cyrilzakka/clinical-trials huggingface dataset:
Treatment of High Risk Adult Acute Lymphoblastic Leukemia

Current therapeutic protocols for adult ALL consider MRD together with the baseline risk factors (age, WBC count, immunophenotype, cytogenetics) and speed in response to therapy for treatment decisions. On the other hand, the systematic use of allogeneic SCT for all adult patients (pts) with Ph- HR-ALL is still a matter of debate. The aim of the prospective study ALL-AR-03 from the Spanish PETHEMA Group was to evaluate the response to a differentiated therapy (chemotherapy or allogeneic SCT) according to early bone marrow blast clearance and MRD levels (assessed by cytofluorometry at the end of induction and consolidation therapy) in HR Ph- adult ALL patients.

HR ALL included one or more of the following baseline parameters: age 30-60 yr, WBC count \>25x109/L and 11q23 or MLL rearrangements. Induction therapy included vincristine, prednisone and daunorubicin for 4 weeks. In pts with slow cytologic response to therapy (≥10% blasts in bone marrow assessed on d14) intensified induction with high dose ARA-C and mitoxantrone was administered. Early consolidation therapy included 3 cycles with rotating cytotoxic drugs including high-dose methotrexate, high-dose ARA-C and high-dose asparaginase. Pts. with slow cytologic response on d14 or MRD level \>0.05% after consolidation were assigned to allogeneic SCT (related or unrelated) and those with standard cytologic response on d14 and MRD level \<0.05% after consolidation received 3 additional cycles of delayed consolidation (identical to those of early consolidation) followed by maintenance therapy up to 2yr in CR.

Eligibility Criteria:
Inclusion Criteria:

* High risk ALL adult patients (age\> 15 years)no treated previously
* High-risk ALL:
* One or more of the following:

  * Age 30-60 yr.
  * WBC count \>25x109/L
  * 11q23 or ALL1/AF4
* Very high-risk ALL:
* HR ALL and one or the following:

  * Slow cytologic response (\>10% blasts in BM on d14 of induction therapy).
  * MRD\>0.05% (by flow cytometry) at the end of consolidation

Exclusion Criteria:

* L3 ALL or B mature(sIg +) or t(8;14), t(2;8), t(8;22).
* ALL Ph (BCR/ABL) positive.
* Bifenotipics ALL as EGIL criteria.
* Indifferentiated ALL.
* Patients with cardiac pathology
* Patients with chronic liver disease in activity fase
* Pulmonary disease
* Renal insufficiency not due to ALL
* Neurological disorders not due to ALL
* PS (grades 3 and 4) not due to ALL.
Intracutaneous Versus Transcutaneous Sutures in the Face (IC vs TC Sutures)

Rationale:

Skin cancer is common in Caucasians and often exists on sun-exposed areas, such as the face. Treatment of choice is mostly excision and result in an irreversible scar. As the incidence of skin cancer is rising, also among young people, it is important to obtain a good cosmetic outcome after treatment. It is believed that the type of closure of the wound after excision can influence the cosmetic result. Currently, primary closure of the excision can occur by transcutaneous (TC) or intracutaneous (IC) suturing. Both techniques are widely used among dermatologists and plastic surgeons and the choice is mainly dependent on the preference of the physician. Research comparing the cosmetic result of both techniques in the craniofacial area is lacking.

Objective:

Evaluation of the cosmetic result of transcutaneous sutures versus intracutaneous sutures in the craniofacial area.

Study design:

A randomized controlled single-blinded multi-center trial.

Study population:

Patients older than 18 years, with craniofacial skin tumor receiving surgery followed by primary closure at the department of Dermatology and Plastic Surgery of the Maastricht University Medical Centre, the department of Dermatology of Catharina hospital Eindhoven and the department of Plastic surgery of Orbis Medical Centre Sittard.

Intervention:

Excision of the tumor followed by IC sutures or TC sutures

Main study endpoints:

Cosmetic result measured on the Patient and Observer Scar Assessment Scale (POSAS) by the patient and the researcher 12 months after surgery.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

All patients who participate have an indication for excision and will be assigned to one of the suture techniques. Both techniques are widely used in the regular patient care. Therefore, no extra risks are associated with it.

Patients will be asked to visit the hospital 3 months and 1 year following treatment, at which point a questionnaire will be filled in and the redness of the scar will be measured by means of non-invasive techniques. In addition, patients will be asked to apply a sunscreen on the scar daily during the first three months of follow-up.


