cyrilzakka/clinical-trials huggingface dataset:
Papuan Indigenous Model of Male Circumcision

The purpose of the study is: AIM 1: To engage Papuan community members to explore acceptability, barriers and facilitators for introducing a school-based age and culturally appropriate, comprehensive VMMC intervention to reduce HIV incidence in the Papuan population. AIM 2: To assess the capacity of the community health system to meet international criteria for safe comprehensive VMMC services and to ensure the availability of resources and training necessary to meet these criteria in selected clinics. AIM 3: To design the PIM of school-based adolescent VMMC based on information collected in Aims 1 and 2 and in consultation with a community advisory board, the Ministry of Health and the Ministry of Education. AIM 4: To pilot-test the school-based PIM Intervention of VMMC with 400 boys ages 12-18 years at two HIV high-risk Papuan locations: the Nabire and Jayapura. Primary outcomes are the proportion of adolescent males exposed to school-based PIM VMMC educational and informational sessions who get circumcised and surgical event safety. Secondary outcomes are satisfaction by adolescent males and parents, any sexual activity within 6 weeks after circumcision, changes in sexual risk behaviors between base-line and 12 weeks after circumcision, and perceptions of providers regarding MC training and implementation, ease of device use, and challenges encountered.


Eligibility Criteria:
Inclusion Criteria:

* Resident of either Nabiri or Jayapura Districts of Papua, Indonesia. Able to provide informed consent if over 17 and parental consent and personal assent if less than 18.

Focus group and interview participants had to be either a parent, boy or girl between 12-18, teacher or administrator, or community leader.

To be eligible for circumcision, a boy had to be uncircumcised, age 15 years or above, and not show signs or symptoms of an STI or any penile abnormality (e.g., hypospadias, phimosis) that made him clinically ineligible for circumcision.

Exclusion Criteria:

* Unable to provide informed consent or assent. Any medical condition indicating should not undergo circumcision.
Effect of Zumba Dance on Premenstrual Tension

Each female sets her experience of 47 manifestations on a 6 point scale separately for the premenstrual, menstrual and intermenstrual phases of her latest and worst menstrual cycle. Daily Symptoms Report will be filled at the start and at end of the study (before and after performing swimming exercise) Females in group I will be instructed to engage into 12 classes of 60-minute Zumba® fitness over an 8-week period.

Each female sets her experience of 47 manifestations on a 6 point scale separately for the premenstrual, menstrual and intermenstrual phases of her latest and worst menstrual cycle. Daily Symptoms Report will be filled at the start and at end of the study (before and after performing swimming exercise) Females in group I will be instructed to engage into 12 classes of 60-minute Zumba® fitness over an 8-week period Each class was one hour in length and a recovery period of at least 48 hours will be taken between classes. The Zumba® fitness scheduling of sessions will be self-selected by the participants. The Zumba sessions will be conducted at a ﬁtness center (SAMIA ALLOUBA gym and fitness center) and will consist of continuous dance movements to Latin music with varying intensity level throughout the sessions. Each session will be initiated with low-intensity movements for the ﬁrst 5 min, followed by an increasing intensity throughout the workout. At the end of the training session, the intensity will be gradually reduced. The Zumba sessions will be supervised by three certiﬁed Zumba instructors, each responsible for regular sessions per week.

Eligibility Criteria:
Inclusion Criteria:

1. Age:18-25 years.
2. BMI :18-25 kg/m2.
3. A regular menstrual cycle of 23-35 days duration.
4. No previous practice of Zumba.
5. Free from musculoskeletal injury.
6. All women did not use oral contraceptive pills or any psychotropic agents.

