cyrilzakka/clinical-trials huggingface dataset:
Efficacy, Safety and Tolerability of Topical 10% Terbinafine Hydrogen Chloride Versus 5% Amorolfine Nail Lacquer in Patients With Mild to Moderate Toenail Onychomycosis

This study will evaluate the efficacy, safety and tolerability of topical 10% terbinafine hydrogen chloride applied daily versus 5% amorolfine nail lacquer applied twice a week in patients with mild to moderate toenail onychomycosis, for a total treatment duration of 48 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Male and females 12 - 75 years of age
* Fungal toenail infection of one or both of the large (great) toenails
* The nail infection must be due to a dermatophyte, (mixed infections \[dermatophyte and non-dermatophyte\] are not allowed)
* The target toenail area must have at least 25% to no more than 75% disease involvement without spikes.

Exclusion Criteria:

* Target foot must not have severe plantar (moccasin) tinea pedis that would require systemic therapy. Mild to moderate tinea pedis (athlete's foot) infection should be treated with terbinafine prior to baseline or at any time during the trial. Other topical treatments for athlete's foot may be recommended at the discretion of the investigator.
* Subjects must not have abnormalities of the nail that could prevent a normal appearing nail if clearing of infection is achieved
* No administration of systemic antifungal medications within 6 months prior to screening visit
* No application of prescription topical antifungal medications for toenail fungus within 3 months or other commercially available topical medications for toenail fungus applied directly to the toenails within 1 month prior to screening visit
* Patients with the target toenail involving the matrix (lunula) or having less than 2mm clear (unaffected) nail plate length beyond the proximal fold.
* Presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail.
* No professional pedicures or application of any nail polish product or nail cosmetic to the toenails after the screening visit
* Known pregnancy or lactation at time of enrollment

Other protocol-defined inclusion/exclusion criteria may apply
High-risk Obstetrical Patient Intervention Utilizing the Contraceptive CHOICE Project Script

High-risk obstetrical patient Intervention to promote Birth Interval Spacing utilizing the Contraceptive CHOICE project script to reduce Unintended Subsequent pregnancies (HIBISCUS) is a collaborative study utilizing qualitative methods to assess the acceptability including a family planning specialist's postpartum contraception counseling during and after prenatal care among Latina obstetric women with pre-gestational diabetes. The investigators will compare the effectiveness of HIBISCUS versus usual contraceptive counseling on Long-Acting Reversible Contraception (LARC) use at 3 months postpartum.

The purpose of this research is to address this gap in long-acting reversible contraception (LARC) counseling among Latinas who have pregnancies complicated by pre-gestational diabetes in order to promote optimal birth-to-pregnancy spacing and planned pregnancies with optimal glucose control. The investigators will utilize Contraceptive CHOICE project which was LARC focused counseling script and removed the cost of contraception. This study had a LARC utilization of 75% compared to the national use of LARC of 7.2% The investigators will conduct a pilot randomized controlled trial among Latina obstetrics patients with pre-gestational diabetes involving a prenatal and postpartum visit with a family planning specialist versus usual contraceptive counseling. The family planning specialist counseling will utilize the Contraceptive CHOICE Project script promoting LARC, 18 month birth-to-pregnancy recommendation and preconception counseling. The intervention's name is HIBISCUS.

Eligibility Criteria:
Inclusion Criteria:

* Latina obstetric women
* Pre-gestational diabetes
* Obtaining prenatal care in the high-risk obstetrical clinic - Diabetes in Pregnancy

Exclusion Criteria:

* Desires sterilization
Early Support and Physiotherapy for Children and Their Motor Skills

The App-eMot-Quali project proposed here is the first phase in the implementation of a care pathway supported by a digital tool. It consists of a qualitative study allowing individual interviews to be conducted with parents of infants at high risk of cerebral palsy and health professionals in order to identify and precisely describe the needs and difficulties present during the child's rehabilitative care during the first months of life.


Eligibility Criteria:
Inclusion Criteria:

1. For the parents:

   Parents of children under 24 months of age at high risk of cerebral palsy who have given their oral consent.

