cyrilzakka/clinical-trials huggingface dataset:
Phase II Study of CAP-232 in Patients With Refractory Metastatic Renal Cell Carcinoma

The purpose of this study was to evaluate the safety and efficacy of CAP-232 in the treatment of patients with previously treated (refractory) renal cell carcinoma

This was a multi-center, open label, single arm study. Approximately 40 patients were initially planned to be recruited.

Each patient was to receive a treatment cycle consisting of CAP-232 via continuous IV infusion over 21 days at 0.48 mg/kg/day followed by a 7-day rest period. Treatment cycles to be repeated in the absence of disease progression or unacceptable toxicity.

Quality of Life questionnaires were to be administered at baseline, after each visit and at the end of the study.

Signs and symptoms of adverse events were closely monitored during treatment cycles. Safety laboratory measures were done at Screening, during the 72hr hospitalization (first cycle), at every interim visit , and at the end of the study. A follow-up safety visit was to be scheduled at least 30 days after the end of treatment.

CAP-232 plasma levels were also determined.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed stage IV kidney clear cell carcinoma.
* Confirmed progressive disease after receiving a previous systemic therapy, including at least one line of standard of care.
* Measurable disease
* Age \>18 years.
* Life expectancy of greater than 3 months.
* At least 5 years free of any other cancer(s). Basal cell carcinoma, provided that is neither infiltrating nor sclerosing and carcinoma in situ of the cervix, is acceptable.
* ECOG performance status 2 or lower (Karnofsky 60%).
* Normal organ and marrow function
* Adequate contraception prior to study entry and for the duration of study participation.
* Ability to understand and have the willingness to sign a written informed consent document.
* Ability to receive central vein access catheter and manage an infusion pump.
* Women of child bearing potential must have a negative serum pregnancy test.

Exclusion Criteria:

* Anti-cancer therapy within 4 weeks prior to entering the study
* Investigational agents less than 30 days prior to enrollment in the study.
* Known brain metastases
* History of allergic reactions attributed to compounds of similar composition to CAP-232.
* Past or current cancer other than kidney cancer, except for: Curatively treated non-melanoma skin cancer, In situ carcinoma of the cervix, Other cancer curatively treated and with no evidence of disease for at least 5 years
* Uncontrolled intercurrent illness /social situations that would limit compliance with study requirements.
* Breastfeeding
* Patients previously enrolled into this study and subsequently withdrawn
The Effect of Treatment With Umbilical Cord Blood Platelet Lysate on Diabetic Foot Ulcers

Application of autologous Platelet Rich Plasma (PRP) has been a major breakthrough for the treatment of diabetic foot ulcers, as it provides the necessary growth factors which enhance tissue healing. Human umbilical cord blood platelet lysate (UCB-PL) contains a supraphysiological concentration of growth factors. The aim of the study is to evaluate the efficacy of umbilical cord blood platelet lysate (UCB-PL) gel for the treatment of diabetic foot ulcer.

110 patients with diabetic foot ulcer will be randomized to receive UCB-PL gel or regular dressing with normal saline. The diabetic foot ulcers will be first debrided to remove any necrotic and infected tissues or hyperkeratotic skin. Afterward, the wound area will be cleaned thoroughly with normal saline. Ulcer length, width and surface will be measured before any study procedure. The UCB-PL gel in the treatment group and the dressing with normal saline in the control group will be applied in the ulcer, and then a few layers of sterile gauze, and non-compressible bandage will be used to cover the wound/ulcer area. This will be repeated every three days for one month. After the fist one month of treatment, the patients will be followed up for a period of 20 weeks post-treatment. Care and management efforts will be provided at each visit included cleansing and assessing of the wound, obtaining an interim wound history, including information regarding adverse events, concomitant medications and other aspects of care since the last visit. Ulcers will be photographed at two weeks, at four weeks, at two months, at four months and at six months.

