cyrilzakka/clinical-trials huggingface dataset:
Clinical Trial of Safety and Efficacy of Daily Application of Topical Dutasteride in Men With Androgenic Alopecia.

Alopecia is a disorder that involves the loss of hair from the body. The causes of hair loss can be multiple, but in all cases this loss causes a lot of discomfort to patients for aesthetic and psychological reasons, especially in the female population.This study is going to focus on the topical use of dutasteride in the treatment of men with androgenic alopecia using a new formulation, as an emulsion, capable of transporting this drug to the different structures of the pilosebaceous unit.

Alopecia is a disorder that involves the loss of hair from the body. The causes of hair loss can be multiple, but in all cases this loss causes a lot of discomfort to patients for aesthetic and psychological reasons, especially in the female population. This disorder, although more visible in men, is suffered by both men and women. Recent studies show that the stress experienced by patients with alopecia can be similar or greater than that suffered by a more serious or chronic disease. For all these reasons, alopecia can prefer a social problem without a definitive therapeutic solution.This study is going to focus on the topical use of dutasteride in the treatment of men with androgenic alopecia using a new formulation, as an emulsion, capable of transporting this drug to the different structures of the pilosebaceous unit. The lipid nature of the formulation and the droplet size of between 150-300 nm means that the emulsion drops easily penetrate the hair follicle and accumulate in the sebaceous glands of said follicles.

Eligibility Criteria:
Inclusion Criteria:

* • - Males over 18 years of age, diagnosed with Sinclair grades I-IV androgenic alopecia, who are not currently undergoing any hair treatment and have not undergone any in the last 3 months.

  * - Understand the purpose of the study and be available for frequent visits to the hospital. Sign the informed consent form.
  * - Males with a partner of childbearing age must agree to use a contraceptive method with the partner for the duration of the study.

Exclusion Criteria:

* • - Patients with a history of hypersensitivity to the active ingredient, to other 5-alpha reductase inhibitors.

  * - Patients with severe hepatic insufficiency.
  * - Patients who are currently undergoing capillary treatment or have undergone capillary treatment in the last 3 months.
  * - Patients unable to understand the objective of the study or to give informed consent.
  * - Patients who, in the opinion of the investigator, present any difficulty or situation that would hinder or contraindicate their participation in this study.
  * - Patients with a history of drug addiction and drug addictions.
  * - Patients who are participating in another clinical trial.
  * - Patients whose partner is pregnant
Safety and Efficacy of a Retinoid for the Treatment of Severe Chronic Hand Dermatitis

Patients with severe chronic hand dermatitis, that has not responded to topical treatment, including topical steroids and the avoidance of aggravating factors, will be treated with the oral medication alitretinoin. The study aims to investigate the safety and efficacy of the medication when given over a period of 6 months.

For severe, chronic hand dermatitis, refractory to topical treatment and the avoidance of aggravating factors such as allergens and irritants, no registered systemic treatment is available. Current systemic treatment options consist in the off-label use of systemic immune suppressants, such as cyclosporine, methotrexate.

Severe chronic hand dermatitis is a debilitating disease, with massive impact on social life and working ability. A huge proportion of the population suffers for more than a decade, and job losses are a frequent consequence.

This open-label trial investigates the safety and efficacy of oral alitretinoin 30mg as a single daily dose for up to 6 months. The trial is complementary to the pivotal efficacy study BAP00089.

Eligibility Criteria:
Inclusion Criteria:

* Chronic hand dermatitis, rated as severe by physicians global assessment, present for at least 6 months, that has not responded to the avoidance of allergens and irritants and the use of topical steroids

Exclusion Criteria:

* female of childbearing potential, unless participating in a pregnancy prevention program
* psoriasis
* active major psychiatric condition
Effect of Segmental Muscle Vibration on Upper Limb Function in Post Stroke Patients

The aim of this study is to observe and to compare effects of segmental vibration on flexors versus extensor muscle groups on upper limb function in post-stroke patients. This study will be helpful in finding out that either low frequency segmental vibration on flexors muscle group is better in improving upper limb function or low frequency segmental vibration on extensor muscle group is more beneficent in improving upper limb function.

