cyrilzakka/clinical-trials huggingface dataset:
Study of Dalotuzumab Alone and With Ridaforolimus in Pediatric Participants With Advanced Solid Tumors (MK-8669-062 AM1)

This is a study of dalotuzumab given as monotherapy and in combination with ridaforolimus for pediatric participants with advanced solid tumors. This study will have three parts. Part 1 will find a maximum tolerated dose (MTD) and collect pharmacokinetic (PK) data for dalotuzumab alone. Part 2 will find an MTD and collect PK data for dalotuzumab in combination with ridaforolimus. Part 3 will be an expansion cohort at the recommended Phase 2 dose (RPTD) found in Part 2 to confirm the RPTD and look at the potential efficacy of the combination therapy.


Eligibility Criteria:
Inclusion criteria:

* Participants of age 3 to 17 years for Part 1 of the study and age 6 to 17 years for Parts 2 and 3 of the study
* Histologic or cytologic diagnosis of a malignant solid tumor, including tumors of the central nervous system and lymphoma, that have progressed despite standard therapy or for which no effective standard therapy is known.
* Measurable or non-measurable disease for Parts 1 and 2; measurable disease for Part 3
* Parts 2 and 3: must be able to swallow tablets
* Performance Status: Lansky Play Scale ≥70 for children \<10 years of age; Karnofsky score ≥70 for children ≥10 to \<16 years; or Eastern Cooperative Oncology Group (ECOG) Status 0-2 for patients age 16 and older
* Adequate organ function
* For females of reproductive potential, a negative pregnancy test must be documented within 72 hours of receiving the first dose of study medication
* Participants of reproductive potential must agree to use (or have their partner use) adequate contraception throughout the study, starting with Visit 1 through 30 days after the last dose of study drug

Exclusion criteria:

* Currently receiving any other investigational agents or using any investigational devices
* Leukemia
* Previously received dalotuzumab or other IGF-1R inhibitors for Part 1
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to dalotuzumab or ridaforolimus
* Persistent acute toxicity from previous therapy ≥Grade 2 (excluding alopecia, neuropathy, or hearing loss)
* Uncontrolled intercurrent illness despite adequate therapy
* Pregnant or breastfeeding
* For Parts 2 and 3: requirement for concurrent treatment with medications that are inducers or inhibitors of cytochrome P450 (CYP3A)
* Poorly controlled Type 1 or 2 diabetes
Improved Detection of Multiple Sclerosis Plaques in Inversion Recovery by Optimization of Sequence Parameters

This study evaluates different optimized MRI sequences for the detection of brain lesions in patients with multiple sclerosis in comparison with the recommended FLAIR sequence

MRI is a tool of choice for detecting demyelinating lesions in Multiple Sclerosis (MS) disease. On a consensual basis, the detection of those lesions in done on FLAIR (FLuid Attenuated Inversion Recovery) sequences, weighted T2 with cancelling of fluid signal, leading to a much better contrast between the lesion and the environment. The environment is displayed as a iso-signal for the surrounding healthy brain's white matter and as a hypo-signal for the fluids. Keys parameters indicative of the sequence's contrast are the echo time, the reversal time, and the repetition time, wich seems to be crucial to detect the lesions, according to relatively discordant results of publications using different technologies of FLAIR. Although 3D FLAIR sequences play an essential role for diagnosis and evaluation (evolution under treatment, prognosis) of demyelinating pathologies there is no consensus on parameters used on routine basis.

The aim of the trial is to discover the optimal combination of theses parameters so as to well detect the lesions.

Eligibility Criteria:
Inclusion Criteria:

* relapsing remitting multiple sclerosis
* MRI required

Exclusion Criteria:

* MRI contraindication
A Phase I Study of Safety and Pharmacokinetics of Nevirapine in HIV-1 Infected Pregnant Women and Neonates Born to HIV-1 Infected Mothers

To determine the bioavailability, pharmacokinetics, and short-term safety and tolerance of nevirapine in HIV-1 infected pregnant women and their newborns when nevirapine is given to the mother during active labor, and when their neonates are dosed during the first week of life. To determine the short-term safety profile of mothers receiving zidovudine (AZT) who received nevirapine during active labor, and their neonates who received no dose, a single dose, or multiple doses of nevirapine and who are receiving AZT during the first 6 weeks of life.

