cyrilzakka/clinical-trials huggingface dataset:
Study of the Effectiveness and Safety of Desloratadine (Aerius) Syrup in Children With Allergic Skin Inflammation (P03475)

The purpose of this study was to test the effectiveness and safety of desloratadine (Aerius) syrup in children with allergic skin inflammation. Patients took desloratadine syrup once a day for 28 days. Once a week, the doctor measured the patient's symptoms. This measurement is called SCORAD. The doctor also rated how much relief the patient got from treatment and recorded any side effects.


Eligibility Criteria:
Inclusion Criteria:

* Children must be from \>= 6 to \< 12 years of age, of either sex and any race.
* Children's parent(s) or legal representative(s) must demonstrate their willingness to participate in the study and comply with its procedures by signing an informed consent.
* Children must be in general good health; i.e. they must be free of any clinically significant disease other than atopic dermatitis (AD) that would interfere with study evaluations.
* Children's parent(s) or legal representative(s) must understand and be able to adhere to the dosing and visit schedule, and agree to report concomitant medications and adverse events to the Investigator or designee.
* The diagnosis of AD will be performed according the Hanifin and Rajka criteria (Hanifin JM, Rajka G. Diagnostic features of atopic dermatitis. Acta Derm Venereol (Stockhr) 92 (suppl): 44-70, 1980): to be included in this study, children needed to manifest at least 3 major features and 3 minor features at visit 1 (day 1).
* Children must be clinically symptomatic with AD at visit 1 (day 1). Disease severity will be estimated using the SCORAD Index (European task force on atopic dermatitis. Severity scoring of atopic dermatitis: the SCORAD Index. Dermatology 186: 23-31, 1993), and child must have a SCORAD Index at least \>= 35.

Exclusion Criteria:

* Children who have not observed the designated washout period for any of the prohibited medications.
* Children with bronchial asthma who require chronic use of inhaled or systemic corticosteroids.
* Children with a history of hypersensitivity to desloratadine, or any of its excipients.
* Children who have any current evidence of clinically significant hematopoietic, metabolic, cardiovascular, immunologic, neurologic, hematologic, gastrointestinal, hepatic, renal, psychiatric, or cerebrovascular, or any other disorder which, in the judgment of the Investigator, may interfere with the study evaluations or affect children safety.
* A known lack or response to H1-antihistamines.
NGR-hTNF Administered in Combination With a Standard Oxaliplatin Based Regimen in Patients With Metastatic Colorectal Cancer

The main objective of the trial is to document the safety of NGR-hTNF administered at low and high doses in combination with a standard oxaliplatin based regimen in patients with metastatic colorectal cancer not amenable to any clinical improvement by current standard treatments

Phase II, open-label, non-randomized study that will be conducted in two sequential cohorts of patients. Patients with metastatic colorectal cancer not amenable to any clinical improvement by current standard treatments are planned to be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years with metastatic colorectal cancer (CRC) treated with no more than three standard systemic regimens (including biologic agents) for metastatic disease
* Life expectancy more than 3 months
* ECOG Performance status 0-1
* Adequate baseline bone marrow, hepatic and renal function, defined as follows:

  * Neutrophils \>1.5 x 10\^9/L and platelets \> 100 x 10\^9/L
  * Bilirubin \<1.5 x ULN
  * AST and/or ALT \<2.5 x ULN in absence of liver metastasis
  * AST and/or ALT \<5 x ULN in presence of liver metastasis
  * Serum creatinine \<1.5 x ULN
  * Creatinine clearance (estimated according to Cockcroft-Gault formula) ≥ 50 ml/min
* Patients may have had prior therapy providing the following conditions are met:

  * Chemotherapy, radiation therapy, hormonal therapy or immunotherapy: wash-out period of 28 days before start treatment
  * Surgery: wash-out period of 14 days before start treatment
* Patients must give written informed consent to participate in the study

Exclusion Criteria:

* Concurrent anticancer therapy
* Patients must not receive any other investigational agents while on study
* Patients with myocardial infarction within the last six (6) months, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
* Uncontrolled hypertension
* Prolonged QTc interval (congenital or acquired)
* Patient with significant peripheral vascular disease
* Clinical signs of CNS involvement
* Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol
* Symptomatic peripheral neuropathy ≥ grade 1 according the NCI CTCAE v.3.0.
* Known hypersensitivity/allergic reaction or contraindications to human albumin preparations or to any of the excipients
* Known hypersensitivity/allergic reaction or contraindications to platinum compounds or fluoropyrimidines
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol
* Pregnancy or lactation.
* Patients - both males and females - with reproductive potential (i.e. menopausal for less than 1-year and not surgically sterilized) must practice effective contraceptive measures throughout the study.
* Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration
Analgesic Efficacy and Safety of V116517 in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis (OA) of the Knee

The primary objective of this study is to evaluate the analgesic efficacy of 2 dose levels of V116517 versus placebo.


Eligibility Criteria:
Key Inclusion Criteria:

1. Subjects with moderate pain due to OA of the knee as their primary pain condition.
2. Subjects with diagnostic criteria for primary pain condition (American college of Rheumatology \[ACR\] clinical and radiographic criteria):

   * At least 1 of the following in addition to knee pain: age \>50, stiffness \<30 min, crepitus on active motion, and
   * Kellgren-Lawrence (K-L) grade ≥ 2 radiographic evidence within the past 2 years.

Key Exclusion Criteria:

1. Subjects with chronic pain conditions other than OA of the knee as their predominant pain condition, including gout, pseudo gout, psoriatic arthritis, active Lyme disease, rheumatoid arthritis or any other inflammatory arthritis, fibromyalgia, neuropathic pain conditions, bursitis, or acute injury or signs of active infection in the target pain area.
2. Subjects who cannot or will not agree to stop all concomitant analgesic medications, apart from specified protocol supplemental analgesic medications.
3. Subjects with history of seizures within the past 5 years.
4. Subjects who use opioids more than 4 days per week.
5. Pain-condition-specific exclusions:

   * Subjects who received local pain-control procedures, including intra- articular steroid injection in the study knee or intramuscular steroid injection at any site within 6 weeks of entering the study or hyaluronate injection in the study knee within 12 weeks of entering the study.
6. Subjects who have had arthroscopy on either knee or hip within 6 months of entering the study, or open surgery on either knee or hip within 12 months of entering the study.
7. Active-comparator-related exclusions:

   * Subjects who are allergic to or cannot tolerate naproxen or acetaminophen, including history of NSAID-induced asthma, or nasal polyps;
   * Subjects with history of bleeding disorders or history of documented gastrointestinal ulcer disease.

Other protocol specific inclusion/exclusion criteria may apply.
Efficacy of N-Acetylcysteine in Improving/Normalizing ALT & AST in Patients of NAFLD

Currently researches are focusing on the effect of antioxidants in the treatment of non-alcoholic fatty liver disease (NAFLD). Since N-acetyl cysteine (NAC) has been proven to have antioxidant and anti-inflammatory properties, therefore, we will conduct this study to determine the effect of NAC in patients of NAFLD with raised liver enzymes.

The prevalence of non-alcoholic fatty liver disease (NAFLD) is increasing globally, and presents a challenge for the medical community since it has no FDA approved treatment. An important feature of non-alcoholic fatty liver disease (NAFLD) is hepatic steatosis leading to hepatic dysfunction . It has been reported that NAFLD patients with increased liver enzymes have a greater risk of developing complications like cirrhosis and end-stage liver disease. since N-acetyl cysteine (NAC) has been proven to have antioxidant and anti-inflammatory properties, therefore, we will conduct this study to determine the effect of NAC in patients of NAFLD with raised liver enzymes (ALT, AST). Patients presenting with ultrasound showing fatty liver with raised liver enzymes will be recruited. They will be randomized into two groups (group A and group B).

The odd number patients will be allocated group A and even number patients will be allocated to group B.

Group A: patients in this group will be advised to follow a diet plan \& daily 20 minutes brisk walking.