Stroke is the leading cause of long-term disability and is often associated with persistent involvement of upper limbs.Several disturbances are the manifestation of UL impairments after stroke (i.e., muscle weakness, changes in muscle tone, joint disturbances, impaired motor control) . Muscular weakness and spasticity are most commonly observed in post stroke patients. There are many strategies are developed to improve functional status and to reduce spasticity pattern in post stroke patients. Among the different approaches to improve motor functions in post stroke patients, vibration therapy gives strong stimulatory effects in post paretic limb. Segmental muscle vibration (SMV) is a fairly new technique that has been used to improve motor function and inhibit spasticity in the hemiplegic upper extremity of patients following a stroke. In SMV, a vibratory stimulus is applied to a specific muscle tendon using a mechanical device unit.The aim of this study is to observe and to compare effects of segmental vibration on flexors versus extensor muscle groups on upper limb function in post-stroke patients. This study will be helpful in finding out that either low frequency segmental vibration on flexors muscle group is better in improving upper limb function or low frequency segmental vibration on extensor muscle group is more beneficent in improving upper limb function.

Eligibility Criteria:
Inclusion Criteria:

* Both genders
* Age: between 50-65 years.
* Spasticity 1-3 on MAS
* 3-6 months post stroke patients

Exclusion Criteria:

* Cardiovascular event (myocardial ischemia or infarction) occurring within 12 months,
* Use of any antispastic drug
* Pain from vibration
* Inflammatory osteoarticular diseases
PAGETEX® Photodynamic Therapy Device for the Treatment of Extra Mammary Paget's Disease of the Vulva (EMPV).

Vulvar Paget's disease is a rare skin tumour which affect Caucasian post-menopausal women. The disease is revealed by erythematous, eczematous, pruritus and vulvar burns. The diagnosis is often late (from a few months to several years) because the symptoms are neglected by patients or misinterpreted by doctors. The reference treatment is based on surgical excision but unfortunately local recurrences are very frequent (17 to 38% of cases).

Photodynamic therapy (PDT) is already used in some dermatological pathologies and could therefore be an alternative treatment.

The objective of this study is to assess the efficacy and evaluate the safety of the new PDT device "PAGETEX" for the treatment of vulvar Paget's disease.


Eligibility Criteria:
Inclusion Criteria:

* Non-invasive, primary or recurrent vulvar Paget's disease after surgical resection
* Ability to give informed consent.
* Ability to adhere to the study protocol
* Patients must have biopsy (\< 1year) proven recurrent extra mammary Paget's disease
* Effective contraception for Women of childbearing potential

Exclusion Criteria:

* Invasive vulvar Paget's Disease
* Underlying adenocarcinoma
* Subject to photosensitive disorders / reactions
* Treatment with Imiquimod / Aldara 5% cream in the last 3 months
* Photodynamic therapy used to treat MPV lesions in the last 3 months
* Use of photosensitive agents in the last 3 months
* Treatment with an experimental drug in the 30 days prior to the start of the study,
* Allergic or hypersensitivity to methyl aminolevulinate or any of the other ingredients of this medication (propyl p-hydroxybenzoate, cetostearyl alcohol, methyl p-hydroxybenzoate)
* Allergic or hypersensitivity to peanut or soya due to the presence of peanut oil in Metvixia®
* Patient with Porphyria
* Patient already treated with topical corticosteroids on the injured area in the last 3 months
* Patients with immunity disorders (HIV, transplantation)
* Clinical follow-up impossible for psychological, family, social or geographical reasons,
* Legal incapacity
* Pregnant or lactating woman
* Refuse to participate in or sign the consent of the study
MASCOT : Multicenter Asia Study in Adjuvant Treatment of Colon Cancer With OxaliplaTin/5FU-LV

Safety \& tolerability of FOLFOX4 regimen in the adjuvant treatment of colon cancer in Asian patients


