cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Relative Bioavailability of a Fixed-dose Combination Tablet of VX-121/Tezacaftor/Deutivacaftor

The purpose of this study is to evaluate the relative bioavailability of a fixed-dose combination tablet (FDC) of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA).

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility Criteria:
Key Inclusion Criteria:

* Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (Kg/m\^2), both inclusive
* A total body weight greater than (\>)50 kg

Key Exclusion Criteria:

* History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug
* Any condition possibly affecting drug absorption
* Female participants who are pregnant, nursing, or planning to become pregnant during the study or 90 days after the last dose of the study drug
* Male participants with a female partner who is pregnant, nursing, or planning to become pregnant during the study
* History of cardiovascular disease or central nervous system disease

Other protocol defined Inclusion/Exclusion criteria may apply.
Real-time Observation of Microcirculatory Hemodynamics in Gastric Intestinal Metaplasia by Confocal Laser Endomicroscopy

The morphologic change of microvessels has the clinical value to distinguish cancerous from non-cancerous mucosa. The aim of this study was to observe gastric mucosa microcirculatory hemodynamic changes real-time using pCLE, compare the differences between chronic nonatrophic gastritis and GIM; then evaluate the possible mechanisms associated with gastric mucosal blood flow in GIM.

Consecutive patients with GIM under endoscopic surveillance or examination at Qilu Hospital from March 1 to September 31, 2015 were recruited into this study. Before the endomicroscopic examination, 20,000 U α-chymotrypsin and 80 mg dimethylpolysiloxane were given orally to remove gastric mucus. All patients were given intravenous injections of 1 ml of 2% fluorescein sodium (Baiyunshan Mingxing Pharmaceutical, Guangzhou, China) as an allergy test before procedures were carried out. Conscious sedation was achieved for each patient by using propofol and fentanyl, and vital signs were monitored during the entire procedure. After successful intubation of the endoscope into the gastric antrum, 1 mL fluorescein sodium solution was applied intravenously as a contrast dye. The CLE procedure did not differ from that of conventional colonoscopy, except for the additional storage of pCLE images and videos in the gastric antrum. Finally, targeted biopsy of the examined site was performed.

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female aged 18-80 ;
2. Those fulfilling the criteria of GIM according to the study by Yuting Guo et al were included.

Exclusion Criteria:

1. patients younger than 18 years or older than 80 years;
2. finding of acute GI bleeding, gastrectomy or known upper gastrointestinal cancer;
3. unwillingness to participate in this study;
4. contraindications to CLE, such as fluorescein allergy, hepatic or renal dysfunction, jaundice, pregnancy and/or breast feeding, coagulopathy.
OT Intervention Via Telehealth for Children With ASD and ADHD

This study aims to measure the impact of a telehealth-based model of occupational therapy (OT) treatment on clinical outcomes for children with autism spectrum disorder (ASD) and/or attention deficit hyperactivity disorder (ADHD). Half of the participants will receive clinic-based, in-person services and half of the participants will receive video-based, Telehealth services.

Children with autism spectrum disorder (ASD) and/or attention deficit hyperactivity disorder (ADHD) often receive occupational therapy (OT), which traditionally takes place in a clinical setting. This setting may present barriers and distractors that make it hard for children to achieve their OT goals. Telehealth-based sessions provide an alternative, allowing the therapist to be virtually present within the home.Once enrolled, children will randomly be assigned to be in one of two groups: (1) Standard, in which children will receive clinic-based services as per standard of care OR (2) Telehealth, in which children will receive in-home services on a video-based platform on a timeline identical to what they would receive if they were in the Standard group. Children in both groups will participate for the duration of the episode of care, estimated to last 10-12 weeks. Assessments will be completed at initial evaluation, discharge, and three months following discharge.

Eligibility Criteria:
Inclusion Criteria:

* Has a Autism Spectrum Disorder and/or Attention Deficit Hyperactivity Disorder
* Has an active occupational therapy referral
* Has occupational therapy goals that are directly related to performance of activities of daily living that might reasonably be affected by the environment (as determined by an evaluating therapist)

Exclusion Criteria:

* Does not have Autism Spectrum Disorder or Attention Deficit Hyperactivity Disorder
* Does not have an active occupational therapy referral
* Does not have occupational therapy goals that are directly related to performance of activities of daily living that might reasonably be affected by the environment (as determined by an evaluating therapist)
Oxaloacetate Pharmacokinetics and Safety

By doing this study, researchers hope to learn how much oxaloacetate (OAA) ends up in the blood after OAA capsules are swallowed, and to assess whether persons with Alzheimer's disease who take OAA for one month have any side-effects.