Eligibility Criteria:
Inclusion Criteria:

* age\>18 years old
* patients with diabetic foot ulcer, foot ulcer located on the plantar, medial, or lateral aspect of the foot (including all toe surfaces)
* ulcer with area(length x width) measurement\<30 cm2
* non-infected ulcers

Exclusion Criteria:

* pregnacy
* venous ulcers
* clinical signs and symptoms of infection
* exposure of bone, muscle, ligaments, or tendons and the presence of tunneling
Safety and Efficacy Study for the Field-directed Treatment of Actinic Keratosis (AK) With Photodynamic Therapy (PDT)

The purpose of this study is to evaluate the safety and efficacy of BF-200 ALA (Ameluz) versus placebo in the field-directed treatment of mild to moderate actinic keratosis with photodynamic therapy (PDT) when using the BF-RhodoLED lamp.

The study was performed as a randomized, multicentre, double-blind, placebo- controlled, parallel-group, phase III trial with BF-200 ALA and placebo in seven centres in Germany. A total of 94 patients were screened in this study; 87 were randomized (55 patients received BF-200 ALA, 32 received placebo). Patients received one PDT. If residual lesions remained at 3 months after treatment, PDT was repeated. Illumination was performed with the PDT lamp BF-RhodoLED.

Eligibility Criteria:
Inclusion Criteria:

* Males or females between 18 and 85 years of age (inclusive)
* Presence of 4 to 8 clinically confirmed actinic keratosis (AK) target lesions of mild to moderate intensity within 1-2 fields

Exclusion Criteria:

* History of hypersensitivity to 5-ALA or any ingredient of BF-200 ALA
* Current treatment with immunosuppressive therapy
* Presence of other malignant or benign tumors of the skin within the treatment area (eg malignant melanoma, basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)) within the last 4 weeks
* Confirmed diagnosis of SCC for the representative lesion by screening biopsy
Levosimendan Compassionate Use in Pediatric Patients With Advanced Decompensated Heart Failure

Open label study of levosimendan; planned comparison for effectiveness and safety to historic matched case controls from participating sites.


Eligibility Criteria:
General Eligibility

All patients must meet at least one of the following definitions of failed standard therapy of decompensated heart failure:

Definition for failure of standard therapy:

1. Decompensated heart failure refractory to standard therapy (Milrinone of ≥0.5mcg/kg/min for \>48 hours with EF \<35%) including any of the following:

   * (SaO2 - SmVO2) \> 30 % or lactate \>3 AND/OR
   * Need for second inotropic agent AND/OR
   * Need for positive pressure ventilation AND
   * Patient not qualifying for long term ventricular assist device support or transplant at the time of assessment.
2. Cardiogenic shock with acute decompensated heart failure (requiring positive pressure ventilation and addition of inotropic support with or without use of Milrinone with EF \<35%) refractory to therapy for more than 48h including any or all of the following:

   * (SaO2 - SmVO2) \> 30 % or lactate \>3
   * Patient not qualifying for long term ventricular assist device support or transplant at the time of assessment.
   * Potential need for short-term mechanical circulatory support.
3. Failure to wean off ECMO support with use of standard inotropic / vasoconstrictor support.

Inclusion Criteria:

1. Male or female, ≤18 years of age with acute or acute on chronic decompensated heart failure.
2. Male or female, ≤18 years of age on ECMO support and unable to wean from ECMO support.
3. Informed Consent signed by the subject's parents or their legally acceptable representatives indicating that they understand the purpose of and procedures required for expanded access and are willing to participate in the study.
4. Patients meeting one of the following definitions of failed standard therapy of decompensated heart failure

Exclusion Criteria:

1. Patients \< 36 weeks gestational age
2. Patients weighing \< 2 kg
3. Obstructive cardiomyopathy, constrictive pericarditis, pericardial tamponade
4. Estimated glomerular filtration rate (eGRF) \< 30 mL/min/1.73m2.
5. Known allergic reaction or sensitivity to levosimendan or excipients.
6. A history of Torsades de Pointes, uncorrectable hypo- or hyperkalemia, uncorrectable hypo- or hypercalcemia
7. Pregnant, suspected to be pregnant, or breast-feeding.
8. Inability or unwillingness of subject or legal guardian/representative to give written informed consent.
Evaluation of Subepithelial Connective Tissue Graft Versus Acellular Dermal Matrix With Tunnel Technique in Treatment of Multiple Gingival Recessions

The goal of the present study is to compare the amount of root coverage resulting from subepithelial connective tissue graft and acellular dermal matrix associated with tunnel technique among patients suffering from multiple gingival recession.

