cyrilzakka/clinical-trials huggingface dataset:
Protein Intake in Patients With Colorectal or Lung Cancer When Receiving a Nutritional Supplement

The PROTEOS study is an randomized controlled, open label, parallel-group, multi-centre and multicounty interventional study to assess the acceptance and implementation of Compact Protein, a low volume, energy dense and high protein oral nutritional support in clinical practice according to the ESPEN guidelines in colorectal and lung cancer patients undergoing chemo(radio)- or immunotherapy treatment.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven CRC stage IIB, III or IV or histologically or cytologically proven NSCLC stage III or IV
* Eligible and scheduled for first line chemotherapy, concurrent chemoradiotherapy or immunotherapy treatment with a planned duration of at least 12 weeks
* Performance status Eastern Cooperative Oncology Group (ECOG) score 0 or 1
* Age ≥ 18 years
* Written informed consent

Exclusion Criteria:

* Scheduled for first line chemotherapy, concurrent chemoradiotherapy or immunotherapy treatment starting ≤4 days after randomization
* Received radiotherapy within 2 months prior to the study
* Weight loss \>10% in the last 6 months
* Body Mass Index \< 20.0 kg/m2
* Life expectancy \< 3 months
* Prescription of oral nutritional supplementation (ONS) before start of first line treatment based on hospital's standard practice
* Presence of ileostoma or ileal pouch
* Contra-indications to oral feeding, high protein nutrition or to the test product (including galactosaemia) in the opinion of the investigator
* Known pregnancy or lactation
* Current alcohol or drug abuse in the opinion of the investigator
* Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
Cetuximab (Erbitux) in Combination With Cisplatin or Carboplatin and 5-Fluorouracil in the First Line Treatment of Subjects With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (EXTREME)

The purpose of this trial is to investigate the efficacy of cetuximab in combination with chemotherapy in comparison to chemotherapy alone in patients with recurrent or metastatic head and neck cancer. Overall survival will be taken as the primary measure of efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the head and neck (SCCHN)
* Recurrent and/or metastatic SCCHN, not suitable for local therapy

Exclusion Criteria:

* Prior systemic chemotherapy, except if given as part of a multimodal treatment for locally advanced disease which was completed more than 6 months prior to study entry
* Surgery (excluding prior diagnostic biopsy), or irradiation within 4 weeks before study entry
* Nasopharyngeal carcinoma
Clinical Assessment of the External Sound Processor Worn by Patients Implanted With Codacs

The purpose of this study is to evaluate the effect of the sound processor upgrade from the C-DACS investigational device Freedom sound processor to the Nucleus® CP810 sound processor for the Codacs™ system on the speech reception threshold in noise, to evaluate the usability of the Codacs™ Fitting Software, to evaluate the quality of life with the Nucleus® CP810 Sound Processor for the Codacs™ system, to collect long term data, to evaluate the acceptance criteria of the postoperative Codacs™ system test and to evaluate the usability of the Codacs™ Test System.


Eligibility Criteria:
Inclusion Criteria:

* Subjects implanted with a Cochlear C-DACS investigational device

Exclusion Criteria:

* Participation in another medical device study
* Unwillingness or inability of the subject to comply with the study requirements
Early Versus Routine Caffeine Administration in Extremely Preterm Neonates

Premature infants are at risk of having pauses in breathing, or apneas, due to their immaturity. Premature infants are routinely given caffeine, a respiratory stimulant, on the first day of life to prevent apneas. However, if they continue to have apneas, they may require a breathing tube to be placed in the trachea. There are risks to having a breathing tube, so it would be beneficial to avoid it if possible. If caffeine is given earlier, it may decrease the need for a breathing tube. Some studies also suggest that caffeine may also improve heart function which may prevent low blood pressure if given early.

