cyrilzakka/clinical-trials huggingface dataset:
Oral Sedation During Cervical Dilator Placement

This will be a randomized, double-blind, placebo-controlled trial involving 2 arms. It will be comparing the effects of placebo compared to 1 mg oral lorazepam/5 mg oral oxycodone on pain scores during cervical dilator placement prior to dilation and evacuation (D\&E).

Potential participants will be first introduced to the study via routine intake call. Participants will be identified at the participant's office visits to the Johns Hopkins' Women's Center for Family Planning. If a patient desires D\&E for a second trimester pregnancy, the patient will first receive standard counseling. Only after providing written informed consent for the procedure will the patients be screened for eligibility in the study. If the patient is eligible the participant will be asked by a member of the research team if the patient is interested in participating. If the patient is, the study will be explained to the participant and written consent will be obtained after participant is given the opportunity to have all questions answered.

The study is randomized, double-blind, placebo-controlled trial involving 2 arms. Participants will first complete a survey to collect demographic data.

Participants in both arms will receive the institution's current standard analgesia for cervical dilator placement. In addition to this standard regimen, participants will be randomized to receive either: (1) a dose of two oral placebo pills, or (2) 1mg of oral lorazepam with 5 mg of oral oxycodone prior to cervical dilator placement.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-50 years
* English speaking
* With an intrauterine pregnancy (either viable or non-viable) between the gestational ages of 17w0d and 23w6d
* Have a support person present with participant
* Have a cell phone capable of text messaging (optional)

Exclusion Criteria:

* Non-English-speaking
* Taking a daily benzodiazepine or opiate
* Have a known allergy or contraindication to NSAIDs, opiates, or benzodiazepines
New Endoscopic Minimal Invasive Approach for Pudendal Nerve and Inferior Cluneal Nerve Neurolysis: a Clinical Study

Pudendal nerve and cluneal nerve entrapment can cause a neuropathic pain syndrome in one, many or all of the sensitive areas innervated by this nerve. In literature, several techniques for the liberation of the pudendal nerve have been described. Here, transvaginal, transperineal and abdominal laparoscopic approaches have been proposed, but none of the latter were able to visualize the entire course of the nerve or allowed to explore the main, currently identified sites of entrapment. Although there have been reports and series of case reports on different surgical approaches, until now, the transgluteal approach is the only one which is validated by a prospective randomized study comparing the medical treatment to these surgical approach.

The investigators already performed a study to describe for the first time a new endoscopic minimal invasive technique using a transgluteal approach which permits to visualize all the nerve structures of the gluteal region. They performed an anatomic description of the region reachable with this minimally invasive approach, and described the anatomic landmarks for the visualization of the pudendal and cluneal nerve and their neurolysis.

In this study, the investigators would like to put in clinical practice this minimal invasive approach for pudendal and cluneal neurolysis. They will perform this endoscopic approach, on patients suffering from pudendalgie or/and clunealgie, who are programmed for a surgical intervention by transgluteal approach.

The investigators would like to test the feasibility of the transgluteal trocar positioning and if necessary, optimize this first important step. Secondly, they will put in practice the step-by-step surgical approach that they have worked out during their cadaver study. Finally, they will perform the entire neurolysis and nerve transposition under endoscopic control.


Eligibility Criteria:
Inclusion Criteria:

Patients suffering from pudendalgie and/ or clunealgie, according to the 5 Nantes criteria and who are candidates for transgluteal surgical treatment.

Exclusion Criteria:

None
OrthoPureXT Multiligament PMCF Study

To monitor residual risks in the post-market phase and to ensure continued clinical evaluation of the device safety and performance to ensure that no new or unexpected risks arise when used during multi-ligament knee reconstructions.

OrthoPureXT is an acellular, sterile, single use, xenograft (porcine) tissue scaffold that is manufactured using a proprietary decellularisation technology that renders the tissue substantially free from cells, leaving the porcine tissue biocompatible, and safe for implantation into the knee.

