cyrilzakka/clinical-trials huggingface dataset:
A Phase I/II Study of Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia

To determine the maximum tolerated dose (MTD) and toxicity of sargramostim (recombinant granulocyte-macrophage colony-stimulating factor; GM-CSF) given by continuous intravenous infusion (CIV) in patients with leukopenia in association with AIDS virus infection. In addition, single dose and steady state pharmacokinetics will also be determined.


Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Met the CDC criteria for the diagnosis of AIDS.
* Total peripheral blood leukocyte count = or \< 3000 cells/mm3 measured on at least two occasions separated by a minimum of one week.
* Must have or have recovered from one or more opportunistic infection.
* Serum antibody to HTLV-III/LAV with or without viremia.
* Anticipated survival of at least 6 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* AIDS related complex (ARC).
* History of malignancy other than Kaposi's sarcoma (KS).
* Excessive diarrhea (more than 5 liquid or non-liquid stools per day).
* Currently hospitalized or hospitalized within the last 4 weeks for the treatment of opportunistic infections.
* Presence of renal dysfunction.
* Other evidence of primary hematologic or infectious disorders unrelated to AIDS virus infection.

Patients with the following are excluded:

* AIDS related complex (ARC).
* History of malignancy other than Kaposi's sarcoma (KS).
* Excessive diarrhea (more than 5 liquid or non-liquid stools per day).
* Currently hospitalized or hospitalized within the last 4 weeks for the treatment of an opportunistic infection.
* Dementia or altered mental status that would prohibit the giving and understanding of informed consent.

Prior Medication:

Excluded:

* Any marrow suppressive medications such as trimethoprim-sulfamethoxazole combination (TMP-PurposeX) or Fansidar.
* Excluded within 6 weeks of study entry:
* Any investigational drug.

Prior Treatment:

Excluded within 6 weeks of study entry:

* Systemic cytotoxic chemotherapy or irradiation.

Risk Behavior:

Excluded within 3 months of study entry:

* Regular, excessive use of alcohol, hallucinogens or agents which are addicting.
Trajectory of Positive Psychological States in Patients With ACS

The purpose of the study is to to determine the natural history of positive psychological states, health status, and functioning, over an 8 week period following admission for an acute coronary syndrome (ACS). We aim to compare the changes in these factors from baseline to 8-week follow-up with corresponding changes in the completed proof-of-concept intervention trial (NCT02004158).


Eligibility Criteria:
Inclusion Criteria:

* Suboptimal adherence to health behaviors. This will be defined as mean item score of \<15 (suboptimal) on three Medical Outcomes Study-Specific Adherence Scale (MOS SAS) items.
* Submaximal self-reported optimism. This will be defined as a total score of \<30 on the Life Orientation Test-Revised (LOT-R) .
* Submaximal self-reported positive affect. This will be defined as a total score of \<50 on the Positive and Negative Affect Schedule (PANAS) .

Exclusion Criteria:

* Cognitive deficits, assessed via a 6-item cognitive screen used to assess appropriate participation of medically-ill patients in research studies.
* Medical conditions precluding interviews or likely to lead to death within 6 months, determined in consultation with the primary treatment team and cardiology co-investigator Dr. Januzzi.
* Inability to communicate in English.
* Inability to participate in physical activity.
Thoracic Ultrasound in the Treatment of Pleural Effusion

The main objective of the study is to assess the cost-effectiveness ratio of two management strategies of pleurisy in adults : a strategy by systematic thoracic ultrasound versus a strategy without thoracic ultrasound.

Comparison of two management strategies pleural effusions from diagnosis and during the first year of follow up care.

Patients are randomized into two groups, each group receiving a different management strategy.

Both strategies are compared:

Strategy A that involves the systematic use of thoracic ultrasound for the treatment of pleural effusion, treatment and follow up care. It will be possible to have recourse to other tests (such as chest CT) if deemed necessary by the practitioner.

Strategy B, which consists of the usual care pleurisy and thus without use of ultrasound: gestures are guided either by chest radiograph or by CT chest as necessary in the treatment and monitoring. A systematic radiographic pleural after each gesture is performed.

The management is inspired by the English recommendations currently validated and applied in Anglo-Saxon countries.

Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized or seen in consultation with pleural effusion diagnosed clinically or radiologically whatever be its initial management.

