cyrilzakka/clinical-trials huggingface dataset:
Open-Label Depakote ER in Patients With Bipolar I or II Depression and Alcohol Abuse or Dependence

The purpose of this study is to determine if Divalproex Sodium can be used to Treat and Prevent Depression in Patients with Bipolar Disorder who have Comorbid Alcohol Dependence/Abuse.

Over half of all patients with bipolar disorder have comorbid substance abuse. The most common substance of abuse is alcohol, which is most commonly associated with the depressed phase of the illness. Although there are available treatments for bipolar depression, no studies have been done to evaluate efficacy in bipolar patients with comorbid substance abuse disorders. Given the independent open-label evidence for efficacy and safety of divalproex sodium in alcohol abuse and bipolar depression, divalproex sodium is the most likely candidate for potential success in bipolar depressed patients with comorbid alcohol abuse or dependence. The purpose of this study is to determine if Divalproex Sodium can be used to Treat and Prevent Depression in Patients with Bipolar Disorder who have Comorbid Alcohol Dependence/Abuse.

Eligibility Criteria:
Inclusion Criteria:

* MADRS \>= 20 at screen and 18 at baseline
* YMRS =\< 11 at screen and baseline
* DMS-IV criteria for past manic or hypomanic episode based on the SCID
* DSM-VI criteria for alcohol dependence or abuse based on the SCID.
* Alcohol dependence/abuse confirmed by corroboration from family member
* Negative urine pregnancy test

Exclusion Criteria:

* Inability to give informed consent
* Inability to give reliable assessment of alcohol consumption
* Evidence of alcohol consumption one week prior to baseline
* Liver function tests greater than 3X upper limit of normal at screen
* History of active hepatitis or hepatic encephalopathy
* History of pancreatitis
* History of adverse reaction to divalproex sodium
* History of seizure other than directly associated w/prior alcohol withdrawl
* History of major head trauma with LOC \> 10 min. or skull fracture
* Hisotry of hypertension or neurologic illness
* If female, not practicing an effective form of birth control
Validation of the Schiller BR-102 Plus PWA Device to Measure Central and Peripheral Hemodynamics

The significance of parameters of the central hemodynamic is based upon their strong association with left ventricular hypertrophy and target organ damage at the heart. Noninvasive, auscultatory/ oscillometric and therefore easy applicable measurements of the central hemodynamic such as presented by the Schiller BR-102 plus PWA device implicate highly promising potential for research and daily clinical praxis for improved cardiovascular risk assessment on the population level. The purpose of this study is to evaluate the validity of the central and peripheral blood pressure and central arterial stiffness measured with the device BR-102 plus PWA from Schiller (Schiller AG, Baar, Switzerland).

The proposed study is an open, monocentric cross-sectional research study for the evaluation of the validity of the central and peripheral blood pressure and central arterial stiffness measured with the device BR-102 plus PWA from Schiller (Schiller AG, Baar, Switzerland). For that purpose measurement of the respective parameters in cardiovascular disease free individuals will be compared with validated devices and the agreement between the devices will be statistically analyzed. Central blood pressure and central arterial stiffness are clinically increasingly meaningful parameters of the cardiovascular system that allow improved, early cardiovascular risk stratification. The significance of parameters of the central hemodynamic is based upon their strong association with left ventricular hypertrophy and target organ damage at the heart. Noninvasive, auscultatory/ oscillometric and therefore easy applicable measurements of the central hemodynamic such as presented by the Schiller BR-102 plus PWA device implicate highly promising potential for research and daily clinical praxis for improved cardiovascular risk assessment on the population level.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals free of clinically relevant cardiovascular diseases or diabetes based on medical history and physical examination.
* Heart rhythm: Sinus rhythm
* Blood pressure range: 10 to 12 subjects in each of the three systolic blood pressure (SBP) and three diastolic blood pressure (DBP) recruitment ranges (low, medium, high).

