cyrilzakka/clinical-trials huggingface dataset:
Clinical Trial of a COX-2 Inhibitor for the Treatment of Women With Preeclampsia

Preeclampsia is a hypertensive disorder of pregnancy and a leading cause of fetal and maternal morbidity and mortality. Recent findings indicate preeclampsia is an inflammatory disorder associated with increased expression of COX-2. This study will test the hypothesis that treatment of women with a COX-2 inhibitor, celecoxib, will stop the inflammatory process and reverse symptoms of preeclampsia.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with preeclampsia between 20 - 32 weeks gestation. Preeclampsia is defined as a maternal blood pressure of \>140/90 mmHg on two readings at least 6 hours apart with proteinuria of \>300 mg/24 hours.

Exclusion Criteria:

* Exclusion criteria includes patients with known sensitivity to celecoxib; patients who have demonstrated allergic-type reactions to sulfonamides; patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Other exclusion criteria will include patients with known cardiovascular disease or risk factors for cardiovascular disease, a prior history of ulcer disease or GI bleeding, impaired renal function, or liver dysfunction. Exclusion criteria will also include concomitant use of oral corticosteroids, anticoagulants, diuretics, ACE inhibitors, aspirin, fluconazole, and lithium.
Gait Control in Parkinson Disease

Previous work has shown that a statistical property of gait characterised by long-range autocorrelation functions is altered in Parkinson disease (PD). On the other hand it has been suggested that the same property is linked to the ability in healthy humans to co-regulate the amplitude and cadence of strides towards maintaining a constant speed. Here the investigators want to better understand why it is altered in PD by measuring the transitions between gait instructed by a metronome, and gait without metronome. The experimental conditions will allow the comparisons between these transitions across PD and healthy groups of volunteers, and assess differences based on statistical and computational modelling. The link with potential freezing episodes will also be studied to assess whether the statistical determinants of gait control in this population can be used as a proxy or predictor of the occurence of freezing episodes.


Eligibility Criteria:
Inclusion Criteria:

* Patients and volunteers able to walk for 20mins and without other neurological disorders.

Exclusion Criteria:

* Patients or volunteers unable to walk for 20mins and with other neurological disorders.
A Study of the Safety and Effects of EMD 72000 in Subjects With Recurrent Ovarian Cancer

EMD 72000 is an experimental, biological drug. Studies in animals indicate that EMD 72000 blocks a factor found on the surface of many cancer cells. The factor is called epidermal growth factor receptor or EGFR. One type of cancer which frequently contains EGFR is ovarian cancer. This study will test the safety and effects of EMD 72000 in subjects with EGFR-positive recurrent ovarian cancer following standard treatment that has failed.


Eligibility Criteria:
Inclusion Criteria:

* Recurrent ovarian cancer (including primary peritoneal cancer) following treatment (e.g., doxorubicin HCL liposome, topotecan, etc.) for primary or secondary platinum-refractory disease
* Immunohistochemical evidence of tumor EGFR (HER-1) expression
* At least one measurable lesion according to the WHO criteria
* Life expectancy ≥ 12 weeks
* ECOG performance status 0-1

Exclusion Criteria:

* History of prior MAb therapy
* History of prior treatment with an EGFR (HER-1) directed therapy
* Known brain metastases
* Presence of a ≥ Grade 2 pre-existing skin disorder (alopecia is permitted)
* Known intercurrent infections or immunosuppression
* Actively infected with, or chronic carriers of HBV
* Evidence of HCV disease
* Previous diagnosis of autoimmune disease
* Known hypersensitivity to the administered drugs or any of their components
* Receipt of chemotherapy, radiation therapy, or another investigational drug within 30 days of enrollment
Root Coverage Comparing an Allograft to a Bovine Xenograft

Root coverage with acellular dermal matrix using the coronally positioned tunnel technique comparing two different donor materials

Thirty patients will be treated: 15 with a coronally positioned tunnel technique with NovaDerm® xenograft using continuous sling suture to secure both the graft and the flap (test treatment) and 15 with a coronally positioned tunnel technique with AlloDerm® allograft using continuous sling suture to secure both the graft and the flap (control treatment). Sutures used for the control group will be Maxon 5-0, 3/8 circle 13 mm needle for both the test and control groups. The coronally positioned tunnel technique was previously described by Edwards Pat Allen (E.P. Allen, Center for Advanced Dental Education, Dallas, Texas; course manual). Each patient will provide at least one Miller Class I or II facial recession defect, ≥ 3 mm. Patients will be randomly selected by a coin toss to receive either the test or control treatment. Mentor will toss the coin immediately prior to suturing. Patients will be evaluated postoperatively for a period of 4 months. The examiner will be blinded and will not be aware of the patient treatment at any time during the term of the study. Three exams for measurements will be performed per patient on total: preoperative, at week eight and 16 (4 months) postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* At least one Miller Class I or II mucogingival defect ≥ 3 mm (Miller 1985).
* The mucogingival defect must be on a non-molar tooth.
* Patients must be at least 18 years of age.

