cyrilzakka/clinical-trials huggingface dataset:
A Study of a Values-Based Intervention to Promote Weight Loss

More than 160 million American adults are overweight or obese. Existing weight loss interventions from self-help to gold standard behavioral treatments, while often effective, do not sufficiently maintain motivation to adhere to dietary goals in the face of powerful biological and environmental influences to consume highly palatable foods. Clarification and awareness of values, a staple of acceptance-based treatments drawn from Acceptance and Commitment Therapy, are thought to enhance autonomous motivation to engage in behaviors consistent with one's personal life values (e.g., health) in the presence of countervailing forces (e.g., hunger, deprivation). However, the independent efficacy of values clarification and awareness in facilitating weight control has never been tested. This pilot study seeks to investigate the feasibility and acceptability of a series of three weight loss workshops (based off the gold standard) infused with values clarification and awareness techniques to promote weight control. Participants will be asked to follow a reduced-calorie dietary prescription while holding their values in mind in moments of dietary decision-making over the course of one month. The primary aims of this study are to: 1) develop the series of values-infused workshops, using participant feedback to iterate and improve the treatment manual; and 2) evaluate treatment acceptability. Secondary aims are: 1) to evaluate whether clinically meaningful changes in measures of values clarification and values awareness occur; 2) to evaluate whether the intervention will lead participants to experience clinically meaningful changes in values-congruent weight control behaviors; 3) to evaluate whether the intervention will lead participants to experience clinically meaningful changes in weight; and 4) to evaluate theorized mechanisms of action in the intervention.


Eligibility Criteria:
Inclusion Criteria:

* BMI of 25-55 kg/m2
* 18-70 years of age
* Have a desire to lose weight
* Own a smartphone
* Live in the Philadelphia area
* Provide informed consent

Exclusion Criteria:

* Any medical or psychiatric conditions (e.g., eating disorder, diabetes) that may pose a risk to the participant during the intervention, cause a change in weight or appetite, or interfere with ability to adhere to diet recommendations
* Recent change in medication dosage that could affect weight or appetite
* Current or planned pregnancy in the next month
* Planned move out of the Philadelphia area in the next month
* History of bariatric surgery
* Weight loss of ≥5% in the last six months
* Concurrent behavioral therapy targeting weight control
Pilot Trial of Cognitive and Behavioral Treatment of Compulsive Hoarding Compared to Wait List Control

This study developed and tested a specialized cognitive and behavioral treatment for the symptoms of hoarding disorder, including excessive acquiring, difficulty discarding items, and extensive clutter in the home.

Compulsive hoarding is characterized by excessive acquisition of possessions, difficulty discarding possessions, and excessive clutter. This condition is resistant to standard pharmacological and psychotherapeutic interventions that have proven effective in treating other obsessive compulsive spectrum disorders. This study aimed to determine the effectiveness of a specialized cognitive behavioral therapy (CBT) designed for treating hoarding symptoms.

This study consists of three phases. In Phase 1, pilot data from previous studies were examined to develop an intervention suitable for use in a waitlist trial. In Phase 2, pilot study information were used to develop and test a treatment manual for compulsive hoarding. During this phase, treatment was applied flexibly to allow for variations in treatment duration and choice of techniques. During Phase 3, participants were randomly assigned to 26 weekly sessions of CBT or to a 12-week wait-list control, followed by active treatment for a fixed duration of 26 sessions. Therapist adherence and competence were assessed through audiotaped therapy sessions.

Eligibility Criteria:
Inclusion criteria:

* Display at least moderately severe hoarding symptoms
* Must live within 45 minutes of Boston, MA or Hartford, CT

Exclusion criteria:

* Ten or more sessions of cognitive behavior therapy for hoarding
* Concurrent psychotherapy or medications
* Suicidal, psychotic, or other psychiatric symptoms requiring hospitalization
* Compulsive buying symptoms that are part of a manic phase of bipolar disorder
* Mental retardation, dementia, brain damage, or other cognitive dysfunction that would interfere with the study
Testing of Four Home Phenylalanine Monitoring Prototype Devices

The objective of this study is to test four home phenylalanine monitoring prototype devices, selected out of a pool of candidates by the National PKU Alliance Scientific Committee.

