cyrilzakka/clinical-trials huggingface dataset:
Mothers Experience of Pain Following Elective Cesarean Section. A Qualitative Study.

Background and aim:

In Denmark, approx 56.000 babies are born every year, and approx 20% of them are born by cesarean sections. Half of these cesarean sections are elective. Previous studies have shown that many women experience severe pain in the days following the cesarean section, thus limiting their ability to care for their baby and recover.

The Danish national anesthesiological research network, CEPRA (Collaboration for Evidence based Practice and Research in Anesthesia) is planning a national study on pain following elective cesarean sections. In order to assure that the investigators will be using actual patient-relevant outcomes in this large national study, the aim with this qualitative study is to obtain knowledge on how Danish women experience pain, recovery and function following an elective cesarean section.

Methods:

This is a qualitative study based on semi-structured telephone interviews with women 4-7 days after an elective cesarean section.

The study will take place in three Danish hospitals (Kolding, Copenhagen and Hillerød).

Women aged 18 or above, scheduled for elective cesarean section, will be eligible for inclusion.

Women will be informed about the study, orally and in writing, at the pre-anesthesiological consultation, which is held a few days before the cesarean section. Participation is completely voluntary. If they to participate, participants will sign a consent form. The investigators will include and interview participants until data saturation occurs. It is expected that 20-30 women should be included in total, evenly distributed at the three participating hospitals.

Interviews will be held by telephone, recorded digitally and transscribed verbatim. Transscribed interviews will be coded for categories and themes using the NVivo software. Data will be analysed using manifest content analysis.

Baseline characteristics will be handled with descriptive statistics.

The primary outcome of the study is a thematic analysis of Danish womens experience of pain, recovery and function following an elective cesarean section.


Eligibility Criteria:
Inclusion Criteria:

* women undergoing an elective cesarean section under spinal anesthesia
* speaking/writing Danish

Exclusion Criteria:

* cesarean section performed under general anesthesia
Effect of Photodynamic Therapy With Low-level Laser on Infected Dentin in Primary Teeth: A Controlled Clinical Trial

The aim of the proposed study is to assess the clinical effect of photodynamic therapy (PDT) on dentin with carious lesions in primary teeth. Patients with primary molars exhibiting deep carious lesions on the occlusal surface indicated for restorative treatment will be randomly allocated to three groups: Group 1 - traditional caries removal with a low-speed drill; Group 2 - PDT + PapaMblue (carious tissue removal agent) modified with methylene blue; and Group 3 - PDT with methylene blue 0.05%. PDT will be performed with low-level laser for the treatment of the carious tissue. Dentin samples will be removed before and after PDT for microbiological analysis. The microbiological samples will be cultured in Brucella blood agar, Mitis Salibarius-bacitracin agar and Rogosa SL agar. The teeth will then be restored using high-viscosity glass ionomer cement, with clinical and radiographic follow up at six, 12 and 24 months. The data will be submitted to descriptive statistics.

The groups of study (Group 1)- Conventional caries removal with low-speed drill (Group 2)- PDT combined with PapaMblue (Group 3)- PDT combined with methylene blue

The data in descriptive statistics will be used The chi-squared test and Fisher's exact test will be used for the comparison of categorical variables (age and gender). The Student's t-test and analysis of variance will be used for the comparison of signs and symptoms of reversible pulpitis. Pearson's correlation coefficients will be calculated to determine the strength of correlations among the continuous variables.

Eligibility Criteria:
Inclusion Criteria:

Adequate health, with no systemic conditions; Cooperative behavior; Presence of at least one primary molar with acute, active carious lesion not surpassing 2/3 of the dentin and only involving the occlusal face, with direct view and access and no clinical or radiographic signs of pulp involvement

Exclusion Criteria:

Systemic condition; Uncooperative behavior; Class II, III, IV or V carious lesion (Black's classification); Clinical evidence of carious lesion involving enamel, deficient restorations, insufficient size of carious lesion on dentin for access to dental instrument, hidden carious lesions, sign or symptom of pulp involvement, clinical impossibility of restoration; Radiographic evidence of pulp involvement; carious lesion surpassing 2/3 of dentin.
Study of Menactra® in US Adolescents When Administered Concomitantly With Tdap Vaccine

The purpose of this study was to evaluate the immunogenicity and safety of the concomitant administration of Menactra® vaccine and Tdap vaccine in adolescents aged 11 to 17 years.

