cyrilzakka/clinical-trials huggingface dataset:
Diabetes Outcomes in COVID-19 Pandemic

Diabetes management and follow-up has become a challenge during the COVID-19 pandemic. Nation-wide lockdowns and social distancing measures adopted in an attempt to break the chain of COVID-19 transmission have significantly disrupted routine care and follow-up of diabetes. In the health sector, especially in low-income countries such as Pakistan, there has been a shift of resources and staff reassignment from stable chronic illnesses to support COVID-19 pandemic. Disruption of routine outpatient health services and travel restrictions increase the risk of worsening diabetes control and diabetes-related health outcomes. Additionally, social isolation amidst an atmosphere of fear and uncertainty contributes to stress further affecting glycaemic control.

An observational cross-sectional study was conducted using telephone interview method in Diabetes Management Centre (DMC), Services hospital, Lahore. The study participants were 1282 diabetic patients selected randomly from electronic medical record (EMR) database of the Centre. A structured questionnaire was used to evaluate parameters which included patients' demographic information; diabetes self-care and general health profile; COVID-related questions and its impact on quality of life (QoL); financial and social support issues.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 and type 2 diabetic patients registered with Diabetes Management Centre, Services hospital, Lahore, Pakistan.

Exclusion Criteria:

* Patients lacking telephonic contact or with invalid contact numbers.
Journey to Better Health

This study is being conducted in 8 rural counties in Alabama and Mississippi (4 per state). Approximately 400 overweight or obese African American women living in the selected counties will participate in a 2-year weight loss study.

Using a cluster-randomized study design, 400 overweight or obese African American women living in 8 rural counties in Alabama and Mississippi associated with the Deep South Network for Cancer Control will be assigned to either a weight loss only or weight loss plus community strategies condition for 2 years.

Weight Loss Only condition: In year 1, participants will attend weekly in-person group sessions (1.5 hours each) aimed at behavioral changes for weight loss (diet and physical activity) for 6 months followed by twice a month meetings for 3 months, then monthly meetings for 3 months. In year 2, monthly phone calls will be used to encourage continued behavior change or weight maintenance. In-person group meetings will be facilitated by a trained lay staff and community health advisors. Monthly phone calls will be conducted by the community health advisor.

Weight Loss Plus Community Strategies condition: Participants will receive the same weight loss program as the Weight Loss Only condition. In addition, a community-based organization or other non-profit group in the targeted community will receive funds and technical assistance to implement community-wide efforts to increase access to healthy affordable food and safe and convenient opportunities for physical activity (e.g., increase farmer's markets, develop walking trails).

Over the course of the study, participants will complete four full assessments to include measurement of height and weight (to calculate BMI), waist circumference, blood pressure, finger-stick blood draw for lipid and glucose testing, dietary recall, and questionnaires concerning participation in physical activity, self-efficacy for eating and exercise behaviors, depressive symptoms, perceived stress, social support, and demographic information (e.g., age, marital status, education, employment, household income).

Eligibility Criteria:
Inclusion Criteria:

* African American female
* Live or work in target county
* BMI \>= 25 kg/m2

Exclusion Criteria:

* Pregnant or planning to become pregnant in the next year
* Known major medical or psychological condition known to influence body weight
* Uncontrolled hypertension (BP \> 160 mmHg systolic or \>100 mmHg diastolic)
* Cardiovascular event in the preceding 12 months
* History of gastric bypass surgery
* History of psychiatric hospitalization in past 2 years
* History of substance abuse or eating disorder
* Any other condition by which a medical professional has suggested diet modification
* Physical activity and/or weight reduction would be contraindicated
IV Versus IM Administration of Oxytocin for Postpartum Bleeding

This double-blind, randomized controlled trial will evaluate the effect of the route of administration of 10 IU of oxytocin on the average blood loss postpartum. Participants will be randomized to receive 10 IU of oxytocin by IV infusion or 10 IU of oxytocin by injection IM


Eligibility Criteria:
Inclusion Criteria:

* She is present to give birth to a live fetus
* Vaginal delivery
* Willing to participate in the study
* Able to give informed consent

