cyrilzakka/clinical-trials huggingface dataset:
Risk Prediction of Taxane Chemotherapy-Induced Peripheral Neuropathy

This is an observational study to discover risk factors of chemotherapy-induced peripheral neuropathy (CIPN) in 350 patients with early stage breast cancer undergoing taxane-based chemotherapy at two main sites (University of North Carolina at Chapel Hill (UNC) Hospital, including Rex Hospital, and the University of Alabama at Birmingham (UAB) Hospital). The primary purpose of this study to explore patient- and procedure-based variables that identify patients at risk for developing CIPN during chemotherapy.

Chemotherapy-induced peripheral neuropathy is common and provokes pain, poor QoL, and loss of independence, as well as increases the risk of falls and opioid addiction. Beyond the inciting agents, risk factors for CIPN are not understood or systematically evaluated in clinical practice, precluding prevention. Therefore, a clinical decision tool to predict an individual patient's risk of neuropathy remains a critical unmet need. A diagnostic test that predicts CIPN risk in this clinical context would provide an essential clinical-decision tool to guide treatment and post-treatment care in breast cancer, prevent CIPN occurrence, and improve patient outcomes.

Investigators' pilot data uncovered a strong association between cellular senescence and CIPN. In this prospective, observational study of participants with early-stage breast cancer, the investigators will assess the contribution of senescence and clinical variables. The investigators will determine the ability of these factors to identify patients at risk for CIPN during chemotherapy and up to one year after the last dose of taxane-based chemotherapy. This study will employ both patient- and clinician reported CIPN scoring systems.

Eligibility Criteria:
Inclusion Criteria:

Study participants must meet all of the following inclusion criteria to participate in the study:

* Adult female study participants (≥18 years) with newly diagnosed early-stage (stages I III) non-metastatic breast cancer receiving neoadjuvant or adjuvant chemotherapy that includes paclitaxel or docetaxel
* Study participants must be capable and willing to provide informed consent, and be willing and able to complete the study questionnaires during the study

Exclusion Criteria:

Study participants who fulfill any of the following criteria will be excluded:

* Patients with metastatic breast cancer
* History of other cancers (except squamous and basal cell carcinoma)
* Autoimmune disorders
* Presence of major active infection for which antibiotics and/or antivirals are prescribed within the last 14 days (chronic or acute, eg, sepsis, HIV, pneumonia, active COVID infection)
* Pregnant women
* Participation in an additional study at the time of enrollment where the intervention could potentially alter CIPN risk (unless in the control arm)
Learning Through Play (LTP) Plus Intervention for Depressed Fathers (LTP Plus Dads)

The aim of the study is to evaluate the clinical and cost effectiveness of culturally adapted group parenting intervention delivered by non-specialists and community health workers for depressed fathers.

Most research on the association between parental depression and child outcomes has focused mainly on mothers. However, studies suggest that the relationship between parental depression and child outcome is not necessarily limited to mothers.

The study has two phases quantitative and qualitative:

Purpose of this quantitative phase is to determine if the LTP plus programme delivered by non-specialists and community health workers reduces symptoms of paternal depression and improves child development compared to treatment as usual.

In the qualitative part of the study focus groups and in-depth digitally recorded interviews will be conducted with participants by trained research staff at two-time points both before and after the intervention. These focus groups and in-depth interviews will continue till the data saturation is achieved. In addition, Participants who refused to participate in the trial will be asked if they would be willing to be contacted by a researcher to discuss their reasons for not taking part. Moreover, in-depth digitally-recorded interviews with stakeholders (grandparents, therapists, health professionals, etc) will also be conducted by trained researchers.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 55 years old fathers
* Having children aged between 0-30 months
* Diagnosis of major depressive disorder using the Structure Clinical Interview for DSM-V,
* Ability to complete a baseline assessment.
* Given written informed consent

Exclusion Criteria:

* Any medical illness that will prevent them from participation in the clinical trial,
* Current or past diagnosis of bipolar depression
* Currently using antidepressants or receiving any kind of psychotherapy
* Active suicidal ideation,
* Any other severe physical or mental disorders
Gastrointestinal STRING Test With Oral Immunotherapy

This STRING study will examine markers of esophageal inflammation using a minimally-invasive testing device, the esophageal string test (EST). The primary objective is to determine the effect of omalizumab (Xolair) and dupilumab (Dupixent) on markers of eosinophilic inflammation in the esophagus of subjects treated with omalizumab-facilitated mOIT(mult-allergen oral immunotherapy) and/or mOIT with concurrent dupilumab.