Group B: Patients in this group will be given NAC 200mg BD along with diet plan \& exercise. This drug will be provided to the patients by the investigators free of cost.

The liver function tests and side effects of NAC will be followed at 12 weeks .

Eligibility Criteria:
Inclusion Criteria:

* • Patients of both genders between the ages of 20 years and 60 years, giving consent to be included in the study.

  * Patients having fatty liver on ultrasound with raised ALT and AST levels

Exclusion Criteria:

* • Patients having other causes of steatosis eg, excessive alcohol consumption,

  * Patients taking steatogenic medications such as, methotrexate , corticosteroids etc.
  * Patients suffering from other diseases that could increase ALT levels eg. Viral hepatitis, HIV, autoimmune liver diseases, infiltrative liver diseases.
  * Patients suffering from malignancies.
  * Patients who are not compliant to the medicine.
  * Pregnant and nursing females
Irinotecan Liposome Combined With Oxaliplatin and Tegafur as Adjuvant Therapy for Pancreatic Cancer

The purpose of this study is to evaluate the efficacy and safety of irinotecan liposome injection in combined with oxaliplatin plus tegafur (NASOX) for postoperative adjuvant chemotherapy for pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

1. ECOG performance status 0 or 1.
2. Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1).
3. ECOG performance status 0 or 1.
4. Life expectancy of greater than or equal to 6 months.
5. Able and willing to provide a written informed consent.

Exclusion Criteria:

1. Patients who cannot eat orally and have gastric emptying disorder after surgery;
2. Patients with moderate diarrhea: diarrhea ≥4 times per day; the moderate and severe effluents from stoma increased; Or diarrhea that limits activities of daily living;
3. Patients who cannot eat orally and have gastric emptying disorder after surgery;
4. Patients who cannot eat orally and have gastric emptying disorder after surgery;
Safety and Efficacy of Acarbose+Saxagliptin Compared With Metformin+Saxagliptin in Patients With Type 2 Diabetes

To investigate the Safety and Efficacy of Acarbose+Saxagliptin Compared With Metformin+Saxagliptin in Patients With Type 2 Diabetes,100 patients with T2DM will be enrolled in this study.They will randomly be assigned to Acarbose+Saxagliptin or Metformin+Saxagliptin group.HbA1c，fasting and postprandial C-peptide will be observed before and after the interventions.

Participants coming on study will be assigned to two groups：Acarbose+Saxagliptin and Metformin+Saxagliptin. It may take 1 weeks to be stabilize to a standardized dose, and then the investigators will follow-up the patients for 3 months.During the period,patients will be asked to come back to the investigators center to receive the related examination every month. The investigators will detect HbA1c，fasting and postprandial C-peptide before and after the interventions.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed type 2 diabetes mellitus（course of disease less than one year） who has not receive drug treatment.
* T2DM patients who has not receive drug treatment for three months at least.
* HbA1c for 7.5-10%.

Exclusion Criteria:

* New or worsening signs or symptoms of coronary heart disease
* Medical history of active liver disease and kidney disease
* Poorly controlled hypertension（systolic blood pressure\>160mmHg or diastolic blood pressure\>95mmHg）
* A clinically important hematological disorder
* A history of intolerance or hypersensitivity or any contraindication to study medications (including saxagliptin, metformin, acarbose)
* Is pregnant or breast feeding or is expecting to conceive or donate eggs
* A medical history of drug abuse
* Can not be followed -up on time
* Endocrinological diseases（eg： hyperthyroidism、hypothyroidisn and cushing syndrom）
* Gastrointestinal diseases
* Mental disorser
* Hypoxic disease
Hypofractionated Radiotherapy in Prostate Cancer Patients Aged 75 Years or Older.

The majority of all new prostate cancer cases are diagnosed in men aged \> 70 years, with the highest incidence in men aged \> 90 years. Management options for localized prostate cancer include active surveillance in patients with low-risk disease, radical prostatectomy or external beam radiation therapy.

In previous studies, hypofractionated prostate cancer irradiation regimens have been shown to represent a highly effective treatment option for prostate cancer. However, patients aged 75 years or older were underrepresented in most trials resulting in the lack of a robust evidence base.

