cyrilzakka/clinical-trials huggingface dataset:
T-cell Depleted Hematopoietic Stem Cell Boosts Without Conditioning for Poor Marrow Graft Function Following Allogeneic Hematopoietic Stem Cell Transplantation

The purpose of this study is to see if giving the patient stem cells their original donor (boost) after removing the T cells (T cell depleted- TCD boost) without further chemotherapy. The investigators want to see if this can improve bone marrow function. This would also improve the patients white blood counts, red blood counts and platelets. This may make the patients chances of improving and surviving better. The investigators will also be looking at the short term side effects and risks of the TCD boost.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are diagnosed with PGF are candidates for this trial.
* Patients who underwent transplant at another facility and suffer from PGF will be eligible as well as long as a donor is available. PGF can be primary (no counts recovery after the preparative regimen) or secondary (cytopenia after engraftment has occurred).
* Patients with auto-immune cytopenia with auto antibodies to neutrophils or platelets or positive Coombs test that did not respond to immunosuppressive agents within 3 months from initiation of therapy are eligible as well.
* Persistent cytopenia requiring growth factors and/or blood products AND evidence of hypocellular BM (\<25%). Persistent cytopenia (at least 4 weeks period) is defined by presence of TWO of the following:

  1. ANC \<1.0x10\^9/L without filgrastim support or any ANC value that requires recurrent support by filgrastim (administered at least once a week).
  2. Plt\<50x10\^9/L
  3. Hb\<8 or PRBC transfusion dependent (once every 2 weeks or more) with reticulocyte count of \< 40x10\^9/L.

This criteria for persistent cytopenia and hypocellular bone marrow does not apply to patients with auto-immune cytopenia, ONLY PGF patients

* Full donor myeloid chimerism. Patients after T cell depletion transplant can have a significant mixed T cell chimerism and this can affect the testing of marrow chimerism. In this case, the neutrophil chimerism will be used to determine eligibility for this trial. Patients will be excluded if neutrophils are less than 90% donor cells; a higher percentage of host cells could be due to relapse or impending relapse.
* Age: pediatrics and adults patients. No age exclusion.
* Each patient must be willing to participate as a research subject and must sign an informed consent form.
* For infections and end organs related criteria (at time of TCD boost administration) see table in protocol.

Exclusion Criteria:

Patients will be excluded from the trial if at time of enrollment:

* Evidence of relapsed disease by morphologic, cytogenetic or molecular diagnostic tools.
* Hypersplenism documented by imaging study (US or CT)
* Pregnant women
* Patient who underwent TCD boost without counts recovery and are considered for another TCD boost will be treated off protocol.
Eustachian Tube Dilation With an Endovascular Balloon

The Eustachian tube is a narrow tube which links the back of the nose to the middle ear. Eustachian tube dysfunction may occur when the mucosal lining of the tube is swollen, or does not open or close properly. It can occur after the start of a cold and other nose, sinus, ear and throat infections causing ear pain and pressure, fullness, cracking/popping sounds. This is an ubiquitous healthcare problem, affecting children and adults, that can lead to severe consequences including hearing loss, chronic otitis media, tinnitus, and vertigo. Numerous studies have consistently failed to support the effectiveness of medical managements. Pressure equalizing tubes are considered a temporary solution that does not treat the underlying pathology. More recent preliminary evidence of using inflation of a noncompressible balloon in the eustachian tube improved clinical outcomes, patients' symptoms and quality of life. This eustachian dilation catheter is not accessible in Canada since the device and procedure is not covered by OHIP (Ontario health insurance plan) or any other health insurance in Canada. In a cadaver study, we have evaluated using an endovascular balloon (Balloon that is used to dilate (expand) vessels) for eustachian tube dilation, which only costs about 10% of the eustachian tube dilation device. This endovascular balloon is Health Canada approved, but not for this specific use. We therefore want to conduct a pilot safety study with the main goal of assessing feasibility of eustachian tube dilation with the endovascular device.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old (of both sexes)
* Diagnosed with unilateral or bilateral persistent obstructive eustachian tube dysfunction (OETD)
* Undergoing tympanoplasty or tympanomastoidectomy