28 patients in total to be evenly distributed across potential ligament reconstruction treatment options (n=7 per sub-group) and resulting in a statistically relevant number per sub-group considering potential loss to follow up.

Sub-groups of n=7 incurring ligament reconstruction using OrthoPure XT in the following anatomical locations:

* Posterior cruciate ligament (PCL)
* Anterior cruciate ligament (ACL)
* Posteromedial corner including the medial collateral ligament (MCL)
* Posterolateral corner including the lateral collateral ligament (LCL)

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 18 years old or above.
* Adults suffering with multiple knee ligament injuries.
* Ability to communicate meaningfully with investigative staff, competence to give written informed consent; and willingness and ability to comply with entire study procedures including rehabilitation protocol.

Exclusion Criteria:

* Those unable to give consent.
* Those considered as conflicting variables by the investigator. This may include, but is not limited to:

  * Open trauma
  * Neurovascular emergencies
  * Compartment syndrome
  * Life threatening injury
* Those considered as physical barriers by the investigator, preventing physical or ethical collection of study data. This may include, but is not limited to:

  * Associated fractures that require external fixators
  * Local severe concomitant injuries
  * Injuries to other parts of the body associated with a high level of daily activity/intervention for the patient
* Those considered as a poor candidate for surgery by the investigator.
* If female and of child-bearing potential must not have a positive pregnancy test at Visit

  1 nor have a stated intention to become pregnant in the next 12 months.
* Those patients contraindicated for in the IFU, i.e.:

  * Showing signs of infection within 24 hours prior to surgery
  * Patients with known allergy, hypersensitivity, or religious objection to, implanted porcine material
  * Patients unable or unwilling to follow the post-operative care and rehabilitation programme
Study Investigating the Efficacy and Safety of a Contraceptive Patch for 13 Cycles

This study is examining a birth control patch for 13 cycles (1 year).


Eligibility Criteria:
Inclusion Criteria:

* Requiring contraception
* Normal cervical smear
* Maximum age for smokers is 35
* History of regular cyclic menstrual periods

Exclusion Criteria:

* Pregnancy or lactation
* Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape
* Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
* Use of other contraceptive methods than study medication
Validation of MRI Instead of CT to Follow-up Ross Procedure With Loose Jacket Technique

Patients who underwent Ross procedure with loose jacket technique will be enrolled in this study and undergo CT and MRI follow-up to compare between both modalities.


Eligibility Criteria:
Inclusion Criteria:

* All patients who underwent Ross procedure with loose jacket technique at Aswan Heart Centre, regardless of the indication and duration after surgery.
* Patients should have survived until discharge and underwent at least one echocardiography with full data related to one or more anatomic subcomponents of the aortic root before surgery.

Exclusion Criteria:

* Patients who have contraindication for conducting cardiac CT scan. For instance, dye sensitivity, pregnancy, CKD, in addition to patients who have factors that interfere with CT image quality as metallic objects within the chest (e.g. Pacemaker).
* Patients who have contra-indication for conducting a safe MRI scan. For instance, metallic implants that are incompatible with MRI.
* Patients who underwent Ross procedure with technique other than loose jacket.
Effectiveness of an Online Quiz in Promoting Tobacco-Related Knowledge, Attitudes, and Behaviours Among Primary Students

The goal of this modified pilot RCT is to evaluate the effects of the intervention (online platform) on tobacco-related knowledge, attitudes and intentions on smoking among local primary 5-6 school students. The main questions it aims to answer are:

* Is the intervention effective in improving tobacco-related knowledge (including alternative smoking products (ASPs) and tobacco control development in the world and Hong Kong)?
* Is the intervention effective in improving tobacco-related attitudes and intentions (including ASPs and tobacco control development in the world and Hong Kong)?

Researchers will compare the questionnaire results from students to see if intervention groups (students doing tobacco-related questions on the online quiz platform) will have better tobacco-related knowledge, higher anti-tobacco attitudes and lower intention to smoke.


