cyrilzakka/clinical-trials huggingface dataset:
Light Therapy to Improve Symptoms in Pregnant Women With Major Depressive Disorder

This study will investigate the effectivenss of bright light therapy(10000 lux white)on pregnant women with major depression disorder.

Depression during pregnancy is a common and high impact disease.Children who are exposed to maternal depression during pregnancy have a higher risk of adverse birth outcomes, such as low birth weight, and more often show cognitive, emotional and behavioral problems.Therefore, early detection and prompt treatment of depression during pregnancy can benefit both mother and child.However, the window of opportunity in pregnancy is small and from the perspective of the child postponement is in fact non-treatment. Psychotherapy might take a long time to be effective and do not work for all people. Further, the safety of pharmacological treatment for pregnant women with depression is still a big concern .Psychiatric medication use for depression in pregnancy may also pose a risk of fetal growth retardation and preterm delivery, as well as withdrawal symptoms in the new born. Therefore, investigating non-pharmacological approaches to treating depression during pregnancy is urgent and relevant, for both mother and child. Preliminary evidence shows that bright light therapy (BLT) is an effective treatment for pregnant women with depression based on several theoretical and clinical considerations, with effect size around 0.45 and without adverse effects to the new born. In this study we aim to investigate the effectiveness of BLT on pregnant women with major depression.

Eligibility Criteria:
Inclusion Criteria:

Women; 18\~45 years of age; medically healthy, with normal ocular function; 13\~28 weeks pregnancy; DSM-V diagnosis of major depressive disorder HAMD score ≥18

Exclusion Criteria:

DSM-V defined bipolar disorder、schizophrenia、schizoaffective disorder,anxiety disorders; substance Use Disorders; substance use within the last 6 months; suicidal ideation, suicidal attempt, suicide behavior, and attempted suicide; being treated by the light therapy; with antidepressant in recent 2 months; Multiple pregnancy; Any obstetrical care or medications for physical disorders that might confound treatment results; current use of β-adrenergic blockers, melatonin, or St. John's wort; thyroid function test results inconsistent with normal pregnancy
Prone Positioning in COVID-19 Patients

Prone positioning improves oxygenation in patients with ARDS (1-3). Patients with severe ARDS due to COVID-19 are candidates for prone position. It should be started within 36-48 h and maintained 1, 3). Prone ventilationARDS based on a randomized trial that showed a mortality benefit (PROSEVA) (3).

The improvement of oxygenation occurs by making ventilation more homogeneous, limiting ventilator-associated lung injury (4-6).

Prone positioning was as effective in improving oxygenation, static respiratory system compliance (Crs) (7).

Higher PEEP should be applied when there is a high recruitability potential of the lung. This study aimed to investigate whether prone positioning changes the recruitability position of the lung.in COVID-ARDS.

Prone positioning improves oxygenation in patients with ARDS (1-3). Patients with severe ARDS due to COVID-19 are candidates for prone position. It should be started within 36-48 h and maintained 1, 3). Prone ventilationARDS based on a randomized trial that showed a mortality benefit (PROSEVA) (3).

The improvement of oxygenation occurs by making ventilation more homogeneous, limiting ventilator-associated lung injury (4-6).

Prone positioning was as effective in improving oxygenation, static respiratory system compliance (Crs) (7).Higher PEEP should be applied when there is a high recruitability potential of the lung. This study aimed to investigate whether prone positioning changes the oxygenation, respiratory mechanics and recruitability position of the lung in COVID-ARDS.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with laboratory-confirmed COVID-19 admitted to the ICU
* The patients receive invasive mechanical ventilation and meet the criteria for ARDS (Berlin definition) (8), with under continuous infusion of sedatives,

Exclusion Criteria:

* Pregnancy
* Pneumothorax and or chest tube
* Chronic obstructive lung disease
* interstitial lung disease
* intraabdominal hypertension
* increase in intracranial blood pressure
* Haemodynamic unstability requiring vasopressors
Feasibility of Re-TREPP in Patients With a Recurrent Inguinal Hernia After Previous TREPP Repair

