cyrilzakka/clinical-trials huggingface dataset:
Physical Function During ARSI Treatment

This single arm observational pilot study aims to determine the longitudinal effects of androgen receptor signaling inhibitors (ARSI) in men with advanced prostate cancer. The primary outcome for this trial is physical function, which will be evaluated at baseline, 12 and 24 weeks. Secondary outcomes including body composition, muscle function, balance, arterial stiffness and patient reported outcomes.

The purpose of this pilot trial is to obtain objective measurements of physical function in men with metastatic prostate cancer (mPC) initiating ARSI treatment at baseline, 12, and 24 weeks later. Grip strength, muscular power, body composition, balance, arterial stiffness, along with QoL, fatigue, anxiety, and depression will also be measured. Finally, the potential associations in primary and secondary outcomes by the type of ARSI, stage of mPC, and physical activity levels will be explored.

With more men requiring ARSI treatment for metastatic castrate resistant prostate cancer (mCRPC), as well as being an efficacious option earlier in metastatic castrate sensitive prostate cancer (mCSPC), accurate estimates of declines from ARSI initiation are required to determine the true effects. Utilizing novel assessments in mPC like muscular power tests will provide insight into potentially more relevant assessments and outcomes to intervene on. The data from this pilot study will also determine effect sizes to adequately power future studies.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
* Subjects is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.
* Age ≥ 18 years at the time of consent.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Diagnosis of metastatic disease from prostate cancer, or recurrent disease following definitive local therapy of prostate cancer, as assessed by their clinician
* Initiation of an ARSI (e.g., abiraterone, enzalutamide, apalutamide, or darolutamide) for mPC with concurrent androgen deprivation therapy (ADT).
* Availability to begin baseline testing within 8 weeks of ARSI treatment initiation.
* Physician clearance to perform physical assessments.
* Ability to speak and read English.

Exclusion Criteria:

* Prior ARSI treatment
* Current chemotherapy
* History of bone fractures or musculoskeletal injuries
* Neurological conditions that affect balance and/or muscle strength
* Intention to leave the region prior to completion of study
* Dementia, altered mental status or any psychiatric condition prohibiting the understanding or rendering of informed consent
Effect of Using Pictograms on Improving Depression and Anxiety Among Type 2 Diabetic Patients.

we will study the impact of using pictograms on improving depression and anxiety among type 2 diabetic patients, we suppose that patients who received pictograms-enriched labels will have lower levels of depression and anxiety in comparison with those who will not receive after three month follow-up evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Participants are eligible if they are Jordanian adults, aged 18 or older, who have been clinically diagnosed with T2DM for at least 6 months, having low health literacy (Individuals who obtained 66 or lower scores in the full TOFHLA instrument are considered as individuals with "low literacy" in the study) \[24\], come personally for the refill.

Exclusion Criteria:

* Patients who are unable to communicate verbally (aphasic or with hearing impairment), those with any visual, learning disabilities, and psychological or hepatorenal disease (according to the clinical diagnosis by a physician), and those deemed too ill or frail to attend the clinic, and who have participated in other diabetes education research projects will be excluded.
Children Vaccination From 11 to 14 Years Old

The human papilloma virus infection is the most frequent sexually transmitted infection around the world. In the vast majority of cases, these are inapparent infections that disappear spontaneously. In some cases, the HPV infection persists and can generate anogenital warts or cancer.

In France, the papillomavirus is responsible for 6000 new cases of cancer/year with several possible localizations : cervical, anal, penile, oropharyngeal, vulvar or vaginal. Among them, 4580 new cases of cancer/year occur in women, and half of them are diagnosis of cervical cancer. A quarter of cancers caused by papillomavirus occur in men.

In France, the commercialization of anti-HPV vaccine in 2007 was addressed only to girls, in order to gain a group immunity that would therefore protect the boys. This vaccination did not achieve the cover immunization target that were announced: the objective was fixed at 60% of vaccination coverage and at the end of 2018, only 24% was achieved on the complete vaccination schedule. In December 2019, the French National Authority for Health recommended the anti-HPV vaccinations in girls and boys.