Exclusion Criteria:

1. Pregnancy.
2. Metabolic/cardiorespiratory contraindications to physical exercise.
3. Cigarette smokers.
4. Recovering from a major injury or illness; or using anti-inflammatory, hyperlipidemia or hypertension medication.
5. any abnormality in ovulation or those with pelvic inflammatory diseases (PID) or a history of endometriosis.
6. Women with endocrine abnormality as diabetes mellitus, thyroid, pituitary, or ovarian disorders.
7. Women who are taking any hormonal drugs or drugs that affect hormones as antidepressant drugs during the preceding three months before the study.
Sleep Behaviour in Athletes During Home Confinement Due to the Covid-19 Outbreak

It is becoming increasingly evident that sleep plays an essential role for human health, and it represents an important biophysiological variable for athletes' well-being and recovery. The International Olympic Committee recently highlighted the importance of obtaining sufficient sleep volume and quality among athletes, but acute sleep deprivation is not unusual. Several factors, both endogenous and exogenous, are able to negatively influence sleep in athletes: body temperature, altitude, chronotype, training volume, anxiety, westward and eastward travels, and many others.

Since December 2019, when a new coronavirus (SARS-CoV-2) was originally revealed by an ophthalmologist in Wuhan (Hubei province, China), a related severe acute respiratory syndrome - namely COVID-19 - has been spreading at a pandemic rate, putting global health systems under unprecedent pressure. Italy, as the first Western country tremendously hit by this disease outbreak, has become the iconic resilient outpost under international policymakers' attention. When initial clusters were identified, restrictive actions to curb isolated upsurges of infection were taken by the health region system of Lombardy, thereafter, were extended to all northern Italy and to the entire country. From February 21, when the first Italian COVID-19 case was diagnosed in southern Lombardy, to March 22, when Italian's government restrictions to contain the pandemic were extended, prohibiting all non-essential business activities and banning all movements of people nationwide, the country faced an unchartered scenario, from several standpoints, along with the psychosocial one.

Inevitably, the Covid-19 outbreak has largely influenced the daily life of athletes too. Therefore, the primary aim of this study was to examine the differences in athletes' sleep quality, quantity and training volumes during the social confinement due to the virus outbreak. For this purpose, a survey will be used. This variables will be evaluated in 3 different time frames: 1) May 2020; 2) September 2020; 3) January 2021.


Eligibility Criteria:
Inclusion Criteria:

* male or female gender.
* age between 18 and 40 years old.
* elite athletes (competing at national or international level).
* no cognitive impairments.
* at least 6 years of practice of a specific sport discipline.
* affiliated to CONI (Comitato Olimpico Nazionale Italiano).

Exclusion Criteria:

* age under 18 years old.
* part-time workers.
* injury or any clinical condition affecting training routines (and sleep).
* pregnant women.
Long-Term Impact of Human Papillomavirus (HPV) on Quality of Life

The investigators are doing this study to learn about the quality of life patients have at the end of treatment. Some patients' cancers are related to human papilloma virus or HPV; others are not. HPV is a virus that can be sexually transmitted and is known to cause some types of cancers. If your throat cancer was related to HPV, your doctor can discuss this with you in detail. The investigators want to see if there are differences in quality of life between patients whose cancers are caused by HPV and those who cancers are not caused by HPV. Throat cancers caused by HPV behave differently than throat cancers not caused by HPV. The investigators believe that patients with these two different types of throat cancer will also have different experiences after completing therapy. The investigators would like to understand what those differences are. The long-term goal of this study is to see what symptoms most patients have. The investigators can then try to treat them earlier, and hopefully, improve the symptoms. The investigators will also be able to plan more research to improve treatment for symptoms following treatment for cancer of the mouth and throat.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Diagnosis of squamous cell carcinoma of the oropharynx confirmed by the pathology department at MSKCC
* Completed last treatment for oropharynx cancer (surgery, chemotherapy, or radiation) at least 12 months and no more than 5 years before the date of study enrollment
* Known tumor status or tumor available for HPV testing \[based on chromogenic in situ hybridization with wide spectrum HPV probe (HPV III family 16 probe (Ventana) with affinity to HPV genotypes 16, 18, 31, 33, 35, 45, 51, 52, 56, 58, and 66) or p16 immunohistochemistry done in a Clinical Laboratory Improvement Amendment (CLIA)-approved laboratory; if either of these 2 tests are positive, the patient is classified as positive\].
* Able to speak and read English (study questionnaire-Aim 1 and interview guide-Aim 2 are currently only available in English).
* Received at least one component of treatment for oropharynx cancer at MSKCC or the regional network sites
* If radiation therapy was part of treatment, it must have been delivered at MSKCC or the regional network sites
* For Aim 2 only, diagnosed with an HPV+ oropharynx cancer and have knowledge of this diagnosis prior to study enrollment

Exclusion Criteria:

* Diagnosed with recurrent disease following completion of primary curative treatment
Assessing the Safety and Efficacy of MK-5592 (Posaconazole) in Japanese Participants With Fungal Infection (MK-5592-101)

The primary objective of this study is to assess and compare the safety of posaconazole with voriconazole in Japanese participants with aspergillosis.