This goal of this observational study is to compare the respiratory and acute hemodynamic effects of caffeine administered in the first 2 hours versus 12 hours of life in infants \<29 weeks gestation. Our primary hypothesis is that caffeine administered in the first two hours of life can prevent the need for endotracheal intubation in the first 12 hours of life.. These evaluations are critical in determining both the safety and efficacy of early caffeine therapy.

Eligibility Criteria:
Inclusion Criteria:

* Any infant delivered at Sharp Mary Birch Hospital between 23 and 28 6/7 weeks; gestation

Exclusion Criteria:

* Any infant with a major congenital anomaly including airway anomalies, congenital diaphragmatic hernia, or hydrops
* Any infant with a known or a discovered major cardiac defect other than a patent ductus arterious (PDA), patent foramen ovale (PFO), or small ventricular septal defect (VSD)
* Inability to place a peripheral IV after two attempts. Severe apnea or bradycardia in the first 60 minutes of life requiring emergent endotracheal intubation.
Neuropeptide Y (NPY) Regulation of Nociceptors

Neuropeptide Y (NPY) potently inhibits pain neurons in rats, but does this occur in human pain neurons? This hypothesis will be tested using microdialysis probes in patients who elect to have root canal treatment or extraction of thier tooth.

The ongoing studies in rats indicate that a sympathetically-derived neuropeptide, neuropeptide Y (NPY), potently inhibits the activity of the capsaicin-sensative class of nociceptors (i.e., "pain" neurons). It is not know whether these results, generated from rodent studies, occur in human tissues under normal or inflamed conditions. We plan to test the hypothesis that NPY inhibits the initiation of neurogenic inflammation, as measured by reduced release of substance P, from capsaicin-sensitive class of petidergic neurons innervating normal and inflamed dental pulp. Such actions would be physiologically and clinically significant, since inhibition of exocytosis from peripheral terminals of nociceptive primary afferent fibers would likely alter neurogenic inflammation, local vasodilation and , possibly pain. Our research strategy takes advantage of a uniquely innervated tissue: dental pulp. Application of any physiologic stimulus to human dental pulp, including thermal, osmotic, chemical or mechanical, produces only pain. Thus, virtually all sensory neurons that innervate pulp appear to be nociceptors. Accordingly, application of drugs to pulpal sensory neurons targets a population of sensory neurons consisting predominantly of nociceptors.

The research questions are as follows:

1. Determine the capsaicin concentration-response curve from evoking the release of immunioreactive substance P (iSP) from normal and inflamed dental pulp.
2. Determine the effect of NPY on altering basal and capsaisin-evoked release of iSP from normal and inflamed dental pulp.

We will evaluate the hypothesis that NPY inhibits capsaicin-sensitive neurons in humans using microdialysis probes implanted into anesthetized dental pulp, with release of immunoreactive substance P (iSP) as our dependent measure. This study will include patients who have elected to have a root canal procedure performed or to have a tooth extracted.

Eligibility Criteria:
Inclusion Criteria:

* teeth with diagnosis of normal pulp or irreversible pulpitis
* mandibular teeth
* indication for either root canal or extraction of tooth
* age between 18-50

Exclusion Criteria:

* history of taking steroids within the last month
* history of hyperthyroidism, hypertension, asthma, uncontrolled or complicated Type-2 diabetes, drug abuse
* age less than 18 or greater than 50
* maxillary teeth
A Phase 1 Trial to Investigate the Biological Equivalence of 5 × 10 mg Tablets and 2 × 25 mg Tablets of Daridorexant in Healthy Male and Female Japanese Participants

A Phase 1 trial to investigate bioequivalence between 5 × 10 mg tablets and 2 × 25 mg tablets of daridorexant in healthy male and female Japanese participants


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent in a language understandable to the participant prior to any trial-mandated procedure.
* Healthy male and female participants aged between 18 and 65 years (inclusive) at Screening.
* Body mass index of 18.5 to 29.9 kg/m2 (inclusive) at Screening.
* Participant must be of native Japanese descent (all parents/grandparents of Japanese descent).
* Participant must not have been away from Japan for more than 10 years (at Screening visit).
* Participant's lifestyle should not have changed significantly since relocation from Japan.