A real time, point-of-care and home phenylalanine monitoring system would provide patients with quick results and feedback. Home monitoring devices' phenylalanine measurements will be compared to the current gold-standard measurement of phenylalanine (plasma concentration) in four subjects with PKU and one control subject. The study will enroll subjects with different baseline phenylalanine concentrations (i.e., patients with poor to good metabolic control, assessed by comparing current phenylalanine concentrations to established treatment ranges).

For each prototype device, three separate measurements of phenylalanine per subject will be performed. Three prototype devices require whole blood, thus 1 teaspoon (approximately 4mL) of whole blood will be collected through venipuncture and blood spots will be used to conduct tests. One prototype requires capillary blood to be collected through a fingerstick, and will require three blood spots from the stick. A single plasma amino acid analysis for each participant will also be performed using leftover whole blood from the 4mL blood draw through quantitative ion exchange chromatography, reported as micromoles/L.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of PKU or hyperphenylalaninemia (PKU group)
* any age
* in good health (PKU and control group)

Exclusion Criteria:

* pregnant
* have any medical comorbidities
* considered unfit for participation by the principal investigator
Benefits of Hysteroscopy Prior to Performing a Cycle of in Vitro Fertilization/Intracytoplasmic Sperm Injection

This is a prospective randomized open-label trial. Women scheduled for their first or second in-vitro fertilization/intracytoplasmatic Sperm Injection (IVF/ICSI) cycle and with no abnormality detected in transvaginal ultrasound examination, were randomized to two groups. In the first group (group I) 31 patients underwent hysteroscopy examination before IVF cycle while in the second group (group II) 37 patients underwent direct cycle without previous hysteroscopy

This is a prospective randomized open-label trial. Women scheduled for their first or second IVF/ICSI cycle and with no abnormality detected in transvaginal ultrasound examination, were randomized to two groups. In the first group (group I) 31 patients underwent hysteroscopy examination before IVF cycle while in the second group (group II) 37 patients underwent direct cycle without previous hysteroscopy. Then IVF cycle was performed with habitual protocol. Beta Corionic Gonatropic hormone (BhCG) test two weeks after embryo transfer was done. If test was positive, patients were followed up for detection pregnancy by transvaginal ultrasound two weeks later. Another transvaginal ultrasound at 12 weeks of gestation was done to confirm ongoing pregnancy. Biochemical pregnancy, implantation, on-going pregnancy and livebirth rates were compared in both groups.

Miscarriage, complications rate and hysteroscopy tolerability were also analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Women with infertility / primary infertility.
* Women who are about to start an IVF/ICSI cycle with their own eggs.
* Age greater than or equal to 18 years and less than or equal to 40 years.
* Women in whom a multiple follicular development will be developed with a short protocol with antagonists or long with agonists, and starting dose of gonadotropins according to clinical criteria.
* Women with uterine ultrasound without endometrial pathology

Exclusion Criteria:

* Ovarian reserve: Antimullerian hormone \<0.5 ng / dl or Count of antral follicles \<5 between both ovaries.
* Myomatous uterus: presence of\> 2 myomas\> 4cm or that deform uterine cavity.
* Uterine malformations.
* Body mass index (BMI) \<18 or\> 30.
* Polycystic ovarian syndrome: according to European Society of Human Reproduction and Embryology (ESRHE)/Rotterdam 2003 criteria.
* Moderate-severe endometriosis.
* Background or presence of pelvic inflammatory disease.
* Hydrosalpinx not excised or occluded.
* Hyperprolactinemia, defined as prolactin levels greater than 50 ng / ml.
* Diagnostic history of endometrial hyperplasia.
* Severe male factor: severe oligoasthenoteratozoospermia with a sperm cell count (REM) \<100,000 spermatozoa / ml.
* Impossibility to apply the treatments provided by the study in the terms established by the protocol.
* Contraindication for the use of any of the treatments provided in the study.
Bradykinesia Subscale Administered Alone Versus Regular Administration: Psychometric Properties