Exclusion Criteria:

* Patients with debilitating systemic or diseases that significantly affect the periodontium.
* Patients with a known allergy to any of the materials that will be used in the study, including systemic antibiotics (tetracycline and doxycycline).
* Patients requiring antibiotic prophylaxis.
* Root surface restorations at the site of recession.
* No detectable CEJ
* Patients who fail to maintain oral hygiene levels of at least 80% plaque free surfaces.
* Patients who are pregnant or lactating.
* Patients who use tobacco products (smoking or smokeless tobacco).
* Patients with alcohol abuse problems.
* Patients undergoing long-term steroid therapy.
* History of previous root coverage procedures, graft or GTR, on the test teeth.
* Patients who fail to complete the informed consent form.
Efficacy Trial of Gemcitabine Containing Regimens As Preoperative Chemotherapy in Non Small Cell Lung Cancer

To evaluate the rate of complete pathological response after 3 cycles of gemcitabine containing chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed non small cell lung cancer
* No prior chemotherapy or radiation for non small cell lung cancer
* No prior malignancy

Exclusion Criteria:

* Pregnancy or breastfeeding
* Serious concomitant disorders
Inelastic Compression in Edema After Revascularization

The appearance of revascularization edema of the lower limb is a frequent complication in peripheral vascular surgery. It can lead to a delay in healing and even to trophic disorders.

The prevention and treatment of this complication have so far been limited to postural measures (elevation of the limbs), in the absence of other recommendations and given the contraindication of elastic compression.

Inelastic compression is another mode of compression sometimes used in the treatment of lymphedema. It exerts a stable continuous pressure regardless of the patient's position. The investigator's aim is to demonstrate that compression with inelastic bands, applied under good conditions, does not have a major effect on distal arterial vascularization in arterial patients who have undergone revascularization by supra-articular bypass or endovascular treatment of the lower limb.


Eligibility Criteria:
Inclusion Criteria:

1. patients over 18 years of age
2. arteriopathic patients requiring femoropopliteal revascularization by bypass surgery who have been revascularized
3. signature of an informed consent
4. person affiliated or beneficiary of a social security plan

Exclusion Criteria:

1. arterial bypasses under the leg or distal joints
2. critical ischemia
3. patients operated on for acute ischemia
4. pregnant or breast-feeding women
5. severe cardiac insufficiency

5) severe peripheral neuropathy 6) allergies to the components of the tapes 7) persons deprived of liberty by judicial or administrative decision 8) persons under legal protection
Visual Outcome in Patients With Symptomatic Macular Polypoidal Choroidal Vasculopathy (PCV) Treated With Either Ranibizumab as Monotherapy or Combined With Verteporfin Photodynamic Therapy (vPDT)

This study compared the effect of ranibizumab administered as monotherapy versus ranibizumab administered in combination with verteporfin photodynamic therapy (PDT) on visual acuity in patients with symptomatic macular polypoidal choroidal vasculopathy (PCV). The results of this study provided long-term safety and efficacy data used to generate further guidance on the management of patients with PCV.

Patients were randomized to the study in 2 treatment groups: ranibizumab + vPDT combination therapy, and ranibizumab monotherapy. Based on the results of the primary analysis at Month 12, patients still in the ranibizumab monotherapy group at the time of the switch cut-off time point were switched to the ranibizumab + vPDT combination therapy group until study exit. A total of 168 and 154 patients were included in the ranibizumab + vPDT combined therapy and ranibizumab monotherapy groups, respectively for the FAS (Month 12 analysis). However, the safety set included 172 and 149 patients, respectively. Four patients in the combination therapy group never took vPDT . Among them, 1 patient actually received verteporfin injection but no laser injection. Thus a total of 3 patients (4-1) in the combination therapy group did not take the actual full vPDT treatment. Additionally, 7 patients in the monotherapy group received vPDT and 1 patient from the monotherapy group did not receive ranibizumab treatment. Considering the above numbers, safety set included 172 patients (i.e., 168-3+7) in the ranibizumab + vPDT combination therapy group and 149 patients (i.e., 154-7+3-1) in the ranibizumab monotherapy group for Month 12 analysis. For the Month 24 safety analysis, the 14 patients in the ranibizumab monotherapy group who were switched to ranibizumab +vPDT combination therapy group were analyzed as a separate group, ie, ranibizumab 0.5 mg + vPDT (switched).