Exclusion Criteria:

* Known hypersensitivity to daridorexant, or any of its excipients.
* History of narcolepsy or cataplexy.
* Clinically relevant findings on the physical examination at Screening.
* Clinically relevant findings on 12-lead ECG, recorded after 5 min in a supine position at Screening.
* Clinically relevant findings in clinical laboratory tests (hematology and clinical chemistry) at Screening.
* Clinically relevant findings in systolic blood pressure, diastolic blood pressure, and pulse rate, measured on either arm, after 5 min in the supine position at Screening.
* History of major medical or surgical disorders which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment (appendectomy and herniotomy allowed if performed \> 12 weeks prior to administration of first study treatment, cholecystectomy not allowed).
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
Autologous Adipose Derived Stem Cells Transplantation in the Treatment of Keloids.

Keloids are the most common disfiguring skin disorder affecting colored population with a prevalence of upto 16%.

Autologous adipose derived stem cells have been found to have potential therapeutic benefits however limited clinical trials have compared there role to standard therapy.

This is a pilot study that is intended to evaluate the feasibility of conducting this clinical trial comparing adipose derived stromal vascular fraction to Triamcinolone in keloid treatment. The full clinical trial is already registered under the clinical trial number NCT04391621.

The objective of this Pilot is to evaluate the feasibility of conducting a full study on the same topic.

Background: Keloids affect upto 16% of Africans and often demonstrate more aggressive behaviour with poor response to existing therapies.

Adipose derived stem cells have been described to have inhibitory effects on keloid growth with several invitro studies and case series reporting promising findings.

Despite this knowledge, no clinical trial has been conducted to compare the efficacy of these adipose derived stem cells to existing standard therapy. We intend to conduct a clinical trial comparing the adipose derived stem cells to the existing standard of care here in Uganda which is Triamcinolone Acetanoide a trial that is registered under the clinical trial number NCT04391621. Before scaling up this study, we intend to evaluate the feasibility to conducting a full scale study by first piloting the same trial to a smaller number of participants.

The primary objective of this study will be to describe the feasibility and safety of adipose derived stem cells in the treatment of keloids as well as to document the process of autologous adipose derived stem cells harvesting and processing. The secondary outcome will be the clinical endpoints of keloid regression and symptom relief at the end of one month.

This will be a pilot parallel and un-blinded randomised controlled trial that will be conducted at Mulago National Referral Hospital. 6 patients will be allocated randomly into either Triamcinolone group and Adipose Derived Stem cells group. Each arm will receive the respective single dose infiltration of the selected treatment.

The patients will be followed up for three months for keloid regression and symptom relief as well as development of side effects.

Utility: This pilot study is intended to evaluate the feasibility of conducting a clinical trial on the efficacy of Autologous adipose derived stem cells in the treatment of keloids

Eligibility Criteria:
Inclusion Criteria:

* Patients with a single keloid of 1-2cm3 as these have the highest response to any treatment administered.

Exclusion Criteria:

* Previous intra-lesional steroid injection treatment in the last three months as the effects may still be ongoing Insufficient abdominal fat pad(depth) of 3cm Confirmed bleeding disorder Ongoing systemic illness Ulceration or local keloid infection
Effects of Preoperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy

The purpose of this study is to determine whether preoperative immunonutrition is effective on infectious complication and Th1/Th2 differentiation in patients with pancreaticoduodenectomy.

The investigators reported that preoperative immunonutrition improve the incidence of postoperative infectious complication in patients after pancreaticoduodenectomy, and modulation of Th1/Th2 differentiation may play important roles in this effect.

Object of this study is to investigate the effects preoperative immunonutrition on incidence of postoperative infectious complication, and Th1/Th2 balance after pancreaticoduodenectomy.