This is a companion study to a phase 2 randomized, controlled, double-blind clinical trial using biologics to improve multi-allergen oral immunotherapy (mOIT) outcomes. The parent study (COMBINE NCT03679676) consists of a screening period, 8 weeks of omalizumab or placebo injections, and 24 weeks of OIT with dupilumab or placebo injections followed by an off-treatment period.

This STRING companion study will examine markers of esophageal inflammation during the COMBINE study using a minimally-invasive testing device, the esophageal string test (EST). If participants of COMBINE consent to this companion study, they will undergo an esophageal string test at the following time points in COMBINE:

* During screening, prior to week 0, which will be baseline for the STRING esophageal test
* Week 8, After the 8 weeks of treatment with omalizumab/placebo
* If dose-related gastrointestinal (GI) side effects occur during the week 10-32 treatment period (OIT and dupilumab/placebo)
* At Week 32, after 24 weeks of treatment with OIT and dupilumab or placebo

Eligibility Criteria:
Inclusion Criteria: • Participants, aged 5-55 years enrolled in the parent COMBINE trial

* Able to swallow the EST.

Exclusion Criteria: • Allergy to, or inability to ingest, gelatin

-
Aprepitant in the Management of Biological Therapies-related Severe Pruritus

Itch is a common side effect of anti-epidermal growth factor receptor antibodies and tyrosine kinase inhibitors. Investigators designed a pilot single-center phase II study evaluating the effects of Aprepitant, a neurokinin receptor inhibitor, in managing biological therapy-induced pruritus.

Investigators enroll patients affected by solid tumors which present itch refractory to standard treatment ("refractory group") and patients who did not receive any treatment for pruritus ("naïve group"). The intensity of itch will be evaluated with Visual Analogue Scale (VAS) score. In the refractory group Aprepitant (125 mg on day 1; 80 mg on day 3; 80 mg on day 5) will be administered after at least 1 week of standard systemic treatment. In the naïve group, Aprepitant will be administered after the first onset of severe pruritus. The primary end point is to evaluate the effect of aprepitant in managing pruritus both in naive and refractory group.

Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed diagnosis of solid tumor
* treatment with anti-EGFR antibodies or TKIs
* first onset of severe pruritus during treatment (≥7 on Visual Analogue Scale (VAS) score)

Exclusion Criteria:

* oral treatment with antimycotics during 4 weeks preceding enrolment
* topical treatment during the previous 2 weeks
* concomitant,chronic renal or hepatic insufficiency , skin infection or dermatitis.
All in One Study: A Prospective Trial of Electromagnetic Navigation for Biopsy of Pulmonary Nodules

This is a multi-center, non-randomized, single-arm, prospective trial to evaluate a staged sampling methodology designed to maximize the diagnostic yield of lung biopsy in a single procedure setting.

The objectives of this study are to evaluate diagnostic yield following biopsy of peripheral pulmonary nodules as identified on chest computed tomography (CT) utilizing (1) Electromagnetic navigation (EMN) bronchoscopy, and/or (2) EMN-transthoracic needle aspiration (TTNA). Overall diagnostic yield will be evaluated to assess the combination of these approaches.

Eligibility Criteria:
Inclusion Criteria:

* The patient is ≥21 years old,
* The patient has a lung nodule identified on chest CT and is a candidate for elective EMN bronchoscopic evaluation as determined by the treating pulmonologist,
* The size of the target nodule, as measured at its greatest diameter, is between 1-3cm,
* Staging at the time of enrollment indicates NO/N1 (does not involve lymph nodes or includes involvement in nodes within ipsilateral hilum),
* The patient has an intermediate risk of malignancy (5-65% per the Mayo Model) and is in need of diagnosis for alternative treatment, OR The patient has a high probability of cancer (\>65%) and will be referred for surgical evaluation or stereotactic body radiation therapy (SBRT). Note: If the patient refuses surgery or if the surgeon requests a definitive diagnosis prior to surgery the patient will have the option to be included in this study,
* The patient has a lack of bleeding disorders, and
* The patient is willing and able to provide informed consent.