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Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of symptomatic macular PCV in the study eye
* A qualifying vision score at study entry
* A qualifying lesion size in the study eye at study entry

Exclusion Criteria:

* Active inflammation or infection in the study eye
* Uncontrolled intraocular pressure in the stuy eye
* Ocular condition in the study eye which may impact vision and confound study outcomes
* Prior treatment of the study eye with anti-VEGF therapy, verteporfin PDT, other laser and surgical interventions, intraocular corticosteroids
CATCH - Catheter Infections in Children

Most children admitted to paediatric intensive care units (PICU) need to have medicines given to them into their veins using a narrow tube, so they do not need repeated injections. This tube is called a central venous catheter. Occasionally these catheters can cause infections in the blood and sometimes the tubes can get blocked by small blood clots.

Some intensive care units already use antibiotic or heparin coated catheters, but there is no proof that these are better than the standard ones at preventing infections. Most of the PICU's in this country use standard lines. The only way to find out for certain is to compare children who are given antibiotic or heparin coated catheters with those who are given standard ones in a clinical trial. Because we do not know which type of catheter is best, the type of catheter each child receives in the study will be decided randomly by chance.

Each child in the trial will have the same chance of getting any of these three catheters:

* Standard central venous catheter (not coated).
* Heparin coated central venous catheter. Heparin is a medicine that can stop blood from clotting and might stop the tubes being blocked and infections in the blood.
* Antibiotic coated central venous catheter. Antibiotics can be used to kill bacteria which cause the infections.

The aim of this study is to see how the three types of catheters compare in reducing the amount of blood infections in children. We will also look at the costs involved. We hope to recruit 1200 children in the UK over 2 years. We hope that the information we get from this study will guide policy about purchasing impregnated Central Venous Catheters across the NHS and thereby improve treatment for children in the future.


Eligibility Criteria:
Inclusion Criteria:

* Weighing ≥3kg and less than 16 years of age;
* Admitted to or being prepared for admission to an intensive care unit participating in the trial;
* Require insertion of a polyurethane CVC as part of good clinical management;
* Require one of the CVC sizes available to the trial (see Appendix A for the list of CVCs);
* Expected to require a CVC for at least 3 days;
* Appropriate consent obtained (prospective consent for elective surgical patients, deferred consent for emergency admission patients).
A Review of External Ventricular Drain Placement at the Bedside Versus Operating Room

External ventricular drain (EVD) placement is a common neurosurgical procedure and provides a way to monitor intracranial pressure. EVDs are utilized in the management of a wide array of neurosurgical indications, such as subarachnoid hemorrhage, trauma, intraventricular hemorrhage, cerebrospinal fluid (CSF) leaks, and hydrocephalus.

External ventricular drain (EVD) placement is a common neurosurgical procedure and provides a way to monitor intracranial pressure. EVDs are utilized in the management of a wide array of neurosurgical indications, such as subarachnoid hemorrhage, trauma, intraventricular hemorrhage, cerebrospinal fluid (CSF) leaks, and hydrocephalus. While generally regarded as safe, EVDs are associated with a significant risk of complications, such as hemorrhage, infection, and improper placement resulting in a need for replacement and the patient undergoing an additional procedure.

Significant research has been conducted reducing these complications, with a major focus on issues with the procedure itself, instruments utilized for EVD placement, or post-procedure care of the EVD. To the knowledge, few investigations have focused on the EVD placement environment ( the operating room versus the bedside). Aim to evaluate the circumstances and complications rates associated with EVD placement between these two settings at Methodist Dallas Medical Center (MDMC).

Eligibility Criteria:
Inclusion Criteria:

* • Patients ≥18 years old

  * Any patient undergoing EVD placement at MDMC between January 2018 and August 2022

Exclusion Criteria:

* • Any patient not meeting criteria in section 3.1
Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris

The objective of this study was to evaluate the efficacy, safety, and tolerability of a once daily topical application of IDP-121 Lotion compared with its vehicle (IDP-121 Vehicle Lotion) in participants with moderate to severe acne vulgaris (acne) (that is, acne having an Evaluator's Global Severity Score \[EGSS\] of 3 \[moderate\] or 4 \[severe\]).


Eligibility Criteria:
Key Inclusion Criteria:

* Male or female at least 9 years of age and older.
* Written and verbal informed consent must be obtained. Participants less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if participant reaches age of consent during the study they should be re-consented at the next study visit).
* Participant must have a score of 3 (moderate) or 4 (severe) on the EGSS assessment at the screening and baseline visit

Key Exclusion Criteria:

* Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study.
* Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram-negative folliculitis.
* Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive.
* Participants with a facial beard or mustache that could interfere with the study assessments.
The Effect of Modified Pillow on Safety During Breastfeeding

This study will investigate the effectiveness of a modified product "safe breastfeeding pillow" in enhancing the comfort and safety of postpartum women during breastfeeding. The results of this study can be used as a reference to promote clinical practice and education on breastfeeding to prolong the duration of breastfeeding and to ensure the safety of newborns.