Exclusion Criteria:

* Scheduled for a cesarean
* Reject the placement of an IV during labor (for intravenous infusion)
* Cannot give informed consent for any reason
* Not willing and / or cannot answer questions about background
Comparing Designs for Restaurant "Eco-Labels"

The aim of this study is to compare responses to 5 different types of labels for restaurant menus: 1) Control (non-sustainability-label: neutral labels not referencing environmental sustainability); 2) Numeric text-only sustainability label; 3) Endorsement text-only sustainability label; 4) Endorsement icon-only sustainability label; 5) Endorsement text-plus-icon sustainability label. Participants will be randomized to 1 of the 5 labeling arms above. Each participant will view 3 labels (shown in random order) from their randomly assigned labeling arm and respond to survey questions about each label (e.g., attention, perceived effectiveness).

This is an online randomized controlled trial. Investigators will recruit participants through a survey company to complete an online survey. In the study, participants will be randomized to 1 of 5 labeling arms: 1) Control (non-sustainability-label: neutral labels not referencing environmental sustainability); 2) Numeric text-only sustainability label; 3) Endorsement text-only sustainability label; 4) Endorsement icon-only sustainability label; 5) Endorsement text-plus-icon sustainability label. Participants will be randomized to 1 of the 5 labeling arms above. Each participant will view 3 labels (shown in random order) from their randomly assigned labeling arm and respond to survey questions about each label (e.g., attention, perceived effectiveness).

Eligibility Criteria:
Inclusion Criteria:

* Participants will be US adults
* Ages 18 or older
* With an over-sample of adults (50% of total sample) 18-29 years

Exclusion Criteria:

* Younger than 18
* Non-US
Oral Azithromycin Versus Doxycycline in Posterior Blepharitis

One hundred patients with the diagnosis of posterior blepharitis based on history taking and proper physical examinations by two experienced ophthalmologists will include in the study.

Patients will diagnose with posterior blepharitis if they score at least one in two symptoms (based on a subjective grading scale) and two signs (based on an objective grading scale) of posterior blepharitis according to study criteria. Patients will exclude if they have the following criteria: age\< 12 years old,history of previous ocular or lacrimal surgery,previous usage of contact lenses,any history of ocular allergy,history of systemic diseases with ocular involvement (except rosacea), history of usage of topical or systemic antibiotic in the last month, pregnancy or lactating mothers, liver failure and any history of sensitivity to cyclines.

Qualified patients then randomly receive oral azithromycin (2 of 250 mg capsules for the first day and 250mg for the next 4 days) or oral doxycycline (100mg capsule every 12 hours for one month) in a double-blinded fashion. each patients in both treatment groups will accurately instruct to apply warm compress and eyelid scrubbing 2 times a day for 5 minutes each in the treatment period. Symptoms and signs were recorded for each patient in two treatment groups at baseline visit (before treatment) and then in the days 7, 31, 37 and 61 after treatment.


Eligibility Criteria:
Inclusion Criteria:

Patients were diagnosed with posterior blepharitis if they scored at least one in two symptoms (based on a subjective grading scale) and two signs (based on an objective grading scale) of posterior blepharitis according to study criteria

Exclusion Criteria:

Patients were excluded if they had the following criteria: age\< 12 years old,history of previous ocular or lacrimal surgery,previous usage of contact lenses,any history of ocular allergy,history of systemic diseases with ocular involvement (except rosacea), history of usage of topical or systemic antibiotic in the last month, pregnancy or lactating mothers, liver failure and any history of sensitivity to cyclines
Neuropsychological and Neuroanatomical Studies of Young Children With and Without Type 1 Diabetes Mellitus

This study is being conducted to see if Type 1 diabetes mellitus has any affect on learning, behavior and development in young children and whether there are associated changes on their MRI scan.

In this pilot study approximately 10-20 children between the ages of 3 to 10 years with Type 1 diabetes mellitus will have neuropsychological testing and a nonsedated MRI scan of the head performed every three years for three years. We will compare this to a control group of 10 children between the ages of 3 adn 10 years without Type 1 diabetes mellitus. The control subjects will neuropsychological testing and a nonsedated MRI scan of the head once. The children with Type 1 diabetes mellitus will not have any changes made to their current diabetes regimen.

