cyrilzakka/clinical-trials huggingface dataset:
Headache in Undergraduate Students and Biopsychosocial Status

The primary aim of this study was to determine the prevalence of headache in undergraduate students. The frequency, duration, localizations and symptoms of headache will be determined with the information obtained as a result of the forms filled in by the participants.

The second aim of this study is to examine the effects of headache on physical, social and psychological status in undergraduate student(participants) from a biopsychosocial perspective.

Headache is one of the most common nervous system disorders in society. 95 percent of the population has experienced a headache at least once in their life. The one-year prevalence is almost 1 in 2 people.

The prevalence of headache increases with age. While there is no difference between the sexes in terms of incidence before adolescence, it is more common in the female population in the post-adolescent period.

The ICF model, developed by the World Health Organization, adopts the biopsychosocial approach to provide a holistic perspective. According to this approach, it is aimed to develop interventions by evaluating and examining the biological and psychosocial effects of illness and disability, functionality, needs and demands of the individual.

Headache is also a disease that should be addressed from a biopsychosocial perspective.

Therefore, the primary aim of this study was to determine the prevalence of headache in undergraduate students. The frequency, duration, localizations and symptoms of headache will be determined with the information obtained as a result of the forms filled in by the participants.

The second aim of this study is to examine the effects of headache on physical, social and psychological status in undergraduate student(participants) from a biopsychosocial perspective.

Eligibility Criteria:
Inclusion Criteria:

* Having undergraduate education at Hacettepe University Faculty of Physical Therapy and Rehabilitation.
* be over 18 years old.
* To know Turkish.
* Volunteer to participate in the study.

Exclusion Criteria:

* Being over 65 years old.
* Having any neurological problem except headache.
* Any additional problems that prevent him from completing the questionnaires and scales.

to be
Effect of Extracorporeal Shock Wave Combined With Autologous Platelet-rich Plasma Injection on Rotator Cuff Calcific Tendinitis

The purpose of this study is to explore the effect of extracorporeal shock wave combined with autologous platelet-rich plasma injection on the rehabilitation of rotator cuff calcific tendinitis, to provide new treatment methods and evidence for the rehabilitation of rotator cuff calcific tendinitis, and to reduce patients; pain and return to normal life as soon as possible.

The purpose of this study is to explore the effect of extracorporeal shock wave combined with autologous platelet-rich plasma injection on the rehabilitation of rotator cuff calcific tendinitis, to provide new treatment methods and evidence for the rehabilitation of rotator cuff calcific tendinitis, and to reduce patients\&#39; pain and return to normal life as soon as possible.

Eligibility Criteria:
Inclusion Criteria:

* Meet the diagnostic criteria for rotator cuff calcific tendonitis, aged between 40 and 60 years old
* Persistent pain in the affected shoulder, with obvious tenderness under the acromion and rotator cuff, as confirmed by X-ray and Computed Tomography (CT) and Magnetic Resonance Imaging (MRI) examination showed one or more round-shaped high-density calcium salt deposits near the greater tuberosity of the humerus
* All were diagnosed for the first time
* Complaints of severe pain in the shoulder joint, obvious

Exclusion Criteria:

* Combined with rotator cuff trauma, long head of biceps tendonitis and other shoulder joint diseases
* Past combined history of shoulder joint surgery
* Patients with internal fixation of the shoulder joint
* Shoulder joint combined with infection, Tumors and other lesions
* Combined with severe heart, liver, and kidney dysfunction
* Do not agree to participate in the study or fail to sign the informed consent form.
Success and Quality of Life Following Complete Pulpotomy and Root Canal Treatment

The purpose of this study is to compare the Success and quality of life following complete pulpotomy and root canal treatment in teeth with clinical signs indicative of irreversible pulpitis.

After thorough history and clinical and radiographic examination, and confirmation of eligibility for the study, risks and benefits associated with the procedure will be explained and written informed consent will be taken from the patients. Study subjects will be randomly allocated to either Complete pulpotomy or Root canal treatment Group.