Eligibility Criteria:
Inclusion Criteria:

* Body weight \>=45 kg
* Can be treated by taking tablet orally or intravenous (IV) formulation via central vein
* Female has a negative pregnancy test
* Female of non-childbearing potential; or if of childbearing potential, agrees to use proper combination of barrier method of birth control
* Met screening criteria for either Invasive aspergillosis, chronic pulmonary aspergillosis, zygomycosis or fusariosis.

Exclusion Criteria:

* Has a fungal infection other than Aspergillus any species (spp.) Zygomycetes (including Mucor spp.) and Fusarium spp. infection
* Has allergic bronchopulmonary aspergillosis, allergic sinusitis of aspergillosis, or aspergillosis of the eye
* Has long-term inactive aspergilloma not expected to respond to investigational product
* Is not expected to survive study duration
* Has an underlying disease, complication and systemic condition which makes it difficult to evaluate effect of study drug
* Has received, or continues to receive any systemic antifungal therapy, and cannot discontinue this treatment; but if fungal infection does not improve, can switch to study drug
* Is expected to need prohibited medications
* Has received posaconazole, has received voriconazole for this infection in the past and has deep-seated fungal infection that has not responded to this treatment, has intolerance for azole antifungal treatments, or is receiving antifungal combination therapy for chronic pulmonary aspergillosis
* Has known hypersensitivity to any medication
* Has history of either Torsade de Pointes, myocardial infarction within previous 90 days, has congenital or acquired long QT interval syndrome, or unstable cardiac arrhythmia
* Has significant liver dysfunction
* Has liver cirrhosis or cholestasis
* Has renal insufficiency
* Has a known hereditary problem of either galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
* Has acute symptomatic pancreatitis within 6 months of study entry or chronic pancreatitis
* Has an active skin lesion consistent with squamous cell carcinoma or melanoma, or within prior 5 years a history of malignant melanoma
* Has known or suspected Gilbert's disease
* Female is pregnant, or nursing, or intends to become pregnant within 14 days after end of study.
Prevention of Liver Damage During Liver Surgery

Liver damage as a consequnce of ischemia (I) and reperfusion (R) is known to harm the liver and could hence be a critical factor of the postoperative outcome of patients undergoing liver surgery. In order to protect the liver from ischemic damage following interventions such as the Pringle Maneuver, preconditioning has been successfully applied in various animal models as well as in humans. Since ischemia inevitably leads to cell hypoxia and subsequnet release of endogenuous metabolites, the investigators hypothesize that instead of brief periods of ischemia, the exogenuous infusion of purine analogues may also protect against subsequent prolonged periods of ischemia. Moreover, after reperfusion, the antiinflamamtory action of purine ananlogue infusion can further attenuated liver damage.


Eligibility Criteria:
Inclusion Criteria:

* elective resection of liver tumors
* age 18 to 80 years
* informed consent

Exclusion Criteria:

* chronic obstructive pulmonary disease
* heart insufficiency NYHA III-IV
* atrio-ventricular conductance blockage II. (Mobitz) or III. degree
* atrial fibrillation
* coronary heart disease (CCS III. or IV. degree)
* arterial hypertension
* acute renal failure
* increased intracranial pressure
* gout
* pregnancy
Patients With Pulmonary Hypertension or Interstitial Lung Disease at Altitude - Effect of Oxygen on Exercise Performance

The purpose of this study is to investigate the effect of travelling to moderate altitude and of nocturnal oxygen therapy during a stay at moderate altitude on exercise performance of patients with pulmonary hypertension or with interstitial lung disease.

