cyrilzakka/clinical-trials huggingface dataset:
Daily Topical Rapamycin for Vitiligo

In current Dermatology practice, options for vitiligo remain limited. The purpose of this study is to determine if once daily dosed topical rapamycin is effective for the treatment of patients with vitiligo. Participants will apply either 0.1% topical rapamycin or 0.001% topical rapamycin for six months to a lesion on one side of the body, and topical placebo to a corresponding lesion on the opposite side of the body. The study also aims to evaluate patient satisfaction and identify any adverse effects on these dosing regimens.


Eligibility Criteria:
Inclusion Criteria:

* Patients 13 years of age and older
* Patients with nonsegmental vitiligo

Exclusion Criteria:

* Patients with segmental or mucosal vitiligo
* Patients with contraindication to use of rapamycin
* Patients with history of transplant
* Patients with a history of natural immunodeficiency
* Patients with a history of artificially induced immunodeficiency
* Patients with a history of a serious or life-threatening infection
* Patients taking CYP3A4 inhibiting medications
* Patients taking strong CYP3A4 inducers
* Patients undergoing current treatment for vitiligo
* Women that are or may become pregnant
Emergency Physician-performed Ultrasound-guided Femoral Nerve Blocks in Patients With Hip Fractures.

In this prospective study, emergency physicians perform ultrasound-guided femoral nerve block for patients with hip fractures. We compare the effectiveness of analgesia and patient satisfaction of ultrasound-guided femoral nerve block with liberal use of the pain medicine in the emergency department. The primary outcome is the assessment of time to relief the pain with fewer adverse effects and less rescue pain medication use. The secondary outcome is patient satisfaction and adverse effects for different method of pain control.

The aim of this study is to compare the effectiveness of ultrasound-guided femoral nerve blocks performed by emergency physicians for pain control in the emergency department with traditional pain medicine.

This study is a prospective before-and-after design. The enrollees are 20-year-old and older adult patients with hip fractures. We use numerical rating scale using a 0-10 scale to assess pain severity at the different time frame after giving pain medicine. The scale zero means "no pain" and scale 10 means "the worst pain imaginable".

The primary outcome is assessed by the reduction of pain scale which are taken on a numeric rating scale every 30 minutes before and after pain management. The secondary outcome compares complications, adverse effects and patient satisfaction for different method of pain control.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 20-year-old with hip fractures
* Stay in the emergency department for at lease two hours

Exclusion Criteria:

* hemodynamic unstable
* major trauma in addition to hip fractures
* the use of any pain management before the arrival of emergency department
* chronic opioid use
* inability to understood the numerical rating scale after instruction
* allergy to local anesthetics
* coagulopathy
* injection site infection
Efficacy of Facilitated Tucking During Pain Procedure in Preterm Infants

Preterm infants undergo very frequent painful procedures during neonatal care particularly during the first few days. The support for the pain of the preterm is a priority for nurses and neonatologists. Previous studies showed that non-nutritive sucking combined with sucrose ensures effective pain-relief for preterm (28-32 weeks GA). Unfortunately, the use of sucrose is limited to 4 administrations per day which is insufficient compared to the average of daily painful procedures. So, validation of an effective non-pharmacological intervention to relieve or avoid pain is essential. Facilitated tucking alone has been validated for preterm less than 37 GA during heel stick procedure with the PIPP score but no study looks for the benefit for pain relief of the association of non-nutritive sucking and facilitated tucking during heel stick procedure.

After randomization, baby will receive heel stick procedure with either non-nutritive sucking and sterile water or non-nutritive sucking and sterile water combined with facilited tucking. The sequence will be filmed. Evaluation of PIPP and DAN will be done after viewing by 3 independent experts. Each child will receive only one procedure.

Eligibility Criteria:
Inclusion Criteria:

* Newborn from 28 weeks to 31 weeks +6 days GA.
* Age from 0 to 48 hours of life.
* Admission in intensive care unit or neonatal unit.
* Need for more than 4 heel stick procedures per 24 hours.
* One parents's consent

Exclusion Criteria:

* Hemodynamic instability with initropic drug need.
* Therapeutic Hypothermia in context of neonatal asphyxia.
* Curarized child.
* Neurologic anomaly of contact/tonus.
* Lidocaine application during the 4 hours before the procedure
Predictors of Postoperative Delirium After Transcatheter Aortic Valve Implantation

Patients undergoing transcatheter aortic valve implantation (TAVI) have distinctive characteristics: they are old, frail, with several co-morbidities and take multiple medications. Hemodynamic instability, cerebral embolism, sedation, general anesthesia and hospitalization in intensive care expose those patients to postprocedural delirium.

Acute neurocognitive dysfunctions are associated with adverse outcomes in these population.

The objective of this study is to determine the incidence of delirium and neurocognitive disorders in elderly patients after TAVI.