Eligibility Criteria:
Inclusion Criteria:

* Mature permanent restorable mandibular molar teeth.
* Tooth should give positive response to pulp sensibility testing.
* Clinical diagnosis of irreversible pulpitis with PAI score≤2.
* Tooth with probing pocket depth and mobility are within normal limits.
* Non-contributory medical history.

Exclusion Criteria:

* Teeth with immature roots.
* No pulp exposure after caries excavation.
* Bleeding could not be controlled in 6 minutes.
* Insufficient bleeding after pulp exposure, the pulp is judged necrotic or partially necrotic.
* Absence of antagonist tooth.
* Positive history of antibiotic use in the past 1 month or requiring antibiotic prophylaxis
* Had taken analgesic in past 3 days.
* Tooth with periapical lesion visible on radiograph
Quality of Life After POEM for Achalasia

Achalasia is an esophageal motility disorder, characterized by insufficient lower esophageal sphincter relaxation and loss of esophageal peristalsis. Patients with achalasia experience distressing gastrointestinal symptoms, including dysphagia, reflux and chest pain, which lead to weight loss and malnutrition. Undoubtedly, health-related quality of life can be significantly diminished in patients with achalasia. At present, POEM has become one of the standard therapies for achalasia. Limited studies have focused on the patient's quality of life before and after POEM. The present study aimed to assess the changes in quality of life of patients with achalasia using the validated achalasia severity questionnaire (ASQ) and the short form (SF)-36 scale.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as achalasia base on high resolution manometry, barium esophagram and upper endoscopy
* Scheduled to undergo POEM for treatment of achalasia

Exclusion Criteria:

* Coagulopathy and systemic disorders that precluded safe general anesthesia
Effect of Alendronate 70mg Formulation on Bone Turnover Markers and Patient Reported Outcomes

Compare the data obtained with two formulations of alendronate 70 mg (tablets vs effervescent tablet for buffered solution) on the change in bone turnover markers, on gastric tolerance and on treatment adherence (including compliance and persistence).


Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal women (at least 5 years after natural / surgical menopause).
* Patients on treatment with alendronate 70mg tablets or alendronate 70mg effervescent tablets for 6-8 months and who will be continued to be treated for a minimum of 12 months.
* Available BTMs (s-CTX), biochemistry (calcium, phosphate, 25-OH vit D, PTH, creatinine) and DXA (lumbar spine, total hip and femoral neck) at the initiation of the treatment.
* Ability to sign an informed patient consent

Exclusion Criteria:

* Patients who had received a prior osteoporosis treatment with anti-resorptive drugs (bisphosphonate or denosumab) or teriparatide before starting alendronate 70 mg.
* Any secondary cause of osteoporosis including current treatment with glucocorticoids or aromatase inhibitors, inflammatory disorders, malabsorption
* Metabolic or cancer bone disease
* Contra-indications to bisphosphonates according to product labelling
* Known or suspected allergy to study product(s) or related products
* Inability to sign an informed consent
* Previous participation in this study
Influence of Prostate Cancer Radiation on Aging

Previous studies have reported that cancer survivors develop age-related chronic conditions like frailty, sarcopenia, cardiac dysfunction, and cognitive impairment earlier and/or at a greater burden than similarly aged individuals never diagnosed with cancer or exposed to cancer therapies.

However, the knowledge about aging-associated consequences of cancer treatment and the processes that underlie differential responses to therapy is very limited. In 2018, a think tank established by the National Cancer Institute has defined various research needs to expand the evidence base for aging-related consequences of cancer treatment, such as studies to examine aging-related processes that include regularly performed assessments capturing factors associated with physical function or studies to elucidate pathways that lead to the emergence of aging phenotypes and to understand the relationships between biomarkers of aging and functional outcomes in cancer survivors. In addition, study inclusion of older adults with comorbidities and higher levels of frailty has been proposed to achieve an improved understanding of functional outcomes at any age.

Hypotheses / objectives We hypothesize that prostate cancer radiotherapy accelerates aging-related processes, furthermore, aging-related biomarkers may predict functional outcomes and represent early indicators of aging phenotypes. Primary objectives of the proposed study are the determination of the aging-related consequences of radiotherapy in prostate cancer patients and the evaluation of the relationship between biomarkers of aging and age-related clinical conditions.