The Trans REctussheath PrePeritoneal (TREPP) mesh repair was introduced in 2006 to decrease the risk of postoperative inguinal pain in hernia surgery. For the repair of a recurrent inguinal hernia after a primary TREPP an alternative open anterior route (Lichtenstein) may seem the most logical option, but coincides with an increased risk of chronic postoperative inguinal pain. Therefore, this study aimed to evaluate the feasibility of a second TREPP procedure to repair a recurrent inguinal hernia after an initial TREPP repair. The hypothesis was that the technique is possible and does not lead to an increased risk of postoperative pain.

Since the development and introduction of TREPP in 2006, TREPP has been the standard operation technique for all patients who present in St. Jansdal Hospital with an inguinal hernia. The electronic patient files of all consecutive patients who were operated at the St Jansdal hospital via TREPP between January 2006 and December 2013 were retrospectively investigated. This patient list was retrieved by an electronic search using the assigned operation codes. Adult patients who had developed a recurrent inguinal hernia and had undergone a re-TREPP were included in this study. A case report form was filled in for each patient that underwent a re-TREPP. Baseline data such as operation time, Body Mass Index (BMI), operation technique, number of conversions, aetiology of the recurrence, type of anesthesia and American Society of Anesthesiology (ASA) classification were retrospectively reviewed through patient files and operation reports. Co-morbidities were extracted from the files. Information on short term complications was taken from the notes of telephone consultation 2 and 30 days postoperatively, which is the local standard protocol for follow-up. Patients were invited for a long-term follow-up (\>30 days postoperative) at the outpatient department for physical examination, or they were visited at home by the investigator. Written informed consent was obtained from all patients who were included for a long term follow-up. A case report form was used for each patient, in order to standardize the investigation. All patients were asked if they experienced any pain or discomfort. If there was pain, the Visual Analogue Scale and Pain Disability Index questionnaire were filled in. All patients were asked if sexual complaints occurred since the operation. Written informed consent was obtained from all patients who were clinically evaluated. Recurrent inguinal hernia was defined as a reappearance of the inguinal hernia, diagnosed by physical examination (a reducible bulge with positive Valsalva).

This was a retrospective case series. Since the numbers were small, no statistical analysis was performed.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who had developed a recurrent inguinal hernia and had undergone a re-TREPP.

Exclusion Criteria:

* Children (age \<18 years)
* Exclusion criterium for long term follow up: no informed consent obtained.
Essential Oils for Electrocautery

The purpose of this study is to assess whether essential oil aromatherapy could improve or eliminate the smell of burnt flesh from electrocautery and subsequently mitigate patient anxiety and discomfort during dermatologic skin surgery.

This is a randomized clinical trial. Approximately 210 electrocautery participants will be randomized to receive sham control/no aromatherapy or aromatherapy. Patients will be asked to complete a questionnaire after completion of the procedure to assess their experience. This study was a pilot study designed to determine the feasibility of this procedure.

Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be invited and considered for enrollment.


Eligibility Criteria:
Inclusion Criteria:

1. \>18 years of age
2. Receiving same day cutaneous surgical procedure that requires electrocautery per protocol
3. In good general health as assessed by the investigator
4. Participants must have the ability to understand and the willingness to sign a written informed consent prior to registration on study

Exclusion Criteria:

1. Surgery site incompatible with the patient holding a handheld aromatherapy device (physician discretion)
2. Subject unwilling to sign an IRB approved consent form
3. Participants who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function are not eligible
Expanded Indications of Endoscopic Submucosal Dissection for Early Gastric Cancer in China

Background: The main treatment methods for early gastric cancer (EGC) include endoscopic submucosal dissection (ESD) and radical gastrectomy. However, appropriate treatment for patients who exceed the absolute indications for ESD remains unestablished. In China, evidence-based medicine for the expanding indications of ESD and accurate diagnostic staging for EGC patients are lacking. Thus, clinical studies involving Chinese patients with EGC are necessary to select appropriate treatment options and promote China's expanded indications for ESD and diagnostic staging scheme.

