cyrilzakka/clinical-trials huggingface dataset:
Study Evaluating The Effects Of Oprelvekin On Cardiac Repolarization In Subjects With Chemotherapy Induced Thrombocytopenia

This is an open-label study in which oprelvekin will be administered for the prevention of severe low blood platelet cell counts (cells in your blood that keep bleeding and clotting stable) in adults with cancer who are taking chemotherapy (anti-cancer drug) that has a side effect of blocking your bone marrow from making platelet cells. The purpose of this study is to learn more about the effects of the recommended dose of oprelvekin on the heart's electrical cycle.


Eligibility Criteria:
Inclusion Criteria:

* Men and women must be 18 to 65 years of age, with nonmyeloid malignancies for whom oprelvekin is indicated.
* At least one documented occasion of adequate hematologic recovery from previous or current chemotherapy.
* Adequate renal and hepatic excretory function.

Exclusion Criteria:

* A marked baseline prolongation of QT/QTc interval (eg, repeated \[two out of three readings\] demonstration of a QTcF interval \>450 msec.
* Additional risk factors for torsades de pointes including heart failure (subjects that have functional class III or IV congestive heart failure), hypokalemia, hypomagnesemia, or hypocalcemia.
* A pace maker or defibrillator.
* A history of LQTS, syncope, seizure, or the unexplained cardiac-related death of a family member at less than 30 years of age.
* Requirement of concomitant prescription or non-prescription medications or dietary supplements that have a risk of causing torsades de pointes or prolonged QT/QTc interval.
Sildenafil for Prevention of Cerebral Vasospasm

A Randomized Clinical Trial with security and dose testing of Sildenafil Citrate in patients with subarachnoid hemorrhage due to a rupture of a cerebral aneurism for prevention of cerebral vasospasm. The cerebral vasospasm is a decrease in blood flow that occurs when the intracranial vessels lose their capability of self-control of dilations and contractions. Patients with subarachnoid hemorrhage without neurological deficits who underwent endovascular or surgical correction of the aneurysm can participate in this trial. They will be randomized to a daily doses of 75 mg of Sildenafil, 150 mg of Sildenafil or Placebo from the third to the 14th day post bleeding. Today there is no proven clinical treatment for prevention of cerebral vasospasm.


Eligibility Criteria:
Inclusion Criteria:

* Males and females between 20 and 80 years old
* Subarachnoid hemorrhage confirmed by CT with Fisher III or IV criteria (blood in cisterns larger than 1 mm with or without blood in the ventricular system).
* Aneurysm detected in the conventional angiography, or angio-CT or angio - MRI.
* Patient underwent surgery for clipping or endovascular treatment in the first 72 hours after the ictus.
* Consent form signed by the patient or legal responsible.

Exclusion Criteria:

* Patient (or legal responsible) refuses to participate.
* Impossibility to collect consent form.
* Hemodynamical instability.
* Previous cardiac ischemic disease.
* History of cardiac arrhythmia within the last 6 months.
* History of Retinitis Pigmentosa.
* Previous use of drugs witch can interact with sildenafil (specially nitrates).
* Pregnancy.
* Known hypersensibility to Sildenafil.
Portable Visual Guidance System Phase II

Abstract: In Phase I, we designed and tested a Portable Visual Guidance System (PVGS), which combines a PDA - for user guidance - and an Internet website - for linking the user to an educational support team. Use of the PVGS 1) significantly improved the in vivo social pragmatics of students diagnosed with Aspergers Syndrome/Higher Functioning Autism (AS/HFA); 2) revealed additional ways of improving social pragmatics; and 3) improved activity management in scheduling and vocational tasks.

In Phase II, we will focus on social pragmatics and two closely related skills: feelings management and assignment management. We aim to:

1. Replicate Phase I success in the most educational setting for AS/HFA high school aged students: mainstream school inclusion classes.
2. Replicate Phase I findings more efficiently, with a less highly trained, on-site coaching staff and with more distant (non-site) expert supervision of that staff.
3. Contrast the outcomes of the curriculum with a diagnosis-matched wait-list control group.
4. Develop and implement software that will enable on-site staff to create and modify individualized guidance and monitoring screens as needs arise.
5. Design a commercially attractive package of software, video training, video-conferenced support, and manuals.
6. Complete the translation of the SymTrend website and all the above tools into Spanish.