Exclusion Criteria:

* Patient with a neoplasia
The Influence and Effects of the COVID-19 Pandemic on Orthopaedic Resident Training

Orthopedic residents, like all other healthcare professionals, face unique challenges during the coronavirus disease 2019 (COVID-19). The rapid spread of COVID-19 has forced healthcare systems around the world to adapt. As in many other specialties, it has led to many changes in the training of orthopedic residents including restructuring of surgical training, a reduction in elective surgery cases, and re-assignment of residents to COVID-19-related clinical duties. As a result, the standard training curriculum has been interrupted and the number of surgical cases has decreased, limiting the ability of the residents to meet the range and number of patient follow-up and treatment requirements set by the Turkish Orthopedics and Traumatology Education Council (TOTEK).

The already stressful work environment of orthopedic residents has become more stressful and anxious with the COVID-19 pandemic.

There are no well-designed survey studies that have shown the impact of the COVID-19 pandemic on orthopedic resident education and well-being from the resident's perspective. Therefore, the purpose of this nationwide survey study was to document and analyze the effects of the COVID-19 pandemic on the real-life experiences of orthopedic residents in Turkey.


Eligibility Criteria:
Inclusion Criteria:

Volunteering to answer survey questions

Exclusion Criteria:

Incomplete answers to survey questions or refusing to participate in the survey
Is the Neosquamous Epithelium "Normal" Following Endoscopic Ablation of Dysplastic Barrett's Esophagus?

The investigators propose a study comparing the morphological and functional aspects of the neosquamous epithelium (NSE) after ablative therapy for dysplastic Barrett's esophagus (BE) to that of native squamous epithelium in normal controls as well as gastroesophageal reflux disease (GERD), non-Barrett's Esophagus (BE) subjects.

Purpose: We propose a study comparing the morphological and functional aspects of the neosquamous epithelium (NSE) after ablative therapy for dysplastic Barrett's esophagus (BE) to that of native squamous epithelium in normal controls as well as gastroesophageal reflux disease (GERD), non-BE subjects.

Participants: Eligible subjects will be women and men between the ages of 18-80, with one of the following:

1. Two or greater cm of dysplastic BE, who will undergo or have undergone radiofrequency ablation for BE at UNC, or
2. Diagnosed with GERD per a gastrointestinal (GI) physician undergoing upper endoscopy for other indications at UNC, or
3. Non-GERD controls per a GI physician with normal esophageal mucosa undergoing upper endoscopy for other indications at UNC.

Procedures (methods): Esophageal biopsies will be obtained specifically for research purposes before ablation therapy or, in subjects not receiving ablative therapy, after completion of the clinically indicated procedure and before withdrawal of the endoscope. Information from the medical record or from patient interview will be obtained regarding diagnosis (Barrett's esophagus, GERD, etc), and a questionnaire administered regarding the duration and frequency of reflux symptoms and complications of reflux disease. Subjects who are enrolled in the pre-ablation group will have additional biopsies and questionnaires administered during scheduled follow-up visits. On the last follow-up visit, this group will also undergo impedance-pH testing using standard methods, to assess for degree of control of esophageal acid exposure, and for number, duration and symptom correlation of non-acid reflux events.

Eligibility Criteria:
Inclusion:

Eligible subjects will be mentally competent women and men between the ages of 18-80, able to speak and read English and who meet one of the following criteria:

* Two or greater cm of dysplastic Barrett's Esophagus (BE), who will undergo or have undergone radiofrequency ablation (RFA) for BE at the University of North Carolina, Chapel Hill (UNC), or
* Diagnosed with gastroesophageal reflux disease (GERD) per a GI physician undergoing upper endoscopy (EGD) for other indications at UNC, or
* Non-GERD controls per a GI physician with normal esophageal mucosa undergoing upper endoscopy for other indications at UNC.

Exclusion:

* Subjects with a bleeding diathesis or other contraindication of endoscopic biopsy.
* Current use of warfarin, heparin, and/or low molecular weight heparin (requires discontinuation of medication 5 days prior to and 7 days after EGD).
* Pregnant women
A Study to Determine the Relief of Dry Eye Symptoms With the Use of TheraTears® Products (DUNLIN)

Dry eye is a very common condition that most often affects women and the elderly, and can be caused when the eyes do not produce enough tears, or when the tears evaporate too quickly. Although there isn't a simple cure for dry eye, there are numerous products on the market that attempt to help relieve some of the discomfort caused by this condition. Some of these products include artificial tears, omega-3 supplements, and/or anti-inflammatory medications. The purpose of this study is to evaluate the performance of a combination of TheraTears® products, and to compare them with the product(s) you have been using.


Eligibility Criteria:
Inclusion Criteria:

1. Is between 18 and 65 years of age and has full legal capacity to volunteer;
2. Has read and signed an information consent letter;
3. Is willing and able to follow instructions and maintain the appointment schedule;
4. Exhibits symptoms of dry eye for at least 3 months;
5. Has an OSDI score of ≥ 23;
6. Is currently on a non-omega 3 dry eye treatment regimen that, at the minimum consists of instilling artificial tears at least once a day for the past 3 months;
7. Has an average non-invasive tear breakup time ≤ 5.00 seconds in at least one eye.

