cyrilzakka/clinical-trials huggingface dataset:
Project EQuIP: Empowering Queer Identities in Psychotherapy

The aim of this study is to develop an evidence-based psychosocial intervention for sexual minority women. This intervention will specifically target the adverse mental and behavioral health outcomes disproportionately experienced by sexual minority women, including depression, suicidality, and alcohol abuse, which are known to be driven by stigma-related stressors associated with their sexual orientation (i.e., minority stress processes).

The purpose of this study is to adapt ESTEEM (Effective Skills to Empower Effective Men), developed by Dr. John Pachankis, to simultaneously target the multiple adverse health outcomes sexual minority women disproportionately face, including depression, suicidality, and alcohol abuse, that are linked to minority stress processes.

Project EQuIP will adapt the ESTEEM program for sexual minority women in three distinct phases. The focus of this registered protocol will be Phase 3, however Phases 1, 2 and 3 are described below.

Phase 1 will involve conducting interviews with 20 sexual minority women (SMW) who report experiencing depression, suicidality, and alcohol abuse. Information from these interviews will be used to gather insight from participants that can help inform the adaptation of a cognitive-behavioral treatment approach to specifically target sexual minority women's unique experiences with minority stress.

Phase 2 will involve consultation interviews with 10 community-based mental health experts who treat psychosocial health problems among at-risk SMW. Involvement of key community members in intervention design optimizes intervention dissemination and allows frontline professionals to shape the intervention that they would be most willing to implement. Input of mental health experts working with the SMW community will be used in order to translate existing, but largely untapped, clinical wisdom regarding SMW's minority stress experiences, mental health, and alcohol use into the development of the intervention.

Phase 3 will involve pilot testing the adapted cognitive-behavioral treatment through a randomized controlled trial with 60 SMW who report experiencing depression, anxiety, and alcohol abuse.

Eligibility Criteria:
For Phase 3

Inclusion Criteria:

* sexual minority status operationalized as identity (e.g., lesbian, bisexual, pansexual, queer)
* aged 18-35
* self-identification as a woman with the option of selecting multiple gender identities
* symptoms of anxiety or depression within the past 90 days (≥ 2.5 on the BSI-4 for either anxiety or depression)
* at least one instance of past-90-day heavy drinking (i.e., ≥ 4 drinks in one sitting)
* 6-month NYC residential stability and availability
* English fluency

Exclusion Criteria:

* active psychosis or active mania
* active suicidality or active homicidality
* currently in mental health treatment exceeding one day per month
* having received any cognitive-behavioral therapy treatment in the past 12 months
* evidence of gross cognitive impairment
Recto Anal Repair or Milligan Morgans Operation of Grade 3 and 4 Symptomatic Haemorrhoidal Disease

The purpose of this study is to compare a new mini invasive surgical procedure (Recto Anal Repair) to the traditional Milligan-Morgan procedure in patients suffering from severe piles.

An estimated 4% of the adult population suffers from haemorrhoidal disease. In 1937 E. T. Milligan and C. N. Morgan described a method for operating piles that still is regarded "the gold standard" in the treatment of severe haemorrhoidal disease. This procedure is followed by a prolonged and painful recovery. To overcome the long recovery often combined with long sick leaves, less invasive methods for treating piles have been introduced during the last decade. However, few studies have compared patient benefits and the long term outcome of these techniques, and the choice of treatment is often based on the skills and experience of the individual surgeon. A new and promising mini invasive approach utilizes doppler-guided ligation of the haemorrhoidal arteries. All haemorrhoidal arteries are identified and then ligated approximately 2 cm above the anal canal. Thereafter the rectal mucosa with the piles is repositioned and fixed in the rectum with running sutures. This procedure is termed Recto Anal Repair (RAR) and leads to shrinking of the piles and restored anatomy of the anus and the rectum. The investigators want to execute a randomized, consecutive, prospective, controlled study with long term follow up to compare the RAR procedure to Milligans operation for the treatment of severe haemorrhoidal disease.