   Children at high risk of cerebral palsy are defined as :
   * Premature children ≤ 31 WG + 6 days or birth weight less than 1000g.
   * Children who have had a stroke or stage 2 or 3 hypoxia-ischemia according to the Sarnat classification.

   The selection of parents may be retrospective with less than 24 months since hospital discharge.
2. For the health professionals:

Physiotherapists, psychomotricians, psychologists and doctors involved in the care of children at high risk of cerebral palsy.

Exclusion Criteria:

* A person who is physically or cognitively unable to participate in a one-on-one interview or who does not have a sufficient command of the French language.
* Parents aged \<18 years
* Parents in protective custody
* Parents of children with major orthopedic or traumatic disorders unrelated to the high risk of cerebral palsy.
* Parents of a child with a genetic disease.
Comparison of a Compound With Pilocarpine and Brimonidine to Improve Near Vision in Healthy Presbyopic Patients

Safety and Efficacy of Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac (PBOHB) ophthalmic compound compared to Pilocarpine and Brimonidine to improve uncorrected near vision in healthy presbyopic patients one hour after instillation.

To determine the safety and efficacy of a novel pharmacological compound of Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac (PBOHB) to improve uncorrected near vision in healthy presbyopic patients compared to Pilocarpine and Brimonidine one hour after binocular instillation.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Presbyopic
* 40 - 59 years

Exclusion Criteria:

* Diabetics
* Previous eye surgery
* Previous eye disease
* \> 0.50 myopia
* \> 1.5 hyperopia or astigmatism
Bioequivalence Study of Generic Tretinoin 0.1% Microsphere Gel, 0.1% Retin-A Micro® and Placebo

The objective will be to assess clinical bioequivalence of 0.1% Retin-A Micro® Gel and Spear Pharmaceutical's generic 0.1% Tretinoin Microsphere Gel with a placebo arm.

Not required

Eligibility Criteria:
Inclusion Criteria:

* Normal, healthy male and female children and adult
* Written and verbal informed consent must be obtained. Patients age 12 to 17 (inclusive) must sign an assent for the study and a parent or a legal guardian must sign the informed consent.
* Women of child-bearing potential must be non-pregnant and non-nursing, and must be willing to avoid pregnancy during the course of the study and during the menstrual cycle following completion of their participation in the study.
* Able to refrain from the use of all other topical acne medications or antibiotics during the treatment period.
* Considered reliable and capable of understanding their responsibility and role in the study.

Exclusion Criteria:

* Significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hepatic, neurological, pancreatic, or renal disease.
* Abnormal pre-existing skin condition which might affect the normal course of acne vulgaris (e.g., eczema, psoriasis, albinism, or chronic vesiculobullous disorders).
* Use topical acne therapy during the two week period prior to study initiation.
* Use of systemic retinoid treatment within six months prior to study initiation.
* Pregnant or breast-feeding.
* Serious psychological illness.
* Participation in any clinical research study during the 30 day period preceding study initiation.
Intraoperative Hypotension in High-risk Patients Undergoing Surgery

The primary objective of this observational study is to investigate the risk factors for intraoperative hypotension and identify the underlying pathomechanisms leading to it, both during the period after general anesthesia induction and throughout its course.

The main questions it aims to answer are:

* how frequent is intraoperative hypotension
* what are the underlying pathomechanism causing it The study is including patients who have been identified as having a high risk of perioperative complications (ASA3 or ASA4). Patients included in the study undergo advanced hemodynamic monitoring during the procedure. Anesthesia induction, maintenance, and termination are conducted by an anesthesiologist in accordance with current medical knowledge, and the planned experiment does not in any way influence the course of action.

Investigators will analyse medical documentation, including the patient's medical history, anesthesia records, and hemodynamic parameter data obtained from the hemodynamic monitor (an Excel file containing comprehensive data related to specific cardiovascular parameters) to describe the incidence of intraoperative hypotension and answer key questions in accordance with the designed study protocol.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old.
* Capability of providing informed consent by the patient.
* Planned surgeries.
* Surgeries other than thoracic, cardiac, or obstetric procedures.
* ASA (American Society of Anesthesiologists) physical status classification of 3 or 4, indicating high risk.
* Patients at high risk of postoperative complications.
* Preoperative qualification for advanced hemodynamic monitoring.
* Access to complete preoperative health status data.
* Access to complete data regarding the course of anesthesia and hemodynamic parameters obtained from the hemodynamic monitoring platform.
* Initiation of hemodynamic monitoring prior to general anesthesia induction.