Exclusion Criteria:

* The patient is pregnant as confirmed by urine or serum pregnancy testing,
* The patients has a body mass index (BMI) \>40,
* There is a predetermined plan to pursue stereotactic body radiation therapy (SBRT) in the event of a nondiagnostic study procedure in patients with a nodule within SPiNPerc range (i.e. The patient would not go on for a CT guided TTNA), OR There is a predetermined plan to pursue stereotactic body radiation therapy (SBRT) in the event of a nondiagnostic study procedure in patients where the target nodule is within a region considered to be not accessible to a percutaneous approach as determined by the radiology core lab and thus would prevent a confirmatory tissue diagnosis before SBRT.
Intense Pulsed Light (IPL) Medical Device as Treatment for Patient Suffering From Skin Disorder

The first IPL device obtained United States Food and Drug Administration (FDA) clearance in 1995 for treatment of lower extremity telangiectasias. Since then, its favorable cost and versatility in contrast to many singlespectrum lasers, has led to its rapid proliferation and use in a number of different clinical settings. As described in the literature, ANTHÉLIA medical device is intended to treat skin disorders:

* Excessive Hairiness (Hirsutism, Hypertrichosis...)
* Vascular lesions (Rosacea....)
* Pigmented lesions (Lentigo et melasma)
* Acne vulgaris


Eligibility Criteria:
Inclusion Criteria:

* Adult men or women
* Excessive Hairiness:
* Patient with unwanted hair on the body (legs, arms, bikini line, or axilla)
* Patient over 18 years.
* Patients with Fitzpatrick skin types from I to V.
* Women were required to be post-menopausal, surgically sterilized, or under a medically acceptable form of birth control (i.e., oral contraceptives, IUD, contraceptive implant, or barrier methods with spermicide or abstinence) during the study time period.

Vascular lesions:

* Patients over 18 years.
* Patients with Fitzpatrick skin types from I to IV.
* Patients with varicosities and Rosacea on the face or upper and lower limbs.

Pigmented lesions:

* Patients over 18 years.
* Patients with solar lentigines on their cheeks, back, hands, arm and leg (\> 3 mm).
* Patient with Fitzpatrick skin type from I to IV.

Acne:

* Patients over 18 years
* Patients with Fitzpatrick skin types from I to IV.
* Patients with facial acne vulgaris on face.
* Willing to sun protect treated area for the duration of enrollment in the study and 4 weeks after treatment.

Exclusion Criteria:

* Patients with history of malignant lesions or pre-malignant lesions, scarring, or infection in the area to be treated History of keloidal or hypertrophic scarring
* Patients with a known photosensitivity
* Pregnancy women
* Patient with diabetes mellitus suntan in the area to be treated
* Use of photo-sensitizing products for 7 days before treatment (selftanning lotions, activators, self-tanning shower gel, etc.)
* Exposure to the sun or UV rays at least 4 weeks before the treatment and 1 week afterwards
* Zones with uncovered tattoos, suspect spots or skin diseases (including spots, inflammation, beauty spots, tumors or melanomas, psoriasis, herpes...)
* Use of medication that induces anticoagulative medication or thromboembolic condition
* Patients with pacemaker or internal defibrillator
* Patients that used of NSAIDS two weeks prior to or 2 weeks following the treatment
* Epileptic patients
* Additional criteria for excessive hair: Patients that use waxing or other methods of photo epilation within 1 month prior to treatment.
* Additional criteria for acne: Patients currently under oral antibiotic or oral therapy for acne.
A Study to Evaluate ERAS-801 in Patients With Recurrent Glioblastoma (THUNDERBBOLT-1)

* To evaluate the safety and tolerability of escalating doses of ERAS-801 in study participants with recurrent glioblastoma multiforme (GBM).
* To determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD) of ERAS-801.
* To evaluate the antitumor activity of ERAS-801.
* To evaluate the PK profile of ERAS-801.