Methods: This is a multicenter, ambispective, observational, open-cohort study that is expected to enroll 554 patients with EGC. The study was launched in May 2018 and is scheduled to end in March 2022. All enrolled patients should meet the inclusion criteria. Case report forms and electronic data capture systems are used to obtain clinical data, which includes demographic information, results of perioperative blood- and auxiliary examinations, surgical information, results of postoperative pathology, and the outcomes of postoperative recovery and follow-up. Patients are followed up every 6 months after surgery for a minimum of 5 years. The primary endpoint is the rate of lymph node metastasis (LNM), whereas the secondary endpoints include the following: consistency, sensitivity, and specificity of the results of preoperative examinations and postoperative pathology cut off values for LNM; logistic regression model of expanded indications for ESD; and incidence of postoperative complications within the 30-day and 5-year relapse-free survival rates.

This study will explore and evaluate expanded indications for ESD that match the characteristics of the Chinese population in patients with EGC and will introduce a related staging procedure and examination scheme that is appropriate for China. Ethical approval was obtained from all participating centers. The findings are expected to be disseminated through publications or presentations and will facilitate clinical decision-making in EGC.

Eligibility Criteria:
Inclusion Criteria:

Patients aged 18-75 years (regardless of sex). Patients with tumor diameter \> 30 mm, ulceration (UL)(+), and differentiated mucosal carcinoma (T1a).

Patients with tumor diameter \> 30 mm and differentiated, submucosal invasion depth \< 500 μm (T1b SM1).

Patients with tumor diameter ≤ 30 mm and differentiated submucosal carcinoma (T1b).

Patients with tumor diameter ≤ 20 mm, UL(-), and undifferentiated (T1a). Patients with tumor diameter \> 20 mm, UL(-), and undifferentiated (T1a). Patients with tumor diameter ≤ 30 mm, UL(+), and undifferentiated (T1a). Patients with tumor diameter \> 30 mm, UL(+), and undifferentiated (T1a).

Exclusion Criteria:

Patients with gastric stump cancer. Patients with recurrent gastric cancer. Patients with multiple primary malignant tumors.
Intermountain Healthcare's Enhanced Recovery Protocol for Colon Surgery With and Without Alvimopan Use

The purpose of this study is to determine if the addition of alvimopan to our care process model for colon resection patients will decrease length of stay. The care process model is a combination of optimal IV fluid management, early feeding, early ambulation, patient education, and pain management.

Narcotic pain medicines bind mu-opioid receptors in the bowel and delay the return of normal function. Alvimopan is a peripherally acting mu-opioid receptor antagonist that blocks mu-opioid receptors in the gastrointestinal tract but does not compromise central nervous system-mediated opioid-based analgesia. Length of stay is an important surrogate measure of quality after colon surgery and the most common reason for prolonged Length of Stay after abdominal surgery is delayed gastrointestinal recovery (postoperative ileus).

The Food and Drug Administration has approved alvimopan (dosed preoperatively and twice daily postoperatively for up to 15 in-hospital doses) for the acceleration of upper and lower gastrointestinal recovery after partial bowel resection with primary anastomosis. In the 5 phase III alvimopan efficacy trials, a simple standardized accelerated postoperative care pathway was used rather than a comprehensive, multidisciplinary colon surgery care process model that is used by Intermountain Healthcare. In the most recently completed alvimopan phase III trial, the mean postoperative length of stay was 5.2 days whereas the mean length of stay at Intermountain Healthcare is 4.4 days without the addition of alvimopan to the multidisciplinary colon care process model.

