cyrilzakka/clinical-trials huggingface dataset:
Induction Chemotherapy and Toripalimab Followed by Radiotherapy in Unresectable Laryngeal/Hypopharyngeal Carcinoma

The aim of this study is to define whether combination of induction chemotherapy and PD-1 inhibitor (Toripalimab) followed by radiotherapy improve progression-free survival, for patients with unresectable laryngeal/hypopharyngeal carcinoma.

Historically, induction chemotherapy has been shown to increase laryngeal-preservation rate, improve disease-free survival and reduce the risk of distant metastasis. However, the prognosis of locally advanced laryngeal/ hypopharyngeal carcinoma remains poor. Recently, phase I-II clinical studies demonstrated excellent pathological response of induction PD-1 inhibitor with/without chemotherapy for locally advanced head and neck cancer. The aim of this study is to define whether combination of induction chemotherapy and PD-1 inhibitor (Toripalimab) followed by radiotherapy improve progression-free survival, for patients with unresectable laryngeal/hypopharyngeal carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed, unresectable locally advanced laryngeal/hypopharyngeal squamous cell carcinoma due to extensively local invasion or medical comorbidities (T3-4b, N0-N3, M0);
* Age between 18-75 years;
* Signed inform consent;
* Had at least one measurable lesion according to RECIST 1.1 criteria
* Anticipated overall survival more than 3 months;
* Satisfactory performance status: ECOG (Eastern Cooperative Oncology Group) scale 0-1;
* Normal organ function and bone marrow function;
* HBV DNA\<500 IU/mL（or 2500 copies/mL）and HCV RNA negative ;
* Male and no pregnant female, able to adapt birth control methods during treatment.

Exclusion Criteria:

* Hypersensitivity to Toripalimab, Paclitaxel or Cisplatin;
* Suffered from malignant tumors, except cervical carcinoma in situ, papillary thyroid carcinoma, or skin cancer (non- melanoma) within five years;
* Severe, uncontrolled heart disease;
* Receive vaccine or live vaccine within 28 days prior to signing the informed consent;
* Equivalent dose more than prednisone 10mg/d or other immunosuppressive treatments within 28 days prior to signing the informed consent;
* Surgery or trauma within 28 days prior to signing the informed consent;
* Received other immune checkpoint inhibitors previously;
* Severe, uncontrolled infections within 28 days of prior to signing the informed consent;
* Active, known or suspected autoimmune disease; Type I Diabetes, hypothyroidism those only need hormone replacement therapy, vitiligo or inactive asthma who don't need systemic therapy can recruit;
* History of interstitial lung disease;
* HIV positive;
* Hepatitis B surface antigen (HBsAg) positive and HBV-DNA ≥500IU/ml, or 2500cps/ml; Positive HCV RNA;
* Other diseases which may influence the safety or compliance of the clinical trial, such as mental illness, or their family and society factors;
* Women of child-bearing potential who are pregnant or breastfeeding.
A Study of VAC85135, a Neoantigen Vaccine Regimen, Concurrently Administered With Ipilimumab for the Treatment of Myeloproliferative Neoplasms

The purpose of this study is to evaluate the safety of VAC85135 administered with ipilimumab for the treatment of myeloproliferative neoplasms (MPNs).


Eligibility Criteria:
Inclusion Criteria:

* Be positive for a CALR (calreticulin) mutation: Type 1 or Type 2; Type 1-like, or Type 2-like may be considered with Sponsor approval; or positive for the JAK2V617F (Janus kinase 2 with valine 617 to phenylalanine mutation) mutation with HLA-A02:01 (human leukocyte antigens) per medical history or local testing
* Have an Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 or 2
* Have the following hematologic laboratory values: Leukocytes greater than or equal to (\>=) 1.5\*10\^9 per liter, Neutrophils \>=1.0\*10\^9 per liter, Platelets \>=20\*10\^9 per liter, Hemoglobin greater than (\>) 7 gram per deciliter (g/dL)
* Have the following chemistry laboratory values: Alanine aminotransferase (ALT): less than or equal to (\<=) 3\*upper limit of normal (ULN), Aspartate aminotransferase (AST): \<=3\*ULN, Total bilirubin: \<=1.5\*ULN, and glomerular filtration rate \>=40 milliliter per minute (mL/min)
* A female participant of childbearing potential must agree to all the following during the study and for 6 months after the last dose of study treatment: use a barrier method of contraception, use a highly effective preferably user-independent method of contraception, not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction, not plan to become pregnant, not to breast-feed
* A male participant must agree to all the following during the study and for 90 days after the last dose of study treatment: wear a condom when engaging in any activity that allows for passage of ejaculate to another person, not to father a child, not to donate sperm or freeze for future use for the purpose of reproduction