Exclusion Criteria:

* Age \<18 years old.
* Cardiac surgeries.
* Thoracic surgeries.
* Obstetric procedures.
* Inability of the patient to provide informed consent.
* ASA physical status classification of 1, 2, or 5, indicating low or moderate risk.
* Urgent and emergent surgeries.
* Lack of complete preoperative health status data.
* Lack of complete data regarding the course of anesthesia.
* Inability to initiate hemodynamic monitoring prior to general anesthesia induction.
* Interruption in hemodynamic monitoring lasting longer than 5 minutes (lack of parameter values in the obtained hemodynamic monitor file).
To Evaluate Newly Developed Pictogram Cards and Their Utility in Improving Inhaler Techniques in Asthmatic Patients

To evaluate newly developed pictogram cards and their utility in improving inhaler techniques in asthmatic patients.

A prospective, open-label, randomized controlled clinical study. For this purpose, pictogram cards are designed for Metered Dose Inhalers (MDI) and Dry Powder Inhalers (DPI).

The pictogram labels are designed and printed in colors with Urdu language and then attached to the inhaler devices as cards. The demographic, clinical, and medical data are collected from the patients and their medical files. Moreover, the different clinical measures are also evaluated in the recruited patients.

Eligibility Criteria:
Inclusion Criteria:

* Asthmatic Patients, should take inhalers regularly for at least 3 months and come personally for re-fill.

Exclusion Criteria:

* Coexistence of other chronic respiratory conditions.
* Those who were difficult to communicate.
Efficacy and Significance of Antiviral Therapy for Unresectable Hepatitis B Virus-related Primary Liver Cancer

This study is working to research the efficacy and significant of the anti-virus therapy in the unresectable Hepatitis B virus (HBV) related primary liver cancer(PLC) so as to establish treatment standards of anti-virus therapy in PLC.

primary liver cancer(PLC)is one of the world's most common malignancies, especially in East-Asian countries.Hepatitis B virus (HBV) infection is associated with 70-90% of PLC cases in China. PLC can develop during any stage of the natural course of chronic HBV infection and anti-virus therapy should be considered during the management of PLC. However, there is no definite guide on when or how to practice the anti-virus therapy, especially in unresectable or inoperable PLC. Because of these facts, research on the significant of the anti-virus therapy in the HBV-related PLC is urgently needed.

200 patients will be randomly assigned to anti-virus therapy group and control gruop.The time to progression(TTP) and overall survival within two years will be used to evaluate the effect of anti-virus therapy on PLC.

The aim of this study is to research the efficacy and significant of the anti-virus therapy in the unresectable HBV-related PLC so as to establish treatment standards of anti-virus therapy in PLC.

Eligibility Criteria:
Inclusion Criteria:

1. Identify patients with PLC in accordance with the clinical diagnostic criteria of PLC.Patients with PLC shall be diagnosed with or without pathology. It is not appropriate to perform liver resection operation.
2. serum positive HBsAg≥6 months.
3. Criteria of liver function: Child A or B level, serum total bilirubin ≤ 1.5 times the upper limit of normal value, alanine aminotransferase and aspartate aminotransferase ≤ 10 times the upper limit of normal value.
4. hemoglobin≥8.5g/dl, PT-INR≤2.3 or PT\>6 seconds of normal value.
5. No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal.
6. Patients who can understand this trial, male or female, aged 18-70 voluntarily participate in clinical trials and have signed information consent.

