cyrilzakka/clinical-trials huggingface dataset:
Randomized Trial of Mobilized Blood/Marrow Versus Blood Transplant

The use of peripheral blood stem cells(PBSCs) is rapidly growing in the allogeneic transplantation setting as an alternative to bone marrow (BM).It was found that the use of PBSCs is associated with faster hematologic recovery but have yielded differing results regarding the incidence of graft-versus-host-disease (GVHD) and relapse.

The study hypothesis:

transplantation of mobilized PBSC to haploidentical donor with standard-risk leukemia had comparable engraftment and non-relapse mortality to mobilized BM combined with PBSCs

The donors were primed with granulocyte-colony stimulating factor (G-CSF) injected subcutaneously for five consecutive days. In the trial group, the PBSCs were harvested on the fourth and fifth day;in the control group, the bone marrow cells were harvested on the fourth day and the PBSCs were harvested on the fifth day.

Eligibility Criteria:
Inclusion Criteria:

* Standard risk of Recipients of haploidentical stem cell transplantation with myeloablative conditioning regimens

Exclusion Criteria:

* Active, uncontrolled infection
Psycho-education Program BLAME-LESS and It's Effect on Traumarelated Shame and Guilt

The primary objective of the BLAME-LESS study is to examine the effectiveness of an online psychoeducation program in reducing trauma-related feelings of shame and guilt in adolescents who experienced sexual or physical abuse .

The study follows a two-arm RCT (n=34). The effects of a brief online psychoeducation program will be compared, with a waiting-list control group. The intervention aims to reduce feelings of trauma-related shame and guilt that adolescents experience regarding their own defense responses during and after (sexual) violence. Assessments take place after screening, at baseline, two weeks after allocation to the intervention or waiting-list, and, only for the waiting-list participants, seven weeks after allocation to the intervention.

Eligibility Criteria:
Inclusion Criteria:

* the participant experienced one or more traumatic life events, including (sexual) violence as indicated by the CTSQ;
* the participant reported one or more feelings of guilt and/or shame on the CERQ (items 1 and/or 10 and/or 19 and/or 28)
* the participant being fluent in written and spoken Dutch;
* the participant is motivated and available for a period of seven weeks to engage in the study, including the psychoeducation program BLAME-LESS, and commit to the assessments.

Exclusion Criteria:

* acute suicidal behavior or suicidal ideations requiring immediate hospitalization;
* the participant has already read the book that this program is based upon: "Paralyzed with Fear" (In Dutch: Verlamd van Angst, van Minnen 2017), or has been intensively informed otherwise in the past 12 months by a psychologist about common defense responses during and after trauma;
* Cognitive Impairments (IQ \< 70);
* the participant has a brother or sister in the present study;
* the participant is already involved in trauma-focused treatment.
Repetitive Transcranial Magnetic Stimulation to Promote Regeneration in Persons With SCI

This is a research study to evaluate the safety, efficacy and feasibility of high-frequency repetitive transcranial magnetic stimulation (HF-rTMS) in patients with subacute spinal cord injury.

This research study is investigating whether repetitive high-frequency transcranial magnetic stimulation (HF-rTMS) in patients with subacute spinal cord injury is safe, efficacious, and feasible. The study will take approximately 7-8 months to complete, during which 15 training sessions with HF-rTMS will be completed. Followed by 30 minutes each session of arm and hand training without HF-rTMS. The participants will complete testing after the 15 training sessions as well as 6 months following completion.