The primary goals are evaluation of pain and sick leave 7, 14 and 21 days after surgery and reported reduction of pile symptoms after 3, 6 and 12 months. In addition the investigators want to compare the overall satisfaction with the two procedures.

Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic grade 3 and 4 haemorrhoidal disease
* Age 18-80
* Patients who are fitted for local and general anaesthesia
* Patients who are able to understand the information given and are willing to give a written consent

Exclusion Criteria:

* Previous operated for piles
* Previous operated in the anal canal
* Faecal incontinence
* Inflammatory bowel disease with affection of the anal canal
* Chronic diarrhea
* Fissura ani
* Fistula in ano
* Chronic anal pain
* Neurological illness with affection of anal sensation
* Patients not able to follow the study protocol
* Patients taking immunosuppressant medication
* Pregnancy
* Disability
* Anal polyps
* Medication affecting the coagulation system
* Circular anal prolapse
Icotinib Versus Placebo as Adjuvant Therapy in EGFR-mutant Lung Adenocarcinoma

The purpose of this study is to compare 3years of disease-free survival (DFS) of Icotinib and placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung adenocarcinoma.

This study is designed to compare 3 years of disease-free survival (DFS) of Icotinib and placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung adenocarcinoma.

Primary Outcome Measure:

Disease-free survival between Icotinib group and placebo group.

Secondary Outcome Measures:

Overall survival between Icotinib group and placebo group. Lung cancer symptoms and health-related quality of life (HRQoL) . Number of participants with adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed lung adenocarcinoma after surgical resection
* Stage II-IIIA disease according to 7th edition of TNM staging
* Patients must harbor sensitive EGFR gene mutation (19/21)
* Received four cycles of platinum-based adjuvant chemotherapy.There are many different kinds of chemotherapy regimens including vinorelbine, gemcitabine, docetaxel, paclitaxel, pemetrexed plus cisplatin or carboplatin.The first cycle of chemotherapy with cisplatin dose of 75 mg / m2 ± 10% or carboplatin AUC = 5 ± 10% to calculate the dose of chemotherapy

Exclusion Criteria:

* Previous systemic anti-tumor therapy, including chemotherapy or targeted therapy(Including but not limited to monoclonal antibodies, small molecule tyrosine kinase inhibitor, etc
* Presence of metastatic disease
* Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
* Any unresolved chronic toxicity from previous anticancer therapy
* Received antitumor radiation therapy (except for the stage IIIA N2 patients who received adjuvant radiotherapy after surgery)
Frailty and Dysphagia in Older Adults

The purpose of this research study is to figure out if there are physical factors such as cognition level, nutrition status, walking speed, and handgrip strength that are associated with the development of swallowing problems. Investigators want to better understand how swallowing problems develop in older adults with and without frailty. Identifying factors that contribute to swallowing problems, can develop therapies in the future to improve swallowing outcomes for older adults.

This study will be done at the University of Wisconsin-Madison (UW-Madison). A total of about 69 people will participate in this study.

This study has 3 specific aims:

Aim 1 will determine the presence and severity of dysphagia in a cohort of older adults based on clinical frailty phenotype; Aim 2 will examine the effects of frailty status on physiological measures of swallowing in older adults; and Aim 3 will characterize relationships among specific functional frailty domains and dysphagia status in older adults.

This proposed research will provide a new understanding of the factors that underlie and contribute to dysphagia across clinical frailty phenotypes. Equipped with this knowledge, future treatment and management approaches can be developed to proactively identify dysphagia risk factors in pre-frail and frail individuals so dysphagia can be prevented or adequately addressed. This work is highly significant due to the large and increasing population of aging people who often suffer from debilitating swallowing impairments and may benefit from optimized treatments that can be developed using knowledge gained from this study.

Per approved protocol amendment on 3/39/2022, saliva samples will be collected to explore the composition and structure of oral microbiota via 16S rRNA gene analysis.