Eligibility Criteria:
Inclusion Criteria:

* Age 65\>years
* Patients undergoing transcatheter aortic valve implantation
* Patients have given informed consent for participation at the study

Exclusion Criteria:

* Patient suffering from delirium (CAM diagnosis) at recruitment
* Inability to understand the national languages
* Emergency procedures
Efficacy and Safety of Involving Field Radiotherapy in the Oligo-lesions(Metastasis/Recurrent/Refractory) of Ovarian Cancer

In this study, The researchers sought to explore the efficacy and safety of involving field radiotherapy in the oligo-metastatic/recurrent/refractory ovarian cancer patients among different groups which include drug therapy alone, radiotherapy alone, and drug therapy plus radiotherapy by inviting clinical multi-center participation.

The recurrent or refractory ovarian cancer tends to recur repeatedly at increasingly short intervals, making treatment more and more difficult.Patients often have limited physical capacity to undergo repeated systematic treatment. Currently, NCCN（ national comprehensive cancer network ）guidelines recommend palliative radiotherapy in patients with local recurrence of ovarian cancer. With the progress of IMRT（ intensity modulated radiation therapy ）, SBRT ( stereotactic body radiation therapy ) and other radiotherapy technologies, better local tumor control rate can also be achieved, while minimizing the damage to surrounding normal tissues. In this study, the patients will be divided into groups according to their wishes: group A (drug therapy alone), group B (radiotherapy alone), and group C (radiotherapy plus drug therapy).The researchers sought to explore the the efficacy and safety of involving field radiotherapy in the oligo-metastatic/recurrent/refractory ovarian cancer patients in different groups after treatment by inviting multiple centers to participate in the study.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18;
2. Evidence of histological diagnosis of ovarian cancer (including fallopian tube cancer and primary peritoneal cancer)
3. Pathology or imaging suggested recurrence, with measurable lesions, and the number of lesions ≤3;
4. No serious hematopoietic dysfunction, abnormal heart, lung, liver, kidney and immune deficiency
5. Cooperative Oncology Group-Status (ECOG Status) score 0-2;
6. Expected survival ≥3 months;
7. Feasible abdomen and pelvic cavity MRI/CT;
8. Good compliance, signed informed consent voluntarily.

Exclusion Criteria:

1. Previous radiotherapy at the target lesion site;
2. History of active inflammatory bowel disease or severe stomach and duodenal ulcers;
3. Human immunodeficiency virus (HIV) infected persons;
4. active hepatitis b (HBVDNA quantitative test results exceed the lower limit), or HCV infection (HCVRNA quantitative test results exceed the lower limit);
5. suffering from serious underlying diseases, including but not limited to active infections requiring systemic medication:
6. patients with a history of other malignant tumors (except cured basal cell carcinoma of the skin);
7. neurological or mental disorders that affect cognitive ability;
8. Patients whose lesions have been evaluated by the investigator and cannot be treated with external irradiation or endovascular radiation therapy;
9. those who cannot follow up regularly as prescribed by the doctor;
10. Other reasons not suitable for participating in this study as judged by the researcher.
A Study of Saquinavir Used Alone or in Combination With Other Anti-HIV Drugs in HIV-Infected Patients

To offer an investigational agent (saquinavir) to people with HIV/AIDS who are in need of additional treatment options and are not eligible to enroll in ongoing clinical trials.

Patients who no longer benefit from existing antiretroviral therapy and who are not currently enrolled in ongoing saquinavir trials are eligible for this compassionate treatment program.

Patients who no longer benefit from existing antiretroviral therapy and who are not currently enrolled in ongoing saquinavir trials are eligible for this compassionate treatment program.

Patients may be registered with the program through their physicians, who will be responsible for supervising the administration of treatment; following guidelines for saquinavir dose interruption, dose reduction, or discontinuation; and assessing patient progress throughout the duration of the study. Access to saquinavir will be determined by a lottery system; 60 percent of the program slots will be reserved for patients with CD4 counts of 50 or less and the remaining 40 percent of the slots will be devoted to patients with CD4 counts between 51 and 300.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Sero-positivity for HIV -1 antibody by an ELISA test, with confirmation by an alternative method.
* CD4 count \<= 300 cells/mm3 (within 4 weeks prior to entry).
* Signed, informed consent from a parent or legal guardian for patients \< 18 years of age.
* Failed previous therapy with or be intolerant to other registered anti-retroviral drugs.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Eligibility for any controlled clinical study of any experimental HIV therapy.
* Grade 4 hematologic and/or Grade 3 hematologic toxicity at baseline.

Patients with the following prior conditions are excluded:

Known hypersensitivity to saquinavir or other protease inhibitors. 1. Drugs, such as rifampin and rifabutin, which induce hepatic enzymes are likely to result in decreased levels of saquinavir and, therefore, should be avoided where possible.