Exclusion Criteria:

1. Patients with apparent cardiac, pulmonary, cerebric and renal dysfunction, which may affect the treatment of liver cancer.
2. Patients with other diseases which may affect the treatment mentioned here.
3. Patients with medical history of other malignant tumors.
4. Subjects participating in other clinical trials.
5. Women in pregnancy and breast-feeding.
Early Detection of Neonatal Shock

The purpose of this study is to evaluate the hypothesis that advanced hemodynamic monitoring results in an earlier detection of circulatory failure in newborn infants


Eligibility Criteria:
Inclusion Criteria:

* Birth weight \>700 grams
* Arterial catheter in place
* Central venous catheter in place
* Informed consent from parents/legal representatives

Exclusion Criteria:

* Life-threatening congenital defects
* Congenital heart defects, except patent ductus arteriosus and patent foramen ovale
Non-Interventional Study of NovoSeven® Used in Patients With Haemophilia A and B With Inhibitors Under Normal Clinical Practice

This study is conducted in Japan. The aim of this non-interventional study is to investigate the safety and effectiveness of treatment with eptacog alpha (NovoSeven®) under normal clinical practice conditions.


Eligibility Criteria:
Inclusion Criteria:

* Patients with haemophilia A and B with inhibitors who received eptacog alpha (NovoSeven®) as treatment

Exclusion Criteria:

* Patients who was not deemed to be appropriate to the treatment of eptacog alpha (NovoSeven®)
Project to Improve the Diagnosis and Treatment Ability of Adult Severe Community Acquired Lower Respiratory Tract Infection

1. Objective to understand the proportion of atypical pathogens in the pathogens of SCAP and AECOPD in urban hospitals in China.
2. Objective to investigate the antimicrobial resistance of atypical pathogens in patients with acute exacerbation of chronic obstructive pulmonary disease (COPD) and SCAP in urban hospitals.
3. Objective to master the important clinical characteristics of patients with acute exacerbation of SCAP and COPD caused by atypical pathogens and mixed infection in urban hospitals in China, and to put forward the experience judgment index.
4. Objective to evaluate the advantages of various diagnostic methods for atypical pathogens causing lower respiratory tract infection.
5. It is suggested that the current empirical treatment of SCAP and severe COPD in China should be improved.


Eligibility Criteria:
Inclusion Criteria:

* SCAP
* AECOPD

Exclusion Criteria:

* Pregnant or lactating women.

  * Patients with bronchiectasis.

    * Patients with active pulmonary tuberculosis.

      * Aspiration pneumonia or obstructive pneumonia.

        * Two weeks before the onset of hospital treatment history, this infection can not be excluded from hospital acquired infection.

          * HIV positive patients (but HIV testing is not required).

            * Patients who are unable and / or unable to understand and / or implement the investigation protocol.
CCRT Followed by Tegafur, Gimeracil and Oteracil Potassium in Cervical Cancer

This is a single institute, single-arm, interventional trial to evaluate the efficacy and toxicity of concurrent chemoradiotherapy (CCRT) followed by Tegafur, Gimeracil and Oteracil Potassium Capsules consolidation chemotherapy in patients with locally advanced cervical cancer.

This is a single institute, single-arm, interventional trial to evaluate the efficacy and toxicity of concurrent chemoradiotherapy (CCRT) followed by Tegafur, Gimeracil and Oteracil Potassium Capsules consolidation chemotherapy in patients with locally advanced cervical cancer. The main inclusive criteria are as follows: histology confirmed cervical cancer; 18-70 years old; 2018 International Federation of Gynecology and Obstetrics (FIGO) stage IIB-IIIC2; ECOG score \<=1 point. The estimated enrollment is 200 patients. After enrollment, patients will receive CCRT, including external beam radiotherapy, intracavitary brachytherapy and concurrent chemotherapy. One month after the completion of CCRT, patients will receive 6 cycles of Tegafur, Gimeracil and Oteracil Potassium Capsules consolidation chemotherapy. The primary endpoint is progression free survival. And the secondary endpoints include overall survival, distant metastasis-free survival, local regional recurrence-free survival, acute toxicities, late toxicities, and treatment compliance.

Eligibility Criteria:
Inclusion Criteria:

Histology confirmed cervical cancer; 18-70 years old; 2018 International Federation of Gynecology and Obstetrics (FIGO) stage IIB-IIIC2; Eastern Cooperative Oncology Group (ECOG) score \<=1 point.; Adequate marrow: neutrophile granulocyte count ≥1.5\*10\^9/L, hemoglobin ≥ 80 g/L, platelet count ≥100\*10\^9/L; Normal liver and kidney function: Creatinine (Cr) \< 1.5 mg/dl, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) \< 2\*upper limit of normal (ULN).