Treatment of HIV-1 infected pregnant women during active labor may result in therapeutic levels of nevirapine in the neonate at the time of exposure to HIV-1 during parturition, decreasing the neonate's risk of infection.

Treatment of HIV-1 infected pregnant women during active labor may result in therapeutic levels of nevirapine in the neonate at the time of exposure to HIV-1 during parturition, decreasing the neonate's risk of infection.

Pregnant women in active labor receive single doses of oral nevirapine. The neonates of the first 4-6 (PER AMENDMENT 8/27/96, was 4) mothers receive no drug, while the neonates of the second 4-6 (PER AMENDMENT 8/27/96, was 4) patient cohort receive a single dose of nevirapine. If neonatal antiviral levels of nevirapine are not sustained for 7 days after the single dose, a third cohort of 4-6 (PER AMENDMENT 8/27/96, was 4) pregnant women will receive a single dose of nevirapine and their neonates will receive multiple doses of nevirapine to maintain an antiviral effect for 7 days.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* AZT (mothers and neonates).
* Oral asthma inhalers (mothers).

Concurrent Treatment:

Allowed:

* Phototherapy (neonates).

MOTHERS must have:

* HIV infection.
* Estimated gestational age \>= 34 weeks.
* No active opportunistic infection at study entry.

PER AMENDMENT 8/27/96:

* A pre-enrollment plasma HIV-1 RNA level greater than 10,000 copies/ml.

Exclusion Criteria

Co-existing Condition:

MOTHERS with the following symptoms or conditions are excluded:

* Intrauterine growth retardation.
* Fetal anomaly incompatible with life as determined by pre-entry ultrasound.
* Participation during current pregnancy in any other therapeutic or vaccine perinatal trial.
* Known hypersensitivity to any benzodiazepine.
* Serious bacterial infection.

Concurrent Medication:

Excluded:

* Any antiretroviral other than AZT.
* Corticosteroids (other than oral asthma inhalers).
* Anticoagulants.
* Any clavulanic acid-containing formulation (e.g., Augmentin, Timentin).
* Benzodiazepines other than study drug.
* Phenobarbital.
* Barbiturates.
* Antacids.
* Magnesium sulfate.

Prior Medication:

Excluded:

* Prior nevirapine.

Current use of illicit substances and/or active chronic alcohol use.
Microalgae as an Alternative Protein Source in Human Nutrition.

Protein is an essential part of the human diet. But with a growing global population and climate emergency, current sources of dietary protein are unable to continue to sustainably meet the global demand. To ensure future food security, new sustainable protein sources are required. Microalgae - a group of plant-like single cells - are thought to be a good option due to their sustainable farming methods and naturally high protein content. Long term health benefits of eating microalgae have been seen in humans. However, the time directly following microalgae ingestion has not been well studied but is an important period when considering a protein source. This research will compare the period after ingestion of three preparations and/or types of microalgae to a traditional source of protein.


Eligibility Criteria:
Inclusion Criteria:

* BMI 18.5 -30 kg/m2
* age 18 - 40 years
* healthy
* non-smoker

Exclusion Criteria:

* BMI \<18.5 or \>30 kg/m2
* smoker
* metabolic disease
* relevant food intolerance
* using medications known to affect metabolism
Arthroscopic Rotator Cuff Repair With Platelet-Rich Plasma (PRP) in Medium to Large Rotator Cuff Tears

* The purpose of this study is to compare the clinical and anatomical outcomes of rotator cuff repair with Platelet-Rich Plasma (PRP) and conventional rotator cuff repair in treatment of medium to large rotator cuff tears.
* PRP application to arthroscopic rotator cuff repair would accelerate recovery after arthroscopic rotator cuff repair in terms of pain relief, functional outcomes, overall satisfaction, and enhance structural integrity of repaired tendon.