Exclusion Criteria:

* History of any significant medical condition per investigators judgment (example: severe asthma/chronic obstructive pulmonary disease (COPD), poorly regulated heart condition, insulin dependent diabetes mellitus)
* Serious known clinically relevant allergies or earlier anaphylactic reactions
* Currently pregnant or breastfeeding
* Prior treatment with any Janus kinase 1/2 (JAK1/2) inhibitor
* Known sensitivity or contraindications to the use of Ipilimumab per local prescribing information
Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in PIONEER

This is a multicenter open-label study of the administration of mavacamten in participants with symptomatic obstructive HCM (oHCM) who previously participated in study MYK-461-004 (PIONEER-HCM).


Eligibility Criteria:
Key Inclusion Criteria:

* Completed Study MYK-461-004. Prior participation in a non-interventional observational study is allowed.
* Body weight \> 45 kg at Screening
* Has safety laboratory parameters (chemistry and hematology) within normal limits

Key Exclusion Criteria:

* Has QTcF \> \> 500 ms or any other ECG abnormality considered by the investigator to pose a risk to subject safety (eg, second degree atrioventricular block type II)
* Since enrollment into Study MYK-461-004, has developed obstructive coronary artery disease (\> 70% stenosis in one or more arteries) or known moderate or severe aortic valve stenosis
* Since enrollment into Study MYK-461-004, has developed any acute or serious comorbid condition (eg, major infection or hematologic, renal, metabolic, gastrointestinal, or endocrine dysfunction) that, in the opinion of the investigator or medical monitor, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion
* Since enrollment into Study MYK-461-004 has developed clinically significant malignant disease
Study of Bimatoprost Solution in Increasing Eyelash Prominence in African Americans With Eyelash Hypotrichosis

This study will evaluate the safety and efficacy of bimatoprost solution 0.03% once daily to the upper eyelid margins (where the eyelashes meet the skin) compared with vehicle in increasing overall eyelash prominence in self-identified African American/ethnic black subjects exhibiting hypotrichosis of the eyelashes (inadequate or not enough eyelashes).


Eligibility Criteria:
Inclusion Criteria:

* African American/ethnic black
* Adults at least 18 years of age
* Eyelash prominence assessment of minimal or moderate

Exclusion Criteria:

* Subjects with uneven lashes or longer on one side than the other
* Any eye disease or abnormality
* Eye surgery
* Severe hyperpigmentation around the eye
* Eyelash implants
* Eyelash extension application
* Any use of eyelash growth products within 6 months
* Any use of prescription eyelash growth products
* Treatments that may affect hair growth
* Requiring eye drop medications for glaucoma
Feasibility and Safety of Ultrasound Guided Installation Central Subclavian Catheter Through Supraclavicular Way

Our goal is to demonstrate the feasibility of laying uncomplicated ultrasound-guided central subclavian catheter by supraclavicular route in the newborn.


Eligibility Criteria:
Inclusion Criteria:

* Patient hospitalized in the neonatal intensive care or neonatal intensive care at the University Hospital of Hautepierre
* All infants less than 44 weeks corrected age who require a surgical approach
* In the first line if neonate over 34 weeks corrected age requiring dual carriageway catheter
* After Failure or inability laying KTEC for children between 30 and 34 weeks of age corrected and heavy over 1000

Exclusion Criteria:

* Nouveau-né de poids \< 1000g
* Nouveau-né de moins de 30 semaines d'âge corrigé
* Choix d'une autre voie d'abord plus judicieux (KTVO, KTC broviac)
* Sortie avant retrait du KTC
The Effect of LDL557 on Improving Degenerative Arthritis in the Elderly

This project is to conduct a clinical trial of SYNBIO TECH INC.'s LDL557 capsule for joint protection. To understand the improvement of joint discomfort and inflammation after supplementation, we hope to provide an updated choice for modern people's joint protection.