Eligibility Criteria:
Inclusion Criteria:

* Meet criteria for Mild or Moderate AD
* Have a study partner
* Speak English as primary language.

Exclusion Criteria:

* Absence of a study partner
* Report a potentially confounding, serious medical risk such as type 1 diabetes, cancer, or a recent cardiac event (i.e. heart attack, angioplasty, etc.)
Zevalin Plus BuCyE High-dose Therapy in B-cell Non-Hodgkin's Lymphoma

In order to improve the clinical result of high-dose chemotherapy and autologous stem cell transplantation for B-cell non-Hodgkin's lymphoma, Zevalin will be added to the conditioning regimen. Investigators expect this radioimmunotherapy of Zevalin plus busulfan, cyclophosphamide and etoposide regimen will improve survival of relapsed or poor-risk B-cell non-Hodgkin's lymphoma.

Title: Combining 90Y-Ibritumomab tiuxetan (Zevalin) with high-dose chemotherapy of BuCyE and autologous stem cell transplantation in patients with relapsed, refractory, or high-risk B-cell non-Hodgkin's lymphoma - an open-labeled phase II study.

Study design: Prospective, multicenter, open-labeled, phase II trial.

Study objectives:

* Primary: event-free survival time following autologous stem cell transplantation with 90Y-Ibritumomab tiuxetan and BuCyE high-dose chemotherapy in patients with relapsed, refractory, or high-risk B-cell non-Hodgkin's lymphoma
* Secondary: overall survival response rate toxicity of the treatment combination

Treatment:

Z-BuCyE Regimen

* Day 21: rituximab, 250 mg/m2, I.V.
* Day 14: rituximab, 250 mg/m2, I.V. 90Y-Ibritumomab tiuxetan, 0.4 mCi/kg, I.V.
* Day 7, 6, 5: busulfan 3.2 mg/kg I.V.
* Day 5, 4: etoposide 200 mg/m2 I.V. every 12 hours
* Day 3, 2: Cytoxan 50 mg/kg I.V.
* Day 0: autologous stem cell infusion

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed B-cell NHL in chemotherapy-sensitive relapse, in partial response to 1st line chemotherapy, or in complete response after 1st line chemotherapy with high IPI score at diagnosis
* Age \< 65 years old
* WHO performance status (PS) of 0-2
* ANC \> 1,500/mm3, platelet \> 100,000/mm3
* Cr \< 2.0 mg% or Ccr \> 50 mL/min
* Transaminase \< 3X upper normal value
* Bilirubin \< 2 mg/dL
* Life expectancy of at least 3 months
* Written informed consent
* Optimal harvest of autologous stem cells (CD34+ cells \> 5 million/kg plus 2 million/kg for back-up)

Exclusion Criteria:

* Prior hematopoietic stem cell transplantation
* Prior RIT
* Prior external radiation to \> 25% of active bone marrow
* CNS involvement of non-Hodgkin's lymphoma
* Serious comorbid diseases
* HIV or HTLV-1 associated malignancy
* History of other malignant disease in the previous 5 years, except squamous cell or basal cell carcinoma of skin or stage I uterine cervical carcinoma or cervical carcinoma in situ
* Known hypersensitivity to murine antibodies/proteins
* Pregnant or breast feeding female patients, adults without effective contraception up to 12 months after RIT
* Persistent toxic side effects from prior therapy
* Prior biologic or immunotherapy less than 4 weeks prior to entry on this study
* Investigational drugs less than 4 weeks prior to entry on this study
Effects of Deep Regional Hyperthermia in Patients With Anal Carcinoma Treated by Standard Radiochemotherapy

Randomized study to investigate the efficacy of deep regional hyperthermia in patients with anal carcinoma treated by standard radiochemotherapy with MMC and 5-FU.

Pat. with anal carcinoma and treated with standard radiochemotherapy with Mitomycin C and 5-FU will in the experimental arm receive deep regional hyperthermia (6x).

