cyrilzakka/clinical-trials huggingface dataset:
Women Overcoming and Managing Adversity Now (WOMAN) Study

The goal of the study is to evaluate the efficacy of a two therapeutic models designed to enhance women's skills for managing reactive emotions in their current lives as well as to educate them about how using these skills can enhance their personal effectiveness and help them to gain control of post-traumatic stress reactions. The interventions adaptations of a manualized psychotherapy that has shown promise with adults with complex Posttraumatic Stress Disorder (PTSD) (Trauma Affect Regulation: Guide for Education and Therapy; TARGET) compared to a supportive group therapy (SGT) that has been found to have modest benefits with women survivors of childhood abuse (Wallis, 2002).

In a randomized treatment design, we will compare offenders receiving skills-based intervention (TARGET) and those receiving a similar amount of supportive intervention (SGT). We will assess the efficacy of treatment by determining if those receiving the TARGET skills training show an improvement in functionality, as compared to those receiving only supportive intervention. We will measure this by analyzing PTSD symptoms, psychological distress, psychosocial functioning, and social/legal adjustment and services using structured interviews, self-report questionnaires and qualitative questions. Questionnaires are listed below in the outcome measure's section. We will collect follow-up data on program participants who successfully finish the program at York. For those offenders who discharge into the community directly from York, we will collect follow-up data on program participants through CDOC Parole or Probation records. Statistically we anticipate a medium effect size difference between the treatment conditions.

Eligibility Criteria:
Inclusion Criteria:

* Incarcerated, release not expected within 6 months
* Probable PTSD on PC-PTSD screen and PTSD by CAPS interview

Exclusion Criteria

* Clinically significant psychopathy (PCL-SV severe range)
* Unable to comprehend study materials (Mini-Mental Status Exam Orientation, Attention, and Recall sections total score \<15).
Efficacy and Safety of ACH24 in the Treatment of Vitiligo

This is a multicenter clinical trial, phase III, randomized, placebo-controlled, parallel group, enroll 94 patients, to assess the efficacy of ACH24 in the repigmentation of achromatic areas in patients with vitiligo.

To evaluate the efficacy and safety of ACH24 compared to placebo in the treatment of vitiligo.The present study aims to register a new product in the country, the ACH24 for the treatment of vitiligo.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes, aged between 18 and 65 years, remaining the feasibility of a legal guardian in accordance with need, able to understand and provide written informed consent and able to allow compliance at the treatment and the requirements of the protocol;
* Presence of generalized vitiligo;
* Able to comprehend and willing to provide written informed consent in accordance with institutional and regulatory guidelines.

Exclusion Criteria:

* Patients with:

  * Inflammatory diseases;
  * Alopecia Areata;
  * Diabetes Type I;
  * Asthma;
  * Collagen disease;
  * Atopic dermatitis;
  * Psoriasis;
  * Autoimmune thyroid disease (self reported). ¬ Thyroid problems (represents 15% of people with vitiligo), exclude only those who need to do treatment with corticosteroid or immunosuppressive.
* Women of childbearing age who had tested positive for pregnancy, or who do not use acceptable contraceptive method, or do not agree to practice reliable contraception during the study;
* Woman in pregnancy or lactation period;
* Known allergic reaction against the phytomedicine as assessed by medical history;
* Patient that is taking any prohibited medication (Item 9.3);
* Participation in last one year of clinical protocols, unless it can be direct benefit to subject;
* Any finding of clinical observation (anamnesis and physical exam) laboratory abnormality (eg, blood glucose, blood count), disease (for example, liver, cardiovascular system, lung) or therapy that, in opinion of the investigator, may endanger the subject or interfere with the endpoints of study.
A Study to Assess Disease Activity and Safety of Lutikizumab in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa

Hidradenitis suppurativa (HS) is a chronic and often painful inflammatory skin disease which includes the forming of lumps, abscesses and scars in areas of the skin such as under the breasts, under armpits, inner thighs, groin and buttocks. This study will compare lutikizumab versus placebo for the treatment of adult and adolescent participants with moderate to severe HS .