Eligibility Criteria:
Inclusion Criteria:

medium to large rotator cuff tear as a determined by clinical examination and MR prior to surgery.

Exclusion Criteria:

* previous history of shoulder surgery
* acute trauma
* chronic dislocation
* pyogenic infection
* rotator cuff arthropathy with glenohumeral osteoarthritis and superior migration of the humeral head
* showed abnormal serological test results
* thrombocytopenia (platelets less than 15000 per microliter)
* had been received anti-platelet medication
* psychiatric problems that precludes informed consent or inability to read or write
* other serious problems that preclude participation of the study
The Effect of Oxytocin on Placebo Analgesia: an Experimental Study in Healthy Volunteers

Placebo responses contribute to medical treatment outcome. The purpose of this study is to determine whether a single intranasal application of oxytocin can increase the placebo response in an experimental model of placebo analgesia in healthy volunteers.

Placebo responses contribute to medical treatment outcome. The purpose of this study is to determine whether a single intranasal application of oxytocin can increase the placebo response in an experimental model of placebo analgesia in healthy volunteers.

The rationale to study the effects of oxytocin on placebo analgesia is based on previous studies showing that oxytocin fosters processes such as empathy, trust and social learning, which are key elements of the patient-physician relationship that is pivotal to placebo responses. In this experimental mechanisms study we used oxytocin as a tool to modulate these factors.

Placebo analgesia is induced verbal instruction. Therefore two identically looking placebo ointments were applied to two sites of the participants' volar forearm. The ointments were introduced as a local anesthetic that could reduce or even abolish pain (placebo) and a control cream (control), respectively.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers, male and female
* being German-speaking
* Agreeing to participate, verified by completion of informed consent

Exclusion Criteria:

* acute or chronic pain condition
* use of any concomitant medication except contraceptives
* currently pregnant (verified by urine pregnancy test) or lactating
* major mental disorder
* Inability to comply with the study procedures
* abnormal pain sensitivity as indicated by pain threshold
* alcohol intake within last 24 hours
Managed Access Programs for LEE011, Ribociclib

The purpose of this registration is to list Managed Access Programs (MAPs) related to LEE011, Ribociclib

CLEE011A2408 - No longer available - Managed Access Program (MAP) Cohort to provide access to ribociclib (LEE011, Kisqali®), for locally advanced or metastatic cancer resistant or refractory to available treatment options and candidate for therapy with a CDK inhibitor (including tumors with D-cyclin-CDK4/6-INK4a-Rb pathway abnormalities)

CLEE011A2006M - Available - Managed Access Program (MAP) Cohort to provide access to Ribociclib for patients diagnosed with early-stage HR+HER2 (stages II and III) - breast cancer requiring adjuvant treatment with an ET based regimen

Eligibility Criteria:
Inclusion Criteria:

1. An independent request was received from a licensed physician.
2. The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment.
3. The patient is not eligible or able to enroll in a clinical trial or continue participation in such trial.
4. There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated.
5. The patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable).
6. Provision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program.
7. Managed Access provision is allowed per local laws/regulations.
Marginal Integrity and Clinical Evaluation of Polyetheretherketone (PEEK) Versus Lithium Disilicate (E-max) Endocrowns.

Patients need Endocrowns for their teeth usually use Emax as an etchable ceramic. Yet they have disadvantages that may influence the outcome of the endocrowns, among which is the high stiffness and rigidity owing to the higher modulus of elasticity (67.2 GPa)( compared to natural dentin (18.6 GPa) which may affect the marginal adaptation.so a less rigid material is needed. PEEKs (polyetheretherketones) are presented as alternative materials to metal and glass ceramics, Their elastic modulus comparable to those of cortical bone and dentin so the polymer could exhibit good stress distribution. Also they have high fracture resistance, and low abrasion to the antagonist enamel.

.but the investigators have to know clinically it is performance , so the investigators are going to have Parallel groups in a randomized clinical trial.