Eligibility Criteria:
Inclusion Criteria:

* 65 years of age or older
* Ability to provide informed consent or the presence of a legally authorized representative (LAR) who can consent on behalf of the patient
* Post-menopausal (female participants)
* Not pregnant

Exclusion Criteria:

* Allergy to barium
* Prior surgery to the head and neck region affecting swallowing-related structures
* Prior chemotherapy or radiation treatment to the head and neck region
* Prior cerebral vascular accident with resulting persistent dysphagia
* Non-English speaking
Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic

This is a double-blind, randomized, placebo-controlled, parallel-group study in infants with colic with the primary objective to evaluate crying and fussing time.


Eligibility Criteria:
Inclusion Criteria:

1. Aged between 3-12 weeks at screening.
2. Gestational age 37+0 weeks - 42+0 weeks at birth.
3. Birth weight appropriate for gestational age (AGA - weight between 10th and 90th percentile) or Large for Gestational Age (LGA - weight above the 90th percentile) determined using WHO Weight-for Age percentile guides.
4. Parents/caregivers/legal guardians are \>18 years.
5. Exclusively or predominantly breastfed infants (\> 50 % breast fed).
6. Willing to maintain current feeding patterns (not change formula/not change ratio of formula:breast milk etc.).
7. Readiness and the opportunity for parents/caregivers/legal guardians to fill out a study diary, questionnaires.
8. Infantile colic diagnosed according to Rome IV criteria (face-to-face consult with a physician, parents/caregivers/legal guardians must report that their infant has cried or fussed for 3 or more hours per day, during 3 or more days in the preceding week). At Visit 2, this will be confirmed by Baby's Day Diary®, at least one 24-hour period should show 3 or more hours of crying/fussing time.
9. Parents/caregivers/legal guardians with ability to understand and comply with the requirements of the study, as judged by the Investigator.
10. Parents/caregivers/legal guardians willing and able to give informed consent for their and their infant's participation in the study.
11. The mother of the infant must be willing to attend Visit 2 (Day 0), Visit 3 (Day 8), and Visit 4 (Day 22).
12. Infant is considered healthy, in the opinion of the investigator following physical exam.

Exclusion Criteria:

1. Infants with severe gastroesophageal reflux (throwing up or spitting up more than a teaspoon of milk \> 8 times daily, projectile, bilious or bloody emesis).
2. Infants with failure to thrive, intrauterine growth retardation, haematochezia (blood in the stools), diarrhoea (watery stools that takes the shape of a container \> 12x in breastfed and \>5 in partially breastfed infants daily), or fever (38.0 degrees), as reported by parents/caregivers/ legal guardians.
3. Infants with congenital heart disease, immunodeficiency, asplenia, cancer, cystic fibrosis, and those with liver disease.
4. Infants with reported exposure to probiotics in the 7 days prior to Screening Visit (V1) and throughout the study period.
5. Infants with reported exposure to oral and/or systemic antibiotics in the 7 days prior to Screening Visit (V1) and throughout the study period.
6. Infants with reported exposure to medications, therapies, or products with the aim to relieve infantile colic including proton pump inhibitors in the 7 days prior to Screening Visit (V1) and throughout the study period.
An Assessment of Residual Spherical Aberration, Postoperative Total High Order Aberrations, and Functional Vision Correlation Following Intraocular Lens (IOL) Implantation

The purpose of this study was to evaluate total residual spherical aberration (TSA) post-IOL implantation, and to determine if an association exists between TSA, postoperative high order aberrations (HOA), and functional vision following IOL implantation in patients grouped by pre-operative corneal spherical aberration (CSA).

Patients will be grouped by pre-operative corneal spherical aberration (CSA) measures, i.e., ≤0.230 micron and ≥0.270 micron.