Lutikizumab is an investigational drug being developed for the treatment of HS. During Period 1 of the study, participants will placed in 1 of 2 groups called treatment arms. There is a 1 in 2 chance that participants will be assigned to placebo. Around 1280 adult and adolescent participants with moderate to severe HS will be enrolled in the study at approximately 275 sites world wide. During Period 2, participants that were part of the lutikizumab treatment arm in Period 1 will be re-randomized to 1 of 2 lutikizumab treatment arms. Participants that were part of the Placebo arm in Period 1 will start Period 2 with an initiation of lutikizumab followed by a re-randomization to 1 of 2 lutikizumab treatment arms.

In Period 1, participants will receive subcutaneous injections of lutikizumab or placebo every week for 16 weeks. In Period 2, participants that were randomized to lutikizumab in Period 1 will receive subcutaneous injections of lutikizumab every week or every other week for 36-weeks. Participants that were randomized to the placebo arm in Period 1 will receive subcutaneous injections of lutikizumab every week for 16 weeks, then either every week or every other week for 20 weeks

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires and diaries.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of moderate to severe HS for at least 6 months prior to Baseline as determined by the investigator (i.e., through medical history and interview of participant).
* Total abscess and inflammatory nodule (AN) count of ≥ 5 at Baseline
* Hidradenitis suppurativa (HS) lesions present in at least two distinct anatomic areas at Baseline.
* At least 1 anatomic area of HS involvement characterized as Hurley Stage II or higher at Baseline.

Exclusion Criteria:

* Any evidence of Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
* Confirmed positive anti-HIV antibody (HIV Ab) test.
* Evidence of active tuberculosis or meets tuberculosis exclusionary parameter
Patient-ventilator Interaction During NIV With Helmet: a Comparison Between PSV and the New NIV NPS Software

The goal of this clinical trial is to evaluate if neural pressure support ventilation is able to improve patient-ventilator synchrony, in ICU patients undergoing non-invasive ventilation (NIV). The main question it aims to answer is:

• Is neural pressure support ventilation better than the pressure support ventilation with respect to patient-ventilator synchrony during helmet NIV?

Researchers will compare neural pressure support ventilation versus pressure support ventilation (Gold standard assisted mode in Europe) to see if the new mode improve patient-ventilator synchrony.

Non-Invasive Ventilation (NIV) has found many different uses in clinical settings, shortening intubation times and preventing orotracheal intubation. NIV success is highly affected by patient comfort and patient-ventilator synchrony. The helmet is one of the most comfortable interfaces, even if synchrony is low due to dead space. The use of Neurally Adjusted Ventilatory Assist (NAVA), in which the Electrical Activity of the Diaphragm (EAdi) drives the ventilator, has shown improvement in comfort and synchrony but still some limitation with helmet, due to the long pressurization time. Pressure-Support Ventilation (PSV) is still the most used and diffused assisted mode in Europe due to its simplicity and effectiveness in helmet-NIV. The aim of this study is to test a new ventilation software called Neural Pressure Support Ventilation (nPSV), which merges the rapid pressurization of PSV along with the EAdi trigger, onto a population of 24 critical care patients ventilated with a helmet NIV.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18aa)
* Non Invasive Ventilation with helmet
* NG tubing for clinical use in position
* Invasive arterial monitoring for clinical use in position

Exclusion Criteria:

* Unable to express consent
* Expected NIV \< 24hrs
* Gastric-esophageal surgery in the preceding 12 months
* Upper-GI bleeding in the last 30 days
* History of esophageal varices
* Recent trauma or facial surgery
* Haemodynamic instability even a after liquid infusion (need of at least dopamine \>5 γ/kg/min or norepinephrine \>0.1 γ/kg min to obtain systolic pressure \>90 mmHg)
* Core temperature \>30 C°
* Coagulation disorders (INR \> 1.5 and/or aPTT \>44 sec)
Effects of Propofol-Induced Anaesthesia on the ST-segment of the ECG