Eligibility Criteria:
Inclusion Criteria:

* BMI 18-40 kg/m2;
* Those with early stage degenerative arthritis symptoms judged by X-ray to be Kellgren-Lawrence Grading Scale level 1 or 2, and the physician determines that long-term treatment is not needed or WOMAC score\>2.0 or WOMAC total scale score\>12 or VAS score ≦3.

Exclusion Criteria:

* Smoking
* alcoholism
* diabetes
* breastfeeding women and pregnant women.
* Those consuming dietary supplements were excluded.
* Those who use non-steroidal anti-inflammatory analgesics and those who have had joint surgery.
* Rheumatoid arthritis.
* Those who have had joint injections within 6 months.
* Those with cardiovascular and cerebrovascular, rheumatoid or mental diseases.
* Patients undergoing cancer treatment.
Effect of High Altitude Exposure, Acclimatization and Re-exposure on Lung Water Content by Ultrasound

Prospective interventional trial in lowlanders evaluating effect of acute exposure, acclimatization and re-exposure to high altitude.

Low altitude baseline measurements will be performed in Santiago de Chile, 520 m, over the course of 3 days. Participants will then travel by commercial airline (5 h flight) and by bus (3 h ride) to the Atacama large Millimeter Array (ALMA) base camp located at 2900 m near San Pedro de Atacama, northern Chile. Participants will stay there for the next 7 nights and they will be spend the days (6-8 h daily) at the telescope station at 5050 m while undergoing physiological testing. Daily transports from 2900 to 5050 m will be by car (1 h ride, one way). After the first 7 day altitude sojourn participants will return to the Santiago area (520 m) for a 7 day recovery period.

A second altitude sojourn cycle with an identical schedule as the one described above and a final low altitude stay of 3 days will follow.

Measurements on study subjects will be performed at baseline (lowland, Santiago de Chile), then at 2nd day of altitude exposure and 7th day at altitude before returning to lowland; those are repeated in the second altitude sojourn cycle. Measurements will be conducted by qualified specialists using a portable ultrasound device.

Eligibility Criteria:
Inclusion Criteria:

* Born, raised and currently living \<800m
* No overnight stay at altitudes \> 1500m 4 weeks before the study

Exclusion Criteria:

* Previous altitude intolerance to altitude \<3000m
* Pregnancy
* Health impairment, which requires regular treatment
A Study to Examine the Effects of Exenatide Once-Weekly Injection on Glucose Control and Safety in Asian Subjects

Previous studies have suggested that a once-weekly formulation of exenatide may provide sustained glycemic control. These previous studies of exenatide once weekly have been conducted in non-Asian populations, so this study has been developed to support the local regulatory requirements of China, Korea, Japan, India, and Taiwan.


Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed with type 2 diabetes.
* Have suboptimal glycemic control as evidenced by an HbA1c between 7.1% and 11.0% inclusive.
* Have a body mass index (BMI) of \>21 kg/m2 and \<35 kg/m2, inclusive.
* Have a history of stable body weight (not varying by \>5% for at least 90 days prior to study start).
* Have been treated with a stable dose regimen of Met, SU, TZD, Met plus SU, Met plus TZD, or SU plus TZD for at least 90 days prior to study start.

Exclusion Criteria:

* Have any contraindication for the OAD(s) that they use.
* Have a known allergy or hypersensitivity to exenatide BID, exenatide QW, or excipients contained in these agents.
* Have received chronic \>14 consecutive days) systemic glucocorticoid therapy by oral, intravenous (IV), or intramuscular (IM) route or intra-articular steroid injection within 4 weeks prior to study start or are regularly treated with potent, inhaled steroids that are known to have a high rate of systemic absorption.
* Have been treated with drugs that promote weight loss (for example, GLP-1 analogue, orlistat, sibutramine, phenylpropanolamine, or similar over-the-counter medications) within 90 days of study start.
* Have been treated for \>2 weeks with any of the following excluded medications within 90 days prior to study start:

  * Insulin
  * Dipeptidyl peptidase (DPP)-4 inhibitors (for example, sitagliptin or vildagliptin)
  * Pramlintide acetate
  * Drugs that directly affect gastrointestinal motility, including, but not limited to: Reglan® (metoclopramide), Propulsid® (cisapride), and chronic macrolide antibiotics.
* Have had prior exposure to exenatide
* Have previously completed or withdrawn from this study or any other study investigating exenatide BID or QW.
* Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
* Are currently enrolled in any other clinical study.
Achalasia and Dysplasia

Patient with achalasia have a 10-50 fold increased risk to develop esophageal squamous cell carcinoma (ESCC). Early diagnosis of ESCC is essential, and detection of an earlier dysplastic stage is preferred. Endoscopic detection is however difficult and often delayed. Chromoendoscopy with Lugol dye increases detection rates dysplasia and ESCC to 91-100%. The aim of this study was therefore to evaluate a screening program using chromoendoscopy with Lugol to detect dysplasia in patients with idiopathic achalasia.