This is a Phase 1, open-label, multicenter clinical study evaluating ERAS-801 as a monotherapy. The study will initially commence with dose escalation of ERAS-801 in study participants with recurrent GBM. Once the MTD and/or RD has been determined from dose escalation, then dose expansion of ERAS-801 may commence in study participants with recurrent GBM harboring alterations in epidermal growth factor receptor (EGFR).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Willing and able to give written informed consent
* Diagnosis of Glioblastoma, IDH WT as defined by the WHO 2021 criteria
* Adequate organ function
* Willing to comply with all protocol-required visits, assessments, and procedures
* Able to swallow oral medication

Exclusion Criteria:

* Prior treatment with an EGFR inhibitor for Glioblastoma
* Currently enrolled in another therapeutic study
* History of clinically significant cardiovascular disease
* Gastrointestinal conditions that may affect administration/absorption of oral medications
* Have an active infection (bacterial, fungal, or viral) requiring systemic therapy
* Pregnant or breastfeeding women
* Any serious underlying medical or psychiatric condition or evidence of any other significant clinical disorder or laboratory finding that renders the patient inappropriate to participate in the study
* Known allergies, hypersensitivity, or intolerance to ERAS-801 or its excipients
ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease

Study Evaluating the Safety and Efficacy of Two Concentrations (0.4% and 1%) of ALY688 Ophthalmic Solution in Subjects with Dry Eye Disease

Randomized, Double-Masked, Vehicle-Controlled Study Evaluating the Safety and Efficacy of Two Concentrations (0.4% and 1%) of ALY688 Ophthalmic Solution in Subjects with Dry Eye Disease

Eligibility Criteria:
Inclusion Criteria:

* Dry eye disease for \> 3 months meeting specific sign and symptom criteria
* Best corrected visual acuity of +0.6 logMAR or better
* Willing to sign informed consent and attend study visits
* Willing to comply with contraception requirements

Exclusion Criteria:

* Unable to meet specific sign and symptom criteria
* Signs of ophthalmic allergic, inflammatory or infection conditions
* Use of contact lenses
* Anatomic abnormalities preventing accurate study assessments
* Use of medications that influence eye dryness
* Recent ophthalmic surgery
* Unwilling to suspend current treatments for dry eye disease
To Compare the Effect of Liraglutide When Given Together With Metformin With the Effect of Metformin Given Alone and With the Effect of Glimepiride and Metformin Given Together

This trial is conducted in Europe, Oceania, Africa, Asia and South America. This trial is designed to show the effect of treatment with liraglutide when adding to existing metformin therapy and to compare it with the effects of metformin monotherapy and combination therapy of metformin and glimepiride. Two trial periods: A 6 month (26 weeks) randomised, double-blinded period followed by an 18 months open-label extension, in total 2 years (104 weeks).


Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed with type 2 diabetes and treated with oral anti-diabetic drugs (OADs) for at least 3 months
* HbA1c: 7.0-11.0 % (both incl.) in subjects on OAD monotherapy. 7.0-10.0 % (both incl.) in subjects on OAD combination therapy
* Body Mass Index (BMI) less than or equal 40 kg/m2

Exclusion Criteria:

* Subjects treated with insulin within the last three months
* Subjects with any serious medical condition
* Females of child bearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant or not using adequate contraceptive methods
* Subjects using any drug (except for OADs), which in the Investigator's opinion could interfere with the glucose level (e.g. systemic corticosteroids)
Randomized Controlled Trials on Adjuvant Intraperitoneal Chemotherapy for Resectable Local Advanced Gastric Cancer

Gastric cancer is the leading cause of death from a intestinal tract cancer in China.In most cases, the high death rate is due to tumor that has spread beyond the gastric cancer at the time of diagnosis. In China, the standard chemotherapy for the initial treatment of gastric cancer is a combination of a platinum analogue with 5-Fu.With modern surgical interventions and contemporary chemotherapy, most patients attain better clinical remission.The majority of them, however, will eventually have a relapse and die of the disease.

The peritoneal cavity is the principal site of disease in gastric cancer.Although the intensity of intravenous chemotherapy is limited mainly by myelotoxicity, several active drugs can be administered directly into the peritoneal cavity. The rationale for intraperitoneal therapy in gastric cancer is that the peritoneum, the predominant site of tumor, receives sustained exposure to high concentrations of antitumor agents while normal tissues, such as the bone marrow, are relatively spared.

The investigators conducted this trial to investigate the efficacy and safety of intraperitoneal chemotherapy in advanced gastric cancer.

To investigate efficacy and safety of intraperitoneal chemotherapy as part of adjuvant treatment for advanced gastric cancer.