Eligibility Criteria:
Inclusion Criteria:

All subjects are required to be:

* From 18-60 years old, and able to read and sign the informed consent document.
* Physically and psychologically able to tolerate conventional restorative procedures
* Have no active periodontal or pulpal diseases.
* Willing to return for follow-up examinations and evaluation

Exclusion Criteria:

* Patients in the growth stage with partially erupted teeth
* Patient with fractured teeth of more than 50% enamel loss
* Patients with poor oral hygiene and motivation
* Pregnant women
* Psychiatric problems or unrealistic expectations
* Lack of opposite occluding dentition in the area intended for restoration
Rehab CARES In USA: Clinical Trial

In Phase 2, Patients in a community-based setting who have had a stroke will be evaluated by rehabilitation professionals and asked to perform a battery of clinical assessments before and after standard of care and robot assisted therapy with Rehab CARES system of simple force-feedback robots that are adapted to deliver single and group therapy.

In Phase 2, we will develop the hardware to allow three haptic robots to dock (a gym) and be configured to allow patients to play therapy games alone or collaboratively. We will test the safety and feasibility of the gym in a community-based rehabilitation setting. We will treat 36 patients randomized to either a control group getting standard of care therapy and a robot group receiving standard of care with upper limb therapy being given using the robot gym instead of an occupational therapist. Therapy will occur over 4 weeks with two follow-up assessments. Key milestones will be to show that the robot group has the same or better functional outcomes, motivation, and adverse events as the control group. Also to show that the robot gym is a cost-effective solution to increasing access to quality rehabilitation care in low-resource, community-based settings. Success here will validate this potential solution, justify design changes revealed via user-feedback and a larger clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Age 55 and older (based on who is admitted to the CBR site)
* \>3 months post-stroke
* Stroke diagnosis
* Diagnosis of hemiparesis as a result of stroke (verified by radiology data)
* Motor control score on Upper Extremity Fugl-Meyer scale \> 15 and \< 60;
* Able to understand and speak
* Upper arm manual muscle strength scores \>1
* Pain Scores \< 8 based on NIH Pain Intensity Scale

Exclusion Criteria:

* no cerebellum lesions due to stroke
* severe cognitive function
SCREEN-HFI (SCReening Evaluation of the Evolution of New Heart Failure Intervention Study)

Individuals who were a part of the investigators Screen-HF study (NCT00400257) whose BNP level are in the top quintile will be offered participation in this study. Participants will be randomised to receive either spironolactone or placebo for three years. Participants will then be monitored for indications of heart failure. It is anticipated that the medication will reduce the development of heart failure in this group.


Eligibility Criteria:
Inclusion Criteria:

1. Was recruited to SCREEN-HF
2. Has provided informed consent

Exclusion Criteria:

1. Uncorrected hyperkalaemia
2. eGFR \< 30 ml/min
Implementing and Sustaining a Transdiagnostic Sleep and Circadian Treatment

The goal is to collect pilot data on an adapted version of the Transdiagnostic Sleep and Circadian intervention (TranS-C), referred to as 'Fitted TranS-C'.

Mental illness is often severe, chronic and difficult to treat. The sleep disturbance commonly experienced by individuals with a severe mental illness reduces capacity to function and contributes to key symptoms. This study seeks to collect pilot data on an adapted version of the Transdiagnostic Sleep and Circadian intervention (TranS-C). The adapted version will be referred to as 'Fitted TranS-C' as it is designed to improve the fit to delivery within community mental health centers. 'Fitted' treatments are needed because the context for implementation (community setting) typically differs from the original testing context (university setting) causing a lack of 'fit' between the setting and evidence based treatments.

Eligibility Criteria:
Inclusion Criteria:

* Can understand treatment in English
* Is not currently at risk for suicide or homicide
* Has not worked the night shift more than 2 nights per week in the past 3 months
* Is not pregnant or nursing
* Has a guaranteed bed to sleep in for the next month, which is not a shelter.