The proposed study will evaluate radiation-induced toxicity as well as outcome after hypofractionated external beam radiotherapy in prostate cancer patients aged 75 years or older.


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed prostate cancer adenocarcinoma
* definitive radiotherapy for curative intent
* low or intermediate risk prostate cancer
* patient age ≥ 75 years
* given informed consent

Exclusion Criteria:

* chronic inflammatory bowel disease
* high risk prostate cancer
* lymph node or distant metastases
* unable to give informed consent
Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice

In this study, Malathion Gel 0.5% will be compared to Nix (permethrin 1%) as a treatment for head lice in patients 2 years of age and older. Malathion Gel 0.5% is a new formulation of an established head lice treatment. The new formulation has been evaluated in 2 previous studies of patients 2 years of age and older.

This is a Phase III, multi-center, investigator-blinded, two-arm, randomized, parallel group study, evaluating the safety and efficacy of a Malathion Gel, 0.5% formulation, manufactured by Taro. The objective is to show superiority of the novel product to an active control, Nix® Crème Rinse, manufactured by Insight Pharmaceuticals.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed active head lice infestation

Exclusion Criteria:

* Allergy to pediculicides or hair care products
* Scalp conditions other than head lice
* Previous head lice treatment within the past 4 weeks
* Current antibiotic treatment
Inspiratory Muscle Training on Diaphragm Thickness, Inspiratory Muscle Strength and Shoulder Pain in Tennis Player

Shoulder pain is one of the most common musculoskeletal conditions among athletes and sports enthusiasts who engage in overhead sports, and it can be highly disabling. Since the shoulder is one of the joints with the greatest range of motion in the human body, it is important to seek strategies that address trunk stability comprehensively to achieve full and effective joint mobility. The central role of the diaphragm in trunk stabilization has been the subject of research for over 50 years, although the exact mechanisms are still not fully understood.

The objective of this study is to assess the effects of inspiratory muscle training on diaphragm thickness, inspiratory muscle strength, and shoulder pain in adult tennis players with non-specific shoulder pain.

This is a single-blind, randomized controlled clinical trial. The intervention will last for 8 weeks. Patients with non-specific shoulder pain will be randomly assigned to one of two groups. The experimental group will undergo specific inspiratory muscle training, while the control group will receive no specific training intervention. Measurements of diaphragm thickness, inspiratory muscle strength, and shoulder pain will be taken before and after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* tennis player who suffered from inespecific shoulder pain
* training at least two times per week
* Have experienced at least 1 episode of non-specific shoulder pain in the last month
* A positive result on diagnostic tests performed: Neer Test and Jobe Test

Exclusion Criteria:

* Having taken anti-inflammatories or muscle relaxants within the last 72 hours before the study
* pregnancy
* Previous diagnosis of respiratory or neurological diseases
* Previous surgeries, fractures, and dislocations in the dominant shoulder
* Inability to follow instructions during the study
* All those for whom measuring maximum inspiratory pressure is contraindicated: unstable angina, recent myocardial infarction (within 4 weeks of the event) or myocarditis, uncontrolled systemic hypertension, recent pneumothorax, post-lung biopsy surgery of less than one week, postoperative abdominal or genitourinary surgery of less than 6 months, and urinary incontinence
Post-marketing Surveillance of Administration of Botulinum Toxin Type B(NerBloc)-Investigation of the Clinical Condition in Patients With Change From Botulinum Toxin Type A

Investigation of the clinical condition in patients with cervical dystonia by Toronto Western Spasmodic Torticollis Scale (TWSTRS)


Eligibility Criteria:
Inclusion criteria:

Patients with cervical dystonia who was treated by botulinum toxin type A in the past.

Patients who was enrolled in NB01S and was evaluated by TWSTRS at the first injection of NerBloc.
Safety and Efficacy of Ampligen in the Treatment of HIV Patients Failing HAART

This is an open-label, prospective, randomized, controlled study of the safety and efficacy including clinical, immunologic, and virologic assessments of adding Ampligen to "HAART" in HIV infected patients with CD4 counts \>300 and HIV-1 plasma RNA \>500 and \<30,000 copies/ml (PCR).