Significance: Successful completion of Phase II will:

1. Provide a very effective and comprehensive system for teaching social pragmatics and related management skills to AS/HFA persons in an inclusion context.
2. Provide a means of evaluating IEP effectiveness, thereby enabling a better use of special education funds and a reduction of litigation over IEP plan appropriateness and utility.
3. Provide substantial support for our theoretical rationale for curriculum building in Special Education - a rationale that can guide the formulation of IEPs.
4. Provide a theoretical rationale, an intervention framework, and intervention support technology that can be extended to cognitive behavioral treatment of other neuropsychiatric disorders and can be adapted for other forms of healthcare guidance.
5. Provide an investigative system, as well as an intervention system, for tracking behavioral change in studies of frontal lobe and limbic neuroplasticity in neuropsychiatric disorders.


Eligibility Criteria:
Inclusion Criteria:

* Ages 11-21
* Diagnosis of AS/HFA
* A student at participating high school and middle schools (Newton, MA; Brockton, MA; Veritas Christian Academy, Fletcher, NC; Durham, NC.

Exclusion Criteria:

* Participating in another study
A Comparative Efficacy Study: Treatment for Non-healing Diabetic Foot Ulcers

The primary objective of this study is to assess the effectiveness of MatriStem devices compared to cellular dermal replacement tissue, for the treatment of non-healing diabetic foot ulcers.

Due to their characteristically poor healing capacity, diabetic foot ulcers (DFUs) are challenging for clinicians to treat. This prospective, multi-center clinical study will examine outcomes following treatment of DFUs, with one of two FDA cleared tissue-engineered devices, MatriStem® or cellular dermal replacement tissue, on DFUs that have demonstrated an inadequate response to initial standard of care therapy. The incidence of ulcer closure, rate of wound closure, and quality of life will be evaluated over a eight week period.

Eligibility Criteria:
Major Inclusion Criteria:

* Subject has a current diagnosis of type I or type II diabetes
* Subject's ulcer is on the forefoot or heel
* Subject has chronic ulcer - has been present for minimum of 4 weeks
* Subject's ulcer extends through the dermis and into the subcutaneous tissue
* Subject's HgbA1c \<12%
* Subject has adequate circulation to the study foot as evidenced by a Doppler measured ABI greater than or equal to 0.7after 10 minutes rest

Major Exclusion Criteria:

* Subject has a known sensitivity to bovine- or porcine-derived products.
* Subject's ulcer is due to a non-diabetic etiology
* Subject's ulcer is over a Charcot deformity of the mid-foot
* Subject's random blood sugar readings are \>450 mg/dL
* Subject is on dialysis
* Subject has a non-study ulcer on the study limb located within 7.0 cm of the study ulcer
A Trial Comparing SHR-1139 Injection With Placebo in Patients With Moderate-to-severe Plaque Psoriasis

The objective of this study is to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of SHR-1139 injection in patients with moderate to severe plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, age ≥ 18 years old at the time of signing the informed consent form (ICF).
2. Subjects voluntarily sign informed consent form (ICF) prior to the commencement of any procedures related to the study, are able to communicate smoothly with the investigator, understand and are willing to complete the study in strict compliance with the requirements of this clinical study protocol.
3. A fertile female subject or a male subject whose partner is a fertile woman who has not had a child, has a sperm/egg donation plan for 72 weeks from the date of signing the informed consent form to the last dose, and is voluntarily using highly effective contraception (including the partner).
4. Female subjects must have negative pregnancy test results during the screening period and before randomized administration, and must be non-lactating.