This qualitative study evaluates parents' opinion regarding the vaccination and the HPV. Parent's eligible to participate in this study are those with boys between 11 and 14 years old.

The anti-HPV vaccination is perceived favorably in 38% of parents, but 42% of parents are undecided.

The investigators would like to evaluate qualitatively the opinions and the obstacles in this vaccination, using interviews in parents of boys aged between 11 and 14 years old.

Eligibility Criteria:
Inclusion Criteria:

* parents having boys between 11 and 14 years old, followed-up by a general practitioner that participate in the study
* signed inform consent form

Exclusion Criteria:

* language barrier that could prevent the understanding or formulation of opinions during the interview
Pulmonary Rehabilitation in Patients Before Lung Transplantation (LTx)

The purpose of this study is to study the effects of a complex pulmonary rehabilitation program on mobility measured by 6 minute walking distance (6MWD) and physical activity, measured via Dynaport and Actibelt Aktivitätsmonitor, dyspnoea (VAS), quality of life (HRQL (SF36, EuroQul)), anxiety and depression (HADS)and PaCO2-behavior under physical activity.


Eligibility Criteria:
Inclusion Criteria:

* pre-LTx (listed for lung-transplantation or currently undergoing evaluation)
* COPD Stadium IV GOLD
* α-1-Antitrypsin-deficiency-Emphysema
* respiratory Insufficiency
* oxygen therapy (LTOT)

Exclusion Criteria:

* serious Exacerbation (Symptoms longer than three days, change of therapy, e.i. antibiotics, steroids) during the last four weeks before rehabilitation
* clinical signs of manifest heart insufficiency
* acute coronar syndrome
* left heart insufficiency(EF \< 40%)
* missing Compliance
Color Doppler Imaging of Orbital Venous Flow in Grave's Orbitopathy

Orbital Venous flow study in patients with Grave's Orbitopathy in different manifestation forms and stages, made with Color Doppler Imaging

Prospective study with Grave's patients in active and fibrotic disease, myogenic and lipogenic forms, with muscle restriction and without muscle restriction and with or without optic compressive neuropathy. Blood flow was studied with Color Doppler Imaging (CDI) in the following orbital vessels:

* Superior Ophthalmic Vein (main target of the study protocol)
* Retinal Central Vein
* Retinal Central Artery
* Ophthalmic Artery

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Grave's Orbitopathy with well defined disease.

Exclusion Criteria:

* Uncertain cases, with an undefined status of Grave's Ophthalmopathy.
Effectiveness of Detachment of the Breathing Circuit on the Rate of DLT Malposition After Postural Change

The goal of this clinical trial is to assess the incidence of double-lumen endobronchial tube displacement in patients undergoing thoracic surgery with a change in position, compared with double-lumen endobronchial tube malposition in chest surgery patients with a fixed breathing circuit. The study is to investigate: whether detaching the breathing circuit in patients undergoing thoracic surgery would reduce the rate of double-lumen endobronchial tube malposition, the incidence of postoperative pulmonary complications, and improve patient outcomes.

Participants will be randomly divided into a disconnected breathing circuit group and a breathing circuit connected group and after entering the operating room, the intravenous access will be opened, and blood pressure, heart rate, electrocardiogram, oxygen saturation, arterial pressure, and end-expiratory carbon dioxide will be monitored. Anesthesia induction will be performed by an anesthesiologist, and then the double-lumen endobronchial tube will be inserted under laryngoscopic guidance. Will the catheter be delivered to the expected depth, the double-lumen endobronchial tube will be connected to the anesthesia machine for mechanical ventilation.

Researchers will compare the malposition rate of the double-lumen endobronchial tube when the patient transitions from the supine to lateral decubitus position, the effect of single-lung ventilation, oxygen saturation at 5 and 10 minutes after single-lung ventilation, and postoperative recovery time.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-II elective surgery for patients
* Patients undergoing thoracic surgery requiring a left-sided double-lumen endobronchial tube;
* Sign the informed consent form for this clinical study.

