cyrilzakka/clinical-trials huggingface dataset:
ALLEVIATE Trial - A Phase 3 Trial in Subjects With Allergic Conjunctivitis

A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Clinical Trial to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solutions in Subjects with Acute Allergic Conjunctivitis


Eligibility Criteria:
Inclusion Criteria:

* be at least 18 years of age of either gender and any race
* have a positive history of ocular allergies and a positive skin test reaction to a seasonal allergen (grasses, ragweed, and/or trees) as confirmed by an allergic skin test at the Screening Visit or within the past 24 months;
* have a calculated visual acuity of 0.7 logMAR or better in each eye as measured using an ETDRS chart

Exclusion Criteria:

* have known contraindications or sensitivities to the use of the investigational product or any of its components
* have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters (including but not limited to narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium or a diagnosis of dry eye)
* have had ocular surgical intervention within three (3) months prior to Visit 1 or during the trial and/or a history of refractive surgery six (6) months prior to Visit 1 or have ocular or systemic surgery planned during the study or within 30 days after
* have a known history of retinal detachment, diabetic retinopathy, or active retinal disease
* have the presence of an active ocular infection (bacterial, viral or fungal) or positive history of an ocular herpetic infection at any visit
* be a female who is currently pregnant, planning a pregnancy, lactating, not using a medically acceptable form of birth control throughout the trial duration, or has a positive urine pregnancy test at Visit 1
Neoadjuvant Chemotherapy Combined With Cetuximab for EGFR Wild Type Locally Advanced Rectal Cancer

A number of pilot studies had shown high rate of complete resection after neoadjuvant chemotherapy alone for local advanced rectal cancer(LARC), but they did not increase the ratio of pathological complete response (pCR) which was associated with improvement of overall survival (OS). On the other hand,some clinical trials show that triple active cytotoxic agents (Fluorouracil, Oxaliplatin, Irinotecan, FOLFOXIRI) combined with cetuximab for EGFR wild type metastatic colorectal cancer had more effective than double agents.Therefore,a hypothesis is the FOLFOXIRI+Cetuximab as the neoadjuvant chemotherapy regimen might improve the patient's ratio of pCR.

This is a multicenter, phase II trial to assess the efficacy and safety of triplet regimen (FOLFOXIRI) combined with cetuximab for patients with EGFR wild type LARC. After 4 cycles of FOLFOXIRI+cetuximab and 2 weeks later, the patients will be evaluated by senior radiologist, oncologist and surgeon through pelvic MRI, CT and Positron Emission Computed Tomography (PET-CT). The patients will go to surgery (TME) if the tumor response is good enough to have complete resection under the decision of the multidisciplinary team (MDT),otherwise, the patients will receive pelvic radiotherapy(45Grey/25Fraction and 5.4Grey/3Fraction boost to the tumor bed) combined with capecitabine(625 mg/m²,bid po,d1-5,qw), and additional four cycles of modified FOLFOX6 (mFOLFOX6) or Oxaliplatin 135mg/m²plus Capecitabine 1.0/m², bid po(XELOX) of each 3 weeks cycle for 2 cycles chemotherapy before TME. All patients will receive 6-8 cycles of mFOLFOX6 or 4-5 cycles XELOX as adjuvant chemotherapy after TME.

FOLFOXIRI+Cetuximab Irinotecan 165 mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 2800 mg/m² cont. inf. 46h + Cetuximab 500 mg/m²,all on day 1 of each 2 weeks cycle for 4-6 cycles,

Other Names:

CPT11，CAMPTO Eloxatin Xelod Erbitux

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 to 75 years at diagnosis
2. Diagnosis of rectal adenocarcinoma
3. ECOG status: 0～1
4. Clinical stage II (T3-4, N0) or stage III (T1-4, N1-2)
5. Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment:

1),Leukocytes ≥ 3.0 x109/ L, 2),Absolute neutrophil count (ANC) ≥ 1.5 x109/ L 3),Platelet count ≥ 100 x109/ L, 4),Hemoglobin (Hb) ≥ 9g/ dL. 5),Total bilirubin ≤1.5 x the upper limit of normal (ULN). 6),Alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) ≤ 3 x ULN. 7),Serum creatinine ≤ 1.5 x the ULN. 8),Signed informed consent;