Exclusion Criteria:

1. There are other skin problems that researchers believe can interfere with the evaluation of psoriasis.
2. A history of moderate to severe congestive heart failure, cardiovascular and cerebrovascular events or severe bleeding events occurred in the 3 months before screening, and the investigator considered this subject to be unfit for clinical study.
3. Had an opportunistic infection within 6 months prior to screening.
4. Allergic to the ingredients or excipients of the study drug.
5. The investigator determined that there were conditions that affected the safety and efficacy evaluation of the study drug.
Unicentric Retrospective Analysis of a Cohort of 602 Young Adult and Adolescent Patients (AJA), Aged 15 to 30 Years, With Haematological Malignancies, and Managed Between 2000 and 2016

Unicentric retrospective analysis of a cohort of 602 young adult and adolescent patients, aged 15 to 30 years, with haematological malignancies, and managed between 2000 and 2016

The therapeutic results (response and survival) of young adult and adolescent patients with hematological malignancies are generally lower than those usually observed in adults over the age of 30, with equivalent treatment, particularly in lymphomatous pathology.The overall analysis of this large cohort of patients in its entirety, then by age groups (15-17 years, 18-25 years, 26-30 years) and pathology aims to describe the future of patients and patients. compare them to the results of the literature observed in this age group, and according to the therapeutic regimens administered (pediatric regimen or adult regimen).

Eligibility Criteria:
Inclusion Criteria:

* Malignant hemopathies (acute leukemia, non-Hodgkin's lymphoma, Hodgkin's lymphoma) in primary care between 2000 and 2016.

Exclusion Criteria:

* Not applicable
Longterm Outcome of Inpatient Cognitive and Behavioral Therapies for Agoraphobia

While cognitive therapy and exposure therapy are both proven to be effective for panic disorder and/or agoraphobia when outcome is assenssed up to one year after treatment (Gould et al., 1995) the scientific knowledge about long-term course of these disorders is still scanty. Although several long-term outcome studies have been conducted, the quality of these studies has been questioned.

The aim is to conduct a follow-up study of patients with either panic disorder with history of agoraphobia or agoraphobia without history of panic disorder. the patients were treated in a group format at Modum Bad during the years 1989 to 1997. Four subsamples will be included in the study. Subsample 1 (76 patients treated in 1989 and 1990) received combined cognitive and psychodynamic treatment. Subsample 2 and 3 (46 patients treated in 1992 - 1993) were allocated to either cognitive therapy or guided mastery treatment. Subsample 4 (45 patients treated in 1994 - 1996) received cognitive and schema focused therapy.

In the follow-up study the participants will be requested to complete the same self report measures as they completed at intake, discharge and at previous follow-up times. the participants will also be interviewed using the SCID-I and II as they were at the previous assessments.

The present sample is relatively unique in having received pure psychosocial experimental treatments. The very long term efficacy of cognitive therapy relative to behavioural treatmetns for agoraphobia can be evaluated, and the potential moderating effects of personality disorders can be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Meet the DSM-IV kriteria for either panic disorder, panic disorder with agoraphobia or agoraphobia

Exclusion Criteria:

* psychosis
* dementia
* substance abuse
Complications of Bladder Augmentation in Children

The goal of this observational study is to describe the complications in participants who underwent enterocystoplasty in childhood.

The main question\[s\] it aims to answer are:

* what kind of complications are there
* the kind of complications depending on the type of enterocystoplasty Participants data will be collected in the medical field. There is no comparison group.

From 1982 to 2020, all patients who had an enterocystoplasty in childhood were collected.

Complications were numbered depending on the type of enterocystoplasty and the investigators tried to find which risk factors exist.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent a enterocystoplasty before 18 years old

Exclusion Criteria:

* Patients who underwent a enterocystoplasty after 18 years old
Evaluate the Pharmacokinetics of a Combined Oral Contraceptive (COC) With and Without Obicetrapib

A study to evaluate the impact of Obicetrapib on the PK levels of Drospirenone and Ethinyl Estradiol (COC) in 30 adult female, healthy volunteers.

This is an interventional, drug-drug interaction study to evaluate the effect of daily doses of Obicetrapib tablets on the pharmacokinetics of a combined oral contraceptive (COC), Drospirenone and Ethinyl Estradiol.