Primary Objective:

To determine whether concomitant administration of two vaccines, Tdap and Menactra®, induces antibody responses that are similar to those observed when each vaccine is given separately.

Secondary Objective:

To compare the rates of injection site reactions at the Tdap injection site after Tdap and Menactra® vaccines are administered concomitantly to the corresponding rates of reactions when Tdap vaccine is administered alone.


Eligibility Criteria:
Inclusion Criteria :

* Healthy as determined by medical history and physical examination.
* Aged ≥ 11 to 17 years at the time of study vaccination on Day 0.
* Informed consent form that has been approved by the Institutional Review Board (IRB) signed by the parent or legal guardian.
* Informed assent form that has been approved by the IRB signed by the subject.
* Subject (female) agrees to use measures to prevent pregnancy during the study.

Exclusion Criteria :

* Serious chronic disease (i.e. cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, etc.).
* Known or suspected impairment of immunologic function.
* Acute medical illness with or without fever within the last 72 hours or an oral temperature ≥ 100.4°F (≥ 38.0°C) at the time of enrolment.
* History of documented invasive meningococcal disease or previous meningococcal vaccination.
* History of documented infection with Bordetella pertussis, Clostridium tetani, or Corynebacterium diphtheriae or vaccination with any tetanus, diphtheria or pertussis vaccine within the previous 5 years.
* Received either immune globulin or other blood products within the last 3 months; or received injected or oral corticosteroids, or other immunomodulator therapy, within 6 weeks of the study vaccines. Individuals on a tapering dose schedule of oral steroids lasting \<7 days and individuals (e.g., asthmatics) on a short schedule of oral steroids lasting 3 to 4 days may be included in the trial as long as they have not received more than one course within the last 2 weeks prior to enrolment.
* Received antibiotic therapy within the 72 hours prior to vaccination on Day 0.
* Received any vaccine 28 days prior to the 1st study vaccination or scheduled to receive any vaccination during the course of the study.
* Suspected or known hypersensitivity to either of the two study vaccines or their components.
* Unavailable for the entire study period, or unable to attend the scheduled visits or to comply with the study procedures.
* Enrolled in another clinical trial.
* Diagnosed with any condition, which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
* For all females, a positive or equivocal urine pregnancy test at time of study vaccination.
* Nursing mothers.
Automated Method for Breast Cancer Detection

Participants with suspicious breast lesions by mammography will undergo fine needle aspiration (FNA) under ultrasound guidance. The FNA will be read by the cytopathologist and analyzed in the breast cancer detection cartridge. All patients will receive standard of care (Ultrasound-guided core needle biopsy and diagnosis). We will also receive FNA collected from 60 patients with palpable lesions in South Africa and analyze them samples in our lab with the same method.


Eligibility Criteria:
Inclusion Criteria:

* Patient must be female
* Patient must be 18 years of age or older
* Patient has been recommended for ultrasound core needle biopsy of a suspicious breast lesion

Exclusion Criteria:

* Patients may be excluded for any condition that in the opinion of the investigator may not make it safe to take part (e.g. certain medicines).
Samarium-153 With Neoadjuvant Hormonal and Radiation Therapy for Locally Advanced Prostate Cancer

The purpose of this study is to determine the safety and effectiveness of Samarium-153 when given in combination with hormonal and external beam radiation therapy in men with high risk prostate cancer.

The likelihood of prostate cancer cells metastasizing to bone has an early and important influence on the natural history of prostate cancer. Bone-targeted therapy, when given sequentially with hormonal therapy (androgen suppression) and radiation therapy, prolongs the progression of the disease in clinically non-metastatic prostate cancer patients.

The use of Samarium-153 EDTMP in conjunction with hormonal therapy and external beam radiation therapy has never been previously evaluated in high risk clinically localized prostate cancer. Many patients with high-risk prostate cancer develop progressive disease within 2 years of therapy indicating that subclinical metastatic disease may be present at the time of initial diagnosis. In these high-risk patients, there may be a therapeutic benefit of combining hormonal therapy with external beam radiation therapy and Samarium-153 EDTMP to treat localized and subclinical bony disease, respectively.