Exclusion Criteria:

* Patulous eustachian tube
* Preoperative nasal endoscopy with evidence of anatomic conditions that would prevent transnasal access to the Eustachian tube
* CT temporal bone scan with evidence of carotid artery dehiscence, superior semicircular canal dehiscence, or extrinsic eustachian tube compression
* Patient unable to follow protocol for any reason
* Cleft palate or Craniofacial syndrome
* Prior eustachian tube intervention
* Prior radiation to the head and neck
High-frequency Ultrasound for Intraoperative Lymph Node Assessment in Gynecological Cancer: From Surgery to Radiomics

Lymph node assessment is crucial in gynecological cancers (ovarian, endometrial, cervical, and vulvar), as nodal involvement significantly impacts prognosis and treatment. Despite high morbidity, systematic lymphadenectomy has been widely used for staging and treatment planning. However, in most cases, lymph nodes are free from metastasis, making the procedure unnecessary and exposing patients to severe complications such as lymphedema and infections.

Sentinel lymph node (SLN) evaluation has emerged as a less invasive alternative, reducing unnecessary lymphadenectomies. However, SLN techniques face challenges, including detection failures, inaccurate frozen section analysis, and imaging limitations like false negatives in FDG PET/CT scans. The need for improved intraoperative imaging techniques is emphasized to enhance lymph node assessment, minimize surgical risks, and better tailor treatment approaches.


Eligibility Criteria:
Inclusion Criteria:

* Women undergoing surgery for gynecological malignancies (ovarian, endometrial, cervical, and vulvar cancer)
* Need for nodal excision (staging or cytoreductive reasons)
* 18-99 years old
* Absence of contemporary lymphatic diseases
* Absence of previous oncological disease in the last 5 years
* Willingness to participate in the study and to provide informed consent

Exclusion Criteria:

* Previous radiotherapy treatments
* Previous chemotherapy treatments
Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10)

Study CA239-0006 is an open-label, randomized Phase 3 clinical trial comparing the efficacy of MRTX849 administered in combination with cetuximab versus chemotherapy in the second-line treatment setting in patients with CRC with KRAS G12C mutation.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of colorectal carcinoma with KRAS G12C mutation in tumor tissue.
* Prior receipt of 1st line treatment in advanced CRC with a fluoropyrimidine-based chemotherapy regimen containing either oxaliplatin or irinotecan, and radiographically documented progression of disease on or after treatment.

Exclusion Criteria:

* Prior treatment with a therapy targeting KRAS G12C mutation (e.g., AMG 510).
* Prior treatment with an anti-EGFR antibody (e.g., cetuximab or panitumumab).
* Active brain metastasis
Examining the Effects of Neural Stimulation on Inhibitory Control and Cigarette Smoking

The purpose of this research study is to examine the effects of theta-burst Transcranial Magnetic Stimulation on inhibitory control and smoking among adult cigarette smokers.


Eligibility Criteria:
Inclusion Criteria:

1. Be between the ages of 18 and 65.
2. Be in stable mental and physical health.
3. Be willing to provide informed consent.
4. Be able to comply with protocol requirements and likely to complete all study procedures.
5. Be a current nicotine dependent cigarette smoker (smoke ≥10 cigs/day) with a minimum smoking history of smoking an average of ≥ 10 cigs/day over the past two years.

Exclusion Criteria:

* 1. Contraindication to MRI (e.g., presence of metal in the skull, orbits or intracranial cavity, claustrophobia).

  2. Contraindication to TMS (history of neurological disorder or seizure, increased intracranial pressure, brain surgery, or head trauma with loss of consciousness for \> 15 minutes, implanted electronic device, metal in the head, or pregnancy, as indicated by a positive urine pregnancy test at screening).

  3. Any use of substances that lower seizure threshold (such as thyroid medications or cocaine).

  4. History of autoimmune, endocrine, viral, or vascular disorder affecting the brain.

  5. History or MRI evidence of neurological disorder that would lead to local or diffuse brain lesions or significant physical impairment.