Exclusion Criteria:

* Cardiac arrhythmia (atrial fibrillation, frequent extrasystoles)
* Pacemaker-dependent
* Pregnancy after the 6th month of the pregnancy
* Body mass index (BMI)\>30 kg/m2
* Known significant carotid or femoral artery stenosis
* Impalpable arterial pulse at site of measurement
* Age under 18 years.
Comparison Between Free Thyroxine and Thyroid Stimulating Hormone Levels on Melasma Severity

The objective of the study was to compare the level of serum FT4 and TSH in patients with mild melasma and moderate-severe melasma. The determination of melasma lesion could also be known by using Janus II facial analysis UV light and polarization light to analyze the pattern of hyperpigmentation on melasma. This was a descriptive-analytic study used a cross-sectional method that was performed in 2019 at two different dermatology and venerology clinics in Indonesia, Cipto Mangunkusumo Hospital Jakarta and Gatot Subroto Army Hospital Jakarta. Forty-eight subjects with melasma, 50% diagnosed with mild melasma and 50% with moderate-severe melasma according to the modified melasma area and severity index (mMASI) score. The level of serum FT4 and TSH were then measured in both groups of the patients.

Melasma has been suspected to be linked with thyroid hormone. There is no study that explains the association of thyroid hormone level with melasma severity.

This study aims to find the difference in the levels of thyroid hormone in varying severity of melasma.

This was a descriptive-analytic study used a cross-sectional method that was performed in 2019 at two different dermatology and venerology clinics in Indonesia, Cipto Mangunkusumo Hospital Jakarta and Gatot Subroto Army Hospital Jakarta.

Forty eight patients participated in this study, 50% diagnosed with mild melasma and 50% with moderate-severe melasma. Subjects are chosen consecutively based on mMASI and Janus II measurement. The level of serum FT4 and TSH were then measured in both groups of the patients. The data is tabulated and a comparative analysis of serum FT4 and TSH levels with mild and moderate-severe melasma is done. In addition, this study also analyzes the level of serum FT4 and TSH with the result of Janus II facial analysis system scoring. The same method of analysis was done to know the association between mMASI and examination by using Janus II facial analysis system.

This study aims to find the difference in the levels of thyroid hormone in varying severity of melasma.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-50 years
* Melasma lesions on the facial area.
* Willing to be the subject of research and sign a letter of research approval after being given an explanation (informed consent)

Exclusion Criteria:

* Pregnancy
* History of thyroid disease
* Using drugs that can affect the thyroid (glucocorticoids, lithium, amiodarone, iodide, octreotide)
* Using hormonal contraception for the past 1 year
* Using anti-seizure drugs
* Using hormone replacement therapy (HRT)
* Brown spots on the face preceded by reddish spots
* Brown spots on the face preceded by contact with facial whitening ingredients (hydroquinone)
New Surgical Approach in Labioplasty

The data of patients who underwent labiaplasty + vaginoplasty between 2020 and 2022 by a single surgeon in our clinic were analyzed. Preoperative and postoperative FSFI (Female sexual function index) questionnaire scores were used to compare the results of the classical surgical approach and the new surgical approach technique designed according to the Fibonacci ratio in the early postoperative period such as operating time, bleeding amount, etc.

The data of patients who underwent labiaplasty + vaginoplasty between 2020-2022 for reasons such as vaginal laxity, personal hygiene problems, recurrent vaginal infections were analyzed retrospectively. The data of the patients who underwent fibonacci ratio, which is a new surgical approach technique( by Okuyan E. M.D), and the patients who underwent classical surgical technique were taken from their files and retrospectively analyzed. Data including age, body mass index, number of live births, preoperative FSFI, FGSIS and postoperative one month FSFI (Female sexual function index) and FGSIS (The Female Genital Self-Image Scale) scores were recorded and compared between both groups.

Eligibility Criteria:
Inclusion Criteria:

1. No history of any disease
2. The presence of at least 2 of the reasons such as dislike of cosmetic appearance, vaginal abundance, personal hygiene disorder, difficulty in wearing underwear.
3. Body mass index between 15-25
4. Informed consent has been obtained for the new surgical approach technique.
5. Not taking any medication continuously
6. Willing to participate in the study.