Exclusion Criteria:

1. Is participating in any concurrent clinical or research study;
2. Has any known active\* ocular disease and/or infection and/or allergies;

   \* For the purposes of study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are typical findings and are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
6. Is pregnant, lactating or planning a pregnancy at the time of enrollment, as determined verbally;
7. Is aphakic;
8. Has undergone refractive error surgery;
9. Has taken part in another (pharmaceutical) research study within the last 30 days;
10. Has worn contact lenses within the past 5 years;
11. Is currently using or have used omega 3 supplements in the past 3 months.
Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells for Dilated Cardiomyopathy

This study describes a controlled randomized clinical trial to evaluate the efficacy of bone marrow derived stem-cell implants by minithoracotomy in patients with dilated cardiomyopathy and cardiac failure class III or NYHA.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis made at more than one year and symptomatic at functional class III-IV by the New York Heart Association classification (NYHA) despite optimal pharmacologic therapy
* Left ventricular ejection fraction (LVEF) less than 35% by echocardiogram
* Age below 70 years
* Absence of neoplasm
* Abscence of hematologic disease or systemic disease
* No previous cardiac intervention

Exclusion Criteria:

* Episodes of tachycardia or ventricular fibrillation
* Severe or moderated mitral insufficiency
* Any other valvulopathies
* Previous cardiac surgery
Elimination of Adjuvant Chemotherapy for Selected Stage II and III Nasopharyngeal Carcinoma

This study evaluates whether some patients with nasopharyngeal carcinoma but with low risk of distant metastasis can be treated with only radiotherapy and concomitant chemotherapy but without additional adjuvant chemotherapy.

The standard treatment for stage II-III nasopharyngeal carcinoma is radiotherapy with concomitant chemotherapy and adjuvant chemotherapy. A subset of these patients has very low risk for distant metastasis that adjuvant chemotherapy is probably unnecessary. The investigators would like to know if same therapeutic effect and survival rate can be achieved without adjuvant chemotherapy, (i.e. less chemotherapy, same effect)

Eligibility Criteria:
Inclusion Criteria:

* (1) biopsy-proven carcinoma of the nasopharynx,
* (2) AJCC 1997 Stage II (T2aN0, T1-T2aN1) or III (T1-T2aN2) disease,
* (3) normal renal function (Cr \< 1.6 mg/dl),

Exclusion Criteria:

* open-neck lymph node biopsy
* previous chemotherapy or radiotherapy to the head and neck region
* distant metastasis or other malignant diseases except skin cancer
The Inspiratory Muscle Training in Patients With Non-Specific Chronic Neck Pain

The aim of the present study is to investigate the effects of additional functional inspiratory muscle training in individuals with non-specific chronic neck pain.

Patients participating in the study will be divided two parallel groups. The patients in study group will instruct to perform both functional inspiratory muscle training and conventional treatments for neck pain, the patients in the control group will instruct to perform just conventional treatments. The severity of the pain, disability, fear of movement and depression levels will be assessed by visual analog scale, neck disability index, Tampa Scale of kinesiophobia and beck depression inventory, respectively. Neck postures (craniovertebral angle) will be evaluated by photogrammetric method.Endurance of deep cervical flexor muscles will be measured using Stabilizer Pressure Biofeedback Unit with cranio-cervical flexion test. Pain threshold will be measured by algometer from the middle point of upper trapezius. Cervical proprioceptions will be evaluated by laser pointer method in the right and left rotational directions. In addition, diaphragma thickness will be measured by two-dimensional ultrasonography. Assessments were repeated before and after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* NDI score above 15
* Be able to adapt exercise commands
* Neck pain for at least six months
* Agree to participate in the study

Exclusion Criteria:

History of spinal surgery Traumatic cervical injuries Acute or chronic musculoskeletal pain other than neck pain Serious comorbidities (neurological, neuromuscular, cardiological, psychiatric) Tumoral conditions Obesity (Body Mass Index-BMI\> 40)
Vasopressin Versus Tranexamic Acid for Control of Blood Loss Related to Abdominal Hysterectomy

To find the best option to reduce blood loss related to abdominal hysterectomy (AH), the present randomized double-blinded study sought to compare the effects of locally administered vasopressin (VP) and tranexamic acid (TXA) on blood loss in women submitted to AH for benign lesions.

To find the best option to reduce blood loss related to abdominal hysterectomy (AH), the present randomized double-blinded study sought to compare the effects of locally administered vasopressin (VP) and tranexamic acid (TXA) on blood loss in women submitted to AH for benign lesions.