Eligibility Criteria:
Inclusion Criteria:

DISEASE CHARACTERISTICS

* Histologically confirmed primary adenocarcinoma of the stomach
* 3-4weeks after radical operation for gastric cancer
* Stage of the gastric cancer was T3-4NxM0

PATIENT CHARACTERISTICS:

* Age: 18 - 70years old

Life expectancy:

* Longer than 3 months

Hematopoietic:

* Granulocyte count at least 1,500/mm3
* Platelet count at least 100,000/mm3
* Hemoglobin at least 80\*10\^12/mm3

Hepatic:

- AST no greater than 2.5 times ULN

Renal:

* Creatinine no greater than 1.5 times ULN

Other:

* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Prior chemotherapy and radiotherapy were not allowed
* No other concurrent chemotherapy

Radiotherapy:

* Locally radiotherapy for local disease of advanced gastric cancer during adjuvant treatment was allowed

Surgery:

* See Disease Characteristics
* Prior surgery for gastric cancer was necessary

Exclusion Criteria:

* Haven't recovery from operation or complication of operation
* With the following risk factors: Uncontrolled or severe cardiovascular disease (e.g., myocardial infarction within the past 6 months, congestive heart failure treated with medications, or uncontrolled hypertension)
* Pregnant or nursing
* Other currently active malignancy except nonmelanoma skin cancer
* Uncontrolled or severe bleeding,diarrhea,intestinal obstruction,adhesion of intestine
* metastasis before enrollment
* Received other chemotherapy or radiotherapy after operation
Clinical Prediction Model of Obstructive Sleep Apnea at Mansoura University Hospitals

Obstructive sleep apnea syndrome (OSAS)is a sleep breathing disorder manifested by complete apnea or partial hypopnea obstruction of the upper airway, which often remains undiagnosed and untreated (Kuczynski, W., 2019). These episodes, which should be more than 5 per hour and last at least 10 s, can lead to a sleep fragmentation and hypoxia (Huon, L.-K.A., 2017). OSAS predominantly affects 26% of individuals between 30 and 70 years in the U.S (apnea hypopnea index ≥5 events per hour) (Schwartz, M., 2018).

Obstructive sleep apnea it is increasingly recognized as an independent risk factor for cardiac, neurologic, and perioperative morbidities. Yet this disorder remains undiagnosed in a substantial portion of our population. It is imperative for all physicians to remain vigilant in identifying patients with signs and symptoms consistent with OSA (Park, J. G., 2011).

The test of hypothesis is to design a clinical prediction model of obstructive sleep apnea from collected data of the patients having symptoms of obstructive sleep apnea and the results of their sleep study

Aim of study:

To identify standard clinical parameters that may predict the presence of obstructive sleep apnea (OSA) among Egyptian patients in sleep study unit, ChestDepartment Mansoura University Hospital, Egypt Study Design :Retrospective study The study will include the patients who visited sleep outpatient clinic of sleep disordered breathing unit of Chest Department, Mansoura University from 2004 to 2022 Inclusion criteria

1. Patients aged \>18 years old
2. presented with symptoms suggestive of OSA like excessive daytime sleepiness, snoring, nocturnal chocking and witnessed apnea Exclusion criteria :Patients with long-term use of medications known to affect sleep integrity,Current alcohol or drug abuse, History of psychosis ,Central sleep apnea syndromes ,Previous OSA surgery ,Other sleep disorders

METHODS:

Study Design: this is retrospective study The recorded data of all patients which include all their symptoms and comorbidities as well as their use of any regular medications will be collected.

1. Physical examination:

   * All recorded vital data, height, weight, and body mass index (BMI) of the patients will be collected
   * The probability of OSA using the STOP-BANG and Berlinequestionnaire in all the patients will be collected
   * The calculated Epworth Sleepiness Scale (ESS) for each patient will be assessed.
2. Sleep Study (PSG) Diagnostic polysomnogram that had been done for all the patients for diagnostic purpose will be assessed.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged \>18 years old
2. presented with symptoms suggestive of OSA like excessive daytime sleepiness, snoring, nocturnal chocking and witnessed apnea

Exclusion Criteria:

1. Patients with long-term use of medications known to affect sleep integrity Current
2. alcohol or drug abuse
3. History of psychosis
4. Central sleep apnea syndromes
5. Previous OSA surgery
6. Other sleep disorders