The purpose of this study is to examine whether scores on questionnaires that rate how much Parkinson's Disease (PD) has slowed movements of the body differ when the order of the questions are changed. The consistency and accuracy of the questionnaires will also be examined. It is hypothesized that there will not be a difference.


Eligibility Criteria:
Inclusion Criteria:

1. Male or Female at least 30 years of age
2. Willing to be assessed using the motor examination section of the UPDRS and the SPES/SCOPA motor evaluation
3. Patients must be willing and able to give written informed consent prior to performing an study procedures
4. Be in the "ON" State (only for patients who fluctuate between "ON" and "OFF" states)

Exclusion Criteria:

1. Absence of bradykinesia at the time of assessment
2. Hoehn and Yahr stage not available from patient's chart or not assessed between 3 and 180 days prior to clinic visit
3. Has received and experimental drug within the last thirty (30) days
Transanal Total Mesorectal Excision Versus Laparoscopic TME for Rectal Cancer

To investigates the feasibility, practicability, safety and subjective as well as functional outcome of transanal minimal invasive surgery toal mesentery excision for rectal cancer.

Natural orifice transluminal endoscopic surgery (NOTES) give the opportunity to reduce surgical access trauma leading to a more painless surgery and enhancing a fast postoperative recovery. Experience with transanal minimal invasive surgery(TAMIS) for rectal cancer show that such NOTES procedures are feasible and safe. And also, lots of experimental studies and small case series reporting the feasibility of transanal anterior resection with single incision laparoscopic surgery(SILS) port or other devices. However any prospective feasibility study demonstrating the safety of the procedure and functional outcomes (sphincter function, sexual function, QOF) are missing. This study investigates the feasibility, practicability, safety and subjective as well as functional outcome of transanal minimal invasive total mesentery excision for rectal cancer.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven adenocarcinoma of the rectum
* Eligible to undergo conventional laparoscopic low anterior resection or transanal hybrid-laparoscopic low anterior resection with or without a temporary diverting stoma
* Node negative (N0), T1 (high risk features), T2 and T3 rectal cancer on pelvic MRI
* Closest distance between tumor edge and mesorectal fascia 5mm or more based on pelvic MRI
* Rectal cancer located 3-10 cm from the anal verge

Exclusion Criteria:

* Metastasis
* Obstructing rectal cancer
* Synchronous colon cancer
* T4 rectal cancer not treated preoperatively with full-course chemoradiation
* Pregnant or breast-feeding
* Receiving any other study agents
* Fecal incontinence
* History of prior colorectal cancer
* History of inflammatory bowel disease
* History of pelvic radiation
* BMI \> 40
* Large uterine fibroids
* Uncontrolled intercurrent illness
Is ENI Necessary For Patients With Thoracic Esophageal Cancer After Esophagectomy And With Pathological Stage Of T1-2,N+,M0

Is elective nodal irradiation (ENI) necessary for patients with thoracic esophageal cancer after esophagectomy and with pathological stage of T1-2,N+,M0?

Patient Population:

Thoracic esophageal squamous cell carcinoma after esophagectomy with at least 15 lymph nodes removed for adequate nodal staging.

R0 resection; T1-2, N+, M0.

Scheme:

After esophagectomy, patients are firstly stratified by numbers of lymph node metastasis (\<3 or \>=3). Then patients are randomized to 2 arms:

Arm A:

Adjuvant chemotherapy (4 cycles).

Arm B:

Adjuvant chemotherapy (4 cycles) + Elective Nodal Irradiation (bilateral supraclavicular fossa and mediastinum).