The purpose of this study is to assess the effect of propofol induced general anaesthesia on the ST-segment of the electrocardiogram. This will be realised by retrospectively analysing the ECG-recordings from adult patients undergoing any treatment at the Catheterisation Laboratory. The ST-segment and other ECG measurements from induction of anaesthesia up to 20 minutes later, will be assessed and compared to the baseline values of the respective segments acquired before injecting propofol. It is essential in this study to exclude any patients burdened with the diagnosis, suspicion or family history of Brugada syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Induction of anaesthesia with propofol
* Monitored anaesthesia in the CathLab of the Universitair Ziekenhuis Brussel

Exclusion Criteria:

* Brugada Syndrome or family history of Brugada syndrome
* Paediatric population (age \<18)
* Patients who did not receive propofol during the procedure
* Patients who presented with fever (central core temperature \>38,0°C)
p16+ Oropharyngeal Cancer Radiation Optimization Trial Reducing Elective Treatment Volumes (PROTEcT)

Volume and Dose De-Intensified Radiotherapy for p16+ Squamous Cell Carcinoma of the Oropharynx: A Multi-Centre, Single Arm Prospective Cohort Study

De-intensified radiotherapy to a dose of 60 Gy to the primary tumour and involved lymph nodes and 54 Gy to subclinical regions at risk in 30 fractions. Omission of level IB lymph node regions from the elective nodal volumes.

Chemotherapy will be administered as per standard of care, consisting of concurrent cisplatin (high-dose: 100mg/m2 IV every 3 weeks or low-dose: 40mg/m2 IV every week) or cetuximab (at the discretion of medical oncologist).

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older

  * Provide informed consent
  * ECOG performance status 0-2
  * Histologically confirmed squamous cell carcinoma
  * p16-positive tumor, as determined by immunohistochemistry at local hospital
  * Primary tumor site in the oropharynx (includes tonsil, soft palate, base of tongue, walls of oropharynx)
  * Eligible for curative intent treatment.
  * Smokers and non-smokers are included
  * Tumor stage (AJCC 8th edition): T1 to T3
  * Nodal stage (AJCC 8th edition): N1 to N2
  * Adequate bone marrow function, hepatic, and renal function for chemotherapy (Hemoglobin \> 80 g/L; Absolute neutrophil count \>1.5x109 /L, platelets \> 100 x109/L; Bilirubin \< 35 umol/L; AST or ALT \< 3 x the upper limit of normal; serum creatinine \< 130 umol/L or creatinine clearance ≥ 50 ml/min)

Exclusion Criteria:

* - Clinical, radiologic or pathologic Ib nodal involvement (including invasion into submandibular gland)
* Primary cancer with extension and involvement of the oral cavity
* Metastatic disease
* Contraindications to radiotherapy or chemotherapy
* Prior history of head and neck cancer within 5 years
* Prior head and neck radiation at any time
* Inability to attend full course of radiotherapy or follow-up visits
* Pregnant or lactating women
Ultrasound-Guided Costoclavicular Block in Patients With a BMI > 30

The Researchers are trying to determine if Costoclavicular brachial plexus block (CCBPB) can be successfully performed in patients with a body mass index greater than thirty.


Eligibility Criteria:
Inclusion Criteria:

18 to 80 years old, with American Society of Anesthesiologists physical status I to IV, undergoing elective hand or forearm surgery under a BPB will be enrolled for this study.

Exclusion Criteria:

Patient's refusal, American Society of Anesthesiologist physical status greater than IV, pregnancy, neuromuscular disease, prior surgery on the intraclavicular fossa, nerve injury or neurological disorders, bleeding tendency or evidence of coagulopathy, history of allergy to local anesthetic drugs, skin infection at the site of needle insertion, or contraindication to regional anesthesia.
Determinants of Intensity of Care of Lung Cancer Patients With Organ Failure

Investigators will evaluate determinants of the patients' care type : palliative, medical or intensive care. The place of patient or family on care's decision will be noticed. Investigators will evaluate 3 month-survival and patients' feelings (visit with a psychologist) according to type of care they benefited.