Exclusion Criteria:

1. Patient had received pelvic radiotherapy;
2. Patient had received systemic chemotherapy
3. Pregnant and Nursing women
4. Had metastatic disease
5. Uncontrolled co-morbid illnesses or other concurrent disease
6. Patient had second malignant disease within 5 years
7. Patients refused to signed informed consent.
Efficacy of Behavioral Therapy and Exercise in Gestational Diabetes Mellitus (GDM)

The purpose of the study is to test whether four lifestyle intervention programs (diet alone; diet and behavioral therapy, diet and exercise, diet and behavioral therapy and exercise), delivered to women with GDM during 24-26 weeks of gestational age will help women to improve their metabolic pattern, and decrease the incidence of adverse maternal and neonatal outcomes.

Women with gestational diabetes (GDM) are at increased risk of adverse pregnancy and neonatal outcomes. It is estimated that most women diagnosed with GDM can achieve targeted glycemic goals with nutrition therapy alone. A moderate exercise is recommended to lower serum glucose and to improve insulin sensitivity. Despite this, few reports examine the effect of exercise on glucose intolerance during pregnancy. Furthermore, no trial on the efficacy of behavioral treatment in women with GDM is available.

The purpose of the study is to test whether four lifestyle intervention programs (diet alone; diet and behavioral therapy, diet and exercise, diet and behavioral therapy and exercise), delivered to women with GDM during 24-26 weeks of gestational age will help women to improve their metabolic pattern, and decrease the incidence of adverse maternal and neonatal outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age between 24 and 26 weeks
* Diagnosis of GDM at the 75g oral glucose tolerance test (OGTT)
* Singleton pregnancy

Exclusion Criteria:

* Body mass index \> 40 or \< 12kg/m2
* Any known diseases (pre-existing diabetes mellitus, cardiovascular diseases, liver/kidney diseases, cancers, arterial hypertension)
* Patients on any drugs
Does Cultivating Self-compassion Improve Resilience to Criticism and Improve Mental Health in Adults With ADHD?

This study aims to investigate the effect that increasing levels of self-compassion may have on levels of perceived criticism, self-criticism, and mental health of adults with ADHD. A secondary aim of the study is to capture how feasible using an online self-guided self-compassion practice maybe with people with ADHD.

Research Questions

1. Does a short self-guided self-compassion intervention increase levels of state and/or trait self-compassion in adults with ADHD over time?
2. Are changes in state and/or trait self-compassion associated with changes in levels of self-criticism or perceived criticism?
3. Are changes in state and/or trait self-compassion associated with improvements in mental health?
4. Are changes in mental health mediated by changes in self-criticism or perceived criticism?


Eligibility Criteria:
Inclusion Criteria:

* Self-report a formal diagnosis of ADHD
* Scores on the Adult ADHD Self Report Questionnaire (ASRS) meet the clinical cut-off.
* No previous engagement with self-compassion interventions/practice

Exclusion Criteria:

* No previous experiences of trauma.
* No PTSD
* No personality disorder
Impact of Caregiver Beliefs on Adherence to Antipsychotic Medications in Patients With Schizophrenia

Only one third of patients with schizophrenia are observant to their treatment knowing that the lack of adherence to treatment is one of the most important predictors of relapse.

Recent work shows that the erroneous or negative beliefs of patients with schizophrenia regarding antipsychotic treatment are associated with poor compliance.

The hypothesis is that negative beliefs about the antipsychotic treatment of caregivers of patients with schizophrenia may be associated with a higher risk of poor compliance compared to caregivers with positive beliefs about treatment.

The primary purpose is to explore the correlation between caregiver beliefs about treatment and patient compliance, taking into account the level of caregiver-patient link.

Non-interventional cross-sectional exploratory study with a single visit for patients with schizophrenia and their caregivers, who agreed to participate in the protocol.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old
* With a diagnosis of schizophrenia according to DSM-5 criteria
* Accompanied by his main caregiver, who will be able to complete the questionnaires after having signed the information form.
* Treated with one or more antipsychotics.
* Able to complete the questionnaires related to the protocol
* Having agreed to sign the information form.