Acellular dermal matrix with Tunnel technique will offers great advantages for patients with multiple gingival recession as regards decrease surgical time, Post-Operative pain and root coverage, clinical attachment level, width of Keratinized gingiva, gingival biotype compared to subepithelial connective tissue graft with Tunnel technique.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with facial multiple gingival recession defects classified as either class I or II defects according to Miller's classification (Miller 1985).
* Subjects aged between 18 - 60 years old.
* Patients should be free from any systemic disease that may affect normal healing of tissue, and predictable outcome.
* Patients with good oral hygiene.

Exclusion Criteria:

* Current and former smokers.
* Pregnant females.
* Subjects received any periodontal therapy for minimum of 6 months prior to the study.
* Subjects taking drugs known to interfere with wound healing.
* Subjects with unacceptable oral hygiene with plaque index \>2.
* Teeth with non-carious cervical lesions (NCCL), cervical caries and malalignment.
Active Symptom Control Alone Or In Combination With Oral Topotecan In Patients With Relapsed Resistant Small Cell Lung Cancer

The purpose of this study is to find out if giving oral HYCAMTIN to patients with relapsed small cell lung cancer benefits them. The study will compare how long patients live when they are given therapy to make them feel better (active symptom control) to the length of time patients live when they are also receiving oral HYCAMTIN.


Eligibility Criteria:
Inclusion Criteria:

* Received one prior chemotherapy regimen only.
* Documented partial or complete response to first-line therapy.
* Documented relapse of limited or extensive SCLC at least 45 days after the cessation of first-line chemotherapy.
* Not considered suitable for further intravenous chemotherapy.
* Considered to have adequate bone marrow reserve.
* Performance Status of 0, 1 or 2.

Exclusion Criteria:

* Pregnant or lactating.
* Received more than one prior regimen of chemotherapy.
* Uncontrolled vomiting.
* Brain metastases.
* Active uncontrolled infection.
* Received previous treatment with HYCAMTIN.
* Received an investigational product within 30 days.
Comparison of Treatment Failure Criteria in HIV-Infected Children in Uganda

The main goal was to compare clinical and immunological versus clinical, immunological plus viral load criteria for switching to second-line ART by comparing 48 week treatment outcomes, including survival rates, viral suppression, failure to thrive, and AIDS-defining illnesses for treatment experienced children randomized to two switching criteria.

The overall goal of the study was aimed at determining whether the use of the current WHO criteria alone (clinical and immunologic) to define treatment failure as the trigger for switching to second-line antiretroviral therapy leads to poorer 6 month and 12 month treatment outcomes when compared to combining clinical and immunologic parameters with viral load (VL) monitoring.

In addition the study aimed at obtaining plasma samples from treatment experienced children, for future resistance testing. The results of this study may help guide WHO and national pediatric ART programs on the need for routine VL monitoring for children initiating HAART in resource limited settings, where virologic tests including resistance testing are not readily available or affordable.

Eligibility Criteria:
Inclusion Criteria:

* HIV-Infected Children, 1 year to 12 years
* ART experienced and enrolled in an existing treatment program that used clinical and immunologic criteria to monitor response to ART.

Exclusion Criteria:

* None
Recovery Profiles After c Spine Surgery: With or Without Dexmedetomidine as an Anesthetic Adjuvant

The purpose of this study is to determine the recovery profiles after general anesthesia in patient undergoing anterior cervical spine surgery. This study will compare the Riker sedation agitation scores between two groups, with or without dexmedetomidine as an anesthetic adjuvant.