Eligibility Criteria:
Inclusion Criteria:

* Age-related cataract grade 3 or lower in at least one eye;
* Planned cataract removal via phacoemulsification with an implantation of an aspheric IOL;
* Able to have an operation within 30 days of preoperative evaluation;
* Good ocular health, with the exception of cataracts;
* ≤ 1.50 diopter (D) of preoperative astigmatism by keratometry;
* Willing and able to understand and sign an informed consent;
* Willing and able to attend postoperative examinations per protocol schedule;
* Able to achieve 6.5mm dilated pupil;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Preoperative ocular pathology as specified in protocol;
* Preoperative corneal pathology as specified in protocol;
* Keratometric astigmatism exceeding 1.50 diopter;
* Planned postoperative refraction for mono-vision;
* Uncontrolled diabetes;
* Use of any systemic or topical drug known to interfere with visual performance;
* Contact lens use during the active treatment portion of the trial;
* Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis;
* Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or study device implantation or may interfere with the interpretation of study results;
* Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial;
* Intraocular conventional surgery within the past three months or intraocular laser surgery within one month in the operated eye;
* Pregnant or nursing mothers and females of childbearing potential not practicing a reliable and medically acceptable method of birth control;
* Other protocol-defined exclusion criteria may apply.
EMD 273066 in Patients With Recurrent EpCAM Positive Ovarian, Prostate, Colorectal or Non-small Cell Lung Cancers When First Given Cyclophosphamide

This study is looking at the safety and tolerability of the experimental biological drug EMD 273066 when given with low dose cyclophosphamide to patients with recurring EpCAM positive ovarian, prostate, colorectal or non-small cell lung cancers. EMD 273066 is an experimental biological drug that may increase the immune response to certain cancers. Patients will be enrolled in groups of 3, with each successive group receiving a higher dose if the prior group adequately tolerates the study medication.


Eligibility Criteria:
Inclusion Criteria:

* Recurrent non-small cell lung, colorectal, ovarian or prostate cancer
* No more than two lines of prior chemotherapy
* Positive EpCAM expression
* Karnofsky Performance Status \> 70%
* Adequate laboratory results
* Normal cardiac stress test

Exclusion Criteria:

* Evidence of brain metastases
* Pregnant or lactating females
* Significant infection
* Prior receipt of EMD 273066
* Unable to interrupt anti-hypertensive medications 2 days prior to and through each cycle of study medication administration
* Uncontrolled hypertension
* Previous diagnosis of Addison's disease
* Previous diagnosis of an autoimmune disease
* Organ transplant
* Insulin-dependent diabetes
* History of acute pancreatitis
* Congestive heart failure
Optimizing Quality of Life by Improved Patient Expectation Following Atrial Fibrillation Catheter Ablation

The aim is to investigate whether optimizing patients' expectations towards the interventional treatment of atrial fibrillation (catheter ablation) leads to a lower disease-related impairment of the patients compared to the control group in the first three months after ablation (the so-called blanking period).


Eligibility Criteria:
Inclusion Criteria:

* symptomatic atrial fibrillation
* indication for pulmonary vein isolation
* sufficient command of the German language

Exclusion Criteria:

* age \<18 years
* permanent atrial fibrillation
* presence of psychiatric disorders which impair the study participitatin
* presence of another medical condiction which influences quality of life stronger than the cardiac condition
* atrial fibrillation induced by intoxication, medicamentation or infection
* inability to grap the course of the study
Study of S-1 Plus LV for Advanced Gastric Cancer

The purpose of this study is to evaluate the effectiveness and safety of S-1 plus Leucovorin (1 week on and 1 week off) as first-line treatment for patients with metastatic and recurrent gastric cancer.

Patients enrolled in this study were orally treated with S-1 in doses of 40 mg (body surface area (BSA)\<1.25 m2), 50 mg (1.25≤BSA\<1.50 m2) and 60 mg (BSA≥1.50 m2) b.i.d. on days 1-7 in combination with LV given simultaneously at a ﬁxed dose of 25 mg b.i.d. on days 1-7, followed by a 7 day rest. Treatment courses were repeated every 2 weeks. Treatment was continued until progressive disease (PD), unacceptable toxicity or patient refusal.