Eligibility Criteria:
Inclusion Criteria:

* patients underwent pancreaticoduodenectomy

Exclusion Criteria:

* age younger than 18 years
* ongoing infection
* gastrointestinal obstruction
* respiratory dysfunction
* cardiac dysfunction
* hepatic dysfunction
* renal failure
* history of recent immunosuppressive or immunological diseases
* preoperative evidence of widespread metastatic disease
Mannitol Challenge Test in Adult Asthma Patients With Fixed Dose Combinations

The primary objective in this pilot study is to explore if asthma patients prescribed fixed dose combinations (budenosid/formoterol (Symbicort®), salmeterol/fluticasone (Seretide®), beclometasone/formoterol (Innovair®) are optimal treated regarding the mannitol challenge test and the following reversibility test.

The primary endpoint is to identify asthma patients responding positive or negative to the mannitol challenge test and/or the reversibility test.

The hypothesis is that not all patients are well treated.


Eligibility Criteria:
Inclusion criteria

1. Males and females, age 18-65 years.
2. Subjects diagnosed with asthma.
3. Subjects with a baseline FEV1 of ≥70% of the predicted value.
4. Outpatients at primary clinic.
5. Subjects treated with a fixed dose combination for at least the last three months.
6. Subjects who have withheld their asthma- and allergy medication according to individual instructions at the day of the challenge test.
7. Subjects who are able to read and comprehend Swedish and are willing to sign an informed consent.

Exclusion Criteria

1. Subjects with evidence of any other respiratory and/or obstructive disease including recent infection/exacerbation.
2. Subjects treated with a oral corticosteroid within 4 weeks (28 days) prior to the day of the challenge test.
3. Any history of hypersensitivity to mannitol challenge test.
4. Any contraindications to use of the diagnostic study medication.
5. Subjects who are unsuitable for other reason(s) in the opinion of the investigator.
A 5 Day Course of Fludarabine and Cytarabine Followed by Full Intensity Allogeneic Stem Cell Transplantation (FA5-Bucy) in Treating Patients With High-risk, Recurrent or Refractory Acute Leukemia and Advanced Myelodysplastic Syndrome

A 5 day course of fludarabine and cytarabine (FA) will be administered followed by full intensity conditioning regimen (Bucy) in the setting of allogeneic stem cell transplantation (SCT). The purpose of this study is to explore the antileukemic, immunosuppressive effects and safety of FA as the backbone of a conditioning regiment for the treatment of patients with high-risk, recurrent or refractory acute Leukemia and advanced myelodysplastic syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Aged between 0-65 years
* Patients suffering from either refractory de novo AML/ALL or relapsed AML/ALL or patients with very high risk AML/ALL in CR1
* Patients with advanced MDS
* Cardiac: Left ventricular ejection fraction ≥ 50%
* Adequate renal and hepatic function
* Performance status: Karnofsky ≥ 70%

Exclusion Criteria:

* Pregnant or lactating females
* Current participation in another clinical trial
* Contra-indication to one of the drug of the regimen
* Any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver or other organ system that may place the patient at undue risk to undergo the agents included in the conditioning regimen
18841- Sun Protection Factor Assay

To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF
* Signed and dated Informed Consent Form
* Signed and dated HIPAA Form
* An unambiguous MED or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma. diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.
Assessing Cardiovascular Dysfunction Pre- & Post-treatment in Inflammatory Bowel Diseases

The aim of this study is to compare medical and surgery treatment in IBD patients and healthy controls, by assessing the endothelial and cardiac function and the inflammation status.

The aim of this study is to compare medical and surgery treatment in IBD patients and healthy controls, by assessing the endothelial and cardiac function and the inflammation status.

In particular, three subject groups will be enrolled, as follows:

40 patients \[Crohn's disease (CD) \& ulcerative colitis (UC)\] who will undergo medical treatment (Group A), 40 patients (CD \& UC) who will undergo surgery (Group B) and a healthy control group (Group C) comprising 40 subjects.