Eligibility Criteria:
Inclusion Criteria:

* All patients aged 18 years or older with a skin tumour of minimal 5mm in diameter in the craniofacial area requiring an excision followed by primary closure will be included. If a patient has more than one lesion, the largest lesion that can be closed primarily will be included as a maximum of one tumour per patient will be studied.

Exclusion Criteria:

* Patients with skin lesions on the ears, nose, mucosal part of the lips or eyelids as patients suited for excision but where a transplantation, flap or secondary granulation is necessary for reconstruction of the defect will be excluded. Patients not capable of informed consent will also be excluded.
Study of Gardasil in Mid-Adult Males (MAM)

The purpose of this study is to test the effectiveness of the research study vaccine, Gardasil, in men ages 27-45 who have completed 4 years of observation in The Human Papillomavirus \[HPV\] infection in men (HIM) Study.

The MAM Study is a prospective pilot intervention trial to investigate patterns of human papillomavirus (HPV) vaccine immunogenicity in men, aged 27-45 years, in which the men will receive Gardasil. Gardasil was administered at 0, 2, and 6 months. Blood was drawn at 0 and 7 months to provide a quadrivalent HPV antibody serologic profile. Participants also completed surveys via computer-assisted interviews (CASI) at Day 1 and Month 7 to record sexual behavior.

Our overall goal is to test the efficacy of Gardasil to reduce HPV 6, 11, 16, 18 persistent infection among men at the external genital epithelium, anal canal, and oral cavity, and to reduce lesions caused by these HPV types at the external genital epithelium and anal canal. The purpose of this Phase II trial is to establish the immunogenicity of Gardasil among mid-adult men and to establish the infrastructure with which to build the larger Phase III trial in the future.

Eligibility Criteria:
Inclusion Criteria:

* Men that have completed 4 years of follow-up in the on-going international prospective natural history study of HPV in men (The HIM Study)
* Willing to comply with 4 scheduled visits within a 7-month period

Exclusion Criteria:

* Have received an HPV vaccine
* Have a prior diagnosis of penile or anal cancers
* Have a prior diagnosis of high grade anal intraepithelial neoplasia
* Have been diagnosed with human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS)
* Have a history of anaphylaxis to vaccines
* Have known impairment of the immune system
* Have received any blood products within 6 months of enrollment
Risk of Recurrent Venous Thrombosis: A Validation Study of the Vienna Prediction Model

Because of a high recurrence risk after unprovoked venous thromboembolism (VTE) indefinite anticoagulation is recommended, but confers a considerable bleeding risk. It is important to identify patients, in whom the recurrence risk is lower than the expected bleeding risk, and who will not benefit from long term anticoagulation. By use of a scoring model (Vienna Prediction Model), patients can be stratified according to their recurrence risk based on their sex, location of VTE and D-Dimer. Before implementation in routine care, an independent validation is required. Patients with unprovoked VTE will stop anticoagulation after 3-7 months and the recurrence risk will be estimated by use of the Vienna Prediction Model. Low risk patients with a score of \<180 will be included and will be left untreated. Patients with a high score will not be included and their management will follow current guidelines. Follow-up will be two years and the endpoint will be recurrent symptomatic VTE.


Eligibility Criteria:
Inclusion Criteria:

Age \> 18 years symptomatic uni- or bilateral proximal (including the trifurcation area, popliteal, superficial femoral, deep femoral, common femoral and iliac vein) or distal DVT of the leg and/or symptomatic PE.

VTE not provoked by one of the following temporary risk factors: surgery, trauma,pregnancy, cancer, immobilisation.

Exclusion Criteria:

History of previous VTE; anticoagulation for longer than 6 months; reasons for long-term anticoagulation other than VTE; poor patient compliance; no consent to participate
BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management

The purpose of this study is to assess the weight loss effect of lorcaserin at the end of the first year of treatment (Week 52) and to assess the ability of lorcaserin to maintain weight loss at the end of the second year of treatment (Week 104)


Eligibility Criteria:
Inclusion Criteria:

* Obese adults with a BMI 30 to 45 kg/m2 or overweight adults with a BMI 27 to 29.9 kg/m2 and at least one obesity-related comorbidity (hypertension, dyslipidemia, cardiovascular disease, glucose intolerance, sleep apnea)
* Ability to complete a 2 year study