Eligibility Criteria:
Inclusion Criteria:

* histologically conﬁrmed metastatic or recurrent gastric cancer
* with at least one measurable lesion by RECIST criteria
* an age of ≥ 18
* adequate oral intake
* no previous radiotherapy, immunotherapy, biotherapy, hormonotherapy and chemotherapy within 5 years (adjuvant chemotherapy without S-1 was allowed if ﬁnished 6 months before enrollment)
* an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* adequate bone marrow function, hepatic function and renal functions

Exclusion Criteria:

* a history of hypersensitivity to S-1 or LV, usage of drugs interacting with S-1
* serious concomitant conditions (severe heart disease, pulmonary ﬁbrosis, intestinal obstruction, enteroplegia, renal failure, liver failure, pre-existing sensory neuropathy ≥ grade 2, uncontrolled infections, psychogenic disorders, human immunodeﬁciency virus infection, severe diarrhea, nausea, or vomiting, severe ascites or pleural effusion, etc.)
* extensive bone metastasis, brain metastasis or meningeal metastasis
* another synchronous cancer
* surgery within 3 weeks before enrollment
* participating in other clinical studies
* women who were or to be pregnant, nursing infants, and men who were to conceive children
Evaluation of the Depth and Duration of Anesthesia From Heated Lidocaine/Tetracaine (Synera®) Patches Compared With 5% Lidocaine (Lidoderm®) Patches Applied to Healthy Adult Volunteers

This will be a randomized, single-blind, active-controlled, two-period crossover study in adult volunteers to compare the duration and depth of anesthesia between Synera® and Lidoderm® patches when applied for 30 minutes and 4 hours. The study will include a Screening Visit, two Treatment Periods, and a Follow-Up Phone Contact.


Eligibility Criteria:
Inclusion:

1. Subject is male or female 18-60 years of age, inclusive.
2. Subject is judged by the Investigator to be in generally good health at screening based upon the results of a medical history, physical examination, clinical laboratory profile, and 12-lead electrocardiogram (ECG).
3. Subject is willing to refrain from using any local topical preparations on the volar aspect of the forearms for 24 hours prior to each site visit.
4. Subject has normal, intact skin bilaterally at the antecubital area.
5. If female, must be of non-childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile \[bilateral tubal ligation, bilateral oophorectomy or hysterectomy\]) or must be using adequate contraception (practicing one of the following methods of birth control):

   * Total abstinence from sexual intercourse (minimum of one complete menstrual cycle before study entry),
   * A vasectomized partner,
   * Contraceptives (oral, parenteral, or transdermal) for 3 consecutive months prior to test product administration,
   * Intrauterine device (IUD), or
   * Double-barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream).
6. If female, must have a negative urine pregnancy test at Screening and at check-in of each Treatment Period.
7. Subject is willing to be blindfolded during the study and agrees to abide by all study restrictions and comply with all study procedures.
8. Able to fluently speak and understand English and be able to provide meaningful written informed consent for the study.

Exclusion:

1. Subject has clinically significant ECG abnormalities at screening.
2. Subject is currently receiving class I, II, or III anti-arrhythmic agents.
3. Subject has used over-the-counter (OTC) or prescription analgesics within 24 hours prior to either study period.
4. Subject has a known allergy or history of significant adverse reaction to any component of the treatment or related compounds.
5. Subject has a history of or active use or abuse of illicit drug substance or alcohol abuse.
6. Subject has a positive urine test result for drugs of abuse or a positive ethanol breath test at the Screening Visit or check-in to Treatment Visit 1.
7. Subject has active dermatological disease of any origin that may interfere with the ability to participate.
8. Subject has denuded or broken skin on either forearm.
9. Subject has a history of unstable peripheral/vascular disease and/or hypertensive vascular disease.