Breastfeeding has a significant long-term positive impact on the health, nutrition and development of children, as well as the physical and mental health of women. Baby-Friendly Hospital Initiative (BFHI) was launched by the World Health Organization and UNICEF in 1991 to encourage comfortable, supportive, and safe breastfeeding environments (Byrom et al., 2021). During breastfeeding, mothers need to maintain the same position with their hands for long periods of time, which can lead to muscle pain due to improper posture. In addition, postpartum fatigue can also lead to newborn fall accidents (Lipke et al., 2018).

Objective: To investigate the effectiveness of a modified pillow to enhance the comfort and safety of postpartum women during breastfeeding.

METHODS: A randomized controlled trial was conducted. Mothers and infants who gave birth naturally without serious postpartum complications at a university affiliate hospital will recruit in northern Taiwan. A questionnaire containing "Breastfeeding Self-Efficacy Scale (BSES)", "B-R-E-A-S-T-Feed scale", "Breastfeeding safety scale", and "Body Part Discomfort Scale (BPDS)" will be used to assess comfort and safety during breastfeeding.

Eligibility Criteria:
Inclusion Criteria:

1. Normal spontaneous delivered mothers without serious postpartum complications.
2. Normal newborns who can breastfeed.
3. The mother is willing to breastfeed at least 3 times in the cradle position during the hospital stay.
4. Mothers can communicate in Chinese and Taiwanese.
5. Agree to participate in the study and complete the informed consent form.

Exclusion Criteria:

1. Infants who cannot continue breastfeeding due to condition changes after birth.
2. Mothers who cannot continue breastfeeding due to medical reasons after childbirth.
Feasibility Study of the Self-Care Immediate Stabilization Procedure (ISP) ® After a Traumatic Experience

The study aims to assess the feasibility of an online intervention platform based on the Immediate Stabilization Procedure (ISP®). This intervention targets early trauma reactions, aiming to reduce the risk of future PTSD.

The primary objective of this study is to assess the effectiveness and feasibility of an immediate stabilization procedure adapted for online self-usage.

This procedure relies on the Eye Movement Desensitization and Reprocessing (EMDR) treatment, a well-known approach for post-traumatic responses. It involves bilateral stimulation of the brain's hemispheres through tapping on the body (i.e., the 'Butterfly Hug') and positive therapist statements during the tapping process. Key advantages of this protocol include: 1) prevents long-term post-traumatic symptoms; 2) short intervention - takes 5-20 minutes on average; 3) simple procedure that does not require recalling traumatic memories; 4) could be administered by non-mental health experts.

The ISP® protocol was found effective and safe in Israel (face-to-face) and the Ukraine (remote). In addition, online variations of the protocol for self-usage have been utilized globally. The on-going state of war emphasizes the critical need for immediate emotional support. A collaborative group involving researchers, mental health clinicians, and software engineers adapted the ISP® protocol for online self-usage. The current study aims to evaluate the efficiency of this intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Hebrew speakers
2. Age 18 years or older
3. Have been in Israel since October 7th 2023 (the start of the war)
4. Were exposed to traumatic events during the war (Alarms, participated in battles, were attacked by terrorists, etcetera)
5. Access to PC/smartphone
6. Basic technological skills, ability to use the internet and email.

Exclusion Criteria:

1. Diagnosed with psychotic conditions.
2. Diagnosed with PTSD or complex PTSD.
3. Diagnosed with alcohol use disorder or drug abuse disorder.
4. Suicidal ideation
5. Treated with medication, psychotherapy, or any other mental treatment

About 10 randomly selected subjects will perform the intervention while recorded via zoom in the presence of a research assistant. This will allow us to assess the way subjects utilize this intervention.
Pneumocystis Jirovecii Pneumonia in Non-HIV-infected Immunocompromised Patients

Pneumocystis jirovecii pneumonia (PjP) is a rare infectiouse disease with a high level of mortality. PjP is a classical opportunistic infection which concern HIV infected and immunocompromised patients. During the past decade, several therapeutic's progresses have been done in oncology, immunology and hematology. As a consequence, patients benefited of greater treatment efficacy but are exposed to a higher risk of opportunistic infections as PjP. The investigators hypothesis is that PjP incidence increase and its form is depending of underlying immune conditions. The investigators aim to describe its incidence, the PjP forms depending on comorbidities and to identifiy pronostics factors.


Eligibility Criteria:
Inclusion Criteria:

* Underlying immune condition at risk of Pneumocystis jirovecii pneumonia excluding HIV infection
* Clinical, biological and radiological presentation which evoke Pneumocystis jirovecii pneumonia
* Microbiological confirmation by respiratory specimen analyses ( specific coloration and/or IFI and/or PRC)

Exclusion Criteria:

* No microbiological confirmation by respiratory specimen analyses
* Proved HIV infection
* Patient denied to particpate