Patients with pulmonary hypertension or with interstitial lung disease living below 800 m will be invited to participate in a randomized, cross-over field trial evaluating the hypotheses that: a), exercise capacity during a 2 day sojourn at moderate altitude is reduced in comparison to low altitude; b), exercise capacity during a 2 day sojourn at moderate altitude is improved by nocturnal oxygen therapy compared to room air (sham oxygen) administered during nights at altitude. Outcomes will be assessed at low altitude (Zurich, 490 m, baseline), and during 2 study periods of 2 days each spent at moderate altitude (St. Moritz Salastrains, 2048 m), separated by a wash-out period of at least 2 weeks spent at low altitude (\<800 m). The order of stays at the different altitudes and of the treatments will be randomized.

Eligibility Criteria:
Inclusion Criteria:

* Precapillary pulmonary hypertension, or interstitial lung disease.
* New York Heart Association class 2-3.
* Residence at low altitude (\<800m).

Exclusion Criteria:

* Unstable or exacerbated condition
* Very severe pulmonary hypertension or interstitial lung disease, New York Heart Association class 4
* Requirement for oxygen therapy at low altitude residence
* Hypoventilation
* More than mild or unstable cardiovascular disease
* Use of drugs that affect respiratory center drive
* Internal, neurologic or psychiatric disease that interfere with protocol compliance including current heavy smoking (\>20 cigarettes per day), inability to perform 6 min walk test.
* Previous intolerance to moderate altitude (\<2600m).
* Exposure to altitudes \>1500m for \>2 days within the last 4 weeks before the study.
* Pregnant or nursing patients
Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries

Obstetric anal sphincter injuries (OASIS) encompass both third and fourth degree perineal tears. These tears can have a significant impact on women's quality of life in the short and long term. One of the most distressing immediate complications of this severe perineal injury is perineal pain. Women can also experience postpartum depression, dyspareunia, and altered sexual function after OASIS.

This is a randomized controlled trial to study the effects of three interventions (placebo, low dose intravenous ketamine plus epidural morphine, or epidural morphine alone) on acute pain after OASIS.

The objective of this study is to assess the incidence of perineal pain in postpartum patients 1 week after obstetric anal sphincter injuries.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years of age
* English-speaking
* Vaginal delivery (spontaneous or assisted)
* A full-term fetus (\>37 weeks' gestation)
* OASIS as assessed by obstetrical provider
* Functional epidural analgesia at time of delivery
* Patient amenable to follow-up in specialty perineal clinic within the first week postpartum

Exclusion Criteria:

* Previous pelvic surgery
* History of chronic pelvic pain
* History of recurrent urinary tract infections
* Women with known malformations of their urinary tract
* True allergies to ketamine and/or morphine
* Preeclampsia or hypertensive disorder at the time of delivery
* Obstructive sleep apnea
TRAUMEEL S in Reducing Pain After Correction of Hallux Valgus-Clinical Trial

Hallux valgus is a common deformity of the big toe, defined as medial deflection of the first metatarsal bone along with lateral deflection of the first toe. Surgery has been shown to be beneficial when compared to orthoses or no treatment. While generally effective, surgery entails significant post-operative pain, inflammation and edema, and several weeks of limited mobility. This will be a double-blind, randomized, placebo-controlled study comparing the homeopathic drug Traumeel S with placebo in pain reduction after surgical Hallux valgus correction.

80 patients, over the age of 18 years, undergoing surgical correction of unilateral hallux valgus will be enrolled in the trial. The patients will be randomized to two groups, one receiving oral Traumeel S and the other oral placebo tablets. Patients will take active or placebo medication for 13 days or until they have a NRS score of 3 or less for 2 consecutive days. Pain will be reported daily by the patient on the patient diary, using an 11-point numerical rating score (NRS-11) during 13 days post-operatively. They will also be asked to report daily consumption of primary and "rescue" analgesics for 13 days post-operatively. Patients will be contacted daily by the research assistant to encourage compliance and to record their daily NRS and analgesic consumption in the CRF. Patients will be evaluated by physicians at six and 13 days postoperatively for redness and compliance.


Eligibility Criteria:
Inclusion Criteria:

Patients of either sex undergoing unilateral surgical correction of Hallux Valgus.