Exclusion Criteria:

1. Absence of at least 2 of the reasons such as dislike of cosmetic appearance, vaginal

   abundance, personal hygiene disorder, difficulty in wearing underwear.
2. History of continuous medication, alcohol and/or smoking.
3. History of chronic diseases (Asthma, Diabetes mellitus, Cardiac disease, Psychiatric disease etc.)
4. Body mass index outside the range of 15-25.
5. Not wanting to be included in the study or wanting to leave the study after inclusion.
Abdominal Wall Transplant

The purpose of this protocol is to determine the safety and efficacy of abdominal wall transplantation as a treatment for the reconstruction of abdominal wall defects. Abdominal wall transplantation may be performed alone or in combination with another transplant.

Within this protocol we propose to perform abdominal wall transplantation in 5 subjects, either as an isolated abdominal wall or in combination with another organ transplant. Each subject will be followed for a study period of 18 months.

Participants receiving an isolated abdominal wall or abdominal wall in combination with another organ transplant will receive the standard immunosuppression therapy as the non-vascularized composite allograft organ transplant. These patients will be studied to determine efficacy of the abdominal wall transplant to restore function of the defective abdominal wall for a study period of 18 months at Duke University Medical Center.

Eligibility Criteria:
Inclusion Criteria:

* Candidates between 18-65 years old
* Willingness and legal ability to give consent
* Abdominal Wall in combination with another organ transplant: they must be eligible for the non-vascularized composite allograft organ transplant at Duke

Exclusion Criteria:

* Malignancy at evaluation or history of malignancy that precludes transplantation
* Pregnancy: Women who are of childbearing potential must have a negative serum pregnancy test within 48 hours of transplant and agree to use reliable contraception with two contraceptive methods for a minimum of 2 years following abdominal wall transplantation. Subjects seeking to become pregnant following 2 years will be made aware during the consent process that the effect of pregnancy on the transplanted abdominal wall and vice versa is unknown.
* Medical exclusion criteria for general anesthesia
* Ongoing substance abuse or history of untreated substance abuse
Assessing Lung Dynamics and Respiratory Functions in Minimal Flow Anesthesia: A Prospective Study

The patients were randomized into two groups medium flow anesthesia (MeFA) and minimal flow anesthesia (MiFA). While MeFA received medium flow anesthesia with 2 lt/min, MiFA received minimal flow anesthesia with 0.5 lt/min fresh gas flow. In both groups dynamic compliance values, peak inspiratory pressure (PIP) values, total inhalation anesthetic drug consumption, total remifentanil drug consumption, duration of anesthesia, and duration of surgery were recorded. The FVC, FEV1, and FEV1/FVC values of the patients in both groups were evaluated and noted 24 hours before the operation, after the operation 2nd, 8th, and 24th hours.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-II
* 18-65 years of age, who will undergo elective laparoscopic cholecystectomy surgery

Exclusion Criteria:

* ASA III-IV
* Smokers
* Body mass index (BMI) \> 40 kg / m2,
* Patients with cardiovascular system disease
* Chronic respiratory diseases,
* Patients whose pulmonary function tests cannot be applied and who have problems with pulmonary function tests during the examination of the chest disease consultant
Can a Self-guided Mobile Phone Application Program Improve Wellbeing in University Students

This study seeks to evaluate and compare the effectiveness of a mobile phone application-based intervention in improving wellbeing in young adults. 400 University students are randomized into 1 of 4 intervention types. Pre, mid and post-intervention outcome measures are compared to determine effectiveness of the various intervention types.


Eligibility Criteria:
Inclusion Criteria:

* Access to a mobile phone with the following requirements: iPhone 8 and above, or Android 5.2+ (display greater than 5 inches)
* Have scores of greater than or equal to 29 on the 'Concerns over Mistakes' subscale on the FMPS

Exclusion Criteria:

* Participants who do not meet the inclusion criteria
* Currently pregnant
* Undergoing psychological treatment or counselling
* Have any change in psychotropic medication within twelve weeks before starting intervention
Focused Ultrasound for the Treatment of Pancreatic Cancer - an International Registry

This pancreatic cancer registry aims to collect information on people around the world who select focused ultrasound (FUS) as part of their treatment for pancreatic cancer to learn about the performance of the focused ultrasound technology and health outcomes; the impact of focused ultrasound on your overall health; and provide an understanding of the current care for pancreatic cancer.