Systematic evaluations of functional and cognitive status, comorbidities, health status, mobility, nutritional status, psychological status, and social circumstances as well as measurements of cellular senescence and chronic inflammation will be performed in a cohort of prostate cancer patients at baseline (before radiotherapy), at the end of radiotherapy and at follow-up intervals thereafter. The evaluation of aging-related biomarkers will include determination of markers of cellular senescence and markers of systemic inflammation. The correlation between genetic variants modulating telomere length and the risk of developing age-related phenotypes will also be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Prostate cancer
* Candidate to definitive radiation treatment
* Local or locally advanced disease
* Aged ≥ 65 years
* Informed consent

Exclusion Criteria:

* Unable to give written informed consent
* Metastatic disease
ANC-501 in the Treatment of Adults With Major Depressive Disorder

A Phase 2 Study of ANC-501 in the treatment of adults with Major Depressive Disorder

This is a single-arm, open-label Phase 2 study to assess the safety, tolerability, pharmacokinetics (PK), and activity of ANC-501 oral capsules as adjunctive treatment in subjects diagnosed with major depressive disorder (MDD)

Eligibility Criteria:
Inclusion Criteria:

* Adult male or female between 18 and 65 years of age, inclusive.
* Diagnosis of current episode of major depressive disorder (MDD) at least 8 weeks prior to screening, confirmed by Structured Clinical Interview for DSM-5 - Clinical Trials Version (SCID-5-CT).
* Have not responded to their current antidepressant therapy or to dose adjustment/treatment changes following a loss of response to their current antidepressant therapy.
* Receiving a stable dose of the same antidepressant (selective serotonin reuptake inhibitor \[SSRI\] or serotonin and norepinephrine reuptake inhibitor \[SNRI\], bupropion or trazodone monotherapy) for the current episode for at least 6 weeks of continuous treatment, which can include some or all of the screening period, with 4 weeks on a stable dose prior to day 1 and has an inadequate response (\<50% improvement) using the MGH ATRQ.
* MADRS total score of ≥26 at screening and Day 1 (prior to dosing).
* 12-hour urine cortisol level \>22.7 nmol/L(greater than or equal to 8.3 mcg/L).

Exclusion Criteria:

* Inadequate response to \>2 prior ADTs (not including current antidepressant) of at least 6 weeks duration each for the episode current at screening.
* Medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
* Administration of drugs to treat psychiatric or neurologic conditions that have not been taken at a stable dose for at least 4 weeks prior to day 1.
* Significant findings on ophthalmic examination including, Best Corrected Visual Acuity (BCVA) worse than 20/30 or, in the opinion of the ophthalmologist or optometrist, any cataract that may become clinically significant and/or need surgical intervention during the course of the trial.
Three Dosing Regimens of Dextromethorphan (DXM) Reportedly Used in Major Depressive Disorder

This is an open-label dosing pilot study of 15 patients aged 18-50 years of age with diagnoses of Major Depressive Disorder (MDD) randomized to 1 of 3 treatment arms.

The study will consist of a screening evaluation performed within the course of 2 weeks, followed by an active treatment period of 28 days where treatment arm 1 will take a supervised dose of 300mg DXM every 14 days for 28 days, treatment arm 2 will take the FDA approved maximum daily ingestion for cough (60mg DXM) daily for 28 days, and treatment arm 3 will take 1 supervised dose of 300mg DXM and 60mg for the remaining 28 days. After the active treatment period, subjects will be followed for 65 days with safety and psychiatric assessments at designated timepoints.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be a man or woman, 18 to 50 years, inclusive
* Subject must meet Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-V) criteria for MDD without psychotic features based on clinician assessment.
* Subjects must have undergone 3 or fewer antidepressant trials
* Subjects must have moderate to severe depression as determined by a screening Montgomery-Åsberg Depression Rating Scale (MADRS) score of 20 or greater

Exclusion Criteria:

* Subject has a current diagnosis of Bipolar Affective Spectrum Disorder, obsessive compulsive disorder, or a DSM-V personality disorder
* Subject has had an incomplete response to more than 3 antidepressant trials
* Subject cannot tolerate 60mg DXM as determined by study physician
* Subject meets DSM-5 severity criteria for moderate or severe substance or alcohol use disorder within 6 months of screening, excluding caffeine or nicotine
* Subject has a current clinical diagnosis of autism, dementia, or intellectual disability
* Subject has history of psychosis not attributable to organic/metabolic causes
* Subject has a history of serotonin syndrome or sensitivity
* Subject has taken venlafaxine or a monoamine oxidase inhibitor (MAOI) within 4 weeks prior to screening
* Subject is actively taking an opiate antagonist for any indication
* Subject is taking a higher-than-recommended dosage of serotonergic antidepressant \[including but not limited to selective serotonin reuptake inhibitor (SSRI), serotonin-norepinephrine reuptake inhibitor (SNRI), serotonin partial agonist/reuptake inhibitor (SPARI), serotonin antagonist and reuptake inhibitor (SARI) within 4 weeks prior to screening
* Subject is actively suicidal
* Subject has participated in another clinical drug trial within 6 months prior to screening
* Subject has a history or current signs of liver or renal insufficiency
* Subject has a clinically significant condition of any organ system that might adversely impact subject health upon consumption of DXM
* Subject has previous history of intolerance to ketamine or its enantiomers
* Subject has previous history of incomplete antidepressant response to ketamine or its enantiomers
* Subject is currently using DXM for any indication
Folfiri as Third Line of Treatment

The aim of this study is to investigate the activity of Folfiri as Third line of treatment in mGC progressed after ramuciramb-based second line.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed, ramucirumab pretreated metastatic gastric cancer who received
* Eastern Cooperative Oncology Group performance status ≤2 (ECOG PS)
* aged \> 18 years
* neutrophil count ≥1500/μl
* platelet count ≥100 000/μl),
* renal (serum creatinine ≤1.5 mg/dl)
* liver (serum bilirubin ≤2 mg/dL) functions
* normal cardiac function,
* absence of second primary tumor other than non-melanoma skin cancer
* no concurrent uncontrolled medical illness.

Exclusion Criteria:

* Eastern Cooperative Oncology Group performance status \>2 (ECOG PS)
* No prior treatment with ramucirumab
* operable metastatic disease were excluded from the study
* severe cardiac dysfunction, congestive heart failure or a recent myocardial infarction
* uncontrolled sites of infection.
Effect of Electric Impedance Tomography-Guided PEEP Titration

Acute respiratory syndrome distress (ARDS) is a clinical common syndrome with high mortality. Mechanical ventilation (MV) is the cornerstone of management of ARDS but can lead to ventilator-induced lung injury. Positive end-expiratory pressure (PEEP), as one of main component of MV, has been widely used in the clinical practice. However, how to best set PEEP is still a difficult problem for moderate to severe ARDS patients. EIT, an imaging tool evaluating the regional ventilation distribution at the bedside, can achieve the individual PEEP selection for all mechanically ventilated patients. This article compared the effect of PEEP titrated guided by EIT with fraction of inspired oxygen (FiO2)-PEEP table on the ventilation-perfusion mismatch.


Eligibility Criteria:
Inclusion Criteria:

1. Intubated patients with moderate and severe ARDS (Berlin definition, PaO2/FiO2 ≤200 mmHg at PEEP 5 cmH2O)
2. undergoing deep sedation on controlled mechanical ventilation within72 hours after ARDS onset

Exclusion Criteria:

1. age \<18 years old
2. patient undergoing legal protection
3. contra-indications to EIT (e. g. severe chest trauma or wounds)
4. pneumothorax
5. patient undergoing ECMO
6. pregnancy
Simplified Negative Pressure Wound Therapy

The objective of this study is to implement a simplified Negative Pressure Wound Therapy (sNPWT) device in a low resource setting. The investigators hypothesize that the sNPWT device is at least equivalent to commercially available NPWT devices. Therefore, the specific aims of this study will be to measure: 1. the mechanical properties of the sNPWT device and 2. the adverse events associated with the sNPWT device.