* Concomitant therapy and treatment should be kept at a minimum.
* Current participation in any study formally excluding concomitant treatment with experimental drugs.

  1. Saquinavir can be used in combination with other registered anti-retroviral drugs such as ZDV, ddC and/or ddl. Other not yet registered anti-retroviral drugs can be used in combination with saquinavir when these drugs are widely available in the respective country or when they are allowed in combination treatment in any on-going clinical study.
* Prophylactic treatment for any opportunistic infections.
COach2Quit TRIAL: Assessing a Prototype Personal Carbon Monoxide Monitor for Smoking Cessation

The objective of this study is to conduct a randomized controlled trial to determine whether the use of the COach2Quit application (app) reduces smoking more than brief advice for smoking cessation. The investigators hypothesize that real time biomarker feedback and messaging support from the COach2Quit app will lead to greater smoking cessation rates than brief anti-smoking advice alone. If effective, the COach2Quit app could be an easily accessible and cost-effective tool to help smokers quit. The findings from this trial could have implications for the delivery of future outpatient smoking cessation programs.

The goal of this randomized controlled trial is to assess the efficacy of the novel COach2Quit smartphone application by determining whether the use of this app reduces smoking more than brief anti-smoking advice alone. This will be a two-arm individually randomized trial and participants who are currently smoking will be assigned 1:1 to either study arm. Smoking behavior will be measured through self-report at baseline, 2-week and 1-month follow up visits. Smoking behavior will also be verified by 2 biomarker measurements: carbon monoxide breath test and urine cotinine, collected at baseline, 2-week and 1-month follow-up visits. In addition, participants will receive weekly follow-up calls. The primary outcome will be smoking cessation at the 1-month follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* current, daily smokers
* agree to participate and anticipate to be living in Baltimore for at least 2 months
* own a phone that is compatible with the app
* be willing to set at baseline assessment a quit date within 2 weeks

Exclusion Criteria:

* are suffering from any unstable medical condition precluding the use of the CO monitor (e.g. severe COPD)
* are currently using smokeless tobacco including e-cigarettes
* are currently using nicotine replacement therapy or other smoking cessation treatment
* are pregnant, determined by participant self-report
* have a negative baseline result on both urine cotinine AND CO monitor
Anthropometric Characteristics of Elite and Olympic Mexican Track and Field Athletes

Sport specialization requires an understanding of morphological variability to optimize performance. However, the current literature lacks a detailed analysis of the anthropometric profile of track and field athletes, especially in Latin America. Additionally, the five-way fractionation method of body mass has been under-documented. These gaps highlight the need for more research to maximize the potential of athletes, particularly in emerging countries like Mexico. This study aims to determine the anthropometric characteristics of elite and Olympic Mexican track and field athletes. A descriptive cross-sectional study will be conducted. Forty-three anthropometric variables will be assessed to characterize the athlete´s physical composition using the standards of the International Society for the Advancement of Kinanthropometry (ISAK). Those variables will be used to describe the anthropometric profile (Heath and Carter somatotype, body composition through five-way fractionation method, muscle bone index, muscular adipose index, sum of skinfold thicknesses, and proportionality through Ross \& Wilson Phantom strategy. Correspondences of those variables will also be established among different tests and specialties: sprint, middle-distance, long-distance, endurance, combined events, jumps, and throws. This study aims to provide the opportunity to generate reliable references for high-performance Mexican athletes.


Eligibility Criteria:
Inclusion Criteria:

* Elite and Olympic Mexican track and field athletes
* Female and male,
* All national teams
* Actively competing in national and/or international competitions

Exclusion Criteria:

* Injured or not classified athletes
* Not informed consent signed
Can Oxytocin Enhance the Placebo Effect?

The current study aimed to investigate whether oxytocin (OXT) had effect on placebo effect.

The current study included three phases to investigate oxytocin effect on placebo effect:

1. In a double-blind, between-subject, placebo controlled design study to investigate the intranasal OXT (24IU) treatment in 66 healthy male subjects using working memory task.
2. In a single-blind(subjects were informed that the treatment was oxytocin), between-subject, placebo controlled design study to investigate the intranasal OXT (24IU) treatment in 53 healthy male subjects using working memory task.They were informed that oxytocin would increase memory perfomance by a female experimenter.
3. In a single-blind(subjects were informed that the treatment was oxytocin), between-subject, placebo controlled design study to investigate the intranasal OXT (24IU) treatment in 53 healthy male subjects using working memory task. But the subjects were told that oxytocin would decrease the performance by the same female experimenter.
4. In a single-blind(subjects were informed that the treatment was oxytocin), between-subject, placebo controlled design study to investigate the intranasal OXT (24IU) treatment in 52 healthy male subjects using working memory task. The subjects were told that oxytocin would increase the performance by a male experimenter.