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 and ≤70
2. ECOG performance status 0-1
3. Weight is not less than 90% of it before operation
4. Registration within 8 weeks after esophagectomy
5. Histologically proven primary thoracic esophageal squamous cell carcinoma
6. R0 resection and number of lymph nodes dissected ≥15 after esophagectomy
7. Stage T1-2N1-3M0 based pathological diagnosis
8. Chest and abdominal contrast enhanced CT within 6 weeks prior to registration(PET/CT scan is selective)
9. Without supraclavicular nodes and abdominal regions nodes existed after surgery
10. Without neo-adjuvant chemotherapy and radiotherapy
11. WBC≥ 4.0X109/L ,Absolute neutrophil count (ANC) ≥ 2.0X109/L
12. Platelets ≥ 100X109/L
13. Hemoglobin ≥ 90g/L(without blood transfusion)
14. AST (SGOT)/ALT (SGPT) ≤ 2.5 x upper limit of normal, Bilirubin ≤ 1.5 x upper limit of normal
15. Creatinine ≤ 1.5 x upper limit of normal
16. Sign study-specific informed consent prior to study entry

Exclusion Criteria:

1. Multiple primary esophageal tumors
2. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
3. Severe, active comorbidity, defined as follows:

   3.1 Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months 3.2 Transmural myocardial infarction within the last 6 months 3.3 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration 3.4 Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration 3.5 Acquired immune deficiency syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
4. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception.
5. Prior systemic chemotherapy, prior radiation therapy or prior target drug therapy
Patient-Centered Decision Support for Eosinophilic Esophagitis

The study team is conducting this project to learn more about how patients with eosinophilic esophagitis (EoE) like to use and receive educational materials about treatment options and treatment decision making.

This study will assess the efficacy of a decision support intervention to make decisions about treatment and disease management for patients with EoE and will assess the feasibility and acceptability of the intervention to inform future R01-level studies.

The study team hypothesize that deploying the intervention will be feasible, and it will demonstrate high acceptability among EoE patients. Additionally, that patients that use the intervention (vs general education about EoE) will report greater treatment knowledge, increased readiness to choose a therapy, adherence to therapy, and follow-up.


Eligibility Criteria:
Inclusion Criteria:

* New EoE patient evaluations ≥18 years old at University of Michigan (UM) that have an upcoming outpatient visit in a UM-gastroenterology or allergy \& immunology clinic,
* Able to speak and read English.

Exclusion Criteria:

* Prisoners and institutionalized individuals due to logistical limitations for use of a web app and follow-up interactions in these populations.
* Patients that have significant cognitive or visual impairment that limits interaction with the decision aid (DA)
* Patients that are terminally ill
* Patients that do not have an email address or reliable access to the internet
Rehabilitation Care for Hip Fracture

Purpose: Hip fracture is a common disease on elderly. They become disabled easily if no adequate rehabilitation was given. The aim of the study is to compare the effectiveness of different types of post acute rehabilitation care for hip fracture.

Method: This study will recruit 150 peoples with hip fracture from hospitals in Taipei from Jan 1, 2014 to Dec 31, 2014. The subjects from wards are randomly divided into group A, B and Group C. Each group includes 50 cases of hip fracture. Group C received 14 days hospitalization for comprehensive rehabilitation and 6 times home rehabilitation services within 3 months; Group B received 14 days hospitalization for comprehensive rehabilitation and Group A was control group.

Eligibility Criteria:
Inclusion Criteria:

1. more than 60 years old,
2. hip fracture s/p within 3 months,
3. potential for rehabilitation.

Exclusion Criteria:

1. Active infection, such as pneumonia, UTI, osteomyelitis, wound infection
2. Other uncontrolled medical condition, such as, dyspnea on exertion, acute renal failure, acute coronary syndrome, acute heart failure, uncontrolled diabetes, active malignancy, DVT, possibility of pulmonary embolism, acute psychosis
3. No caregiver
4. No potential for rehabilitation, such as severe dementia, poor cognition, poor cooperation and motivation, poor family support
5. ESRD on Hemodialysis
" Sweeper " and Epiretinal Membrane Surgery

Epiretinal membrane (ERM) is a pathological phenomenon requiring surgery when vision is altered.