Interventions Study interventions Patients in all groups will receive identically looking pharmaceutical preparations which differ according to the study group

1. Vasopressin group Just before beginning of AH, patients in this group will be injected with a 10-ml syringe containing 10 units of VP (5 mL bilaterally), 1 cm medial to the uterine vessels in the most distal area of the lower uterine segment not to compromise the bladder. If this site is not accessible, patients will be alternatively injected in the midline at the fundus (Okin et al., 2001). In addition, and just before closure of peritoneum, 100 ml of normal saline (NS) will be applied topically over the raw surface.
2. Tranexamic acid group Just before AH, patients in this group will be injected with a 10-ml syringe containing 10 ml of NS (5 mL bilaterally) as described above. Just before closure of peritoneum, 1.5 g of TXA mixed in 100 ml of NS will be applied topically over the raw surface (Mitra et al., 2022).
3. Control group Just before AH, patients in this group will be injected with a 10-ml syringe containing 10 ml of NS (5 mL bilaterally) as described above. In addition, and just before closure of peritoneum, 100 ml of normal saline (NS) will be applied topically over the raw surface.

Eligibility Criteria:
Inclusion Criteria:

- Patients will be included in the present study if they are indicated for abdominal hysterectomy for benign lesions.

Exclusion Criteria:

* history of coagulation or bleeding disorders or
* if they were under antithrombotic treatment.
* associated malignancy, renal impairment or allergy to TA.
Brief Digital CBT for Mood and Anxiety Symptoms in Acute Psychiatric Inpatients

A randomized control trial examining the feasibility, acceptability, and preliminary efficacy of providing access to the MindShift CBT mobile app via tablet for acute psychiatric inpatients.

Psychiatric inpatients expect more psychosocial intervention during their inpatient stay than they receive. During the COVID-19 pandemic, existing interventions have been further reduced. Mood and anxiety symptoms are common for all inpatients across diagnostic categories. Studies have shown that cognitive behavioural therapy (CBT) can be effective for treating these symptoms among inpatients. The purpose of this study is to determine whether the Mindshift CBT app (an app based on principles of cognitive behavioural therapy) is an acceptable, feasible, and useable intervention for inpatients.

The Mindshift CBT app is a tool designed and maintained by Anxiety Canada. It includes tools for daily mood check-ins, healthy thinking, calming intense emotions, and taking actions to change behaviours associated with anxiety and low mood. It also includes information about the common types of anxiety.

The proposed trial includes 12 patients per arm. All participants in control and intervention groups will have access to assigned tablet devices throughout the study period, though only those in the intervention group will have the MindShift CBT app on their device. All participants will undergo assessments at baseline and at the end of the intervention period (1 week).

Eligibility Criteria:
Inclusion Criteria:

* Admitted to the acute inpatient unit
* Fluent in English
* Dynamic Appraisal for Situational Aggression (DASA) score \<=3
* Capable to consent to participation as assessed by the treating physician

Exclusion Criteria:

* Diagnosis of moderate-severe learning disability
* Diagnosis of moderate-severe neurocognitive disorder
ACE Acetabular Cup UK Multi-centre PMCF Study

A total hip replacement is one of the most successful and cost-effective surgical procedures in orthopaedics, and involves replacing both the hip ball and socket. Its goal is to provide pain relief, allowing the person to return to a normal lifestyle. JRI Orthopaedics have developed the ACE Acetabular Cup System, which has a H-A.C. coating to promote ossoeintegration of the device within the host bone. To increase the surgeons choice and thus suitability for the patient, there is the option of 3 different socket liners (ceramic, polymer or dual mobility).

To ensure maximum safety and performance of medical devices surveillance of the device should be carried out over the devices lifetime. This study is a 10 year surveillance study to assess the clinical, functional and radiological outcomes of the CE-marked ACE Acetabular Cup System. This is done by examining patient outcomes through questionnaires, reviews of X-rays and complications by patients who have received a total hip replacement using the ACE Acetabular Cup System at participating sites.


Eligibility Criteria:
Inclusion Criteria:

* Patients deemed suitable for elective primary THR, as per indications in the IFU.
* Male or female, 18 years or older.

Exclusion Criteria:

* Patients who are unable to provide written informed consent.
* Patients deemed unsuitable for THR, as per contra-indications in the IFU.
* Patients indicated for THR as a result of trauma (i.e. neck of femur fracture).
* Patients receiving implants other than the approved combination, i.e. an ACE Acetabular Cup System with a JRI femoral stem and head.
* Patients who are unable to comply with the protocol.