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven stage Dukes " B2 " (stage II: T3-T4 N0 M0) and " C " (stage III: any T N1-2 M0) colon carcinoma. The inferior pole of the tumor must be above the peritoneal reflection (\> 15 cm from the anal margin).
* Patients must have undergone complete resection of the primary tumor without gross or microscopic evidence of residual disease
* Patients must be entered in the study in order to start treatment within 7 weeks after surgery
* Age 18-75 years old
* Performance Status ≤ 2 (Karnofsky \> or = 60%)
* No previous chemotherapy, immunotherapy or radiotherapy
* No biological major abnormalities :Absolute neutrophil count \> 1.5 x 10\^9/l,Platelets ≥ 100 x 10\^9/l,Serum creatinine ≤ 1.25 times the upper limit of normal, total bilirubin, ASAT / ALAT \< 2 times the upper limit of the normal range,carcinoembryonic antigen \< 10 ng/ml.
* Documentation of a negative pregnancy test must be available for premenopausal women with intact reproductive organs
* Men and women who are fertile must use a medically acceptable contraceptive throughout the treatment period and for 3 months following cessation of treatment with oxaliplatin. Subjects must be made aware, before entering this trial of the risk of becoming pregnant or in fathering children
* Signed informed consent obtained prior to study entry

Exclusion criteria

* Pregnant or lactating women
* Women of child bearing potential not using a contraceptive method
* Previous cancer of the colon or rectum
* Previous malignancies other than adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell carcinoma of the skin, unless there has been a disease-free interval of at least 10 years
* Participation in another clinical trial with any investigational drug within 30 days prior to randomization
* Peripheral neuropathy (NCI CTC \[National Cancer Institute Common Toxicity Criteria\] \> or = Grade I)
* Uncontrolled congestive heart failure or angina pectoris, or hypertension or arrhythmia
* History of significant neurologic or psychiatric disorders
* Active infection

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Maintaining Bone Strength in Men With Prostate Cancer

The purpose of this study is to see if giving zoledronic acid three times a year is as effective as five times a year, in increasing bone strength in men with prostate cancer. All participants will receive the active drug but half will receive drug every 6 months and the other half will receive drug every 3 months. Both patient and doctor will know which treatment a patient is receiving.

After 1 year of treatment bone strength will be measured with scans and compared to the strength at the start of the study. All participants will stop receiving the drug after 1 year and will be seen back in the clinic, annually for another 2 years for follow-up.


Eligibility Criteria:
Inclusion criteria:

Histologically confirmed diagnosis of carcinoma of the prostate

* No distant metastases
* Patients must be candidates for androgen deprivation therapy (ADT)
* Patient with a baseline BMD T-score at or below -1 standard deviations in the lumbar spine (L2-L4) are eligible

Exclusion criteria:

Patients with normal BMD at trial entry

* Patients who received any prior bisphosphonate therapy in the past 12 months
* Treatment with anti-androgen mono- or combination therapy
* Patients who are currently receiving diethylstilbesterol (DES) or who have previously received PC-SPES
* Patients who have received prior treatment with systemic corticosteroids within the past 12 months
* Patients with prior exposure to anabolic steroids or growth hormone within the past 6 months
* Patients with any prior treatment for osteoporosis

Other protocol-defined inclusion/exclusion criteria may apply.
Tolerance of Infants With Cow's Milk Protein Allergy to Extensively Hydrolyzed Rice Protein or Casein Infant Formulas

The objective of this double blinded randomized study is to assess the tolerance of two extensively protein hydrolyzed infant formulas, one based on rice protein and the other one on casein, at introduction, and after 3 months of consumption, and their efficacy on growth and on the reduction of allergy symptoms through a 3 months consumption period.