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria for study subjects:

* To be between ages 3 to 10 years
* Have been diagnosed with type 1 diabetes for at least 6 months; and
* Do not have plans to move out of the area within the next 36 months.

Inclusion Criteria for control subjects:

* To be between ages 3 to 10 years

Exclusion Criteria:

* No history of head trauma with any loss of consciousness,
* Cystic fibrosis,
* Prematurity (born less than 30 weeks of gestation),
* Significant developmental delay (lack of single word speech or ability to walk independently by 18 months of age),
* Neurologic disease independent of diabetes (eg seizure disorder); or
* Medical contraindication to MRI procedure (eg metal appliances such as braces).
Clinical Feasibility Study of Allium's Biliary Stent

The purpose of this study is to evaluate the safety and efficacy of the Allium Biliary Stent in malignant obstructions of the common bile duct.

Biliary duct stenoses are caused by intrinsic malignant disease of the common bile duct or by compression or infiltration of malignancies of the abdominal organs, i.e. pancreas, liver, stomach, duodenum, etc, or by iatrogenic reasons such as endoscopic biliary stone manipulations, biliary anastomoses or biliary duct reimplantation. In these diseases, a stent can be placed in the biliary duct canal to "open it" and relieve the obstruction. The Allium Biliary Stent is to be inserted into the biliary duct to allow free flow of biliary fluid from the liver to the duodenum by supporting the obstructed area of the biliary duct lumen, keep it open, and prevent its re-obstruction.

Eligibility Criteria:
Inclusion Criteria:

* Patient is 18 years or older
* Patient has malignant obstructive jaundice
* Patient is unfit for surgery
* Patient is capable of giving informed consent
* Patient is willing to comply with study requirements

Exclusion Criteria:

* Patient has a benign biliary duct obstruction
* Patient cannot tolerate any form of antibiotic treatment
* Patient is currently receiving anticoagulation therapy
* Patient has history of illness, medication, or surgery that may affect the efficacy of the stent (e.g.: a previous surgical change in the anatomy of the common bile duct)
Perioperative Muscle Relaxant and Postoperative Outcomes

Muscle relaxant is usually needed for surgery. However, the optimal depth of neuro-muscular blockade is still on debate. Deep neuro-muscular blockade may benefit the patients during surgery, but may increase the risk of residual blockade after surgery. Residual blockade has been reported to increase risk of morbidity. In this study, we tend to observe the postoperative outcomes in patients undergoing abdominal surgery under general anesthesia. And to compare the outcomes in patients received different depth of neuro-muscular blockade.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old
* Body mass \<18 kg/m2
* American Society of Anesthesiologists status I-II
* Patients scheduled for elective laparoscopic colorectal or urological surgery
* Patients received general anesthesia and muscle relaxant
* Patients with written informed consent.

Exclusion Criteria:

* Second surgery during the same admission.
* Outpatient surgery
* Retroperitoneal laparoscopic surgery
* Patients scheduled for mechanical ventilation after surgery
* Patients scheduled for muscle relaxant other than rocuronium
* Patients with pregnancy or planned for breeding
* Patients who are involved in other studies
Project Gullstrand - European Project for the Determination of Average Biometric Values of Human Eyes

The purpose of this study is to determine the average values of human ocular biometry and to correlate these values with visual function.


Eligibility Criteria:
Inclusion Criteria:

* Two normal eyes
* Ametropia between -10D and +10D.