The purpose of the registry is to collect data on the performance of the focused ultrasound (FUS) technology and health outcomes. A wide variety of approaches exist for using FUS on pancreatic cancer patients, and the primary goal is to capture this broad spectrum of approaches and their impact on patients overall health. This information will help provide a better understanding of current care, and may possibly direct further, more specific investigations that will follow this registry. After obtaining informed consent a baseline history, physical examination, laboratory studies, and imaging studies needed per standard of care will be performed. Patients' treatment is determined by their caregivers only, and thus the registry will evaluate patient management in "real-world" conditions.

Enrollment Goal: 100

Primary Outcomes: Pain related to pancreatic cancer, Objective response, Progression-free and overall survival, Performance Status, Clinical Benefit Response (CBR), Health-related quality of life

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all registry procedures and availability for the duration of the registry
* Histology proven pancreatic carcinoma in any area of pancreas
* Pancreatic tumor that can be treated by FUS
* Willingness and ability to complete follow-up interviews

Exclusion Criteria:

* Any disease, condition or surgery which would result in a contraindication to undergoing FUS therapy.
* Clinical trials of pancreatic cancer not of focused ultrasound or related activities
* Other non-pancreatic cancer clinical trials
Impact of the HELPeN Program on Social Isolation in Community-dwelling Elders (HELPeN)

The main objective is to determine the effectiveness of the HELPeN Program, a 12-month telephone telenursing program for community-dwelling elderly in social isolation, evaluating the main changes in levels of social isolation, loneliness, quality of life, mental health status (depression), sleep and functional capacity, as well as changes in care management (demand for services and consumption of drugs).

Methodology Two-arm parallel stratified randomized clinical trial with 12 months duration performing measurements at time 0, 3, 6, 6, 9 and 12 months.

Participating subjects will be selected by nursing professionals from users of Area 3 of Health of the Region of Murcia over 65 years old, residing in the community and with a Social Isolation score \<32 (Low perceived social support with DUFSS). Randomization will be performed after stratification according to whether the subjects live alone or accompanied, with a 1:1 ratio. Given an alpha level of 0.05, an anticipated effect size of 1.58, beta power equal to 1, 42 subjects are required in each group.

The intervention consists of a telephonic telenursing program HELPeN (Help eNursing) to be carried out in collaboration with the Poncemar Volunteer Bank.

The control group will not receive any intervention.


Eligibility Criteria:
Inclusion Criteria:

* score \< 32 (Low perceived social support with the DUFSS scale)
* Residence in the community

Exclusion Criteria:

* Severe cognitive impairment (8-10 errors on the Pfeiffer test)
* Non Spanish speakers
* Failure to consent to the study
Proton Radiation for the Treatment of Pediatric Bone and Non-Rhabdomyosarcoma Soft Tissue Sarcomas

The main purpose of this study is to assess the short term and the long term side effects of proton beam radiation for pediatric bone and non-rhabdomyosarcoma soft tissue sarcomas.

* Participants will receive radiation treatments once per day, 5 days a week for a total of 4 to 6 weeks, depending on how much total dose the tumor requires. The radiation doctor will see the participant once each week to monitor and record any side effects they may have from radiation treatment.
* A special device will be made for each participant to help them hold still during the treatment. This may either be a mask or foam cradle, depending on the area to be treated.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven NRSTS or bone sarcoma
* Less than or equal to 30 years of age
* Patients must have been treated with a standardly accepted chemotherapy regimen if chemotherapy is indicated
* Patients must be willing to receive follow-up care for a minimum of five years after treatment at MGH and annual visits unless it is too difficult to return to MGH for follow-up care. In that event, the patient or guardian must be willing to have their outside medical information released in order to track the results of treatment
* They or their legal guardian must give their informed consent
* Timing of radiation may be according to concurrent protocol