Eligibility Criteria:
Inclusion Criteria:

* Non-pregnant, non-lactating, non-tobacco-, non-nicotine-using female, 18-35 years of age, inclusive, who is a candidate for hormonal contraception (as determined by the Investigator).
* Subject has a BMI of 18.5-29.9 kg/m², inclusive. BMI will be calculated using Novum Pharmaceutical Research Services Standard Operating Procedures.
* If the subject is currently using a hormonal method of contraception, the subject is willing and agrees to stop using her hormonal contraceptive throughout the duration of the study and is prepared to abstain from sexual intercourse or use a reliable non-hormonal method of contraception, as outlined below

Exclusion Criteria:

* Male
* Have given birth or been pregnant within 3 months before initial dosing, or is currently pregnant, lactating or likely to become pregnant during the study.
* History of Hypertension, or seated blood pressure for a minimum of 5 minutes \>140mmHg systolic, or \> 80 mmHg, diastolic at screening
Level of Immunity, Neutralization of the COVID-19 Virus and Reinfections in Residents of 2 Migrant Workers' Residences

A previous seroprevalence survey showed very high seroprevalence levels among residents of the two among the residents of the two migrant workers' hostels surveyed, indicating a high level of circulation of the virus SARS-COV-2 during the 1st wave of COVID-19. The constitution of a cohort after the event would be an opportunity to obtain opportunity to obtain answers to crucial questions: duration of immunity, potential reinfections potential reinfections, potential re-clustering. Going back to check the serological status seems feasible, especiallyespecially in the Foyers de Travailleurs Migrants (high probability of finding the participants).

There is an obvious scientific interest around the duration of immunity and reinfections in a population highly exposed during the first wave. Several articles document the decline of IgG antibodies in the months following an infection, but very few infection, but very few evaluate the protective character in the medium term (\>=6 months), especially in asymptomatic individuals. We are also concerned about the circulation of We are also concerned about the circulation of new variants and the immunity acquired after infection in residents.

To date, no study on the duration of immunity has been conducted in migrant worker's residences.


Eligibility Criteria:
Inclusion Criteria:

* All individuals who consented to participate in the 1st study and who consent to participate in this study
* All individuals 18 years of age or older not residing in the 2 MWRs in July 2020 and permanently living in the MWR since September 2020 who consent to participate in this study

Exclusion Criteria:

* Unwillingness to provide informed consent
* Unwillingness to provide blood
* Contraindication to venepuncture
Elitek (Rasburicase) Immuno-Monitoring Study

Primary Objective:

To determine the incidence, titer and type of anti-rasburicase antibodies in the context of hypersensitivity reaction(s) or the loss of uricolytic activity occurring in patients with relapsed leukemia/lymphoma who have been re-treated with rasburicase and have experienced a hypersensitivity reaction or loss of uricolytic activity.


Eligibility Criteria:
Inclusion criteria:

1. Previous history of rasburicase exposure and history of administration of a repeat (2nd) series of rasburicase injections (in the context of supportive care for relapsing leukemia/lymphoma) and subsequent development of either a hypersensitivity reaction (HSR) or loss of uricolytic activity (defined as failure to achieve uric acid level of \< or = 7.5 mg/dl measured 48 hours after the first rasburicase injection).

   1. A severe hypersensitivity reaction (NCI Grade 3, 4 or 5) is defined as:

      Allergic reaction; allergy; anaphylactic shock; bronchospasm; bullous skin eruption; dermatitis - exfoliative; drug hypersensitivity; dyspnea; hypotension; hypoxia; rash; rash - erythematous; rash - maculopapular, urticaria; pyrexia/fever; edema; chest discomfort; hypersensitivity (NOS); pharynx discomfort; hoarseness; pharyngeal erythema; pruritus; erythema; localized exfoliation; rash - papular; swelling ¿ face/facial; toxic skin eruption; hot flush; flushing; rash - macular; rash - pruritic; pruritus - allergic.
   2. Loss of uricolytic activity can be defined as:

      * uric acid levels \> 7.5 mg/dl measured 48 hours after the first rasburicase injection¿, which is a time point coincident with administration of the third dose of rasburicase (within that second course of treatment with this agent).
2. Patients should have received at least 2 doses of rasburicase during the repeat (2nd) administration in the event of loss or uricolytic activity. At least 1 dose of rasburicase should be administered during the repeat (2nd) administration for diagnosis of HSR.