Eligibility Criteria:
Inclusion Criteria:

* Primary 5-6 students from local primary schools
* Able to read and communicate in Chinese
* Have a digital device for online access to the quiz game at home

Exclusion Criteria:

* None
Intravitreous CytokinE Level in pAtient With retiNal Detachment

Photoreceptor apoptosis is the basis for permanent visual loss in a number of retinal disorders including age-related macular degeneration (AMD) and retinal detachment (RD). Thus, despite tremendous advances in vitreoretinal surgery and management of rhegmatogenous RD leading to a primary reattachment rate over 95%, some patients show poor visual recovery because of photoreceptor apoptosis.

Physiologically, microglial cells (resident macrophages) are present only in the inner retina. The subretinal space, located between the retinal pigment epithelium (RPE) and the photoreceptor outer segments (POS), is devoid of all mononuclear phagocytes and form a zone of immune privilege. In AMD, several studies showed a strong association between subretinal mononuclear phagocytes infiltration and advanced forms of AMD. Experimental work in mice suggest that this infiltration plays an important role in the pathogenesis of this condition by producing inflammatory cytokines.

RD-induced photoreceptor apoptosis might result from similar mechanisms. The aim of this study is to determine the cytokine profile in vitreous samples from patients with RD and to compare it with those from control patients with macular hole.


Eligibility Criteria:
Inclusion Criteria:

* Patients with primary retinal detachment requiring vitrectomy
* Patients with idiopathic macular hole requiring vitrectomy

Exclusion Criteria:

* History of retinal detachment or intraocular inflammatory diseases
A New Surgical Approach to Treat Medial or Low Condylar Fractures

The aim of the study was to compare the new approach and the retromandibular approach, so that the therapeutic effect and the advantages of the new approach would be clear.

Sixty patients (72 sides) with medial or low condylar fractures were treated with surgical intervention. Thirty-six patients (42 sides) were treated with minor parotid anterior approach, and the other 24 patients (30 sides) were treated with retromandibular approach. The data about the operations and complications were recorded. The follow-up periods were 3-12 months.

Eligibility Criteria:
Inclusion Criteria:

* (1)clinical and imaging diagnosis of medial or low condylar fractures
* (2)bone fragments that were obviously dislocated, that affected patients appearance and function, requiring surgical intervention
* (3)no previous surgical treatment

Exclusion Criteria:

* (1)medial or low condylar fractures without obvious displacement
* (2)patients who had previously undergone unsuccessful surgery
* (3)the surgical site had traumatic scar, so the approach could be carried out on the original incision
Comparative Study Efficacy and Safety of of Activated Versus Non-Activated PRP

This was comparative prospective study conducted on 40 subjects, diagnosed with alopecia areata of 40 the scalp, carried in a period from February 2020 and March 2021

Alopecia areata is a common recurrent T cell-mediated autoimmune-induced non-scarring hair loss with not fully understood pathogenesis which affects nearly 2% of the general population during lifetime. The course of the disease is unpredictable and currently, no treatment is available for complete cure or prevention. Platelet-rich plasma is an autologous blood-derived product which widely spread in the last decades for the treatment of different dermatological conditions including different hair disorders.

The aim of this work was to evaluate the efficacy and safety of activated platelet-rich plasma in comparison to non-activated platelet-rich plasma in the treatment of alopecia areata.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed clinically and dermatoscopically as Alopecia areata of the scalp (uni- or 50 multilocularis).
2. Age ranged between 18-50 years in both sex.

Exclusion criteria:

1. Previously treated patients.
2. Pregnant women. 3 Patients with hematological disorders.

4. Local infection at the site. 5. Patients with Hemoglobin \<10 g/dL and Platelet count \<105/µL. 6. Patients suffer from chronic and psychiatric diseases. 7.Age below 18years or age above 50 years ago.
Vaccination Against Pertussis, Tetanus and Diphtheria in Patients Suffering From Rheumatoid Arthritis

Pertussis is an acute respiratory infection caused by Bordetella pertussis. Rates of recent B. pertussis infection between 8%--26% have been reported among adults with cough illness of at least 5 days duration who sought medical care. The CDC recommends vaccinating patients aged 15 to 64 years old, once in 10 years. Although acellular vaccines such as BOOSTRIX have been evaluated in healthy population, the safety and efficacy of this vaccine in patients suffering from rheumatic diseases have not been established.