Age over 18 years. Signature upon informed consent form. Meeting none of exclusion criteria.

Exclusion criteria Participation in another clinical trial within 4 weeks prior to enrollment. Inability to comply with the study protocol. Previous surgical Hallux Valgus correction on ipsilateral foot. Current use of analgesia for any other reason.
Effect of 4 Weeks of Shuttle Run Training on Insulin Sensitivity in Sedentary Men

A number of studies have shown that short duration, high intensity interval training can improve health-related outcomes, such as insulin sensitivity and cardiorespiratory fitness. However, these often use specialized equipment, such as cycle ergometers, which makes it difficult to roll these interventions out for wide-scale use in the general population. This study aims evaluate the effects of a high intensity shuttle running intervention on insulin sensitivity, fitness and related cardiometabolic risk factors in men who are currently inactive. Participants will be randomized into intervention (4 weeks of shuttle running) and control groups. We hypothesize that the shuttle running programme will result in improved insulin sensitivity, fitness and increased fat oxidation at rest compared with the control group.


Eligibility Criteria:
Inclusion Criteria:

* male
* 18-40 years
* undertaking \< 1 hour per week of planned exercise

Exclusion Criteria:

* BMI \> 35 kg/m2
* Blood pressure \> 160/90 mm Hg (on anti-hypertensive medication)
* history of established coronary heart disease
* family history of early cardiac death (\<40 years)
Stratified Therapy on Pediatric AAGN

Clinical information of children with ANCA-associated nephritis admitted to Children's Hospital Affiliated to Chongqing Medical University and partner centers from January 1, 2023 to December 31, 2023 was collected:

To evaluate and compare the differences in survival, renal outcomes, and adverse reactions in children with ANCA-associated nephritis given different interventions according to the revised PARRG risk stratification, and to evaluate the superiority of ANCA-associated nephritis given according to the revised PARRG risk stratification.

(2) To evaluate the efficacy and safety of glucocorticoid combined with rituximab and cyclophosphamide as induction regimen in high-risk group and glucocorticoid combined with rituximab as induction regimen in children with ANCA-associated nephritis (AAGN) in low and middle risk group based on PARRG risk stratification


Eligibility Criteria:
Inclusion Criteria:

* 1) Newly diagnosed AAGN patients with onset age of 5-17 years, complete renal biopsy and regular follow-up in the hospital; 2) All enrolled children met the following inclusion criteria: ANCA classification criteria: Patients who meet the 2007 European Medicines Agency (EMA) classification algorithm or the 2012 CHCC definition. Clinical classification includes: micropolyvasculitis (MPA), granulomatous polyvasculitis (GPA) and eosinophilic granulomatous polyvasculitis (EGPA);

AAGN diagnostic criteria: ANCA vasculitis combined with any of the following:

1. Hematuria: gross hematuria or microscopic hematuria: 3 times microscopic hematuria within 1 week: red blood cells \&gt in urine routine; 3 / high magnification field (HP) or \> 17 /ul (higher than normal value, can be adjusted according to the standard of the laboratory of each center);
2. proteinuria: meet any of the following: ① 3 times in 1 week urine routine protein positive; 2) 24h urinary protein quantification \&gt; 150 mg or urinary protein/creatinine (mg/mg)\&gt; 0.2; 3 urinary microalbumin higher than normal for 3 times in 1 week;
3. Renal insufficiency: increased serum creatinine \&gt; 10% base or decreased creatinine clearance \&gt; 25%.

Exclusion Criteria:

- 1) Patients who relied on dialysis for more than 1 month at the time of diagnosis, or the proportion of glomerular sclerosis ≥75% at the time of renal biopsy; 2) Patients with severe infection (such as diffuse peritonitis, severe pneumonia, cellulitis, active Epstein-Barr virus infection, active cytomegalovirus infection, hepatitis B virus infection, tuberculosis infection, fungal infection, etc.) and tumor.

3) Patients with other primary or secondary kidney diseases (such as IgA nephropathy, membranous nephropathy, anti-glomerular basement membrane nephritis, polycystic kidney disease, renal dysplasia, urinary tract malformation, etc.); 4) Parents or children refused to join the group.