Eligibility Criteria:
Inclusion Criteria:

* PSA 20-150 and Gleason score greater than or equal to 7 or clinical stage greater than or equal to T2, Gleason greater than or equal to 8, PSA less than or equal to 150
* Pathologically positive lymph nodes
* Pretreatment must be prior to study entry and prior to any hormonal therapy
* Zubrod 0-1
* Adequate hematologic function

Exclusion Criteria:

* Patients with PSA equal to or greater than 150
* Neuroendocrine features on histologic examination
* Radiologic evidence of metastatic disease
* Previous malignancy within last 5 years
* Prior pelvic radiation therapy or orchiectomy
Evaluating the Efficacy and Safety of TJO-087 in Moderate to Severe Dry Eye Disease Patients

The purpose of this clinical study is to prove that the test drug (TJO-087) is not clinically inferior to the control drug after 32 weeks of administration to patients with suppressed tear production due to moderate or severe dry eye syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 20 or over
* Patients with moderate to severe dry eye
* Screening both eyes, the corrected visual acuity is 0.2 or more
* Written informed consent to participate in the trial

Exclusion Criteria:

* Screening visits within 2 weeks who treated with topical NSAIDs/hyaluronate sodium ophthalmic solutions
* Screening visits within 2 months the patients with systemic or ocular disorders affected the test results (ocular surgery, trauma, or disease)
* Intraocular pressure(IOP)\> 25 mmHg
* Patient using or to use punctual plug within 1 months.
* Patients with contact lens.
Growth Hormone in Amyotrophic Lateral Sclerosis

Several drugs have been proposed for ALS. These drugs included: Topiramate, Lamotrigine, creatine, Vit. E, Pentoxifylline, etc. Although most of the trials showed a positive trend, none of them reached a statistically significant result. The only exception is the Riluzole trial, that demonstrated a small but significant reduction in mortality between treated and untreated patients. Aim of our study is to determine if the add-on of GH to treatment with Riluzole is able to reduce neuronal loss in the motor cortex of ALS patients.

Several drugs have been proposed for ALS. These drugs included: Topiramate, Lamotrigine, creatine, Vit. E, Pentoxifylline. Although most of the trials showed a positive trend, none of them reached a statistically significant result. The only exception is the Riluzole trial, that demonstrated a small but significant reduction in mortality between treated and untreated patients. When administered to SOD-1 transgenic mice, IGF-I prolongs survival, ameliorates muscular strength, and reduces weight and motor neuron loss, astrocyte gliosis, and ubiquitin positive protein inclusions.

Two clinical trials have been performed in ALS patients with s.c. administration of IGF-I indicating a possible beneficial effect, and a third clinical trial is in progress. Methionyl growth hormone (mGH) showed no effect on survival, disease progression and muscular strength. MGH was administered at a fixed dose and peripheral production of IGF-I appeared to be normal. We propose a double-blind trial of Growth Hormone (GH) as add-on therapy to Riluzole, with an individually regulated dose based on the peripheral response of IGF-I. Aim of our study is to determine if the add-on of GH to treatment with Riluzole is able to reduce neuronal loss in the motor cortex of ALS patients. As secondary objectives, effect of GH on mortality, QoL, and motor function will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Definite/probable ALS according to El Escorial criteria
* Aged \> 40, \< 85 years
* Progression from onset
* Disease duration ≤3 years
* Treatment with Riluzole

Exclusion Criteria:

* Rapid disease progression in the first 6 months after diagnosis
* Patients with tracheostomy and/or Gastrostomy
* Disease duration \> 3 years
* Patient with exclusive bulbar or 2° motorneuron involvement
* Hepatic/renal failure
* Pregnant or breastfeeding
* Signs of active neoplasia
* Complicated Diabetes
* Severe hypertension
* Unable to undergo MRI exams
Validation of the Identification of Functional Ankle Instability (IdFAI) in Italian

The purpose of the study is actually the translation, cultural adaptation and psychometric validation in the Italian Version of the Identification of Functional Ankle Instability (IdFAI) English Version for use in outpatient clinics in non-English subjects to objectify chronic ankle instability.