  6. Unstable cardiac disease, uncontrolled hypertension, severe renal or liver insufficiency, or sleep apnea.

  7. BAC greater than 0.0. 8. Any other condition or concern that in the Investigator's opinion would impact participant safety, compliance with study instructions, or potentially confound the interpretation of the study results.
Internet-delivered Attention Training for Obsessive-Compulsive Disorder

The goal of this study is to investigate an attention training program for participants with Obsessive-Compulsive Disorder. The attention training consists of a modified dot probe task with picture stimuli related to washing and checking paired with neutral pictures.

Participants are randomly assigned to an experimental and a placebo-control group. After a minimum of 4 weeks of attention training we expect to find differences between participants of the experimental and the control group in terms of attention bias, OCD symptoms, anxiety and depression.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of primary OCD according to OCI-R self report (cut-off \>=18)

Exclusion Criteria:

* suicidal
* substance abuse or addiction
* psychotic symptoms
* visual impairment if not compensated with optical aid

Current treatment is not an exclusion criterion, but data on treatment status (current psycho- or pharmacotherapy for OCD) will enter our statistical analyses.
Comparison of the Efficacy and Safety of Mirogabalin and Duloxetine in Chemotherapy-induced Peripheral Neuropathy in a Randomized Controlled Trial: a Quality of Life Study in Cancer Survivors

To conduct a two-arm, parallel, prospective, randomized controlled, open-label trial to compare the efficacy of the novel drug mirogabalin with the conventional treatment duloxetine in reducing pain associated with chemotherapy-induced peripheral neuropathy (CIPN).

There will be a difference in pain reduction after 4 weeks of treatment between the mirogabalin group and the duloxetine group in patients with chemotherapy-induced peripheral neuropathy (CIPN).

Participants will:

* Take drug duloxetine or a mirogabalin every day for 4 weeks.
* Visit the clinic once every 2 weeks for checkups and tests


Eligibility Criteria:
Inclusion Criteria:

* Cancer survivors aged 19 years or older.
* Peripheral, symmetrical pain in both feet occurring within 12 weeks of initiating chemotherapy with taxane or platinum agents (or their combination).
* Patients experiencing at least grade 2 peripheral neuropathy as defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, with an average pain intensity of 4 or higher on the Numerical Rating Scale (NRS) during the past week, following the completion of chemotherapy.
* Concurrent use of selected analgesics (acetaminophen, nonsteroidal anti-inflammatory drugs \[NSAIDs\]) is permitted if the following conditions are met:

  1. No new analgesics are introduced.
  2. Current analgesics are not discontinued.
  3. The total weekly 24-hour dose of analgesics does not vary by more than 10% during the 2 weeks prior to enrollment.
* Ongoing treatment for peripheral neuropathy or neuropathic pain must be discontinued at least 7 days before randomization

Exclusion Criteria:

* Patients with a prior diagnosis of peripheral neuropathy due to diabetes, trauma, alcohol abuse, compression, or other causes, or those with a previously diagnosed central nervous system disorder. (Patients with pre-existing diabetes or thyroid disease who had no symptoms of peripheral neuropathy, such as numbness or tingling in the hands or feet, before chemotherapy may be included.)
* Patients with significant psychiatric disorders, such as severe depression, bipolar disorder, or suicidal ideation.
* Pregnant or breastfeeding patients.
* Patients with a history of prior treatment with other neurotoxic chemotherapeutic agents.
* Patients with renal impairment (creatinine clearance \< 30 mL/min) or hepatic dysfunction.
* Patients with planned surgical procedures within 4 weeks of enrollment.
Investigation of the 24 Hour Forced Expiratory Flow in 1 Second (FEV1) Profile of a Single Dose of Indacaterol/Mometasone Delivered Via the TWISTHALER® Device in Adult Patients With Persistent Asthma

This study is designed to provide data about the 24 hours FEV1 profile, safety and tolerability of indacaterol/mometasone TWISTHALER device compared to placebo and using fluticasone/salmeterol as an active control.