Exclusion Criteria:

* Mouth opening \<3cm;
* History of previous difficult intubation;
* Patients with diseases of the upper respiratory tract and main bronchi;
* Cardiac insufficiency;
* People with liver dysfunction;
* Renal insufficiency;
* Previous stroke;
* Patients with severe obstructive ventilation dysfunction;
* Bronchial asthma or airway hyperresponsiveness;
* Patients who have participated in other clinical studies in the past 3 months.
Feasibility and Accuracy of a Novel Xpert Cartridge

Consenting adults will be interviewed for demographic and medical information, and then will be asked to provide two expectorated sputum specimens. In the study laboratory, sputa will be tested using conventional and investigational diagnostic tests for tuberculosis.

* For each of isoniazid, ofloxacin, moxifloxacin, amikacin, and kanamycin: sensitivity and specificity of the investigational Xpert test for detection of drug resistance, using phenotypic drug susceptibility testing as the reference comparator
* For each of isoniazid, ofloxacin, moxifloxacin, amikacin, and kanamycin: sensitivity and specificity of the investigational Xpert test for detection of drug resistance, using mycobacterial DNA sequencing as the reference comparator
* Sensitivity and specificity, for detection of M. tuberculosis in sputum, of the investigational Xpert test and of the conventional Xpert MTB/RIF test, using culture as the reference comparator
* Diagnostic yield (for tuberculosis) of the investigational Xpert test and of the conventional Xpert MTB/RIF test
* For the investigational Xpert test, the proportion of specimens with a result of 'invalid' and the proportion of specimens with a result of 'error'
* Proportion of study participants with M. tuberculosis detected in sputum
* Proportion of participants with drug resistant tuberculosis, by drug resistance pattern and by tuberculosis categorization (new case or not new case)

Eligibility Criteria:
Inclusion Criteria:

* Individuals must meet all of the following inclusion criteria in order to be eligible to participate:

  * Age ≥ 19 years (age of majority) if enrolled in South Korea; age ≥ 18 years (age of majority) if enrolled in China
  * Provision of informed consent
  * Clinical signs and/or symptoms suggestive of pulmonary tuberculosis
  * Meets one of the following criteria:

A. Suspected or confirmed new pulmonary tuberculosis case who has received anti-tuberculosis drugs for less than 3 (three) days (target enrollment for Group A is approximately 50 participants).

B. Confirmed pulmonary tuberculosis with documented rifampin resistance, who has received anti-tuberculosis drugs for 31 days or less C. History of prior tuberculosis PLUS ongoing signs and/or symptoms of pulmonary tuberculosis PLUS suspected drug resistance

Exclusion Criteria:

* Inability to provide a sputum specimen
Clinical Study of LPI on Different Sites of Iris

Glaucoma is the second cause of blindness worldwide. Laser peripheral iridoplasty (LPI) is a simple and effective treatment for angle closure glaucoma. LPI can widen or reopen an existing angle close or angle adhesion in order to reduce the risk of attack of the angle closure glaucoma. However, there are very little research on the laser site, laser wavelengths, laser energy and laser spot intervals. The purpose of this study is to determine the optimum laser site of LPI.

Glaucoma is the second cause of blindness worldwide. Laser peripheral iridoplasty (LPI) is a simple and effective treatment for angle closure glaucoma. LPI can widen or reopen an existing angle close or angle adhesion in order to reduce the risk of attack of the angle closure glaucoma. However, there are very little research on the laser site, laser wavelengths, laser energy and laser spot intervals.

The purpose of this study is to determine the optimum laser site of LPI. Before and 7days, 1 month, 3 months after LPI, the structure of anterior chamber, including angle anterior chamber depth(ACD), angle of anterior chamber (AA), anterior chamber angle opening distance 750(AOD750) are measured with ultrasound biomicroscopy. Before and 7days, 1 month, 3 months after LPI, the outflow resistance of aqueous humor are evaluated with C value. Before and 1hour, 1days, 3day, 7days, 1 month, 3 months after LPI, intraocular pressure are measured with Goldmann tonometry. Before and 3 months after LPI, retinal nerve layer thickness and the optic disc cup disc ratio are measure with optical coherence tomography.