The hypothesis is to translate and culturally adapt the scale successfully and demonstrate a good factorial structure and psychometric properties, replicating the results of the original English version of the questionnaire

Eligibility Criteria:
Participants without ankle sprain.

1. Age ≥ 18aa
2. Speak Italian on a daily basis
3. No pathologies or surgical treatments in the lower limbs currently or in the past

Participants with ankle sprain.

Inclusion Criteria

1. Age ≥ 18aa
2. Speak Italian on a daily basis
3. At least one ankle sprain
4. Recurrent sprain to the same ankle and/or sensation of ankle instability and/or 'giving way'

Exclusion Criteria

1. Inability to understand written Italian
2. Acute lower extremity injury occurred in the three months preceding the compilation of the questionnaire
3. History of others lower extremity musculoskeletal diseases or injuries of other joints (i.e, hip, knee), previous ankle fractures or systemic pathologies (i.e., neurological disorders, rheumatoid arthritis) currently or in the past
4. History of surgical treatments in either lower limb (bones, joints, nerves)
Evaluation of the Effect of Pulmonary Rehabilitation on Patients With High Flow Oxygen Therapy

Evaluation of the effect of pulmonary rehabilitation on patients with high flow oxygen therapy

Objective: the purpose of this study was to evaluate the effect of lung rehabilitation on patients treated with high flow humidification apparatus in ICU. Methods: 70 patients in ICU who were treated with high flow humidification apparatus from June 2019 to June 2020 were randomly divided into two groups. The experimental group was treated with pulmonary rehabilitation and the control group was treated with routine medical treatment only. All patients were evaluated and measured by bedside diaphragm ultrasound. The vital signs of all patients were monitored every day. MRCsum assessment of peripheral muscle strength, 30s sitting test, modified Barthel index, Borg dyspnea score, arterial blood gas analysis and bedside diaphragm ultrasound monitoring were performed at admission and discharge. Finally, statistics were made on the use of non-invasive ventilator, endotracheal intubation, new complications (pressure sore, aspiration, thrombus, etc.) and the time of patients getting out of bed for the first time.The end point of the experiment was 28 days.

Eligibility Criteria:
Inclusion Criteria:

* The age is ≥ 18 years old;
* the hemodynamics is stable;
* 50 \< heart rate \< 120 beats / min ;
* 90 \< systolic blood pressure \< 200mmHg ;
* 55 \< mean arterial pressure \< 120mmHg;
* do not increase the dose of pressor drugs for at least 2 hours;
* intracranial pressure is stable and there are no seizures within 24 hours;
* the respiratory state is stable;
* the patient's finger pulse oxygen saturation ≥ 88%;
* 10 \< respiratory frequency \< 35 beats / min.

Exclusion Criteria:

* Pregnancy;
* acute cardio-cerebrovascular events;
* spinal or limb fractures;
* active bleeding.
Carotid Plaque Burden in Patients With Philadelphia Negative Myeloproliferative Neoplasms

In around 90% of the patients with MPNs, an acquired mutation that promotes JAK/STAT signaling is identified \[3, 4\]. The JAK/STAT pathway transduces signals from cytokines including erythropoietin, thrombopoietin, and granulocyte colony-stimulating factor.24 A point mutation that activates JAK2, JAK2V617F, is present in around 95% of patients with PV and 40% to 60% of patients with ET and MF

All patients will be subjected to a thorough assessment of history, complete clinical examination, and investigations as complete blood picture including neutrophil-lymphocyte ratio which will be analyzed with automated blood count analyzers, serum uric acid, serum creatinine and lipid profile. All patients will undergo carotid imaging using Colour Doppler ultrasonography for assessment of carotid plaque burden.

The control group will undergo carotid ultrasonography who will be recruited among apparently healthy volunteers aiming to match the patient group regarding age, sex and classical risk factors for atherosclerosis as arterial hypertension, hyperlipidemia, diabetes, smoking or obesity.