Eligibility Criteria:
Inclusion Criteria:

* open wound appropriate for NPWT
* wound size greater than 2 cm2 and less than 150 cm2
* adequate adjacent intact skin for application of sNPWT
* adequate contour of wound location for application of sNPWT
* patient is expected to tolerate change of the NPWT dressing with the chosen analgesia and sedation plan by the treating physician
* the patient is expected to remain clinically stable for the duration of the study
* the patient is to remain hospitalized for the duration of the study
* patient or their legal representative is willing and able to sign an IRB-approved informed consent
* patient less than 21 years old is willing to sign an approved assent form if able to sign

Exclusion Criteria:

* exposed blood vessels
* ischemic wound
* wound with necrotic tissue requiring further debridement at the time of enrollment
* infection
* acute osteomyelitis
* malignancy in the wound
* latex or rubber containing product sensitivity
NGS Diagnostic in COVID-19 Hosts - Genetic Cause Relating to the Course of Disease Progression

In this study (i) the host genome to identify susceptibility regions of infection, inflammation, and host defense, (ii) host response to Severe Acute Respiratory Syndrome-Corona-Virus-2 (SARS-CoV-2) infection, and (iii) viral sequence composition to define viral sequences which may be correlated with disease severity in addition to the metagenome of the throat swab will be analysed .

This study aims to recruit adult persons with diagnostically confirmed Corona-Virus- Disease-19 (COVID-19) infection and with different disease manifestation who are included into diagnostic or therapeutic care at the University Hospital Tübingen (UKT).

The COVID-19 Next-Generation-Sequencing (NGS) study aims to cover as many patients in Germany as possible. It is expected to include in Phase 1 (pilot study): 250 patients with different disease manifestation (extreme phenotypes) and individual risk factors by whole genome analysis Phase 2 (verification study): 1.000 clinically well-defined patients to ensure a broader range of overlapping phenotypes, to verify data from the pilot study.

Phase 3 (confirmation study): \> 10.000 patients to increase the power (anticipated).

Eligibility Criteria:
Inclusion Criteria:

* COVID-19 infection confirmed
* COVID-19 disease manifestation
* Age \> 18 years

Exclusion Criteria:

* Missing informed consent of the patient/ legal guardian/ relatives
Community-based Intervention for Cervical Cancer Screening Uptake in Nepal

This study aims to evaluate the effect of a Female Community Health Volunteer (FCHV) led community-based educational intervention through home visits increasing cervical cancer screening uptake.

Cervical cancer is the major cause of cancer deaths among women in Nepal. Screening is one of the most effective tools for early diagnosis, prevention, and treatment. However, skilled health professionals and tools available for cervical cancer screening are limited in low and middle-income countries (LMICs) including Nepal. The World Health Organization (WHO) and Alliance for Cervical Cancer Prevention (ACCP) recommends that countries, areas, or institutions seeking to initiate or strengthen cervical cancer screening programs should consider introducing or expanding Visual Inspection with Acetic acid (VIA) until more appropriate and affordable HPV-based tests become available. 'National Guideline for Cervical Cancer Screening and Prevention in Nepal, 2010' includes VIA as a screening method for cervical cancer. Current studies reveal Nepalese women's participation in cervical cancer screening is low. Thus, there is a need for appropriate, cost-effective and sustainable interventions to increase VIA screening uptake at the primary health care level across Nepal.

The primary objective of this study is to evaluate the effect of a Female Community Health Volunteer (FCHV) led community-based educational intervention through home visits increasing cervical cancer screening uptake. The primary outcome of the study is to increase the cervical cancer-screening uptake in the intervention group. This will be the first community-based cluster-randomized trial designed to mobilize FCHVs for increasing cervical cancer screening uptake in Nepal.

Eligibility Criteria:
Inclusion Criteria:

* All women of age group 30-60 years who were recruited in the COBIN Wave I survey

Exclusion Criteria:

* Women who are not able to give consent
* Severely ill,
* Pregnant or less than 6 weeks after delivery,
* Who is already diagnosed with cervical pre-cancer and cancer
* With a history of total hysterectomy
* Who are reluctant to participate in the study or unable to complete the interview