Exclusion Criteria:

* Not understanding French, unable to answer questions linguistically
* Presenting an organic pathology and / or cognitive deterioration likely to hinder a good understanding of the interview
* Having already participated in the study
* presenting disorders related to the use of substances of severe intensity (such as acute intoxication, withdrawal syndrome or any state of delirium)
The Effect of (L-PRF) Membrane in The Treatment of Gingival Recession

evaluation of the use of L-PRF membrane with coronally repositioned flap in treatment of localized gingival recession (Class I \& II) in comparison with the use of connective tissue graft

Twenty patients, who are candidates for gingival recession coverage, will participate in this prospective clinical trial.

Group 1(10 patients) :

Coronally repositioned flap will be done and L PRF membrane will be placed into the tissues

Group 2 (Control group)(10 patients) :

Coronally repositioned flap will be done with sub epithelial connective tissue Parameters

* Clinical evaluation of percentage of root coverage and keratinized tissue width
* Esthetic outcome evaluation Will be done using the root coverage esthetic score (Cairo et al. 2009) that include

Both evaluations will be done at 3, 6 and 9 months

Eligibility Criteria:
Inclusion Criteria:

* Systemically free patients (American Society of Anesthesiologists I; ASA I).
* Age range (20 -40) years.
* Good compliance with the plaque control instructions following initial therapy.
* Patients diagnosed with Miller class I or II in anterior and premolar teeth
* Availability for follow up and maintenance program.

Exclusion Criteria:

* Patient suffering from periodontitis
* Presence of smoking habit.
* Presence of occlusion interference.
* Pregnant and lactating females.
* Vulnerable group of patients (handicapped, mentally retarded and prisoners).
Vital Signs and Pain During Insertion of IUD

Cross-sectional cohort study to evaluating pain and vital signs variations (blood pressure and radial pulse) during the placement of the intrauterine device.

The intrauterine device (IUD), which is one of the most effective and safe contraceptives is still little used by women. It is considered a long action reversible contraception (LARC). Among the many reasons for this resistance stands the fear of pain, the complications that can occur during the insertion.

Objective: To evaluate the intensity of pain on outpatient insertion of IUD. In addition to evaluating changes in vital signs and detect which are the factors associated with pain on outpatient insertion of IUD. Methods: Cross Sectional Retrospective study of 285 procedures of outpatient insertion of IUD.

Inclusion criteria were age older than 18 years, cervical cytology without abnormalities, classification for Category 1 or 2 of the WHO eligibility criteria for IUD. The criteria for non inclusion were patients with cardiac arrhythmias and gynecological disorders. The insertions of IUD were conducted on an outpatient basis without the use of painkillers.

Evaluation of vital signs ( blood pressure and radial pulse) was performed pre and five minutes after the procedure. The pain assessment was performed using the scale visual analog (VAS), five minutes after the procedure.Correlations of the pain's score with clinical factors as age, parity, BMI, hysterometry, previous vaginal delivery were also performed.

Eligibility Criteria:
Inclusion Criteria:

* age older than 18 years
* cytology without abnormalities
* classification for Category 1 or 2 of the WHO eligibility criteria for IUD / IUS.

Exclusion Criteria:

* patients with cardiac arrhythmias
* gynecological disorders
Encore Revelation Hip Stem

The purpose of this study is to obtain long-term (10+ yrs) clinical and patient outcomes data on patients who received the Revelation Hip Stem prior to 2002.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have received the Revelation™ Hip Stem as part of a total hip arthroplasty prior to 2002.
* Surgery must have been a primary total hip replacement
* Subject must have received only one primary hip replacement per hospitalization
* Subject must have had a diagnosis of inflammatory tissue disorder, osteoarthritis, post-traumatic arthritis/secondary arthritis or avascular necrosis
* Subject must be willing and able to sign the informed consent document

Exclusion Criteria:

* Subject must not have had any previous hip implants (hemi or total joint)
* Subject has a mental condition that may interfere with the ability to give an informed consent (i.e., severe mental retardation such that the subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
* Subject is a prisoner
* Subject is pregnant
Quality of Life During a Twin Pregnancy

Quality of life has recently appeared as a component of health. Pregnancy has an impact on the quality of life of the parturient, whether through physical or psychological changes.