Exclusion Criteria:

* Diabetes
* Pregnancy
* History of heart valve disease
* Serious or unstable current or past medical conditions
PD-L1 Targeting Nanobody Probe for PET Imaging of Solid Tumor

The objective of this study is to construct a noninvasive approach using 68Ga-THP-APN09 PET/CT to detect the PD-L1 expression of tumor lesion in patients with lung cancer, melanoma and other solid tumor to identify patients benefiting from anti-PD-(L)1 treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-75, male and female, with ECOG score of 0 or 1;
2. Subjects with head and neck tumors, lung cancer, esophageal cancer, breast cancer, ovarian cancer, cholangiocarcinoma, colorectal cancer, gastric cancer, pancreatic cancer, melanoma, bone or soft tissue sarcoma, solid tumors or suspected tumor subjects who intend to undergo pathological tissue biopsy or receive tumor surgical treatment in the near future (within 2 months);
3. The expected survival was more than 26 weeks;
4. Blood routine test, liver and kidney function meet the following standards: blood routine: WBC \>= 4.0 x 10\^9/L or neutrophil \>= 1.5 x 10\^9/:, PLT \>= 100 x 10\^9 / L, Hb \>= 90g / L; Pt or APTT \<= 1.5 upper limit of normal value; liver and kidney function: total bilirubin \<= 1.5 x ULT (upper limit of normal value), ALT / AST \<= 2.5 upper limit of normal value or \<= 5 x ULT (subject with liver metastasis), ALP \<= 2.5 upper limit of normal value (if bone metastasis or liver metastasis exists, ALP \<= 4.5 upper limit of normal value); BUN \<= 1.5 x ULT, SCR \<= 1.5 x ULT;
5. According to RECIST1.1, there was at least one measurable target lesion;
6. Women must take effective contraceptive measures during the study period and within 6 months after the end of the study; men should agree to use contraceptive measures during the study period and within 6 months after the end of the study period;
7. Understand and sign informed consent voluntarily with good compliance.

Exclusion Criteria:

1. The function of liver and kidney was seriously abnormal;
2. Preparation for pregnant, pregnant and lactating women;
3. Inability to lie flat for half an hour;
4. Suffering from claustrophobia or other mental disorders; 5) Other researchers considered it unsuitable to participate in the trial.
Treatment of Epidemic Keratoconjunctivitis With 2% Povidone-iodine

The purpose of this study is to determine the outcomes of treating epidemic keratoconjunctivitis with 2% povidone-iodine.

The study design was a prospective interventional case series. Our institutional ethical committee approved the study protocol in April 2004. We performed this study between July 2004 and December 2009. During this period, there were 2 episodes of EKC epidemic. The first episode was in 2006 and the second in 2009.

Eligibility Criteria:
Inclusion Criteria:

* patients who were diagnosed with EKC at the outpatient ophthalmic unit

Exclusion Criteria:

* children younger than six years
* women being pregnant or during lactation
* history of allergy to povidone-iodine
* prior ocular surgery
* contact lens usage and chronic eye diseases with current eye medications.
Preventing Post-Operative Delirium in Patients Undergoing a Pneumonectomy, Esophagectomy or Thoracotomy

The purpose of this study is to investigate the effectiveness of a preventative low-dose of Haloperidol to prevent delirium in patients undergoing a esophagectomy, pneumonectomy or thoracotomy.

Delirium is state of severe confusion and some symptoms include:

* Cannot think clearly
* Have trouble paying attention
* Have a hard time understanding what is going on around them
* May see or hear things that are not there. These things seem very real to them.

50% of patients who undergo esophageal and/or lung resection suffer from acute brain dysfunction or delirium postoperatively. Delirium is a state of brain failure characterized by disturbance of consciousness with reduced ability to focus, sustain, or shift attention that occurs over a short period of time and tends to fluctuate over the course of the day. Presence of delirium in the post-operative phase is associated with a longer length of both intensive care unit and hospital stay, increased health-care costs, long-term functional and cognitive decline, and an increased risk of in-hospital and post-discharge mortality.