Memory performance was included as dependant factor. All subjects completed a range of questionnaires measuring personality and affective traits and levels of anxiety: State-Trait Anxiety Inventory (STAI), Beck Depression Inventory (BDI), Interpersonal Trust Scale(ITS).

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects without past or current psychiatric or neurological disorder

Exclusion Criteria:

* history of head injury;
* claustrophobia;
* medical or psychiatric illness.
Evaluating Effectiveness and Long Term Safety of Damoctocog Alfa Pegol in Patients, Who Have Been Diagnosed With Hemophilia A

The aim of the HEM-POWR study is to understand better how Damoctocog alfa pegol (Jivi) is used to treat people with Hemophilia A in day-to-day life, how well the treatment is tolerated and how satisfied patients and physicians are with the treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of hemophilia A.
* Patients previously treated for Hemophilia A.
* Patients without previous history of inhibitors or patients with previous history of inhibitors on standard prophylaxis therapy for at least 1 year prior to study entry.
* No current evidence of FVIII inhibitor or clinical suspicion of FVIII inhibitor.
* Initiation of or currently on damoctocog alfa pegol with any kind of treatment modality (on-demand, prophylaxis, or intermittent prophylaxis).
* Signed informed consent/assent.

Exclusion Criteria:

* Concurrent participation in an investigational program with interventions outside of routine clinical practice.
* Diagnosis of any other bleeding/coagulation disorder other than hemophilia A.
* Contra-indications according to the local marketing authorization.
* Patient on immune tolerance induction (ITI) treatment at the time of enrollment.
Japan Morning Surge-1 Study

The purpose of this study is to examine whether strict blood pressure (BP) control by doxazosin using home BP monitoring, especially targeting the morning BP level, can reduce hypertensive target organ damage.

Morning blood pressure may play an important role in the pathogenesis of hypertensive target organ damage. Increased sympathetic nerve activity is reported to be one of the mechanisms of morning hypertension; however, there are no available data that show whether strict home blood pressure control, especially in the morning period, can reduce target organ damage.We will evaluate whether strict morning blood pressure control by sympathetic nervous system blockade using an alfa-blocker, doxazosin, and with the addition of a beta-blocker if needed, can reduce hypertensive target organ damage.

Eligibility Criteria:
Inclusion Criteria:

* Morning systolic blood pressure \>135 mmHg in a sitting position at home while on stable antihypertensive medication for at least 3 months

Exclusion Criteria:

* History of heart failure
* Presence of orthostatic hypotension, dementia, malignancy and chronic inflammatory disease
* Taking an alfa-blocker or beta-blocker
* Atrial fibrillation or atrial flutter
Myelodysplastic Syndrome (MDS) Gastrointestinal (GI) Tolerability Study

The objective of the study is to evaluate and compare the frequency and severity of GI adverse events in different dose administration regimens. The patient population consists of low or intermediate (int-1) risk myelodysplastic syndrome (MDS) patients with transfusional iron overload. The study patients are randomized to either a morning dose of 20 mg/kg/day deferasirox or an evening dose of the same. Patients are then followed up for 6 months for any GI events and are assessed using patient reported outcomes tools e.g. a patient diary.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent prior to any screening procedures
* Male or female patients ≥ 18 years of age
* Patient must weigh between 45-135 kg
* Patients with low or intermediate (int-1) risk MDS, as determined by IPSS score or RA, RARS by WHO criteria. IPSS must be confirmed by a bone marrow examination within 6 months prior to study entry and must be hematologically stable

Deferasirox naïve:

Sexually active pre-menopausal female patients must use double-barrier contraception, oral contraceptive plus barrier contraceptive, or must have undergone clinically documented total hysterectomy and/or oophorectomy, tubal ligation

Exclusion Criteria:

* History or current GI disease
* Systemic diseases which could prevent study treatments
* Left ventricular ejection fraction\< 50 % by echo cardiography
* Serum creatinine \> 1.2 x ULN at screening
* Platelet counts \< 25x 109/L except in cases where guidance is already given in the local deferasirox label
* AST or ALT \> 2.5 xULN at screening

Other protocol-defined inclusion/exclusion criteria may apply
HORizontal Instability AC Joint Study: A Prospective Randomised Clinical Trial

Comparing different treatement strategies in augmenting clavicle stabilisation


Eligibility Criteria:
Inclusion Criteria:

* consensus indication for surgical treatment of AC syndesmolysis
* OP in 3 weeks after injury
* patient age between 16 and 65 years
* normal shoulder function before injury

Exclusion Criteria:

* open injury
* ipsilateral arm/shoulder girdle/hand injuries
* very low patient's physical demands
* previous injuries of the affected area
* Rockwood classification 1, 2, or 6