Assessment of the inflammation load (CRP, WBC, IL-6, TNFa), the endothelial function (FMD, PWV, cIMT, endothelial glycocalyx) and the cardiac function - via echocardiographic parameters (systolic and diastolic echo values, tissue doppler imaging-GLS-strain rate) - will be carried out for every subject group in two phases: prior to treatment and four months after the treatment, as applicable.

The objective is to investigate whether there is a statistically significant reduction of endothelial and cardiac dysfunction following medical and surgery treatment in IBD patients as well as to examine associations across the three groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients with IBD diagnosed \> 6 months via biopsy confirming the diagnosis
* Patients with IBD at an advanced \& non-controllable phase (IBD scores,clinical status, endoscopic and biochemical values) requiring the initiation of a new medical treatment or surgical intervention.

Exclusion Criteria:

* Coronary Artery Disease
* Peripheral Arterial Disease
* Thromboembolic Disease (acute or chronic)
* Heart failure of any cause
* Valvular Disease
* Congenital Heart Defect
* Heart Rhythm Disorder
* Stroke, Renal or liver failure, malignancy, endocrine disorder
* Other autoimmune disorder or angiitis
* IBD diagnosed \< 6 months
* BMI \> 40 Kg/m2
Comparison of Gut Microbiota in Sedentary and Active Women

Gut microbiota comparison of active and sedentary women

Observational study comparing gut microbiota of people who did not practice any physical exercise (sedentary) with the gut microbiota of people who at least practice exercise a minimum of 3 hours per week but they were not professional athletes. Since the hormonal status and gender are factors that influence gut microbiota, this study has been conducted in premenopausal women.

Eligibility Criteria:
Inclusion Criteria:

* healthy women

Exclusion Criteria:

* Smokers, pregnant, vegetarian, vegan, taking antibiotics in the last 3 months, any kind of disease, body mass index\>25
Amifostine Plus Chemotherapy and Radiation Therapy in Treating Patients With Advanced, Unresectable Head and Neck Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses x-rays to damage tumor cells. Drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy and radiation therapy.

PURPOSE: Phase I/II trial to study the effectiveness of amifostine plus cisplatin, paclitaxel, and radiation therapy in treating patients who have advanced unresectable head and neck cancer.

OBJECTIVES: I. Assess the efficacy and role of amifostine as a cytoprotection agent with concurrent chemoradiotherapy in advanced, previously irradiated or metastatic head and neck cancer. II. Determine the toxicity and response to cisplatin, paclitaxel and radiation therapy in these patients. III. Determine the toxicity of amifostine in these patients.

OUTLINE: This is an open label study. Patients receive paclitaxel by continuous infusion on days 0-3. Amifostine IV is administered over 5 minutes on days 1-5. Radiation therapy is administered once daily on days 1-5. Cisplatin IV is administered on day 5. Patients receive no treatment on days 6-13. Treatment is repeated every 2 weeks for up to 7 courses in the absence of disease progression and unacceptable toxicity. Patients are followed monthly during the first year, every 2 months during the second year, then every 3 months thereafter.

PROJECTED ACCRUAL: This study will accrue 16-46 patients.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically documented metastatic or previously irradiated recurrent locoregional squamous cell or mucoepidermoid carcinoma of the head and neck Unresectable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 OR Karnofsky 70-100% Life expectancy: Greater than 4 months Hematopoietic: WBC at least 3000/mm3 Platelet count at least 100,000/mm3 Granulocyte count at least 1500/mm3 Hepatic: Bilirubin no greater than 2.5 times normal SGOT and SGPT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min Other: No other significant infection No other medical or psychiatric illness Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 1 month since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 3 months since prior radiotherapy (patients with recurrent disease) to head and neck region Surgery: Not speciified Other: At least 24 hours since antihypertensive medication