Haloperidol primarily acts by blocking dopamine (D2) receptors. This dopamine blockade in the cerebral cortex improves cognition and reduces delirium. Along with the dopamine blockade, haloperidol has anti-inflammatory properties. It inhibits production of lipopolysaccharide induced pro-inflammatory cytokines, interleukin (IL-1) and tumor necrosis factor alpha (TNF-α). Haloperidol also increases levels of Interleukin -1 receptor antagonist (IL-1RA), an anti-inflammatory cytokine that blocks the action of other pro-inflammatory cytokines. If unchecked, the inflammatory cytokines cause impaired concentration, sleep disturbances, and agitation the cardinal symptoms of delirium; and induce a reduction in cholinergic activity. Given the inhibitory effect of acetylcholine on certain cytokines such as interleukin-6, a repetitive cycle of inadequate regulation of inflammation due to cholinergic depletion ensues. Haloperidol with its anti-inflammatory properties seeks to mitigate this repetitive vicious cycle.

Eligibility Criteria:
Inclusion Criteria:

1. At least ≥ 18 years of age and older
2. Undergoing a possible or scheduled thoracotomy
3. English speaking

Exclusion Criteria:

1. History of Schizophrenia and Parkinson's disease
2. History of Severe Dementia
3. History of Alcohol Abuse
4. On Cholinesterase Inhibitors or Levodopa
5. Pregnant or Nursing
6. Corrected QT interval \> 550 milliseconds at the time of randomization
7. History of Neuroleptic Malignant Syndrome or Haloperidol Allergy
FSME IMMUN NEW Follow-up to Study 199 in Children Aged 1 to 6 Years

The purpose of this study is to investigate the safety and immunogenicity of the third vaccination with one of three different concentrations of a TBE vaccine in all subjects who completed two vaccinations in one of the three treatment groups of Baxter study 199 (a dose-finding study to investigate the safety and immunogenicity of two vaccinations with FSME IMMUN NEW in healthy subjects aged 1 to 6 years).


Eligibility Criteria:
Inclusion Criteria:

All volunteers who participated in Baxter study 199 and received two vaccinations will be invited to participate. Male and female children will be eligible for participation in this study if:

* They received two vaccinations with one of the three different dosages of FSME IMMUN NEW during the course of Baxter study 199
* Written informed consent from the legal guardian is available.

Exclusion Criteria:

There are no specific exclusion criteria for this study entry. However volunteers will be assessed for eligibility to receive a third vaccination.

Volunteers will be excluded from vaccination and consecutive visits in this study if they:

* Are not clinically healthy, (i. e. the physician would have reservations vaccinating with FSME IMMUN NEW outside the scope of a clinical trial)
* Have already been administered a third TBE vaccination elsewhere after the two vaccinations in Baxter study 199
* Have had an allergic reaction to one of the components of the vaccine since the last vaccination in Baxter study 199
* Suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence immunological functions
* Have received banked human blood or immunoglobulins within one month of study entry
* Are known to be HIV positive (a special HIV test is not required for the purpose of the study) since the last visit of Baxter study 199
* Have had a vaccination against yellow fever and / or Japanese B-encephalitis since the last visit in Baxter study 199
* Had received an investigational new drug within 6 weeks prior to study start
Pharmacokinetics of LCQ908 in Patients With Renal Impairment

This study will compare the pharmacokinetics of LCQ908 in subjects with varying degrees of renal impairment to healthy subjects


Eligibility Criteria:
Inclusion Criteria:

* Individuals with renal impairment only

  * Estimated Creatinine Clearance (CLcr) by the Cockroft-Gault equation ≤80mL/min;
  * Mild renal impairment defined as CLcr 50-80 mL/min
  * Moderate renal impairment defined as CLcr 30-50 mL/min
  * Severe renal impairment defined as CLcr \<30 mL/min
* Healthy subjects only • Estimated CLcr by the Cockroft-Gault equation \>80mL/min

Exclusion Criteria:

* All Individuals

  * A past medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome.
  * Female subjects must be of non child bearing potential or use an effective method of contraception.
* Individuals with renal impairment

  * Renal transplant at any time.
  * Subjects undergoing any method of dialysis (hemodialysis, peritoneal dialysis) within the last 3 months.
  * History of clinically significant chronic or recurrent urinary tract infection active and requiring antibiotic treatment within the past 30 days.
  * Any medication that is contraindicated in moderate or severe renally impaired population
* Healthy subjects

  * History or presence of impaired renal function as indicated by clinically significantly abnormal creatinine or BUN and/or urea values, or abnormal urinary constituents (e.g., albuminuria)
  * Evidence of urinary obstruction or difficulty in voiding at screening
  * History or presence of hepatitis B or C and/or positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result at screening.