Exclusion Criteria:

Prior surgery (including pelvic or para-aortic lymph nodes resection, except for tumor biopsy), radiotherapy or chemotherapy to primary tumor or nodes; Prior malignancy;History of previous radiotherapy to the abdomen or pelvis; Pregnancy or lactation; Active infection with fever; Ssevere disease which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control, and emotional disturbance.
WBV and Serial Casting for Children with Cerebral Palsy

Children with cerebral palsy have increased muscle tone which often results in decreased active and passive movement at the ankle. While many management strategies exist (including passive stretching, WBV, serial casting, Botox, and surgical tendon lengthening), the utilization of WBV in combination with active exercises and serial casting has not been previously explored. Serial casting is the repeated application of a fiberglass cast (such as that applied to manage stable fractures) on a scheduled (usually weekly basis) to gradually increase the range of motion at a specific joint. It is theorized that combining previously established standard of care practices may result in more rapid clinical change, and hence reduce the need for prolonged intervention; ultimately reducing healthcare costs.


Eligibility Criteria:
Inclusion Criteria:

* Ages 3-17 and 32 weeks exclusive years;
* Diagnosis of cerebral palsy;
* GMFCS levels I-III;
* Stands with upper extremity support or less support;
* Active referral from a prescribing provider for serial casting with ankle DF of \<10 degrees;
* Willing to pursue care at \[primary site\] outpatient physical therapy clinic for the duration of the study;
* Subjects/families must be able to communicate in the English language without the need for interpreter.

Exclusion Criteria:

* History of selective dorsal rhizotomy;
* previous Achilles tendon lengthening or other orthopedic interventions to the lower extremities in 1 year prior to enrollment;
* No Botox or changes in oral medication to reduce spasticity within 6 months prior to enrollment;
* skin, circulation, vascular conditions;
* Previous history of cancer;
* Reduced ankle/foot sensation;
* Allergies to casting materials.
Vorinostat in Combination With Bortezomib, Doxorubicin and Dexamethasone (VBDD) in Patients With Refractory or Relapsed Multiple Myeloma (MM)

Primary objective of the study is the determination of the maximum tolerated dose (MTD) of Vorinostat (V), given in combination with fixed doses of Doxorubicin (D), Bortezomib (B) and Dexamethasone (D).

Secondary objectives are:

Assessment of safety and tolerability of VBDD; efficacy data of VBDD.

A first cohort of three patients will be treated at the starting dose level of Vorinostat 100 mg/d, on day 1-4, 8-11, and 15-18 in combination with BDD.

The dose level of Vorinostat will be escalated in each new cohort:

if no dose limiting toxicity (DLT) has been observed in the previous dose level in 3 patient, the second cohort of 3 new patients will be treated with Vorinostat 200 mg/d and the third cohort will be given Vorinostat with 300 mg/d.

Bortezomib will be administered intravenously (i.v.) 1.3mg/m2 d1, 8, 15. Doxorubicin will be administered i.v. with a total dose of 18 mg/m2 per cycle (9 mg/m2, d1 and 8).

Dexamethasone will be administered per os (p.o.) with 40mg (first cycle) and 20mg (all other subsequent cycles) on d1, 8, 15, 22.

Eligibility Criteria:
Inclusion Criteria:

* Patients with refractory or relapsed MM after at least first-line chemotherapy (CTx) or PBSCT (autologous and allogeneic SCT). All lines of relapse are eligible.
* KPS ≥60%
* Adequate BM function
* Adequate hepatic and renal function (AST and ALT ≤2.5 times ULN, Bilirubin ≤1.5 times ULN, eGFR \>20 ml/min)

Exclusion Criteria:

* Patient has had prior treatment with Vorinostat or HDAC inhibitors
* Patients with severe hepatic impairment or acute diffuse infiltrative pulmonary and pericardial disease
* Patient has preexisting NCI CTC ≥grade 3 neuropathy
* Patient with known CNS MM-involvement and/or MM-related/induced meningitis