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven anal squamous cell carcinoma (SCC) (WHO 2004), including anal canal carcinoma (UICC 2002) and anal margin carcinoma (UICC 2002)
* All stages except T1 N0 M0 after local excision (UICC 2002)
* Age ≥ 18 years
* ECOG Status 0-1
* Patients that have understand protocol and signed informed consent form
* Sufficient bone marrow function: WBC ≥ 3,0 x 10\^9/l, Platelets ≥ 100 x 10\^9/l, Hemoglobin ≥ 10 g/dl
* Sufficient liver function: Bilirubin \< 1,5 mg/dl, SGOT, SGPT, alkaline phosphatase, gGT less than 3 times upper limit of normal

Exclusion Criteria:

* Stage T1 N0 M0 after local excision (UICC 2002)
* Uncontrolled, severe cardiac dysfunction (NYHA III/IV)
* Pre-existing uncontrolled cardiac disease, signs of cardiac failure, or rhythm disturbances requiring therapy
* Myocardial infarction within the past 12 months
* Congestive heart failure
* Complete bundle branch block
* New York Heart Association (NYHA) class III or IV heart disease
* Chronic inflammatory disease of the intestine
* Active intractable or uncontrolled infection
* Chronic diarrhea ( \> NCI CTC-Grad 1)
* Acute thrombosis
* Collagen vascular disease
* Cardiac pacemaker
* HIV-infection; Patients with hepatitis A or B virus infection, with HPV infection or Patients receiving immune suppressive treatment can be included
* Devices that preclude deep regional hyperthermia (Endoprosthesis, stent in vascular system, acute thrombosis)
* Any metal implants (with exception of non-clustered marker clips)
* Conditions that preclude the application of fractionated pelvic radiotherapy
* Conditions that preclude regular follow-up
* Pregnant or breast feeding women
* Prior pelvic radiotherapy
* Prior chemotherapy
* Drug addiction
* On-treatment participation on other trials
* Prior or concurrent malignancy or leucemia (≤ 5 years prior to enrolment in study) except anal cancer or non-melanoma skin cancer or cervical carcinoma FIGO stage 0-1 if the patient is continuously disease-free
* The presence of increased radiation sensitivity, for example ataxia teleangiectatica, or similar
* Psychological, familial, sociological, or geographical condition that would preclude study compliance
Ketamine Enhances Analgesia and Mood in Chronic Pain Patients

Most chronic pain patients have mood disorders. The mood disorders may improve with better analgesia produced by Ketamine injections. A prospective study of patients undergoing interventional pain therapy using Ketamine injections. Pre-injection and post-injection patient data is collected. Pain is measured using numeric pain rating scale, and change in pain score by 2-points is considered significant. Sleep is measured using Likert sleep scale, and change in sleep score by 2-points is considered significant. Anxiety is measured using general anxiety disorder (GAD-7) scale, and change in anxiety score by 4-points is considered significant. Depression is measured using patient health questionnaire (PHQ-9), and change in depression score by 5-points is considered significant.

Chronic pain is usually associated with psychological and mood disorders. Many chronic pain patients have various forms of mood abnormalities; and these mood issues may improve with better analgesia produced by Ketamine injections.

This is a prospective observational study of consenting adult patients who are undergoing interventional pain management. The patients undergo routine interventional pain therapy using Ketamine injections. Pre-injection and post-injection patient data is collected using validated tools. Data collection includes patients' age, psychiatric diagnosis, pain score, sleep score, anxiety score and depression score.

Pain score is measured using the numeric pain rating scale, and a change in the pain score by 2-points is considered significant. Sleep score is measured using the Likert sleep scale, and a change in the sleep score by 2-points is considered significant. Anxiety is measured using the general anxiety disorder (GAD-7) scale, and a change in the anxiety score by 4-points is considered significant. Depression is measured using the patient health questionnaire (PHQ-9) scale, and a change in the depression score by 5-points is considered significant.

Data is analyzed with IBM® SPSS® Statistics 25; using Student's t-test, ANOVA, Pearson Chi-square test, and regression analysis. P-value \<0.05 is considered significant.