Other protocol-defined inclusion/exclusion criteria may apply.
IVM Versus Standard IVF in Infertile Patients Diagnosed With PCOS

A single center, prospective, open-label, non-inferiority randomized controlled clinical trials (1:1 treatment ratio) regarding pregnancy outcomes between IVM and standard IVF among infertility couples with PCOS in China.

A single center, randomized controlled clinical trial will enroll 350 couples with PCOS undergoing their first cycle of IVF. The participation in this study will be approximately 2 years with a total of 7 visits from the cycle beginning, pregnancy to delivery. On day 2 or day 3 following the onset of menstrual bleeding, eligible patients will be allocated to two groups at a ratio of 1:1- IVM protocol, and standard IVF protocol. All participants will be randomized through stratified block randomization according to the study sites.

Eligibility Criteria:
Inclusion Criteria:

1. Infertile couples scheduled for their first IVF cycle.
2. Women diagonosed with polycystic ovarian syndrome.
3. Voluntary participation and informed consent obtained.

Exclusion Criteria:

1. Couple with contraindication for IVF or ICSI.
2. Couples receiving donor sperm or donor eggs.
3. Couples with indications or have plan to receive PGD and PGS.
4. Sperm analysis diagnosed as azoospermia;
5. Either male partner or female partner with an abnormal chromosome karyotype (chromosome polymorphisms was not included).
6. Women who have undergone unilateral ovariectomy.
Treatment of Vascular Lesions With a Tandem 532/1064 nm Laser

Dermatologists have for many years treated vascular lesions by a variety of modalities including cryosurgery, electrotherapy, dermabrasion and radiation.

It has been hypothesized that simultaneous delivery of these two wavelengths may provide safer, and in some cases more effective, vascular lesion removal.

The Tandem laser is capable of emitting multiple cryogen spurts intermittently with multiple 532/1064 nm laser pulses.This mode may reduce malformed blood vessels with a low incidence of long-term side effects.

The researcher can determine the blanching of vascular lesions after Tandem laser with multiple 532/1064 nm laser pulses treatment.

The researcher will select one to four test sites spots for laser treatment. will be Different laser parameters can be used for each test site. The research will evaluate of the test sites at 6-12 weeks for bruising and blanching. Parameters of the test area with the greatest degree of blanching without adverse effects will be utilized for further treatment. If no test area is determined to have blanching without adverse effects, further test sites may be performed.

Eligibility Criteria:
Inclusion Criteria:

* Adult age 18 years and older
* Diagnosis of vascular lesion

Exclusion Criteria:

* Age \<18
* Pregnancy
* History of cutaneous photosensitivity
* Any therapy to the proposed treatment sites within the previous two months
* Current participation in any other investigational drug or device evaluation
Hyperekplexia in Patients With CTNNB1 Mutation

A few years ago, a new genetic disorder (OMIM # 615075) has been associated with loss-of-function variations in the CTNNB1 gene. The clinical features include a delayed psychomotor development usually leading to severe intellectual disability with or without autistic spectrum disorders, progressive spastic diplegia, and various visual defects. Among over 30 cases described worldwide, 2 were reported with an exaggerated startle response to sudden stimulus corresponding to a very rare neurological phenomenon called hyperekplexia. The investigators also have a 3rd patient carrying a CTNNB1 syndrome associated with hyperekplexia.

Hyperekplexia can impair daily life because the affected person will fall unexpectedly and stiffly, causing repeated head- or body- wounds. It may be treated empirically by various drugs. Hyperekplexia has so far not been associated with CTNNB1 variations.

In this study, we aim to describe the prevalence and clinical characteristics of hyperekplexia in CTNNB1 syndrome carriers, in order to improve diagnosis and thus treatment.

The investigators will recruit CTNNB1 subjects through health care providers and also by contacting the families through dedicated social media and databases. The families and health care providers will be invited to fill in a questionnaire related to hyperekplexia (clinical, pharmacological, and genetic data).

Eligibility Criteria:
Inclusion Criteria:

* Patient carrying a CTNNB1 syndrome showing an exaggerated startle response
* child whose parents have signed a consent form to participate in the study

Exclusion Criteria:

* Absence of molecular diagnosis
* Refusal to participate