everyday movement in boys with Duchenne muscular dystrophy (DMD) using wearable activity sensors. The activity sensors could provide useful information beyond what is currently collected by functional (movement, strength) assessments in clinic. This information can help with the understanding of the impact of DMD, and perhaps with how possible treatments can affect this impact.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Duchenne muscular dystrophy confirmed by medical history and genetic testing
* Body weight between 15 and 50 kg
* Receipt of glucocorticoids for 6 months and a stable daily dose for at least 3 months prior to study entry
* Ability to rise from floor within seven (7) seconds and ability to walk

Exclusion Criteria:

* Current exposure to systemic immunosuppressant agents other than glucocorticoids.
* Prior exposure to any gene therapy agent, including exon-skipping and missense agents.
* Exposure to other investigational drugs within 30 days or 5 half-lives, whichever is longer.
* Any injury which may impact functional testing per investigator's judgement. Previous injuries must be fully healed prior to consenting. Prior lower limb fractures must be fully healed and at least 3 months from injury date at screening.
* Any planned surgeries which may impact physical activity and performance.
* Presence or history of musculoskeletal or neurological disease in addition to DMD.
* Any known allergies or skin reactions to stainless steel, versaflex, and silicon that may cause possible discomfort by wearable sensors.
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, cancer, autoimmune or allergic disease that may interfere with the study conduct as per investigator's judgment, excluding untreated, asymptomatic, seasonal allergies at time of screening.
* Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or participants who are Pfizer employees, including their family members, directly involved in the conduct of the study.
Acupuncture for Migraine: a Functional Magnetic Resonance Imaging (fMRI) Study

Selecting acupoints along meridians is the predominant principle in acupuncture treatment, and it is also considered to ensure acupuncture efficacy. This experiment is to investigate whether specific brain networks gradually come in formation in accordance with this kind of acupoint selection methods.

Every participants in the four intervention groups will go through functional magnetic imaging (fMRI) scan four times: the 1st scan will be performed at their baselines; the 2nd scan will be done after 2 courses (10 times) acupuncture treatment; the 3rd scan will be performed when the 4 courses end; the 4th scan will be operated after three-month enrollment.

Volunteers in waiting list group will undergo the above scans at the same time points in exception of acupuncture treatment.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of non-aura Migraine formulated by the international headache society in 2004

Exclusion Criteria:

* people with other types of headache
* people with organic cerebral disorders
* people with primary disorders
* people in moderate or severe anxiety or depression
* people in pregnancy
Efficacy of Hydrocortisone in Treatment of Severe Sepsis/Septic Shock Patients With Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)

Severe sepsis/septic shock is a serious condition associated with high mortality rate. Hydrocortisone has been recommended as a useful treatment to decrease mortality in hemodynamically unstable septic shock patients, not response to fluid and moderate dose of vasopressor. During the progression of severe sepsis/septic shock, multi-organ dysfunction can develop. Acute lung injury (ALI) and its more severe form, acute respiratory syndrome (ARDS) is one of the common organ dysfunction associated with septic shock. Information from a meta-analysis suggested that moderate dose of hydrocortisone may improve the ARDS patients' outcome. Whether hydrocortisone can effectively prevent disease progression and death in severe sepsis/septic shock patients who complicated with ALI/ARDS has not been proven.

Severe sepsis/septic shock is a serious condition associated with high mortality rate. The pathophysiology of the disease involves the complex interaction between host's immunity and the microorganisms toxin. The release of immune complex and cascade of inflammatory cytokines are responsible for multiorgan dysfunction, especially the cardiovascular system. Hydrocortisone has been recommended as a useful treatment to decrease mortality in hemodynamically unstable septic shock patients, not response to fluid and moderate dose of vasopressor. Both anti-inflammation and supplementation of relatively adrenal insufficiency are the main hypothesis of the benefit of hydrocortisone. During the progression of severe sepsis/septic shock, multi-organ dysfunction can develop. Acute lung injury (ALI) and its more severe form, acute respiratory syndrome (ARDS) is one of the common organ dysfunction associated with septic shock. Although there is controversy about timing and favorable patients'characteristic, the information from a meta-analysis suggested that moderate dose of hydrocortisone may improve the ARDS patients' outcome. Whether hydrocortisone can effectively prevent disease progression and death in severe sepsis/septic shock patients who complicated with ALI/ARDS has not been proven.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Diagnosis of severe sepsis or septic shock according to the American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference 1992
* Diagnosis of acute lung injury or acute respiratory distress syndrome according to the American-European Consensus Conference on ARDS 1994
* Onset of organ dysfunction within 12 hours before enrollment

Exclusion Criteria:

* Indicated for receive corticosteroid
* Congestive heart failure
* Contra-indication for hydrocortisone: For example: allergy to hydrocortisone
* Pregnancy
* Not agree to sign the consent form