This trial will investigate if the addition of alvimopan to the Intermountain Healthcare multidisciplinary care process can decrease length of stay compared with the multidisciplinary care process plus placebo.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18
2. Patient scheduled to receive opioid-based postoperative pain management ≥ 48 hrs
3. Elective colon/rectal resection with anastomosis as primary procedure
4. Patient enrolled in multidisciplinary colon care process

Exclusion Criteria:

1. Pregnancy or lactation
2. Chronic opioid use or \> 3 doses in 7 days prior to surgery
3. History of multiple previous abdominal operations, gastrectomy, bariatric surgery, short bowel syndrome
4. Complete bowel obstruction
5. Patients with end-stage renal disease as defined by the need for dialysis and the commonly accepted threshold for dialysis is a Glomerular Filtration Rate of \< 15.
6. Patients with severe hepatic impairment (Childs-Pugh class C)
7. ASA 4 or 5 (ASA 4 s incapacitating systemic disease that is a constant threat to life)
8. Non-English speaking patients
Study Evaluating Intepirdine (RVT-101) in Subjects With Mild to Moderate Alzheimer's Disease on Donepezil: MINDSET Study

This study seeks to confirm a demonstrated treatment effect of intepirdine (RVT-101) as an adjunctive therapy to donepezil for the treatment of subjects with Alzheimer's disease.

This Phase 3 study seeks to confirm a demonstrated treatment effect of intepirdine (RVT-101) on both cognition and activities of daily living when added to stable donepezil treatment in subjects with mild-to-moderate Alzheimer's disease after 24 weeks of double-blind treatment. This study will also provide further information on the safety and tolerability of the 35-mg dose of intepirdine (RVT-101) when used in combination with donepezil compared to donepezil alone. This study is being conducted under the agreement of a Special Protocol Assessment by FDA. Subjects completing this study will be eligible to enroll in a 12 month open-label study of RVT-101 (RVT-101-3002) in which concomitant medications for the treatment of Alzheimer's disease including memantine will be allowed.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subject with AD
* Ongoing donepezil therapy for AD
* An MMSE score 12 to 24 inclusive at Screening; MMSE score 10-26 inclusive at Baseline
* Hachinski Ischaemia score less than or equal to 4 at Screening.
* If female, subject must be: a. of non-childbearing potential or surgically sterile; or, b. willing to use an adequate methods of birth control. Male subjects who are sexually active will also be required to use an adequate form of birth control.
* Subject has the ability to comply with procedures for cognitive and other testing in the opinion of the investigator.
* Subject has a reliable caregiver who is willing to report on subject's status throughout the study.

Exclusion Criteria:

Other Causes for Dementia

* Diagnosis of vascular dementia
* Atypical clinical features or clinical course of dementia that would lead the investigator to conclude symptoms are more likely due to an alternate dementia diagnosis including, but not limited to, frontotemporal dementia, Lewy body dementia, or others.

Confounding Medical Conditions

* History of significant psychiatric illness such as schizophrenia or bipolar affective disorder or any other significant psychiatric illness that in the opinion of the investigator would interfere with participation in the study;
* Any clinically relevant concomitant disease, which, in the opinion of the investigator, makes the subject unsuitable for inclusion in the study.
Study of Motexafin Gadolinium and Docetaxel for Advanced Cancer

The primary purpose of this study is to evaluate the safety, side effects, and dosage for Motexafin Gadolinium given with the chemotherapy drug docetaxel to patients with advanced cancers. Secondly, tumor response to the combined treatment, drug levels in the body, and drug interactions will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Metastatic, or unresectable solid tumors from breast, head, and neck, gastrointestinal, genitourinary, lung, or ovarian cancer or recurrent glioblastoma multiforme
* ECOG performance status score either 0, 1, or 2
* Willing and able to provide written informed consent

Exclusion Criteria:

* Greater than two prior cytotoxic regimens
* Laboratory values showing adequate function of bone marrow, liver, and kidneys
* Uncontrolled hypertension
* Known sensitivity to or intolerable adverse effects from taxanes (eg. paclitaxel, docetaxel) or polysorbate 80
Comparison of Misoprostol and Prostaglandin E2 (PGE2) Gel for Induction of Labour in Premature Rupture of Membranes at Term

The purpose of this study is to determine whether induction of labor with vaginal misoprostol application will result in fewer cesarean deliveries than vaginal PGE2 gel application in women with premature rupture of membranes at term.