Study population : 50 Rheumatoid Arthritis (RA) patients and 5 healthy controls

Evaluation : the evaluation will be performed on week 0 and 4-6 weeks later. In terms of safety, the patients will be evaluated according to the Disease Activity Index (DAS). Blood will be drawn at each visit at tested for humoral response to tetanus and pertussis.


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from RA
* Aged 18 to 64 years old

Exclusion Criteria:

* Active disease requiring a change in drug regimen
* Known allergy to vaccine
Trauma-informed Cognitive Behavioural Therapy (TiCBT) to Aid Reintegration of Repentant Terrorists and Their Families in Nigeria: A Pilot Study

The aim of the study is to describe the feasibility, cultural appropriateness, and acceptability of Trauma-informed Cognitive Behaviour Therapy (TiCBT) to promote community healing and encourage the reintegration of repentant terrorists and their families to avoid reoffending.

The study will adopt a mixed-method single-arm experimental design. Approximately 24 participants will be recruited for the intervention. The Trauma-informed Cognitive Behaviour Therapy (TiCBT) is an 8-session intervention lasting approximately 1 hour each and designed to address trauma, dispel negative attitudes and encourage positive behaviour towards repentant terrorists. Measurement will be collected at baseline pre-intervention, end of intervention and three months post-intervention to determine its feasibility and effectiveness. Interviews will also be conducted post-intervention. Repeated-measures univariate analyses of variance (ANOVA) will be performed to examine differences between the pre- and post-intervention stages. Interviews will be analysed using thematic analysis.

Eligibility Criteria:
Inclusion Criteria:

* community members who are victims of Boko Haram terrorism and had previous experiences of trauma/depression,
* score five and above for the culturally-adapted Trauma Screening Questionnaire (Brewinn et al., 2002)
* aged 18+ years,
* able to give informed consent,
* speak English
* are residents or from areas within Nigeria including Maiduguri, Adamawa, and Plateau environs.

Exclusion Criteria:

* less than 18 or above 85 years
* unable to give consent
* clinically diagnosed with severe PTSD/suicidal ideations or undergoing treatment
* temporary or non-residents who are unlikely to be available for follow up
Pupillary Response After Glaucoma Medication

Investigation of the effect on the pupillary constriction by latanoprost, dorzolamide,timolol in healthy subjects. The pupillary constriction is compared to no drug.


Eligibility Criteria:
Inclusion Criteria:

* healthy subjects

Exclusion Criteria:

* ophthalmological diseases
* systemic disease
* smoking
* refractive error \>= 6 diopters
Efficacy of Dry Needling in Cervical Pain

The presence of latent myofascial trigger points (MTrPs) in the angular muscle of the scapula is one of the possible causes of non-specific neck pain. Dry needling (DN) and ischaemic compression (IC) techniques may be useful for the treatment of these MTrPs. Methods: 80 participants were divided into two groups: the dry needling group, which received a single session of DN on the angular muscle plus hyperalgesia (n=40), and the IC group, which received a single session of IC on the angular muscle plus hyperalgesia (n=40). Pain intensity, pain pressure threshold (PPT), range of motion (ROM) and quality of life were assessed at baseline, immediately after, 48 hours and one week after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with neck pain
* Patients presenting with trigger point activation of the angularis scapulae muscle

Exclusion Criteria:

* Patients who have an absolute fear of needles (belonephobia).
* Patients presenting with cervical pain with radiculopathy or irradiation of pain to the upper limb.
Studying First Line Treatment of Chronic Myeloid Leukemia (CML) in a Real-world Setting

The purpose of this study is to better understand the use of tyrosine kinase inhibitors (TKI) in patients newly diagnosed with CML and their quality of life in a real-world setting.