It is common to think that quality of life is altered in the context of a twin pregnancy, but this has never been scientifically demonstrated.

The hypothesis is to observe a decrease in the quality of life of pregnant women with twins at the end of pregnancy, in particular in case of a pregnancy-related pathology.


Eligibility Criteria:
Inclusion Criteria:

* woman over 18
* ongoing twin pregnancy (2 live fetuses)
* pregnancy \<15 weeks (weeks of gestation) completed
* patient with follow-up at the Hôpital Femme Mère Enfant
* person having expressed her non-opposition

Exclusion Criteria:

* inability to understand the information given and the questionnaire
* person deprived of liberty, under guardianship
Prophylactic Peptide Vaccine in Advanced ALK+ NSCLC

The purpose of this study is to evaluate the safety of a cancer peptide vaccine to prevent or delay acquired resistance in advanced ALK+ lung cancer patients currently on ALK targeted therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed diagnosis of stage IV NSCLC (or recurrent NSCLC not a candidate for definitive multimodality therapy)
2. Documented ALK rearrangement as detected by: (1) fluorescence in situ hybridization (FISH), (2) immuno-histochemistry (IHC), (3) tissue next-generation sequencing (NGS), or (4) circulating tumor DNA (ctDNA) NGS
3. Ongoing treatment with crizotinib, ceritinib, alectinib, brigatinib, or lorlatinib with at least stable disease ≥ 4 months
4. No known presence of the specific ALK acquired resistance alterations targeted by the study vaccine
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
6. Males or females at least 18 years old

Exclusion Criteria:

1. Known additional malignancy that is progressing or has required active treatment within the past 3 years. Adequately resected non-melanoma skin cancer, curatively treated in-situ disease, and other solid tumors treated with potentially curative therapy are allowed.
2. Cytotoxic chemotherapy within 14 days of first dose of study vaccine or concurrent with study vaccine
3. Anti-neoplastic immunotherapy within 28 days of first dose of study vaccine or concurrent with study vaccine
4. Systemic immune suppression:

   1. Use of chronic oral or systemic steroid medication (topical or inhalational steroids are permitted)
   2. Other clinically relevant systemic immune suppression
5. Symptomatic central nervous system (CNS) metastasis. Asymptomatic CNS disease requiring increasing dose of corticosteroids within 7 days prior to study enrollment is also not permitted
6. Current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression are allowed
A Study to Determine the Effect of 500 mg Oral Dose of KD025 in Healthy Male and Post-menopausal Female Subjects

The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of 500 mg oral BID dose of KD025 in healthy male and post-menopausal female participants.

Up to approximately 58 days including safety follow up period of 30 days after participant is treated with the last dose of study drug.

Eligibility Criteria:
Inclusion Criteria:

* Healthy participants between the ages of 18 and 55 years, inclusive.
* Female who is not of reproductive potential.
* Able to provide written informed consent prior to the performance of any study specific procedures.
* Body mass index (BMI) range of 19-30 kilogram per square meter (kg/m2), inclusive.

Exclusion Criteria:

* Past or present disease that is judged by the investigator to have the potential to interfere with the study procedures, compromise safety, or affect the PK evaluations.
* Known sensitivity to Rho-associated coiled-coil containing serine/threonine protein kinases (ROCK2) inhibitor agents or to any of the constituents of the KD025 formulation.

The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
Zoledronic Acid in the Prevention of Bone Loss in Postmenopausal Women With Osteopenia, 45 Years of Age and Older

Osteoporosis prevention is important in patients with osteopenia (low bone density). This study will test the safety and efficacy of zoledronic acid in patients diagnosed with osteopenia.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal
* Greater than or equal to 45 years of age
* Osteopenia (lumbar spine bone mineral density \[BMD\] T-score between -1.0 and -2.5, and BMD T-score \> -2.5 at the femoral neck)

Exclusion Criteria:

* Patients with more than one Grade 1 vertebral fracture (as per Genant method; patients with one Grade 1 vertebral fracture are eligible to participate)
* Patients with any Grade 2 or 3 vertebral fracture (as per Genant method)
* Patients with 25-(OH) vitamin D levels less than 15 ng/mL prior to randomization

Other protocol-defined inclusion/exclusion criteria may apply.
Clinical Trial of Vildagliptin in Early Parkinson's Disease

Investigating the efficacy of Vildagliptin in delaying the progression of Parkinson's disease.