Eligibility Criteria:
1. Adults at least 18 years of age.
2. CD4 cell count of \>300 cells.
3. HIV-1 plasma RNA \>500 and \<30,000 copies/ml.

   A qualifying ("screening") HIV-1 RNA level \>500 and \<30,000 copies/ml must be documented at least once within 40 days prior to starting Baseline while patient is receiving a HAART regimen containing at least two of the following antiretroviral drugs:
   * Abacavir (Ziagen)
   * Zidovudine (Retrovir) AZT
   * Zalcitabine (Hivid) ddC
   * Didanosine (Videx) ddI
   * Stavudine (Zerit) d4T
   * Efavirenz (Sustiva)
   * Indinavir (Crixivan)
   * Ritonavir (Norvir)
   * Nelfinavir (Viracept)
   * Amprenavir (Agenerase)

   The patient must have been taking this HAART regimen for four months or longer at the time of the qualifying HIV-1 RNA determination.
4. History of prior treatment (including the current HAART regimen) with at least one protease inhibitor (PI) and at least two nucleoside reverse transcriptase inhibitors (NRTI) and/or at least one non-nucleoside reverse transcriptase inhibitor (NNRTI) and at least two nucleoside reverse transcriptase inhibitors (NRTI).
5. Karnofsky performance status of at least 70.
6. The following laboratory parameters within 14 days prior to treatment:

   * Hemoglobin \> 9.2 g/dL for men and \> 8.9 g/dL for women
   * Neutrophil count \> 1000
   * Platelet count \> 75,000
   * AST/ALT \< 4.0 x upper limit of normal (ULN)
   * Serum creatinine \< 1.5 x ULN or a creatinine clearance \> 50 mL/min.
7. For females with child bearing potential: A negative serum pregnancy test within 14 days prior to randomization. Males and females of child bearing potential agree to use an effective means of contraception.
Effects of "Telerehabılıtatıon Based Structured Home Program Implementatıons" Chıldren With Cerebral Palsy

The aim of the study is to examine the effectiveness of Telerehabilitation Based Structured Home Program Implementations on functional status, activity and participation in preschool children with Cerebral Palsy.

The structured home program will consist of activities determined by the family members according to the functional level of the child and the activities child can't do, and which are determined according to the goals specific to the child. In order to ensure that the structured home program created can be implemented by the family, a 1 hour family training will be provided.

After the structured home program training, a 45-minute video interview will be held with one of the family members (mother-father-caregiver) once a week, in order to check by the physiotherapist whether the home program is implemented correctly. Video interviews will be the telerehabilitation part of the study.

During routine physiotherapy and rehabilitation practices, activities organized by physiotherapists as one or two sessions per week according to the functional levels of children with CP. Routine physiotherapy and rehabilitation applications include increasing postural control, gaining motor development steps, strengthening training, balance training, long-term stretching training, manual therapy, hydrotherapy, hippotherapy and neurodevelopmental therapy approaches. Telerehabilitation-based structured home program applications, which are given in addition to routine physiotherapy and rehabilitation applications, and only individuals who receive routine physiotherapy and rehabilitation will be followed for 24 weeks. Individuals who receive routine physiotherapy and rehabilitation will be monitored only for control purposes, and a structured home program will be given to the group that receives Telerehabilitation Based Structured Home Program Practices, which are given in addition to routine physiotherapy and rehabilitation applications. The researcher will not be included in the program of the group that only benefits from routine physiotherapy and rehabilitation practices. A total of three evaluations will be made for both groups, after the training before the training and after 12 weeks from the training.

Eligibility Criteria:
Inclusion Criteria:

1. Being in preschool period (3-5 years old)
2. Receiving routine physiotherapy and rehabilitation services 2 sessions in a week
3. Family members being active mobile phone or computer and internet users

Exclusion Criteria:

1. Uncontrolled epileptic seizures
2. Incomplete assesments
3. Family's discontinuation of treatment