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary angle closure suspect (PACS), primary angle closure (PAC) or primary angle closure glaucoma (PACG).
* PACS is diagnosed in eyes with an occludable angle but no other abnormality.
* PAC is diagnosed in eyes with an occludable angle, normal optic discs and visual fields and any of the following: raised IOP (\>19 mm Hg), PAS, pigment smearing in the superior angle, or sequelae of acute angle closure (iris whirling or glaucomatous fleck).
* PACG is diagnosed in eyes with an occludable angle and glaucomatous optic neuropathy. Evidence of glaucomatous optic neuropathy is defined as a cup: disc ratio (CDR) of \>0.7 or \>0.2 CDR asymmetry.
* An occludable angle is defined as one in which three quarters of the posterior pigmented trabecular meshwork is not visible on viewing with a Goldmann two mirror lens in the primary position of gaze without indentation.

Exclusion Criteria:

* Patients with previous ocular surgery, and those with secondary angle closure, such as lens intumescence or subluxation, iris neovascularisation and a history of uveitis.
* Patients who have systemic contraindications to medical therapy (including renal impairment, sulfur allergy, asthma and heart failure), pre-existing corneal opacities obstructing laser access to more than one quadrant of the peripheral iris and single-eyed patients are also excluded.
A Phase 1/2 Study of GEN1286 in Patients With Advanced Solid Tumors

The purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics (PK), anti-tumor activity and immunogenic potential of GEN1286 in participants with advanced solid tumors.

This trial consists of 2 parts:

* Part A: Dose escalation and dose level expansion
* Part B: Tumor-specific expansion with dose optimization


Eligibility Criteria:
Key Inclusion Criteria:

* Participants must be ≥ 18 years of age at the time of informed consent; have measurable disease according to RECIST 1.1; Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1; adequate organ, bone marrow, liver, coagulation, and renal function; and be willing to provide a pretreatment tumor specimen.
* All participants must have pathologically confirmed diagnosis of advanced solid tumor.
* Participants must have metastatic or unresectable locally advanced, recurrent disease not amenable to further local therapy and must have previously received therapies known to confer clinical benefit (unless ineligible to receive, refused to receive, or therapy is unavailable in the region).

Key Exclusion Criteria:

* Prior treatment with topoisomerase 1-based antibody-drug conjugate (ADC) therapy.

Note: Other protocol-defined inclusion and exclusion criteria may apply.
Electroacupuncture for Dysmenorrhea Secondary to Adenomyosis

The aim of this study is to preliminarily evaluate the is to assess the effects and safety of electroacupuncture for moderate to severe dysmenorrhea secondary to adenomyosis.


Eligibility Criteria:
Inclusion Criteria:

* Meeting the diagnosis criteria of dysmenorrhea secondary to adenomyosis.
* Female patients aged between 18 and 50.
* Dysmenorrhea lasting for 3 consecutive menstrual cycles or more.
* At least three consecutive menstrual cycles with an interval of 24 to 38 days, differing by less than 7 days, and menstrual periods lasting 2 to 8 days before screening.
* At least 2 days of worst pain score ≥4 on Numerical Rating Scale during the screening period.
* Having not used medications, other than rescue medicine, or therapies for dysmenorrhea secondary to adenomyosis for at least 1 month before randomization, and consenting not to use throughout the process of the research.
* Volunteering to participate the trial and signing written informed consent.

Exclusion Criteria:

* Diagnosed with Endometriosis or having a history of endometriosis-related surgery
* Currently taking hormonal medications, including: a.use of GnRH agonists within 6 months before the screening period; b. use of progestins or danazol and other long-acting hormones within 3 months before the screening period; c. use of oral contraceptive-like short-acting hormones within one month before the screening period;
* Having clinically significant gynecologic condition such as clinically significant endometrial pathology, persistent complex ovarian cyst larger than 3 cm or simple ovarian cyst larger than 5 cm, or single fibroid 4 cm or larger or more than 4 fibroids measuring at least 2 cm or symptomatic submucosal fibroid of any size.
* having an IUD.
* HB \< 90G/L.
* Having any other chronic pain syndrome that required chronic analgesic or other chronic therapy.
* Having a current history of undiagnosed abnormal genital bleeding.
* Malignant tumors (including the reproductive system and other systems).
* Combined with severe diseases in the cardiac, respiratory, renal, liver, and hematopoietic systems, psychiatric disorder and/or cognitive disorders.
* Pregnant, breast feeding, planning a pregnancy within the next 7 months.
Web-based Personal or Peer Group Weight Management Study

The PERGROUP trial aims to investigate whether Web-based personal or Web-based group counselling weight management program can help to achieve lifestyle changes needed for weight loss and improvement in quality of life and cardiovascular risk factors. The control group is the traditional nurse-lead weight management group counselling.