Eligibility Criteria:
Inclusion Criteria:

* Male and female adult patients aged 18-75 years (inclusive), who have signed an Informed Consent Form prior to initiation of any study-related procedure,
* Patients with persistent asthma, diagnosed according to Global Initiative for Asthma (GINA) guidelines (National Institute of Health, National Heart, Lung and Blood Institute, 2006) and who additionally meet the following criteria:

  * Patients receiving daily treatment with inhaled corticosteroid up to the maximum dose per day indicated in the product label, in a stable regimen for the month prior to Visit 1.
  * Patients with an FEV1 at Visit 1 ≥50% of predicted normal.
  * Patients who demonstrate an increase of ≥ 12% and ≥ 200 mL in FEV1 over their pre-bronchodilator.

Exclusion Criteria:

* Pregnant women, nursing mothers, or females of childbearing potential, regardless of whether or not sexually active, if they are not using a reliable form of contraception.
* Patients who have used tobacco products within the 6 months period prior to Visit 1, or who have a smoking history of greater than 10 pack years.
* Patients diagnosed with Chronic Obstructive Pulmonary disease (COPD) as defined by the GOLD guidelines (Global Initiative for Chronic Obstructive Lung Disease 2006).
* Patients with seasonal allergy whose asthma is likely to deteriorate during the study period.
* Patients who have had an acute asthma attack/exacerbation requiring hospitalization in the 6 months prior to Visit 1.
* Patients who have had an acute asthma attack / exacerbation requiring an emergency room visit within 6 weeks prior to Visit 1 or at any time between Visit 1 and Visit 2.
* Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1 or at any time between Visit 1 and Visit 2.
* Patients with a history of long QT interval syndrome or whose QT interval corrected for heart rate (QTc) interval (Bazett's) measured at Visit 1 or Visit 2 is prolonged: \> 450 ms (males) or \> 470 ms (females).
* Other clinically significant conditions which may interfere with the study conduct or patient safety as specified in the protocol.

Other protocol-defined inclusion/exclusion criteria may apply.
Ketone Plasma Kinetics After Oral Intake Of Different MCT

This research project is aimed at identifying the MCT formulation matrixes that provide the highest ketoindex values and extended half-life, as well as to provide an initial evaluation of the GI tolerability of the various formula. For comparison, ketones salts and esters (food grade) will be also evaluated.

Monocentric, open, randomized, controlled research project. The global research project will include several testing cycles as described in the figure 1. In each cycle, several research products (up to 4) will be tested on up to 20 participants in a partial or full cross-over design. Once cycle 1 is completed, blood parameters will be analysed and ketoindex will be calculated as area under the curve (AUC) of total ketones (BHB + AcA) over 4h / quantity of ingested MCTs in g. Based on ketoindex and ketones Thalf (T1/2: time to reach half of AUC-infinite of total ketones) values, new products will be developed for cycle 2.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-50 years
2. Healthy men and women, based on the medical screening visit and medical history
3. BMI in the normal and overweight range 18.5 ≤ BMI ≤ 27.
4. Able to understand and to sign a written informed consent prior to study entry

Exclusion Criteria:

1. Any medication possibly impacting the postprandial glucose and insulin response (on anamnesis, to the opinion of the medical expert)
2. Any medication impacting dietary fat absorption and metabolism or impacting postprandial glucose and insulin response, to the opinion of the medical expert
3. Pregnancy (on anamnesis) and/or lactation
4. Known food allergy and food intolerance
5. Individuals undergoing either dietary or exercise mediated weight loss program prescribed by a health care professional
6. Individuals under ketogenic diets, or taking regular ketones products such as MCT, ketone esters or ketone salts (calcium, magnesium, sodium, potassium)
7. Alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of bier
8. Having given blood within the last month, or willing to make a blood donation until one month following the end of the study
9. Participant having a hierarchical link with the research team members
10. Not expected to follow the protocol.
11. Smokers unable to stop for the day of the visit
Bioequivalence of Empagliflozin and Metformin Given as a Fixed Dose Combination Compared to Single Tablets