Two hundred patients have to be enrolled in 2 years in the Grenoble Teaching Hospital and in the Saint Louis hospital in Paris between November 2010 and November 2012. Each lung cancer patient with at least one organ failure, admitted in emergency, thoracic oncology or directly in ICU will be included.

The objectives are to identify patients' characteristics associated with proposition for intensive care unit admission and those associated with the decision of intensive care unit admission.

Eligibility Criteria:
Inclusion Criteria:

* lung cancer
* Organ failure

Exclusion Criteria:

-
Prospective Study Evaluating the Medullary Thyroid Cancer Management's Care Using PET F-DOPA in Patients With a High Level of Postoperative Residual Thyrocalcitonin

The aim of the trial is to study a radiating diagnosis agent used in post surgery when the biological assessment highlighted a residual disease.

This is an inter-regional multicentric, prospective study evaluating the benefit of PET F-DOPA imaging in involved node detection compared to standard imaging assessment in patient with medullary thyroid cancer.

The purpose of the study is to evaluate the impact and performance of a new PET / CT (computerized tomography ) tracer targeting dopamine receptor in patient with residual ganglionar biological disease after initial surgery of medullary thyroid cancer compared to standard imaging.

Obtained data will be compared to the "gold standard" based on :

* nodes cytology when they could be punctured
* histology when a new surgery will be recommended
* surveillance when the 2 first cases will be not applicable (imaging monitoring, evolution of thyrocalcitonin)


Eligibility Criteria:
Inclusion Criteria:

1. Age \> or = 18 years.
2. Patient with medullary thyroid cancer (sporadic or hereditary form).
3. Patient treated by total thyroidectomy with uni or bi-lateral lymph node dissection (in the central and/or lateral neck compartment).
4. Patient with elevated thyrocalcitonin rate \> or = 150 pg/ml assessed within 6 weeks or more after surgery.
5. Patient with standard imaging assessment performed during 3 months before PET 18-FDOPA.
6. Standard imaging assessment including at least a cervical ultra-sound, a cervico-thoracic CT-scan and/or a cervico-thoraco-abdomino-pelvic CT-scan and a liver MRI.
7. Patient able to be followed at least 6 months after PET 18-FDOPA.
8. If women are breastfeeding, nursing should be discontinued during 24 hours after PET 18-FDOPA.
9. Patient must provide written informed consent prior to any specific procedure or assessment.
10. Patient must be affiliated to the French Social Security System.

Exclusion Criteria:

1. Pregnant patient.
2. Post-operative radiotherapy initiated before PET 18-FDOPA.
3. Patient with PET 18-FDG performed within 24 hours before PET 18-FDOPA.
4. Participation in any other clinical trial for therapeutic use.
5. Patient with PET / CT-scan exam contra-indication.
6. Any serious and/or unstable pre-existing psychological, familial, geographic or social condition that could interfere with medical follow-up and compliance to study procedures.
7. Patient protected by law.
First-In-Human Study of STX-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations

Study STX-721-101 is an open label, Phase 1/2 study evaluating the safety, tolerability, pharmacokinetic (PK) exposure, and preliminary antitumor activity of STX-721 in participants with non-small cell lung cancer (NSCLC) carrying EGFR/HER2 exon 20 insertion (ex20ins) mutations.