Eligibility Criteria:
Inclusion Criteria:

* Full term healthy newborns (37-42 Weeks gestation)
* Weight at birth ≥ 2500 g
* Aged between birth to 9 months
* Symptoms of allergy (Skin or digetive)
* Suspicion of cow milk protein allergy
* Infants whose parents/caregivers/legal guardians have the ability to understand and comply with the requirements of the study
* Infants whose parents/caregivers/legal guardians gave their written informed consent to the infant's participation in the study

Exclusion Criteria:

* Children who have returned to breastfeeding
* Presence of any condition, that, in the opinion of the investigator is a contra-indication to the particpation of the infant in the study
* In the past 15 days, treatment or medication likely to :

  * induce confusion in the allergy tets (ex. : Skin Prick Test) and / or
  * mask the symptoms of an allergic reaction (Anti-allergy medications ; anti-histaminic, anti-leucotrienes, corticosteroids, ...)
* Newbonrs presenting a chronic or a genetic malformation, or a chromosomal or other disease, that in the opinion of the investigator could mask the study results
* Children who show signs of malnutrition, or prolonged diarrhea
* Children whose parents show no willingness to comply with study requirements
* Consumption of soya protein based, hydrolyzed protein or elemental (amino acid) formula for more than 21 days before inclusion, unless the skin prick test to cow's milk protein is positive, and the IgE level indicates the existence of IgE mediated allergy to cow's milk protein.
Efficacy and Mechanism of Acupuncture for Chronic Sciatica Using fMRI

This research is planned to build a basis about the efficacy and mechanism of acupuncture on pain and emotional disorder in patients with chronic sciatica using fMRI.

Clinical research to assess the effect of acupuncture for chronic sciatica on pain and emotional disorder will be processed with randomized, patient-assessor blinding, and sham-acupuncture controlled study design. Sixty eight subjects would be collected and divided into two groups(experimental and placebo, 34 subjects each). Experimental group will undergo with real acupuncture treatment(manual acupuncture + electroacupuncture) and placebo group will undergo with sham acupuncture treatment (acupuncture without skin penetration + electroacupuncture without electrical stimulation) twice a week, for 4 weeks. The effect on parameters related with pain and emotional disorder will be assessed at 1(baseline: just before the beginning of treatment) and 5(primary end point: 1 week after the end of treatment) weeks. Functional magnetic resonance imaging will be also conducted for 52 subjects(experimental and placebo, 20 among 34 subjects each + normal control 12 subjects) at 1 and 5 weeks to seek machanism of acupuncture.

Eligibility Criteria:
Inclusion Criteria:

* adults 19 years of age or more and 70 years of age or less
* clinical diagnosis of chronic sciatica (pain lasting 3 months or more)
* 40mm or more of 100mm VAS for bothersomeness due to sciatica
* volunteers through announcements and advertisements with written informed consent

Exclusion Criteria:

* spinal surgery within the past 6 months
* diagnosis of specific severe diseases resulting in sciatica: malignant tumor, spinal infection, inflammatory sponlylitis
* progressive neurological deficit or severe neurological signs
* other chronic diseases which could disturb the effect of treatments and the results of the study: cardiovascular diseases, autoimmune diseases, renal diseases, diabetic neuropathy, dementia, epilepsy
* inadequate or insafe for the treatment of acupuncture/ electroacupuncture: hemorrhagic diseases, medication of anticoagulant, serious diabetes mellitus vulnerable to infections, serious cardiovascular diseases/ pacemaker, metal materials interior of the body
* currently or might be pregnant
* severe mental illness
* currently participating other clinical trials
* experience of acupuncture or electroacupuncture treatment, or taking medicines which might affect the symptom of pain such as corticosteroids, narcotics, NSAIDs or considered to be inadequate by the investigators within the past week (But they could be included only after going through 2 weeks of wash out period.)
* difficulty of writing informed consent
* inadeguate or insafe for MRI scanning: claustrophobia, metal materials interor of the body
* other inadequate subjects assessed by the study investigators
Prewarming Effect in Preventing Perioperative Hypothermia