The primary objective of this trial is to establish bioequivalence of two fixed dose combination (FDC) tablets (containing medium dose empagliflozin/500 mg metformin \[Test 1\] and low dose empagliflozin/500 mg metformin \[Test 2\]) and of the single tablets (medium dose empagliflozin tablets + Glucophage® 500 mg tablet \[Reference 1\] and low dose empagliflozin tablet + Glucophage® 500 mg tablet \[Reference 2\]) when administered together after a high fat, high caloric meal.

The assessment of safety and tolerability will be an additional objective of this trial.


Eligibility Criteria:
Inclusion criteria:

1. Healthy male and female subjects
2. Subjects must be able to understand and comply with study requirements
3. Age 18 to 50 years
4. Body mass index (BMI) 18.5 to 29.9 kg/m2

Exclusion criteria:

1. Any relevant deviation from healthy conditions
Evaluation of Biomarkers of Atopic Dermatitis in Pediatric Patients (PEDISTAD BIOMARKER STUDY)

Primary Objective:

To explore associations between biomarkers of atopic dermatitis (AD) and:

* Disease state and time course of AD,
* Disease state and evolution of selected atopic comorbid conditions,
* Effectiveness of specific AD treatments.

The estimated enrollment duration is approximately 2 years, while duration of observation is approximately 5 years.

Eligibility Criteria:
Inclusion criteria:

* Participation in the OBS15333 pediatric atopic dermatitis (AD) registry.
* Signed informed consent by the parent/legally acceptable representative and assent by the participant appropriate to the participant's age.

Exclusion criteria:

Not applicable.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Multiple Sclerosis Intimacy and Sexuality Questionnaire

Aims: This study aimed to psychometrically evaluate the Turkish version of the Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-15) in women with MS.

Methods: The study included 130 women with MS. The Turkish linguistic validation process of the original English MSISQ-15 was performed according to standardized guidelines. Reliability analysis was evaluated with test-retest analysis and intra-class correlation (ICC). Internal consistency between the items was analyzed using the Cronbach's alpha coefficient. Item analysis results were used to assess the contribution of the items to the scale. In evaluating the validity of the scale, the relationship between the MSISQ and the Female Sexual Function Index (FSFI), the Multiple Sclerosis Quality of Life Questionnaire-54 (MSQOL-54), and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PSIQ-12) was investigated. Psychometric properties were analyzed using internal consistency, test-rest reliability, construct validity, and floor-ceiling effect.


Eligibility Criteria:
Inclusion Criteria:

* Women over the age of 18 who were literate,
* who did not have any mental problems preventing cooperation and understanding,
* who were diagnosed with MS

Exclusion Criteria:

* Having pelvic organ prolapse stage 2 or more;
* having a history of relapse in the past 30 days;
* experiencing loss of balance or gait disturbance caused by a condition other than MS;
* being pregnant; having a history of gynecological, urological and/or neurological surgery;
* having a history of cesarean or vaginal birth in the past six months;
* being sexually inactive; and, having urinary tract infections
Effect of Osimertinib in Ethnic Chinese With EGFR and T790M Mutated NSCLC

To assess the effectiveness and safety of osimertinib treatment in a real world setting.

The current study will not only assess the effectiveness of osimertinib treatment in a real world setting, but will also help us to understand the real-world testing patterns among T790M mutation positive locally advanced or metastatic NSCLC patients who have progressed after EGFR TKI treatment.

Eligibility Criteria:
Inclusion Criteria:

* Above 18 years of age;
* Locally advanced (stage IIIB) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy
* Confirmed T790M mutation
* Progressed on previous EGFR TKI treatment. Patients may have also received additional lines of treatment
* Received osimertinib treatment in the participating site between May 1st and Oct 31st 2016

Exclusion Criteria:

• Enrolment in studies that prohibit any participation in this observational study