A second objective is to study the relationship between foodstasis and the development op dysplasia


Eligibility Criteria:
Inclusion Criteria:

* longstanding achalasia (\> 15y)
* \> 18y old
* informed consent

Exclusion Criteria:

* allergy to iodine
* esophageal carcinoma
Synaptic Injury and Functional Connectivity in Alzheimer's Disease

The purpose of this study is to examine cross-sectional associations between CSF markers of synaptic injury (Ng and SNAP-25) and functional connectivity in default and semantic memory networks using 3T- fMRI in individuals with MCI (i.e. the earliest clinically detectable stage of cognitive impairment) due to AD or mild AD dementia (CDR 0.5-1; n=20) and cognitively normal controls (CDR 0; n=20).

SPECIFIC AIMS:

Aim 1: Investigate correlations between CSF biomarkers of synaptic injury (Ng and SNAP-25) and functional connectivity (FC) within the default mode network (DMN) using resting-state fMRI (adjusting for age, gender, apolipoprotein-E4 \[APOE4\] genotype, task performance, and regional brain atrophy) in MCI/AD and controls.

Aim 2: Examine correlations between CSF biomarkers of synaptic injury and functional connectivity (FC) within the semantic memory network on task-activated fMRI using the Famous Name Discrimination Task (FNDT) (adjusting for age, gender, APOE4 genotype, task performance, and regional brain atrophy) in MCI/AD and controls.

Eligibility Criteria:
Inclusion Criteria: Participants included in the study should meet all 4 inclusion criteria:

1. 60 years of age or older
2. A clinical diagnosis of MCI, mild AD dementia, or normal cognition
3. No significant medical or surgical co-morbidities
4. No contraindications to LP or MRI.

Exclusion criteria: Participants with any of the following criteria will be excluded from the study:

1. Participants with MCI due to AD or mild AD dementia who have been treated with cholinesterase inhibitors or glutamate antagonists in the 3 months prior to study enrollment
2. Individuals with any past history of ischemic or traumatic brain injury
3. Individuals with imaging evidence of significant cerebrovascular disease or structural brain lesions (e.g. tumor, demyelinating disorders, infection, or congenital anomalies)
4. Active mood disorder
5. Active alcohol use
6. Active use of benzodiazepines, barbiturates, anticholinergic, or anti-epileptic medications
Bioequivalence Study of Gabapentin 400 mg Capsules Under Fed Conditions

To compare the single-dose oral bioavailability of metformin HCI liquid 500 mg/5 mL of Ranbaxy with Glucophage® 1000 mg tablets of Bristol-Myers, USA following administration of a 1000 mg dose in healthy, adult, male and female volunteers under fasting conditions

This was an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 24 healthy adult volunteers and 2 alternates. All 26 subjects completed the clinical phase of the study. In each period, subjects were housed from the evening before dosing until after the 36-hour blood draw. Single oral 400 mg doses were separated by a washout period of 7 days A total of 24 healthy adult volunteers and 2 alternates (17 males and 9 non-pregnant females) enrolled in and completed the clinical phase of the study

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult male or female volunteers, 18-55 years of age
2. Weighing at least 52 kg for males and 45 kg for females and within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983)
3. Medically healthy subjects with clinically normal laboratory profiles
4. Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to the study and throughout the study or be using one of the following acceptable birth control methods:

   * surgically sterile (bilateral tubal ligation, hysterectomy bilateral oophorectomy) 6 months minimum
   * IUD in place for at least 3 months
   * barrier methods (condom, diaphragm) with spermicide for at least 14 days prior to the start of the study and throughout the study
   * surgical sterilization of the partner (vasectomy for 6 months minimum)
   * hormonal contraceptives for at least 3 months prior to the start of the study

   Other birth control methods may be deemed acceptable. Postmenopausal women with amenorrhea for at least 2 years will be eligible.
5. Voluntarily consent to participate in the study.