Exclusion Criteria:

* One pathological eye
* Prior ocular surgery
* Amblyopia, refraction larger than ±10D
* Corneal or retinal pathologies
* Systemic diseases (e.g. diabetes, multiple sclerosis, ...)
* More than 5 months pregnant at the moment of testing
* Recent wear of hard contact lenses
* Epilepsy (if C-Quant is used).
An Implantable Spinal Cord Stimulation Pain Management System

There are many treatment options available for the management of chronic pain . Some include, but are not limited to, over-the-counter medications, Non-Steroidal Anti-Inflammatory Drugs, Physical Therapy, Transcutaneous Electrical Nerve Stimulation (TENS) and nerve blocks. Historically, the mainstay of pain treatment has been pharmacotherapy. However, pharmacotherapy has varying degrees of effectiveness and is often associated with undesirable side effects. Although many patients are successfully treated, for those who fail some of these more conservative therapies the remaining option is limited to spinal cord stimulation (SCS), proven to be an effective therapy to more than half of those failing conservative treatments . Over 50% of those who have failed these more conservative methods of pain management, can now, under the guidance of a clinician utilizing SCS, have their pain levels successfully managed. SCS is a less invasive therapy that is a reversible treatment with greater long-term benefits than more permanent, radical approaches and one that deserves greater consideration in the management of chronic, intractable pain.

This clinical trial was a confirmatory study for the Advanced Bionics totally implantable Spnial Cord Stimulation(SCS) System, the Stimulus System. This system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: Dailed back surgery syndrome, intractable low backpain and leg pain.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with chronic, intractable pain of the trunk and/or limbs which includes but is not limited to, unilateral or bilateral pain associated with any of the following: failed back surgery syndrome, intractable low back pain and leg pain.
2. Be an appropriate candidate for surgery.
3. Be capable of giving informed consent.
4. Be capable and willing to follow all study related procedures.

Exclusion Criteria:

1. Have an inability to operate the system either by self or care-giver.
2. Are currently participating or have participated within the past 30 days in any clinical investigation that could conflict with the requirements of this study.
3. Have any implanted electrical devices, regardless of whether active or inactive.
4. Have any active implantable device regardless of whether stimulation is ON or OFF.
Varenicline in Drug Treatment

The aim of this study is to assess the efficacy of varenicline compared to placebo in tobacco dependent individuals who are undergoing concurrent treatment for alcohol dependence. As they will be inpatients and under 24 hour medical care for the first 21 days of treatment, or receiving outpatient treatment through the Alcohol Research and Treatment Clinic, this will allow for a comprehensive assessment of the safety of varenicline in this population with minimal risk of adverse consequences. The patients will continue their cessation treatment for an additional 10 weeks as outpatients through the Nicotine Dependence Clinic at CAMH. They will also be contacted at 6 months for follow-up.

Drinking alcohol and cigarette smoking are closely associated and use of one often leads to the use of the other. Also, since tobacco-related illness is the number one cause of death among recovered alcoholics it is imperative that we provide strong evidence-based treatment options for this population. Since smoking can be a strong trigger to drink in those who are dependent on both alcohol and tobacco, treating both at the same time may result in better treatment outcomes. This study will examine the efficacy of starting smoking cessation treatment while patients are in residential treatment for alcohol dependence, or outpatient in the Alcohol Research and Treatment Clinic. It will compare the effectiveness of varenicline, the most effective medication for smoking cessation with placebo. Both groups will receive weekly cessation counselling and support by a trained research analyst. We will measure abstinence from smoking at the end of the 12-week treatment period and again after 6-months to determine longer-term smoking cessation.

Eligibility Criteria:
Inclusion Criteria:

* current daily smokers enrolled in residential treatment or outpatient in Alcohol Treatment and Research Clinic for Alcohol Use Disorder at CAMH
* smoke minimum of 10 cigarettes per day
* Fagerstrom Test of Nicotine Dependence score \> 3
* able to provide written informed consent
* able and willing to attend weekly appointments at the NDC following discharge

Exclusion Criteria:

* any serious medical condition requiring immediate investigation or treatment
* pregnancy or lactation
* current DSM-IV Axis I psychiatric disorder
* any know contraindication to using varenicline
Laparoscopic Cryoablation of Uterine Fibroids

The goal of this study is to evaluate the safety \& efficacy of cryoablation using IceCure medical's IceSense3™ device for the treatment of symptomatic uterine fibroids in a percutaneous lap-assisted approach.