Eligibility Criteria:
Inclusion Criteria:

* Be less than 8 weeks post injury
* Must have an incomplete spinal cord injury at a neurological level of injury between the C2-C6 level and an impairment grade A, B, C, or D, according to the American Spinal Injury association (ASIA) Impairment Scale
* If an outpatient, will be at least 6 months post injury

Exclusion Criteria:

* Have a pacemaker
* Have metal in the skull
* Have a history of seizures, or a brain injury
* Being pregnant
* Have skin issues or open wounds
* Have severe contractures and/or spasms in my elbow/wrists as determined by study staff examination at screening
* Study staff will review medications to determine if taking any drugs that would increase risk of having a seizure while undergoing TMS. If taking such medications, will not be enrolled
Auto-evaluation of Dyspnea

The primary aim of this study was to compare patients-rated evaluation and caregiver's assessment of dyspnea with the standard tools in pulmonology unit (Borg scale and visual analog scale) and the secondary aim was to performed an analysis depending on the diseases (lung cancer vs. other lung diseases) and to verify the agreement between the evaluation between both visual analog scale and modified Borg scale.


Eligibility Criteria:
Inclusion Criteria:

* age ≥18 and
* to have a diagnosis of acute or chronic respiratory disease

Exclusion Criteria:

* mental or cognitive disorders
* inability to understand the local language
A Study Evaluating Safety and Efficacy of the Addition of ABT-888 Plus Carboplatin Versus the Addition of Carboplatin to Standard Chemotherapy Versus Standard Chemotherapy in Subjects With Early Stage Triple Negative Breast Cancer

This is a 3 arm Phase 3 study to evaluate the safety and efficacy of the addition of veliparib plus carboplatin versus the addition of carboplatin to standard neoadjuvant chemotherapy versus standard neoadjuvant chemotherapy in subjects with early stage TNBC.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed invasive breast cancer by core needle or incisional biopsy (excisional biopsy is not allowed). Clinical stage T2-3 N0-2 or T1 N1-2 by physical exam or radiologic studies.
2. Documented Breast Cancer Gene (BRCA) germline mutation testing.
3. Estrogen Receptor (ER)-, Progesterone Receptor (PR)-, and Human Epidermal Growth Factor Receptor (HER)2-negative (triple-negative) cancer of the breast.
4. ECOG Performance status of 0 to 1.
5. Women must be determined to be not of childbearing potential (surgically sterile, or postmenopausal defined as amenorrheic for at least 12 months) by the Investigator OR they must have a negative serum pregnancy test prior to randomization.

Exclusion Criteria:

1. Previous anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, biologic therapy radiotherapy or investigational agents) with therapeutic intent for current breast cancer.
2. Previous treatment with carboplatin, paclitaxel, doxorubicin, cyclophosphamide and a Poly-(ADP-ribose)-Polymerase (PARP) inhibitor.
3. Concurrent treatment with an ovarian hormonal replacement therapy or with hormonal agents such as raloxifene, tamoxifen or other selective estrogen receptor modulator (SERM). Subjects must have discontinued use of such agents prior to beginning study treatment.
4. A history of seizure within 12 months prior to study entry.
5. Pre-existing neuropathy from any cause in excess of Grade 1.
Cognitive Behavior Therapy for Atopic Dermatitis

Atopic dermatitis is an inflammatory skin disease characterized by itching, dry skin and recurrent inflammatory eczema. It is one of the most common skin diseases and is associated with reduced quality of life, functional impairment and sleep difficulties. The present study aims to investigate a new exposure-based cognitive behavioral psychological treatment for the disorder. The trial is a small scale open trial (n=25) with assessments at baseline, post-treatment and 6-month follow-up. The primary outcome is the SCORAD.

Atopic dermatitis (AD)is an inflammatory skin disease characterized by itching, dry skin and recurrent inflammatory eczema. It is one of the most common skin diseases and is associated with reduced quality of life, functional impairment and sleep difficulties. There are currently no pharmacological treatments that are effective in curing the disorder in the longer-term. Itching is one of the core symptoms in AD and it has been shown that the behavioral response to itching, scratching, has a maintaining function in AD. Reducing scratching may therefore play an important role in alleviating AD. Although behavioral aspects play a significant role in AD only a few studies have investigated the effect of psychological treatment for AD. These studies have shown promising results and the present study aim to add to the body of knowledge by testing a new form of cognitive behavioral treatment for AD. This new treatment is based on the idea that patients could benefit from training in exposure to events that could lead to increase in itching while refraining from scratching. To enable this the treatment incorporates more recently developed cognitive behavioral components such as mindfulness training.