Eligibility Criteria:
Inclusion Criteria:

* adult chronic pain patients
* associated mood disorder
* good treatment compliance
* associated chronic insomnia
* regular ketamine pain therapy injection
* consent for clinical record quality assurance review

Exclusion Criteria:

* severe cognitive disorder
* inability to provide consent
* major neuropsychiatric disorder
* cannabis use
* stimulant use
* substance abuse
* poor treatment compliance
* lack of ketamine pain therapy injection
The Effect of Vitamin D Repletion on Kidney Stone Risk

Examine the effect of nutritional vitamin D repletion on urinary calcium excretion and kidney stone burden in calcium kidney stone formers

The investigators plan to conduct a clinic-based interventional study of 50 patients followed at Miriam Hospital Kidney Stone Clinic with history of nephrolithiasis, urinary calcium excretion between 150 and 400 mg/day, and 25-vitamin D deficiency/insufficiency (defined as serum level ≤ 30ng/ml). The intervention is oral ergocalciferol 50,000 IU per week for 12 weeks (repletion course). After that, the same repletion course will be repeated if serum 25-vitamin D remains ≤ 30ng/ml or drops to ≤ 30ng/ml anytime during the study. Otherwise, a maintenance dose of cholecalciferol 1,000 IU daily or ergocalciferol 50,000 IU monthly will be prescribed for the rest of the study. Each participant will serve as his own control. The outcome is the change in urinary calcium excretion and stone burden assessed by renal ultrasound. The planned study duration is 12 months. The investigators will have greater than 95% power to detect a 10% increase in 24-hour urinary calcium.

Eligibility Criteria:
Inclusion Criteria:

* History of nephrolithiasis
* 25(OH)D deficiency (defined as serum level ≤ 30ng/ml) within 3 months of enrollment
* 24-hour urinary calcium excretion \> 150 mg/day and \< 400 mg/day (measured less than 2 months prior to study enrollment)

Exclusion Criteria:

* Known uric acid, cystine, or struvite stone disease
* Hypercalcemia (serum calcium \>10.4 mg/dl within the past 12 months)
* Gross hematuria within the past 6 months
* Acute stone event within the past 1 month
* Recent stone intervention within the past 1 month
* Suspected or known secondary causes of hypercalciuria such as primary hyperparathyroidism, sarcoidosis, hyperthyroidism, or malignancy (except non-melanoma skin cancer)
* Addition or dose change of medicines potentially affecting urinary calcium since enrollment 24-hour urine collection (including diuretics, magnesium supplements, potassium supplements, potassium citrate, and vitamin D supplementation)
* Pregnancy
Sibling Oocyte Study of Medium for In Vitro Fertilization/Intracytoplasmic Sperm Injection (IVF/ICSI) With no Human Serum Albumine

The purpose of this study is to determine if a new medium with no human serum albumine added is as good as the media conventionally used for IVF/ICSI.

Cells attained in IVF/ICSI procedures are kept in a medium that nurture the cells. Until now all such media have contained human serum albumine. The purpose of this study is to determine if a new medium with no human serum albumine added is as good as the media conventionally used for IVF/ICSI.

Eligibility Criteria:
Inclusion Criteria:

* Couples seeking IVF/ICSI.
* Female under 38 years of age.
* No more than two previous IVF/ICSI treatments without pregnancy.
* Regular menstruation periods.
* No endocrine disease that requires treatment in the female.
* BMI below 30 in the female.
* At least 8 mature follicles upon monitoring or 6 MII oocytes upon ICSI.
* Written informed consent.

Exclusion Criteria:

* Low responders to FSH.
* Females in danger of developing OHSS.
* Sperm sample below ICSI-quality.
A Study of Safety and the Local Anesthetic Effect of AG-920 Ophthalmic Solution in a Pediatric Population

A Phase 3, randomized, active-controlled, study in pediatric subjects. It is designed to evaluate the safety and anesthetic efficacy of one dose of AG-920 ophthalmic solution compared to Proparacaine Hydrochloride Ophthalmic Solution.

A Phase 3, randomized, active-controlled, single-masked, parallel-group design study in pediatric subjects performed in the US. It is designed to evaluate the safety and anesthetic efficacy of one dose of AG-920 compared to Proparacaine. In this study, parent/legal guardians will provide informed consent (and where applicable, subjects will provide assent). Subjects who fulfill all the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to receive a single dose of AG 920 or Proparacaine into one (study) eye.

Each dose of AG-920 or Proparacaine HCl will consist of two drops in the study eye. After the completion of dosing, subjects will undergo an eye exam, and the ability to conduct that eye exam will be documented. Investigational medicinal product (IMP) dosing will be performed by the study staff.