Exclusion Criteria:

* Co-morbidities that would make the use of radiation too toxic to deliver safely, such as serious local injury of collagen vascular disease
* Patients who are pregnant
* Previous treatment with radiation therapy
* Concurrent adriamycin or gemcitabine chemotherapy is planned, unless on a concurrent protocol
Effect of Spencer Muscle Energy Technique on Pain in Diabetic Stiff Shoulder

Stiff shoulder is a painful and severely debilitating condition. The inflammatory contracture of the glenohumeral joint capsule in stiff shoulder restricts both active and passive range of motion, with loss of external rotation being especially characteristic of this condition (Dyer et al., 2023). Stiff shoulder is clinically described by the continuing onset of shoulder pain and advanced exacerbation of the shoulder joint leading to exertion in the higher extremity activity, significant disability, and functional restrictions. The most common symptom of a stiff shoulder is night pain, resulting in sleep impediment that leads to one-sided sleep on the uninfected shoulder (Mao et al., 2022).

Spencer technique is a standardized series of treatments with broad application to diagnose, treat and establish prognosis for restricted mobility in shoulder. It was developed by Spencer in 1961. It is a multistep technique that combines Spencer's positioning, sequencing, slow stretching of the shoulder complex within pain-free limits done by physical therapist while incorporating muscular energy with post-isometric contraction and relaxation (Babu And Putcha., 2022).

thirty diabetic female patients with Stiff shoulder with ages 45-55 years:

Group A(study group) :

15 patients received Spencer Muscle Energy Technique along with postural exercise 3 times a week for 8 week.

Group B (control group) :

15 patients received Classical physiotherapy treatment includes Transcutaneous Electrical Nerve Stimulation (TENS) for 15 minutes hotpack on the painful area for 15 minutes along with postural exercise 3 times per week for 8 week.

Eligibility Criteria:
Inclusion Criteria:

* 1) Women's age between 45 to 55 years old 2)Suffering from stiff shoulder for 2-12 months (stage 1 and 2) confirmed by an orthopaedic specialist.

  3) Diagnosed as type 2 DM for at least 5 years. 4) No treatment other than analgesics

Exclusion Criteria:

* 1. cases of traumatic stiff shoulder. 2. Osteoporosis and malignance of shoulder region. 3. Neurological deficit affect shoulder function. 4. rheumatoid arthritis. 5. recurrent subluxation of shoulder. 6. cervical radiculopathy. 7. history of shoulder surgery. 8. vascular diseases.
Prospective Analysis of Eosinophilic Esophagitis in Patients Presenting With Dysphagia

This is a prospective descriptive cross sectional study to determine the percentage of patients presenting with dysphagia who are found to have eosinophilic esophagitis (EoE) and to establish which presenting factors warrant esophageal biopsies. We hypothesize that a greater than expected percentage of patients who are biopsies will have histologic changes consistent with EE.

All patients presenting with dysphagia who do not already carry a previous diagnosis for their dysphagia will be asked to enroll. If patients have undergone previous work up for dysphagia such as manometry, 24-hour probe, or barium swallow they can still participate in this study. Informed consent will take place prior to enrollment. After patients present with dysphagia they will fill-out a questionnaire regarding their dysphagia symptoms. An EGD with biopsies will then be performed. Biopsies will be taken from 4 quadrants in the proximal and distal esophagus. The distal esophagus biopsies will be taken 5 cm proximal to the Z-line. Proximal biopsies will be taken anywhere proximal to 30 cm from the incisors.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-90 presenting with dysphagia or food impaction
* Ability to undergo esophagogastroduodenoscopy and biopsies
* No significant cardiopulmonary disease, or other contraindication to EGD

Exclusion Criteria:

* Contradiction to EGD and/or biopsies such as Boerhaave's syndrome, or history or bleeding disorder or elevated INR
* Inability to provide informed consent
* Esophageal varices