Eligibility Criteria:
Inclusion Criteria:

* ASA 1-3
* elective case for ACDF surgery
* plan for extubation after surgery

Exclusion Criteria:

* SBP\>140 mmHg
* CAD
* HR\<50 BPM, heart block
* motor weakness \> grade 4
* BMI \>30
* allergic to dexmedetomidine, fentanyl
Effect of Intravenous Lignocaine Infusion on Intraoperative End Tidal Desflurane Concentration Requirements

Lignocaine is a local anaesthetic that is widely used in all medical and surgical fields. Many clinical studies have shown that intravenous (IV) lignocaine given in the perioperative period was safe, reduced airway complications, obtunds cough reflex, reduce sore throat, pain, opioid consumption, nausea, length of hospital stay. Multiple animal studies have shown that IV lignocaine was able to lower anaesthetic gas requirements. Desflurane is an anaesthetic gas that has a rapid onset and offset of action. This study aims to evaluate the effect of IV lignocaine infusion on desflurane requirements.

Hypothesis of the study is that IV lignocaine infusion reduces desflurane requirements.

All volunteers will be randomly assigned into two groups based on computer generated randomisation tables.

Group Lignocaine will receive an IV bolus dose of 1.5 mg/kg of 2% lignocaine HCL diluted up to 10 ml with normal saline in a 10 ml syringe which will be delivered via a syringe pump over a period of 3 min. This is then followed by an IV infusion at the rate of 1 mg/kg/h of 2% lignocaine HCL in a 20 ml syringe which will be administered by another syringe pump.

Group Placebo will receive an IV bolus of 10 ml of normal saline over a period of 3 min followed by an IV infusion of an equal volume of normal saline, both of which will be delivered by separate syringe pumps.

After induction of anaesthesia, all volunteers will be ventilated with Aisys™ CS² anaesthesia machine. Anaesthesia shall be maintained with desflurane, in 50% oxygen-air balance with a total flow of 1.0 L/min. The end tidal desflurane (Et-Des) concentration will be adjusted to maintain a target BIS of between 40-60.

Desflurane and study infusions will be discontinued and estimation of desflurane cost and volume used will be estimated at the end of surgery.

Eligibility Criteria:
Inclusion Criteria:

1. American Society of Anaesthesiology (ASA) I or II patients.
2. Patients aged between 18-75 years of age.
3. Patients scheduled for elective laparoscopic cholecystectomy.
4. Patients scheduled for laparoscopic hernioplasty.
5. Patients scheduled for emergency laparoscopic appendicectomy.
6. Patients scheduled for emergency laparoscopic cystectomy.
7. Patient weight ranging from 50 - 100 kg.
8. Surgery lasting at least one hour.

Exclusion Criteria:

1. Patients with a known allergy to study drug.
2. Patients with body mass index (BMI) more than 35 kg m-2.
3. Patients who are taking sedatives.
4. Patients with chronic substance abuse.
2D Strain Evaluation: Children With Duchenne Muscular Dystrophy Versus Healthy Children

Compare systolic function of left ventricle (LV) and right ventricle (VD) by 2D strain evaluation in Duchenne muscular dystrophy children versus a control group.

Among the new echocardiographic techniques, two dimensional Speckle Tracking Imaging or "2D Strain" allows a dynamic study of regionalized and global ventricular contraction. With software for the spatial and temporal processing of a standard 2D image, this technique measures the displacement of natural markers present on the myocardial wall.

Used in adult cardiology since 2000, it could be eligible to pediatric population because of many potential applications. In Duchenne muscular dystrophy, myocardial disease leads to death in the third decade. Early diagnosis and preventive therapy remain a challenge. No clinic, biologic or radiologic markers can predict myocardial disease before advanced and irreversible heart failure.

Recent animals and human studies suggest that 2D strain anomalies could predict left ventricular systolic dysfunction in Duchenne muscular dystrophy. If it is confirmed, 2D strain could be used as early marker of myocardial disease in routine patient follow-up and in future therapeutic studies.