Exclusion Criteria:

* At risk for suicide or homicide
* Has worked the night shift more than 2 nights per week in the past 3 months
* Is pregnant or nursing
* Does not have a guaranteed bed to sleep in for the next month
The Comparison of Single Incision Laparoscopic Appendectomy and Three Port Laparoscopic Appendectomy

Laparoscopic techniques have allowed surgeons to perform complicated intrabdominal surgery with minimal trauma. In numerous studies, when conventional laparoscopic appendectomy using 3 ports is compared with open appendectomy, it has advantages of reduced pain, reduced hospital stay, and enhanced cosmetic effects. Single incision laparoscopic surgery (SILS) was developed with the aim of reducing the invasiveness of conventional laparoscopy. In this study the investigators aimed to compare results of SILS appendectomy and three port conventional laparoscopic appendectomy prospectively.

Total of 50 patients who undergoing laparoscopic appendectomy for acute appendicitis will randomly assign to undergo SILS appendectomy group (n = 25) or Three port laparoscopic appendectomy group (n= 25) according to a computer-generated table of random numbers. Demographics (ie, age, gender, body mass index (BMI), American Society of Anesthesiology (ASA) score, need for conversion to a standard or three port laparoscopic appendectomy, need for conversion to an open appendectomy will be recorded. Outcome measures include operative morbidity, operative time, pain score, hospital stay. Morbidity will be evaluated by rates of colonic leak, wound infection, intrabdominal abscess hospital readmission, and hernia.

Eligibility Criteria:
Inclusion Criteria:

* Required laparoscopic cholecystectomy for gallbladder disease.

Exclusion Criteria:

* American Society of Anesthesiologists score (ASA) more than III,
* Patients had prior abdominal surgery,
* Pregnancy,
* Ongoing peritoneal dialysis,
* Lack of written informed consent.
Study of Daclatasvir (BMS-790052) and Simeprevir (TMC435) in Patients With Genotype 1 Chronic Hepatitis C Virus

The purpose of this study is to assess the safety and efficacy of daclatasvir and simeprevir with and without ribavirin for genotype 1 chronic hepatitis C virus infection in patients who are treatment-naive or null responders to previous pegylated interferon/ribavirin therapy.


Eligibility Criteria:
Key Inclusion Criteria:

* Hepatitis C virus (HCV) genotype 1a or 1b
* Males and females, ≥18 years of age
* HCV RNA ≥10,000 IU/mL
* Participants with compensated cirrhosis are permitted

  * Advanced fibrosis (F3/F4) is capped at approximately 35% of the total treated population with a minimum of 20% F4 patients
  * If no cirrhosis, a liver biopsy within 3 years prior to enrollment
  * If cirrhosis is present, any prior liver biopsy

Key Exclusion Criteria:

* Liver or any other transplant (other than cornea and hair)
* Evidence of a medical condition contributing to chronic liver disease other than HCV infection
* Current or known history of cancer, (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment
* Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
* Patients infected with HIV or hepatitis B virus
* Gastrointestinal disease impacting absorption of study drug
* Uncontrolled diabetes or hypertension
* Prior exposure to an HCV direct-acting agent
* Any criteria that would exclude the patient from receiving ribavirin
* Absolute neutrophil count \<1.5\*1,000,000,000 cells/L (\<1.2\*1,000,000,000 cells/L for Black/African Americans)
* Platelets \<90\*1,000,000,000 cells/L
* Hemoglobin \<12 g/dL for females, \<13 g/dL for males
* Alanine aminotransferase ≥5\*upper limit of normal
* In patients without cirrhosis, total bilirubin ≥2 mg/dL unless patient has a documented history of Gilbert's disease
* In patients with cirrhosis, total bilirubin o ≥1.5 mg/dL
* International normalized ratio ≥1.7
* QTcF or QTcB \>500 mSec
* Creatinine clearance ≤50 mL/min
* Alpha fetoprotein (AFP) \>100 ng/mL OR
* AFP ≥50 ng/mL and ≤100 ng/mL requiring liver ultrasound
* Albumin \<3.5 g/dL