Exclusion criteria:

1. Concomitant treatment with human IV immunoglobulin (IVIG)
2. Concomitant treatment with TNF-alpha antagonists/inhibitors, i.e. adalimumab, infliximab, and etanercept
3. Concomitant treatment with Interferon-alpha (IFN-alpha)
4. Unwillingness or inability to comply with the requirements of the protocol.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Endometriosis Biomarker Discovery Study

This is a prospective, Single time point, discovery study intending to identify biomarkers that can differentiate endometriosis from other underlying reasons for pelvic pain. Patients undergoing laparoscopy for evaluation of chronic pelvic pain or elective tubal ligation will be enrolled for collection of tissue samples at the time of laparoscopy.

This study will be a prospective collection of blood, urine, and endometrial tissue from women with chronic pelvic pain symptoms, with or without infertility, who require evaluation by laparoscopy. Women undergoing laparoscopy for elective tubal ligation will also be investigated similarly and serve as the negative control. Subjects will be queried regarding sociodemographic characteristics, medical and reproductive history, pain and lifestyle as well as assessment for differential diagnoses such as interstitial cystitis and idiopathic bowel syndrome. Endometriosis severity will be captured by rASRM staging during laparoscopy.

Eligibility Criteria:
Inclusion Criteria:

1. Able to give informed consent.
2. Aged 18-45 years old who has a regular menstrual cycle (26 to 32 days in length).
3. Undergoing a planned diagnostic or therapeutic laparoscopy for the indication of pelvic pain or for elective tubal ligation.
4. One prior pregnancy for tubal ligation patients.

Exclusion Criteria:

1. Prior surgical diagnosis of endometriosis.
2. Currently pregnant or breastfeeding.
3. Clinical suspicion of pelvic inflammatory disease (PID) or urinary tract infection.
4. Current malignancy except non-melanoma skin cancer adequately treated.
5. Known major systemic disease, including but not limited to inflammatory disease, autoimmune disease.
6. Use of immunosuppressants in the past 3 months.
7. Use of injectable reproductive hormonal therapy within the past 3 months and have not menstruated since last dose.
8. If reproductive hormonal implant has been used in the past, it must have been removed \> 3 months prior to study entry and subject must have menstruated since removal.
9. Use of intrauterine device (IUD) in the past 3 months.
10. Use of any other reproductive hormone therapy within the past 3 months, except for oral contraceptives (OCPs).
Safety Study of BMS-986015 (Anti-KIR) in Combination With Ipilimumab in Subjects With Selected Advanced Tumor

To assess the safety and tolerability, characterize the dose-limiting toxicities (DLTs), and identify the maximally tolerated dose (MTD) of BMS-986015 given in combination with ipilimumab in subjects with select advanced (metastatic and/or unresectable) solid tumors.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Histologic confirmation of one of the following solid tumors that is advanced (unresectable or metastatic) for dose escalation or cohort expansion:Non-Small Cell Lung Cancer (NSCLC), Castrate Resistant Prostate Cancer (CRPC), Melanoma (MEL)
* At least one measurable lesion at baseline by Computed tomography (CT) or Magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
* Biopsies: Subjects in the melanoma cohort must have at least 1 tumor site that can be biopsied at acceptable clinical risk
* Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
* Estimated life expectancy of ≥ 12 weeks
* White blood cell (WBC) ≥2000/μL, Neutrophils ≥1500/μL, Platelets ≥ 100x1000/μL, Hemoglobin ≥ 8.5 g/dL, creatinine ≤ 1.5 X upper limit of normal (ULN) mL/min, Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 3x ULN
* Normal thyroid function or be on stable hormone supplementation

Exclusion Criteria:

* Participation in any prior clinical study with BMS-936558 or ipilimumab that has overall survival listed as a primary/co-primary endpoint
* Subjects with known or suspected brain metastasis
* Subjects with active autoimmune disease, uncontrolled or significant cardiovascular disease
* Prior therapy with anti- Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) antibody or anti- Killer cell immunoglobulin-like receptor (KIR) antibody
* Grade 2 neuropathy