The present study aims to investigate a new exposure-based cognitive behavioral psychological treatment for the disorder. The trial is a small scale open trial (n=25) with assessments at baseline, post-treatment and 6-month follow-up. The primary outcome is the SCORAD.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AD with at least moderate severity
* AD for at least 6 months
* Age 18-65
* Ability to read and write in Swedish

Exclusion Criteria:

* Serious psychiatric illness
* Concurrent light treatment or peroral treatment for AD
* Pregnancy
* Other concurrent or recently finished psychological treatment for AD
Post-authorization Safety Study of Euforvac-Hib Vaccine for Active Primary Immunization in Infants From 6 Weeks

A multicenter, observational study to evaluate the safety of Euforvac-Hib vaccine for active primary immunization against diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenza type B in infants.

Euforvac-Hib vaccine manufactured by LG Life science in Korea, but it's not marketed in Korea. It is distributed to UN agencies in diverse countries. Thus, WHO recommended LG Life Science to conduct the safety study for assessing the vaccine safety if Euforvac-Hib is prequalified.

The objectives of this safety study are to identify any problems and questionable issues likely to emerge from the actual use of Euforvac-Hib vaccine after launching in the market.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who had been signed informed consent by subjects legally acceptable Representative
2. Infant from 6 weeks of age.who is given this vaccine for active primary immunization against diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenza type B

Exclusion Criteria:

1. Patients with hypersensitivity to any component for the vaccine
2. Patients who had a severe reaction to a previous dose of the combination vaccine or any of its constituents is absolute contraindication to subsequent doses of the combination vaccine.
3. Patients who had pertussis, encephalopathy or other serious neurological abnormality in the newborn period
Refining Paracervical Block Techniques for Pain Control in First Trimester Surgical Abortion

The purpose of this study is to determine the level of pain women experience with a surgical abortion and the effect that varying paracervical block techniques might have on that pain. These different techniques involve wait time following the injection as well as the number of sites injected.

The investigators plan to conduct a single-blinded randomized trial of 350 women undergoing elective first-trimester surgical abortion. Subjects will be randomized to two different paracervical block techniques, but both the medications and the amount of medications will remain the same. Subjects will not know to which group they have been randomized as this knowledge may affect how much pain is felt.

Primary Outcome:

Patient reported pain with cervical dilation during first trimester surgical abortion. Pain is measured as mm distance from the left of the 100-mm visual analogue (VAS) scale with the anchors 0 = none, 100 mm = worst imaginable (reflecting magnitude of pain) and recorded immediately after completion of cervical dilation. The 100-mm VAS scale is a well established and validated study instrument.

Secondary Outcomes:

1. Socio-demographic and clinical data: age, race, gravidity, parity, gestational age, prior vaginal delivery, prior abortion, level of menstrual symptoms
2. Pain (VAS scale):

   * anticipated
   * baseline
   * with speculum insertion
   * with placement of the PCB
   * with aspiration
   * 30 min postoperatively
   * intrapersonal pain changes (calculated in analysis)
   * anxiety \[baseline\] (VAS scale; anchors 0 = none, 100mm = worst imaginable):
   * of pain
   * of surgery
   * satisfaction (VAS scale; anchors 0 = not, 100mm = very satisfied):
   * with pain control
   * overall abortion experience
   * adverse events
   * need for additional intraoperative and/or postoperative pain medication
   * participants' belief if they were in the intervention or control group

Eligibility Criteria:
Inclusion Criteria:

* age 18 years or older
* voluntarily requesting pregnancy termination
* ultrasound-confirmed intrauterine pregnancy up to 10 6/7 weeks gestational age
* generally healthy
* English or Spanish speaking
* able or willing to sign an informed consent and agree to terms of the study

Exclusion Criteria:

* gestational age over 10 6/7 weeks (due to routine use of misoprostol starting at this gestational age at the study sites)
* incomplete abortion
* failed medical abortion
* required or requested IV sedation (prior to randomization)
* patient who declines Ibuprofen, Lorazepam or PCB
* medical contraindication or allergy to any of the study medications
* chronic use of narcotic pain medication or heroin
* significant physical or mental health condition
* adnexal mass or tenderness on pelvic exam consistent with inflammatory disease
* known hepatic disease
* women who, in the opinion of the investigator, are not suitable for the study protocol
Safety and Efficacy Study of JTT-851 in Patients With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the effect of JTT-851 on diabetes as well as to assess the safety, tolerability, and pharmacokinetics of JTT-851 in type 2 diabetic patients either treated with metformin or treatment-naïve.

This is a randomized, double-blind, double-dummy, placebo and active-controlled (glimepiride), multi-center, parallel-group study to investigate the effect of JTT-851 on HbA1c and other ancillary efficacy parameters and to assess the safety, tolerability, and pharmacokinetics of JTT-851 in inadequately-controlled treatment-naïve or metformin-treated type 2 diabetic patients.

Eligibility Criteria:
Inclusion Criteria:

* Males and females with type 2 diabetes, 18-70 years of age at Visit 1
* Managing diabetes with diet and exercise only or currently being treated with a stable dose of metformin (at least 1500 mg/day)
* Glycosylated hemoglobin at Visit 1 between 7.5% and 10.0%, if on metformin and between 7.5% and 10.9%, if without treatment
* Body mass index (BMI) ≥ 23.0 kg/m\^2 and ≤ 45.0 kg/m\^2 at Visit 1

Exclusion Criteria:

* Females who are pregnant or breast-feeding
* Known medical history or presence of type 1 diabetes or acute metabolic diabetic complications, unstable or rapidly progressing retinopathy, nephropathy or neuropathy
* Acute coronary syndrome or uncontrolled hypertension
* Does not meet all diet or previous/concomitant medication restriction criteria
Stanford Regulating Circuits of the Brain Study- Ketamine

This study is a biomarker study designed to characterize how ketamine impacts the reward circuits of the human brain.

The investigators will assess the effect of acute ketamine modulation on the functioning of reward-related human brain circuits. Reward-related brain circuits will be assessed using functional magnetic resonance imaging.

Participants will include volunteers who report more than two prior uses of ketamine (also known as "Special K"), when they were 18 years or older.

The investigators will recruit individuals who have previously tried ketamine rather than those who are ketamine-naïve.

Participants will receive an IV infusion of ketamine (\~.05mg/kg and 0.5mg/kg) or placebo (saline). Following established procedures, these three sessions will be randomized in a blinded protocol in order to limit expectancy effects.

Throughout each session, participants will be monitored. Functional imaging will commence after the drug has reached peak levels, following previously established time courses for ketamine infusion. Participants will also be monitored after the functional imaging session. Secondary effects of ketamine on behavior and self-reported experience will be assessed.

In the assessment of the acute effects of ketamine, the investigators will take into account the cumulative effects of prior drug exposure.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-55 years
* At least 2 prior uses of ketamine when aged 18+
* BMI within healthy range (18-30)
* Ability to speak, read, or understand English

Exclusion Criteria:

* Current active suicide ideation or history of suicide attempts
* Current mood, anxiety, eating, psychotic, or substance use disorder
* Lifetime psychotic or bipolar disorder
* Schizophrenia in a first degree relative
* Current use of psychotropic medication
* Prior adverse ketamine response
* Allergy or hypersensitivity to ketamine
* Use of ketamine in past 7 days
* Cannabis use in the past 7 days, illicit recreational drug use in the 48 hours prior to sessions, and/or alcohol use in the 24 hours prior to sessions
* Concurrent use of any medications that might increase the risk of participation (e.g., drug interactions)
* History of epilepsy, convulsions, seizures, LOC \>10 min
* Renal/hepatic impairment
* Hypertension (Stage 1 defined as systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg on 2 of 3 measurements at least 15 min apart at initial screening; systolic blood pressure \>155 mmHg or diastolic blood pressure \>99 mmHg on 2 of 3 measurements at least 15 min apart during infusion visits)
* Heart rate \<50 bpm or \>150 bpm at initial screening
* Chronic congestive heart failure, tachyarrhythmias, myocardial ischemia assessed via EKG at initial screening
* EKG QTcF intervals \>430 ms for men and \>470 ms for women
* Direct physical access to or routine handling of addicting drugs in the regular course of work duties
* MRI contraindication
* Pregnant or nursing females
Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children (3 to < 9 Years)

This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in healthy young children.


Eligibility Criteria:
Inclusion Criteria:

* Children 3 to \< 9 years of age in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months.

Exclusion Criteria:

* History of serious disease.
* History of serious reaction following administration of vaccine or hypersensitivity to vaccine components.
* Known or suspected impairment/alteration of immune function.
* Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination.

For additional entry criteria, please refer to protocol.
Effectiveness of a Natural Ingredient on Obesity

randomized, placebo-controlled clinical trial, with two parallel branches whose objective is to evaluate the efficacy of the product investigated on blood pressure and fat mass of subjects without pharmacotherapy.

The subjects that meet the selection criteria will make a total of five visits to the research laboratory and will carry out the pre-established tests in the protocol. Subsequently, a statistical analysis will be carried out with the variables measured in the study to obtain results.

Eligibility Criteria:
Inclusion Criteria:

* Subjects of both sexes with age between 18-65 years.
* Subjects with a body mass index greater than 25 and less than 35.
* Volunteers capable of understanding the clinical study and willing to comply with the procedures and requirements of the study.

Exclusion Criteria:

* Subjects under treatment that may affect body weight.
* Subjects with acute diseases.
* Volunteers with a history or presence of chronic pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunological, dermatological, urological, neurological, psychiatric, cardiovascular or pathology or malignant tumor disease.
* Subjects undergoing major surgery in the last 3 months.
* Subjects who quit smoking in the last 6 months or who intend to quit during the study.
* Subjects with allergies or eating disorders.
* Volunteers who are participating in another study that includes blood draws or dietary intervention.
* Pregnant or breastfeeding woman.
* Subjects whose condition does not make them eligible for the study, according to the researcher.
Optimalisation of the Treatment of Acute Neonatal Hyperammonaemia

Acute neonatal hyperammonemia is associated with poor neurological outcomes and high mortality. A user-friendly and widely applicable algorithm - based on kinetics - to tailor the treatment of acute neonatal hyperammonemia. A single compartmental model was calibrated assuming a distribution volume equal to the patient's total body water (V), as calculated using Wells' formula, and dialyzer clearance as derived from the measured ammonia time-concentration curves during 11 dialysis sessions in four patients (3.2 +/- 0.4 kg). Based on these kinetic simulations, dialysis protocols could be derived for clinical use with different body weights, start concentrations, dialysis machines/dialyzers and dialysis settings (e.g., blood flow QB). By a single measurement of ammonia concentration at the dialyzer inlet and outlet, dialyzer clearance (K) can be calculated as K = QB\[(Cinlet - Coutlet)/Cinlet\]. The time (T) needed to decrease the ammonia concentration from a predialysis start concentration Cstart to a desired target concentration Ctarget is then equal to T = (-V/K)LN(Ctarget/Cstart). By implementing these formulae in a simple spreadsheet, medical staff can draw an institution-specific flowchart for patient-tailored treatment of hyperammonemia.

The aim of this study is to validate these formula with a prospective study.


Eligibility Criteria:
Inclusion Criteria:

* severe acute neonatal hyperammonaemia for which acute hemodialysis is indicated
* inborn error of metabolism
* below 1 year of age

Exclusion Criteria:

* older than 1 year