Eligibility Criteria:
Key Inclusion Criteria:

1. Has histologically- or cytologically confirmed diagnosis of NSCLC Stage IIIB/C or IV not eligible for curative intent surgery or chemoradiation
2. Part 1: Tumor tissue EGFR or HER2 exon 20 insertion mutations confirmed by qualified local laboratories. Parts 2 and 3: EGFR exon 20 insertion mutations confirmed by qualified local laboratories
3. Part 1: Has received all approved therapies for advanced or metastatic NSCLC or is ineligible. Part 2 and Part 3: Has received at least 1, but not more than 2, prior lines of treatment for advanced or metastatic NSCLC, 1 of which must be platinum-based chemotherapy unless contraindicated
4. Has documented tumor progression (based on radiological imaging)
5. Has new or recent tumor biopsy (collected at screening, if feasible) or archival tumor specimen collected in the past 10 years available for genomic profiling
6. Has at least one measurable tumor lesion per RECIST v1.1
7. Is ≥18 years of age at the time of signing the ICF
8. Has Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Key Exclusion Criteria:

1. Has a tumor that is known to harbor EGFR ex20ins p.H773_V774insH variant, or any EGFR kinase domain activating mutation concurrent with either a T790M and/or C797S resistance mutations
2. Has history (within ≤2 years before screening) of solid tumor or hematological malignancy that is histologically distinct from NSCLC
3. Has symptomatic brain or spinal metastases
4. Has toxicities from previous anticancer therapies that have not resolved to baseline levels or to CTCAE Grade ≤1, except for alopecia and peripheral neuropathy
5. Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., could compromise the participant's well-being) or would prevent, limit, or confound the protocol-specified assessments
Study Evaluating TheSafety And Efficacy Of PF-05212377 Or Placebo In Subjects With Alzheimer's Disease With Existing Neuropsychiatric Symptoms On Donepezil

This study will evaluate safety and efficacy of PF-05212377 in subjects with mild-to-moderate Alzheimer's Disease with existing neuropsychiatric symptoms on a stable dose of Donepezil. The 4-week run-in will minimize placebo effect. The 12-week treatment period is considered the minimum length necessary to reliably evaluate the effect PF-05212377 on cognition and and neuropsychiatric symptoms in this population. The 2-week washout will allow to monitor re-emergence of neuropsychiatric and cognitive symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of probable AD with supportive brain imaging documentation
* Have existing neuropsychiatric symptoms as defined by a score equal or greater than 10 on the NPI at screening, arising from item scores equal or greater than 2 (frequency X severity) on at least 2 domains.
* Has been on donepezil (stable dose of 5 mg or 10 mg) for at least four months, with no intent to change such for the duration of the study.

Exclusion Criteria:

* Demonstrate extreme agitation, physical aggression or violence to themselves, their caregiver, or others, and/or an inability to complete the ADAS-cog assessment at Screening.
* Have major structural brain disease other than Alzheimer's Disease
* Other severe acute or chronical medical or psychiatric condition or laboratory abnormality
Safety, Tolerability and Pharmacokinetics of SAR231893 (REGN668) in Healthy Japanese Adult Male Subjects

Primary Objective:

Assess the safety and tolerability of SAR231893 (REGN668) after ascending single subcutaneous (SC) doses in healthy Japanese adult male subjects

Secondary Objectives:

Assess the following parameters after ascending single SC doses in healthy Japanese adult male subjects

* The pharmacokinetics of SAR231893 (REGN668)
* The immunogenicity of SAR231893 (REGN668)
* Exploratory analyses of the pharmacodynamics of SAR231893 (REGN668)

Total duration of the study period per subject is 11 weeks broken down as follows:

Screening period = 2 to 21 days Treatment period = 57 days, including 1 treatment day

Eligibility Criteria:
Inclusion criteria:

* Japanese adult male subjects, between 20 and 45 years of age, inclusive.
* Body weight between 50.0 and 95.0 kg, inclusive, body mass index between 18.0 and 28.0 kg/m2, inclusive.
* Certified as healthy by a comprehensive clinical assessment.
* Having given written informed consent prior to undertaking any study-related procedure.

Exclusion criteria:

* Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.
* Any subject who cannot prohibit intensive physical activity throughout the study duration.
* Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis B core antibodies (anti-HBc Ab), anti-hepatitis C virus (anti-HCV) antibodies, human immunodeficiency virus (HIV) antigen and antibodies.
* Positive result on urine drug screen (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
* Serum alcohol level over the upper limit of normal range (ULN).
* Previous exposure to any therapeutic or investigational biological agent.

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