Eligibility Criteria:
Inclusion Criteria:

1. Pre-pubescent with no childbearing potential
2. Capable of undergoing an eye exam
3. Subject's legally appointed and authorized representative willing to sign and date an informed consent form (ICF) and, where appropriate, the subject willing to sign an assent form prior to any study-related procedures being performed.
4. Parent/legal guardian and subject are willing and able to follow instructions and can be present for the required study visits and Follow-up Phone Call for the duration of the study.
5. Have a healthy, normal cornea.

Exclusion Criteria:

1. Have participated in an investigational study (drug or device) within the past 30 days.
2. Have a known contraindication to local anesthetics.
3. Children with known autism spectrum disorders or known to have heightened sensitivity.
4. Corneal pathology that would make the corneal sensitivity lower/higher or make the test hard to perform or interpret.
5. Have low visual acuity
6. Manifest nystagmus
7. Have had ocular surgery or general surgery within the past 45 days.
8. Have had an intravitreal injection in either eye within 14 days of randomization.
9. Have ocular surface disease.
A Study to Investigate the Procoagulant Effect of Tenecteplase (TNK-tPA), Alteplase (Rt-PA) and Streptokinase (SK) Administered to Patients With Acute Myocardial Infarction (AMI)

Primary objective: to evaluate the procoagulant effect of TNK-tPA compared to rt-PA and streptokinase, administered to patients with AMI, by measuring the concentration of TAT at 2 hours after the start of treatment versus baseline values.

Secondary objective: change from baseline in concentration of TAT at 6 and 24 hours; change from baseline in concentration of D-dimers, F1+2, PAI-1, PAP at 2, 6 and 24 hours. Incidence of adverse events (AE's), in -hospital complications, major or minor bleedings and serious adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Onset of symptoms of AMI within 6 hours from randomisation
* A twelve-lead electrocardiogram (ECG) showing ST-segment elevation ≥ 0.1 millivolt (mV) in two or more limb leads, or ≥ 0.2 mV in two or more contiguous precordial leads indicative of AMI, or new left bundle-branch block
* Age ≥ 18

Exclusion Criteria:

* Hypertension defined as blood pressure \> 180/110 mmHg (systolic BP \> 180 mmHg and/or diastolic BP \> 110 mmHg) on repeated measurements during current admission prior to randomisation
* Use of abciximab (ReoPro®) within the preceding 7 days or eptifibatide (Integrilin®) or tirofiban (aggrastat®) within the past 48 hours
* Use of heparin within the preceding 12 hours
* Current therapeutic oral anticoagulation
* Major surgery, biopsy of a parenchymal organ, or significant trauma within 2 months
* Any minor head trauma and any other trauma occurring after the onset of the current myocardial infarction
* Any known history of stroke or transient ischemic attack or dementia
* Any known structural damage of the central nervous system
* Ruptured aortic aneurism
* Active bleeding
* Prolonged cardiopulmonary resuscitation (\> 10 minutes) in the previous two weeks
* Pregnancy or lactation, parturition within the previous 30 days. Women of childbearing potential must have a negative pregnancy test
* Any known active participation in another investigative drug study or device protocol in the past 30 days
* Previous enrolment in this study
* Any other condition that the investigator feels would place the patient at increased risk if the investigational therapy were initiated
* Inability to follow the protocol and comply with follow-up requirements
Effect of AQW051 on Cognitive Function in Patients With Chronic Stable Schizophrenia

This PoC study is designed to assess the cognitive effects of doses of AQW051 in patients with chronic stable schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of schizophrenia
2. Symptomatically stable and currently treated with a stable regimen for at least 3 (three) months prior to dosing with one of the following second generation of antipsychotics: risperidone, paliperidone, quetiapine, ziprasidone, aripiprazole.
3. Specific cognitive impairment
4. Smokers and non-smokers

Exclusion Criteria:

1. Current treatment with an anticholinergic or other agent known to adversely interfere with the cholinergic system, and/ or treatment with cholinesterase inhibitor within the last three (3) months prior to dosing.
2. Current treatment with conventional antipsychotics (e.g fluphenazine, haloperidol) or clozapine.
3. History of neuroleptic malignant syndrome.
4. Diagnosis of substance abuse (other than nicotine) within the last month and alcohol or substance dependence (other than nicotine) within the last 6 months.
5. Any clinically significant suicidal ideation (Type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) in the last month) or previous history of suicide behavior Other protocol-defined inclusion/exclusion criteria may apply