Exploring the effectiveness and safety of vildagliptin in delaying the progression of Parkinson's disease.

Eligibility Criteria:
Inclusion Criteria:

* 1: Patients aged 40 to 75 years who were diagnosed with Parkinson's disease according to the UK Brain Bank criteria within the past three years.

  2: Participants must have received an optimized and stable dopaminergic medication regimen (dopamine agonists, levodopa, or monoamine oxidase B \[MAOB\] inhibitors, or combinations of these medications) determined by the study site investigators for at least one month prior to the baseline initiation of the trial drug, with the expectation that the participants will be able to continue this regimen for at least six months.

  3: Sign the informed consent form

Exclusion Criteria:

* 1: The key exclusion criterion is a score of at least 3 on the Hoehn and Yahr scale (ranging from 1 to 5, with higher scores indicating more severe disability), which indicates that Parkinson's disease has led to at least mild to moderate bilateral motor involvement due to some postural instability.

  2: Presence of motor fluctuations or motor complications (or both).

  3: The presence of severe psychiatric disorders, such as severe (treatment-resistant) anxiety, depression, or schizophrenia, that cannot be effectively controlled by medication.

  4: Atypical or secondary Parkinsonism

  5: A score of 18 or lower on the Montreal Cognitive Assessment (MoCA) (range: 0 to 30, with a score of 26 or higher indicating normal cognitive function), indicating at least mild cognitive impairment.

  6: Diabetes mellitus (Type 1 and Type 2), as well as prior treatment with dipeptidyl peptidase-4 (DPP-4) inhibitors or glucagon-like peptide-1 (GLP-1) receptor agonists.

  7: Individuals with severe renal impairment (creatinine clearance \<30 ml/min), active liver disease, history of drug or alcohol abuse, idiopathic pancreatitis, chronic pancreatitis, or a history of pancreatectomy.

  8: Individuals with a body mass index (weight in kilograms divided by the square of height in meters) less than 18.5, or those with a weight change exceeding 5 kilograms within the 3 months prior to screening.

  9: Currently participating in other relevant clinical trials involving pharmacological or surgical treatments.

  10: Other situations where the investigator believes that the subject is unable to participate in or cooperate with the entire assessment process of the clinical trial.
Phase 1/2 Study of Enzastaurin in Newly Diagnosed Glioblastoma Multiforme (GBM) and Gliosarcoma (GS) Patients

There will be 2 phases in this study. Patients will either be enrolled to the first phase or to the second phase, depending upon when they enroll into the study.

The first phase of this study is done to evaluate the safety of enzastaurin in patients. This is done by gradually increasing the dose of the drug in small groups of patients and watching closely for side effects.

In the second phase of the study, the dose determined to be safe will be used with temozolomide during and following radiation therapy to see if the combination can help patients with brain tumors live longer.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have a histologically confirmed diagnosis of intracranial glioblastoma multiforme (GBM) or gliosarcoma (GS).
* Biopsy or resection must have been performed no more than 5 weeks prior to treatment.
* An MRI or CT scan must be obtained within 14 days prior to treatment.
* Patients must not have received prior drug therapy for brain tumors.
* Patients must have adequate organ function demonstrated by lab tests within 14 days prior to treatment.

Exclusion Criteria:

* Patients will be excluded if unable to swallow tablets.
* Patients will be excluded if unable to discontinue use of enzyme inducing antiepileptic drugs or have been off of these agents less than 2 weeks prior to treatment (i.e. phenytoin (Dilantin®), carbamazepine, etc.).
* Patients will be excluded if have active infection.
* Patients will be excluded if have a significant medical illness that, in the investigator's opinion, cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy.
* Patients will be excluded if they have concurrent therapy with an anticoagulant. If the patient requires anticoagulant therapy after starting treatment, the patient may remain on study but should be monitored carefully.