ERM surgery requires ERM peeling, then active internal limiting membrane (ILM) peeling if it is not spontaneously peeled with ERM. Initiation of peeling is very delicate and can lead to micro scotoma when realized with microscopic forceps. The Sweeper is a microscopic tool with a soft silicon tip covered with diamond dust which allows peeling initiation without retina prehension. It may reduce retinal trauma and visual sequelae.

Purpose of our study is to evaluate use of sweeper during 20 ERM surgeries. The investigator will compare microperimetry before surgery versus those after 1 month (M1) and 3 months (M3), and measure difference of number and depths of micro scotoma.

The investigator will note: number of forceps uses if sweeper is inefficient and all areas of sweeper use to correlate them with micro scotoma.

The investigator will evaluate visual and optical coherence tomography improvement after surgery.

Epiretinal membrane (ERM) is a pathological phenomenon that leads to visual loss, visual distortions, central scotoma, and diplopia. No medical treatment is yet available.

ERM surgery requires separation of normal retina and epiretinal membrane. After epiretinal peeling, if internal limiting membrane (ILM) is not spontaneously peeled with ERM, surgeon peels ILM from retina (also named active peeling). Initiation of peeling is very accurate and delicate. Either microscopic forceps or sweeper are used to initiate peeling. Sweeper is a microscopic tool with a soft silicon tip covered with diamond dust which allows peeling initiation without retina prehension. It may reduce retinal trauma and visual sequelae.

ILM active peeling reduces recurrence of ERM and rate of repeat surgery. No visual acuity loss has been found. But 2 studies show increase of micro scotoma at micro-perimetry after active ILM peeling with forceps.

Purpose of our study is to evaluate use of sweeper during 20 ERM surgeries. The investigator will compare microperimetry before surgery versus those after 1 month (M1) and 3 months (M3), and measure difference of number and depths of micro scotoma.

The investigator will note: number of forceps uses if sweeper is inefficient, all areas of sweeper use to correlate them with micro scotoma.

The investigator will evaluate visual and optical coherence tomography improvement after surgery.

Our study doesn't include any intervention while surgeries would be realized with or without study participation. Examinations are non-invasive, usual, and done during usual medical visit without additional visit.

Eligibility Criteria:
Inclusion Criteria:

* consent,
* adult patient,
* Epiretinal membrane

Exclusion Criteria:

* perimetry impossible
Study of Nasonex in the Relief of Nasal Congestion in Patients With Seasonal Allergic Rhinitis (Study P05583)

This study seeks to prospectively demonstrate that Nasonex is better than placebo in relieving nasal congestion in patients with seasonal allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* A subject must be 12 years of age or older, of either sex, and of any race.
* A subject must have at least a 2-year history of SAR which exacerbates during the study season.
* A subject must have a positive skin prick test response to an appropriate seasonal allergen at Visit 1.
* A subject must be clinically symptomatic at the Screening and Baseline Visits.

Exclusion Criteria:

* A subject with a history of severe local reaction(s) or anaphylaxis to skin testing.
* A subject who has had an upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or who has had a viral upper respiratory infection within 7 days prior to the Screening Visit.
* A subject who has used any drug in an investigational protocol in the 30 days prior to the Screening Visit.
* A subject who is participating in any other clinical study.
* A subject who is part of the staff personnel directly involved with this study.
* A subject who is a family member (parent, spouse, or sibling) of the investigational study staff.
* A female subject who is breast-feeding, pregnant, or intends to become pregnant.
* A subject previously randomized into this study.
* A subject who has a family member (parent, spouse, or sibling) currently enrolled in this study.