Eligibility Criteria:
Inclusion Criteria:

* Premature rupture of membranes at 37 or more weeks
* Single live fetus in cephalic presentation

Exclusion Criteria:

* Women in labour
* Women with contraindication of induction of labour
* Women with previous caesarean section or uterine surgery
Vitiligo Severity, Quality of Life, Work Productivity and Activity Impairment

translate and validate the vitiligo specific quality of life (VITIQOL) questionnaire to Arabic language.

evaluate the effect of vitiligo on patient quality of life using vitiligo specific quality of life questionnaire (VitiQoL).

measure the impact of vitiligo on work productivity using work productivity and activity impairment questionnaire (WPAI) and general self efficacy scale (GSE) .

analyze how disease severity and location influence patients quality of life and work pro

Vitiligo is a common disorder of depigmentation caused by the progressive destruction of melanocytes that affect the skin, hair and mucous membranes, clinically presenting as depigmented macules and leukotrichia.

Vitiligo was historically regarded as a cosmetic disorder; however, it is an immune disease as it affects patient well-being . It affects approximately 0.5-1% of the global population. A Study reported a prevalence of 1.2% in the Egyptian population.

Vitiligo is asymptomatic disease, so its effect on quality of life is much more related to psychological problems, such as lack of self-confidence unpleasant body images unsuccessful social relationships, and lower quality of marital relations, than the exclusive physical issues. It has been shown that patients with vitiligo are at risk of higher social discrimination and stigma Lesions that are more severe, on the face, or covering a greater BSA are more often associated with poorer outcomes and activity impairment.

Recently a study conducted in Egypt in 2023 noted that more than half of studied sample had low level of self-esteem and quality of life. While more than half of studied sample had moderate negative body image. Also, half of studied sample had moderate level of social problems .

limited studies have been conducted in Upper Egypt which assess life quality of patients with vitiligo and but those Studies employed non-specific tools like Dermatology Life Quality Index (DLQI).

Lilly et al have developed a reliable tool with high internal consistency named as Vitiligo specific Quality of life questionnaire(VITIQOL) that consists of 16 questions comprising of demographic and clinical parameters of the patients.

Also the work productivity and activity impairment among vitiligo patients in Egypt have not been assessed before .

Eligibility Criteria:
Inclusion Criteria:

* Adults \> 18 years and less than 60 years old diagnosed with vitiligo by a physician Patients willing to complete the survey questionnaires Patients who can speak Arabic

Exclusion Criteria:

* Patients with other major skin disease affecting QOL . Patient with chronic diseases as diabetes mellitus and hypertension Not working patients
A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease

This is a study to demonstrate the effect of oral ozanimod as maintenance therapy in participants with moderately to severely active Crohn's Disease.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com

Inclusion Criteria:

* Fulfilled the inclusion criteria at time of entry into the induction study and completed the week 12 efficacy assessments of the induction study
* In clinical response and/or clinical remission and/or an average daily stool frequency score ≤ 3 and an average abdominal pain score ≤ 1 with abdominal pain and stool frequency no worse than baseline at Week 12 of the Induction Study

Exclusion Criteria:

* Partial or total colectomy, small bowel resection, or an ostomy since day 1 of the induction studies or has developed a symptomatic fistula
* Had a rectal steroid therapy, rectal 5-aminosalicylates, parenteral corticosteroids, immunomodulatory agents, investigational agents or apheresis

Other protocol-defined inclusion/exclusion criteria apply