Purpose : - To compare systolic function of left ventricle (LV) and right ventricle (RV) by 2D strain evaluation in Duchenne muscular dystrophy children versus a control group.

* To correlate 2D Strain variables to conventional LV and RV echo variables.
* To evaluate 2D strain feasibility in normal children and Duchenne muscular myopathy population

Eligibility Criteria:
Inclusion Criteria:

* Duchenne's muscular dystrophy (group 1) followed in our institution's referral center of neuromuscular diseases, during regular annual echocardiography follow-up.
* Healthy children (group 2), addressed in pediatric cardiology
The Effect of Exercise on Menstrual Symptoms

The aim of this study is to contribute to the determination of the relationship between exercise and menstrual symptoms and to create an alternative for non-pharmacological coping methods with menstrual symptoms.

The type of research is randomized controlled trial. An average of 50 people who do not have exercise habits will participate in the study, and two randomized groups will be formed as exercise group and control group. Everyone will be asked to fill in the Menstruation Symptom Scale, the Menstruation Distress Scale, the Pittsburgh Sleep Quality Scale, the Fatigue Severity Scale, the International Physical Activity Scale, the Personal Information Form prepared by us, and the Voluntary and Consent Form during their menstrual period. The duration of the study will cover 3 (three) menstrual periods of the individuals. At the beginning and end of the study; They will be asked to fill in the Pittsburgh Sleep Quality Scale, Fatigue severity scale, International Physical Activity Questionnaire Short form, Menstruation Symptom Scale and Menstruation Distress Complaint List.

Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 18-50 whose menstrual cycle continues,
* Those who have emotional or physical problems during menstruation periods,
* Those whose menstrual cycle is between 21-40 days on average

Exclusion Criteria:

* Those with chronic disease
* Those with a diagnosed gynecological disease,
* Those who receive any medical treatment,
* Persons with dysmenorrhea and anemia.
* People who exercise regularly.
Long-term Safety and Efficacy of Momelotinib in Subjects With Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis, Polycythemia Vera or Essential Thrombocythemia

This open-label study is to determine the long-term safety and tolerability of momelotinib in previously enrolled study participants with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (post-PV MF), post-essential thrombocythemia myelofibrosis (post-ET MF), polycythemia vera (PV), or essential thrombocythemia (ET), who have tolerated and achieved stable disease or better with momelotinib treatment while enrolled in a previous clinical trial.


Eligibility Criteria:
Key Inclusion Criteria:

* Currently enrolled in study CCL09101E, or YM387-II-02, or successfully completed 24 weeks of study GS-US-352-1672
* Able to comprehend and willing to sign informed consent form

Key Exclusion Criteria:

* Known hypersensitivity to momelotinib, its metabolites, or formulation excipients

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Long-Term Follow-up Study for Non-Hodgkin's Lymphoma Patients Who Received Study Treatment (Plerixafor or Placebo) in the AMD3100-3101 Study (NCT00103610).

This is a long-term observational study of patients that were treated with at least 1 dose of study treatment (plerixafor or placebo) in the AMD3100-3101 protocol (NCT00103610).

This is a long-term observational study of patients who received at least one dose of study treatment (plerixafor or placebo) in a multicenter, randomized, double blind, placebo-controlled investigational study to evaluate granulocyte colony stimulating factor (G-CSF) plus AMD3100 versus G-CSF plus placebo to mobilize and transplant Non-Hodgkin's Lymphoma (NHL) patients (protocol AMD3100-3101 \[NCT00103610\]). The objective of this study is to assess progression-free survival and overall survival of patients treated with at least 1 dose of study treatment (placebo or plerixafor) for a period of 5 years following the first dose of study treatment (placebo or plerixafor) in protocol AMD3100-3101 (NCT00103610).

Eligibility Criteria:
Inclusion Criteria:

* All patients who received a dose of study treatment (plerixafor or placebo)in protocol AMD3100-3101 (NCT00103610)

Exclusion Criteria:

* No Exclusion Criteria