Time Perspective : Most patients are expected to be a mix of retrospective and prospective data collection. Patients can be enrolled after their study index date (retrospective component) and have to be followed until 5 years from study index date are complete (time between enrollment and 5 year follow-up is the prospective component)

Eligibility Criteria:
Inclusion Criteria:

* Newly-diagnosed chronic phase chronic myeloid leukemia (CP-CML) patients who started their first-line Tyrosine Kinase Inhibitor (TKI) treatment on imatinib, dasatinib or nilotinib in accordance with the timelines below
* 18 years or older at time of of CP-CML diagnosis

  a) Imatinib Cohorts
* Patients who started their first-line Imatinib treatment between January 2, 2008 and September 30, 2010.Patients fitting this criterion are defined as retrospective Imatinib patients
* Patients who started their first-line Imatinib treatment on or after October 1, 2010

  b) Dasatinib Cohort
* Patients who started their first-line Dasatinib treatment after the drug was approved in this indication

  c) Nilotinib Cohort
* Patients who started their first-line Nilotinib treatment after the drug was approved in this indication
* Patients are also eligible when they have already switched to a subsequent therapy (TKI or other) at the time of enrollment, as long as their first-line and subsequent CML treatment information is available at site for data entry into the study Electronic Case Report Form (eCRF)
* Receiving treatment at medical practice (eg. community-based, office-based, hospital-based, academic setting, oncology center)

Exclusion Criteria:

* Patients who are participating in an interventional trial which may influence the management of their CML disease will be excluded

Discontinuation Criteria:

* Enrolled patients who join an interventional trial which may influence the management of their CML disease will be excluded at the time of entry into the interventional trial
Probiotics Alleviate Functional Constipation in Adults

To investigate the clinical effects of probiotics in relieving chronic constipation in adults, and evaluate the improvement of symptoms in patients with constipation as well as their impacts on gastrointestinal function, immunity, and gut microbiota.


Eligibility Criteria:
Inclusion Criteria:

1. Chinese adults aged 18-70 who meet the following Rome-IV diagnostic criteria for Functional constipation:

   i. If the following symptoms started at least 6 months ago and have been present for the past 3 months with two or more of the following:
   1. Straining during more than 25% of defecations
   2. Lumpy or hard stools (Bristol Stool Form Scale 1-2) more than 25% of defecations
   3. Sensation of incomplete evacuation more than 25% of defecations
   4. Sensation of anorectal obstruction/blockage more than 25% of defecations
   5. Manual maneuvers to facilitate more than 25% of defecations (e.g., digital evacuation, support of the pelvic floor)
   6. Fewer than three SBM per week ii Loose stools are rarely present without the use of laxatives iii. Insufficient criteria for irritable bowel syndrome.
2. Able to complete the study according to the requirements of the trial protocol;
3. Patients who have signed the informed consent form;
4. Research participants (including male participants) who have no fertility plans from 14 days before screening until 6 months after the end of the trial and are willing to take effective contraceptive measures.

Only those who meet all the above conditions can be selected for the study. -

Exclusion Criteria:

1. The use of probiotics, prebiotics, or antibiotics within 2 weeks of enrollment.
2. Regular use of a high-fiber diet, as measured by the recommended food score (RFS);
3. Regular use of medications affecting bowel habits, such as irritable bowel syndrome, functional bloating, and functional diarrhea.
4. Currently have, or have had in the past 2 years, any gastrointestinal conditions such as: Crohn's disease, celiac disease, Ulcerative colitis, Malignant tumor of the colon.
5. Medical history of cardiovascular, liver, or renal diseases; alcoholics.
6. Hypersensitivity to probiotics or the ingredients used in this study.
7. Pregnancy or breastfeeding.
8. Participation in another clinical trial in the 3 months before enrollment. All participants provided written informed consent. -