Perioperative hypothermia brings numerous and recognized postoperative complications. Active warming intraoperatively helps to maintain body temperature in the postoperative period, but there are few studies in Brazil, assessing the effect of prewarming in maintaining normothermia. It is believed that prewarming with forced air warming system keep the body temperature during intra and post-operative. This study aims to evaluate the effect on prewarming maintaining body temperature of patients undergoing elective surgery of Gynecology specialty using the forced air warming system. The study is experimental design, controlled type randomized clinical trial, with simple blinding for patients. Eighty adult patients undergoing gynecological surgery in the art, with a surgical time of at least an hour will be randomized and allocated into experimental groups - prewarming system with forced air warming system for 20 minutes, and control - Prewarming with sheet and blanket for 20 minutes. The patients will be kept warm during the anesthetic-surgical procedure. The measurement of temperature will be using a tympanic thermometer. Participants will be followed from receiving the surgical center to the end of surgery. Data will be recorded in validated instrument. Data analysis will be used the Model Linear Mixed Effects and the Structure Error Auto-Regressive.

Maintaining the patient in the perioperative normothermia is a challenge for surgical and nursing staff. Despite advances in the development of new technologies for the prevention of perioperative hypothermia, this event still happens in the operating room of the health services To prevent patient's body temperature loss, passive and active cutaneous warming methods can be used. Passive methods prevent loss of body heat through the heat transfer block, as blankets, clothes and cotton sheets; however, there is evidence to show that although assist in maintaining body temperature, passive methods alone are not effective.

Active warming methods are effective in keeping the perioperative normothermia. Among the different technologies available we emphasize the circulating water mattress, the forced air warming system and the carbon fiber resistive heating blankets.

Based on these and due to the lack of research in the Brazilian reality on effective measures for the prevention of perioperative hypothermia, among these, prewarming, and the finding guided by the professional experience that just directed investment for the maintenance of body temperature patient in the perioperative period, in health services, justified the conduct of this study.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years;
* Undergoing elective surgery with duration of at least one hour in the gynecological specialty with open technique;
* Under general, regional or combined anesthesia.

Exclusion Criteria:

* Patients with a body temperature above or below 36oC 37,5oC at the reception of the operating room.
Phosphodiesterase Type 5 Inhibition to Improve Endothelial Function and Vascular Remodeling in Chronic Kidney Disease and End Stage Renal Disease Patients Requiring New Arteriovenous Fistula

Patients with stage IV and V chronic kidney disease and end stage renal disease requiring hemodialysis at University of Alabama at Birmingham (UAB) Dialysis Clinics will be recruited from the UAB Vascular Access Clinic, which has been the site for recruitment of patients requiring new vascular access for the last 10 years.

The main purpose of this research study is to conduct a research study to determine if Sildenafil compared to placebo will improve the vascular health of arteries and veins before arteriovenous fistula creation (shunt) and how quickly your veins and arteries dilate and increase in blood flow after fistula creation. An arteriovenous fistula (shunt) is a connection between the artery and vein in the arm for dialysis use. Another purpose of this study is to determine if Sildenafil reduces the blood and tissue levels of oxidants prior to fistula creation. Oxidants are harmful substances in the body that damage the cells tissues, and organs.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥19 years of age male or female
2. Chronic Kidney Disease Stage IV or V patients or End Stage Renal Disease Patient requiring arteriovenous fistula surgery

Exclusion Criteria:

1. Patient currently on nitrate therapy or any nitric oxide donor in any form
2. Patient currently on protease inhibitor or non-nucleoside reverse transcriptase inhibitor
3. Patient with resting systolic blood pressure \<90 mm Hg and diastolic blood pressure \< 50 mm Hg.
4. Patient life expectancy \< nine months.
5. Patient unable or unwilling to meet study requirements.
Running Successful Journal Club

Running successful journal club is of the important goals for postgraduate education.In this study, the effect of a 6-month interactive educational course on journal clubs of Mashhad Dental school was observed using a valid and reliable checklist(r=0.74). Data will be evaluated and compared using spss software by t-test.


Eligibility Criteria:
Inclusion Criteria:

* Faculty members of Dental School,Postgraduate departments

Exclusion Criteria:

* Faculty members of other schools,Undergraduate departments