Exclusion Criteria:

Subject candidates must not be enrolled in the study if they meet any of the following criteria:

1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
2. In addition, history or presence of:

   * alcoholism or drug abuse within the past 2 years
   * hypersensitivity or idiosyncratic reaction to anticonvulsants
3. Female subjects who are pregnant or lactating
4. Subjects who have been on an abnormal diet (for whatever reason) during the 30 days prior to the first dose
5. Subjects who, through completion of the study, would have donated in excess of:

   * 500 mL of blood in 14 days, or
   * 500 - 750 mL of blood in 14 days (unless approved by the Principal Investigator)
   * 1000 mL of blood in 90 days
   * 1250 mL of blood in 12 days
   * 1500 mL of blood in 180 days
   * 2000 mL of blood in 270 days
   * 2500 mL of blood in I year
6. Subjects who have participated in another clinical trial within 28 days prior to the first dose
Dynamic Arterial Elastance as a Predictor of Arterial Blood Pressure Response to Fluid Administration in Septic Patients

Correction of arterial hypotension is essential for adequate cellular metabolism. maintaining MAP above a minimum level has been recommended in order to prevent further tissue hypoperfusion and organ dysfunction.Functional assessment of arterial load by dynamic arterial elastance (Eadyn), has recently been shown to predict the arterial pressure response to volume expansion (VE) in hypotensive, preload-dependent septic patients.

After approval from the ethics and research committee of Faculty of Medicine, Cairo University, an informed consent will be obtained from each patient's next of kin. Arteial cathter will be inserted in radial artery and connected through an arterial line to invasive arterial blood pressure monitor. Electrical Cardiometry will be attached to patient through the placement of four skin sensors on the neck and left side of the thorax12. A set of hemodynamic measurements will be obtained at baseline and after infusing a fluid challenge (FC) of 150-250 ml normal saline over 5-10 minutes.Fluid-responders are patients with a SV increase ≥10% after fluid challenge (FC).

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (more than 18 years).
* Sepsis as a cause of admission.

Exclusion Criteria:

* • Patients younger than 18 years of age.

  * Pregnant females.
  * Trauma as a cause of intensive care unit (ICU)admission.
  * Known medical history of vasodilator therapy.
  * Cardiac arrhythmias.
  * Any absolute contraindication for fluid administration such as congestive heart failure, pulmonary edema and/or fluid overload
Impact of Fluid Resuscitation Protocol on the Incidence of Reoperation for Bleeding After Emergency Cardiopulmonary Bypass Grafting

This is a retrospective data analysis of patients that underwent elective or emergency cardiopulmonary bypass. Resternotomy due to bleeding is frequent after sternotomy. Also due to implementation of Argipressin into clinical practice fluid resuscitation protocol has changed to more vasopressors and less fluid within the past five years. The investigators want to explore the influence of volume resuscitation protocol on incidence of rethoracotomy during the past twenty years.


Eligibility Criteria:
Inclusion Criteria:

* All patients that underwent elective or emergency aortocoronary bypass at the University Hospital Basel between 2009 and 2020.

Exclusion Criteria:

* None.
Effects of an Exercise Program on Bone Density

Physical inactivity and low adherence to the Mediterranean diet cause alterations in body composition, which increases the risk factors for cardiovascular and metabolic diseases. In addition, exercise in different surfaces or water could affect the bone density specially in women. Objective: The purpose of the study was to analyze the effect of a short-term aerobic exercise program in different surfaces on the body composition and bone density of women within at work, and to evaluate the quality of the Mediterranean diet and distribution of macronutrients in the studied population. Material \& Methods: Randomized controlled trial. 63 women from a randomized work environment (IG, n=34) and a control group (CG, n=29) participated in a short-term aerobic exercise programmed (12 weeks), for body composition and bone density Dual-energy X-ray absorptiometry (DXA) was used and to evaluate diet, the Mediterranean Diet Quality Questionnaire (KIDMED) and the Food Frequency Questionnaire for macronutrient distribution were used.


Eligibility Criteria:
Inclusion Criteria:

* Not diagnosed with any disease that contraindicates the practice of physical exercise
* Do not perform physical activity with continuity

Exclusion Criteria:

* Diagnosed with chronic disease including cardiovascular and respiratory diseases that contraindicate the practice of physical exercise
* Being pregnant before or during the intervention (for intervention and control group)