In this study, efficacy of two web-based weight management systems will be compared to a traditional nurse-lead sessions for weight management.

Ten nurse-lead group counselling sessions lasting 90 minutes each will be conducted in three groups of 10-14 participants. Each session comprise education about healthy diet, psychoeducation and discussions.

The web-based group counselling program offers informative weight management system with peer-based conversation possibility. Three groups of 10-14 participants who gather together for three nurse-lead sessions in the weeks 0, 5, and 12. The web-based program can be used for a year.

The web-based personal counselling program offers informative weight management system with conversation possibility with the nurse for 12 weeks. Altogether 37 participants are enrolled and they can use the web-based weight management system for one year.

In each intervention arm, intervention and counselling provided by the study nurses last for three months. Among all participants, weight loss, cardiometabolic data, information of lifestyle and quality of life will be measured at baseline, after the nurse-lead intervention (three months) and 12 months from the baseline.

Eligibility Criteria:
Inclusion Criteria:

* body mass index 25 kg/m2 or higher

Exclusion Criteria:

* pregnancy
* active cancer
* acute cardiovascular event less than three months before
* untreated thyroid disease
* systematic corticosteroid medication
* anorexia or bulimia
* impaired communication ability
Ano-genital Human Papillomavirus (HPV) Infection, Precancerous Lesions and Genital Warts Among Danish Renal Transplant Recipients

Transplant-related malignancies have emerged as one of the important complications after organ transplantation. Some studies have shown that transplant recipients have an increased risk of developing cancer, especially non-melanoma skin cancer. Because of iatrogenic immunosuppression in these patients, there is an increasing focus on human papillomavirus (HPV) related cancers.

The occurrence of HPV infection and ano-genital precancerous lesions and genital warts among Danish renal transplant recipients (RTRs) is not known. Relatively few controlled studies exist on the prevalence of ano-genital HPV infection, anal precancerous lesions and cervical precancerous lesions among RTRs.

Knowledge about HPV infection and HPV-related ano-genital precancerous lesions in renal transplant recipients, together with identification of factors that play a role for development of anal and cervical precancerous lesions, is important for the possibility of early detection and treatment to prevent progression to ano-genital cancers. Cervical cytology has been used for decades to detect cervical intra-epithelial neoplasia (CIN), whereas high-resolution anoscopy is a newer modality for the detection of anal intra-epithelial neoplasia (AIN). International guidelines recommend annually screening against cervical cancer for female renal transplant recipients, but currently no recommendation exists on screening against anal cancer.

Aim: In a clinical study it is the aim to examine the prevalence of anal, penile, oral and cervical HPV infection as well as ano-genital dysplasia and ano-genital warts among 250 renal transplant recipients and an immunocompetent control group. Furthermore to identify factors associated with the development of AIN or CIN such as HPV type, viral load, duration of immunosuppression, and lifestyle factors such as sexual habits, reproductive history, smoking and alcohol habits, history of genital warts and other infections, and socio-economic variables.


Eligibility Criteria:
Inclusion Criteria:

-

Case group:

1. Renal transplant recipients men and women ≥ 18 years of age
2. ≥ 6 months posttransplantation
3. Stabile immunosuppressive regime
4. No signs of acute rejection og the transplant

Control group:

1. Health men and women ≥18years of age from the Nevus clinic, Laser clinic and non-melanoma skin cancer clinic, Bispebjerg Hospital, Copenhagen

Exclusion Criteria:

* Case group:

  1. Other known immunosuppression

     Both case- og control group:
  2. Previous HPV vaccination
  3. Previous total hysterectomy
  4. Inflammatory bowel disease
  5. HIV infection