Eligibility Criteria:
Inclusion Criteria:

* All patients aged 18 years and older who were newly diagnosed to have Philadelphia negative myeloproliferative neoplasms between September 2014 and November 2022 at Sohag university hospital, department of internal medicine, hematology unit and hematology outpatient clinic.

Exclusion Criteria:

* Patients were excluded if: (1) their disease of thrombocytosis or polycythemia was determined to be reactive, (2) their disease was not newly diagnosed, (3) their disease met WHO criteria for chronic or acute myeloid leukemia.
The Evaluation of External Thermomechanical Stimulation for Pain Reduction in Patients Undergoing Nail Injection

The purpose of this study is to assess the efficacy and safety of a thermomechanical device delivering vibration and cold stimuli in lowering pain during intramatricial nail injections


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 years or older
* Must understand and voluntarily sign an informed consent form
* All patients undergoing intramatricial nail injections at the Weill Cornell Medicine (WCM) Department of Dermatology
* Willingness to participate in the study

Exclusion Criteria:

* Inability of the patient to provide written informed consent for any reason
* Failure to have nail injection performed
* Likely inability to comply with the study protocol or cooperate fully with the research team
Study of the Efficacy and Safety of AMT-101 in Combination With Adalimumab in Subjects With Ulcerative Colitis (MARKET)

Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Combination With Adalimumab in Subjects with Moderate to Severe Ulcerative Colitis.

This is a Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study to evaluate the Efficacy and Safety of Oral AMT-101 in Combination with Adalimumab in Subjects with Moderate to Severe Ulcerative Colitis.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects aged 18 to 75 years.
* Moderate to severe UC.
* Eligible for Humira (adalimumab) therapy.
* Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and at the randomization visit.
* Written informed consent must be obtained and documented.

Exclusion Criteria:

* Known gastrologic, or systemic condition that may compromise severity or diagnosis of disease.
* History or current evidence of colonic or abdominal abnormalities.
* Prohibited therapies or procedures before the screening period as specified per protocol.
* A concurrent clinically significant, serious, unstable, or uncontrolled underlying cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, might confound the study results, pose additional risk to the subject, or interfere with the subject's ability to participate fully in the study.
* Pregnant or lactating females.
* Current or recent history of alcohol dependence, illicit drug use, mental or legal incapacitation, or a history of clinically significant psychiatric disorders that, in the opinion of the investigator, may interfere with the subject's ability to comply with the study procedures.
* Unable to attend study visits or comply with procedures.
* Previous exposure to AMT-101 or similar and known hypersensitivity to AMT-101 or its excipients.
Study on the Safety and Effects on Lipids of FM-VP4 in Subjects With Primary Hypercholesterolemia

The purpose of this study is to evaluate the safety and effects on lipids of FM-VP4 administered for 12 weeks in subjects with mild to moderate primary hypercholesterolemia.


Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate primary hypercholesterolemia
* Able to give informed consent and to comply with study procedures (including diet)

Exclusion Criteria:

* Homozygous familial hypercholesterolemia
* Age \<18 or \>75 years
* Pregnant women or women of child-bearing potential
A Prospective Evaluation of Clinical Equivalence Between iX and PID

Patients with chronic wounds will be imaged using 2 imaging devices. Two types of images will be acquired with each device, a standard photograph (ST-image) and a fluorescence image (FL-image). The images captured with the 2 imaging devices will be compared off-line by many interpreters to assess for any differences in the images that would alter a clinical decision.

Patients (n = 50) with chronic wounds will be imaged using 2 imaging devices. Two types of images will be acquired with each device, as standard photograph (ST-image) and a fluorescence image (FL-image). The images captured with the 2 imaging devices will be compared off-line by many interpreters to assess for any differences in the images that would alter a clinical decision.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects presenting at an advanced outpatient wound care clinic with wound(s) of unknown infection status
2. 18 years of age or older

Exclusion Criteria:

1. Treatment with an investigational drug within 1 month before study enrollment
2. Subjects with recent (\<30 days) biopsy or curettage of target wound
3. Subjects with wounds that cannot be completely imaged by study device due to anatomic location
4. Unable or unwilling to consent