Eligibility Criteria:
Inclusion Criteria:

1. Pre-menopausal woman between the ages of 30 and 50 (inclusive)
2. Patient had completed her family planning and does not desire future childbearing.
3. Patient is suffering from menorrhagia as a result of symptomatic uterine fibroids.
4. Patient's uterus size is smaller than 18 gestational weeks.
5. Patient wishes to preserve her uterus and avoid hysterectomy.
6. Patient has 1-3 treatable uterine fibroids in size of up to 10cm measured by US/MRI.
7. Overall treated fibroid volume is ≤ 3,138cm3 (width x length x height x 0.523)
8. Patient has clinical menorrhagia as indicated by menstrual blood loss of ≥160 ml during one baseline cycle prior to treatment.
9. Patient is able to visit the clinic as needed during the 1 year follow-up period following the treatment.
10. The patient has been informed of the study and agrees to its provisions, and has signed an IRB approved written informed consent, including data privacy authorization.

Exclusion Criteria:

1. Patient had not finished her family planning
2. Patient was already treated for uterine fibroids in the past (UAE, myomectomy, HIFU,...) or undergone endometrial ablation.
3. Patient had been treated with GnRH over the last 3 months.
4. Patient has known symptomatic endometriosis that cannot be completely removed during laparoscopic procedure.
5. Patient has known or suspected adenomyosis
6. Patient had any active abdominal/pelvic inflammatory disease.
7. Patient has known or suspected gynecologic malignancy.
8. Patient with submucosal fibroids type "zero"
9. Patient with undiagnosed vaginal bleeding
10. Patient with blood clotting disorders
11. Patients carrying contagious diseases such as Tuberculosis Hepatitis or AIDS.
12. Patient participating in other trials using drugs or devices.
13. Patient is unable to commit all study requirements including follow-up visits and questionnaires.
14. Patient has any contraindication for laparoscopic surgery
A Study To Assess Adverse Events and Effectiveness of Upadacitinib Oral Tablets in Adult and Adolescent Participants With Vitiligo

Vitiligo is a common chronic autoimmune disease that causes the body's immune system to attack its own pigment producing skin cells. This study is to evaluate how safe and effective upadacitinib is in participants with non-segmental vitiligo (NSV). Adverse effects and change in disease activity will be assessed.

Upadacitinib is an approved drug for various immune-mediated inflammatory diseases and is currently being investigated for the treatment of NSV. There will be 2 replicate studies running at the same time (Study 1 and Study 2 with periods A and B) and an optional exploratory Narrow-Band Ultraviolet B (NB-UVB) phototherapy study (Study 3). In Period A, participants are placed in 1 of 2 groups called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will receive placebo and 2 in 3 chance participants will receive upadacitinib. In Period B, all participants will receive upadacitinib. Approximately 270 adult and adolescent participants with NSV will be enrolled in each main study ((Study 1 and Study 2, 540 subjects total) at approximately 90 sites worldwide with an option for adult participants who completed Period A of either study and did not achieve T-VASI 90 at week 48 while on study drug, to enter Study 3.

In Studies 1 and 2: Period A, participants will receive oral tablets of upadacitinib or placebo once a day for 48 weeks. In Period B, participants will receive oral tablets of upadacitinib 15 mg once a day for 112 weeks. Participants will be followed up for 30 days. Study 3 participants will receive upadacitinib monotherapy or upadacitinib with NB-UBV phototherapy for at least 24 weeks followed by upadacitinib alone.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Documented clinical diagnosis of non-segmented vitiligo (NSV).
* At Screening and Baseline Visits, participants must satisfy at least 1 of the following criteria:

  * \>= 0.5 F-VASI and 5 \<= T-VASI \< 50 AND have failed at least 1 topical corticosteroid and/or at least 1 topical calcineurin inhibitor for vitiligo; or
  * \>= 0.5 F-VASI and 5 \<= T-VASI \< 50 AND have a sign of actively progressing vitiligo; or
  * \>= 0.5 F-VASI and 10 \<= T-VASI \< 50.

Exclusion Criteria:

* Segmental or localized vitiligo.
* History of active skin disease other than vitiligo that could interfere with the assessment of vitiligo.
* \>33% leukotrichia in areas of vitiligo on the face or \> 33% leukotrichia in areas of vitiligo on the body (including the face).